HCV Hub

SAN DIEGO – Despite better therapies, deaths from hepatitis C virus (HCV) infection continue to rise, indicating poor penetrance of medications and care to patients who need them, Dr. Scott Holmberg said at an annual scientific meeting on infectious diseases.

“Deaths in chronic HCV–infected persons, even when grossly under-enumerated on death certificates, far outstrip deaths from 60 other infectious conditions reportable to CDC,” said Dr. Holmberg of the Centers for Disease Control and Prevention Division of Viral Hepatitis in Atlanta.

E.H. Cook, Jr./CDC

Drugs for chronic HCV infection have vastly improved in the past several years, yielding far better rates of sustained viral response (SVR) and high chances of cure after 8-24 weeks of treatment. To see if better antiviral therapies have affected HCV mortality rates, Dr. Holmberg and his associates studied ICD-9 data from Multiple Cause of Death records for all U.S. death certificates between 2003 and 2013. They divided deaths that were linked to HCV or 60 other nationally notifiable infectious diseases by U.S. Census numbers for the same year. They also examined data from the Chronic Hepatitis Cohort Study (Clin Infect Dis. 2014;58:1055-61), which includes patients presumed to have adequate access to HCV treatment.

Chronic HCV-related deaths climbed from about 12,000 annually in 2003 to more than 19,000 in 2013, said Dr. Holmberg. In contrast, deaths from the 60 other reportable infectious diseases dropped from about 25,000 annually to below 20,000 per year. Annual deaths tied to HIV infection ranked second behind HCV at about 8,800, followed by Staphylococcus aureus (including MRSA), hepatitis B virus, tuberculosis, and pneumococcal disease. “This does not include 4,444 adult influenza deaths, but does include 165 childhood influenza deaths in 2013,” Dr. Holmberg noted.

The analysis of the Chronic Hepatitis Cohort Study revealed a doubling in mortality from chronic HCV infection among patients who should have had adequate access to treatment, according to Dr. Holmberg. For every 100 person-years of observation, about 2.5 people died from consequences of chronic HCV infection in 2007, compared with about 5.5 in 2013, he said. “Hidden mortality from HCV is considerable,” he added. “Only 19% of HCV patients who died had their infection noted anywhere on their death certificates, despite the fact that more than 75% had premortem evidence of liver disease.”

Uptake of sofosbuvir-based regimens more than quintupled in the second quarter of 2015, compared with a year earlier, according to data from Gilead Sciences presented by Dr. Holmberg. But high drug costs have spurred state Medicaid programs and private payers to stipulate many preapproval requirements, he noted. Patients must be drug and alcohol free for at least 6 months, and in many states, must provide evidence of liver scarring from a recent biopsy or FibroScan, which is not always easy to access. “This is often a barrier,” Dr. Holmberg said. “For those in more rural areas, finding a specialist, as required by many state Medicaid offices, can be very difficult.”

And there are even more obstacles. Many clinicians still see HCV as a “benign condition,” and patients often have other urgent health, social, or financial problems, Dr. Holmberg said. The public, for its part, may not prioritize infectious diseases. “These patients lack a strong advocacy group,” he added. “Most are former injection drug users, and the public is often reluctant to help them.”

So what are the measurable results of these barriers? Among about 3.2 million individuals in the United States with chronic HCV infection, only half were ever tested for HCV, 38% received some sort of care related to their infection, 11% were treated, and 6% achieved SVR, Dr. Holmberg and his associates noted in a perspective piece (N Engl J Med. 2013;368:1859-861).

At the same time, the United States faces an emerging epidemic of new HCV infections in nonurban areas among young persons who inject drugs (MMWR. 64;453-8). “This is really a tale of two epidemics,” he added. “Control of the chronic and the acute outbreaks will require a multipronged approach, with interventions along a testing to cure continuum of care.”

Dr. Holmberg and his associates reported their findings at the combined annual meetings of the Infectious Diseases Society of America, the Society for Healthcare Epidemiology of America, the HIV Medicine Association, and the Pediatric Infectious Diseases Society. The researchers reported no funding sources and had no financial disclosures.

SAN DIEGO – Despite better therapies, deaths from hepatitis C virus (HCV) infection continue to rise, indicating poor penetrance of medications and care to patients who need them, Dr. Scott Holmberg said at an annual scientific meeting on infectious diseases.

“Deaths in chronic HCV–infected persons, even when grossly under-enumerated on death certificates, far outstrip deaths from 60 other infectious conditions reportable to CDC,” said Dr. Holmberg of the Centers for Disease Control and Prevention Division of Viral Hepatitis in Atlanta.

E.H. Cook, Jr./CDC

Drugs for chronic HCV infection have vastly improved in the past several years, yielding far better rates of sustained viral response (SVR) and high chances of cure after 8-24 weeks of treatment. To see if better antiviral therapies have affected HCV mortality rates, Dr. Holmberg and his associates studied ICD-9 data from Multiple Cause of Death records for all U.S. death certificates between 2003 and 2013. They divided deaths that were linked to HCV or 60 other nationally notifiable infectious diseases by U.S. Census numbers for the same year. They also examined data from the Chronic Hepatitis Cohort Study (Clin Infect Dis. 2014;58:1055-61), which includes patients presumed to have adequate access to HCV treatment.

Chronic HCV-related deaths climbed from about 12,000 annually in 2003 to more than 19,000 in 2013, said Dr. Holmberg. In contrast, deaths from the 60 other reportable infectious diseases dropped from about 25,000 annually to below 20,000 per year. Annual deaths tied to HIV infection ranked second behind HCV at about 8,800, followed by Staphylococcus aureus (including MRSA), hepatitis B virus, tuberculosis, and pneumococcal disease. “This does not include 4,444 adult influenza deaths, but does include 165 childhood influenza deaths in 2013,” Dr. Holmberg noted.

The analysis of the Chronic Hepatitis Cohort Study revealed a doubling in mortality from chronic HCV infection among patients who should have had adequate access to treatment, according to Dr. Holmberg. For every 100 person-years of observation, about 2.5 people died from consequences of chronic HCV infection in 2007, compared with about 5.5 in 2013, he said. “Hidden mortality from HCV is considerable,” he added. “Only 19% of HCV patients who died had their infection noted anywhere on their death certificates, despite the fact that more than 75% had premortem evidence of liver disease.”

Uptake of sofosbuvir-based regimens more than quintupled in the second quarter of 2015, compared with a year earlier, according to data from Gilead Sciences presented by Dr. Holmberg. But high drug costs have spurred state Medicaid programs and private payers to stipulate many preapproval requirements, he noted. Patients must be drug and alcohol free for at least 6 months, and in many states, must provide evidence of liver scarring from a recent biopsy or FibroScan, which is not always easy to access. “This is often a barrier,” Dr. Holmberg said. “For those in more rural areas, finding a specialist, as required by many state Medicaid offices, can be very difficult.”

And there are even more obstacles. Many clinicians still see HCV as a “benign condition,” and patients often have other urgent health, social, or financial problems, Dr. Holmberg said. The public, for its part, may not prioritize infectious diseases. “These patients lack a strong advocacy group,” he added. “Most are former injection drug users, and the public is often reluctant to help them.”

So what are the measurable results of these barriers? Among about 3.2 million individuals in the United States with chronic HCV infection, only half were ever tested for HCV, 38% received some sort of care related to their infection, 11% were treated, and 6% achieved SVR, Dr. Holmberg and his associates noted in a perspective piece (N Engl J Med. 2013;368:1859-861).

