Diana Mahoney

BOSTON – the forthcoming availability of the protease inhibitors telaprevir and boceprevir for the treatment of chronic hepatitis C is likely to vastly improve virologic response rates and cut treatment times, but experts warn that such advancements need to be balanced against the "huge potential" for misuse of the agents and the need to manage side effects and monitor for antiviral resistance.

When used in combination with standard therapy of pegylated interferon plus ribavirin-based therapy, both of these investigational drugs improved sustained virologic response rates and reduced treatment duration, compared with standard therapy alone, in four pivotal, phase III trials reported at the annual meeting of the American Association for the Study of Liver Diseases.

Telaprevir Boosts Viral Cure Rates

In the ADVANCE trial, a three-arm, double-blind, placebo-controlled study, investigators compared two telaprevir-based regimens with standard therapy in 1,088 treatment-naive patients with chronic genotype 1 hepatitis C virus (HCV) infection, according to lead investigator Dr. Ira M. Jacobson of New York Weill Cornell Medical Center in New York City.

Patients in treatment arms 1 and 2 received 750 mg of telaprevir plus standard therapy for 8 and 12 weeks, respectively, whereas patients in the control group received standard therapy alone, which consisted of 180 mcg/week of pegylated interferon alfa-2a and 1,000-1,200 mg/day of ribavirin.

Patients who achieved extended, rapid virologic response (RVR) – defined as undetectable HCV RNA viral load at treatment weeks 4 and 12 – were treated with standard therapy for an additional 16 and 12 weeks in the 8- and 12-week telaprevir arms, respectively, for a total of 24 weeks, Dr. Jacobson explained. Patients in whom HCV RNA was detectable at either week 4 or 12 received an additional 40 and 36 weeks of therapy, respectively, for a total of 48 weeks, he said. The control group underwent standard therapy for 48 weeks.

Compared with 44% of patients in the control group who achieved sustained virologic responses (SVR) 24 weeks after the last treatment, significantly more patients in both telaprevir arms – 69% of the 8-week group and 75% of the 12-week group – met that end point, Dr. Jacobson reported.

The extended RVR rates in the 8- and 12-week groups were 57% and 58%, respectively, compared with 8% in the control arm, he said.

Significantly improved SVRs were also observed in difficult-to-treat subgroups, according to Dr. Jacobson.

"Among black patients, the [SVR] rates were 58% and 62% in the 8- and 12-week treatment arms, and 25% in the control arm, and in cirrhotic patients the respective rates were 53%, 62%, and 33%," he reported.

Rates of treatment discontinuation due to adverse events, such as rash and anemia, were 8% and 7% in the 8- and 12-week telaprevir groups and 4% in the control group, "which is an improvement, compared with the previously reported profile," he said.

The phase III, open-label ILLUMINATE trial was designed to determine whether extending the telaprevir and standard therapy regimen from 24 to 48 weeks would be beneficial in treatment-naive, genotype 1 HCV patients who achieved extended RVR. In all, 540 patients were initially treated with the 12-week telaprevir regimen described above. Of the 352 patients who achieved RVR, 322 remained on treatment and were randomized to either a 24-week or 48-week treatment arm.

"The [SVR] rates associated with the 24-week and the 48-week arms were statistically similar, at 92% and 87.5%, respectively," reported Dr. Kenneth E. Sherman of the University of Cincinnati. Analyses of the data based on race and extent of liver damage showed that 88% of black patients who experienced extended RVR achieved SVR in both the 24- and 48-week treatment arms, and 82% and 88% of patients with advanced fibrosis/cirrhosis achieved SVR in the 24-week and 48-week arms, respectively, he said.

There were more adverse event–related treatment discontinuations in the longer-treatment group (12.5% vs. 0.6%), suggesting a benefit to the shorter-duration therapy, Dr. Sherman stated. The high viral cure rate observed in the study – the overall SVR rate was 72% in an intent-to-treat analysis – "[supports] the role of response-guided therapy with telaprevir-based regimens" in treatment-naive patients," he said.

Previous Nonresponders Benefit From Boceprevir

Response-guided, fixed-duration therapy with boceprevir was safe and effective in a cohort of HCV genotype 1 patients who were enrolled in the RESPOND-2 study and who failed standard therapy, reported lead investigator Dr. Bruce R. Bacon of St. Louis University. The 403 patients included those in whom prior standard therapy induced no notable decrease in HCV viral load (null responders) or a "not undetectable" decrease in HCV viral load (nonresponders), as well as those in whom prior treatment initially resulted in undetectable HCV RNA, followed by a viral rebound (relapsers), he said.

All the patients underwent a 4-week lead-in phase of standard therapy followed by a random assignment to continue standard therapy alone or in conjunction with 800 mg of boceprevir taken three times daily. The treatment duration for patients in the boceprevir arm with undetectable HCV RNA at study weeks 8 and 12 was 36 weeks, whereas those patients in whom HCV RNA was detectable at study week 8, but undetectable at study week 12, stopped boceprevir at week 36 but continued standard therapy for an additional 12 weeks, for a total treatment duration of 48 weeks, Dr. Bacon said. Patients in the control group were treated for 48 weeks.

The SVR rates at 24 weeks after treatment conclusion were significantly higher in the boceprevir groups, compared with the control group. In the response-guided and fixed-duration boceprevir groups, the SVR rates were 59% and 66%, respectively, compared with 21% in the control patients, he said.

In all study arms, "previous relapsers and previous null responders fared better than prior nonresponders," Dr. Bacon said, noting that the respective SVR rates for previous relapsers, null responders, and nonresponders were 29%, 7%, and 0% in the control group; 69%, 40%, and 33% in the response-guided therapy group; and 75%, 52%, and 34% in the fixed-duration group.

Although the rates of anemia were significantly higher in the boceprevir arms, "the rate of treatment discontinuation related to side effects was similar across all three arms," Dr. Bacon reported, possibly because the use of erythropoietin was allowed to treat anemia, he said.

The findings of this study answer an important question about response-guided therapy "by confirming that many patients can be treated successfully with a treatment duration that is reduced by 3 months relative to the current standard of care treatment," Dr. Bacon said.

Boceprevir with a standard therapy lead-in strategy was also evaluated in the SPRINT-2 study involving HCV genotype 1 treatment-naive patients, according to Dr. Fred Poordad of Cedars-Sinai Medical Center in Los Angeles. The trial included 1,097 patients who underwent a similar 4-week standard therapy lead-in strategy as defined above, followed by the addition of placebo for 44 more weeks or by the addition of boceprevir, either for 24 more weeks for patients with undetectable HCV RNA at week 8 or for 24 more weeks plus 20 additional weeks of standard therapy for patients with detectable HCV RNA at week 8, but not at week 24, Dr. Poordad explained. Patients with detectable HCV RNA at week 24 were discontinued for futility, he said.

"In both the response-guided and fixed-treatment arms, boceprevir increased viral cure rates significantly, by approximately 70%," Dr. Poordad stated. Specifically, the SVR rate was 63% in the 28-week response-guided group, 66% in the 48-week fixed-duration group, and 38% in the 48-week control group, he said.

In a cohort analysis of treatment response for the study’s 159 black patients, the relative improvement in SVR rates remained significantly improved in the boceprevir arms, although the differences were not as robust, Dr. Poordad said. In this subgroup, the respective SVR rates in the response-guided therapy, fixed-duration therapy, and control groups were 42%, 53%, and 23%, respectively.

The rationale for using a lead-in strategy "is to help physicians identify patient responsiveness to interferon before adding boceprevir," Dr. Poordad explained. This can provide an early indication of the likelihood of treatment success. The advantage of subsequent response-guided therapy, he noted, is that it enables physicians to be flexible in managing their patients’ therapy "by adapting treatment duration to individual patient response."

All the sources disclosed relationships with numerous pharmaceutical companies. Among them, Dr. Jacobson and Dr. Sherman disclosed relationships with Vertex Pharmaceuticals, which manufactures telaprevir. Dr. Jacobson also has a relationship with Tibotec, which also is involved with the development of telaprevir. Dr. Poordad and Dr. Bacon also disclosed relationships with Merck, which manufactures boceprevir. Dr. Pockros disclosed relationships with Vertex and Tibotec, which are involved in the development of telaprevir, and Merck, which manufactures boceprevir.

BOSTON – the forthcoming availability of the protease inhibitors telaprevir and boceprevir for the treatment of chronic hepatitis C is likely to vastly improve virologic response rates and cut treatment times, but experts warn that such advancements need to be balanced against the "huge potential" for misuse of the agents and the need to manage side effects and monitor for antiviral resistance.

When used in combination with standard therapy of pegylated interferon plus ribavirin-based therapy, both of these investigational drugs improved sustained virologic response rates and reduced treatment duration, compared with standard therapy alone, in four pivotal, phase III trials reported at the annual meeting of the American Association for the Study of Liver Diseases.

Telaprevir Boosts Viral Cure Rates

In the ADVANCE trial, a three-arm, double-blind, placebo-controlled study, investigators compared two telaprevir-based regimens with standard therapy in 1,088 treatment-naive patients with chronic genotype 1 hepatitis C virus (HCV) infection, according to lead investigator Dr. Ira M. Jacobson of New York Weill Cornell Medical Center in New York City.

Patients in treatment arms 1 and 2 received 750 mg of telaprevir plus standard therapy for 8 and 12 weeks, respectively, whereas patients in the control group received standard therapy alone, which consisted of 180 mcg/week of pegylated interferon alfa-2a and 1,000-1,200 mg/day of ribavirin.

Patients who achieved extended, rapid virologic response (RVR) – defined as undetectable HCV RNA viral load at treatment weeks 4 and 12 – were treated with standard therapy for an additional 16 and 12 weeks in the 8- and 12-week telaprevir arms, respectively, for a total of 24 weeks, Dr. Jacobson explained. Patients in whom HCV RNA was detectable at either week 4 or 12 received an additional 40 and 36 weeks of therapy, respectively, for a total of 48 weeks, he said. The control group underwent standard therapy for 48 weeks.

Compared with 44% of patients in the control group who achieved sustained virologic responses (SVR) 24 weeks after the last treatment, significantly more patients in both telaprevir arms – 69% of the 8-week group and 75% of the 12-week group – met that end point, Dr. Jacobson reported.

The extended RVR rates in the 8- and 12-week groups were 57% and 58%, respectively, compared with 8% in the control arm, he said.

Significantly improved SVRs were also observed in difficult-to-treat subgroups, according to Dr. Jacobson.

"Among black patients, the [SVR] rates were 58% and 62% in the 8- and 12-week treatment arms, and 25% in the control arm, and in cirrhotic patients the respective rates were 53%, 62%, and 33%," he reported.

Rates of treatment discontinuation due to adverse events, such as rash and anemia, were 8% and 7% in the 8- and 12-week telaprevir groups and 4% in the control group, "which is an improvement, compared with the previously reported profile," he said.

The phase III, open-label ILLUMINATE trial was designed to determine whether extending the telaprevir and standard therapy regimen from 24 to 48 weeks would be beneficial in treatment-naive, genotype 1 HCV patients who achieved extended RVR. In all, 540 patients were initially treated with the 12-week telaprevir regimen described above. Of the 352 patients who achieved RVR, 322 remained on treatment and were randomized to either a 24-week or 48-week treatment arm.

"The [SVR] rates associated with the 24-week and the 48-week arms were statistically similar, at 92% and 87.5%, respectively," reported Dr. Kenneth E. Sherman of the University of Cincinnati. Analyses of the data based on race and extent of liver damage showed that 88% of black patients who experienced extended RVR achieved SVR in both the 24- and 48-week treatment arms, and 82% and 88% of patients with advanced fibrosis/cirrhosis achieved SVR in the 24-week and 48-week arms, respectively, he said.

There were more adverse event–related treatment discontinuations in the longer-treatment group (12.5% vs. 0.6%), suggesting a benefit to the shorter-duration therapy, Dr. Sherman stated. The high viral cure rate observed in the study – the overall SVR rate was 72% in an intent-to-treat analysis – "[supports] the role of response-guided therapy with telaprevir-based regimens" in treatment-naive patients," he said.

Previous Nonresponders Benefit From Boceprevir

Response-guided, fixed-duration therapy with boceprevir was safe and effective in a cohort of HCV genotype 1 patients who were enrolled in the RESPOND-2 study and who failed standard therapy, reported lead investigator Dr. Bruce R. Bacon of St. Louis University. The 403 patients included those in whom prior standard therapy induced no notable decrease in HCV viral load (null responders) or a "not undetectable" decrease in HCV viral load (nonresponders), as well as those in whom prior treatment initially resulted in undetectable HCV RNA, followed by a viral rebound (relapsers), he said.

All the patients underwent a 4-week lead-in phase of standard therapy followed by a random assignment to continue standard therapy alone or in conjunction with 800 mg of boceprevir taken three times daily. The treatment duration for patients in the boceprevir arm with undetectable HCV RNA at study weeks 8 and 12 was 36 weeks, whereas those patients in whom HCV RNA was detectable at study week 8, but undetectable at study week 12, stopped boceprevir at week 36 but continued standard therapy for an additional 12 weeks, for a total treatment duration of 48 weeks, Dr. Bacon said. Patients in the control group were treated for 48 weeks.

The SVR rates at 24 weeks after treatment conclusion were significantly higher in the boceprevir groups, compared with the control group. In the response-guided and fixed-duration boceprevir groups, the SVR rates were 59% and 66%, respectively, compared with 21% in the control patients, he said.

In all study arms, "previous relapsers and previous null responders fared better than prior nonresponders," Dr. Bacon said, noting that the respective SVR rates for previous relapsers, null responders, and nonresponders were 29%, 7%, and 0% in the control group; 69%, 40%, and 33% in the response-guided therapy group; and 75%, 52%, and 34% in the fixed-duration group.

Although the rates of anemia were significantly higher in the boceprevir arms, "the rate of treatment discontinuation related to side effects was similar across all three arms," Dr. Bacon reported, possibly because the use of erythropoietin was allowed to treat anemia, he said.

The findings of this study answer an important question about response-guided therapy "by confirming that many patients can be treated successfully with a treatment duration that is reduced by 3 months relative to the current standard of care treatment," Dr. Bacon said.

Boceprevir with a standard therapy lead-in strategy was also evaluated in the SPRINT-2 study involving HCV genotype 1 treatment-naive patients, according to Dr. Fred Poordad of Cedars-Sinai Medical Center in Los Angeles. The trial included 1,097 patients who underwent a similar 4-week standard therapy lead-in strategy as defined above, followed by the addition of placebo for 44 more weeks or by the addition of boceprevir, either for 24 more weeks for patients with undetectable HCV RNA at week 8 or for 24 more weeks plus 20 additional weeks of standard therapy for patients with detectable HCV RNA at week 8, but not at week 24, Dr. Poordad explained. Patients with detectable HCV RNA at week 24 were discontinued for futility, he said.

"In both the response-guided and fixed-treatment arms, boceprevir increased viral cure rates significantly, by approximately 70%," Dr. Poordad stated. Specifically, the SVR rate was 63% in the 28-week response-guided group, 66% in the 48-week fixed-duration group, and 38% in the 48-week control group, he said.

In a cohort analysis of treatment response for the study’s 159 black patients, the relative improvement in SVR rates remained significantly improved in the boceprevir arms, although the differences were not as robust, Dr. Poordad said. In this subgroup, the respective SVR rates in the response-guided therapy, fixed-duration therapy, and control groups were 42%, 53%, and 23%, respectively.

The rationale for using a lead-in strategy "is to help physicians identify patient responsiveness to interferon before adding boceprevir," Dr. Poordad explained. This can provide an early indication of the likelihood of treatment success. The advantage of subsequent response-guided therapy, he noted, is that it enables physicians to be flexible in managing their patients’ therapy "by adapting treatment duration to individual patient response."

