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Grim projections for hepatitis C disease burden in the U.S.

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Grim projections for hepatitis C disease burden in the U.S.

Although highly effective oral direct-acting antivirals (DAAs) provide clinicians with the opportunity to reduce the substantial disease burden associated with hepatitis C virus (HCV) infection in the United States, the promise of these agents cannot be realized without the expansion of HCV screening and treatment capacity, according to a report published online in Hepatology.

Working with his colleagues, Dr. Jagpreet Chhatwal of the Massachusetts General Hospital Institute for Technology Assessment and of the department of radiology at Harvard Medical School, both in Boston, utilized a validated projection model previously developed by this research team to estimate the numbers of people in the United States who will die, develop hepatocellular carcinoma, and develop decompensated cirrhosis over the next 35 years (Hepatology. 2016 Mar 25. doi: 10.1002/hep.28571).

Jezperklauzen/ThinkStock

The results of the model provided an estimate of 320,000 for the cumulative number of HCV-associated deaths in individuals treated with oral DAAs from 2015 to 2050. In addition, the projected cumulative incidence of hepatocellular carcinoma was 157,000, and the projected cumulative incidence of decompensated cirrhosis was 203,000 in individuals treated with oral DAAs from 2015 to 2050. Furthermore, the projected number of liver transplants for those on DAAs between 2015 and 2050 was 32,000.

When assessing the variables that most heavily influenced the projections, the authors said that most of the ongoing burden of HCV is related to the proportion of infected individuals who remain unaware of their infection status.

Despite such grim predictions, the research suggests hope remains, the authors said. With the same model, changing the rate of treatment from 150,000 patients per year in 2014 to 280,000 patients per year from 2015 onward would result in large reductions in the projected disease burden. For example, 8,600 cases of decompensated cirrhosis, 5,400 cases of hepatocellular carcinoma, 9,700 liver-related deaths, and 900 liver transplants would be prevented. These numbers would increase further if the annual treatment rate was increased to 500,000 patients per year from 2015 onward, preventing 12,000 cases of decompensated cirrhosis, 7,400 cases of hepatocellular carcinoma, 13,500 liver-related deaths, and 1,400 liver transplants. These model-based results emphasize the importance of expanding treatment capacity, as well as HCV screening efforts, the investigators said.

The results are important for the planning and distribution of health care resources and personnel in order to ensure that they match both current and future treatment demands, the investigators added. As an example, they highlighted their projection indicating that the number of clinicians and facilities offering HCV treatment would need to increase substantially over the next 3-4 years. Toward this end, they suggested that primary care physicians or infectious disease specialists be incorporated into HCV treatment capacity expansion.

This project was funded in part by the National Institutes of Health and Gilead Sciences. No conflicts of interest were declared.

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Although highly effective oral direct-acting antivirals (DAAs) provide clinicians with the opportunity to reduce the substantial disease burden associated with hepatitis C virus (HCV) infection in the United States, the promise of these agents cannot be realized without the expansion of HCV screening and treatment capacity, according to a report published online in Hepatology.

Working with his colleagues, Dr. Jagpreet Chhatwal of the Massachusetts General Hospital Institute for Technology Assessment and of the department of radiology at Harvard Medical School, both in Boston, utilized a validated projection model previously developed by this research team to estimate the numbers of people in the United States who will die, develop hepatocellular carcinoma, and develop decompensated cirrhosis over the next 35 years (Hepatology. 2016 Mar 25. doi: 10.1002/hep.28571).

Jezperklauzen/ThinkStock

The results of the model provided an estimate of 320,000 for the cumulative number of HCV-associated deaths in individuals treated with oral DAAs from 2015 to 2050. In addition, the projected cumulative incidence of hepatocellular carcinoma was 157,000, and the projected cumulative incidence of decompensated cirrhosis was 203,000 in individuals treated with oral DAAs from 2015 to 2050. Furthermore, the projected number of liver transplants for those on DAAs between 2015 and 2050 was 32,000.

When assessing the variables that most heavily influenced the projections, the authors said that most of the ongoing burden of HCV is related to the proportion of infected individuals who remain unaware of their infection status.

Despite such grim predictions, the research suggests hope remains, the authors said. With the same model, changing the rate of treatment from 150,000 patients per year in 2014 to 280,000 patients per year from 2015 onward would result in large reductions in the projected disease burden. For example, 8,600 cases of decompensated cirrhosis, 5,400 cases of hepatocellular carcinoma, 9,700 liver-related deaths, and 900 liver transplants would be prevented. These numbers would increase further if the annual treatment rate was increased to 500,000 patients per year from 2015 onward, preventing 12,000 cases of decompensated cirrhosis, 7,400 cases of hepatocellular carcinoma, 13,500 liver-related deaths, and 1,400 liver transplants. These model-based results emphasize the importance of expanding treatment capacity, as well as HCV screening efforts, the investigators said.

The results are important for the planning and distribution of health care resources and personnel in order to ensure that they match both current and future treatment demands, the investigators added. As an example, they highlighted their projection indicating that the number of clinicians and facilities offering HCV treatment would need to increase substantially over the next 3-4 years. Toward this end, they suggested that primary care physicians or infectious disease specialists be incorporated into HCV treatment capacity expansion.

This project was funded in part by the National Institutes of Health and Gilead Sciences. No conflicts of interest were declared.

Although highly effective oral direct-acting antivirals (DAAs) provide clinicians with the opportunity to reduce the substantial disease burden associated with hepatitis C virus (HCV) infection in the United States, the promise of these agents cannot be realized without the expansion of HCV screening and treatment capacity, according to a report published online in Hepatology.

Working with his colleagues, Dr. Jagpreet Chhatwal of the Massachusetts General Hospital Institute for Technology Assessment and of the department of radiology at Harvard Medical School, both in Boston, utilized a validated projection model previously developed by this research team to estimate the numbers of people in the United States who will die, develop hepatocellular carcinoma, and develop decompensated cirrhosis over the next 35 years (Hepatology. 2016 Mar 25. doi: 10.1002/hep.28571).

Jezperklauzen/ThinkStock

The results of the model provided an estimate of 320,000 for the cumulative number of HCV-associated deaths in individuals treated with oral DAAs from 2015 to 2050. In addition, the projected cumulative incidence of hepatocellular carcinoma was 157,000, and the projected cumulative incidence of decompensated cirrhosis was 203,000 in individuals treated with oral DAAs from 2015 to 2050. Furthermore, the projected number of liver transplants for those on DAAs between 2015 and 2050 was 32,000.

When assessing the variables that most heavily influenced the projections, the authors said that most of the ongoing burden of HCV is related to the proportion of infected individuals who remain unaware of their infection status.

Despite such grim predictions, the research suggests hope remains, the authors said. With the same model, changing the rate of treatment from 150,000 patients per year in 2014 to 280,000 patients per year from 2015 onward would result in large reductions in the projected disease burden. For example, 8,600 cases of decompensated cirrhosis, 5,400 cases of hepatocellular carcinoma, 9,700 liver-related deaths, and 900 liver transplants would be prevented. These numbers would increase further if the annual treatment rate was increased to 500,000 patients per year from 2015 onward, preventing 12,000 cases of decompensated cirrhosis, 7,400 cases of hepatocellular carcinoma, 13,500 liver-related deaths, and 1,400 liver transplants. These model-based results emphasize the importance of expanding treatment capacity, as well as HCV screening efforts, the investigators said.

The results are important for the planning and distribution of health care resources and personnel in order to ensure that they match both current and future treatment demands, the investigators added. As an example, they highlighted their projection indicating that the number of clinicians and facilities offering HCV treatment would need to increase substantially over the next 3-4 years. Toward this end, they suggested that primary care physicians or infectious disease specialists be incorporated into HCV treatment capacity expansion.

This project was funded in part by the National Institutes of Health and Gilead Sciences. No conflicts of interest were declared.

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FROM HEPATOLOGY

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Key clinical point: Unless screening and treatment capacity for hepatitis C virus infection are expanded, associated disease burdens are projected to remain high, despite the availability of highly efficacious direct-acting antiviral agents.

Major Finding: Model-based projections suggest that hundreds of thousands of people will die, develop hepatocellular carcinoma, and develop decompensated cirrhosis in the United States by 2050.

Data Source: A validated hepatitis C disease burden simulation model previously developed and used to project the changing prevalence of hepatitis C virus in the United States.

Disclosures: This project was funded in part by the National Institutes of Health and Gilead Sciences. No conflicts of interest were declared.

VIDEO: Myths and truths of gluten-free diets

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VIDEO: Myths and truths of gluten-free diets

PHILADELPHIA – Do you have patients with undiagnosed celiac disease or legitimate gluten sensitivity, or are they self-diagnosing with the need to steer clear of gluten, only to find themselves in danger of nutritional deficiencies and other health concerns?

Of the roughly 1% of Americans who have celiac disease, only about 17% ever receive a diagnosis, leaving the remainder at risk for serious health complications, according to Dr. Peter H.R. Green, director of the Celiac Disease Center at Columbia University, New York.

Meanwhile, many people choose to go gluten free, which Dr. Green calls the most popular “fad” diet in the country. Aside from this trend being more expensive, and often inconvenient, it’s also a health risk. “It’s ironic that so many people who should be on a gluten-free diet aren’t, and those who are don’t need to be, and might even be harming their health,” he said in an interview.

In this video, Dr. Green discusses how to determine whether patients have celiac disease or another diagnosis, and how to counsel those who do have the disease and those who don’t.

The video was recorded at this year’s Digestive Diseases: New Advances, held by Global Academy for Medical Education and Rutgers, the State University of New Jersey. Global Academy and this news organization are owned by the same company.

 

 

 

 

wmcknight@frontlinemedcom.com

On Twitter @whitneymcknight

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PHILADELPHIA – Do you have patients with undiagnosed celiac disease or legitimate gluten sensitivity, or are they self-diagnosing with the need to steer clear of gluten, only to find themselves in danger of nutritional deficiencies and other health concerns?

Of the roughly 1% of Americans who have celiac disease, only about 17% ever receive a diagnosis, leaving the remainder at risk for serious health complications, according to Dr. Peter H.R. Green, director of the Celiac Disease Center at Columbia University, New York.

Meanwhile, many people choose to go gluten free, which Dr. Green calls the most popular “fad” diet in the country. Aside from this trend being more expensive, and often inconvenient, it’s also a health risk. “It’s ironic that so many people who should be on a gluten-free diet aren’t, and those who are don’t need to be, and might even be harming their health,” he said in an interview.

In this video, Dr. Green discusses how to determine whether patients have celiac disease or another diagnosis, and how to counsel those who do have the disease and those who don’t.

The video was recorded at this year’s Digestive Diseases: New Advances, held by Global Academy for Medical Education and Rutgers, the State University of New Jersey. Global Academy and this news organization are owned by the same company.

 

 

 

 

wmcknight@frontlinemedcom.com

On Twitter @whitneymcknight

PHILADELPHIA – Do you have patients with undiagnosed celiac disease or legitimate gluten sensitivity, or are they self-diagnosing with the need to steer clear of gluten, only to find themselves in danger of nutritional deficiencies and other health concerns?

Of the roughly 1% of Americans who have celiac disease, only about 17% ever receive a diagnosis, leaving the remainder at risk for serious health complications, according to Dr. Peter H.R. Green, director of the Celiac Disease Center at Columbia University, New York.

Meanwhile, many people choose to go gluten free, which Dr. Green calls the most popular “fad” diet in the country. Aside from this trend being more expensive, and often inconvenient, it’s also a health risk. “It’s ironic that so many people who should be on a gluten-free diet aren’t, and those who are don’t need to be, and might even be harming their health,” he said in an interview.

In this video, Dr. Green discusses how to determine whether patients have celiac disease or another diagnosis, and how to counsel those who do have the disease and those who don’t.

The video was recorded at this year’s Digestive Diseases: New Advances, held by Global Academy for Medical Education and Rutgers, the State University of New Jersey. Global Academy and this news organization are owned by the same company.

 

 

 

 

wmcknight@frontlinemedcom.com

On Twitter @whitneymcknight

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Hepatitis Outlook: March 2016

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Hepatitis Outlook: March 2016

If you work on the front lines of medical care treating patients with hepatitis, you may not have time to review all the hepatitis research that enters the medical literature every month. Here’s a quick look at some notable news items and journal articles published over the past month, covering a variety of the major hepatitis viruses.

In the United States, hepatitis C virus (HCV)-associated mortality is increasing. From 2003-2013, the number of deaths associated with HCV has now surpassed 60 other nationally notifiable infectious conditions combined.