At the same time, the United States faces an emerging epidemic of new HCV infections in nonurban areas among young persons who inject drugs (MMWR. 64;453-8). “This is really a tale of two epidemics,” he added. “Control of the chronic and the acute outbreaks will require a multipronged approach, with interventions along a testing to cure continuum of care.”

Dr. Holmberg and his associates reported their findings at the combined annual meetings of the Infectious Diseases Society of America, the Society for Healthcare Epidemiology of America, the HIV Medicine Association, and the Pediatric Infectious Diseases Society. The researchers reported no funding sources and had no financial disclosures.

SAN DIEGO – Despite better therapies, deaths from hepatitis C virus (HCV) infection continue to rise, indicating poor penetrance of medications and care to patients who need them, Dr. Scott Holmberg said at an annual scientific meeting on infectious diseases.

“Deaths in chronic HCV–infected persons, even when grossly under-enumerated on death certificates, far outstrip deaths from 60 other infectious conditions reportable to CDC,” said Dr. Holmberg of the Centers for Disease Control and Prevention Division of Viral Hepatitis in Atlanta.

E.H. Cook, Jr./CDC

Drugs for chronic HCV infection have vastly improved in the past several years, yielding far better rates of sustained viral response (SVR) and high chances of cure after 8-24 weeks of treatment. To see if better antiviral therapies have affected HCV mortality rates, Dr. Holmberg and his associates studied ICD-9 data from Multiple Cause of Death records for all U.S. death certificates between 2003 and 2013. They divided deaths that were linked to HCV or 60 other nationally notifiable infectious diseases by U.S. Census numbers for the same year. They also examined data from the Chronic Hepatitis Cohort Study (Clin Infect Dis. 2014;58:1055-61), which includes patients presumed to have adequate access to HCV treatment.

Chronic HCV-related deaths climbed from about 12,000 annually in 2003 to more than 19,000 in 2013, said Dr. Holmberg. In contrast, deaths from the 60 other reportable infectious diseases dropped from about 25,000 annually to below 20,000 per year. Annual deaths tied to HIV infection ranked second behind HCV at about 8,800, followed by Staphylococcus aureus (including MRSA), hepatitis B virus, tuberculosis, and pneumococcal disease. “This does not include 4,444 adult influenza deaths, but does include 165 childhood influenza deaths in 2013,” Dr. Holmberg noted.

The analysis of the Chronic Hepatitis Cohort Study revealed a doubling in mortality from chronic HCV infection among patients who should have had adequate access to treatment, according to Dr. Holmberg. For every 100 person-years of observation, about 2.5 people died from consequences of chronic HCV infection in 2007, compared with about 5.5 in 2013, he said. “Hidden mortality from HCV is considerable,” he added. “Only 19% of HCV patients who died had their infection noted anywhere on their death certificates, despite the fact that more than 75% had premortem evidence of liver disease.”

Uptake of sofosbuvir-based regimens more than quintupled in the second quarter of 2015, compared with a year earlier, according to data from Gilead Sciences presented by Dr. Holmberg. But high drug costs have spurred state Medicaid programs and private payers to stipulate many preapproval requirements, he noted. Patients must be drug and alcohol free for at least 6 months, and in many states, must provide evidence of liver scarring from a recent biopsy or FibroScan, which is not always easy to access. “This is often a barrier,” Dr. Holmberg said. “For those in more rural areas, finding a specialist, as required by many state Medicaid offices, can be very difficult.”

And there are even more obstacles. Many clinicians still see HCV as a “benign condition,” and patients often have other urgent health, social, or financial problems, Dr. Holmberg said. The public, for its part, may not prioritize infectious diseases. “These patients lack a strong advocacy group,” he added. “Most are former injection drug users, and the public is often reluctant to help them.”

So what are the measurable results of these barriers? Among about 3.2 million individuals in the United States with chronic HCV infection, only half were ever tested for HCV, 38% received some sort of care related to their infection, 11% were treated, and 6% achieved SVR, Dr. Holmberg and his associates noted in a perspective piece (N Engl J Med. 2013;368:1859-861).

At the same time, the United States faces an emerging epidemic of new HCV infections in nonurban areas among young persons who inject drugs (MMWR. 64;453-8). “This is really a tale of two epidemics,” he added. “Control of the chronic and the acute outbreaks will require a multipronged approach, with interventions along a testing to cure continuum of care.”

Dr. Holmberg and his associates reported their findings at the combined annual meetings of the Infectious Diseases Society of America, the Society for Healthcare Epidemiology of America, the HIV Medicine Association, and the Pediatric Infectious Diseases Society. The researchers reported no funding sources and had no financial disclosures.

Individuals infected with the hepatitis C virus who have a higher ratio of alanine aminotransferase to aspartate aminotransferase may be at greater risk of developing nonalcoholic fatty liver disease and hepatosteatosis, new data suggest.

A community-based observational study in 1,354 Taiwanese individuals seropositive for hepatitis C virus – including 433 with nonalcoholic fatty liver disease – found a high alanine aminotransferase to aspartate aminotransferase ratio was significantly and independently associated with nonalcoholic fatty liver disease (OR, 1.90; 95% CI, 1.37 to 2.65; P less than .001) and high-degree nonalcoholic fatty liver disease (OR, 2.44; 95% CI, 1.58 to 3.77; P less than .001).

Courtesy NIH

This effect was observed even after researchers accounted for potential confounders: age, body mass index, metabolic syndrome, cholesterol level, hepatitis B virus infection, and smoking.

The study found the ALT/AST ratio was significantly higher among patients with nonalcoholic fatty liver disease (1.2 ± 0.4 vs. 1.1 ± 0.4; P less than .001) – defined as hepatic steatosis by echogenic imaging – according to a paper published online Sept. 14 in BMJ Open.

Nonalcoholic fatty liver disease is a particular issue because not only can it progress to severe liver disease but it is also associated with a lower likelihood of achieving a sustained virologic response to antiviral therapy. In addition, the majority of cases of nonalcoholic fatty liver disease are silent and are discovered incidentally, the authors wrote.

“This is the first study to reveal a strong relationship between the ALT/AST ratio and NAFLD in patients with HCV, and the ALT/AST ratio was also an independent risk factor apart from the conventional risk factors for hepatosteatosis including the MetS [metabolic syndrome], LDL, TC, waist/hip ratio, and body mass index,” wrote Dr. Ming-Shyan Lin of Chang Gung Memorial Hospital, Taiwan, and coauthors.

While the AST/ALT ratio is a marker of liver cirrhosis and advanced liver disease, the ALT/AST ratio is also a marker for insulin resistance and metabolic syndrome.

Researchers also noted that individuals with hepatitis C infection and nonalcoholic fatty liver disease had a significantly higher incidence of metabolic syndrome, significantly higher fasting glucose, uric acid, and triglycerides, and a lower HDL than did those with low-degree nonalcoholic fatty liver disease.

“The prevalence of hepatosteatosis in chronic hepatitis C infection has been reported in up to 31%-72%, which is significantly higher than that in participants with other chronic liver disease such as hepatitis B or autoimmune hepatitis, suggesting a direct effect of HCV replication in the development of excess fat accumulation in the liver,” the authors wrote.

In this cohort, the prevalence of nonalcoholic fatty liver disease was 31.9%, and 19.6% of participants had moderate to severe hepatosteatosis (BMJ Open 2015, Sep 14. doi:10.1136/bmjopen-2015-008797).

