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WHO report sets baseline for viral hepatitis elimination

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– An estimated 328 million people worldwide were living with chronic hepatitis B or C virus infection in 2015 according to a new report issued by the World Health Organization and launched at the International Liver Congress sponsored by the European Association for the Study of the Liver (EASL).

The WHO Global Hepatitis Report gives the worldwide prevalence of chronic hepatitis B (HBV) infection as 257 million and that of chronic hepatitis C (HCV) infection as 71 million at this time point, reported Yvan Hutin, MD, medical officer at the WHO Department of HIV and Global Hepatitis Programme (HIV/GHP) in Geneva.

Sara Freeman/Frontline Medical News
"We have a public health issue that obviously still needs to be addressed," said Dr. Hirnschall.
“We worked with a number of institutions and experts to produce most of these estimates, including the London School of Hygiene & Tropical Medicine and The Center for Disease Analysis,” Dr. Hutin said.

Dr. Hutin explained that the report was needed as it sets the baseline or “year zero” for tracking the success of WHO’s new global health sector strategy on viral hepatitis, which aims to eliminate viral hepatitis as a public health threat, reduce the number of new HBV and HCV infections by 90%, and reduce viral hepatitis mortality by 65% by 2030.

The report was “a very important statement for all of us who work in this field,” said EASL Vice-Secretary Tom Hemming Karslen, MD, during a press briefing. “This is a wonderful initiative helping all the activities that are now already ongoing and need to be strengthened to move in a coordinated manner.”

The launch of the report at the International Liver Congress was “win-win situation”, Gottfried Hirnschall, MD, director of the WHO Department of HIV/GHP, said at the press briefing.

“We are in the era of elimination. It is not only the commitment of the WHO, it is the commitment of the 194 member states who have signed up for elimination,” he said.

“An important message is that people are still dying of hepatitis, the numbers are still going up,” Dr. Hirnschall said. There were an estimated 1.34 million viral hepatitis deaths worldwide in 2015, most (95%) were due to the development of cirrhosis or hepatocellular carcinoma, according to the new report. “We have a public health issue that obviously still needs to be addressed.”

Three decades ago, little could be done to prevent or treat infection with HBV or HCV, Dr. Hutin said during the opening general scientific session. A lot has changed since then, prevention of hepatitis B started to become a reality with the availability of a vaccine and understanding of the importance of improved blood safety and injection practices. Since 2010, there have also been improvements in the drugs available to treat, and potentially eliminate, HCV, notably direct-acting antiviral agents.

“To reach elimination, we modeled that we needed to reach sufficient service coverage for five core interventions,” Dr. Hutin said. Specifically:
  • At least 90% of the world’s eligible population receives the three-dose hepatitis B vaccine
  • 100% of blood donations are screened appropriately
  • Proper injection technique is employed in 90% of cases
  • Clean needles made available where they are needed
  • 90% of people infected are diagnosed and 80% are treated.

Vaccination against HBV has been one success in the past 20 years, Ana Maria Henao Restrepo, MD, medical officer at the WHO Department of Immunization Vaccination and Biologicals, said at the press briefing.

Vaccination against HBV started in 1982, she said, “when the first safe and effective vaccine became available, and now four out of five children receive this life-saving vaccine. We are very pleased with this achievement but we know that there is still more work to do.”

The WHO report estimates that the global incidence of chronic HBV infection in children under 5 years of age was reduced from 4.7% in the pre-vaccination era to 1.3% in 2015 because of immunization.

But while uptake of the three-dose hepatitis B vaccine has increased, with 85% coverage of the worlds population in 2015, the number of children receiving this vaccine at birth is just 39% overall, with lower rates in the African region.

Sara Freeman/Frontline Medical News
As for HCV, Dr. Hutin said,“Overall, there are still 1.75 million new HCV infection each year; this is more than the number of people that we can manage to cure each year, which means the epidemic is still expanding.” He noted that deaths from viral hepatitis continue to rise year, which is in contrast to other viral infections such as malaria and HIV.

“Unsafe health care injections and injection drug use continue to transmit HCV, particularly in the eastern Mediterranean region and the European region,” Dr. Hutin said.

The WHO has already set up a campaign to improve blood and injection safety called “Get the Point,” but there is still a long way to go. The target is to provide 300 needle and syringe sets per person per year to people who inject drugs; the current rate is around 27 sets.