All the sources disclosed relationships with numerous pharmaceutical companies. Among them, Dr. Jacobson and Dr. Sherman disclosed relationships with Vertex Pharmaceuticals, which manufactures telaprevir. Dr. Jacobson also has a relationship with Tibotec, which also is involved with the development of telaprevir. Dr. Poordad and Dr. Bacon also disclosed relationships with Merck, which manufactures boceprevir. Dr. Pockros disclosed relationships with Vertex and Tibotec, which are involved in the development of telaprevir, and Merck, which manufactures boceprevir.

BOSTON – the forthcoming availability of the protease inhibitors telaprevir and boceprevir for the treatment of chronic hepatitis C is likely to vastly improve virologic response rates and cut treatment times, but experts warn that such advancements need to be balanced against the "huge potential" for misuse of the agents and the need to manage side effects and monitor for antiviral resistance.

When used in combination with standard therapy of pegylated interferon plus ribavirin-based therapy, both of these investigational drugs improved sustained virologic response rates and reduced treatment duration, compared with standard therapy alone, in four pivotal, phase III trials reported at the annual meeting of the American Association for the Study of Liver Diseases.

Telaprevir Boosts Viral Cure Rates

In the ADVANCE trial, a three-arm, double-blind, placebo-controlled study, investigators compared two telaprevir-based regimens with standard therapy in 1,088 treatment-naive patients with chronic genotype 1 hepatitis C virus (HCV) infection, according to lead investigator Dr. Ira M. Jacobson of New York Weill Cornell Medical Center in New York City.

Patients in treatment arms 1 and 2 received 750 mg of telaprevir plus standard therapy for 8 and 12 weeks, respectively, whereas patients in the control group received standard therapy alone, which consisted of 180 mcg/week of pegylated interferon alfa-2a and 1,000-1,200 mg/day of ribavirin.

Patients who achieved extended, rapid virologic response (RVR) – defined as undetectable HCV RNA viral load at treatment weeks 4 and 12 – were treated with standard therapy for an additional 16 and 12 weeks in the 8- and 12-week telaprevir arms, respectively, for a total of 24 weeks, Dr. Jacobson explained. Patients in whom HCV RNA was detectable at either week 4 or 12 received an additional 40 and 36 weeks of therapy, respectively, for a total of 48 weeks, he said. The control group underwent standard therapy for 48 weeks.

Compared with 44% of patients in the control group who achieved sustained virologic responses (SVR) 24 weeks after the last treatment, significantly more patients in both telaprevir arms – 69% of the 8-week group and 75% of the 12-week group – met that end point, Dr. Jacobson reported.

The extended RVR rates in the 8- and 12-week groups were 57% and 58%, respectively, compared with 8% in the control arm, he said.

Significantly improved SVRs were also observed in difficult-to-treat subgroups, according to Dr. Jacobson.

"Among black patients, the [SVR] rates were 58% and 62% in the 8- and 12-week treatment arms, and 25% in the control arm, and in cirrhotic patients the respective rates were 53%, 62%, and 33%," he reported.

Rates of treatment discontinuation due to adverse events, such as rash and anemia, were 8% and 7% in the 8- and 12-week telaprevir groups and 4% in the control group, "which is an improvement, compared with the previously reported profile," he said.

The phase III, open-label ILLUMINATE trial was designed to determine whether extending the telaprevir and standard therapy regimen from 24 to 48 weeks would be beneficial in treatment-naive, genotype 1 HCV patients who achieved extended RVR. In all, 540 patients were initially treated with the 12-week telaprevir regimen described above. Of the 352 patients who achieved RVR, 322 remained on treatment and were randomized to either a 24-week or 48-week treatment arm.

"The [SVR] rates associated with the 24-week and the 48-week arms were statistically similar, at 92% and 87.5%, respectively," reported Dr. Kenneth E. Sherman of the University of Cincinnati. Analyses of the data based on race and extent of liver damage showed that 88% of black patients who experienced extended RVR achieved SVR in both the 24- and 48-week treatment arms, and 82% and 88% of patients with advanced fibrosis/cirrhosis achieved SVR in the 24-week and 48-week arms, respectively, he said.

There were more adverse event–related treatment discontinuations in the longer-treatment group (12.5% vs. 0.6%), suggesting a benefit to the shorter-duration therapy, Dr. Sherman stated. The high viral cure rate observed in the study – the overall SVR rate was 72% in an intent-to-treat analysis – "[supports] the role of response-guided therapy with telaprevir-based regimens" in treatment-naive patients," he said.

Previous Nonresponders Benefit From Boceprevir

Response-guided, fixed-duration therapy with boceprevir was safe and effective in a cohort of HCV genotype 1 patients who were enrolled in the RESPOND-2 study and who failed standard therapy, reported lead investigator Dr. Bruce R. Bacon of St. Louis University. The 403 patients included those in whom prior standard therapy induced no notable decrease in HCV viral load (null responders) or a "not undetectable" decrease in HCV viral load (nonresponders), as well as those in whom prior treatment initially resulted in undetectable HCV RNA, followed by a viral rebound (relapsers), he said.

All the patients underwent a 4-week lead-in phase of standard therapy followed by a random assignment to continue standard therapy alone or in conjunction with 800 mg of boceprevir taken three times daily. The treatment duration for patients in the boceprevir arm with undetectable HCV RNA at study weeks 8 and 12 was 36 weeks, whereas those patients in whom HCV RNA was detectable at study week 8, but undetectable at study week 12, stopped boceprevir at week 36 but continued standard therapy for an additional 12 weeks, for a total treatment duration of 48 weeks, Dr. Bacon said. Patients in the control group were treated for 48 weeks.

The SVR rates at 24 weeks after treatment conclusion were significantly higher in the boceprevir groups, compared with the control group. In the response-guided and fixed-duration boceprevir groups, the SVR rates were 59% and 66%, respectively, compared with 21% in the control patients, he said.

In all study arms, "previous relapsers and previous null responders fared better than prior nonresponders," Dr. Bacon said, noting that the respective SVR rates for previous relapsers, null responders, and nonresponders were 29%, 7%, and 0% in the control group; 69%, 40%, and 33% in the response-guided therapy group; and 75%, 52%, and 34% in the fixed-duration group.

Although the rates of anemia were significantly higher in the boceprevir arms, "the rate of treatment discontinuation related to side effects was similar across all three arms," Dr. Bacon reported, possibly because the use of erythropoietin was allowed to treat anemia, he said.

The findings of this study answer an important question about response-guided therapy "by confirming that many patients can be treated successfully with a treatment duration that is reduced by 3 months relative to the current standard of care treatment," Dr. Bacon said.

Boceprevir with a standard therapy lead-in strategy was also evaluated in the SPRINT-2 study involving HCV genotype 1 treatment-naive patients, according to Dr. Fred Poordad of Cedars-Sinai Medical Center in Los Angeles. The trial included 1,097 patients who underwent a similar 4-week standard therapy lead-in strategy as defined above, followed by the addition of placebo for 44 more weeks or by the addition of boceprevir, either for 24 more weeks for patients with undetectable HCV RNA at week 8 or for 24 more weeks plus 20 additional weeks of standard therapy for patients with detectable HCV RNA at week 8, but not at week 24, Dr. Poordad explained. Patients with detectable HCV RNA at week 24 were discontinued for futility, he said.

"In both the response-guided and fixed-treatment arms, boceprevir increased viral cure rates significantly, by approximately 70%," Dr. Poordad stated. Specifically, the SVR rate was 63% in the 28-week response-guided group, 66% in the 48-week fixed-duration group, and 38% in the 48-week control group, he said.

In a cohort analysis of treatment response for the study’s 159 black patients, the relative improvement in SVR rates remained significantly improved in the boceprevir arms, although the differences were not as robust, Dr. Poordad said. In this subgroup, the respective SVR rates in the response-guided therapy, fixed-duration therapy, and control groups were 42%, 53%, and 23%, respectively.

The rationale for using a lead-in strategy "is to help physicians identify patient responsiveness to interferon before adding boceprevir," Dr. Poordad explained. This can provide an early indication of the likelihood of treatment success. The advantage of subsequent response-guided therapy, he noted, is that it enables physicians to be flexible in managing their patients’ therapy "by adapting treatment duration to individual patient response."

All the sources disclosed relationships with numerous pharmaceutical companies. Among them, Dr. Jacobson and Dr. Sherman disclosed relationships with Vertex Pharmaceuticals, which manufactures telaprevir. Dr. Jacobson also has a relationship with Tibotec, which also is involved with the development of telaprevir. Dr. Poordad and Dr. Bacon also disclosed relationships with Merck, which manufactures boceprevir. Dr. Pockros disclosed relationships with Vertex and Tibotec, which are involved in the development of telaprevir, and Merck, which manufactures boceprevir.

BOSTON – the forthcoming availability of the protease inhibitors telaprevir and boceprevir for the treatment of chronic hepatitis C is likely to vastly improve virologic response rates and cut treatment times, but experts warn that such advancements need to be balanced against the "huge potential" for misuse of the agents and the need to manage side effects and monitor for antiviral resistance.

When used in combination with standard therapy of pegylated interferon plus ribavirin-based therapy, both of these investigational drugs improved sustained virologic response rates and reduced treatment duration, compared with standard therapy alone, in four pivotal, phase III trials reported at the annual meeting of the American Association for the Study of Liver Diseases.

Telaprevir Boosts Viral Cure Rates

In the ADVANCE trial, a three-arm, double-blind, placebo-controlled study, investigators compared two telaprevir-based regimens with standard therapy in 1,088 treatment-naive patients with chronic genotype 1 hepatitis C virus (HCV) infection, according to lead investigator Dr. Ira M. Jacobson of New York Weill Cornell Medical Center in New York City.

Patients in treatment arms 1 and 2 received 750 mg of telaprevir plus standard therapy for 8 and 12 weeks, respectively, whereas patients in the control group received standard therapy alone, which consisted of 180 mcg/week of pegylated interferon alfa-2a and 1,000-1,200 mg/day of ribavirin.

Patients who achieved extended, rapid virologic response (RVR) – defined as undetectable HCV RNA viral load at treatment weeks 4 and 12 – were treated with standard therapy for an additional 16 and 12 weeks in the 8- and 12-week telaprevir arms, respectively, for a total of 24 weeks, Dr. Jacobson explained. Patients in whom HCV RNA was detectable at either week 4 or 12 received an additional 40 and 36 weeks of therapy, respectively, for a total of 48 weeks, he said. The control group underwent standard therapy for 48 weeks.

Compared with 44% of patients in the control group who achieved sustained virologic responses (SVR) 24 weeks after the last treatment, significantly more patients in both telaprevir arms – 69% of the 8-week group and 75% of the 12-week group – met that end point, Dr. Jacobson reported.

The extended RVR rates in the 8- and 12-week groups were 57% and 58%, respectively, compared with 8% in the control arm, he said.

Significantly improved SVRs were also observed in difficult-to-treat subgroups, according to Dr. Jacobson.

"Among black patients, the [SVR] rates were 58% and 62% in the 8- and 12-week treatment arms, and 25% in the control arm, and in cirrhotic patients the respective rates were 53%, 62%, and 33%," he reported.

Rates of treatment discontinuation due to adverse events, such as rash and anemia, were 8% and 7% in the 8- and 12-week telaprevir groups and 4% in the control group, "which is an improvement, compared with the previously reported profile," he said.

The phase III, open-label ILLUMINATE trial was designed to determine whether extending the telaprevir and standard therapy regimen from 24 to 48 weeks would be beneficial in treatment-naive, genotype 1 HCV patients who achieved extended RVR. In all, 540 patients were initially treated with the 12-week telaprevir regimen described above. Of the 352 patients who achieved RVR, 322 remained on treatment and were randomized to either a 24-week or 48-week treatment arm.

"The [SVR] rates associated with the 24-week and the 48-week arms were statistically similar, at 92% and 87.5%, respectively," reported Dr. Kenneth E. Sherman of the University of Cincinnati. Analyses of the data based on race and extent of liver damage showed that 88% of black patients who experienced extended RVR achieved SVR in both the 24- and 48-week treatment arms, and 82% and 88% of patients with advanced fibrosis/cirrhosis achieved SVR in the 24-week and 48-week arms, respectively, he said.

There were more adverse event–related treatment discontinuations in the longer-treatment group (12.5% vs. 0.6%), suggesting a benefit to the shorter-duration therapy, Dr. Sherman stated. The high viral cure rate observed in the study – the overall SVR rate was 72% in an intent-to-treat analysis – "[supports] the role of response-guided therapy with telaprevir-based regimens" in treatment-naive patients," he said.

Previous Nonresponders Benefit From Boceprevir

Response-guided, fixed-duration therapy with boceprevir was safe and effective in a cohort of HCV genotype 1 patients who were enrolled in the RESPOND-2 study and who failed standard therapy, reported lead investigator Dr. Bruce R. Bacon of St. Louis University. The 403 patients included those in whom prior standard therapy induced no notable decrease in HCV viral load (null responders) or a "not undetectable" decrease in HCV viral load (nonresponders), as well as those in whom prior treatment initially resulted in undetectable HCV RNA, followed by a viral rebound (relapsers), he said.

All the patients underwent a 4-week lead-in phase of standard therapy followed by a random assignment to continue standard therapy alone or in conjunction with 800 mg of boceprevir taken three times daily. The treatment duration for patients in the boceprevir arm with undetectable HCV RNA at study weeks 8 and 12 was 36 weeks, whereas those patients in whom HCV RNA was detectable at study week 8, but undetectable at study week 12, stopped boceprevir at week 36 but continued standard therapy for an additional 12 weeks, for a total treatment duration of 48 weeks, Dr. Bacon said. Patients in the control group were treated for 48 weeks.

The SVR rates at 24 weeks after treatment conclusion were significantly higher in the boceprevir groups, compared with the control group. In the response-guided and fixed-duration boceprevir groups, the SVR rates were 59% and 66%, respectively, compared with 21% in the control patients, he said.

In all study arms, "previous relapsers and previous null responders fared better than prior nonresponders," Dr. Bacon said, noting that the respective SVR rates for previous relapsers, null responders, and nonresponders were 29%, 7%, and 0% in the control group; 69%, 40%, and 33% in the response-guided therapy group; and 75%, 52%, and 34% in the fixed-duration group.

Although the rates of anemia were significantly higher in the boceprevir arms, "the rate of treatment discontinuation related to side effects was similar across all three arms," Dr. Bacon reported, possibly because the use of erythropoietin was allowed to treat anemia, he said.

The findings of this study answer an important question about response-guided therapy "by confirming that many patients can be treated successfully with a treatment duration that is reduced by 3 months relative to the current standard of care treatment," Dr. Bacon said.

Boceprevir with a standard therapy lead-in strategy was also evaluated in the SPRINT-2 study involving HCV genotype 1 treatment-naive patients, according to Dr. Fred Poordad of Cedars-Sinai Medical Center in Los Angeles. The trial included 1,097 patients who underwent a similar 4-week standard therapy lead-in strategy as defined above, followed by the addition of placebo for 44 more weeks or by the addition of boceprevir, either for 24 more weeks for patients with undetectable HCV RNA at week 8 or for 24 more weeks plus 20 additional weeks of standard therapy for patients with detectable HCV RNA at week 8, but not at week 24, Dr. Poordad explained. Patients with detectable HCV RNA at week 24 were discontinued for futility, he said.

"In both the response-guided and fixed-treatment arms, boceprevir increased viral cure rates significantly, by approximately 70%," Dr. Poordad stated. Specifically, the SVR rate was 63% in the 28-week response-guided group, 66% in the 48-week fixed-duration group, and 38% in the 48-week control group, he said.

In a cohort analysis of treatment response for the study’s 159 black patients, the relative improvement in SVR rates remained significantly improved in the boceprevir arms, although the differences were not as robust, Dr. Poordad said. In this subgroup, the respective SVR rates in the response-guided therapy, fixed-duration therapy, and control groups were 42%, 53%, and 23%, respectively.