Courtesy NIH

Chronic hepatitis B infection increased mortality and complexity among a cohort of HIV-coinfected patients in South Africa, according to a study in HIV Medicine. Researchers found that mortality was increased for chronic hepatitis B patients with hepatitis B virus DNA levels greater than 10,000 copies/mL, compared with non-coinfected patients.

A study in the Journal of Infectious Diseases found that Interferon Lambda (IFNL) genotypes were individually linked to higher rates of fibrosis in HIV–hepatitis C co-infection. Investigators said IFNL genotypes may be useful to target hepatitis C virus treatments to those who are at higher risk of liver disease.

A phase I study of a new NS3/4A protease inhibitor for treatment of chronic hepatitis C virus genotype 1-4 infection yielded positive tolerability, efficacy, and pharmacokinetic results, indicating further evaluation is warranted. The drug, GS-9857, produced by Gilead Sciences, achieved mean and median maximum reductions in HCV RNA of greater than or equal to 3 log10 IU/mL following administration of a 100-mg dose in patients with HCV genotype 1a, 1b, 2, 3, or 4 infection.

High baseline bilirubin and low albumin predict liver decompensation and serious adverse events in hepatitis C-infected patients treated with sofosbuvir-containing regimens, according to a study in the Journal of Viral Hepatitis. Among 499 previously stable patients in the cohort, the incidence of decompensation/events was 4.5%, and the mortality rate was 0.6%.

A meta-analysis of national-level hepatitis C virus prevalence in the Arabian Gulf region found that it is comparable to global levels, although higher HCV prevalence is found in specific expatriate populations reflecting the prevalence in their countries of origin.

A resistance analysis of the drug GS-9190, a NS5B non-nucleoside analogue for the treatment of hepatitis C virus infection, found that the Y448H mutation was rapidly selected in the majority of patients receiving multiple doses of GS-9190 as monotherapy, despite undetectable levels in pretreatment samples. Researchers concluded that Y448H confers reduced susceptibility to GS-9190 and other non-nucleoside inhibitors and persisted in most patients for months post-treatment.

A study published in the International Journal of Infectious Diseases found that hepatitis delta virus (HDV) patients in the Amazon region can be treated with a combination of Pegylated Interferon Alpha and Entecavir for 48 weeks, with good chances of negative HDV RNA at week 24. The results suggest that HDV-3 in the native population may be an “easy to treat” variant compared to HDV-1.

Development of acute hepatitis B virus disease in successfully vaccinated individuals is a rare event, affirmed a study of the Italian Surveillance System for Acute Viral Hepatitis (SEIEVA) from 1993 to 2014. Only 3.2% of acute hepatitis B cases had been vaccinated. Investigators said further efforts are needed to enhance the vaccine coverage rate in people at increased risk of infection, as hepatitis B is a vaccine-preventable disease.

Lab-made hepatocyte transplantation has therapeutic potential as a bridge or even alternative to whole organ liver transplantation, but researchers say deficiencies and uncertainties must be addressed in future studies aimed at developing liver cell therapies with such hepatocytes.

A major concern in potential liver transplant candidates is of unintended harm by achieving sustained viral response rates to direct-acting antiviral treatment, but without improvement in hepatic function to an extent where the patients might function well. A review essay in the Journal of Viral Hepatitis says there is a growing sentiment in some transplant quarters that those with decompensated liver disease awaiting liver transplant be treated for HCV after liver transplant instead of pre-transplant. The authors say it is essential that to develop robust predictors of improvement in liver function so patients can be carefully selected for therapy in the context of liver transplantation.

Treating mild-stage hepatitis C infection in people who inject drugs had virtually no impact on HCV-related end-stage liver disease/hepatocellular carcinoma (ESLD/HCC) within 15 years, a recent study found, but the long timescale of liver disease means relatively few people who inject drugs reach cirrhosis before cessation of injecting. Investigators said strategies focusing on treating advanced disease have the potential for dramatic reductions in severe morbidity, but virtually no preventative impact.

 

 

rpizzi@frontlinemedcom.com

On Twitter @richpizzi

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If you work on the front lines of medical care treating patients with hepatitis, you may not have time to review all the hepatitis research that enters the medical literature every month. Here’s a quick look at some notable news items and journal articles published over the past month, covering a variety of the major hepatitis viruses.

In the United States, hepatitis C virus (HCV)-associated mortality is increasing. From 2003-2013, the number of deaths associated with HCV has now surpassed 60 other nationally notifiable infectious conditions combined.

Courtesy NIH

Chronic hepatitis B infection increased mortality and complexity among a cohort of HIV-coinfected patients in South Africa, according to a study in HIV Medicine. Researchers found that mortality was increased for chronic hepatitis B patients with hepatitis B virus DNA levels greater than 10,000 copies/mL, compared with non-coinfected patients.

A study in the Journal of Infectious Diseases found that Interferon Lambda (IFNL) genotypes were individually linked to higher rates of fibrosis in HIV–hepatitis C co-infection. Investigators said IFNL genotypes may be useful to target hepatitis C virus treatments to those who are at higher risk of liver disease.

A phase I study of a new NS3/4A protease inhibitor for treatment of chronic hepatitis C virus genotype 1-4 infection yielded positive tolerability, efficacy, and pharmacokinetic results, indicating further evaluation is warranted. The drug, GS-9857, produced by Gilead Sciences, achieved mean and median maximum reductions in HCV RNA of greater than or equal to 3 log10 IU/mL following administration of a 100-mg dose in patients with HCV genotype 1a, 1b, 2, 3, or 4 infection.

High baseline bilirubin and low albumin predict liver decompensation and serious adverse events in hepatitis C-infected patients treated with sofosbuvir-containing regimens, according to a study in the Journal of Viral Hepatitis. Among 499 previously stable patients in the cohort, the incidence of decompensation/events was 4.5%, and the mortality rate was 0.6%.

A meta-analysis of national-level hepatitis C virus prevalence in the Arabian Gulf region found that it is comparable to global levels, although higher HCV prevalence is found in specific expatriate populations reflecting the prevalence in their countries of origin.

A resistance analysis of the drug GS-9190, a NS5B non-nucleoside analogue for the treatment of hepatitis C virus infection, found that the Y448H mutation was rapidly selected in the majority of patients receiving multiple doses of GS-9190 as monotherapy, despite undetectable levels in pretreatment samples. Researchers concluded that Y448H confers reduced susceptibility to GS-9190 and other non-nucleoside inhibitors and persisted in most patients for months post-treatment.

A study published in the International Journal of Infectious Diseases found that hepatitis delta virus (HDV) patients in the Amazon region can be treated with a combination of Pegylated Interferon Alpha and Entecavir for 48 weeks, with good chances of negative HDV RNA at week 24. The results suggest that HDV-3 in the native population may be an “easy to treat” variant compared to HDV-1.

Development of acute hepatitis B virus disease in successfully vaccinated individuals is a rare event, affirmed a study of the Italian Surveillance System for Acute Viral Hepatitis (SEIEVA) from 1993 to 2014. Only 3.2% of acute hepatitis B cases had been vaccinated. Investigators said further efforts are needed to enhance the vaccine coverage rate in people at increased risk of infection, as hepatitis B is a vaccine-preventable disease.

Lab-made hepatocyte transplantation has therapeutic potential as a bridge or even alternative to whole organ liver transplantation, but researchers say deficiencies and uncertainties must be addressed in future studies aimed at developing liver cell therapies with such hepatocytes.

A major concern in potential liver transplant candidates is of unintended harm by achieving sustained viral response rates to direct-acting antiviral treatment, but without improvement in hepatic function to an extent where the patients might function well. A review essay in the Journal of Viral Hepatitis says there is a growing sentiment in some transplant quarters that those with decompensated liver disease awaiting liver transplant be treated for HCV after liver transplant instead of pre-transplant. The authors say it is essential that to develop robust predictors of improvement in liver function so patients can be carefully selected for therapy in the context of liver transplantation.

Treating mild-stage hepatitis C infection in people who inject drugs had virtually no impact on HCV-related end-stage liver disease/hepatocellular carcinoma (ESLD/HCC) within 15 years, a recent study found, but the long timescale of liver disease means relatively few people who inject drugs reach cirrhosis before cessation of injecting. Investigators said strategies focusing on treating advanced disease have the potential for dramatic reductions in severe morbidity, but virtually no preventative impact.

 

 

rpizzi@frontlinemedcom.com

On Twitter @richpizzi

If you work on the front lines of medical care treating patients with hepatitis, you may not have time to review all the hepatitis research that enters the medical literature every month. Here’s a quick look at some notable news items and journal articles published over the past month, covering a variety of the major hepatitis viruses.

In the United States, hepatitis C virus (HCV)-associated mortality is increasing. From 2003-2013, the number of deaths associated with HCV has now surpassed 60 other nationally notifiable infectious conditions combined.

Courtesy NIH

Chronic hepatitis B infection increased mortality and complexity among a cohort of HIV-coinfected patients in South Africa, according to a study in HIV Medicine. Researchers found that mortality was increased for chronic hepatitis B patients with hepatitis B virus DNA levels greater than 10,000 copies/mL, compared with non-coinfected patients.

A study in the Journal of Infectious Diseases found that Interferon Lambda (IFNL) genotypes were individually linked to higher rates of fibrosis in HIV–hepatitis C co-infection. Investigators said IFNL genotypes may be useful to target hepatitis C virus treatments to those who are at higher risk of liver disease.

A phase I study of a new NS3/4A protease inhibitor for treatment of chronic hepatitis C virus genotype 1-4 infection yielded positive tolerability, efficacy, and pharmacokinetic results, indicating further evaluation is warranted. The drug, GS-9857, produced by Gilead Sciences, achieved mean and median maximum reductions in HCV RNA of greater than or equal to 3 log10 IU/mL following administration of a 100-mg dose in patients with HCV genotype 1a, 1b, 2, 3, or 4 infection.

High baseline bilirubin and low albumin predict liver decompensation and serious adverse events in hepatitis C-infected patients treated with sofosbuvir-containing regimens, according to a study in the Journal of Viral Hepatitis. Among 499 previously stable patients in the cohort, the incidence of decompensation/events was 4.5%, and the mortality rate was 0.6%.

A meta-analysis of national-level hepatitis C virus prevalence in the Arabian Gulf region found that it is comparable to global levels, although higher HCV prevalence is found in specific expatriate populations reflecting the prevalence in their countries of origin.

A resistance analysis of the drug GS-9190, a NS5B non-nucleoside analogue for the treatment of hepatitis C virus infection, found that the Y448H mutation was rapidly selected in the majority of patients receiving multiple doses of GS-9190 as monotherapy, despite undetectable levels in pretreatment samples. Researchers concluded that Y448H confers reduced susceptibility to GS-9190 and other non-nucleoside inhibitors and persisted in most patients for months post-treatment.

A study published in the International Journal of Infectious Diseases found that hepatitis delta virus (HDV) patients in the Amazon region can be treated with a combination of Pegylated Interferon Alpha and Entecavir for 48 weeks, with good chances of negative HDV RNA at week 24. The results suggest that HDV-3 in the native population may be an “easy to treat” variant compared to HDV-1.

Development of acute hepatitis B virus disease in successfully vaccinated individuals is a rare event, affirmed a study of the Italian Surveillance System for Acute Viral Hepatitis (SEIEVA) from 1993 to 2014. Only 3.2% of acute hepatitis B cases had been vaccinated. Investigators said further efforts are needed to enhance the vaccine coverage rate in people at increased risk of infection, as hepatitis B is a vaccine-preventable disease.

Lab-made hepatocyte transplantation has therapeutic potential as a bridge or even alternative to whole organ liver transplantation, but researchers say deficiencies and uncertainties must be addressed in future studies aimed at developing liver cell therapies with such hepatocytes.

A major concern in potential liver transplant candidates is of unintended harm by achieving sustained viral response rates to direct-acting antiviral treatment, but without improvement in hepatic function to an extent where the patients might function well. A review essay in the Journal of Viral Hepatitis says there is a growing sentiment in some transplant quarters that those with decompensated liver disease awaiting liver transplant be treated for HCV after liver transplant instead of pre-transplant. The authors say it is essential that to develop robust predictors of improvement in liver function so patients can be carefully selected for therapy in the context of liver transplantation.