Of the 257 people infected with hepatitis B in 2015, only 9% were diagnosed and 1.7 million received treatment. As for hepatitis C, 20% of 71 million were diagnosed and 1.1 million received treatment.

“We need a public health approach that delivers all the basic services to all, including to specific groups that may differ from the general population in terms of incidence, prevalence, vulnerability, or needs,” said Dr. Hutin. This includes health care workers, intravenous drug users, prisoners, migrants, blood donors, men who have sex with men, sex workers, and indigenous populations.

“We have all the tools we need to eliminate hepatitis,” he said, adding that improved point of care tests, a functional cure for HBV, and a vaccine against HCV would accelerate the process.

“A year ago, elimination by 2030 looked very ambitious, but not that we’ve carefully looked at the baseline, it seems that we have a start. It’s going to be a lot of work but the train has left the station and we should get there,” Dr. Hutin concluded.

The U.S. Centers for Disease Control and Prevention provided funding for the production of the report. All speakers had no conflicts of interest.

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– An estimated 328 million people worldwide were living with chronic hepatitis B or C virus infection in 2015 according to a new report issued by the World Health Organization and launched at the International Liver Congress sponsored by the European Association for the Study of the Liver (EASL).

The WHO Global Hepatitis Report gives the worldwide prevalence of chronic hepatitis B (HBV) infection as 257 million and that of chronic hepatitis C (HCV) infection as 71 million at this time point, reported Yvan Hutin, MD, medical officer at the WHO Department of HIV and Global Hepatitis Programme (HIV/GHP) in Geneva.

Sara Freeman/Frontline Medical News
"We have a public health issue that obviously still needs to be addressed," said Dr. Hirnschall.
“We worked with a number of institutions and experts to produce most of these estimates, including the London School of Hygiene & Tropical Medicine and The Center for Disease Analysis,” Dr. Hutin said.

Dr. Hutin explained that the report was needed as it sets the baseline or “year zero” for tracking the success of WHO’s new global health sector strategy on viral hepatitis, which aims to eliminate viral hepatitis as a public health threat, reduce the number of new HBV and HCV infections by 90%, and reduce viral hepatitis mortality by 65% by 2030.

The report was “a very important statement for all of us who work in this field,” said EASL Vice-Secretary Tom Hemming Karslen, MD, during a press briefing. “This is a wonderful initiative helping all the activities that are now already ongoing and need to be strengthened to move in a coordinated manner.”

The launch of the report at the International Liver Congress was “win-win situation”, Gottfried Hirnschall, MD, director of the WHO Department of HIV/GHP, said at the press briefing.

“We are in the era of elimination. It is not only the commitment of the WHO, it is the commitment of the 194 member states who have signed up for elimination,” he said.

“An important message is that people are still dying of hepatitis, the numbers are still going up,” Dr. Hirnschall said. There were an estimated 1.34 million viral hepatitis deaths worldwide in 2015, most (95%) were due to the development of cirrhosis or hepatocellular carcinoma, according to the new report. “We have a public health issue that obviously still needs to be addressed.”

Three decades ago, little could be done to prevent or treat infection with HBV or HCV, Dr. Hutin said during the opening general scientific session. A lot has changed since then, prevention of hepatitis B started to become a reality with the availability of a vaccine and understanding of the importance of improved blood safety and injection practices. Since 2010, there have also been improvements in the drugs available to treat, and potentially eliminate, HCV, notably direct-acting antiviral agents.

“To reach elimination, we modeled that we needed to reach sufficient service coverage for five core interventions,” Dr. Hutin said. Specifically:
  • At least 90% of the world’s eligible population receives the three-dose hepatitis B vaccine
  • 100% of blood donations are screened appropriately
  • Proper injection technique is employed in 90% of cases
  • Clean needles made available where they are needed
  • 90% of people infected are diagnosed and 80% are treated.

Vaccination against HBV has been one success in the past 20 years, Ana Maria Henao Restrepo, MD, medical officer at the WHO Department of Immunization Vaccination and Biologicals, said at the press briefing.

Vaccination against HBV started in 1982, she said, “when the first safe and effective vaccine became available, and now four out of five children receive this life-saving vaccine. We are very pleased with this achievement but we know that there is still more work to do.”