Given the silent nature of nonalcoholic fatty liver disease, the authors suggested that the findings could help clinicians identify individuals with hepatosteatosis and implement interventions such as weight loss to reduce their risk of further progression.

No conflicts of interest were declared.

Individuals infected with the hepatitis C virus who have a higher ratio of alanine aminotransferase to aspartate aminotransferase may be at greater risk of developing nonalcoholic fatty liver disease and hepatosteatosis, new data suggest.

A community-based observational study in 1,354 Taiwanese individuals seropositive for hepatitis C virus – including 433 with nonalcoholic fatty liver disease – found a high alanine aminotransferase to aspartate aminotransferase ratio was significantly and independently associated with nonalcoholic fatty liver disease (OR, 1.90; 95% CI, 1.37 to 2.65; P less than .001) and high-degree nonalcoholic fatty liver disease (OR, 2.44; 95% CI, 1.58 to 3.77; P less than .001).

Courtesy NIH

This effect was observed even after researchers accounted for potential confounders: age, body mass index, metabolic syndrome, cholesterol level, hepatitis B virus infection, and smoking.

The study found the ALT/AST ratio was significantly higher among patients with nonalcoholic fatty liver disease (1.2 ± 0.4 vs. 1.1 ± 0.4; P less than .001) – defined as hepatic steatosis by echogenic imaging – according to a paper published online Sept. 14 in BMJ Open.

Nonalcoholic fatty liver disease is a particular issue because not only can it progress to severe liver disease but it is also associated with a lower likelihood of achieving a sustained virologic response to antiviral therapy. In addition, the majority of cases of nonalcoholic fatty liver disease are silent and are discovered incidentally, the authors wrote.

“This is the first study to reveal a strong relationship between the ALT/AST ratio and NAFLD in patients with HCV, and the ALT/AST ratio was also an independent risk factor apart from the conventional risk factors for hepatosteatosis including the MetS [metabolic syndrome], LDL, TC, waist/hip ratio, and body mass index,” wrote Dr. Ming-Shyan Lin of Chang Gung Memorial Hospital, Taiwan, and coauthors.

While the AST/ALT ratio is a marker of liver cirrhosis and advanced liver disease, the ALT/AST ratio is also a marker for insulin resistance and metabolic syndrome.

Researchers also noted that individuals with hepatitis C infection and nonalcoholic fatty liver disease had a significantly higher incidence of metabolic syndrome, significantly higher fasting glucose, uric acid, and triglycerides, and a lower HDL than did those with low-degree nonalcoholic fatty liver disease.

“The prevalence of hepatosteatosis in chronic hepatitis C infection has been reported in up to 31%-72%, which is significantly higher than that in participants with other chronic liver disease such as hepatitis B or autoimmune hepatitis, suggesting a direct effect of HCV replication in the development of excess fat accumulation in the liver,” the authors wrote.

In this cohort, the prevalence of nonalcoholic fatty liver disease was 31.9%, and 19.6% of participants had moderate to severe hepatosteatosis (BMJ Open 2015, Sep 14. doi:10.1136/bmjopen-2015-008797).

Given the silent nature of nonalcoholic fatty liver disease, the authors suggested that the findings could help clinicians identify individuals with hepatosteatosis and implement interventions such as weight loss to reduce their risk of further progression.

No conflicts of interest were declared.

Individuals infected with the hepatitis C virus who have a higher ratio of alanine aminotransferase to aspartate aminotransferase may be at greater risk of developing nonalcoholic fatty liver disease and hepatosteatosis, new data suggest.

A community-based observational study in 1,354 Taiwanese individuals seropositive for hepatitis C virus – including 433 with nonalcoholic fatty liver disease – found a high alanine aminotransferase to aspartate aminotransferase ratio was significantly and independently associated with nonalcoholic fatty liver disease (OR, 1.90; 95% CI, 1.37 to 2.65; P less than .001) and high-degree nonalcoholic fatty liver disease (OR, 2.44; 95% CI, 1.58 to 3.77; P less than .001).

Courtesy NIH

This effect was observed even after researchers accounted for potential confounders: age, body mass index, metabolic syndrome, cholesterol level, hepatitis B virus infection, and smoking.

The study found the ALT/AST ratio was significantly higher among patients with nonalcoholic fatty liver disease (1.2 ± 0.4 vs. 1.1 ± 0.4; P less than .001) – defined as hepatic steatosis by echogenic imaging – according to a paper published online Sept. 14 in BMJ Open.

Nonalcoholic fatty liver disease is a particular issue because not only can it progress to severe liver disease but it is also associated with a lower likelihood of achieving a sustained virologic response to antiviral therapy. In addition, the majority of cases of nonalcoholic fatty liver disease are silent and are discovered incidentally, the authors wrote.

“This is the first study to reveal a strong relationship between the ALT/AST ratio and NAFLD in patients with HCV, and the ALT/AST ratio was also an independent risk factor apart from the conventional risk factors for hepatosteatosis including the MetS [metabolic syndrome], LDL, TC, waist/hip ratio, and body mass index,” wrote Dr. Ming-Shyan Lin of Chang Gung Memorial Hospital, Taiwan, and coauthors.

While the AST/ALT ratio is a marker of liver cirrhosis and advanced liver disease, the ALT/AST ratio is also a marker for insulin resistance and metabolic syndrome.

Researchers also noted that individuals with hepatitis C infection and nonalcoholic fatty liver disease had a significantly higher incidence of metabolic syndrome, significantly higher fasting glucose, uric acid, and triglycerides, and a lower HDL than did those with low-degree nonalcoholic fatty liver disease.

“The prevalence of hepatosteatosis in chronic hepatitis C infection has been reported in up to 31%-72%, which is significantly higher than that in participants with other chronic liver disease such as hepatitis B or autoimmune hepatitis, suggesting a direct effect of HCV replication in the development of excess fat accumulation in the liver,” the authors wrote.

In this cohort, the prevalence of nonalcoholic fatty liver disease was 31.9%, and 19.6% of participants had moderate to severe hepatosteatosis (BMJ Open 2015, Sep 14. doi:10.1136/bmjopen-2015-008797).

Given the silent nature of nonalcoholic fatty liver disease, the authors suggested that the findings could help clinicians identify individuals with hepatosteatosis and implement interventions such as weight loss to reduce their risk of further progression.

No conflicts of interest were declared.

Antiviral treatment with sofosbuvir reduced liver fibrosis, as measured by three independent noninvasive predictors for liver fibrosis, and liver stiffness, in patients with chronic hepatitis C (CHC), according to new research published in the Digestive and Liver Disease (doi:10.1016/j.dld.2015.09.015).

“Despite the relatively small sample size, the effects on fibrosis parameters are impressive, implying clinically significant fibrosis regression and potential reduction of cirrhosis-associated mortality in successfully treated patients with CHC,” wrote Dr. Sebastian Bernuth of Cirrhosis Center Mainz (CCM), Johannes Gutenberg University Mainz, Germany, and colleagues.

Courtesy US. Dept of Veterans Affairs

CHC is a major cause of liver-associated mortality, and is responsible for approximately 25% of primary hepatocellular carcinomas and 25% of liver cirrhosis. Successful antiviral therapy with a sustained virological response (SVR) can reduce liver-related morbidity and mortality, including a decreased need for transplantation.