Treating mild-stage hepatitis C infection in people who inject drugs had virtually no impact on HCV-related end-stage liver disease/hepatocellular carcinoma (ESLD/HCC) within 15 years, a recent study found, but the long timescale of liver disease means relatively few people who inject drugs reach cirrhosis before cessation of injecting. Investigators said strategies focusing on treating advanced disease have the potential for dramatic reductions in severe morbidity, but virtually no preventative impact.

 

 

rpizzi@frontlinemedcom.com

On Twitter @richpizzi

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VIDEO: Management of difficult-to-treat IBD cases

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PHILADELPHIA – The lack of evidence-based management strategies for the treatment of difficult inflammatory bowel disease cases, such as with Crohn’s disease, can lead to confusion for some clinicians.

Dr. Mark T. Osterman, assistant professor of medicine at the University of Pennsylvania, Philadelphia, discusses when to use antibiotics in Crohn’s disease and when to consider antibiotics in combination with draining fistulae. He also discusses available pharmacotherapies, and the value of bowel rest.

“The best treatment of all for difficult inflammatory bowel disease is aggressive and early, so that the condition doesn’t go from bad to worse,” Dr. Osterman said.

The video was recorded at this year’s meeting of Digestive Diseases: New Advances, a meeting held by Global Academy for Medical Education and Rutgers, the State University of New Jersey. Global Academy and this news organization are owned by the same company.

 

The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel

 

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PHILADELPHIA – The lack of evidence-based management strategies for the treatment of difficult inflammatory bowel disease cases, such as with Crohn’s disease, can lead to confusion for some clinicians.

Dr. Mark T. Osterman, assistant professor of medicine at the University of Pennsylvania, Philadelphia, discusses when to use antibiotics in Crohn’s disease and when to consider antibiotics in combination with draining fistulae. He also discusses available pharmacotherapies, and the value of bowel rest.

“The best treatment of all for difficult inflammatory bowel disease is aggressive and early, so that the condition doesn’t go from bad to worse,” Dr. Osterman said.

The video was recorded at this year’s meeting of Digestive Diseases: New Advances, a meeting held by Global Academy for Medical Education and Rutgers, the State University of New Jersey. Global Academy and this news organization are owned by the same company.

 

The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel

 

wmcknight@frontlinemedcom.com

On Twitter @whitneymcknight

PHILADELPHIA – The lack of evidence-based management strategies for the treatment of difficult inflammatory bowel disease cases, such as with Crohn’s disease, can lead to confusion for some clinicians.

Dr. Mark T. Osterman, assistant professor of medicine at the University of Pennsylvania, Philadelphia, discusses when to use antibiotics in Crohn’s disease and when to consider antibiotics in combination with draining fistulae. He also discusses available pharmacotherapies, and the value of bowel rest.

“The best treatment of all for difficult inflammatory bowel disease is aggressive and early, so that the condition doesn’t go from bad to worse,” Dr. Osterman said.

The video was recorded at this year’s meeting of Digestive Diseases: New Advances, a meeting held by Global Academy for Medical Education and Rutgers, the State University of New Jersey. Global Academy and this news organization are owned by the same company.

 

The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel

 

wmcknight@frontlinemedcom.com

On Twitter @whitneymcknight

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VIDEO: Rectal indomethacin does not prevent pancreatitis post ERCP

Rectal indomethacin may still be protective in high-risk patients
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VIDEO: Rectal indomethacin does not prevent pancreatitis post ERCP

Patients who receive rectal indomethacin after undergoing endoscopic retrograde cholangiopancreatography (ERCP) are not any less likely to develop pancreatitis than individuals who don’t, according to the findings of a recent study published in Gastroenterology (2016 Jan 9. doi: 10.1053/j.gastro.2015.12.018).

 
 

“These results are in contrast to recent studies highlighting the benefit of rectal NSAIDS to prevent PEP [post-ECRP pancreatitis] in high-risk patients [and] counter the guidelines espoused by the European Society for Gastrointestinal Endoscopy, which recently recommended giving rectal indomethacin to prevent PEP in all patients undergoing ERCP,” said the study authors, led by Dr. John M. Levenick of Penn State University in Hershey, Pa.

 

 

SOURCE: AMERICAN GASTROENTEROLOGICAL ASSOCIATION

Dr. Levenick and his coinvestigators screened 604 consecutive patients undergoing ERCP, with and without endoscopic ultrasound, at the Dartmouth-Hitchcock Medical Center between March 2013 and December 2014, eventually enrolling and randomizing 449 subjects into two cohorts: one in which subjects were given indomethacin after undergoing ERCP (n = 223), and one in which subjects were simply given a placebo (n = 226). Randomization happened after subjects’ major papilla had been reached, and cannulation attempts were started.

Individuals were excluded if they had active acute pancreatitis or had undergone ERCP to treat or diagnose acute pancreatitis, if they had any contraindications or allergies to NSAIDs, or were younger than 18 years of age, among other factors. The mean age of the indomethacin cohort was 64.9 years, with 118 (52.9%) females; in the placebo cohort, mean age was 64.3 years and 118 (52.2%) were female.

Pancreatitis occurred in 27 subjects overall, 16 (7.2%) of whom were in the indomethacin cohort and the other 11 (4.9%) were on placebo followed ERCP (P = .33). No subjects receiving indomethacin had severe or moderately severe PEP, but one subject had severe PEP and one had moderately severe PEP in the placebo cohort (P = 1.0). There was no necrotizing pancreatitis in either cohort, nor were there any significant differences in gastrointestinal bleeding (P = .75), death (P = .25), or 30-day hospital readmission (P = .1) between the two cohorts.

“Prophylactic rectal indomethacin did not reduce the incidence or severity of PEP in consecutive patients undergoing ERCP,” Dr. Levenick and his coauthors concluded, adding that “guidelines that recommend the administration of rectal indomethacin in all patients undergoing ERCP should be reconsidered.”

This study was funded by the National Pancreas Foundation and a grant from the National Institutes of Health. Dr. Levenick and his coauthors did not report any financial disclosures.

dchitnis@frontlinemedcom.com

Body

Acute pancreatitis is the most common and feared complication of endoscopic retrograde cholangiopancreatography (ERCP). The incidence of post-ERCP pancreatitis is around 10% with a mortality of 0.7% (Gastrointest Endosc. 2015;81:143-9). Recent advances in noninvasive pancreaticobiliary imaging, risk stratification before ERCP, prophylactic pancreatic stent placement, and administration of nonsteroidal anti-inflammatory drugs (NSAIDs) have improved the overall risk benefit ratio of ERCP.  

NSAIDs are potent inhibitors of phospholipase A2, cyclooxygenase, and of the activation of platelets and endothelium, all of which play a central role in the pathogenesis of post-ERCP pancreatitis. NSAIDs constitute an attractive option in clinical practice, because they are inexpensive and widely available with a favorable risk profile. A recent multicenter randomized controlled trial (RCT) of 602 patients at high-risk for post-ERCP pancreatitis showed that rectal indomethacin is associated with a 7.7% absolute and a 46% relative risk reduction of post-ERCP pancreatitis (N Engl J Med. 2012;366:1414-22). These findings have been broadly adapted in endoscopic practice in the United States.

 

Dr. Georgios Papachristou

The presented RCT by Dr. Levenick and his colleagues evaluated the efficacy of rectal indomethacin in preventing post-ERCP pancreatitis among consecutive patients undergoing ERCP in a single U.S. center. This study was a well designed and conducted RCT following the CONSORT guidelines and utilizing an independent data and safety monitoring board.

The authors reported that rectal indomethacin did not result in reduction of post-ERCP pancreatitis (7.2%) when compared with placebo (4.9%). Of importance, 70% of patients included were at average risk for post-ERCP pancreatitis. Furthermore, despite a calculated sample size of 1,398 patients, the study was terminated early after enrolling only 449 patients based on the interim analysis showing futility to reach a statistically different outcome.

This well executed RCT reports no benefit in administering rectal indomethacin in all patients undergoing ERCP. Evidence strongly supports that rectal indomethacin remains an important advancement in preventing post-ERCP pancreatitis. However, its benefit is likely limited to a selected group of patients, those at high-risk for post-ERCP pancreatitis. Further studies are under way to clarify whether rectal indomethacin alone vs. indomethacin plus prophylactic pancreatic stenting is more effective in preventing post-ERCP pancreatitis in high-risk patients.

Dr. Georgios Papachristou is associate professor of medicine at the University of Pittsburgh. He is a consultant for Shire and has received funding from the National Institutes of Health and the VA Health System.

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Acute pancreatitis is the most common and feared complication of endoscopic retrograde cholangiopancreatography (ERCP). The incidence of post-ERCP pancreatitis is around 10% with a mortality of 0.7% (Gastrointest Endosc. 2015;81:143-9). Recent advances in noninvasive pancreaticobiliary imaging, risk stratification before ERCP, prophylactic pancreatic stent placement, and administration of nonsteroidal anti-inflammatory drugs (NSAIDs) have improved the overall risk benefit ratio of ERCP.  

NSAIDs are potent inhibitors of phospholipase A2, cyclooxygenase, and of the activation of platelets and endothelium, all of which play a central role in the pathogenesis of post-ERCP pancreatitis. NSAIDs constitute an attractive option in clinical practice, because they are inexpensive and widely available with a favorable risk profile. A recent multicenter randomized controlled trial (RCT) of 602 patients at high-risk for post-ERCP pancreatitis showed that rectal indomethacin is associated with a 7.7% absolute and a 46% relative risk reduction of post-ERCP pancreatitis (N Engl J Med. 2012;366:1414-22). These findings have been broadly adapted in endoscopic practice in the United States.

 

Dr. Georgios Papachristou

The presented RCT by Dr. Levenick and his colleagues evaluated the efficacy of rectal indomethacin in preventing post-ERCP pancreatitis among consecutive patients undergoing ERCP in a single U.S. center. This study was a well designed and conducted RCT following the CONSORT guidelines and utilizing an independent data and safety monitoring board.

The authors reported that rectal indomethacin did not result in reduction of post-ERCP pancreatitis (7.2%) when compared with placebo (4.9%). Of importance, 70% of patients included were at average risk for post-ERCP pancreatitis. Furthermore, despite a calculated sample size of 1,398 patients, the study was terminated early after enrolling only 449 patients based on the interim analysis showing futility to reach a statistically different outcome.

This well executed RCT reports no benefit in administering rectal indomethacin in all patients undergoing ERCP. Evidence strongly supports that rectal indomethacin remains an important advancement in preventing post-ERCP pancreatitis. However, its benefit is likely limited to a selected group of patients, those at high-risk for post-ERCP pancreatitis. Further studies are under way to clarify whether rectal indomethacin alone vs. indomethacin plus prophylactic pancreatic stenting is more effective in preventing post-ERCP pancreatitis in high-risk patients.

Dr. Georgios Papachristou is associate professor of medicine at the University of Pittsburgh. He is a consultant for Shire and has received funding from the National Institutes of Health and the VA Health System.

Body

Acute pancreatitis is the most common and feared complication of endoscopic retrograde cholangiopancreatography (ERCP). The incidence of post-ERCP pancreatitis is around 10% with a mortality of 0.7% (Gastrointest Endosc. 2015;81:143-9). Recent advances in noninvasive pancreaticobiliary imaging, risk stratification before ERCP, prophylactic pancreatic stent placement, and administration of nonsteroidal anti-inflammatory drugs (NSAIDs) have improved the overall risk benefit ratio of ERCP.  

NSAIDs are potent inhibitors of phospholipase A2, cyclooxygenase, and of the activation of platelets and endothelium, all of which play a central role in the pathogenesis of post-ERCP pancreatitis. NSAIDs constitute an attractive option in clinical practice, because they are inexpensive and widely available with a favorable risk profile. A recent multicenter randomized controlled trial (RCT) of 602 patients at high-risk for post-ERCP pancreatitis showed that rectal indomethacin is associated with a 7.7% absolute and a 46% relative risk reduction of post-ERCP pancreatitis (N Engl J Med. 2012;366:1414-22). These findings have been broadly adapted in endoscopic practice in the United States.

 

Dr. Georgios Papachristou

The presented RCT by Dr. Levenick and his colleagues evaluated the efficacy of rectal indomethacin in preventing post-ERCP pancreatitis among consecutive patients undergoing ERCP in a single U.S. center. This study was a well designed and conducted RCT following the CONSORT guidelines and utilizing an independent data and safety monitoring board.

The authors reported that rectal indomethacin did not result in reduction of post-ERCP pancreatitis (7.2%) when compared with placebo (4.9%). Of importance, 70% of patients included were at average risk for post-ERCP pancreatitis. Furthermore, despite a calculated sample size of 1,398 patients, the study was terminated early after enrolling only 449 patients based on the interim analysis showing futility to reach a statistically different outcome.