The WHO report estimates that the global incidence of chronic HBV infection in children under 5 years of age was reduced from 4.7% in the pre-vaccination era to 1.3% in 2015 because of immunization.

But while uptake of the three-dose hepatitis B vaccine has increased, with 85% coverage of the worlds population in 2015, the number of children receiving this vaccine at birth is just 39% overall, with lower rates in the African region.

Sara Freeman/Frontline Medical News
As for HCV, Dr. Hutin said,“Overall, there are still 1.75 million new HCV infection each year; this is more than the number of people that we can manage to cure each year, which means the epidemic is still expanding.” He noted that deaths from viral hepatitis continue to rise year, which is in contrast to other viral infections such as malaria and HIV.

“Unsafe health care injections and injection drug use continue to transmit HCV, particularly in the eastern Mediterranean region and the European region,” Dr. Hutin said.

The WHO has already set up a campaign to improve blood and injection safety called “Get the Point,” but there is still a long way to go. The target is to provide 300 needle and syringe sets per person per year to people who inject drugs; the current rate is around 27 sets.

Of the 257 people infected with hepatitis B in 2015, only 9% were diagnosed and 1.7 million received treatment. As for hepatitis C, 20% of 71 million were diagnosed and 1.1 million received treatment.

“We need a public health approach that delivers all the basic services to all, including to specific groups that may differ from the general population in terms of incidence, prevalence, vulnerability, or needs,” said Dr. Hutin. This includes health care workers, intravenous drug users, prisoners, migrants, blood donors, men who have sex with men, sex workers, and indigenous populations.

“We have all the tools we need to eliminate hepatitis,” he said, adding that improved point of care tests, a functional cure for HBV, and a vaccine against HCV would accelerate the process.

“A year ago, elimination by 2030 looked very ambitious, but not that we’ve carefully looked at the baseline, it seems that we have a start. It’s going to be a lot of work but the train has left the station and we should get there,” Dr. Hutin concluded.

The U.S. Centers for Disease Control and Prevention provided funding for the production of the report. All speakers had no conflicts of interest.


– An estimated 328 million people worldwide were living with chronic hepatitis B or C virus infection in 2015 according to a new report issued by the World Health Organization and launched at the International Liver Congress sponsored by the European Association for the Study of the Liver (EASL).

The WHO Global Hepatitis Report gives the worldwide prevalence of chronic hepatitis B (HBV) infection as 257 million and that of chronic hepatitis C (HCV) infection as 71 million at this time point, reported Yvan Hutin, MD, medical officer at the WHO Department of HIV and Global Hepatitis Programme (HIV/GHP) in Geneva.

Sara Freeman/Frontline Medical News
"We have a public health issue that obviously still needs to be addressed," said Dr. Hirnschall.
“We worked with a number of institutions and experts to produce most of these estimates, including the London School of Hygiene & Tropical Medicine and The Center for Disease Analysis,” Dr. Hutin said.

Dr. Hutin explained that the report was needed as it sets the baseline or “year zero” for tracking the success of WHO’s new global health sector strategy on viral hepatitis, which aims to eliminate viral hepatitis as a public health threat, reduce the number of new HBV and HCV infections by 90%, and reduce viral hepatitis mortality by 65% by 2030.

The report was “a very important statement for all of us who work in this field,” said EASL Vice-Secretary Tom Hemming Karslen, MD, during a press briefing. “This is a wonderful initiative helping all the activities that are now already ongoing and need to be strengthened to move in a coordinated manner.”

The launch of the report at the International Liver Congress was “win-win situation”, Gottfried Hirnschall, MD, director of the WHO Department of HIV/GHP, said at the press briefing.

“We are in the era of elimination. It is not only the commitment of the WHO, it is the commitment of the 194 member states who have signed up for elimination,” he said.

“An important message is that people are still dying of hepatitis, the numbers are still going up,” Dr. Hirnschall said. There were an estimated 1.34 million viral hepatitis deaths worldwide in 2015, most (95%) were due to the development of cirrhosis or hepatocellular carcinoma, according to the new report. “We have a public health issue that obviously still needs to be addressed.”