In 2014, the first NS5B RNA-polymerase inhibitor, sofosbuvir, was approved for use in conjunction with pegylated interferon-alpha (PEG-IFN) and/or ribavirin to treat hepatitis C infection, and yielded high SVR rates of around 90% after short-term therapy in genotype 1-3-infected patients.In this study, Dr. Benuth and his colleagues evaluated early changes in dynamic fibrosis-related parameters using the enhanced liver fibrosis (ELF) panel, combined with liver stiffness measurement (LSM), along with metabolic alterations in insulin resistance, and lipid and iron metabolism during sofosbuvir-based antiviral therapy.

A total of 32 patients were included in the analysis, and all received treatment with sofosbuvir, 19 in combination with PEG-IFN, 29 in combination with ribavirin, and four in combination with simeprevir.Patients experienced a biochemical and virological response within 4 weeks of starting treatment. At 12 weeks, the SVR was 93.8% and two patients experienced a relapse.There was a significant decrease from baseline to 12-week posttreatment follow-up in ELF (10.00 vs. 9.37; P = .007), and the median of the LSM (measured by Fibroscan) significantly decreased over the whole observation period, from 8 kPa (METAVIR F2) at baseline to 6.8 kPa (METAVIR F0-1) at 12 weeks (P = .016). This suggests a significant regression of liver fibrosis at 12 weeks, compared to baseline.The liver enzymes (ALT, AST, and gamma-GT) rapidly normalized under treatment, and total bilirubin also decreased from the baseline upper normal values (0.91 mg/dL) to 0.74 mg/dL (P = .034).“In conclusion, this is the first study implying significant and clinically relevant reduction in liver fibrosis measures by three independent noninvasive predictors for liver fibrosis assessment and liver stiffness measurement under highly effective antiviral regimens with sofosbuvir,” said the authors.

The study was supported by intramural funding of the University of Mainz (Inneruniversitäre Forschungsförderung Stufe I grant) to Dr. Tim Zimmermann, who has also received consultant/lecture fees and/or travel support from Abbvie, BMS, Gilead, Janssen-Cilag, Merck, and Roche. Dr. Martin F. Sprinzl received research funding from Gilead and lecture fees from Roche. All other authors have no conflicts of interest to declare in terms of this manuscript.

Antiviral treatment with sofosbuvir reduced liver fibrosis, as measured by three independent noninvasive predictors for liver fibrosis, and liver stiffness, in patients with chronic hepatitis C (CHC), according to new research published in the Digestive and Liver Disease (doi:10.1016/j.dld.2015.09.015).

“Despite the relatively small sample size, the effects on fibrosis parameters are impressive, implying clinically significant fibrosis regression and potential reduction of cirrhosis-associated mortality in successfully treated patients with CHC,” wrote Dr. Sebastian Bernuth of Cirrhosis Center Mainz (CCM), Johannes Gutenberg University Mainz, Germany, and colleagues.

Courtesy US. Dept of Veterans Affairs

CHC is a major cause of liver-associated mortality, and is responsible for approximately 25% of primary hepatocellular carcinomas and 25% of liver cirrhosis. Successful antiviral therapy with a sustained virological response (SVR) can reduce liver-related morbidity and mortality, including a decreased need for transplantation.

In 2014, the first NS5B RNA-polymerase inhibitor, sofosbuvir, was approved for use in conjunction with pegylated interferon-alpha (PEG-IFN) and/or ribavirin to treat hepatitis C infection, and yielded high SVR rates of around 90% after short-term therapy in genotype 1-3-infected patients.In this study, Dr. Benuth and his colleagues evaluated early changes in dynamic fibrosis-related parameters using the enhanced liver fibrosis (ELF) panel, combined with liver stiffness measurement (LSM), along with metabolic alterations in insulin resistance, and lipid and iron metabolism during sofosbuvir-based antiviral therapy.

A total of 32 patients were included in the analysis, and all received treatment with sofosbuvir, 19 in combination with PEG-IFN, 29 in combination with ribavirin, and four in combination with simeprevir.Patients experienced a biochemical and virological response within 4 weeks of starting treatment. At 12 weeks, the SVR was 93.8% and two patients experienced a relapse.There was a significant decrease from baseline to 12-week posttreatment follow-up in ELF (10.00 vs. 9.37; P = .007), and the median of the LSM (measured by Fibroscan) significantly decreased over the whole observation period, from 8 kPa (METAVIR F2) at baseline to 6.8 kPa (METAVIR F0-1) at 12 weeks (P = .016). This suggests a significant regression of liver fibrosis at 12 weeks, compared to baseline.The liver enzymes (ALT, AST, and gamma-GT) rapidly normalized under treatment, and total bilirubin also decreased from the baseline upper normal values (0.91 mg/dL) to 0.74 mg/dL (P = .034).“In conclusion, this is the first study implying significant and clinically relevant reduction in liver fibrosis measures by three independent noninvasive predictors for liver fibrosis assessment and liver stiffness measurement under highly effective antiviral regimens with sofosbuvir,” said the authors.

The study was supported by intramural funding of the University of Mainz (Inneruniversitäre Forschungsförderung Stufe I grant) to Dr. Tim Zimmermann, who has also received consultant/lecture fees and/or travel support from Abbvie, BMS, Gilead, Janssen-Cilag, Merck, and Roche. Dr. Martin F. Sprinzl received research funding from Gilead and lecture fees from Roche. All other authors have no conflicts of interest to declare in terms of this manuscript.

Antiviral treatment with sofosbuvir reduced liver fibrosis, as measured by three independent noninvasive predictors for liver fibrosis, and liver stiffness, in patients with chronic hepatitis C (CHC), according to new research published in the Digestive and Liver Disease (doi:10.1016/j.dld.2015.09.015).

“Despite the relatively small sample size, the effects on fibrosis parameters are impressive, implying clinically significant fibrosis regression and potential reduction of cirrhosis-associated mortality in successfully treated patients with CHC,” wrote Dr. Sebastian Bernuth of Cirrhosis Center Mainz (CCM), Johannes Gutenberg University Mainz, Germany, and colleagues.

Courtesy US. Dept of Veterans Affairs

CHC is a major cause of liver-associated mortality, and is responsible for approximately 25% of primary hepatocellular carcinomas and 25% of liver cirrhosis. Successful antiviral therapy with a sustained virological response (SVR) can reduce liver-related morbidity and mortality, including a decreased need for transplantation.

In 2014, the first NS5B RNA-polymerase inhibitor, sofosbuvir, was approved for use in conjunction with pegylated interferon-alpha (PEG-IFN) and/or ribavirin to treat hepatitis C infection, and yielded high SVR rates of around 90% after short-term therapy in genotype 1-3-infected patients.In this study, Dr. Benuth and his colleagues evaluated early changes in dynamic fibrosis-related parameters using the enhanced liver fibrosis (ELF) panel, combined with liver stiffness measurement (LSM), along with metabolic alterations in insulin resistance, and lipid and iron metabolism during sofosbuvir-based antiviral therapy.

A total of 32 patients were included in the analysis, and all received treatment with sofosbuvir, 19 in combination with PEG-IFN, 29 in combination with ribavirin, and four in combination with simeprevir.Patients experienced a biochemical and virological response within 4 weeks of starting treatment. At 12 weeks, the SVR was 93.8% and two patients experienced a relapse.There was a significant decrease from baseline to 12-week posttreatment follow-up in ELF (10.00 vs. 9.37; P = .007), and the median of the LSM (measured by Fibroscan) significantly decreased over the whole observation period, from 8 kPa (METAVIR F2) at baseline to 6.8 kPa (METAVIR F0-1) at 12 weeks (P = .016). This suggests a significant regression of liver fibrosis at 12 weeks, compared to baseline.The liver enzymes (ALT, AST, and gamma-GT) rapidly normalized under treatment, and total bilirubin also decreased from the baseline upper normal values (0.91 mg/dL) to 0.74 mg/dL (P = .034).“In conclusion, this is the first study implying significant and clinically relevant reduction in liver fibrosis measures by three independent noninvasive predictors for liver fibrosis assessment and liver stiffness measurement under highly effective antiviral regimens with sofosbuvir,” said the authors.