This well executed RCT reports no benefit in administering rectal indomethacin in all patients undergoing ERCP. Evidence strongly supports that rectal indomethacin remains an important advancement in preventing post-ERCP pancreatitis. However, its benefit is likely limited to a selected group of patients, those at high-risk for post-ERCP pancreatitis. Further studies are under way to clarify whether rectal indomethacin alone vs. indomethacin plus prophylactic pancreatic stenting is more effective in preventing post-ERCP pancreatitis in high-risk patients.

Dr. Georgios Papachristou is associate professor of medicine at the University of Pittsburgh. He is a consultant for Shire and has received funding from the National Institutes of Health and the VA Health System.

Title
Rectal indomethacin may still be protective in high-risk patients
Rectal indomethacin may still be protective in high-risk patients

Patients who receive rectal indomethacin after undergoing endoscopic retrograde cholangiopancreatography (ERCP) are not any less likely to develop pancreatitis than individuals who don’t, according to the findings of a recent study published in Gastroenterology (2016 Jan 9. doi: 10.1053/j.gastro.2015.12.018).

 
 

“These results are in contrast to recent studies highlighting the benefit of rectal NSAIDS to prevent PEP [post-ECRP pancreatitis] in high-risk patients [and] counter the guidelines espoused by the European Society for Gastrointestinal Endoscopy, which recently recommended giving rectal indomethacin to prevent PEP in all patients undergoing ERCP,” said the study authors, led by Dr. John M. Levenick of Penn State University in Hershey, Pa.

 

 

SOURCE: AMERICAN GASTROENTEROLOGICAL ASSOCIATION

Dr. Levenick and his coinvestigators screened 604 consecutive patients undergoing ERCP, with and without endoscopic ultrasound, at the Dartmouth-Hitchcock Medical Center between March 2013 and December 2014, eventually enrolling and randomizing 449 subjects into two cohorts: one in which subjects were given indomethacin after undergoing ERCP (n = 223), and one in which subjects were simply given a placebo (n = 226). Randomization happened after subjects’ major papilla had been reached, and cannulation attempts were started.

Individuals were excluded if they had active acute pancreatitis or had undergone ERCP to treat or diagnose acute pancreatitis, if they had any contraindications or allergies to NSAIDs, or were younger than 18 years of age, among other factors. The mean age of the indomethacin cohort was 64.9 years, with 118 (52.9%) females; in the placebo cohort, mean age was 64.3 years and 118 (52.2%) were female.

Pancreatitis occurred in 27 subjects overall, 16 (7.2%) of whom were in the indomethacin cohort and the other 11 (4.9%) were on placebo followed ERCP (P = .33). No subjects receiving indomethacin had severe or moderately severe PEP, but one subject had severe PEP and one had moderately severe PEP in the placebo cohort (P = 1.0). There was no necrotizing pancreatitis in either cohort, nor were there any significant differences in gastrointestinal bleeding (P = .75), death (P = .25), or 30-day hospital readmission (P = .1) between the two cohorts.

“Prophylactic rectal indomethacin did not reduce the incidence or severity of PEP in consecutive patients undergoing ERCP,” Dr. Levenick and his coauthors concluded, adding that “guidelines that recommend the administration of rectal indomethacin in all patients undergoing ERCP should be reconsidered.”

This study was funded by the National Pancreas Foundation and a grant from the National Institutes of Health. Dr. Levenick and his coauthors did not report any financial disclosures.

dchitnis@frontlinemedcom.com

Patients who receive rectal indomethacin after undergoing endoscopic retrograde cholangiopancreatography (ERCP) are not any less likely to develop pancreatitis than individuals who don’t, according to the findings of a recent study published in Gastroenterology (2016 Jan 9. doi: 10.1053/j.gastro.2015.12.018).

 
 

“These results are in contrast to recent studies highlighting the benefit of rectal NSAIDS to prevent PEP [post-ECRP pancreatitis] in high-risk patients [and] counter the guidelines espoused by the European Society for Gastrointestinal Endoscopy, which recently recommended giving rectal indomethacin to prevent PEP in all patients undergoing ERCP,” said the study authors, led by Dr. John M. Levenick of Penn State University in Hershey, Pa.

 

 

SOURCE: AMERICAN GASTROENTEROLOGICAL ASSOCIATION

Dr. Levenick and his coinvestigators screened 604 consecutive patients undergoing ERCP, with and without endoscopic ultrasound, at the Dartmouth-Hitchcock Medical Center between March 2013 and December 2014, eventually enrolling and randomizing 449 subjects into two cohorts: one in which subjects were given indomethacin after undergoing ERCP (n = 223), and one in which subjects were simply given a placebo (n = 226). Randomization happened after subjects’ major papilla had been reached, and cannulation attempts were started.

Individuals were excluded if they had active acute pancreatitis or had undergone ERCP to treat or diagnose acute pancreatitis, if they had any contraindications or allergies to NSAIDs, or were younger than 18 years of age, among other factors. The mean age of the indomethacin cohort was 64.9 years, with 118 (52.9%) females; in the placebo cohort, mean age was 64.3 years and 118 (52.2%) were female.

Pancreatitis occurred in 27 subjects overall, 16 (7.2%) of whom were in the indomethacin cohort and the other 11 (4.9%) were on placebo followed ERCP (P = .33). No subjects receiving indomethacin had severe or moderately severe PEP, but one subject had severe PEP and one had moderately severe PEP in the placebo cohort (P = 1.0). There was no necrotizing pancreatitis in either cohort, nor were there any significant differences in gastrointestinal bleeding (P = .75), death (P = .25), or 30-day hospital readmission (P = .1) between the two cohorts.

“Prophylactic rectal indomethacin did not reduce the incidence or severity of PEP in consecutive patients undergoing ERCP,” Dr. Levenick and his coauthors concluded, adding that “guidelines that recommend the administration of rectal indomethacin in all patients undergoing ERCP should be reconsidered.”

This study was funded by the National Pancreas Foundation and a grant from the National Institutes of Health. Dr. Levenick and his coauthors did not report any financial disclosures.

dchitnis@frontlinemedcom.com

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Key clinical point: Rectal indomethacin does not prevent pancreatitis in patients who undergo endoscopic retrograde cholangiopancreatography (ERCP).

Major finding: 7.2% of subjects on indomethacin and 4.9% on placebo developed post-ERCP pancreatitis, indicating no significant difference between the two cohorts (P = .33).

Data source: Prospective, double-blind, placebo-controlled study of 449 ERCP patients between March 2013 and December 2014.

Disclosures: Study funded by National Pancreas Foundation and National Institutes of Health. Dr. Levenick and his coauthors did not report any relevant financial disclosures.

VIDEO: Newer MRI hardware, software significantly better at detecting pancreatic cysts

Newer MRIs much better at detecting pancreatic cysts
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VIDEO: Newer MRI hardware, software significantly better at detecting pancreatic cysts

As magnetic resonance imaging technology continues to advance year after year, so does MRI’s ability to accurately detect pancreatic cysts, according to a new study published in the April issue of Clinical Gastroenterology and Hepatology (doi: 10.1016/j.cgh.2015.08.038).

“To our knowledge, this is the first study to analyze the relationship between the technical improvements in imaging techniques (specifically, MRI) and the presence of incidentally found PCLs [pancreatic cystic lesions],” said the study authors, led by Dr. Michael B. Wallace of the Mayo Clinic in Jacksonville, Fla.

 

 

Dr. Michael B. Wallace
Dr. Michael B. Wallace

Dr. Wallace and his coinvestigators launched this retrospective descriptive study selecting the first 50 consecutive abdominal MRI patients at the Jacksonville Mayo Clinic during January and February of each year from 2005 through 2014, for a total of 500 cases who met inclusion criteria included in the study. Patients were excluded if they had preexisting symptomatic or asymptomatic pancreatitis, either acute or chronic, pancreatic masses, pancreatic cysts, pancreatic surgery, pancreatic symptoms, or any pancreas-related indications found by MRI.

The clinic underwent periodic MRI updates over the course of the 10-year study, along with requisite software updates to “take advantage of the new hardware technology,” the study explains. Major hardware improvements, provided by Siemens Medical Solutions USA, were Symphony/Sonata, Espree/Avanto, and Aera/Skyra, while software updates corresponding to each hardware update were VA, VB, and VD, respectively.

 

 

SOURCE: AMERICAN GASTROENTEROLOGICAL ASSOCIATION

Furthermore, each software update had other, smaller upgrades, leading to a total of 20 combinations of MRI hardware and software on which MRIs were performed over the 10 years. Every MRI taken included “an axial and a coronal T2-weighted single-shot (HASTE) pulse sequence [with] TR 1400-1500 ms, TE 82-99 ms, and slice thickness 5-7 mm (gap, 0.5-0.7 mm).” Each MRI was analyzed by a pancreatic MRI specialist to find incidental cysts.

The number of patients found with pancreatic cysts increased incrementally from 2005 to 2014, with 2010 being the year with the highest number. A total of 208 subjects (41.6%) were found to have incidental cysts, but only 44 of these cases were discovered in the original MRI. The presence of cysts was associated with older age in patients who had them; only 20% of all subjects under 50 years of age had cysts, compared to 32.4% of those between 50 and 60 years, 54.9% of those between 60 and 70 years, and 61.5% of those over the age of 70 years (P less than .01).

Additionally, 56.4% of all subjects with diabetes (P less than .01), 59.0% of subjects with nonmelanoma skin cancer (P less than .03), and 58.1% of those with hepatocarcinoma (P less than .02) were also found to have cysts. Most striking, however, is that newer hardware and software permutations were able to detect cysts in 56.3% (Skyra) of patients who had them, compared with only 30.3% (Symphony) of patients who underwent MRI on older technology.

“The variable field strength” (1.5 T vs. 3 T) was not significantly related to the presence of PCLs,” Dr. Wallace and his coauthors concluded. “We believe this may be secondary to the lack of power of the analysis, because only 6% of the examinations were 3-T studies. Therefore, we speculate that this relationship may be confirmed if the number of 3-T studies increased.”

Males and females each made up roughly 50% of the study population, with a median age of 60 years and 85% being white. Additionally, 4% of subjects had a family history of pancreatic cancer, 12% had a personal history of solid organ transplant, and 53% had a personal history of smoking.

This study was funded by the Mayo Clinic. Dr. Wallace disclosed that he has received grant funding from Olympus, Boston Scientific, and Cosmo Pharmaceuticals, and travel support from Olympus. No other authors reported any financial disclosures.

dchitnis@frontlinemedcom.com

Body

The increasing prevalence of pancreatic cystic lesions on MRI scanning may provide an important opportunity for detection of early precursors of pancreatic cancer – or may represent just another insignificant incidental finding. What is the implication of a small asymptomatic cyst?

MRI scanning of the pancreas has revolutionized our ability to detect early cystic neoplasms of the pancreas. Pancreatic cysts appear as well-defined, small, round fluid-filled structures within the pancreas. The inner structures – such as septations, nodules, and adjacent masses – offer clues as to the type of cyst and the risk of malignancy. But the real strength of pancreatic MRI scanning is the ability to detect and portray small cysts and the adjacent main pancreatic duct.  

The size, number, and distribution of cysts over time can be tracked with MRI surveillance. By tracking the diameter of cysts and calculating the rate of growth of cysts, clinicians may be able to predict the development of malignancy in intraductal papillary mucinous neoplasms.

How should these patients be managed clinically? Once a cyst has been identified, are clinicians obligated to notify the patient, monitor the cyst with an established surveillance program, or biopsy the cyst? If the cyst is very small and benign appearing, can the clinician ignore the finding and perhaps not notify the patient?  

Once again, we are watching dilemmas unfold as technology outstrips our understanding of diseases and their management. We are going to need some good correlations between imaging and tissue of pancreatic cystic lesions. In the meantime, it is important to reserve the use of pancreatic MRI scanning to high-risk patients or patients with CT scan abnormalities.

Dr. William R. Brugge, AGAF, is professor of medicine, Harvard Medical School, and director, Pancreas Biliary Center, Massachusetts General Hospital, both in Boston. He is a consultant with Boston Scientific.

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The increasing prevalence of pancreatic cystic lesions on MRI scanning may provide an important opportunity for detection of early precursors of pancreatic cancer – or may represent just another insignificant incidental finding. What is the implication of a small asymptomatic cyst?