The rationale for using a lead-in strategy "is to help physicians identify patient responsiveness to interferon before adding boceprevir," Dr. Poordad explained. This can provide an early indication of the likelihood of treatment success. The advantage of subsequent response-guided therapy, he noted, is that it enables physicians to be flexible in managing their patients’ therapy "by adapting treatment duration to individual patient response."

All the sources disclosed relationships with numerous pharmaceutical companies. Among them, Dr. Jacobson and Dr. Sherman disclosed relationships with Vertex Pharmaceuticals, which manufactures telaprevir. Dr. Jacobson also has a relationship with Tibotec, which also is involved with the development of telaprevir. Dr. Poordad and Dr. Bacon also disclosed relationships with Merck, which manufactures boceprevir. Dr. Pockros disclosed relationships with Vertex and Tibotec, which are involved in the development of telaprevir, and Merck, which manufactures boceprevir.

BOSTON – the forthcoming availability of the protease inhibitors telaprevir and boceprevir for the treatment of chronic hepatitis C is likely to vastly improve virologic response rates and cut treatment times, but experts warn that such advancements need to be balanced against the "huge potential" for misuse of the agents and the need to manage side effects and monitor for antiviral resistance.

When used in combination with standard therapy of pegylated interferon plus ribavirin-based therapy, both of these investigational drugs improved sustained virologic response rates and reduced treatment duration, compared with standard therapy alone, in four pivotal, phase III trials reported at the annual meeting of the American Association for the Study of Liver Diseases.

Telaprevir Boosts Viral Cure Rates

In the ADVANCE trial, a three-arm, double-blind, placebo-controlled study, investigators compared two telaprevir-based regimens with standard therapy in 1,088 treatment-naive patients with chronic genotype 1 hepatitis C virus (HCV) infection, according to lead investigator Dr. Ira M. Jacobson of New York Weill Cornell Medical Center in New York City.

Patients in treatment arms 1 and 2 received 750 mg of telaprevir plus standard therapy for 8 and 12 weeks, respectively, whereas patients in the control group received standard therapy alone, which consisted of 180 mcg/week of pegylated interferon alfa-2a and 1,000-1,200 mg/day of ribavirin.

Patients who achieved extended, rapid virologic response (RVR) – defined as undetectable HCV RNA viral load at treatment weeks 4 and 12 – were treated with standard therapy for an additional 16 and 12 weeks in the 8- and 12-week telaprevir arms, respectively, for a total of 24 weeks, Dr. Jacobson explained. Patients in whom HCV RNA was detectable at either week 4 or 12 received an additional 40 and 36 weeks of therapy, respectively, for a total of 48 weeks, he said. The control group underwent standard therapy for 48 weeks.

Compared with 44% of patients in the control group who achieved sustained virologic responses (SVR) 24 weeks after the last treatment, significantly more patients in both telaprevir arms – 69% of the 8-week group and 75% of the 12-week group – met that end point, Dr. Jacobson reported.

The extended RVR rates in the 8- and 12-week groups were 57% and 58%, respectively, compared with 8% in the control arm, he said.

Significantly improved SVRs were also observed in difficult-to-treat subgroups, according to Dr. Jacobson.

"Among black patients, the [SVR] rates were 58% and 62% in the 8- and 12-week treatment arms, and 25% in the control arm, and in cirrhotic patients the respective rates were 53%, 62%, and 33%," he reported.

Rates of treatment discontinuation due to adverse events, such as rash and anemia, were 8% and 7% in the 8- and 12-week telaprevir groups and 4% in the control group, "which is an improvement, compared with the previously reported profile," he said.

The phase III, open-label ILLUMINATE trial was designed to determine whether extending the telaprevir and standard therapy regimen from 24 to 48 weeks would be beneficial in treatment-naive, genotype 1 HCV patients who achieved extended RVR. In all, 540 patients were initially treated with the 12-week telaprevir regimen described above. Of the 352 patients who achieved RVR, 322 remained on treatment and were randomized to either a 24-week or 48-week treatment arm.

"The [SVR] rates associated with the 24-week and the 48-week arms were statistically similar, at 92% and 87.5%, respectively," reported Dr. Kenneth E. Sherman of the University of Cincinnati. Analyses of the data based on race and extent of liver damage showed that 88% of black patients who experienced extended RVR achieved SVR in both the 24- and 48-week treatment arms, and 82% and 88% of patients with advanced fibrosis/cirrhosis achieved SVR in the 24-week and 48-week arms, respectively, he said.

There were more adverse event–related treatment discontinuations in the longer-treatment group (12.5% vs. 0.6%), suggesting a benefit to the shorter-duration therapy, Dr. Sherman stated. The high viral cure rate observed in the study – the overall SVR rate was 72% in an intent-to-treat analysis – "[supports] the role of response-guided therapy with telaprevir-based regimens" in treatment-naive patients," he said.

Previous Nonresponders Benefit From Boceprevir

Response-guided, fixed-duration therapy with boceprevir was safe and effective in a cohort of HCV genotype 1 patients who were enrolled in the RESPOND-2 study and who failed standard therapy, reported lead investigator Dr. Bruce R. Bacon of St. Louis University. The 403 patients included those in whom prior standard therapy induced no notable decrease in HCV viral load (null responders) or a "not undetectable" decrease in HCV viral load (nonresponders), as well as those in whom prior treatment initially resulted in undetectable HCV RNA, followed by a viral rebound (relapsers), he said.

All the patients underwent a 4-week lead-in phase of standard therapy followed by a random assignment to continue standard therapy alone or in conjunction with 800 mg of boceprevir taken three times daily. The treatment duration for patients in the boceprevir arm with undetectable HCV RNA at study weeks 8 and 12 was 36 weeks, whereas those patients in whom HCV RNA was detectable at study week 8, but undetectable at study week 12, stopped boceprevir at week 36 but continued standard therapy for an additional 12 weeks, for a total treatment duration of 48 weeks, Dr. Bacon said. Patients in the control group were treated for 48 weeks.

The SVR rates at 24 weeks after treatment conclusion were significantly higher in the boceprevir groups, compared with the control group. In the response-guided and fixed-duration boceprevir groups, the SVR rates were 59% and 66%, respectively, compared with 21% in the control patients, he said.

In all study arms, "previous relapsers and previous null responders fared better than prior nonresponders," Dr. Bacon said, noting that the respective SVR rates for previous relapsers, null responders, and nonresponders were 29%, 7%, and 0% in the control group; 69%, 40%, and 33% in the response-guided therapy group; and 75%, 52%, and 34% in the fixed-duration group.

Although the rates of anemia were significantly higher in the boceprevir arms, "the rate of treatment discontinuation related to side effects was similar across all three arms," Dr. Bacon reported, possibly because the use of erythropoietin was allowed to treat anemia, he said.

The findings of this study answer an important question about response-guided therapy "by confirming that many patients can be treated successfully with a treatment duration that is reduced by 3 months relative to the current standard of care treatment," Dr. Bacon said.

Boceprevir with a standard therapy lead-in strategy was also evaluated in the SPRINT-2 study involving HCV genotype 1 treatment-naive patients, according to Dr. Fred Poordad of Cedars-Sinai Medical Center in Los Angeles. The trial included 1,097 patients who underwent a similar 4-week standard therapy lead-in strategy as defined above, followed by the addition of placebo for 44 more weeks or by the addition of boceprevir, either for 24 more weeks for patients with undetectable HCV RNA at week 8 or for 24 more weeks plus 20 additional weeks of standard therapy for patients with detectable HCV RNA at week 8, but not at week 24, Dr. Poordad explained. Patients with detectable HCV RNA at week 24 were discontinued for futility, he said.

"In both the response-guided and fixed-treatment arms, boceprevir increased viral cure rates significantly, by approximately 70%," Dr. Poordad stated. Specifically, the SVR rate was 63% in the 28-week response-guided group, 66% in the 48-week fixed-duration group, and 38% in the 48-week control group, he said.

In a cohort analysis of treatment response for the study’s 159 black patients, the relative improvement in SVR rates remained significantly improved in the boceprevir arms, although the differences were not as robust, Dr. Poordad said. In this subgroup, the respective SVR rates in the response-guided therapy, fixed-duration therapy, and control groups were 42%, 53%, and 23%, respectively.

The rationale for using a lead-in strategy "is to help physicians identify patient responsiveness to interferon before adding boceprevir," Dr. Poordad explained. This can provide an early indication of the likelihood of treatment success. The advantage of subsequent response-guided therapy, he noted, is that it enables physicians to be flexible in managing their patients’ therapy "by adapting treatment duration to individual patient response."

All the sources disclosed relationships with numerous pharmaceutical companies. Among them, Dr. Jacobson and Dr. Sherman disclosed relationships with Vertex Pharmaceuticals, which manufactures telaprevir. Dr. Jacobson also has a relationship with Tibotec, which also is involved with the development of telaprevir. Dr. Poordad and Dr. Bacon also disclosed relationships with Merck, which manufactures boceprevir. Dr. Pockros disclosed relationships with Vertex and Tibotec, which are involved in the development of telaprevir, and Merck, which manufactures boceprevir.

BOSTON – the forthcoming availability of the protease inhibitors telaprevir and boceprevir for the treatment of chronic hepatitis C is likely to vastly improve virologic response rates and cut treatment times, but experts warn that such advancements need to be balanced against the "huge potential" for misuse of the agents and the need to manage side effects and monitor for antiviral resistance.

When used in combination with standard therapy of pegylated interferon plus ribavirin-based therapy, both of these investigational drugs improved sustained virologic response rates and reduced treatment duration, compared with standard therapy alone, in four pivotal, phase III trials reported at the annual meeting of the American Association for the Study of Liver Diseases.

Telaprevir Boosts Viral Cure Rates

In the ADVANCE trial, a three-arm, double-blind, placebo-controlled study, investigators compared two telaprevir-based regimens with standard therapy in 1,088 treatment-naive patients with chronic genotype 1 hepatitis C virus (HCV) infection, according to lead investigator Dr. Ira M. Jacobson of New York Weill Cornell Medical Center in New York City.

Patients in treatment arms 1 and 2 received 750 mg of telaprevir plus standard therapy for 8 and 12 weeks, respectively, whereas patients in the control group received standard therapy alone, which consisted of 180 mcg/week of pegylated interferon alfa-2a and 1,000-1,200 mg/day of ribavirin.

Patients who achieved extended, rapid virologic response (RVR) – defined as undetectable HCV RNA viral load at treatment weeks 4 and 12 – were treated with standard therapy for an additional 16 and 12 weeks in the 8- and 12-week telaprevir arms, respectively, for a total of 24 weeks, Dr. Jacobson explained. Patients in whom HCV RNA was detectable at either week 4 or 12 received an additional 40 and 36 weeks of therapy, respectively, for a total of 48 weeks, he said. The control group underwent standard therapy for 48 weeks.

Compared with 44% of patients in the control group who achieved sustained virologic responses (SVR) 24 weeks after the last treatment, significantly more patients in both telaprevir arms – 69% of the 8-week group and 75% of the 12-week group – met that end point, Dr. Jacobson reported.

The extended RVR rates in the 8- and 12-week groups were 57% and 58%, respectively, compared with 8% in the control arm, he said.

Significantly improved SVRs were also observed in difficult-to-treat subgroups, according to Dr. Jacobson.

"Among black patients, the [SVR] rates were 58% and 62% in the 8- and 12-week treatment arms, and 25% in the control arm, and in cirrhotic patients the respective rates were 53%, 62%, and 33%," he reported.

Rates of treatment discontinuation due to adverse events, such as rash and anemia, were 8% and 7% in the 8- and 12-week telaprevir groups and 4% in the control group, "which is an improvement, compared with the previously reported profile," he said.

The phase III, open-label ILLUMINATE trial was designed to determine whether extending the telaprevir and standard therapy regimen from 24 to 48 weeks would be beneficial in treatment-naive, genotype 1 HCV patients who achieved extended RVR. In all, 540 patients were initially treated with the 12-week telaprevir regimen described above. Of the 352 patients who achieved RVR, 322 remained on treatment and were randomized to either a 24-week or 48-week treatment arm.

"The [SVR] rates associated with the 24-week and the 48-week arms were statistically similar, at 92% and 87.5%, respectively," reported Dr. Kenneth E. Sherman of the University of Cincinnati. Analyses of the data based on race and extent of liver damage showed that 88% of black patients who experienced extended RVR achieved SVR in both the 24- and 48-week treatment arms, and 82% and 88% of patients with advanced fibrosis/cirrhosis achieved SVR in the 24-week and 48-week arms, respectively, he said.

There were more adverse event–related treatment discontinuations in the longer-treatment group (12.5% vs. 0.6%), suggesting a benefit to the shorter-duration therapy, Dr. Sherman stated. The high viral cure rate observed in the study – the overall SVR rate was 72% in an intent-to-treat analysis – "[supports] the role of response-guided therapy with telaprevir-based regimens" in treatment-naive patients," he said.

Previous Nonresponders Benefit From Boceprevir

Response-guided, fixed-duration therapy with boceprevir was safe and effective in a cohort of HCV genotype 1 patients who were enrolled in the RESPOND-2 study and who failed standard therapy, reported lead investigator Dr. Bruce R. Bacon of St. Louis University. The 403 patients included those in whom prior standard therapy induced no notable decrease in HCV viral load (null responders) or a "not undetectable" decrease in HCV viral load (nonresponders), as well as those in whom prior treatment initially resulted in undetectable HCV RNA, followed by a viral rebound (relapsers), he said.

All the patients underwent a 4-week lead-in phase of standard therapy followed by a random assignment to continue standard therapy alone or in conjunction with 800 mg of boceprevir taken three times daily. The treatment duration for patients in the boceprevir arm with undetectable HCV RNA at study weeks 8 and 12 was 36 weeks, whereas those patients in whom HCV RNA was detectable at study week 8, but undetectable at study week 12, stopped boceprevir at week 36 but continued standard therapy for an additional 12 weeks, for a total treatment duration of 48 weeks, Dr. Bacon said. Patients in the control group were treated for 48 weeks.

The SVR rates at 24 weeks after treatment conclusion were significantly higher in the boceprevir groups, compared with the control group. In the response-guided and fixed-duration boceprevir groups, the SVR rates were 59% and 66%, respectively, compared with 21% in the control patients, he said.

In all study arms, "previous relapsers and previous null responders fared better than prior nonresponders," Dr. Bacon said, noting that the respective SVR rates for previous relapsers, null responders, and nonresponders were 29%, 7%, and 0% in the control group; 69%, 40%, and 33% in the response-guided therapy group; and 75%, 52%, and 34% in the fixed-duration group.

Although the rates of anemia were significantly higher in the boceprevir arms, "the rate of treatment discontinuation related to side effects was similar across all three arms," Dr. Bacon reported, possibly because the use of erythropoietin was allowed to treat anemia, he said.

The findings of this study answer an important question about response-guided therapy "by confirming that many patients can be treated successfully with a treatment duration that is reduced by 3 months relative to the current standard of care treatment," Dr. Bacon said.

Boceprevir with a standard therapy lead-in strategy was also evaluated in the SPRINT-2 study involving HCV genotype 1 treatment-naive patients, according to Dr. Fred Poordad of Cedars-Sinai Medical Center in Los Angeles. The trial included 1,097 patients who underwent a similar 4-week standard therapy lead-in strategy as defined above, followed by the addition of placebo for 44 more weeks or by the addition of boceprevir, either for 24 more weeks for patients with undetectable HCV RNA at week 8 or for 24 more weeks plus 20 additional weeks of standard therapy for patients with detectable HCV RNA at week 8, but not at week 24, Dr. Poordad explained. Patients with detectable HCV RNA at week 24 were discontinued for futility, he said.

"In both the response-guided and fixed-treatment arms, boceprevir increased viral cure rates significantly, by approximately 70%," Dr. Poordad stated. Specifically, the SVR rate was 63% in the 28-week response-guided group, 66% in the 48-week fixed-duration group, and 38% in the 48-week control group, he said.