The study was supported by intramural funding of the University of Mainz (Inneruniversitäre Forschungsförderung Stufe I grant) to Dr. Tim Zimmermann, who has also received consultant/lecture fees and/or travel support from Abbvie, BMS, Gilead, Janssen-Cilag, Merck, and Roche. Dr. Martin F. Sprinzl received research funding from Gilead and lecture fees from Roche. All other authors have no conflicts of interest to declare in terms of this manuscript.

Cirrhosis nearly doubled among Veterans Affairs patients between 2001 and 2013, while cirrhosis-related mortality rose by about 50% and deaths from hepatocellular carcinoma almost tripled, investigators reported in the November issue of Gastroenterology.

Hepatitis C virus infection was “the overwhelming driver of these trends, with smaller contributions from alcoholic liver disease, nonalcoholic fatty liver disease, and other liver diseases,” said Dr. Lauren Beste of the University of Washington, Seattle, and her associates. Based on their data, the prevalence of cirrhosis in the United States will peak in 2021, they said. “In contrast, the incidence of HCC continues to increase, confirming worrisome predictions of rapid growth put forward by work (Gastroenterology. 2010;138[2]:513-21) conducted” in the early 2000s.

New HCV infections have dropped sharply in the United States since about 1990, but cases of HCV-related cirrhosis and HCC continue to rise as chronically infected patients age and their liver disease progresses. Although the burden of cirrhosis and HCC due to HCV infection is expected to peak in about the year 2020, the population-level effects of nonalcoholic fatty liver disease, alcoholic liver disease, and hepatitis B virus infection remained unclear, the investigators said. Therefore, they retrospectively studied underlying etiologies among a national cohort of almost 130,000 Veterans Affairs patients with cirrhosis and more than 21,000 patients with HCC between 2001 and 2013 (Gastroenterology 2015. doi: 10.1053/j.gastro.2015.07.056).

In 2013, the VA cared for more than 5.7 million patients, including about 1% with cirrhosis and 0.13% with HCC. Between 2001 and 2013, the prevalence of cirrhosis almost doubled, rising from 664 to 1,058 cases for every 100,000 patients. Deaths among cirrhotic patients also increased by about half, rising from 83 to 126 for every 100,000 patient-years. These liver-related deaths were mainly caused by HCC, whose incidence rose about 2.5 times from 17 to 45 per 100,000 patient-years, Dr. Beste and her associates reported.

Notably, deaths due to liver cancer rose threefold – from 13 to 37 per 100,000 patient-years between 2001 and 2013, “driven overwhelmingly by HCV with much smaller contributions from NAFLD and alcoholic liver disease,” said the researchers. By 2013, almost half of cirrhosis cases and related deaths occurred among HCV-infected patients, as did 67% of HCC cases and related deaths, they noted.

About 60% of patients with cirrhosis and HCV infection also had a longstanding history of alcohol use, the researchers noted. Addressing both factors, as well as diabetes, obesity, and other drivers of nonalcoholic fatty liver disease, could help ease the national burden of liver disease and liver-related mortality among U.S. veterans and other groups, they added. “The increasing burden of cirrhosis and HCC highlights the need for greater efforts to address their causes at a population level,” Dr. Beste and her associates wrote. “Health care systems will need to accommodate rising numbers of patients with cirrhosis and HCC.”

The Department of Veterans Affairs and the Veterans Health Administration funded the study. The investigators declared no competing interests.

Cirrhosis nearly doubled among Veterans Affairs patients between 2001 and 2013, while cirrhosis-related mortality rose by about 50% and deaths from hepatocellular carcinoma almost tripled, investigators reported in the November issue of Gastroenterology.

Hepatitis C virus infection was “the overwhelming driver of these trends, with smaller contributions from alcoholic liver disease, nonalcoholic fatty liver disease, and other liver diseases,” said Dr. Lauren Beste of the University of Washington, Seattle, and her associates. Based on their data, the prevalence of cirrhosis in the United States will peak in 2021, they said. “In contrast, the incidence of HCC continues to increase, confirming worrisome predictions of rapid growth put forward by work (Gastroenterology. 2010;138[2]:513-21) conducted” in the early 2000s.

New HCV infections have dropped sharply in the United States since about 1990, but cases of HCV-related cirrhosis and HCC continue to rise as chronically infected patients age and their liver disease progresses. Although the burden of cirrhosis and HCC due to HCV infection is expected to peak in about the year 2020, the population-level effects of nonalcoholic fatty liver disease, alcoholic liver disease, and hepatitis B virus infection remained unclear, the investigators said. Therefore, they retrospectively studied underlying etiologies among a national cohort of almost 130,000 Veterans Affairs patients with cirrhosis and more than 21,000 patients with HCC between 2001 and 2013 (Gastroenterology 2015. doi: 10.1053/j.gastro.2015.07.056).

In 2013, the VA cared for more than 5.7 million patients, including about 1% with cirrhosis and 0.13% with HCC. Between 2001 and 2013, the prevalence of cirrhosis almost doubled, rising from 664 to 1,058 cases for every 100,000 patients. Deaths among cirrhotic patients also increased by about half, rising from 83 to 126 for every 100,000 patient-years. These liver-related deaths were mainly caused by HCC, whose incidence rose about 2.5 times from 17 to 45 per 100,000 patient-years, Dr. Beste and her associates reported.

Notably, deaths due to liver cancer rose threefold – from 13 to 37 per 100,000 patient-years between 2001 and 2013, “driven overwhelmingly by HCV with much smaller contributions from NAFLD and alcoholic liver disease,” said the researchers. By 2013, almost half of cirrhosis cases and related deaths occurred among HCV-infected patients, as did 67% of HCC cases and related deaths, they noted.

About 60% of patients with cirrhosis and HCV infection also had a longstanding history of alcohol use, the researchers noted. Addressing both factors, as well as diabetes, obesity, and other drivers of nonalcoholic fatty liver disease, could help ease the national burden of liver disease and liver-related mortality among U.S. veterans and other groups, they added. “The increasing burden of cirrhosis and HCC highlights the need for greater efforts to address their causes at a population level,” Dr. Beste and her associates wrote. “Health care systems will need to accommodate rising numbers of patients with cirrhosis and HCC.”

The Department of Veterans Affairs and the Veterans Health Administration funded the study. The investigators declared no competing interests.

Cirrhosis nearly doubled among Veterans Affairs patients between 2001 and 2013, while cirrhosis-related mortality rose by about 50% and deaths from hepatocellular carcinoma almost tripled, investigators reported in the November issue of Gastroenterology.

Hepatitis C virus infection was “the overwhelming driver of these trends, with smaller contributions from alcoholic liver disease, nonalcoholic fatty liver disease, and other liver diseases,” said Dr. Lauren Beste of the University of Washington, Seattle, and her associates. Based on their data, the prevalence of cirrhosis in the United States will peak in 2021, they said. “In contrast, the incidence of HCC continues to increase, confirming worrisome predictions of rapid growth put forward by work (Gastroenterology. 2010;138[2]:513-21) conducted” in the early 2000s.