MRI scanning of the pancreas has revolutionized our ability to detect early cystic neoplasms of the pancreas. Pancreatic cysts appear as well-defined, small, round fluid-filled structures within the pancreas. The inner structures – such as septations, nodules, and adjacent masses – offer clues as to the type of cyst and the risk of malignancy. But the real strength of pancreatic MRI scanning is the ability to detect and portray small cysts and the adjacent main pancreatic duct.  

The size, number, and distribution of cysts over time can be tracked with MRI surveillance. By tracking the diameter of cysts and calculating the rate of growth of cysts, clinicians may be able to predict the development of malignancy in intraductal papillary mucinous neoplasms.

How should these patients be managed clinically? Once a cyst has been identified, are clinicians obligated to notify the patient, monitor the cyst with an established surveillance program, or biopsy the cyst? If the cyst is very small and benign appearing, can the clinician ignore the finding and perhaps not notify the patient?  

Once again, we are watching dilemmas unfold as technology outstrips our understanding of diseases and their management. We are going to need some good correlations between imaging and tissue of pancreatic cystic lesions. In the meantime, it is important to reserve the use of pancreatic MRI scanning to high-risk patients or patients with CT scan abnormalities.

Dr. William R. Brugge, AGAF, is professor of medicine, Harvard Medical School, and director, Pancreas Biliary Center, Massachusetts General Hospital, both in Boston. He is a consultant with Boston Scientific.

Body

The increasing prevalence of pancreatic cystic lesions on MRI scanning may provide an important opportunity for detection of early precursors of pancreatic cancer – or may represent just another insignificant incidental finding. What is the implication of a small asymptomatic cyst?

MRI scanning of the pancreas has revolutionized our ability to detect early cystic neoplasms of the pancreas. Pancreatic cysts appear as well-defined, small, round fluid-filled structures within the pancreas. The inner structures – such as septations, nodules, and adjacent masses – offer clues as to the type of cyst and the risk of malignancy. But the real strength of pancreatic MRI scanning is the ability to detect and portray small cysts and the adjacent main pancreatic duct.  

The size, number, and distribution of cysts over time can be tracked with MRI surveillance. By tracking the diameter of cysts and calculating the rate of growth of cysts, clinicians may be able to predict the development of malignancy in intraductal papillary mucinous neoplasms.

How should these patients be managed clinically? Once a cyst has been identified, are clinicians obligated to notify the patient, monitor the cyst with an established surveillance program, or biopsy the cyst? If the cyst is very small and benign appearing, can the clinician ignore the finding and perhaps not notify the patient?  

Once again, we are watching dilemmas unfold as technology outstrips our understanding of diseases and their management. We are going to need some good correlations between imaging and tissue of pancreatic cystic lesions. In the meantime, it is important to reserve the use of pancreatic MRI scanning to high-risk patients or patients with CT scan abnormalities.

Dr. William R. Brugge, AGAF, is professor of medicine, Harvard Medical School, and director, Pancreas Biliary Center, Massachusetts General Hospital, both in Boston. He is a consultant with Boston Scientific.

Title
Newer MRIs much better at detecting pancreatic cysts
Newer MRIs much better at detecting pancreatic cysts

As magnetic resonance imaging technology continues to advance year after year, so does MRI’s ability to accurately detect pancreatic cysts, according to a new study published in the April issue of Clinical Gastroenterology and Hepatology (doi: 10.1016/j.cgh.2015.08.038).

“To our knowledge, this is the first study to analyze the relationship between the technical improvements in imaging techniques (specifically, MRI) and the presence of incidentally found PCLs [pancreatic cystic lesions],” said the study authors, led by Dr. Michael B. Wallace of the Mayo Clinic in Jacksonville, Fla.

 

 

Dr. Michael B. Wallace
Dr. Michael B. Wallace

Dr. Wallace and his coinvestigators launched this retrospective descriptive study selecting the first 50 consecutive abdominal MRI patients at the Jacksonville Mayo Clinic during January and February of each year from 2005 through 2014, for a total of 500 cases who met inclusion criteria included in the study. Patients were excluded if they had preexisting symptomatic or asymptomatic pancreatitis, either acute or chronic, pancreatic masses, pancreatic cysts, pancreatic surgery, pancreatic symptoms, or any pancreas-related indications found by MRI.

The clinic underwent periodic MRI updates over the course of the 10-year study, along with requisite software updates to “take advantage of the new hardware technology,” the study explains. Major hardware improvements, provided by Siemens Medical Solutions USA, were Symphony/Sonata, Espree/Avanto, and Aera/Skyra, while software updates corresponding to each hardware update were VA, VB, and VD, respectively.

 

 

SOURCE: AMERICAN GASTROENTEROLOGICAL ASSOCIATION

Furthermore, each software update had other, smaller upgrades, leading to a total of 20 combinations of MRI hardware and software on which MRIs were performed over the 10 years. Every MRI taken included “an axial and a coronal T2-weighted single-shot (HASTE) pulse sequence [with] TR 1400-1500 ms, TE 82-99 ms, and slice thickness 5-7 mm (gap, 0.5-0.7 mm).” Each MRI was analyzed by a pancreatic MRI specialist to find incidental cysts.

The number of patients found with pancreatic cysts increased incrementally from 2005 to 2014, with 2010 being the year with the highest number. A total of 208 subjects (41.6%) were found to have incidental cysts, but only 44 of these cases were discovered in the original MRI. The presence of cysts was associated with older age in patients who had them; only 20% of all subjects under 50 years of age had cysts, compared to 32.4% of those between 50 and 60 years, 54.9% of those between 60 and 70 years, and 61.5% of those over the age of 70 years (P less than .01).

Additionally, 56.4% of all subjects with diabetes (P less than .01), 59.0% of subjects with nonmelanoma skin cancer (P less than .03), and 58.1% of those with hepatocarcinoma (P less than .02) were also found to have cysts. Most striking, however, is that newer hardware and software permutations were able to detect cysts in 56.3% (Skyra) of patients who had them, compared with only 30.3% (Symphony) of patients who underwent MRI on older technology.

“The variable field strength” (1.5 T vs. 3 T) was not significantly related to the presence of PCLs,” Dr. Wallace and his coauthors concluded. “We believe this may be secondary to the lack of power of the analysis, because only 6% of the examinations were 3-T studies. Therefore, we speculate that this relationship may be confirmed if the number of 3-T studies increased.”

Males and females each made up roughly 50% of the study population, with a median age of 60 years and 85% being white. Additionally, 4% of subjects had a family history of pancreatic cancer, 12% had a personal history of solid organ transplant, and 53% had a personal history of smoking.

This study was funded by the Mayo Clinic. Dr. Wallace disclosed that he has received grant funding from Olympus, Boston Scientific, and Cosmo Pharmaceuticals, and travel support from Olympus. No other authors reported any financial disclosures.

dchitnis@frontlinemedcom.com

As magnetic resonance imaging technology continues to advance year after year, so does MRI’s ability to accurately detect pancreatic cysts, according to a new study published in the April issue of Clinical Gastroenterology and Hepatology (doi: 10.1016/j.cgh.2015.08.038).

“To our knowledge, this is the first study to analyze the relationship between the technical improvements in imaging techniques (specifically, MRI) and the presence of incidentally found PCLs [pancreatic cystic lesions],” said the study authors, led by Dr. Michael B. Wallace of the Mayo Clinic in Jacksonville, Fla.

 

 

Dr. Michael B. Wallace
Dr. Michael B. Wallace

Dr. Wallace and his coinvestigators launched this retrospective descriptive study selecting the first 50 consecutive abdominal MRI patients at the Jacksonville Mayo Clinic during January and February of each year from 2005 through 2014, for a total of 500 cases who met inclusion criteria included in the study. Patients were excluded if they had preexisting symptomatic or asymptomatic pancreatitis, either acute or chronic, pancreatic masses, pancreatic cysts, pancreatic surgery, pancreatic symptoms, or any pancreas-related indications found by MRI.

The clinic underwent periodic MRI updates over the course of the 10-year study, along with requisite software updates to “take advantage of the new hardware technology,” the study explains. Major hardware improvements, provided by Siemens Medical Solutions USA, were Symphony/Sonata, Espree/Avanto, and Aera/Skyra, while software updates corresponding to each hardware update were VA, VB, and VD, respectively.

 

 

SOURCE: AMERICAN GASTROENTEROLOGICAL ASSOCIATION

Furthermore, each software update had other, smaller upgrades, leading to a total of 20 combinations of MRI hardware and software on which MRIs were performed over the 10 years. Every MRI taken included “an axial and a coronal T2-weighted single-shot (HASTE) pulse sequence [with] TR 1400-1500 ms, TE 82-99 ms, and slice thickness 5-7 mm (gap, 0.5-0.7 mm).” Each MRI was analyzed by a pancreatic MRI specialist to find incidental cysts.

The number of patients found with pancreatic cysts increased incrementally from 2005 to 2014, with 2010 being the year with the highest number. A total of 208 subjects (41.6%) were found to have incidental cysts, but only 44 of these cases were discovered in the original MRI. The presence of cysts was associated with older age in patients who had them; only 20% of all subjects under 50 years of age had cysts, compared to 32.4% of those between 50 and 60 years, 54.9% of those between 60 and 70 years, and 61.5% of those over the age of 70 years (P less than .01).

Additionally, 56.4% of all subjects with diabetes (P less than .01), 59.0% of subjects with nonmelanoma skin cancer (P less than .03), and 58.1% of those with hepatocarcinoma (P less than .02) were also found to have cysts. Most striking, however, is that newer hardware and software permutations were able to detect cysts in 56.3% (Skyra) of patients who had them, compared with only 30.3% (Symphony) of patients who underwent MRI on older technology.

“The variable field strength” (1.5 T vs. 3 T) was not significantly related to the presence of PCLs,” Dr. Wallace and his coauthors concluded. “We believe this may be secondary to the lack of power of the analysis, because only 6% of the examinations were 3-T studies. Therefore, we speculate that this relationship may be confirmed if the number of 3-T studies increased.”

Males and females each made up roughly 50% of the study population, with a median age of 60 years and 85% being white. Additionally, 4% of subjects had a family history of pancreatic cancer, 12% had a personal history of solid organ transplant, and 53% had a personal history of smoking.

This study was funded by the Mayo Clinic. Dr. Wallace disclosed that he has received grant funding from Olympus, Boston Scientific, and Cosmo Pharmaceuticals, and travel support from Olympus. No other authors reported any financial disclosures.

dchitnis@frontlinemedcom.com

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Key clinical point: Newer MRI technology is more effective at detecting pancreatic cysts, particularly in patients with diabetes or advanced age.

Major finding: Newer MRI hardware and software detected pancreatic cysts in 56.3% of patients, compared with only 30.3% on older MRI hardware and software.

Data source: Retrospective, descriptive study of 500 patients undergoing MRI for nonpancreatic indications during January and February of 2005-2014.

Disclosures: Study funded by the Mayo Clinic. Dr. Michael B. Wallace disclosed relationships with Olympus, Boston Scientific, and Cosmo Pharmaceuticals.

Privacy measure inadvertently suppresses substance abuse data

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Privacy measure inadvertently suppresses substance abuse data

An action taken to protect patient privacy – removing claims related to substance abuse from Medicare and Medicaid databases – inadvertently caused an immediate and marked suppression of vital data pertaining to related disorders such as HIV, depression, anxiety, and hepatitis C, according to data published online March 15 in JAMA.

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In 2007, the Centers for Medicare & Medicaid Services implemented a federal regulation that prohibits third-party payers from releasing information from federally funded substance abuse treatment programs. To comply, the CMS had to change its longstanding practice of making all claims data available to researchers, instead removing from its database all claims containing a diagnostic or procedure code related to substance abuse, said Kathryn Rough of the division of Pharmacoepidemiology and Pharmacoeconomics, Brigham and Women’s Hospital, Boston, and her associates.

To gauge the effect this had on the information available to researchers, the investigators compared de-identified Medicaid data from before the policy change (2000-2006) against that from afterward (2007-2010). They focused on diagnoses for six disorders that frequently occur in tandem with substance abuse (HIV, tobacco use, depression, anxiety, hepatitis C, and cirrhosis) and four that are unrelated to substance abuse (type 2 diabetes, stroke, hypertension, and kidney disease).