Three decades ago, little could be done to prevent or treat infection with HBV or HCV, Dr. Hutin said during the opening general scientific session. A lot has changed since then, prevention of hepatitis B started to become a reality with the availability of a vaccine and understanding of the importance of improved blood safety and injection practices. Since 2010, there have also been improvements in the drugs available to treat, and potentially eliminate, HCV, notably direct-acting antiviral agents.

“To reach elimination, we modeled that we needed to reach sufficient service coverage for five core interventions,” Dr. Hutin said. Specifically:
  • At least 90% of the world’s eligible population receives the three-dose hepatitis B vaccine
  • 100% of blood donations are screened appropriately
  • Proper injection technique is employed in 90% of cases
  • Clean needles made available where they are needed
  • 90% of people infected are diagnosed and 80% are treated.

Vaccination against HBV has been one success in the past 20 years, Ana Maria Henao Restrepo, MD, medical officer at the WHO Department of Immunization Vaccination and Biologicals, said at the press briefing.

Vaccination against HBV started in 1982, she said, “when the first safe and effective vaccine became available, and now four out of five children receive this life-saving vaccine. We are very pleased with this achievement but we know that there is still more work to do.”

The WHO report estimates that the global incidence of chronic HBV infection in children under 5 years of age was reduced from 4.7% in the pre-vaccination era to 1.3% in 2015 because of immunization.

But while uptake of the three-dose hepatitis B vaccine has increased, with 85% coverage of the worlds population in 2015, the number of children receiving this vaccine at birth is just 39% overall, with lower rates in the African region.

Sara Freeman/Frontline Medical News
As for HCV, Dr. Hutin said,“Overall, there are still 1.75 million new HCV infection each year; this is more than the number of people that we can manage to cure each year, which means the epidemic is still expanding.” He noted that deaths from viral hepatitis continue to rise year, which is in contrast to other viral infections such as malaria and HIV.

“Unsafe health care injections and injection drug use continue to transmit HCV, particularly in the eastern Mediterranean region and the European region,” Dr. Hutin said.

The WHO has already set up a campaign to improve blood and injection safety called “Get the Point,” but there is still a long way to go. The target is to provide 300 needle and syringe sets per person per year to people who inject drugs; the current rate is around 27 sets.

Of the 257 people infected with hepatitis B in 2015, only 9% were diagnosed and 1.7 million received treatment. As for hepatitis C, 20% of 71 million were diagnosed and 1.1 million received treatment.

“We need a public health approach that delivers all the basic services to all, including to specific groups that may differ from the general population in terms of incidence, prevalence, vulnerability, or needs,” said Dr. Hutin. This includes health care workers, intravenous drug users, prisoners, migrants, blood donors, men who have sex with men, sex workers, and indigenous populations.

“We have all the tools we need to eliminate hepatitis,” he said, adding that improved point of care tests, a functional cure for HBV, and a vaccine against HCV would accelerate the process.

“A year ago, elimination by 2030 looked very ambitious, but not that we’ve carefully looked at the baseline, it seems that we have a start. It’s going to be a lot of work but the train has left the station and we should get there,” Dr. Hutin concluded.

The U.S. Centers for Disease Control and Prevention provided funding for the production of the report. All speakers had no conflicts of interest.

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Letter from the Editor: Spring brings flowers and liver stories

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Happy spring (finally, for many of us)! This month’s issue of GI & Hepatology News is “weighted” towards liver. The decrease in hepatitis C–related liver disease means that steatohepatitis will emerge as the most frequent cause of cirrhosis and transplantation. Finding medical therapies to slow obesity-related liver damage has proven challenging. Bariatric surgery may be the best option for patients, as pointed out by one of our lead stories. Another page one story lays out a roadmap to eliminate viral hepatitis in the United States, a situation unheard of until direct-acting antiviral agents were developed.

Dr. John I. Allen
A couple stories about celiac disease will be of interest, including one that discusses a viral etiology (albeit an animal study). A second story focuses on the prevalence of sprue in children.

The AGA’s contribution to this month’s issue is excellent. First, there is the continuing controversy regarding maintenance of certification. AGA has worked hard to eliminate the 10-year high-impact closed book examination (now an anachronism). We will have the option of a 2-year exam (open book) and you will need to become familiar with testing proposals so we all can add voices of reason to the ABIM process.