In a cohort analysis of treatment response for the study’s 159 black patients, the relative improvement in SVR rates remained significantly improved in the boceprevir arms, although the differences were not as robust, Dr. Poordad said. In this subgroup, the respective SVR rates in the response-guided therapy, fixed-duration therapy, and control groups were 42%, 53%, and 23%, respectively.

The rationale for using a lead-in strategy "is to help physicians identify patient responsiveness to interferon before adding boceprevir," Dr. Poordad explained. This can provide an early indication of the likelihood of treatment success. The advantage of subsequent response-guided therapy, he noted, is that it enables physicians to be flexible in managing their patients’ therapy "by adapting treatment duration to individual patient response."

All the sources disclosed relationships with numerous pharmaceutical companies. Among them, Dr. Jacobson and Dr. Sherman disclosed relationships with Vertex Pharmaceuticals, which manufactures telaprevir. Dr. Jacobson also has a relationship with Tibotec, which also is involved with the development of telaprevir. Dr. Poordad and Dr. Bacon also disclosed relationships with Merck, which manufactures boceprevir. Dr. Pockros disclosed relationships with Vertex and Tibotec, which are involved in the development of telaprevir, and Merck, which manufactures boceprevir.

BOSTON – There are no walls or even a roof. But a new type of home being built in Jacksonville, Fla., seeks to shelter to some of the city’s most vulnerable residents from the devastating effects of persistent mental illness. Through an academic-public sector collaboration between the University of Florida department of psychiatry and a comprehensive service facility called the Sulzbacher Center, a transdisciplinary team of outreach workers take to the streets to lay the foundation for "mental health homes" for the city’s large population of unsheltered homeless men and women.

Modeled after the primary care concept of a "medical home" in which multidisciplinary teams of specialists and care administrators provide comprehensive and continuous care of an individual through active communication and coordination of health care services, the fundamental elements of the mental health homes being developed in Jacksonville include psychiatric street outreach, coordination of and increased access to comprehensive care, and the integration of medical, psychiatric care, and addiction services, Dr. Richard C. Christensen said during a presentation at the American Psychiatric Association’s Institute on Psychiatric Services.

Two days per week, Dr. Christensen hits the road with an outreach nurse and case managers with expertise in the areas of housing and addiction services to attempt to bring the city’s street-dwellers into the health care fold – a monumental challenge considering city census data estimates that, on any given night, there are 2,900-3,000 homeless people in Jacksonville "and there are only 600 shelter beds available," he said. "That leaves 2,300-2,400 persons who are unsheltered and outside the realm of any kind of treatment or attachment to any kind of medical system."

The outreach team is described as transdisciplinary rather than multidisciplinary, because the members do not work independently, but rather they integrate their skills and knowledge and share in clinical decision making, according to Dr. Christensen, professor and chief of the division of public psychiatry at the University of Florida, Gainesville, and director of behavioral health services at the Sulzbacher Center.

Photo credit: Courtesy of Jeanne Ciasullo  Dr. Richard Christensen and his team hit the streets to serve the homeless through a transdisciplinary outreach program.

Just as the medical home is most beneficial to individuals with difficult-to-treat illnesses, a history of nonadherence, and limited access to consistent, comprehensive care, the mental health home is potentially of greatest value to "the most highly underserved members in our community: persons who are literally and systemically homeless," he said. The corollary, however, is that those who stand to gain the most from the integrated model of treatment are often the most difficult to engage and retain. In particular, the unsheltered homeless – those who chronically live on the streets, rather than in a temporary shelter – tend to have the high rates of severe mental illness and are the least likely to receive services, Dr. Christensen said in an interview.

A recent report by the U.S. Conference of Mayors estimated that 26%-28% of the homeless people in this country have a serious mental illness, and other estimates place that percentage over 30%, with the highest rates being seen among the unsheltered homeless, Dr. Christensen said. Additionally, "unsheltered homeless persons with mental illness have high rates of co-occurring substance use disorders, making them a particularly difficult population to engage," Dr. Christensen said.

Exacerbating the engagement challenge is the fact that these individuals have a pervasive mistrust of outreach workers and the public mental health care system. "There is a fundamental difference between the unsheltered homeless and those within a shelter system or service program who are open to receiving help," according to Dr. Christensen. "The people we are targeting are not the ones who come looking for treatment. We are going to them, and they’re often not interested." Thus, engaging the clients is often an arduous task that can take days, weeks, and even months and requires adapting communication styles and expectations and, often, a fair degree of bargaining on the part of the outreach team.

"We are fortunate because [through the Sulzbacher Center] we are able to offer emergency shelter, which is sometimes the hook that gets people in, but it can take weeks and weeks to even get that point," he said.

For this reason, the goals of the program are not lofty. While there are some remarkable success stories – Dr. Christensen tells of one client with psychosis who, after months of refusing the outreach team members’ dogged efforts, eventually accepted their offer of safe housing and has since become "an active participant in her own recovery – most gains are more modest. "The success of psychiatric street outreach cannot be evaluated with the same outcome measures as those used in clinical practice," he said. Certainly, the ideal progression is to engage the client to the point where he or she is willing to accept a shelter bed, food, water, clothing, and medical and psychiatric care, followed by the development of a diagnosis and treatment plan. However, he noted, the realistic goal is to simply get the homeless individual to agree to interact with any member of the team. "When that happens, we consider it a success," he said.

Because of this, evidence-based medicine with measurable clinical outcomes takes a back seat to relationship building, intuition, and tolerance, according to Dr. Christensen. The concept of recovery is impossible without establishing a respectful relationship with each client, he said, noting that "my goal is to get them to talk to me. That’s it. We don’t discuss medication or treatment plans." By building a trusting relationship, the outreach team can begin to help each client establish social, medical, and mental health connections through "open and welcoming doors" via ongoing street outreach, easily accessible walk-in clinics, and extreme tolerance of nonadherence and missed appointments, he said.

Once clients have established a connection to a caring, compassionate community, they can begin to take steps toward healing and recovery, including participating in their own psychiatric care, entering substance-abuse treatment, reestablishing family and social connections, and, ultimately, finding stable housing, Dr. Christensen said.

Psychiatric street outreach and the establishment of a comprehensive, coordinated mental health homes for unsheltered homeless individuals is a complex, often arduous endeavor, as is the establishment and maintenance of funding needed to keep such efforts alive. "The financial aspect can be complicated. Our funding comes from many different streams, mostly in the form of grants from various sources for specific services," Dr. Christensen said. As such, the availability of services necessarily expands and contracts along with the financial support for those services, he said.

Working with homeless populations has been Dr. Christensen’s passion since medical school – in fact, he said, he went to medical school expressly to be able to provide care to the homeless. However, "even if you’re not doing this as full-time work, psychiatrists have many opportunities to link people to services by virtue of our credentials and training," he said. Toward this end, he stressed, "When treating patients in the emergency department or in the inpatient setting, look broadly at the person and not just at the constellation of symptoms in order to really identify what else is needed beside a diagnosis and medication.

"Ask yourself what else might be needed in terms of basic life needs and housing and supports." There are many things psychiatrists can do to not only provide direct care to these individuals, he said, "but also to be advocates for these people who don’t have a voice."

Dr. Christensen had no conflicts of interest to report.

BOSTON – There are no walls or even a roof. But a new type of home being built in Jacksonville, Fla., seeks to shelter to some of the city’s most vulnerable residents from the devastating effects of persistent mental illness. Through an academic-public sector collaboration between the University of Florida department of psychiatry and a comprehensive service facility called the Sulzbacher Center, a transdisciplinary team of outreach workers take to the streets to lay the foundation for "mental health homes" for the city’s large population of unsheltered homeless men and women.

Modeled after the primary care concept of a "medical home" in which multidisciplinary teams of specialists and care administrators provide comprehensive and continuous care of an individual through active communication and coordination of health care services, the fundamental elements of the mental health homes being developed in Jacksonville include psychiatric street outreach, coordination of and increased access to comprehensive care, and the integration of medical, psychiatric care, and addiction services, Dr. Richard C. Christensen said during a presentation at the American Psychiatric Association’s Institute on Psychiatric Services.

Two days per week, Dr. Christensen hits the road with an outreach nurse and case managers with expertise in the areas of housing and addiction services to attempt to bring the city’s street-dwellers into the health care fold – a monumental challenge considering city census data estimates that, on any given night, there are 2,900-3,000 homeless people in Jacksonville "and there are only 600 shelter beds available," he said. "That leaves 2,300-2,400 persons who are unsheltered and outside the realm of any kind of treatment or attachment to any kind of medical system."

The outreach team is described as transdisciplinary rather than multidisciplinary, because the members do not work independently, but rather they integrate their skills and knowledge and share in clinical decision making, according to Dr. Christensen, professor and chief of the division of public psychiatry at the University of Florida, Gainesville, and director of behavioral health services at the Sulzbacher Center.

Photo credit: Courtesy of Jeanne Ciasullo  Dr. Richard Christensen and his team hit the streets to serve the homeless through a transdisciplinary outreach program.

Just as the medical home is most beneficial to individuals with difficult-to-treat illnesses, a history of nonadherence, and limited access to consistent, comprehensive care, the mental health home is potentially of greatest value to "the most highly underserved members in our community: persons who are literally and systemically homeless," he said. The corollary, however, is that those who stand to gain the most from the integrated model of treatment are often the most difficult to engage and retain. In particular, the unsheltered homeless – those who chronically live on the streets, rather than in a temporary shelter – tend to have the high rates of severe mental illness and are the least likely to receive services, Dr. Christensen said in an interview.

A recent report by the U.S. Conference of Mayors estimated that 26%-28% of the homeless people in this country have a serious mental illness, and other estimates place that percentage over 30%, with the highest rates being seen among the unsheltered homeless, Dr. Christensen said. Additionally, "unsheltered homeless persons with mental illness have high rates of co-occurring substance use disorders, making them a particularly difficult population to engage," Dr. Christensen said.

Exacerbating the engagement challenge is the fact that these individuals have a pervasive mistrust of outreach workers and the public mental health care system. "There is a fundamental difference between the unsheltered homeless and those within a shelter system or service program who are open to receiving help," according to Dr. Christensen. "The people we are targeting are not the ones who come looking for treatment. We are going to them, and they’re often not interested." Thus, engaging the clients is often an arduous task that can take days, weeks, and even months and requires adapting communication styles and expectations and, often, a fair degree of bargaining on the part of the outreach team.

"We are fortunate because [through the Sulzbacher Center] we are able to offer emergency shelter, which is sometimes the hook that gets people in, but it can take weeks and weeks to even get that point," he said.

For this reason, the goals of the program are not lofty. While there are some remarkable success stories – Dr. Christensen tells of one client with psychosis who, after months of refusing the outreach team members’ dogged efforts, eventually accepted their offer of safe housing and has since become "an active participant in her own recovery – most gains are more modest. "The success of psychiatric street outreach cannot be evaluated with the same outcome measures as those used in clinical practice," he said. Certainly, the ideal progression is to engage the client to the point where he or she is willing to accept a shelter bed, food, water, clothing, and medical and psychiatric care, followed by the development of a diagnosis and treatment plan. However, he noted, the realistic goal is to simply get the homeless individual to agree to interact with any member of the team. "When that happens, we consider it a success," he said.

Because of this, evidence-based medicine with measurable clinical outcomes takes a back seat to relationship building, intuition, and tolerance, according to Dr. Christensen. The concept of recovery is impossible without establishing a respectful relationship with each client, he said, noting that "my goal is to get them to talk to me. That’s it. We don’t discuss medication or treatment plans." By building a trusting relationship, the outreach team can begin to help each client establish social, medical, and mental health connections through "open and welcoming doors" via ongoing street outreach, easily accessible walk-in clinics, and extreme tolerance of nonadherence and missed appointments, he said.

Once clients have established a connection to a caring, compassionate community, they can begin to take steps toward healing and recovery, including participating in their own psychiatric care, entering substance-abuse treatment, reestablishing family and social connections, and, ultimately, finding stable housing, Dr. Christensen said.

Psychiatric street outreach and the establishment of a comprehensive, coordinated mental health homes for unsheltered homeless individuals is a complex, often arduous endeavor, as is the establishment and maintenance of funding needed to keep such efforts alive. "The financial aspect can be complicated. Our funding comes from many different streams, mostly in the form of grants from various sources for specific services," Dr. Christensen said. As such, the availability of services necessarily expands and contracts along with the financial support for those services, he said.

Working with homeless populations has been Dr. Christensen’s passion since medical school – in fact, he said, he went to medical school expressly to be able to provide care to the homeless. However, "even if you’re not doing this as full-time work, psychiatrists have many opportunities to link people to services by virtue of our credentials and training," he said. Toward this end, he stressed, "When treating patients in the emergency department or in the inpatient setting, look broadly at the person and not just at the constellation of symptoms in order to really identify what else is needed beside a diagnosis and medication.

"Ask yourself what else might be needed in terms of basic life needs and housing and supports." There are many things psychiatrists can do to not only provide direct care to these individuals, he said, "but also to be advocates for these people who don’t have a voice."

Dr. Christensen had no conflicts of interest to report.

BOSTON – There are no walls or even a roof. But a new type of home being built in Jacksonville, Fla., seeks to shelter to some of the city’s most vulnerable residents from the devastating effects of persistent mental illness. Through an academic-public sector collaboration between the University of Florida department of psychiatry and a comprehensive service facility called the Sulzbacher Center, a transdisciplinary team of outreach workers take to the streets to lay the foundation for "mental health homes" for the city’s large population of unsheltered homeless men and women.

Modeled after the primary care concept of a "medical home" in which multidisciplinary teams of specialists and care administrators provide comprehensive and continuous care of an individual through active communication and coordination of health care services, the fundamental elements of the mental health homes being developed in Jacksonville include psychiatric street outreach, coordination of and increased access to comprehensive care, and the integration of medical, psychiatric care, and addiction services, Dr. Richard C. Christensen said during a presentation at the American Psychiatric Association’s Institute on Psychiatric Services.

Two days per week, Dr. Christensen hits the road with an outreach nurse and case managers with expertise in the areas of housing and addiction services to attempt to bring the city’s street-dwellers into the health care fold – a monumental challenge considering city census data estimates that, on any given night, there are 2,900-3,000 homeless people in Jacksonville "and there are only 600 shelter beds available," he said. "That leaves 2,300-2,400 persons who are unsheltered and outside the realm of any kind of treatment or attachment to any kind of medical system."

The outreach team is described as transdisciplinary rather than multidisciplinary, because the members do not work independently, but rather they integrate their skills and knowledge and share in clinical decision making, according to Dr. Christensen, professor and chief of the division of public psychiatry at the University of Florida, Gainesville, and director of behavioral health services at the Sulzbacher Center.

Photo credit: Courtesy of Jeanne Ciasullo  Dr. Richard Christensen and his team hit the streets to serve the homeless through a transdisciplinary outreach program.

Just as the medical home is most beneficial to individuals with difficult-to-treat illnesses, a history of nonadherence, and limited access to consistent, comprehensive care, the mental health home is potentially of greatest value to "the most highly underserved members in our community: persons who are literally and systemically homeless," he said. The corollary, however, is that those who stand to gain the most from the integrated model of treatment are often the most difficult to engage and retain. In particular, the unsheltered homeless – those who chronically live on the streets, rather than in a temporary shelter – tend to have the high rates of severe mental illness and are the least likely to receive services, Dr. Christensen said in an interview.

A recent report by the U.S. Conference of Mayors estimated that 26%-28% of the homeless people in this country have a serious mental illness, and other estimates place that percentage over 30%, with the highest rates being seen among the unsheltered homeless, Dr. Christensen said. Additionally, "unsheltered homeless persons with mental illness have high rates of co-occurring substance use disorders, making them a particularly difficult population to engage," Dr. Christensen said.