The study period included 63 million inpatient and 13.6 billion outpatient claims. Compared with data available to researchers before the policy change, afterward there was an immediate and substantial reduction. Inpatient diagnosis rates declined 24% for HIV, 51% for tobacco use, 38% for depression, 27% for anxiety, 57% for hepatitis C, and 49% for cirrhosis. Declines in outpatient diagnosis rates were less marked and reached statistical significance only for anxiety, which dropped 6.3%.

In contrast, diagnosis rates for disorders unrelated to substance abuse did not change appreciably after the new policy was implemented, Ms. Rough and her associates said (JAMA. 2016;315:1164-6). “Underestimation of diagnoses has the potential to bias health services research studies and epidemiological analyses” and could lead to “spurious conclusions.” For example, “a hospital that regularly admits substance abusers will [show] artificially low rates of readmission, giving a false appearance of better performance,” they noted.

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An action taken to protect patient privacy – removing claims related to substance abuse from Medicare and Medicaid databases – inadvertently caused an immediate and marked suppression of vital data pertaining to related disorders such as HIV, depression, anxiety, and hepatitis C, according to data published online March 15 in JAMA.

©Katarzyna Bialasiewicz/thinkstockphotos.com

In 2007, the Centers for Medicare & Medicaid Services implemented a federal regulation that prohibits third-party payers from releasing information from federally funded substance abuse treatment programs. To comply, the CMS had to change its longstanding practice of making all claims data available to researchers, instead removing from its database all claims containing a diagnostic or procedure code related to substance abuse, said Kathryn Rough of the division of Pharmacoepidemiology and Pharmacoeconomics, Brigham and Women’s Hospital, Boston, and her associates.

To gauge the effect this had on the information available to researchers, the investigators compared de-identified Medicaid data from before the policy change (2000-2006) against that from afterward (2007-2010). They focused on diagnoses for six disorders that frequently occur in tandem with substance abuse (HIV, tobacco use, depression, anxiety, hepatitis C, and cirrhosis) and four that are unrelated to substance abuse (type 2 diabetes, stroke, hypertension, and kidney disease).

The study period included 63 million inpatient and 13.6 billion outpatient claims. Compared with data available to researchers before the policy change, afterward there was an immediate and substantial reduction. Inpatient diagnosis rates declined 24% for HIV, 51% for tobacco use, 38% for depression, 27% for anxiety, 57% for hepatitis C, and 49% for cirrhosis. Declines in outpatient diagnosis rates were less marked and reached statistical significance only for anxiety, which dropped 6.3%.

In contrast, diagnosis rates for disorders unrelated to substance abuse did not change appreciably after the new policy was implemented, Ms. Rough and her associates said (JAMA. 2016;315:1164-6). “Underestimation of diagnoses has the potential to bias health services research studies and epidemiological analyses” and could lead to “spurious conclusions.” For example, “a hospital that regularly admits substance abusers will [show] artificially low rates of readmission, giving a false appearance of better performance,” they noted.

An action taken to protect patient privacy – removing claims related to substance abuse from Medicare and Medicaid databases – inadvertently caused an immediate and marked suppression of vital data pertaining to related disorders such as HIV, depression, anxiety, and hepatitis C, according to data published online March 15 in JAMA.

©Katarzyna Bialasiewicz/thinkstockphotos.com

In 2007, the Centers for Medicare & Medicaid Services implemented a federal regulation that prohibits third-party payers from releasing information from federally funded substance abuse treatment programs. To comply, the CMS had to change its longstanding practice of making all claims data available to researchers, instead removing from its database all claims containing a diagnostic or procedure code related to substance abuse, said Kathryn Rough of the division of Pharmacoepidemiology and Pharmacoeconomics, Brigham and Women’s Hospital, Boston, and her associates.

To gauge the effect this had on the information available to researchers, the investigators compared de-identified Medicaid data from before the policy change (2000-2006) against that from afterward (2007-2010). They focused on diagnoses for six disorders that frequently occur in tandem with substance abuse (HIV, tobacco use, depression, anxiety, hepatitis C, and cirrhosis) and four that are unrelated to substance abuse (type 2 diabetes, stroke, hypertension, and kidney disease).

The study period included 63 million inpatient and 13.6 billion outpatient claims. Compared with data available to researchers before the policy change, afterward there was an immediate and substantial reduction. Inpatient diagnosis rates declined 24% for HIV, 51% for tobacco use, 38% for depression, 27% for anxiety, 57% for hepatitis C, and 49% for cirrhosis. Declines in outpatient diagnosis rates were less marked and reached statistical significance only for anxiety, which dropped 6.3%.

In contrast, diagnosis rates for disorders unrelated to substance abuse did not change appreciably after the new policy was implemented, Ms. Rough and her associates said (JAMA. 2016;315:1164-6). “Underestimation of diagnoses has the potential to bias health services research studies and epidemiological analyses” and could lead to “spurious conclusions.” For example, “a hospital that regularly admits substance abusers will [show] artificially low rates of readmission, giving a false appearance of better performance,” they noted.

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Key clinical point: An action taken to protect patient privacy inadvertently caused an immediate marked suppression of vital data pertaining to other related disorders.

Major finding: Inpatient diagnosis rates declined 24% for HIV, 51% for tobacco use, 38% for depression, 27% for anxiety, 57% for hepatitis C, and 49% for cirrhosis.

Data source: A comparison of CMS data concerning 10 disorders before and after the 2007 implementation of a new patient-privacy regulation.

Disclosures: This study was supported by the Harvard T. H. Chan School of Public Health and several institutes at the National Institutes of Health. The investigators reported no relevant conflicts of interest.

Birth-cohort HCV testing misses one-quarter of infections

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Birth-cohort HCV testing misses one-quarter of infections

Birth-cohort screening for hepatitis C virus according to U.S. Centers for Disease Control and Prevention guidelines may miss around one-quarter of infections, researchers said.

An 8-week seroprevalence survey in an urban emergency department tested excess blood samples from 4,713 patients for hepatitis C virus, finding an overall prevalence of 13.8%, of which 31.3% was undocumented infection.

Jezperklauzen/ThinkStock

According to a paper published in Clinical Infectious Diseases, among the 204 patients with undocumented HCV infection, 48.5% were born between 1945 and 1965 and therefore would have been included in birth-cohort testing, and 26.5% would have been picked up for risk-based testing.

But 25% of the patients found to be infected with HCV in the study would not have been tested based on birth cohort or risk (Clin Infect Dis. 2016 Feb 21. doi: 10.1093/cid/ciw074).

The CDC added the recommendation for one-time testing of individuals born between 1945 and 1965 to its existing advice on risk-based screening in 2012, and this was backed by the U.S. Preventive Services Task Force in 2013.

“Since the CDC’s revised HIV testing recommendations for the health care settings were released, many EDs have had great success in implementing routine HIV testing to the population they serve over the past decade,” wrote Dr. Yu-Hsiang Hsieh of Johns Hopkins University, Baltimore, and coauthors. “This coupled with the availability of effective therapeutics makes EDs a key and strategic component of the national plan to expand HCV testing.”

At the same time, a second study, also in an urban emergency department, tested samples from 924 individuals enrolled in an HIV prevalence survey.

In this study, published in the same issue of Clinical Infectious Diseases, researchers found HCV antibodies in samples from 128 patients (14%); 34% of whom self-reported a history of HCV or hepatitis and 81% of whom were RNA positive.

The researchers noted, however, that, had they only implemented birth-cohort or risk-based screening, they would have missed 28% of individuals with antibodies and 25% of individuals with replicative HCV.

In this study, individuals with HCV infection were more likely to report injection drug use and high-risk sexual behavior, even among individuals reporting neither of these risk factors, but the prevalence of HCV infection was 7% (Clin Infect Dis. 2016 Feb 21. doi: 10.1093/cid/ciw073).

“We also cannot compare our results with the epidemiology of the surrounding population not using the ED, but suggest that as is the case with HIV, EDs are likely to provide a uniquely high level of access to populations with undiagnosed HCV who are in need of treatment,” wrote Dr. Michael S. Lyons and colleagues from the University of Cincinnati.

The authors, however, suggested that their survey may have underestimated the current prevalence of HCV because of an increase in heroin use in the area in more recent years.

Dr. Hsieh and colleagues suggested there was a need to revise the CDC recommendations and expand the age cut-off to all individuals aged 18 years or over.

The first study was supported by the National Institutes of Health and the authors declared no conflicts of interest. The second study was partly supported by Gilead Sciences, the National Institutes of Health, and Bristol-Myers Squibb. Four of the seven authors reported support, research grants, consultancies, or advisory board positions with pharmaceutical companies including Gilead and Bristol-Myers Squibb.

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Birth-cohort screening for hepatitis C virus according to U.S. Centers for Disease Control and Prevention guidelines may miss around one-quarter of infections, researchers said.

An 8-week seroprevalence survey in an urban emergency department tested excess blood samples from 4,713 patients for hepatitis C virus, finding an overall prevalence of 13.8%, of which 31.3% was undocumented infection.

Jezperklauzen/ThinkStock

According to a paper published in Clinical Infectious Diseases, among the 204 patients with undocumented HCV infection, 48.5% were born between 1945 and 1965 and therefore would have been included in birth-cohort testing, and 26.5% would have been picked up for risk-based testing.

But 25% of the patients found to be infected with HCV in the study would not have been tested based on birth cohort or risk (Clin Infect Dis. 2016 Feb 21. doi: 10.1093/cid/ciw074).

The CDC added the recommendation for one-time testing of individuals born between 1945 and 1965 to its existing advice on risk-based screening in 2012, and this was backed by the U.S. Preventive Services Task Force in 2013.

“Since the CDC’s revised HIV testing recommendations for the health care settings were released, many EDs have had great success in implementing routine HIV testing to the population they serve over the past decade,” wrote Dr. Yu-Hsiang Hsieh of Johns Hopkins University, Baltimore, and coauthors. “This coupled with the availability of effective therapeutics makes EDs a key and strategic component of the national plan to expand HCV testing.”

At the same time, a second study, also in an urban emergency department, tested samples from 924 individuals enrolled in an HIV prevalence survey.

In this study, published in the same issue of Clinical Infectious Diseases, researchers found HCV antibodies in samples from 128 patients (14%); 34% of whom self-reported a history of HCV or hepatitis and 81% of whom were RNA positive.

The researchers noted, however, that, had they only implemented birth-cohort or risk-based screening, they would have missed 28% of individuals with antibodies and 25% of individuals with replicative HCV.

In this study, individuals with HCV infection were more likely to report injection drug use and high-risk sexual behavior, even among individuals reporting neither of these risk factors, but the prevalence of HCV infection was 7% (Clin Infect Dis. 2016 Feb 21. doi: 10.1093/cid/ciw073).

“We also cannot compare our results with the epidemiology of the surrounding population not using the ED, but suggest that as is the case with HIV, EDs are likely to provide a uniquely high level of access to populations with undiagnosed HCV who are in need of treatment,” wrote Dr. Michael S. Lyons and colleagues from the University of Cincinnati.

The authors, however, suggested that their survey may have underestimated the current prevalence of HCV because of an increase in heroin use in the area in more recent years.

Dr. Hsieh and colleagues suggested there was a need to revise the CDC recommendations and expand the age cut-off to all individuals aged 18 years or over.

The first study was supported by the National Institutes of Health and the authors declared no conflicts of interest. The second study was partly supported by Gilead Sciences, the National Institutes of Health, and Bristol-Myers Squibb. Four of the seven authors reported support, research grants, consultancies, or advisory board positions with pharmaceutical companies including Gilead and Bristol-Myers Squibb.

Birth-cohort screening for hepatitis C virus according to U.S. Centers for Disease Control and Prevention guidelines may miss around one-quarter of infections, researchers said.

An 8-week seroprevalence survey in an urban emergency department tested excess blood samples from 4,713 patients for hepatitis C virus, finding an overall prevalence of 13.8%, of which 31.3% was undocumented infection.

Jezperklauzen/ThinkStock

According to a paper published in Clinical Infectious Diseases, among the 204 patients with undocumented HCV infection, 48.5% were born between 1945 and 1965 and therefore would have been included in birth-cohort testing, and 26.5% would have been picked up for risk-based testing.

But 25% of the patients found to be infected with HCV in the study would not have been tested based on birth cohort or risk (Clin Infect Dis. 2016 Feb 21. doi: 10.1093/cid/ciw074).

The CDC added the recommendation for one-time testing of individuals born between 1945 and 1965 to its existing advice on risk-based screening in 2012, and this was backed by the U.S. Preventive Services Task Force in 2013.