New HCV infections have dropped sharply in the United States since about 1990, but cases of HCV-related cirrhosis and HCC continue to rise as chronically infected patients age and their liver disease progresses. Although the burden of cirrhosis and HCC due to HCV infection is expected to peak in about the year 2020, the population-level effects of nonalcoholic fatty liver disease, alcoholic liver disease, and hepatitis B virus infection remained unclear, the investigators said. Therefore, they retrospectively studied underlying etiologies among a national cohort of almost 130,000 Veterans Affairs patients with cirrhosis and more than 21,000 patients with HCC between 2001 and 2013 (Gastroenterology 2015. doi: 10.1053/j.gastro.2015.07.056).

In 2013, the VA cared for more than 5.7 million patients, including about 1% with cirrhosis and 0.13% with HCC. Between 2001 and 2013, the prevalence of cirrhosis almost doubled, rising from 664 to 1,058 cases for every 100,000 patients. Deaths among cirrhotic patients also increased by about half, rising from 83 to 126 for every 100,000 patient-years. These liver-related deaths were mainly caused by HCC, whose incidence rose about 2.5 times from 17 to 45 per 100,000 patient-years, Dr. Beste and her associates reported.

Notably, deaths due to liver cancer rose threefold – from 13 to 37 per 100,000 patient-years between 2001 and 2013, “driven overwhelmingly by HCV with much smaller contributions from NAFLD and alcoholic liver disease,” said the researchers. By 2013, almost half of cirrhosis cases and related deaths occurred among HCV-infected patients, as did 67% of HCC cases and related deaths, they noted.

About 60% of patients with cirrhosis and HCV infection also had a longstanding history of alcohol use, the researchers noted. Addressing both factors, as well as diabetes, obesity, and other drivers of nonalcoholic fatty liver disease, could help ease the national burden of liver disease and liver-related mortality among U.S. veterans and other groups, they added. “The increasing burden of cirrhosis and HCC highlights the need for greater efforts to address their causes at a population level,” Dr. Beste and her associates wrote. “Health care systems will need to accommodate rising numbers of patients with cirrhosis and HCC.”

The Department of Veterans Affairs and the Veterans Health Administration funded the study. The investigators declared no competing interests.

The Patient-Centered Outcomes Research Institute (PCORI) board has approved $83 million in funding for research on hepatitis C virus and other diseases, the group announced Sept. 28.

Two of the 26 awards, totaling $29.5 million, will be used towards studies on caring for HCV patients, PCORI said in a statement.

Jezperklauzen/ThinkStock.com

The HCV awards were the result of a “targeted funding opportunity PCORI issued in response to input from the health care community, which identified HCV infection as a top health concern,” the statement said. PCORI is an independent, nonprofit organization based in Washington.

Studies will focus on comparing different antiviral medication regimens and improving treatment adherence in injection drug users.

“New oral medications for HCV offer significant improvements over previous therapies, but they were tested in specialized settings with carefully selected groups of patients,” PCORI said. The group hopes the grants will help close these research gaps and provide evidence of long-term efficacy, so patients and providers can make informed treatment decisions.

The HCV trials “will involve national advocacy organizations, major professional associations, payers, or other key patient and stakeholder groups in their research design and implementation,” PCORI said.

Read more at the PCORI website.

mrajaraman@frontlinemedcom.com

The Patient-Centered Outcomes Research Institute (PCORI) board has approved $83 million in funding for research on hepatitis C virus and other diseases, the group announced Sept. 28.

Two of the 26 awards, totaling $29.5 million, will be used towards studies on caring for HCV patients, PCORI said in a statement.

Jezperklauzen/ThinkStock.com

The HCV awards were the result of a “targeted funding opportunity PCORI issued in response to input from the health care community, which identified HCV infection as a top health concern,” the statement said. PCORI is an independent, nonprofit organization based in Washington.

Studies will focus on comparing different antiviral medication regimens and improving treatment adherence in injection drug users.

“New oral medications for HCV offer significant improvements over previous therapies, but they were tested in specialized settings with carefully selected groups of patients,” PCORI said. The group hopes the grants will help close these research gaps and provide evidence of long-term efficacy, so patients and providers can make informed treatment decisions.

The HCV trials “will involve national advocacy organizations, major professional associations, payers, or other key patient and stakeholder groups in their research design and implementation,” PCORI said.

Read more at the PCORI website.

mrajaraman@frontlinemedcom.com

The Patient-Centered Outcomes Research Institute (PCORI) board has approved $83 million in funding for research on hepatitis C virus and other diseases, the group announced Sept. 28.

Two of the 26 awards, totaling $29.5 million, will be used towards studies on caring for HCV patients, PCORI said in a statement.

Jezperklauzen/ThinkStock.com

The HCV awards were the result of a “targeted funding opportunity PCORI issued in response to input from the health care community, which identified HCV infection as a top health concern,” the statement said. PCORI is an independent, nonprofit organization based in Washington.

Studies will focus on comparing different antiviral medication regimens and improving treatment adherence in injection drug users.

“New oral medications for HCV offer significant improvements over previous therapies, but they were tested in specialized settings with carefully selected groups of patients,” PCORI said. The group hopes the grants will help close these research gaps and provide evidence of long-term efficacy, so patients and providers can make informed treatment decisions.

The HCV trials “will involve national advocacy organizations, major professional associations, payers, or other key patient and stakeholder groups in their research design and implementation,” PCORI said.

Read more at the PCORI website.

mrajaraman@frontlinemedcom.com

A once-daily, fixed-dose combination of sofosbuvir (SOF) plus velpatasvir (VEL) had high success rates for the treatment of all six genotypes of hepatitis C virus, manufacturer Gilead Sciences reported.

In three of four phase III trials (ASTRAL-1, ASTRAL-2, and ASTRAL-3), 1,035 HCV patients were given the drug combination for 12 weeks. In the fourth trial (ASTRAL-4), 267 HCV patients with decompensated cirrhosis were randomized to receive either the SOF/VEL combination for 12 weeks with or without ribavirin or 24 weeks of just SOF/VEL. The primary efficacy endpoint for all studies was a sustained virological response at 12 weeks, the company said in a statement.

Courtesy US. Dept of Veterans Affairs

Results showed that 98% of patients in the first three trials achieved the efficacy endpoint. In the ASTRAL-4 study, 94% of patients in the SOF/VEL plus ribavirin group achieved sustained virological response at 12 weeks. The rates of success in patients receiving the SOF/VEL combination for 12 or 24 weeks were 83% and 86%, respectively. The most common adverse effects were fatigue, nausea, and headache.

The FDA has designated the SOF/VEL combination as “breakthrough therapy” status, granted to “investigational medicines that may offer major advances in treatment over existing options,” the statement said.

mrajaraman@frontlinemedcom.com

A once-daily, fixed-dose combination of sofosbuvir (SOF) plus velpatasvir (VEL) had high success rates for the treatment of all six genotypes of hepatitis C virus, manufacturer Gilead Sciences reported.

In three of four phase III trials (ASTRAL-1, ASTRAL-2, and ASTRAL-3), 1,035 HCV patients were given the drug combination for 12 weeks. In the fourth trial (ASTRAL-4), 267 HCV patients with decompensated cirrhosis were randomized to receive either the SOF/VEL combination for 12 weeks with or without ribavirin or 24 weeks of just SOF/VEL. The primary efficacy endpoint for all studies was a sustained virological response at 12 weeks, the company said in a statement.