Exacerbating the engagement challenge is the fact that these individuals have a pervasive mistrust of outreach workers and the public mental health care system. "There is a fundamental difference between the unsheltered homeless and those within a shelter system or service program who are open to receiving help," according to Dr. Christensen. "The people we are targeting are not the ones who come looking for treatment. We are going to them, and they’re often not interested." Thus, engaging the clients is often an arduous task that can take days, weeks, and even months and requires adapting communication styles and expectations and, often, a fair degree of bargaining on the part of the outreach team.

"We are fortunate because [through the Sulzbacher Center] we are able to offer emergency shelter, which is sometimes the hook that gets people in, but it can take weeks and weeks to even get that point," he said.

For this reason, the goals of the program are not lofty. While there are some remarkable success stories – Dr. Christensen tells of one client with psychosis who, after months of refusing the outreach team members’ dogged efforts, eventually accepted their offer of safe housing and has since become "an active participant in her own recovery – most gains are more modest. "The success of psychiatric street outreach cannot be evaluated with the same outcome measures as those used in clinical practice," he said. Certainly, the ideal progression is to engage the client to the point where he or she is willing to accept a shelter bed, food, water, clothing, and medical and psychiatric care, followed by the development of a diagnosis and treatment plan. However, he noted, the realistic goal is to simply get the homeless individual to agree to interact with any member of the team. "When that happens, we consider it a success," he said.

Because of this, evidence-based medicine with measurable clinical outcomes takes a back seat to relationship building, intuition, and tolerance, according to Dr. Christensen. The concept of recovery is impossible without establishing a respectful relationship with each client, he said, noting that "my goal is to get them to talk to me. That’s it. We don’t discuss medication or treatment plans." By building a trusting relationship, the outreach team can begin to help each client establish social, medical, and mental health connections through "open and welcoming doors" via ongoing street outreach, easily accessible walk-in clinics, and extreme tolerance of nonadherence and missed appointments, he said.

Once clients have established a connection to a caring, compassionate community, they can begin to take steps toward healing and recovery, including participating in their own psychiatric care, entering substance-abuse treatment, reestablishing family and social connections, and, ultimately, finding stable housing, Dr. Christensen said.

Psychiatric street outreach and the establishment of a comprehensive, coordinated mental health homes for unsheltered homeless individuals is a complex, often arduous endeavor, as is the establishment and maintenance of funding needed to keep such efforts alive. "The financial aspect can be complicated. Our funding comes from many different streams, mostly in the form of grants from various sources for specific services," Dr. Christensen said. As such, the availability of services necessarily expands and contracts along with the financial support for those services, he said.

Working with homeless populations has been Dr. Christensen’s passion since medical school – in fact, he said, he went to medical school expressly to be able to provide care to the homeless. However, "even if you’re not doing this as full-time work, psychiatrists have many opportunities to link people to services by virtue of our credentials and training," he said. Toward this end, he stressed, "When treating patients in the emergency department or in the inpatient setting, look broadly at the person and not just at the constellation of symptoms in order to really identify what else is needed beside a diagnosis and medication.

"Ask yourself what else might be needed in terms of basic life needs and housing and supports." There are many things psychiatrists can do to not only provide direct care to these individuals, he said, "but also to be advocates for these people who don’t have a voice."

Dr. Christensen had no conflicts of interest to report.

BOSTON – Older adults with mental illness are less likely to undergo chemotherapy after a cancer diagnosis than those without mental illness, a study has shown. The findings are consistent with those from previous studies suggesting disparities in the care of chronic conditions among mentally ill older adults, Dr. Simha E. Ravven reported at the American Psychiatric Association’s Institute on Psychiatric Services.

"Even though adults with mental illness are often well connected to primary care, our findings suggest that they may not be receiving the same kind of cancer treatment and that they may need more support and counseling to get the same care," said Dr. Ravven, a fellow at Harvard Medical School, Boston.

To determine whether cancer screening and treatment vary for people with prior mental illness, and if mortality after a cancer diagnosis differs in this population, Dr. Ravven and her colleagues reviewed records for the 19,045 participants of the year 2000 wave of the National Institute on Aging’s nationally representative, longitudinal Health and Retirement Study (HRS). The study, conducted by the University of Michigan, Ann Arbor, surveyed adults born in 1947 or earlier to assess mental health, financial status, family support, and retirement planning among aging Americans, she said.

Of the full study cohort, about 14% had a history of mental illness, according to Dr. Ravven. While both men and women with a history of mental illness were as likely to receive clinical cancer screening, including a breast exam, a Pap test, mammography, and a prostate exam within 2 years prior to the survey as part of the general population, individuals with mental illness who had a recent cancer diagnosis were significantly less likely to receive chemotherapy, with an odds ratio of 0.33, she said. No significant differences were found in receipt of radiation therapy, surgery, or biopsy, she reported.

When assessed by gender, the odds ratio for receiving chemotherapy among women with a history of mental illness was especially low relative to women without mental illness, with an odds ratio of 0.18. No significant difference was found between men with and without mental illness, Dr. Ravven said.

With respect to mortality, men with a history of mental illness and cancer were nearly three times more likely to die from their cancer within 2 years than were men without mental illness, while the opposite was true for women, Dr. Ravven noted. "Women with a history of mental illness who had had a cancer diagnosis had a significantly lower risk of mortality within 2 years than [did] those without," she said.

While the reasons for the disparities are unclear, it is possible that patients with mental illness avoid chemotherapy because they are not psychologically prepared for the rigorous treatment or their physicians have concerns about treatment adherence, Dr. Ravven hypothesized.

The findings are limited by the study’s retrospective design and the fact that it did not look at stage of cancer diagnosis or cancer site, Dr. Ravven acknowledged. It is possible that treatment disparities relate to the fact that chemotherapy might not have been part of the standard treatment protocol for certain stage cancers, she said.

Dr. Ravven and her colleagues plan to further investigate the treatment disparities, she said, noting that future research will include more detailed information, including cancer stage and site, and the nature and severity of the mental illness, with the goal being to determine where the ball is being dropped after screening and to intervene appropriately so that "individuals with mental illness receive the same standard of care [as do those without mental illness]." At the very least, clinicians should be aware of individuals who are having emotional difficulties with their cancer diagnosis and refer them for a psychiatric consultation, when necessary, she said.

Dr. Ravven reported having no financial conflicts of interest with respect to this presentation.

BOSTON – Older adults with mental illness are less likely to undergo chemotherapy after a cancer diagnosis than those without mental illness, a study has shown. The findings are consistent with those from previous studies suggesting disparities in the care of chronic conditions among mentally ill older adults, Dr. Simha E. Ravven reported at the American Psychiatric Association’s Institute on Psychiatric Services.

"Even though adults with mental illness are often well connected to primary care, our findings suggest that they may not be receiving the same kind of cancer treatment and that they may need more support and counseling to get the same care," said Dr. Ravven, a fellow at Harvard Medical School, Boston.

To determine whether cancer screening and treatment vary for people with prior mental illness, and if mortality after a cancer diagnosis differs in this population, Dr. Ravven and her colleagues reviewed records for the 19,045 participants of the year 2000 wave of the National Institute on Aging’s nationally representative, longitudinal Health and Retirement Study (HRS). The study, conducted by the University of Michigan, Ann Arbor, surveyed adults born in 1947 or earlier to assess mental health, financial status, family support, and retirement planning among aging Americans, she said.

Of the full study cohort, about 14% had a history of mental illness, according to Dr. Ravven. While both men and women with a history of mental illness were as likely to receive clinical cancer screening, including a breast exam, a Pap test, mammography, and a prostate exam within 2 years prior to the survey as part of the general population, individuals with mental illness who had a recent cancer diagnosis were significantly less likely to receive chemotherapy, with an odds ratio of 0.33, she said. No significant differences were found in receipt of radiation therapy, surgery, or biopsy, she reported.

When assessed by gender, the odds ratio for receiving chemotherapy among women with a history of mental illness was especially low relative to women without mental illness, with an odds ratio of 0.18. No significant difference was found between men with and without mental illness, Dr. Ravven said.

With respect to mortality, men with a history of mental illness and cancer were nearly three times more likely to die from their cancer within 2 years than were men without mental illness, while the opposite was true for women, Dr. Ravven noted. "Women with a history of mental illness who had had a cancer diagnosis had a significantly lower risk of mortality within 2 years than [did] those without," she said.

While the reasons for the disparities are unclear, it is possible that patients with mental illness avoid chemotherapy because they are not psychologically prepared for the rigorous treatment or their physicians have concerns about treatment adherence, Dr. Ravven hypothesized.

The findings are limited by the study’s retrospective design and the fact that it did not look at stage of cancer diagnosis or cancer site, Dr. Ravven acknowledged. It is possible that treatment disparities relate to the fact that chemotherapy might not have been part of the standard treatment protocol for certain stage cancers, she said.

Dr. Ravven and her colleagues plan to further investigate the treatment disparities, she said, noting that future research will include more detailed information, including cancer stage and site, and the nature and severity of the mental illness, with the goal being to determine where the ball is being dropped after screening and to intervene appropriately so that "individuals with mental illness receive the same standard of care [as do those without mental illness]." At the very least, clinicians should be aware of individuals who are having emotional difficulties with their cancer diagnosis and refer them for a psychiatric consultation, when necessary, she said.

Dr. Ravven reported having no financial conflicts of interest with respect to this presentation.

BOSTON – Older adults with mental illness are less likely to undergo chemotherapy after a cancer diagnosis than those without mental illness, a study has shown. The findings are consistent with those from previous studies suggesting disparities in the care of chronic conditions among mentally ill older adults, Dr. Simha E. Ravven reported at the American Psychiatric Association’s Institute on Psychiatric Services.

"Even though adults with mental illness are often well connected to primary care, our findings suggest that they may not be receiving the same kind of cancer treatment and that they may need more support and counseling to get the same care," said Dr. Ravven, a fellow at Harvard Medical School, Boston.

To determine whether cancer screening and treatment vary for people with prior mental illness, and if mortality after a cancer diagnosis differs in this population, Dr. Ravven and her colleagues reviewed records for the 19,045 participants of the year 2000 wave of the National Institute on Aging’s nationally representative, longitudinal Health and Retirement Study (HRS). The study, conducted by the University of Michigan, Ann Arbor, surveyed adults born in 1947 or earlier to assess mental health, financial status, family support, and retirement planning among aging Americans, she said.

Of the full study cohort, about 14% had a history of mental illness, according to Dr. Ravven. While both men and women with a history of mental illness were as likely to receive clinical cancer screening, including a breast exam, a Pap test, mammography, and a prostate exam within 2 years prior to the survey as part of the general population, individuals with mental illness who had a recent cancer diagnosis were significantly less likely to receive chemotherapy, with an odds ratio of 0.33, she said. No significant differences were found in receipt of radiation therapy, surgery, or biopsy, she reported.

When assessed by gender, the odds ratio for receiving chemotherapy among women with a history of mental illness was especially low relative to women without mental illness, with an odds ratio of 0.18. No significant difference was found between men with and without mental illness, Dr. Ravven said.

With respect to mortality, men with a history of mental illness and cancer were nearly three times more likely to die from their cancer within 2 years than were men without mental illness, while the opposite was true for women, Dr. Ravven noted. "Women with a history of mental illness who had had a cancer diagnosis had a significantly lower risk of mortality within 2 years than [did] those without," she said.

While the reasons for the disparities are unclear, it is possible that patients with mental illness avoid chemotherapy because they are not psychologically prepared for the rigorous treatment or their physicians have concerns about treatment adherence, Dr. Ravven hypothesized.

The findings are limited by the study’s retrospective design and the fact that it did not look at stage of cancer diagnosis or cancer site, Dr. Ravven acknowledged. It is possible that treatment disparities relate to the fact that chemotherapy might not have been part of the standard treatment protocol for certain stage cancers, she said.

Dr. Ravven and her colleagues plan to further investigate the treatment disparities, she said, noting that future research will include more detailed information, including cancer stage and site, and the nature and severity of the mental illness, with the goal being to determine where the ball is being dropped after screening and to intervene appropriately so that "individuals with mental illness receive the same standard of care [as do those without mental illness]." At the very least, clinicians should be aware of individuals who are having emotional difficulties with their cancer diagnosis and refer them for a psychiatric consultation, when necessary, she said.

Dr. Ravven reported having no financial conflicts of interest with respect to this presentation.

BOSTON – Nearly one-third of patients on antidepressant pharmacotherapy in a large-scale analysis did not take their original antidepressant dose as prescribed within the 6 months prior to dose escalation, a study has shown.

The findings suggest that the lack of adequate treatment response that drives dosage increases in many patients might be linked to suboptimal medication adherence rather than to dose insufficiency, Dr. David J. Muzina reported at the institute.

To evaluate patient nonadherence to chronic antidepressant therapy and a resulting upward dosage titration of the same medication, Dr. Muzina of Medco Health Solutions Inc. and his colleagues identified 53,530 patients from Medco's administrative patient claims database who were on antidepressant medications at the same dosage level for at least 6 months, followed by a subsequent submission of claims for a higher dose.

Patients with only one claim for antidepressant medication in a 6-month period were excluded from the analysis, as were those taking multiple antidepressants, Dr. Muzina explained.

To measure adherence status – which was determined by the proportion of days the patient possessed a supply of the medication, or the medication possession ratio (MPR) – researchers required a minimum of two claims for the same antidepressant drug. According to the National Committee for Quality Assurance's antidepressant performance measures, adherence was defined as an MPR of at least 80%, Dr. Muzina said.

With respect to patient demographics and prescription characteristics, the study cohort was predominantly female (72%), with a mean age of 51 years. More than two-thirds of the sample (68%) filled their antidepressant prescriptions at retail pharmacies, and 62% received generic medications, Dr. Muzina said. Most of the prescriptions were ordered by nonpsychiatrists, with only 15% ordered by psychiatrists; nearly half of the 49,524 patients for whom Chronic Disease Scores (CDS) were available had scores indicating a high degree of comorbidity, he said. Of the full study cohort, “only 70.3% were adherent to their antidepressant medication in the 6 months prior to their dosage increase. Nearly 30% were nonadherent,” Dr. Muzina reported.

Among the nonadherent patients, “one in four was in possession of their prescribed medication during less than 3 months of the 6-month period,” he said.

An analysis of medication adherence by study subgroup – including age, sex, comorbidity, pharmacy channel (mail vs. retail), formulation (brand vs. generic), and prescriber (psychiatrist vs. nonpsychiatrist) – showed significant differences for all but the type of clinician prescriber, Dr. Muzina said, noting that similarly high rates of nonadherence were observed among the psychiatrist (30.4%) and nonpsychiatrist (29.5%) groups.

Regarding pharmacy channel and formulation, 19.2% of patients who filled their prescriptions by mail were nonadherent, which was significantly lower than the 34.6% of those who used a retail pharmacy.

Those receiving generic-only drugs had a small but significantly higher nonadherence rate (30.2%) than the 28.9% rate that was observed among patients receiving brand-name drugs, according to Dr. Muzina.

Older age, male sex, and a higher CDS – perhaps because of the increased interaction with clinicians required by sicker patients – were also associated with significantly improved adherence relative to their respective corollaries, he said.

Although the study did not investigate the reasons for patient nonadherence, some possibilities include undesired or intolerable side effects, negative stigma, and forgetfulness, Dr. Muzina hypothesized.

The findings are limited by the study's retrospective design and the use of an administrative claims database, which doesn't provide certain relevant clinical information, according to Dr. Muzina. However, he suggested that the results indicate that clinicians should investigate and address adherence issues in all patients on antidepressant medications prior to prescribing a dose increase “to enable patients with depression to fully benefit from their medications.”

Additionally, factors associated with adherence to antidepressant treatment should be investigated in future studies, he said.

BOSTON – Nearly one-third of patients on antidepressant pharmacotherapy in a large-scale analysis did not take their original antidepressant dose as prescribed within the 6 months prior to dose escalation, a study has shown.