“Since the CDC’s revised HIV testing recommendations for the health care settings were released, many EDs have had great success in implementing routine HIV testing to the population they serve over the past decade,” wrote Dr. Yu-Hsiang Hsieh of Johns Hopkins University, Baltimore, and coauthors. “This coupled with the availability of effective therapeutics makes EDs a key and strategic component of the national plan to expand HCV testing.”

At the same time, a second study, also in an urban emergency department, tested samples from 924 individuals enrolled in an HIV prevalence survey.

In this study, published in the same issue of Clinical Infectious Diseases, researchers found HCV antibodies in samples from 128 patients (14%); 34% of whom self-reported a history of HCV or hepatitis and 81% of whom were RNA positive.

The researchers noted, however, that, had they only implemented birth-cohort or risk-based screening, they would have missed 28% of individuals with antibodies and 25% of individuals with replicative HCV.

In this study, individuals with HCV infection were more likely to report injection drug use and high-risk sexual behavior, even among individuals reporting neither of these risk factors, but the prevalence of HCV infection was 7% (Clin Infect Dis. 2016 Feb 21. doi: 10.1093/cid/ciw073).

“We also cannot compare our results with the epidemiology of the surrounding population not using the ED, but suggest that as is the case with HIV, EDs are likely to provide a uniquely high level of access to populations with undiagnosed HCV who are in need of treatment,” wrote Dr. Michael S. Lyons and colleagues from the University of Cincinnati.

The authors, however, suggested that their survey may have underestimated the current prevalence of HCV because of an increase in heroin use in the area in more recent years.

Dr. Hsieh and colleagues suggested there was a need to revise the CDC recommendations and expand the age cut-off to all individuals aged 18 years or over.

The first study was supported by the National Institutes of Health and the authors declared no conflicts of interest. The second study was partly supported by Gilead Sciences, the National Institutes of Health, and Bristol-Myers Squibb. Four of the seven authors reported support, research grants, consultancies, or advisory board positions with pharmaceutical companies including Gilead and Bristol-Myers Squibb.

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Birth-cohort HCV testing misses one-quarter of infections
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Key clinical point: CDC recommendations for birth-cohort and high-risk screening for hepatitis C infection may miss one-quarter of infections.

Major finding: One in four patients with undocumented HCV infection would not otherwise have been tested based on birth cohort or risk.

Data source: A cross-sectional prevalence study involving 924 individuals and a seroprevalence study of 4,713 individuals.

Disclosures: The first study was supported by the National Institutes of Health and the authors declared no conflicts of interest. The second study was partly supported by Gilead Sciences, the National Institutes of Health, and Bristol-Myers Squibb. Four of the seven authors reported support, research grants, consultancies, or advisory board positions with pharmaceutical companies including Gilead and Bristol-Myers Squibb.

Lessons from the Indiana HIV/HCV outbreak

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BOSTON – Nearly 1 year after 11 new HIV infections were diagnosed in Scott County, Ind., a region that had an incidence of fewer than 1 HIV infection per year over the previous decade, 188 new HIV infections have now been diagnosed, and more than 90% of the cases were coinfected with hepatitis C (HCV), according to Dr. John T. Brooks of the Centers for Disease Control and Prevention.

Lessons from the outbreak, he said, include the inescapable fact that the United States is experiencing an expanding epidemic of heroin use that is driving an increase in injection drug use, putting many more U.S. residents at risk for the spread of HIV and HCV infection.

The response to the outbreak “required a large and extremely intensive collaboration of local, state, and federal public health resources in close partnership with community members, and like all outbreak investigations, there are two goals: First, establish the extent of the outbreak, and then institute prevention and control measures,” Dr. Brooks reported at a plenary session at the Conference on Retroviruses and Opportunistic Infections.

The United States is experiencing an expanding epidemic of heroin use that is driving an increase in injection drug use, putting many more U.S. residents at risk for the spread of HIV and HCV infection.
©PaulPaladin/thinkstockphotos.com
The United States is experiencing an expanding epidemic of heroin use that is driving an increase in injection drug use, putting many more U.S. residents at risk for the spread of HIV and HCV infection.

Once the cases were detected and confirmed, the health authorities went into action, deploying emergency command at the state level, similar to that deployed during a weather disaster, with a team of 35 disease intervention specialists and other public health workers from 14 states and the District of Columbia who went door to door, testing as many people as possible to find HIV infections, and tracing contacts to determine where additional, undiagnosed cases might be.

“The pattern of how we approached this outbreak is very much how you might approach tuberculosis, where you first detect that there’s a disease and confirm the diagnosis, you deploy an intervention to treat – sort of induction therapy – and once it’s under control you switch to consolidation therapy to keep the disease at bay, and then over time you might scan the person or follow up to see if the disease is recurring. The difference here is that we’re doing it on a population level,” said Dr. Brooks of the CDC’s division of HIV/AIDS prevention.

Astute observer spotted trend

The outbreak came to the attention of public health authorities when a “very, very astute” disease intervention specialist working in the county health department recognized that there were 11 new infections related to one another in Scott County, with the epicenter in the town of Austin.

Early in the outbreak, investigators determined that the HIV and HCV transmissions were occurring in a dense network of persons who inject drugs, mostly the opioid analgesic oxymorphone, but also heroin, methamphetamine, and cocaine. “During interviews, it was evident that 96% of the people had injected in the past 12 months, and that oxymorphone was the preferred drug used by 92%,” Dr. Brooks said.

Dr. John T. Brooks
Dr. John T. Brooks

Oxymorphone is available in generic and branded formulations. Although the brand name version (Opana and Opana ER) has a coating intended to prevent crushing the pills and dissolving the drug for the purpose of injection, “addiction can make you very creative, and the residents of this town had figured how to get around that,” Dr. Brooks said.

The outbreak was multigenerational, and it was not uncommon to find a household with three generations of drug abusers – grandparent, parents, and children – who injected drugs between 4 and 15 times each day, with one to as many as six needle-sharing partners per injection event, and sharing of injection equipment. Information was available on 181 of the 188 HIV-infected cases. The median age was 34 years (interquartile range, 28-42), 58% were male, 99% were non-Hispanic whites, and 96% had injected drugs within the past 12 months.

Jailhouse testing

The investigators established HIV testing both in the Scott County jail and in detention centers in surrounding counties in a sentinel system to determine whether the outbreak might have spread beyond the county line. The disease intervention specialists collected intravenous blood samples and performed point-of-care rapid testing for later confirmation, and for testing for acute HIV and HCV infection.

The workers also provided county residents with disease prevention educational materials and directed them to services as required, including treatment and antiretroviral therapy, and/or addition and harm reduction services and preexposure prophylaxis, if appropriate.

Major logistical challenges for responders included the fact that very few affected individuals were either employed or insured, and most lacked the necessary documents to enroll in state-supported care Medicaid expansion, recently adopted by Indiana as part of the Affordable Care Act.

 

 

In addition, residents in this impoverished, remote community in Southeastern Indiana – which ranks last among Indiana’s 92 counties in many health statistic categories – were aware of HIV or had correct information about transmission risks or treatment benefits.

Efforts were further hampered by the atmosphere of distrust between drug injectors and law enforcement; the lack of outpatient HIV or HCV care in the community; meager addiction services, including medication-assisted therapy; and a statewide ban on needle-exchange programs. In May of 2015, Indiana Gov. Mike Pence signed into law a bill allowing syringe exchange in areas where there was an urgent need because of disease outbreak.

In November of 2015, there was a retesting “blitz” in which disease intervention teams returned to the community and attempted to locate all persons who had previously tested negative, or had not been located on the first go-round and tested again to determine whether any of the residents had developed new infections.

“If there’s one message I’d like you to take away today,” Dr. Brooks told attendees, “it’s this: We all know now that this could happen again, but with your help and commitment, it doesn’t have to.”

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BOSTON – Nearly 1 year after 11 new HIV infections were diagnosed in Scott County, Ind., a region that had an incidence of fewer than 1 HIV infection per year over the previous decade, 188 new HIV infections have now been diagnosed, and more than 90% of the cases were coinfected with hepatitis C (HCV), according to Dr. John T. Brooks of the Centers for Disease Control and Prevention.

Lessons from the outbreak, he said, include the inescapable fact that the United States is experiencing an expanding epidemic of heroin use that is driving an increase in injection drug use, putting many more U.S. residents at risk for the spread of HIV and HCV infection.

The response to the outbreak “required a large and extremely intensive collaboration of local, state, and federal public health resources in close partnership with community members, and like all outbreak investigations, there are two goals: First, establish the extent of the outbreak, and then institute prevention and control measures,” Dr. Brooks reported at a plenary session at the Conference on Retroviruses and Opportunistic Infections.

The United States is experiencing an expanding epidemic of heroin use that is driving an increase in injection drug use, putting many more U.S. residents at risk for the spread of HIV and HCV infection.
©PaulPaladin/thinkstockphotos.com
The United States is experiencing an expanding epidemic of heroin use that is driving an increase in injection drug use, putting many more U.S. residents at risk for the spread of HIV and HCV infection.

Once the cases were detected and confirmed, the health authorities went into action, deploying emergency command at the state level, similar to that deployed during a weather disaster, with a team of 35 disease intervention specialists and other public health workers from 14 states and the District of Columbia who went door to door, testing as many people as possible to find HIV infections, and tracing contacts to determine where additional, undiagnosed cases might be.

“The pattern of how we approached this outbreak is very much how you might approach tuberculosis, where you first detect that there’s a disease and confirm the diagnosis, you deploy an intervention to treat – sort of induction therapy – and once it’s under control you switch to consolidation therapy to keep the disease at bay, and then over time you might scan the person or follow up to see if the disease is recurring. The difference here is that we’re doing it on a population level,” said Dr. Brooks of the CDC’s division of HIV/AIDS prevention.

Astute observer spotted trend

The outbreak came to the attention of public health authorities when a “very, very astute” disease intervention specialist working in the county health department recognized that there were 11 new infections related to one another in Scott County, with the epicenter in the town of Austin.

Early in the outbreak, investigators determined that the HIV and HCV transmissions were occurring in a dense network of persons who inject drugs, mostly the opioid analgesic oxymorphone, but also heroin, methamphetamine, and cocaine. “During interviews, it was evident that 96% of the people had injected in the past 12 months, and that oxymorphone was the preferred drug used by 92%,” Dr. Brooks said.

Dr. John T. Brooks
Dr. John T. Brooks

Oxymorphone is available in generic and branded formulations. Although the brand name version (Opana and Opana ER) has a coating intended to prevent crushing the pills and dissolving the drug for the purpose of injection, “addiction can make you very creative, and the residents of this town had figured how to get around that,” Dr. Brooks said.

The outbreak was multigenerational, and it was not uncommon to find a household with three generations of drug abusers – grandparent, parents, and children – who injected drugs between 4 and 15 times each day, with one to as many as six needle-sharing partners per injection event, and sharing of injection equipment. Information was available on 181 of the 188 HIV-infected cases. The median age was 34 years (interquartile range, 28-42), 58% were male, 99% were non-Hispanic whites, and 96% had injected drugs within the past 12 months.

Jailhouse testing

The investigators established HIV testing both in the Scott County jail and in detention centers in surrounding counties in a sentinel system to determine whether the outbreak might have spread beyond the county line. The disease intervention specialists collected intravenous blood samples and performed point-of-care rapid testing for later confirmation, and for testing for acute HIV and HCV infection.

The workers also provided county residents with disease prevention educational materials and directed them to services as required, including treatment and antiretroviral therapy, and/or addition and harm reduction services and preexposure prophylaxis, if appropriate.

Major logistical challenges for responders included the fact that very few affected individuals were either employed or insured, and most lacked the necessary documents to enroll in state-supported care Medicaid expansion, recently adopted by Indiana as part of the Affordable Care Act.

 

 

In addition, residents in this impoverished, remote community in Southeastern Indiana – which ranks last among Indiana’s 92 counties in many health statistic categories – were aware of HIV or had correct information about transmission risks or treatment benefits.

Efforts were further hampered by the atmosphere of distrust between drug injectors and law enforcement; the lack of outpatient HIV or HCV care in the community; meager addiction services, including medication-assisted therapy; and a statewide ban on needle-exchange programs. In May of 2015, Indiana Gov. Mike Pence signed into law a bill allowing syringe exchange in areas where there was an urgent need because of disease outbreak.

In November of 2015, there was a retesting “blitz” in which disease intervention teams returned to the community and attempted to locate all persons who had previously tested negative, or had not been located on the first go-round and tested again to determine whether any of the residents had developed new infections.