Courtesy US. Dept of Veterans Affairs

Results showed that 98% of patients in the first three trials achieved the efficacy endpoint. In the ASTRAL-4 study, 94% of patients in the SOF/VEL plus ribavirin group achieved sustained virological response at 12 weeks. The rates of success in patients receiving the SOF/VEL combination for 12 or 24 weeks were 83% and 86%, respectively. The most common adverse effects were fatigue, nausea, and headache.

The FDA has designated the SOF/VEL combination as “breakthrough therapy” status, granted to “investigational medicines that may offer major advances in treatment over existing options,” the statement said.

mrajaraman@frontlinemedcom.com

A once-daily, fixed-dose combination of sofosbuvir (SOF) plus velpatasvir (VEL) had high success rates for the treatment of all six genotypes of hepatitis C virus, manufacturer Gilead Sciences reported.

In three of four phase III trials (ASTRAL-1, ASTRAL-2, and ASTRAL-3), 1,035 HCV patients were given the drug combination for 12 weeks. In the fourth trial (ASTRAL-4), 267 HCV patients with decompensated cirrhosis were randomized to receive either the SOF/VEL combination for 12 weeks with or without ribavirin or 24 weeks of just SOF/VEL. The primary efficacy endpoint for all studies was a sustained virological response at 12 weeks, the company said in a statement.

Courtesy US. Dept of Veterans Affairs

Results showed that 98% of patients in the first three trials achieved the efficacy endpoint. In the ASTRAL-4 study, 94% of patients in the SOF/VEL plus ribavirin group achieved sustained virological response at 12 weeks. The rates of success in patients receiving the SOF/VEL combination for 12 or 24 weeks were 83% and 86%, respectively. The most common adverse effects were fatigue, nausea, and headache.

The FDA has designated the SOF/VEL combination as “breakthrough therapy” status, granted to “investigational medicines that may offer major advances in treatment over existing options,” the statement said.

mrajaraman@frontlinemedcom.com

Researchers have road-tested an app based on the Stroop test, which is designed to detect covert hepatic encephalopathy, with results suggesting it achieves results similar to those of a paper-based Stroop test.

The smartphone-based EncephalApp was tested in 167 patients with cirrhosis and 114 healthy age-matched controls, and showed significant correlation with individual paper/pen test and with crashes and illegal turns in driving simulation tests, as well as high test/retest reliability at 1 and 3 months.

The study also found that patients with prior overt hepatic encephalopathy had significantly worse response times with the EncephalApp compared to controls (Clin Gastroenterol Hepatol. 2015;13:1828-35).

“Although these [gold standard paper-pencil] measures are used to diagnose CHE [covert hepatic encephalopathy] in research studies, they have not found traction in clinical practice because of their copyrighted nature, need for psychological expertise, and time requirements,” wrote Dr. Jasmohan S. Bajaj of Virginia Commonwealth University and McGuire VA Hospital, both in Richmond, Va.

“Our results are in sync with the prior experience with the old Stroop App in that in similar prior HE [hepatic encephalopathy] studies, we found that the psychomotor function, i.e., the time required to complete tasks, was much more predictive than the errors committed (number of runs required) and the cognitive flexibility measures (OnTime-OffTime) in differentiating groups,” wrote Dr. Bajaj and colleagues.

The National Institute of Diabetes and Digestive and Kidney Diseases, the National Center for Advancing Translational Research and the McGuire Research Institute funded the study. There were no other conflicts of interest declared.

Researchers have road-tested an app based on the Stroop test, which is designed to detect covert hepatic encephalopathy, with results suggesting it achieves results similar to those of a paper-based Stroop test.

The smartphone-based EncephalApp was tested in 167 patients with cirrhosis and 114 healthy age-matched controls, and showed significant correlation with individual paper/pen test and with crashes and illegal turns in driving simulation tests, as well as high test/retest reliability at 1 and 3 months.

The study also found that patients with prior overt hepatic encephalopathy had significantly worse response times with the EncephalApp compared to controls (Clin Gastroenterol Hepatol. 2015;13:1828-35).

“Although these [gold standard paper-pencil] measures are used to diagnose CHE [covert hepatic encephalopathy] in research studies, they have not found traction in clinical practice because of their copyrighted nature, need for psychological expertise, and time requirements,” wrote Dr. Jasmohan S. Bajaj of Virginia Commonwealth University and McGuire VA Hospital, both in Richmond, Va.

“Our results are in sync with the prior experience with the old Stroop App in that in similar prior HE [hepatic encephalopathy] studies, we found that the psychomotor function, i.e., the time required to complete tasks, was much more predictive than the errors committed (number of runs required) and the cognitive flexibility measures (OnTime-OffTime) in differentiating groups,” wrote Dr. Bajaj and colleagues.

The National Institute of Diabetes and Digestive and Kidney Diseases, the National Center for Advancing Translational Research and the McGuire Research Institute funded the study. There were no other conflicts of interest declared.

Researchers have road-tested an app based on the Stroop test, which is designed to detect covert hepatic encephalopathy, with results suggesting it achieves results similar to those of a paper-based Stroop test.

The smartphone-based EncephalApp was tested in 167 patients with cirrhosis and 114 healthy age-matched controls, and showed significant correlation with individual paper/pen test and with crashes and illegal turns in driving simulation tests, as well as high test/retest reliability at 1 and 3 months.

The study also found that patients with prior overt hepatic encephalopathy had significantly worse response times with the EncephalApp compared to controls (Clin Gastroenterol Hepatol. 2015;13:1828-35).

“Although these [gold standard paper-pencil] measures are used to diagnose CHE [covert hepatic encephalopathy] in research studies, they have not found traction in clinical practice because of their copyrighted nature, need for psychological expertise, and time requirements,” wrote Dr. Jasmohan S. Bajaj of Virginia Commonwealth University and McGuire VA Hospital, both in Richmond, Va.

“Our results are in sync with the prior experience with the old Stroop App in that in similar prior HE [hepatic encephalopathy] studies, we found that the psychomotor function, i.e., the time required to complete tasks, was much more predictive than the errors committed (number of runs required) and the cognitive flexibility measures (OnTime-OffTime) in differentiating groups,” wrote Dr. Bajaj and colleagues.

The National Institute of Diabetes and Digestive and Kidney Diseases, the National Center for Advancing Translational Research and the McGuire Research Institute funded the study. There were no other conflicts of interest declared.

Patients with hepatitis C and psychiatric disorders or substance abuse problems benefit significantly from an integrated care model of treatment, with a randomized controlled trial showing such an approach is linked to greater rates of antiviral therapy and treatment response.

The prospective trial of integrated care versus usual care involved 363 patients attending three hepatitis C (HCV) clinics, with the integrated care being delivered by a midlevel mental health provider within the clinic who served as the regular contact and case manager.

Patients randomized to integrated care, which included brief psychological interventions and case management, were more than twice as likely to start antiviral therapy earlier and achieve a sustained virologic response than those who received usual care, according to Dr. Samuel B. Ho of the VA San Diego Healthcare System and his coauthors.

While individuals with a history of prior psychiatric disorder or active drug use were significantly less likely to achieve sustained virologic response, the integrated-care approach had particularly positive effects on treatment initiative and response for individuals with a risk for active psychiatric disease at baseline, they said (Clin Gastroenterol Hepatol. 2015. doi: 10.1016/j.cgh.2015.02.022).

“To optimize the public health impact of antiviral treatments for HCV, the number of patients who are able to receive these treatments must be expanded,” wrote Dr. Ho and his associates, adding that “new interferon-free regimens have fewer side effects and are expected to expand treatment populations to include a broader range of patients, many with very significant psychiatric and substance abuse disorders.”