The findings suggest that the lack of adequate treatment response that drives dosage increases in many patients might be linked to suboptimal medication adherence rather than to dose insufficiency, Dr. David J. Muzina reported at the institute.

To evaluate patient nonadherence to chronic antidepressant therapy and a resulting upward dosage titration of the same medication, Dr. Muzina of Medco Health Solutions Inc. and his colleagues identified 53,530 patients from Medco's administrative patient claims database who were on antidepressant medications at the same dosage level for at least 6 months, followed by a subsequent submission of claims for a higher dose.

Patients with only one claim for antidepressant medication in a 6-month period were excluded from the analysis, as were those taking multiple antidepressants, Dr. Muzina explained.

To measure adherence status – which was determined by the proportion of days the patient possessed a supply of the medication, or the medication possession ratio (MPR) – researchers required a minimum of two claims for the same antidepressant drug. According to the National Committee for Quality Assurance's antidepressant performance measures, adherence was defined as an MPR of at least 80%, Dr. Muzina said.

With respect to patient demographics and prescription characteristics, the study cohort was predominantly female (72%), with a mean age of 51 years. More than two-thirds of the sample (68%) filled their antidepressant prescriptions at retail pharmacies, and 62% received generic medications, Dr. Muzina said. Most of the prescriptions were ordered by nonpsychiatrists, with only 15% ordered by psychiatrists; nearly half of the 49,524 patients for whom Chronic Disease Scores (CDS) were available had scores indicating a high degree of comorbidity, he said. Of the full study cohort, “only 70.3% were adherent to their antidepressant medication in the 6 months prior to their dosage increase. Nearly 30% were nonadherent,” Dr. Muzina reported.

Among the nonadherent patients, “one in four was in possession of their prescribed medication during less than 3 months of the 6-month period,” he said.

An analysis of medication adherence by study subgroup – including age, sex, comorbidity, pharmacy channel (mail vs. retail), formulation (brand vs. generic), and prescriber (psychiatrist vs. nonpsychiatrist) – showed significant differences for all but the type of clinician prescriber, Dr. Muzina said, noting that similarly high rates of nonadherence were observed among the psychiatrist (30.4%) and nonpsychiatrist (29.5%) groups.

Regarding pharmacy channel and formulation, 19.2% of patients who filled their prescriptions by mail were nonadherent, which was significantly lower than the 34.6% of those who used a retail pharmacy.

Those receiving generic-only drugs had a small but significantly higher nonadherence rate (30.2%) than the 28.9% rate that was observed among patients receiving brand-name drugs, according to Dr. Muzina.

Older age, male sex, and a higher CDS – perhaps because of the increased interaction with clinicians required by sicker patients – were also associated with significantly improved adherence relative to their respective corollaries, he said.

Although the study did not investigate the reasons for patient nonadherence, some possibilities include undesired or intolerable side effects, negative stigma, and forgetfulness, Dr. Muzina hypothesized.

The findings are limited by the study's retrospective design and the use of an administrative claims database, which doesn't provide certain relevant clinical information, according to Dr. Muzina. However, he suggested that the results indicate that clinicians should investigate and address adherence issues in all patients on antidepressant medications prior to prescribing a dose increase “to enable patients with depression to fully benefit from their medications.”

Additionally, factors associated with adherence to antidepressant treatment should be investigated in future studies, he said.

BOSTON – Nearly one-third of patients on antidepressant pharmacotherapy in a large-scale analysis did not take their original antidepressant dose as prescribed within the 6 months prior to dose escalation, a study has shown.

The findings suggest that the lack of adequate treatment response that drives dosage increases in many patients might be linked to suboptimal medication adherence rather than to dose insufficiency, Dr. David J. Muzina reported at the institute.

To evaluate patient nonadherence to chronic antidepressant therapy and a resulting upward dosage titration of the same medication, Dr. Muzina of Medco Health Solutions Inc. and his colleagues identified 53,530 patients from Medco's administrative patient claims database who were on antidepressant medications at the same dosage level for at least 6 months, followed by a subsequent submission of claims for a higher dose.

Patients with only one claim for antidepressant medication in a 6-month period were excluded from the analysis, as were those taking multiple antidepressants, Dr. Muzina explained.

To measure adherence status – which was determined by the proportion of days the patient possessed a supply of the medication, or the medication possession ratio (MPR) – researchers required a minimum of two claims for the same antidepressant drug. According to the National Committee for Quality Assurance's antidepressant performance measures, adherence was defined as an MPR of at least 80%, Dr. Muzina said.

With respect to patient demographics and prescription characteristics, the study cohort was predominantly female (72%), with a mean age of 51 years. More than two-thirds of the sample (68%) filled their antidepressant prescriptions at retail pharmacies, and 62% received generic medications, Dr. Muzina said. Most of the prescriptions were ordered by nonpsychiatrists, with only 15% ordered by psychiatrists; nearly half of the 49,524 patients for whom Chronic Disease Scores (CDS) were available had scores indicating a high degree of comorbidity, he said. Of the full study cohort, “only 70.3% were adherent to their antidepressant medication in the 6 months prior to their dosage increase. Nearly 30% were nonadherent,” Dr. Muzina reported.

Among the nonadherent patients, “one in four was in possession of their prescribed medication during less than 3 months of the 6-month period,” he said.

An analysis of medication adherence by study subgroup – including age, sex, comorbidity, pharmacy channel (mail vs. retail), formulation (brand vs. generic), and prescriber (psychiatrist vs. nonpsychiatrist) – showed significant differences for all but the type of clinician prescriber, Dr. Muzina said, noting that similarly high rates of nonadherence were observed among the psychiatrist (30.4%) and nonpsychiatrist (29.5%) groups.

Regarding pharmacy channel and formulation, 19.2% of patients who filled their prescriptions by mail were nonadherent, which was significantly lower than the 34.6% of those who used a retail pharmacy.

Those receiving generic-only drugs had a small but significantly higher nonadherence rate (30.2%) than the 28.9% rate that was observed among patients receiving brand-name drugs, according to Dr. Muzina.

Older age, male sex, and a higher CDS – perhaps because of the increased interaction with clinicians required by sicker patients – were also associated with significantly improved adherence relative to their respective corollaries, he said.

Although the study did not investigate the reasons for patient nonadherence, some possibilities include undesired or intolerable side effects, negative stigma, and forgetfulness, Dr. Muzina hypothesized.

The findings are limited by the study's retrospective design and the use of an administrative claims database, which doesn't provide certain relevant clinical information, according to Dr. Muzina. However, he suggested that the results indicate that clinicians should investigate and address adherence issues in all patients on antidepressant medications prior to prescribing a dose increase “to enable patients with depression to fully benefit from their medications.”

Additionally, factors associated with adherence to antidepressant treatment should be investigated in future studies, he said.

BOSTON – There are no walls or even a roof. But a new type of home being built in Jacksonville, Fla., seeks to shelter some of the city's most vulnerable residents from the devastating effects of persistent mental illness. Through an academic–public sector collaboration between the University of Florida department of psychiatry and a comprehensive service facility called the Sulzbacher Center, a transdisciplinary team of outreach workers takes to the streets to lay the foundation for “mental health homes” for the city's large population of unsheltered homeless men and women.

Modeled after the primary care concept of a “medical home” in which multidisciplinary teams of specialists and care administrators provide comprehensive and continuous care of an individual through active communication and coordination of health care services, the fundamental elements of the mental health homes being developed in Jacksonville include psychiatric street outreach, coordination of and increased access to comprehensive care, and the integration of medical, psychiatric care, and addiction services, Dr. Richard C. Christensen said at the meeting.

Two days a week, Dr. Christensen hits the road with an outreach nurse and case managers with expertise in the areas of housing and addiction services to attempt to bring the city's street-dwellers into the health care fold – a monumental challenge considering city census data estimate that, on any given night, there are 2,900-3,000 homeless people in Jacksonville “and there are only 600 shelter beds available,” he said. “That leaves 2,300-2,400 persons who are unsheltered and outside the realm of any kind of treatment or attachment to any kind of medical system.”

The outreach team is described as transdisciplinary rather than multidisciplinary, because the members do not work independently, but rather they integrate their skills and knowledge and share in clinical decision making, according to Dr. Christensen, professor and chief of the division of public psychiatry at the University of Florida, Gainesville, and director of behavioral health services at the Sulzbacher Center.

Just as the medical home is most beneficial to individuals with difficult-to-treat illnesses, a history of nonadherence, and limited access to consistent, comprehensive care, the mental health home is potentially of greatest value to “the most highly underserved members in our community: persons who are literally and systemically homeless,” he said. The corollary, however, is that those who stand to gain the most from the integrated model of treatment are often the most difficult to engage and retain. In particular, the unsheltered homeless – those who chronically live on the streets, rather than in a temporary shelter – tend to have the high rates of severe mental illness and are the least likely to receive services, Dr. Christensen said in an interview.

A recent report by the U.S. Conference of Mayors estimated that 26%-28% of the homeless people in this country have a serious mental illness, and other estimates place that percentage over 30%, with the highest rates being seen among the unsheltered homeless, Dr. Christensen said. Additionally, “unsheltered homeless persons with mental illness have high rates of co-occurring substance use disorders, making them a particularly difficult population to engage.”

Exacerbating the engagement challenge is the fact that these individuals have a pervasive mistrust of outreach workers and the public mental health care system. “There is a fundamental difference between the unsheltered homeless and those within a shelter system or service program who are open to receiving help,” according to Dr. Christensen. “The people we are targeting are not the ones who come looking for treatment. We are going to them, and they're often not interested.” Thus, engaging the clients is often an arduous task that can take days, weeks, and even months and requires adapting communication styles and expectations and, often, a fair degree of bargaining on the part of the outreach team. “We are fortunate because [through the Sulzbacher Center] we are able to offer emergency shelter, which is sometimes the hook that gets people in, but it can take weeks and weeks to even get that point,” he said.

For this reason, the goals of the program are not lofty. While there are some remarkable success stories – Dr. Christensen tells of one client with psychosis who, after months of refusing the outreach team members' dogged efforts, eventually accepted their offer of safe housing and has since become “an active participant in her own recovery – most gains are more modest. “The success of psychiatric street outreach cannot be evaluated with the same outcome measures as those used in clinical practice,” he said. Certainly, the ideal progression is to engage the client to the point where he or she is willing to accept a shelter bed, food, water, clothing, and medical and psychiatric care, followed by the development of a diagnosis and treatment plan. However, he noted, the realistic goal is to simply get the homeless individual to agree to interact with any member of the team. “When that happens, we consider it a success,” he said.

Because of this, evidence-based medicine with measurable clinical outcomes takes a back seat to relationship building, intuition, and tolerance, according to Dr. Christensen. The concept of recovery is impossible without establishing a respectful relationship with each client, he said, noting that “my goal is to get them to talk to me. That's it. We don't discuss medication or treatment plans.” By building a trusting relationship, the outreach team can begin to help each client establish social, medical, and mental health connections through “open and welcoming doors” via ongoing street outreach, easily accessible walk-in clinics, and extreme tolerance of nonadherence and missed appointments, he said.

Once clients have established a connection to a caring, compassionate community, they can begin to take steps toward healing and recovery, including participating in their own psychiatric care, entering substance-abuse treatment, reestablishing family and social connections, and, ultimately, finding stable housing, Dr. Christensen said.

Psychiatric street outreach and the establishment of comprehensive, coordinated mental health homes for unsheltered homeless individuals is a complex, often arduous endeavor, as is the establishment and maintenance of funding needed to keep such efforts alive.

“The financial aspect can be complicated. Our funding comes from many different streams, mostly in the form of grants from various sources for specific services,” Dr. Christensen said. As such, the availability of services necessarily expands and contracts along with the financial support for those services, he said.

Working with homeless populations has been Dr. Christensen's passion since medical school – in fact, he said, he went to medical school expressly to be able to provide care to the homeless. However, “even if you're not doing this as full-time work, psychiatrists have many opportunities to link people to services by virtue of our credentials and training,” he said. There are many things psychiatrists can do to not only provide direct care to these individuals, he said, “but also to be advocates.”

Dr. Christensen had no conflicts of interest to report.

Dr. Richard C. Christensen (center, left) spends 2 days a week with his team trying to bring the unsheltered homeless into the health care fold.

Source Courtesy Jeanne Ciasullo

BOSTON – There are no walls or even a roof. But a new type of home being built in Jacksonville, Fla., seeks to shelter some of the city's most vulnerable residents from the devastating effects of persistent mental illness. Through an academic–public sector collaboration between the University of Florida department of psychiatry and a comprehensive service facility called the Sulzbacher Center, a transdisciplinary team of outreach workers takes to the streets to lay the foundation for “mental health homes” for the city's large population of unsheltered homeless men and women.

Modeled after the primary care concept of a “medical home” in which multidisciplinary teams of specialists and care administrators provide comprehensive and continuous care of an individual through active communication and coordination of health care services, the fundamental elements of the mental health homes being developed in Jacksonville include psychiatric street outreach, coordination of and increased access to comprehensive care, and the integration of medical, psychiatric care, and addiction services, Dr. Richard C. Christensen said at the meeting.

Two days a week, Dr. Christensen hits the road with an outreach nurse and case managers with expertise in the areas of housing and addiction services to attempt to bring the city's street-dwellers into the health care fold – a monumental challenge considering city census data estimate that, on any given night, there are 2,900-3,000 homeless people in Jacksonville “and there are only 600 shelter beds available,” he said. “That leaves 2,300-2,400 persons who are unsheltered and outside the realm of any kind of treatment or attachment to any kind of medical system.”

The outreach team is described as transdisciplinary rather than multidisciplinary, because the members do not work independently, but rather they integrate their skills and knowledge and share in clinical decision making, according to Dr. Christensen, professor and chief of the division of public psychiatry at the University of Florida, Gainesville, and director of behavioral health services at the Sulzbacher Center.

Just as the medical home is most beneficial to individuals with difficult-to-treat illnesses, a history of nonadherence, and limited access to consistent, comprehensive care, the mental health home is potentially of greatest value to “the most highly underserved members in our community: persons who are literally and systemically homeless,” he said. The corollary, however, is that those who stand to gain the most from the integrated model of treatment are often the most difficult to engage and retain. In particular, the unsheltered homeless – those who chronically live on the streets, rather than in a temporary shelter – tend to have the high rates of severe mental illness and are the least likely to receive services, Dr. Christensen said in an interview.

A recent report by the U.S. Conference of Mayors estimated that 26%-28% of the homeless people in this country have a serious mental illness, and other estimates place that percentage over 30%, with the highest rates being seen among the unsheltered homeless, Dr. Christensen said. Additionally, “unsheltered homeless persons with mental illness have high rates of co-occurring substance use disorders, making them a particularly difficult population to engage.”

Exacerbating the engagement challenge is the fact that these individuals have a pervasive mistrust of outreach workers and the public mental health care system. “There is a fundamental difference between the unsheltered homeless and those within a shelter system or service program who are open to receiving help,” according to Dr. Christensen. “The people we are targeting are not the ones who come looking for treatment. We are going to them, and they're often not interested.” Thus, engaging the clients is often an arduous task that can take days, weeks, and even months and requires adapting communication styles and expectations and, often, a fair degree of bargaining on the part of the outreach team. “We are fortunate because [through the Sulzbacher Center] we are able to offer emergency shelter, which is sometimes the hook that gets people in, but it can take weeks and weeks to even get that point,” he said.

For this reason, the goals of the program are not lofty. While there are some remarkable success stories – Dr. Christensen tells of one client with psychosis who, after months of refusing the outreach team members' dogged efforts, eventually accepted their offer of safe housing and has since become “an active participant in her own recovery – most gains are more modest. “The success of psychiatric street outreach cannot be evaluated with the same outcome measures as those used in clinical practice,” he said. Certainly, the ideal progression is to engage the client to the point where he or she is willing to accept a shelter bed, food, water, clothing, and medical and psychiatric care, followed by the development of a diagnosis and treatment plan. However, he noted, the realistic goal is to simply get the homeless individual to agree to interact with any member of the team. “When that happens, we consider it a success,” he said.