“If there’s one message I’d like you to take away today,” Dr. Brooks told attendees, “it’s this: We all know now that this could happen again, but with your help and commitment, it doesn’t have to.”

BOSTON – Nearly 1 year after 11 new HIV infections were diagnosed in Scott County, Ind., a region that had an incidence of fewer than 1 HIV infection per year over the previous decade, 188 new HIV infections have now been diagnosed, and more than 90% of the cases were coinfected with hepatitis C (HCV), according to Dr. John T. Brooks of the Centers for Disease Control and Prevention.

Lessons from the outbreak, he said, include the inescapable fact that the United States is experiencing an expanding epidemic of heroin use that is driving an increase in injection drug use, putting many more U.S. residents at risk for the spread of HIV and HCV infection.

The response to the outbreak “required a large and extremely intensive collaboration of local, state, and federal public health resources in close partnership with community members, and like all outbreak investigations, there are two goals: First, establish the extent of the outbreak, and then institute prevention and control measures,” Dr. Brooks reported at a plenary session at the Conference on Retroviruses and Opportunistic Infections.

The United States is experiencing an expanding epidemic of heroin use that is driving an increase in injection drug use, putting many more U.S. residents at risk for the spread of HIV and HCV infection.
©PaulPaladin/thinkstockphotos.com
The United States is experiencing an expanding epidemic of heroin use that is driving an increase in injection drug use, putting many more U.S. residents at risk for the spread of HIV and HCV infection.

Once the cases were detected and confirmed, the health authorities went into action, deploying emergency command at the state level, similar to that deployed during a weather disaster, with a team of 35 disease intervention specialists and other public health workers from 14 states and the District of Columbia who went door to door, testing as many people as possible to find HIV infections, and tracing contacts to determine where additional, undiagnosed cases might be.

“The pattern of how we approached this outbreak is very much how you might approach tuberculosis, where you first detect that there’s a disease and confirm the diagnosis, you deploy an intervention to treat – sort of induction therapy – and once it’s under control you switch to consolidation therapy to keep the disease at bay, and then over time you might scan the person or follow up to see if the disease is recurring. The difference here is that we’re doing it on a population level,” said Dr. Brooks of the CDC’s division of HIV/AIDS prevention.

Astute observer spotted trend

The outbreak came to the attention of public health authorities when a “very, very astute” disease intervention specialist working in the county health department recognized that there were 11 new infections related to one another in Scott County, with the epicenter in the town of Austin.

Early in the outbreak, investigators determined that the HIV and HCV transmissions were occurring in a dense network of persons who inject drugs, mostly the opioid analgesic oxymorphone, but also heroin, methamphetamine, and cocaine. “During interviews, it was evident that 96% of the people had injected in the past 12 months, and that oxymorphone was the preferred drug used by 92%,” Dr. Brooks said.

Dr. John T. Brooks
Dr. John T. Brooks

Oxymorphone is available in generic and branded formulations. Although the brand name version (Opana and Opana ER) has a coating intended to prevent crushing the pills and dissolving the drug for the purpose of injection, “addiction can make you very creative, and the residents of this town had figured how to get around that,” Dr. Brooks said.

The outbreak was multigenerational, and it was not uncommon to find a household with three generations of drug abusers – grandparent, parents, and children – who injected drugs between 4 and 15 times each day, with one to as many as six needle-sharing partners per injection event, and sharing of injection equipment. Information was available on 181 of the 188 HIV-infected cases. The median age was 34 years (interquartile range, 28-42), 58% were male, 99% were non-Hispanic whites, and 96% had injected drugs within the past 12 months.

Jailhouse testing

The investigators established HIV testing both in the Scott County jail and in detention centers in surrounding counties in a sentinel system to determine whether the outbreak might have spread beyond the county line. The disease intervention specialists collected intravenous blood samples and performed point-of-care rapid testing for later confirmation, and for testing for acute HIV and HCV infection.

The workers also provided county residents with disease prevention educational materials and directed them to services as required, including treatment and antiretroviral therapy, and/or addition and harm reduction services and preexposure prophylaxis, if appropriate.

Major logistical challenges for responders included the fact that very few affected individuals were either employed or insured, and most lacked the necessary documents to enroll in state-supported care Medicaid expansion, recently adopted by Indiana as part of the Affordable Care Act.

 

 

In addition, residents in this impoverished, remote community in Southeastern Indiana – which ranks last among Indiana’s 92 counties in many health statistic categories – were aware of HIV or had correct information about transmission risks or treatment benefits.

Efforts were further hampered by the atmosphere of distrust between drug injectors and law enforcement; the lack of outpatient HIV or HCV care in the community; meager addiction services, including medication-assisted therapy; and a statewide ban on needle-exchange programs. In May of 2015, Indiana Gov. Mike Pence signed into law a bill allowing syringe exchange in areas where there was an urgent need because of disease outbreak.

In November of 2015, there was a retesting “blitz” in which disease intervention teams returned to the community and attempted to locate all persons who had previously tested negative, or had not been located on the first go-round and tested again to determine whether any of the residents had developed new infections.

“If there’s one message I’d like you to take away today,” Dr. Brooks told attendees, “it’s this: We all know now that this could happen again, but with your help and commitment, it doesn’t have to.”

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FDA revises Olysio label after adverse reactions in East Asian patients

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FDA revises Olysio label after adverse reactions in East Asian patients

The U.S. Food and Drug Administration has revised labeling for the hepatitis C drug Olysio (simeprevir) after adverse reactions were experienced by East Asian patients during a phase III trial.

Olysio, produced by Janssen Products LP, is a hepatitis C virus NS3/4A protease inhibitor indicated for the treatment of chronic hepatitis C (CHC) genotype 1 or 4 infection as a component of a combination antiviral treatment regimen. It was initially approved by the FDA in November 2013.

The update was announced in a March 1 FDA Hepatitis Email Updates letter signed by Richard Klein and his colleagues at the FDA Office of Health and Constituent Affairs. The updated labeling comes as a result of a randomized, double-blind phase III trial (the TIGER trial) conducted in China and South Korea. Olysio, in combination with Peg interferon (IFN) -alfa and ribavirin (RBV), was studied in treatment-naive subjects with chronic HCV genotype 1 infection.

The TIGER investigators observed a higher incidence of the laboratory abnormality hyperbilirubinemia in trial subjects receiving 150 mg Olysio plus Peg IFN-alfa and RBV, compared with patients receiving placebo plus Peg IFN-alfa and RBV. Elevation of total bilirubin was observed in 66% (99/151) of subjects treated with 150 mg Olysio plus Peg IFN-alfa and RBV and in 26% (40/152) of subjects treated with placebo plus Peg IFN-alfa and RBV. Bilirubin elevations were mainly grade 1 or grade 2. Grade 3 elevations in bilirubin were observed in 9% (13/151) of subjects treated with 150 mg Olysio plus Peg IFN-alfa and RBV and in 1% (2/152) of subjects treated with placebo plus Peg IFN-alfa and RBV. There were no grade 4 elevations in bilirubin.

Importantly, the bilirubin elevations were not associated with increases in liver transaminases and were reversible after the end of treatment.

The new labeling on Olysio includes the following: “Patients of East Asian ancestry exhibit higher simeprevir plasma exposures, but no dosage adjustment is required based on race. In a phase III trial conducted in China and South Korea, the mean plasma exposure of simeprevir in East Asian HCV-infected subjects was 2.1-fold higher, compared with non Asian HCV-infected subjects in a pooled phase III population from global trials.”

To read the FDA labeling for Olysio, the email announcement suggests visiting the Drugs@FDA website or the DailyMed website managed by the National Library of Medicine. As of this writing, these sites have yet to be updated.

rpizzi@frontlinemedcom.com

On Twitter @richpizzi

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The U.S. Food and Drug Administration has revised labeling for the hepatitis C drug Olysio (simeprevir) after adverse reactions were experienced by East Asian patients during a phase III trial.

Olysio, produced by Janssen Products LP, is a hepatitis C virus NS3/4A protease inhibitor indicated for the treatment of chronic hepatitis C (CHC) genotype 1 or 4 infection as a component of a combination antiviral treatment regimen. It was initially approved by the FDA in November 2013.

The update was announced in a March 1 FDA Hepatitis Email Updates letter signed by Richard Klein and his colleagues at the FDA Office of Health and Constituent Affairs. The updated labeling comes as a result of a randomized, double-blind phase III trial (the TIGER trial) conducted in China and South Korea. Olysio, in combination with Peg interferon (IFN) -alfa and ribavirin (RBV), was studied in treatment-naive subjects with chronic HCV genotype 1 infection.

The TIGER investigators observed a higher incidence of the laboratory abnormality hyperbilirubinemia in trial subjects receiving 150 mg Olysio plus Peg IFN-alfa and RBV, compared with patients receiving placebo plus Peg IFN-alfa and RBV. Elevation of total bilirubin was observed in 66% (99/151) of subjects treated with 150 mg Olysio plus Peg IFN-alfa and RBV and in 26% (40/152) of subjects treated with placebo plus Peg IFN-alfa and RBV. Bilirubin elevations were mainly grade 1 or grade 2. Grade 3 elevations in bilirubin were observed in 9% (13/151) of subjects treated with 150 mg Olysio plus Peg IFN-alfa and RBV and in 1% (2/152) of subjects treated with placebo plus Peg IFN-alfa and RBV. There were no grade 4 elevations in bilirubin.

Importantly, the bilirubin elevations were not associated with increases in liver transaminases and were reversible after the end of treatment.

The new labeling on Olysio includes the following: “Patients of East Asian ancestry exhibit higher simeprevir plasma exposures, but no dosage adjustment is required based on race. In a phase III trial conducted in China and South Korea, the mean plasma exposure of simeprevir in East Asian HCV-infected subjects was 2.1-fold higher, compared with non Asian HCV-infected subjects in a pooled phase III population from global trials.”

To read the FDA labeling for Olysio, the email announcement suggests visiting the Drugs@FDA website or the DailyMed website managed by the National Library of Medicine. As of this writing, these sites have yet to be updated.

rpizzi@frontlinemedcom.com

On Twitter @richpizzi

The U.S. Food and Drug Administration has revised labeling for the hepatitis C drug Olysio (simeprevir) after adverse reactions were experienced by East Asian patients during a phase III trial.

Olysio, produced by Janssen Products LP, is a hepatitis C virus NS3/4A protease inhibitor indicated for the treatment of chronic hepatitis C (CHC) genotype 1 or 4 infection as a component of a combination antiviral treatment regimen. It was initially approved by the FDA in November 2013.

The update was announced in a March 1 FDA Hepatitis Email Updates letter signed by Richard Klein and his colleagues at the FDA Office of Health and Constituent Affairs. The updated labeling comes as a result of a randomized, double-blind phase III trial (the TIGER trial) conducted in China and South Korea. Olysio, in combination with Peg interferon (IFN) -alfa and ribavirin (RBV), was studied in treatment-naive subjects with chronic HCV genotype 1 infection.

The TIGER investigators observed a higher incidence of the laboratory abnormality hyperbilirubinemia in trial subjects receiving 150 mg Olysio plus Peg IFN-alfa and RBV, compared with patients receiving placebo plus Peg IFN-alfa and RBV. Elevation of total bilirubin was observed in 66% (99/151) of subjects treated with 150 mg Olysio plus Peg IFN-alfa and RBV and in 26% (40/152) of subjects treated with placebo plus Peg IFN-alfa and RBV. Bilirubin elevations were mainly grade 1 or grade 2. Grade 3 elevations in bilirubin were observed in 9% (13/151) of subjects treated with 150 mg Olysio plus Peg IFN-alfa and RBV and in 1% (2/152) of subjects treated with placebo plus Peg IFN-alfa and RBV. There were no grade 4 elevations in bilirubin.

Importantly, the bilirubin elevations were not associated with increases in liver transaminases and were reversible after the end of treatment.

The new labeling on Olysio includes the following: “Patients of East Asian ancestry exhibit higher simeprevir plasma exposures, but no dosage adjustment is required based on race. In a phase III trial conducted in China and South Korea, the mean plasma exposure of simeprevir in East Asian HCV-infected subjects was 2.1-fold higher, compared with non Asian HCV-infected subjects in a pooled phase III population from global trials.”

To read the FDA labeling for Olysio, the email announcement suggests visiting the Drugs@FDA website or the DailyMed website managed by the National Library of Medicine. As of this writing, these sites have yet to be updated.

rpizzi@frontlinemedcom.com

On Twitter @richpizzi

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