Additionally, the AGA highlights the POWER guideline (weight management) and its obesity resources, DDSEP® 8 and a new clinical guideline concerning transient elastography.

We close this month’s issue with a discussion from Ray Cross and Sunanda Kane about telemedicine and its impact on gastroenterology. There are multiple examples of how telemedicine is changing our practices and the piece provides hope for increased efficiencies and leveraged resources.

I hope you enjoy this issue. I have avoided my usual hints about our chaotic politics and its impact on our practices. We all need some relief and should take time to note the spring flowers.
 

John I. Allen, MD, MBA, AGAF

Editor in Chief

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Happy spring (finally, for many of us)! This month’s issue of GI & Hepatology News is “weighted” towards liver. The decrease in hepatitis C–related liver disease means that steatohepatitis will emerge as the most frequent cause of cirrhosis and transplantation. Finding medical therapies to slow obesity-related liver damage has proven challenging. Bariatric surgery may be the best option for patients, as pointed out by one of our lead stories. Another page one story lays out a roadmap to eliminate viral hepatitis in the United States, a situation unheard of until direct-acting antiviral agents were developed.

Dr. John I. Allen
A couple stories about celiac disease will be of interest, including one that discusses a viral etiology (albeit an animal study). A second story focuses on the prevalence of sprue in children.

The AGA’s contribution to this month’s issue is excellent. First, there is the continuing controversy regarding maintenance of certification. AGA has worked hard to eliminate the 10-year high-impact closed book examination (now an anachronism). We will have the option of a 2-year exam (open book) and you will need to become familiar with testing proposals so we all can add voices of reason to the ABIM process.

Additionally, the AGA highlights the POWER guideline (weight management) and its obesity resources, DDSEP® 8 and a new clinical guideline concerning transient elastography.

We close this month’s issue with a discussion from Ray Cross and Sunanda Kane about telemedicine and its impact on gastroenterology. There are multiple examples of how telemedicine is changing our practices and the piece provides hope for increased efficiencies and leveraged resources.

I hope you enjoy this issue. I have avoided my usual hints about our chaotic politics and its impact on our practices. We all need some relief and should take time to note the spring flowers.
 

John I. Allen, MD, MBA, AGAF

Editor in Chief

 

Happy spring (finally, for many of us)! This month’s issue of GI & Hepatology News is “weighted” towards liver. The decrease in hepatitis C–related liver disease means that steatohepatitis will emerge as the most frequent cause of cirrhosis and transplantation. Finding medical therapies to slow obesity-related liver damage has proven challenging. Bariatric surgery may be the best option for patients, as pointed out by one of our lead stories. Another page one story lays out a roadmap to eliminate viral hepatitis in the United States, a situation unheard of until direct-acting antiviral agents were developed.

Dr. John I. Allen
A couple stories about celiac disease will be of interest, including one that discusses a viral etiology (albeit an animal study). A second story focuses on the prevalence of sprue in children.

The AGA’s contribution to this month’s issue is excellent. First, there is the continuing controversy regarding maintenance of certification. AGA has worked hard to eliminate the 10-year high-impact closed book examination (now an anachronism). We will have the option of a 2-year exam (open book) and you will need to become familiar with testing proposals so we all can add voices of reason to the ABIM process.

Additionally, the AGA highlights the POWER guideline (weight management) and its obesity resources, DDSEP® 8 and a new clinical guideline concerning transient elastography.

We close this month’s issue with a discussion from Ray Cross and Sunanda Kane about telemedicine and its impact on gastroenterology. There are multiple examples of how telemedicine is changing our practices and the piece provides hope for increased efficiencies and leveraged resources.

I hope you enjoy this issue. I have avoided my usual hints about our chaotic politics and its impact on our practices. We all need some relief and should take time to note the spring flowers.
 

John I. Allen, MD, MBA, AGAF

Editor in Chief

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FDA approves Sovaldi, Harvoni for HCV in ages 12-plus

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The Food and Drug Administration has approved the use of Sovaldi (sofosbuvir) and Harvoni (ledipasvir and sofosbuvir) for the treatment of hepatitis C virus (HCV) in children aged 12 years and older.