Because of this, evidence-based medicine with measurable clinical outcomes takes a back seat to relationship building, intuition, and tolerance, according to Dr. Christensen. The concept of recovery is impossible without establishing a respectful relationship with each client, he said, noting that “my goal is to get them to talk to me. That's it. We don't discuss medication or treatment plans.” By building a trusting relationship, the outreach team can begin to help each client establish social, medical, and mental health connections through “open and welcoming doors” via ongoing street outreach, easily accessible walk-in clinics, and extreme tolerance of nonadherence and missed appointments, he said.

Once clients have established a connection to a caring, compassionate community, they can begin to take steps toward healing and recovery, including participating in their own psychiatric care, entering substance-abuse treatment, reestablishing family and social connections, and, ultimately, finding stable housing, Dr. Christensen said.

Psychiatric street outreach and the establishment of comprehensive, coordinated mental health homes for unsheltered homeless individuals is a complex, often arduous endeavor, as is the establishment and maintenance of funding needed to keep such efforts alive.

“The financial aspect can be complicated. Our funding comes from many different streams, mostly in the form of grants from various sources for specific services,” Dr. Christensen said. As such, the availability of services necessarily expands and contracts along with the financial support for those services, he said.

Working with homeless populations has been Dr. Christensen's passion since medical school – in fact, he said, he went to medical school expressly to be able to provide care to the homeless. However, “even if you're not doing this as full-time work, psychiatrists have many opportunities to link people to services by virtue of our credentials and training,” he said. There are many things psychiatrists can do to not only provide direct care to these individuals, he said, “but also to be advocates.”

Dr. Christensen had no conflicts of interest to report.

Dr. Richard C. Christensen (center, left) spends 2 days a week with his team trying to bring the unsheltered homeless into the health care fold.

Source Courtesy Jeanne Ciasullo

BOSTON – There are no walls or even a roof. But a new type of home being built in Jacksonville, Fla., seeks to shelter some of the city's most vulnerable residents from the devastating effects of persistent mental illness. Through an academic–public sector collaboration between the University of Florida department of psychiatry and a comprehensive service facility called the Sulzbacher Center, a transdisciplinary team of outreach workers takes to the streets to lay the foundation for “mental health homes” for the city's large population of unsheltered homeless men and women.

Modeled after the primary care concept of a “medical home” in which multidisciplinary teams of specialists and care administrators provide comprehensive and continuous care of an individual through active communication and coordination of health care services, the fundamental elements of the mental health homes being developed in Jacksonville include psychiatric street outreach, coordination of and increased access to comprehensive care, and the integration of medical, psychiatric care, and addiction services, Dr. Richard C. Christensen said at the meeting.

Two days a week, Dr. Christensen hits the road with an outreach nurse and case managers with expertise in the areas of housing and addiction services to attempt to bring the city's street-dwellers into the health care fold – a monumental challenge considering city census data estimate that, on any given night, there are 2,900-3,000 homeless people in Jacksonville “and there are only 600 shelter beds available,” he said. “That leaves 2,300-2,400 persons who are unsheltered and outside the realm of any kind of treatment or attachment to any kind of medical system.”

The outreach team is described as transdisciplinary rather than multidisciplinary, because the members do not work independently, but rather they integrate their skills and knowledge and share in clinical decision making, according to Dr. Christensen, professor and chief of the division of public psychiatry at the University of Florida, Gainesville, and director of behavioral health services at the Sulzbacher Center.

Just as the medical home is most beneficial to individuals with difficult-to-treat illnesses, a history of nonadherence, and limited access to consistent, comprehensive care, the mental health home is potentially of greatest value to “the most highly underserved members in our community: persons who are literally and systemically homeless,” he said. The corollary, however, is that those who stand to gain the most from the integrated model of treatment are often the most difficult to engage and retain. In particular, the unsheltered homeless – those who chronically live on the streets, rather than in a temporary shelter – tend to have the high rates of severe mental illness and are the least likely to receive services, Dr. Christensen said in an interview.

A recent report by the U.S. Conference of Mayors estimated that 26%-28% of the homeless people in this country have a serious mental illness, and other estimates place that percentage over 30%, with the highest rates being seen among the unsheltered homeless, Dr. Christensen said. Additionally, “unsheltered homeless persons with mental illness have high rates of co-occurring substance use disorders, making them a particularly difficult population to engage.”

Exacerbating the engagement challenge is the fact that these individuals have a pervasive mistrust of outreach workers and the public mental health care system. “There is a fundamental difference between the unsheltered homeless and those within a shelter system or service program who are open to receiving help,” according to Dr. Christensen. “The people we are targeting are not the ones who come looking for treatment. We are going to them, and they're often not interested.” Thus, engaging the clients is often an arduous task that can take days, weeks, and even months and requires adapting communication styles and expectations and, often, a fair degree of bargaining on the part of the outreach team. “We are fortunate because [through the Sulzbacher Center] we are able to offer emergency shelter, which is sometimes the hook that gets people in, but it can take weeks and weeks to even get that point,” he said.

For this reason, the goals of the program are not lofty. While there are some remarkable success stories – Dr. Christensen tells of one client with psychosis who, after months of refusing the outreach team members' dogged efforts, eventually accepted their offer of safe housing and has since become “an active participant in her own recovery – most gains are more modest. “The success of psychiatric street outreach cannot be evaluated with the same outcome measures as those used in clinical practice,” he said. Certainly, the ideal progression is to engage the client to the point where he or she is willing to accept a shelter bed, food, water, clothing, and medical and psychiatric care, followed by the development of a diagnosis and treatment plan. However, he noted, the realistic goal is to simply get the homeless individual to agree to interact with any member of the team. “When that happens, we consider it a success,” he said.

Because of this, evidence-based medicine with measurable clinical outcomes takes a back seat to relationship building, intuition, and tolerance, according to Dr. Christensen. The concept of recovery is impossible without establishing a respectful relationship with each client, he said, noting that “my goal is to get them to talk to me. That's it. We don't discuss medication or treatment plans.” By building a trusting relationship, the outreach team can begin to help each client establish social, medical, and mental health connections through “open and welcoming doors” via ongoing street outreach, easily accessible walk-in clinics, and extreme tolerance of nonadherence and missed appointments, he said.

Once clients have established a connection to a caring, compassionate community, they can begin to take steps toward healing and recovery, including participating in their own psychiatric care, entering substance-abuse treatment, reestablishing family and social connections, and, ultimately, finding stable housing, Dr. Christensen said.

Psychiatric street outreach and the establishment of comprehensive, coordinated mental health homes for unsheltered homeless individuals is a complex, often arduous endeavor, as is the establishment and maintenance of funding needed to keep such efforts alive.

“The financial aspect can be complicated. Our funding comes from many different streams, mostly in the form of grants from various sources for specific services,” Dr. Christensen said. As such, the availability of services necessarily expands and contracts along with the financial support for those services, he said.

Working with homeless populations has been Dr. Christensen's passion since medical school – in fact, he said, he went to medical school expressly to be able to provide care to the homeless. However, “even if you're not doing this as full-time work, psychiatrists have many opportunities to link people to services by virtue of our credentials and training,” he said. There are many things psychiatrists can do to not only provide direct care to these individuals, he said, “but also to be advocates.”

Dr. Christensen had no conflicts of interest to report.

Dr. Richard C. Christensen (center, left) spends 2 days a week with his team trying to bring the unsheltered homeless into the health care fold.

Source Courtesy Jeanne Ciasullo

BOSTON – Decreased expression of the PTPN13 gene is associated with improved survival of patients with head and neck squamous cell carcinoma positive for the human papillomavirus, a small retrospective study suggests.

Dr. George F. Harris IV of the University of Iowa, Iowa City, and his colleagues examined the correlation of human papillomavirus (HPV) status; protein tyrosine phosphatase, nonreceptor type 13 (PTPN13) status, and survival over 10 years in 21 patients for whom tissues samples were available for analysis. The patients, identified from University of Iowa Health Care (UIHC) Oncology Registry, were diagnosed with oropharyngeal head and neck squamous cell carcinoma (HNSCC) in 1995.

All 21 patients had HPV-positive cancer – 9 with decreased PTPN13 expression and 12 with unchanged or increased expression of PTPN13. Average survival was approximately 105 months in the low-PTPN13 group vs. 61 months in patients with unchanged or increased PTPN13 expression, Dr. Harris reported at the annual meeting of the American Academy of Otolaryngology–Head and Neck Surgery.

"An average increase in survival of about 30 months was seen for those patients who had decreased expression of PTPN13 within the tumor," he stated.

Looking at demographics, the investigators found that patients in the "decrease" group were younger at diagnosis but had more advanced disease. Observed Dr. Harris, "These may be confounding variables, but the finding is consistent with other authors' experience with HPV-associated H&N cancer in general."

The investigators employed real-time polymerase chain reaction (RT-PCR) to detect HPV type and activity. Dr. Harris said they used immunohistochemistry to evaluate the status of PTPN13, which has been shown to have a physiologically significant role in regulating mitogen-activated protein (MAP) kinase signaling. The identification and activity of HPV was confirmed by increased p16 immunochemical staining – an accepted marker for HPV activity because, in oropharyngeal HNSCC, HPV integration induces an overexpression of P16, he noted.

The improved survival observed among HPV positive HNSCC patients with decreased PTPN13 expression may be related to the fact that PTPN13 degradation is associated with fewer genetic changes than stable or elevated PTPN13 expression, according to Dr. Harris. It is possible that analyzing PTPN13 status in HPV-positive HNSCC "may identify those patients that will have better survival or, conversely, those patients who may require additional treatment," he said.

Dr. Harris reported having no conflicts of interest with respect to this presentation.

BOSTON – Decreased expression of the PTPN13 gene is associated with improved survival of patients with head and neck squamous cell carcinoma positive for the human papillomavirus, a small retrospective study suggests.

Dr. George F. Harris IV of the University of Iowa, Iowa City, and his colleagues examined the correlation of human papillomavirus (HPV) status; protein tyrosine phosphatase, nonreceptor type 13 (PTPN13) status, and survival over 10 years in 21 patients for whom tissues samples were available for analysis. The patients, identified from University of Iowa Health Care (UIHC) Oncology Registry, were diagnosed with oropharyngeal head and neck squamous cell carcinoma (HNSCC) in 1995.

All 21 patients had HPV-positive cancer – 9 with decreased PTPN13 expression and 12 with unchanged or increased expression of PTPN13. Average survival was approximately 105 months in the low-PTPN13 group vs. 61 months in patients with unchanged or increased PTPN13 expression, Dr. Harris reported at the annual meeting of the American Academy of Otolaryngology–Head and Neck Surgery.

"An average increase in survival of about 30 months was seen for those patients who had decreased expression of PTPN13 within the tumor," he stated.

Looking at demographics, the investigators found that patients in the "decrease" group were younger at diagnosis but had more advanced disease. Observed Dr. Harris, "These may be confounding variables, but the finding is consistent with other authors' experience with HPV-associated H&N cancer in general."

The investigators employed real-time polymerase chain reaction (RT-PCR) to detect HPV type and activity. Dr. Harris said they used immunohistochemistry to evaluate the status of PTPN13, which has been shown to have a physiologically significant role in regulating mitogen-activated protein (MAP) kinase signaling. The identification and activity of HPV was confirmed by increased p16 immunochemical staining – an accepted marker for HPV activity because, in oropharyngeal HNSCC, HPV integration induces an overexpression of P16, he noted.

The improved survival observed among HPV positive HNSCC patients with decreased PTPN13 expression may be related to the fact that PTPN13 degradation is associated with fewer genetic changes than stable or elevated PTPN13 expression, according to Dr. Harris. It is possible that analyzing PTPN13 status in HPV-positive HNSCC "may identify those patients that will have better survival or, conversely, those patients who may require additional treatment," he said.

Dr. Harris reported having no conflicts of interest with respect to this presentation.

BOSTON – Decreased expression of the PTPN13 gene is associated with improved survival of patients with head and neck squamous cell carcinoma positive for the human papillomavirus, a small retrospective study suggests.

Dr. George F. Harris IV of the University of Iowa, Iowa City, and his colleagues examined the correlation of human papillomavirus (HPV) status; protein tyrosine phosphatase, nonreceptor type 13 (PTPN13) status, and survival over 10 years in 21 patients for whom tissues samples were available for analysis. The patients, identified from University of Iowa Health Care (UIHC) Oncology Registry, were diagnosed with oropharyngeal head and neck squamous cell carcinoma (HNSCC) in 1995.

All 21 patients had HPV-positive cancer – 9 with decreased PTPN13 expression and 12 with unchanged or increased expression of PTPN13. Average survival was approximately 105 months in the low-PTPN13 group vs. 61 months in patients with unchanged or increased PTPN13 expression, Dr. Harris reported at the annual meeting of the American Academy of Otolaryngology–Head and Neck Surgery.

"An average increase in survival of about 30 months was seen for those patients who had decreased expression of PTPN13 within the tumor," he stated.

Looking at demographics, the investigators found that patients in the "decrease" group were younger at diagnosis but had more advanced disease. Observed Dr. Harris, "These may be confounding variables, but the finding is consistent with other authors' experience with HPV-associated H&N cancer in general."

The investigators employed real-time polymerase chain reaction (RT-PCR) to detect HPV type and activity. Dr. Harris said they used immunohistochemistry to evaluate the status of PTPN13, which has been shown to have a physiologically significant role in regulating mitogen-activated protein (MAP) kinase signaling. The identification and activity of HPV was confirmed by increased p16 immunochemical staining – an accepted marker for HPV activity because, in oropharyngeal HNSCC, HPV integration induces an overexpression of P16, he noted.

The improved survival observed among HPV positive HNSCC patients with decreased PTPN13 expression may be related to the fact that PTPN13 degradation is associated with fewer genetic changes than stable or elevated PTPN13 expression, according to Dr. Harris. It is possible that analyzing PTPN13 status in HPV-positive HNSCC "may identify those patients that will have better survival or, conversely, those patients who may require additional treatment," he said.

Dr. Harris reported having no conflicts of interest with respect to this presentation.

BOSTON – Decreased expression of the PTPN13 gene is associated with improved survival of patients with head and neck squamous cell carcinoma positive for the human papillomavirus, a small retrospective study suggests.

Dr. George F. Harris IV of the University of Iowa, Iowa City, and his colleagues examined the correlation of human papillomavirus (HPV) status; protein tyrosine phosphatase, nonreceptor type 13 (PTPN13) status, and survival over 10 years in 21 patients for whom tissues samples were available for analysis. The patients, identified from University of Iowa Health Care (UIHC) Oncology Registry, were diagnosed with oropharyngeal head and neck squamous cell carcinoma (HNSCC) in 1995.

All 21 patients had HPV-positive cancer – 9 with decreased PTPN13 expressionand 12 with unchanged or increased expression of PTPN13. Average survival was approximately 105 months in the low-PTPN13 group vs. 61 months in patients with unchanged or increased PTPN13 expression, Dr. Harris reported at the annual meeting of the American Academy of Otolaryngology–Head and Neck Surgery.

"An average increase in survival of about 30 months was seen for those patients who had decreased expression of PTPN13 within the tumor," he stated.

Looking at demographics, the investigators found that patients in the "decrease" group were younger at diagnosis but had more advanced disease. Observed Dr. Harris, "These may be confounding variables, but the finding is consistent with other authors’ experience with HPV-associated H&N cancer in general."

The investigators employed real-time polymerase chain reaction (RT-PCR) to detect HPV type and activity. Dr. Harris said they used immunohistochemistry to evaluate the status of PTPN13, which has been shown to have a physiologically significant role in regulating mitogen-activated protein (MAP) kinase signaling. The identification and activity of HPV was confirmed by increased p16 immunochemical staining – an accepted marker for HPV activity because, in oropharyngeal HNSCC, HPV integration induces an overexpression of P16, he noted.