The study was supported by VA Health Services Research and Development. Three authors declared research support, grants, advisory board positions or speakers bureau roles with the pharmaceutical industry.

Patients with hepatitis C and psychiatric disorders or substance abuse problems benefit significantly from an integrated care model of treatment, with a randomized controlled trial showing such an approach is linked to greater rates of antiviral therapy and treatment response.

The prospective trial of integrated care versus usual care involved 363 patients attending three hepatitis C (HCV) clinics, with the integrated care being delivered by a midlevel mental health provider within the clinic who served as the regular contact and case manager.

Patients randomized to integrated care, which included brief psychological interventions and case management, were more than twice as likely to start antiviral therapy earlier and achieve a sustained virologic response than those who received usual care, according to Dr. Samuel B. Ho of the VA San Diego Healthcare System and his coauthors.

While individuals with a history of prior psychiatric disorder or active drug use were significantly less likely to achieve sustained virologic response, the integrated-care approach had particularly positive effects on treatment initiative and response for individuals with a risk for active psychiatric disease at baseline, they said (Clin Gastroenterol Hepatol. 2015. doi: 10.1016/j.cgh.2015.02.022).

“To optimize the public health impact of antiviral treatments for HCV, the number of patients who are able to receive these treatments must be expanded,” wrote Dr. Ho and his associates, adding that “new interferon-free regimens have fewer side effects and are expected to expand treatment populations to include a broader range of patients, many with very significant psychiatric and substance abuse disorders.”

The study was supported by VA Health Services Research and Development. Three authors declared research support, grants, advisory board positions or speakers bureau roles with the pharmaceutical industry.

Patients with hepatitis C and psychiatric disorders or substance abuse problems benefit significantly from an integrated care model of treatment, with a randomized controlled trial showing such an approach is linked to greater rates of antiviral therapy and treatment response.

The prospective trial of integrated care versus usual care involved 363 patients attending three hepatitis C (HCV) clinics, with the integrated care being delivered by a midlevel mental health provider within the clinic who served as the regular contact and case manager.

Patients randomized to integrated care, which included brief psychological interventions and case management, were more than twice as likely to start antiviral therapy earlier and achieve a sustained virologic response than those who received usual care, according to Dr. Samuel B. Ho of the VA San Diego Healthcare System and his coauthors.

While individuals with a history of prior psychiatric disorder or active drug use were significantly less likely to achieve sustained virologic response, the integrated-care approach had particularly positive effects on treatment initiative and response for individuals with a risk for active psychiatric disease at baseline, they said (Clin Gastroenterol Hepatol. 2015. doi: 10.1016/j.cgh.2015.02.022).

“To optimize the public health impact of antiviral treatments for HCV, the number of patients who are able to receive these treatments must be expanded,” wrote Dr. Ho and his associates, adding that “new interferon-free regimens have fewer side effects and are expected to expand treatment populations to include a broader range of patients, many with very significant psychiatric and substance abuse disorders.”

The study was supported by VA Health Services Research and Development. Three authors declared research support, grants, advisory board positions or speakers bureau roles with the pharmaceutical industry.

A significant number of cases of acute liver failure may be caused by the hepatitis E virus, which a new study suggests may not necessarily be identified or excluded using serologic tests.

A retrospective analysis of 80 European patients with acute liver failure or acute hepatitis found that, while 12 patients (15%) tested positive for hepatitis E virus (HEV) IgG antibodies, seven of these patients were negative for IgM antibodies or HEV RNA, according to a study published in Clinical Gastroenterology and Hepatology.

CDC/Wikimedia Commons/Public Domain

Eight patients (10%) tested positive for HEV RNA, but only four of these were definitely positive for HEV IgG and five for HEV IgM.

Four were initially diagnosed as having idiosyncratic drug-induced liver injury, with other diagnoses being acetaminophen intoxication, amanita intoxication, and Wilson’s disease; one patient who had received a hematopoietic stem cell transplant was initially diagnosed with graft-versus-host disease.

One patient died, two received liver transplants, and the remaining patients survived (Clin Gastro Hepatol. 2015. doi: 10.1016/j.cgh.2015.04.014).

“Our data confirms recent descriptions of cases of severe liver injury in Europe, and underlines the necessity to consider hepatitis E as an underlying or additional cause for ALF [acute liver failure],” wrote Dr. Paul Manka of the University Duisburg-Essen in Essen, Germany, and coauthors.

The study was supported by the Deutsche Forschungsgemeinschaft (German Research Foundation) and by the Wilhelm-Laupitz Foundation. There were no other conflicts of interest declared.

A significant number of cases of acute liver failure may be caused by the hepatitis E virus, which a new study suggests may not necessarily be identified or excluded using serologic tests.

A retrospective analysis of 80 European patients with acute liver failure or acute hepatitis found that, while 12 patients (15%) tested positive for hepatitis E virus (HEV) IgG antibodies, seven of these patients were negative for IgM antibodies or HEV RNA, according to a study published in Clinical Gastroenterology and Hepatology.

CDC/Wikimedia Commons/Public Domain

Eight patients (10%) tested positive for HEV RNA, but only four of these were definitely positive for HEV IgG and five for HEV IgM.

Four were initially diagnosed as having idiosyncratic drug-induced liver injury, with other diagnoses being acetaminophen intoxication, amanita intoxication, and Wilson’s disease; one patient who had received a hematopoietic stem cell transplant was initially diagnosed with graft-versus-host disease.

One patient died, two received liver transplants, and the remaining patients survived (Clin Gastro Hepatol. 2015. doi: 10.1016/j.cgh.2015.04.014).

“Our data confirms recent descriptions of cases of severe liver injury in Europe, and underlines the necessity to consider hepatitis E as an underlying or additional cause for ALF [acute liver failure],” wrote Dr. Paul Manka of the University Duisburg-Essen in Essen, Germany, and coauthors.

The study was supported by the Deutsche Forschungsgemeinschaft (German Research Foundation) and by the Wilhelm-Laupitz Foundation. There were no other conflicts of interest declared.

A significant number of cases of acute liver failure may be caused by the hepatitis E virus, which a new study suggests may not necessarily be identified or excluded using serologic tests.

A retrospective analysis of 80 European patients with acute liver failure or acute hepatitis found that, while 12 patients (15%) tested positive for hepatitis E virus (HEV) IgG antibodies, seven of these patients were negative for IgM antibodies or HEV RNA, according to a study published in Clinical Gastroenterology and Hepatology.

CDC/Wikimedia Commons/Public Domain

Eight patients (10%) tested positive for HEV RNA, but only four of these were definitely positive for HEV IgG and five for HEV IgM.

Four were initially diagnosed as having idiosyncratic drug-induced liver injury, with other diagnoses being acetaminophen intoxication, amanita intoxication, and Wilson’s disease; one patient who had received a hematopoietic stem cell transplant was initially diagnosed with graft-versus-host disease.

One patient died, two received liver transplants, and the remaining patients survived (Clin Gastro Hepatol. 2015. doi: 10.1016/j.cgh.2015.04.014).

“Our data confirms recent descriptions of cases of severe liver injury in Europe, and underlines the necessity to consider hepatitis E as an underlying or additional cause for ALF [acute liver failure],” wrote Dr. Paul Manka of the University Duisburg-Essen in Essen, Germany, and coauthors.

The study was supported by the Deutsche Forschungsgemeinschaft (German Research Foundation) and by the Wilhelm-Laupitz Foundation. There were no other conflicts of interest declared.