The drugs – the first direct-acting, potentially curative antiviral treatments approved for children and adolescents with HCV – previously were approved for adults. The supplemental applications submitted by Gilead Sciences, which markets the drugs, were approved by the FDA on April 7 and expand the use of these drugs to pediatric patients aged 12 and up who weigh at least 77 pounds, and who have either mild or no cirrhosis; Sovaldi is indicated for those with HCV genotypes 2 or 3, and Harvoni is indicated for those with HCV genotypes 1, 4, 5, or 6.
 

 

“These approvals will help change the landscape for HCV treatment by addressing an unmet need in children and adolescents,” Edward Cox, MD, director of the Office of Antimicrobial Products in the FDA’s Center for Drug Evaluation and Research, said in a press statement.

The safety, pharmacokinetics, and efficacy of the drugs as established in trials leading to their approval for adults were confirmed in open-label trials in the pediatric population. Adverse effects with Sovaldi, which was studied in combination with ribavirin, included headache and fatigue.

Of note, hepatitis B virus (HBV) reactivation has been reported in adults with HCV/HBV coinfection who were treated with these drugs, but who were not receiving HBV antiviral therapy; therefore, all patients should be screened for evidence of current or prior HBV infection before starting treatment with Harvoni or Sovaldi, according to the FDA statement.
 

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The Food and Drug Administration has approved the use of Sovaldi (sofosbuvir) and Harvoni (ledipasvir and sofosbuvir) for the treatment of hepatitis C virus (HCV) in children aged 12 years and older.

The drugs – the first direct-acting, potentially curative antiviral treatments approved for children and adolescents with HCV – previously were approved for adults. The supplemental applications submitted by Gilead Sciences, which markets the drugs, were approved by the FDA on April 7 and expand the use of these drugs to pediatric patients aged 12 and up who weigh at least 77 pounds, and who have either mild or no cirrhosis; Sovaldi is indicated for those with HCV genotypes 2 or 3, and Harvoni is indicated for those with HCV genotypes 1, 4, 5, or 6.
 

 

“These approvals will help change the landscape for HCV treatment by addressing an unmet need in children and adolescents,” Edward Cox, MD, director of the Office of Antimicrobial Products in the FDA’s Center for Drug Evaluation and Research, said in a press statement.

The safety, pharmacokinetics, and efficacy of the drugs as established in trials leading to their approval for adults were confirmed in open-label trials in the pediatric population. Adverse effects with Sovaldi, which was studied in combination with ribavirin, included headache and fatigue.

Of note, hepatitis B virus (HBV) reactivation has been reported in adults with HCV/HBV coinfection who were treated with these drugs, but who were not receiving HBV antiviral therapy; therefore, all patients should be screened for evidence of current or prior HBV infection before starting treatment with Harvoni or Sovaldi, according to the FDA statement.
 

The Food and Drug Administration has approved the use of Sovaldi (sofosbuvir) and Harvoni (ledipasvir and sofosbuvir) for the treatment of hepatitis C virus (HCV) in children aged 12 years and older.

The drugs – the first direct-acting, potentially curative antiviral treatments approved for children and adolescents with HCV – previously were approved for adults. The supplemental applications submitted by Gilead Sciences, which markets the drugs, were approved by the FDA on April 7 and expand the use of these drugs to pediatric patients aged 12 and up who weigh at least 77 pounds, and who have either mild or no cirrhosis; Sovaldi is indicated for those with HCV genotypes 2 or 3, and Harvoni is indicated for those with HCV genotypes 1, 4, 5, or 6.
 

 

“These approvals will help change the landscape for HCV treatment by addressing an unmet need in children and adolescents,” Edward Cox, MD, director of the Office of Antimicrobial Products in the FDA’s Center for Drug Evaluation and Research, said in a press statement.

The safety, pharmacokinetics, and efficacy of the drugs as established in trials leading to their approval for adults were confirmed in open-label trials in the pediatric population. Adverse effects with Sovaldi, which was studied in combination with ribavirin, included headache and fatigue.

Of note, hepatitis B virus (HBV) reactivation has been reported in adults with HCV/HBV coinfection who were treated with these drugs, but who were not receiving HBV antiviral therapy; therefore, all patients should be screened for evidence of current or prior HBV infection before starting treatment with Harvoni or Sovaldi, according to the FDA statement.
 