The improved survival observed among HPV positive HNSCC patients with decreased PTPN13 expression may be related to the fact that PTPN13 degradation is associated with fewer genetic changes than stable or elevated PTPN13 expression, according to Dr. Harris. It is possible that analyzing PTPN13 status in HPV-positive HNSCC "may identify those patients that will have better survival or, conversely, those patients who may require additional treatment," he said.

Dr. Harris reported having no conflicts of interest with respect to this presentation.

BOSTON – Decreased expression of the PTPN13 gene is associated with improved survival of patients with head and neck squamous cell carcinoma positive for the human papillomavirus, a small retrospective study suggests.

Dr. George F. Harris IV of the University of Iowa, Iowa City, and his colleagues examined the correlation of human papillomavirus (HPV) status; protein tyrosine phosphatase, nonreceptor type 13 (PTPN13) status, and survival over 10 years in 21 patients for whom tissues samples were available for analysis. The patients, identified from University of Iowa Health Care (UIHC) Oncology Registry, were diagnosed with oropharyngeal head and neck squamous cell carcinoma (HNSCC) in 1995.

All 21 patients had HPV-positive cancer – 9 with decreased PTPN13 expressionand 12 with unchanged or increased expression of PTPN13. Average survival was approximately 105 months in the low-PTPN13 group vs. 61 months in patients with unchanged or increased PTPN13 expression, Dr. Harris reported at the annual meeting of the American Academy of Otolaryngology–Head and Neck Surgery.

"An average increase in survival of about 30 months was seen for those patients who had decreased expression of PTPN13 within the tumor," he stated.

Looking at demographics, the investigators found that patients in the "decrease" group were younger at diagnosis but had more advanced disease. Observed Dr. Harris, "These may be confounding variables, but the finding is consistent with other authors’ experience with HPV-associated H&N cancer in general."

The investigators employed real-time polymerase chain reaction (RT-PCR) to detect HPV type and activity. Dr. Harris said they used immunohistochemistry to evaluate the status of PTPN13, which has been shown to have a physiologically significant role in regulating mitogen-activated protein (MAP) kinase signaling. The identification and activity of HPV was confirmed by increased p16 immunochemical staining – an accepted marker for HPV activity because, in oropharyngeal HNSCC, HPV integration induces an overexpression of P16, he noted.

The improved survival observed among HPV positive HNSCC patients with decreased PTPN13 expression may be related to the fact that PTPN13 degradation is associated with fewer genetic changes than stable or elevated PTPN13 expression, according to Dr. Harris. It is possible that analyzing PTPN13 status in HPV-positive HNSCC "may identify those patients that will have better survival or, conversely, those patients who may require additional treatment," he said.

Dr. Harris reported having no conflicts of interest with respect to this presentation.

BOSTON – Decreased expression of the PTPN13 gene is associated with improved survival of patients with head and neck squamous cell carcinoma positive for the human papillomavirus, a small retrospective study suggests.

Dr. George F. Harris IV of the University of Iowa, Iowa City, and his colleagues examined the correlation of human papillomavirus (HPV) status; protein tyrosine phosphatase, nonreceptor type 13 (PTPN13) status, and survival over 10 years in 21 patients for whom tissues samples were available for analysis. The patients, identified from University of Iowa Health Care (UIHC) Oncology Registry, were diagnosed with oropharyngeal head and neck squamous cell carcinoma (HNSCC) in 1995.

All 21 patients had HPV-positive cancer – 9 with decreased PTPN13 expressionand 12 with unchanged or increased expression of PTPN13. Average survival was approximately 105 months in the low-PTPN13 group vs. 61 months in patients with unchanged or increased PTPN13 expression, Dr. Harris reported at the annual meeting of the American Academy of Otolaryngology–Head and Neck Surgery.

"An average increase in survival of about 30 months was seen for those patients who had decreased expression of PTPN13 within the tumor," he stated.

Looking at demographics, the investigators found that patients in the "decrease" group were younger at diagnosis but had more advanced disease. Observed Dr. Harris, "These may be confounding variables, but the finding is consistent with other authors’ experience with HPV-associated H&N cancer in general."

The investigators employed real-time polymerase chain reaction (RT-PCR) to detect HPV type and activity. Dr. Harris said they used immunohistochemistry to evaluate the status of PTPN13, which has been shown to have a physiologically significant role in regulating mitogen-activated protein (MAP) kinase signaling. The identification and activity of HPV was confirmed by increased p16 immunochemical staining – an accepted marker for HPV activity because, in oropharyngeal HNSCC, HPV integration induces an overexpression of P16, he noted.

The improved survival observed among HPV positive HNSCC patients with decreased PTPN13 expression may be related to the fact that PTPN13 degradation is associated with fewer genetic changes than stable or elevated PTPN13 expression, according to Dr. Harris. It is possible that analyzing PTPN13 status in HPV-positive HNSCC "may identify those patients that will have better survival or, conversely, those patients who may require additional treatment," he said.

Dr. Harris reported having no conflicts of interest with respect to this presentation.

BOSTON – Nearly one-third of patients on antidepressant pharmacotherapy in a large-scale analysis did not take their original antidepressant dose as prescribed within the 6 months prior to dose escalation, a study has shown.

The findings suggest that the lack of adequate treatment response that drives dosage increases in many patients may be linked to suboptimal medication adherence rather than to dose insufficiency, Dr. David J. Muzina reported at the American Psychiatric Association’s Institute on Psychiatric Services.

To evaluate patient nonadherence to chronic antidepressant therapy and a resulting upward dosage titration of the same medication, Dr. Muzina of Medco Health Solutions Inc. and his colleagues identified 53,530 patients from Medco’s administrative patient claims database who were on antidepressant medications at the same dosage level for at least 6 months, followed by a subsequent submission of claims for a higher dose.

Patients with only one claim for antidepressant medication in a 6-month period were excluded from the analysis, as were those taking multiple antidepressants, Dr. Muzina explained.

To measure adherence status – which was determined by the proportion of days the patient possessed a supply of the medication, or the medication possession ratio (MPR) – a minimum of two claims for the same antidepressant drug was required. According to the National Committee for Quality Assurance’s antidepressant performance measures, adherence was defined as an MPR of at least 80%, Dr. Muzina said.

With respect to patient demographics and prescription characteristics, the study cohort was predominantly female (72%), with a mean age of 51 years. More than two-thirds of the sample (68%) filled their antidepressant prescriptions at retail pharmacies, and 62% received generic medications, Dr. Muzina said. Most of the prescriptions were ordered by nonpsychiatrists, with only 15% ordered by psychiatrists; nearly half of the 49,524 patients for whom Chronic Disease Scores (CDS) were available had scores indicating a high degree of comorbidity, he said.

Of the full study cohort, “only 70.3% were adherent to their antidepressant medication in the 6 months prior to their dosage increase. Nearly 30% were nonadherent,” Dr. Muzina reported. Among the nonadherent patients, “one in four was in possession of their prescribed medication during less than 3 months of the 6-month period,” he said.

An analysis of medication adherence by study subgroup – including age, sex, comorbidity, pharmacy channel (mail vs. retail), formulation (brand vs. generic), and prescriber (psychiatrist vs. nonpsychiatrist) – showed significant differences for all but the type of clinician prescriber, Dr. Muzina said, noting that similarly high rates of nonadherence were observed among the psychiatrist (30.4%) and nonpsychiatrist (29.5%) groups.

Regarding pharmacy channel and formulation, 19.2% of patients who filled their prescriptions by mail were nonadherent, which was significantly lower than the 34.6% of those who used a retail pharmacy. Those receiving generic-only drugs had a small but significantly higher nonadherence rate (30.2%) than the 28.9% rate that was observed among patients receiving brand-name drugs.

Older age, male sex, and a higher CDS – perhaps because of the increased interaction with clinicians required by sicker patients –were also associated with significantly improved adherence relative to their respective corollaries, he said.

Although the study did not investigate the reasons for patient nonadherence, some possibilities include undesired or intolerable side effects, negative stigma, and forgetfulness, Dr. Muzina hypothesized.

Although the findings are limited by the study’s retrospective design and the use of an administrative claims database, which doesn’t provide certain relevant clinical information, according to Dr. Muzina, the results indicate that clinicians should investigate and address adherence issues in all patients on antidepressant medications prior to prescribing a dose increase “to enable patients with depression to fully benefit from their medications.” Additionally, factors associated with adherence to antidepressant treatment should be investigated in future studies, he said.

Medco Health provided funding for the extraction of data from the patient claims database and statistical analysis. Dr. Muzina became national practice leader of Medco Neuroscience Resource Center after the study began and received no compensation for his participation.

BOSTON – Nearly one-third of patients on antidepressant pharmacotherapy in a large-scale analysis did not take their original antidepressant dose as prescribed within the 6 months prior to dose escalation, a study has shown.

The findings suggest that the lack of adequate treatment response that drives dosage increases in many patients may be linked to suboptimal medication adherence rather than to dose insufficiency, Dr. David J. Muzina reported at the American Psychiatric Association’s Institute on Psychiatric Services.

To evaluate patient nonadherence to chronic antidepressant therapy and a resulting upward dosage titration of the same medication, Dr. Muzina of Medco Health Solutions Inc. and his colleagues identified 53,530 patients from Medco’s administrative patient claims database who were on antidepressant medications at the same dosage level for at least 6 months, followed by a subsequent submission of claims for a higher dose.

Patients with only one claim for antidepressant medication in a 6-month period were excluded from the analysis, as were those taking multiple antidepressants, Dr. Muzina explained.

To measure adherence status – which was determined by the proportion of days the patient possessed a supply of the medication, or the medication possession ratio (MPR) – a minimum of two claims for the same antidepressant drug was required. According to the National Committee for Quality Assurance’s antidepressant performance measures, adherence was defined as an MPR of at least 80%, Dr. Muzina said.

With respect to patient demographics and prescription characteristics, the study cohort was predominantly female (72%), with a mean age of 51 years. More than two-thirds of the sample (68%) filled their antidepressant prescriptions at retail pharmacies, and 62% received generic medications, Dr. Muzina said. Most of the prescriptions were ordered by nonpsychiatrists, with only 15% ordered by psychiatrists; nearly half of the 49,524 patients for whom Chronic Disease Scores (CDS) were available had scores indicating a high degree of comorbidity, he said.

Of the full study cohort, “only 70.3% were adherent to their antidepressant medication in the 6 months prior to their dosage increase. Nearly 30% were nonadherent,” Dr. Muzina reported. Among the nonadherent patients, “one in four was in possession of their prescribed medication during less than 3 months of the 6-month period,” he said.

An analysis of medication adherence by study subgroup – including age, sex, comorbidity, pharmacy channel (mail vs. retail), formulation (brand vs. generic), and prescriber (psychiatrist vs. nonpsychiatrist) – showed significant differences for all but the type of clinician prescriber, Dr. Muzina said, noting that similarly high rates of nonadherence were observed among the psychiatrist (30.4%) and nonpsychiatrist (29.5%) groups.

Regarding pharmacy channel and formulation, 19.2% of patients who filled their prescriptions by mail were nonadherent, which was significantly lower than the 34.6% of those who used a retail pharmacy. Those receiving generic-only drugs had a small but significantly higher nonadherence rate (30.2%) than the 28.9% rate that was observed among patients receiving brand-name drugs.

Older age, male sex, and a higher CDS – perhaps because of the increased interaction with clinicians required by sicker patients –were also associated with significantly improved adherence relative to their respective corollaries, he said.

Although the study did not investigate the reasons for patient nonadherence, some possibilities include undesired or intolerable side effects, negative stigma, and forgetfulness, Dr. Muzina hypothesized.

Although the findings are limited by the study’s retrospective design and the use of an administrative claims database, which doesn’t provide certain relevant clinical information, according to Dr. Muzina, the results indicate that clinicians should investigate and address adherence issues in all patients on antidepressant medications prior to prescribing a dose increase “to enable patients with depression to fully benefit from their medications.” Additionally, factors associated with adherence to antidepressant treatment should be investigated in future studies, he said.

Medco Health provided funding for the extraction of data from the patient claims database and statistical analysis. Dr. Muzina became national practice leader of Medco Neuroscience Resource Center after the study began and received no compensation for his participation.

BOSTON – Nearly one-third of patients on antidepressant pharmacotherapy in a large-scale analysis did not take their original antidepressant dose as prescribed within the 6 months prior to dose escalation, a study has shown.

The findings suggest that the lack of adequate treatment response that drives dosage increases in many patients may be linked to suboptimal medication adherence rather than to dose insufficiency, Dr. David J. Muzina reported at the American Psychiatric Association’s Institute on Psychiatric Services.

To evaluate patient nonadherence to chronic antidepressant therapy and a resulting upward dosage titration of the same medication, Dr. Muzina of Medco Health Solutions Inc. and his colleagues identified 53,530 patients from Medco’s administrative patient claims database who were on antidepressant medications at the same dosage level for at least 6 months, followed by a subsequent submission of claims for a higher dose.

Patients with only one claim for antidepressant medication in a 6-month period were excluded from the analysis, as were those taking multiple antidepressants, Dr. Muzina explained.

To measure adherence status – which was determined by the proportion of days the patient possessed a supply of the medication, or the medication possession ratio (MPR) – a minimum of two claims for the same antidepressant drug was required. According to the National Committee for Quality Assurance’s antidepressant performance measures, adherence was defined as an MPR of at least 80%, Dr. Muzina said.

With respect to patient demographics and prescription characteristics, the study cohort was predominantly female (72%), with a mean age of 51 years. More than two-thirds of the sample (68%) filled their antidepressant prescriptions at retail pharmacies, and 62% received generic medications, Dr. Muzina said. Most of the prescriptions were ordered by nonpsychiatrists, with only 15% ordered by psychiatrists; nearly half of the 49,524 patients for whom Chronic Disease Scores (CDS) were available had scores indicating a high degree of comorbidity, he said.

Of the full study cohort, “only 70.3% were adherent to their antidepressant medication in the 6 months prior to their dosage increase. Nearly 30% were nonadherent,” Dr. Muzina reported. Among the nonadherent patients, “one in four was in possession of their prescribed medication during less than 3 months of the 6-month period,” he said.

An analysis of medication adherence by study subgroup – including age, sex, comorbidity, pharmacy channel (mail vs. retail), formulation (brand vs. generic), and prescriber (psychiatrist vs. nonpsychiatrist) – showed significant differences for all but the type of clinician prescriber, Dr. Muzina said, noting that similarly high rates of nonadherence were observed among the psychiatrist (30.4%) and nonpsychiatrist (29.5%) groups.

Regarding pharmacy channel and formulation, 19.2% of patients who filled their prescriptions by mail were nonadherent, which was significantly lower than the 34.6% of those who used a retail pharmacy. Those receiving generic-only drugs had a small but significantly higher nonadherence rate (30.2%) than the 28.9% rate that was observed among patients receiving brand-name drugs.

Older age, male sex, and a higher CDS – perhaps because of the increased interaction with clinicians required by sicker patients –were also associated with significantly improved adherence relative to their respective corollaries, he said.

Although the study did not investigate the reasons for patient nonadherence, some possibilities include undesired or intolerable side effects, negative stigma, and forgetfulness, Dr. Muzina hypothesized.

Although the findings are limited by the study’s retrospective design and the use of an administrative claims database, which doesn’t provide certain relevant clinical information, according to Dr. Muzina, the results indicate that clinicians should investigate and address adherence issues in all patients on antidepressant medications prior to prescribing a dose increase “to enable patients with depression to fully benefit from their medications.” Additionally, factors associated with adherence to antidepressant treatment should be investigated in future studies, he said.

Medco Health provided funding for the extraction of data from the patient claims database and statistical analysis. Dr. Muzina became national practice leader of Medco Neuroscience Resource Center after the study began and received no compensation for his participation.