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Liver disease likely to become increasing indication for bariatric surgery

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– There is a long list of benefits from bariatric surgery in the morbidly obese, but prevention of end-stage liver disease and the need for a first or second liver transplant is likely to grow as an indication, according to an overview of weight loss surgery at Digestive Diseases: New Advances, held by Rutgers, the State University of New Jersey, and Global Academy for Medical Education.

“Bariatric surgery is associated with significant improvement not just in diabetes, dyslipidemia, hypertension, and other complications of metabolic disorders but for me more interestingly, it is effective for treating fatty liver disease where you can see a 90% improvement in steatosis,” reported Subhashini Ayloo, MD, chief of minimally invasive robotic hepato-pancreato-biliary surgery and liver transplantation at New Jersey Medical School, Newark.

Trained in both bariatric surgery and liver transplant, Dr. Ayloo predicts that these fields will become increasingly connected because of the obesity epidemic and the related rise in nonalcoholic fatty liver disease (NAFLD). Dr. Ayloo reported that bariatric surgery is already being used in her center to avoid a second liver transplant in obese patients who are unable to lose sufficient weight to prevent progressive NAFLD after a first transplant.

Courtesy of Wikimedia / Nephron / Creative Commons License


The emphasis Dr. Ayloo placed on the role of bariatric surgery in preventing progression of NAFLD to nonalcoholic steatohepatitis and the inflammatory process that leads to fibrosis, cirrhosis, and liver decompensation, was drawn from her interest in these two fields. However, she did not ignore the potential of protection from obesity control for other diseases.

“Obesity adversely affects every organ in the body,” Dr. Ayloo pointed out. As a result of weight loss achieved with bariatric surgery, there is now a large body of evidence supporting broad benefits, not just those related to fat deposited in hepatocytes.

“We have a couple of decades of experience that has been published [with bariatric surgery], and this has shown that it maintains weight loss long term, it improves all the obesity-associated comorbidities, and it is cost effective,” Dr. Ayloo said. Now with long-term follow-up, “all of the studies are showing that bariatric surgery improves survival.”

Although most of the survival data have been generated by retrospective cohort studies, Dr. Ayloo cited nine sets of data showing odds ratios associating bariatric surgery with up to a 90% reduction in death over periods of up to 10 years of follow-up. In a summary slide presented by Dr. Ayloo, the estimated mortality benefit over 5 years was listed as 85%. The same summary slide listed large improvements in relevant measures of morbidity for more than 10 organ systems, such as improvement or resolution of dyslipidemia and hypertension in the circulatory system, improvement or resolution of asthma and other diseases affecting the respiratory system, and resolution or improvement of gastroesophageal reflux disease and other diseases affecting the gastrointestinal system.

Specific to the liver, these benefits included a nearly 40% reduction in liver inflammation and 20% reduction in fibrosis. According to Dr. Ayloo, who noted that NAFLD is expected to overtake hepatitis C virus as the No. 1 cause of liver transplant within the next 5 years, these data are important for drawing attention to bariatric surgery as a strategy to control liver disease. She suggested that there is a need to create a tighter link between efforts to treat morbid obesity and advanced liver disease.

“There is an established literature showing that if somebody is morbidly obese, the rate of liver transplant is lower than when compared to patients with normal weight,” Dr. Ayloo said. “There is a call out in the transplant community that we need to address this and we cannot just be throwing this under the table.”

Because of the strong relationship between obesity and NAFLD, a systematic approach is needed to consider liver disease in obese patients and obesity in patients with liver disease, she said. The close relationship is relevant when planning interventions for either. Liver disease should be assessed prior to bariatric surgery regardless of the indication and then monitored closely as part of postoperative care, she said.

Dr. Ayloo identified weight control as an essential part of posttransplant care to prevent hepatic fat deposition that threatens transplant-free survival.
 

Global Academy and this news organization are owned by the same company. Dr. Ayloo reports no relevant financial relationships.

AGA Resource

The AGA Obesity Practice Guide provides tools for gastroenterologists to lead a multidisciplinary team of health-care professionals for the management of patients with obesity. Learn more at www.gastro.org/obesity.

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– There is a long list of benefits from bariatric surgery in the morbidly obese, but prevention of end-stage liver disease and the need for a first or second liver transplant is likely to grow as an indication, according to an overview of weight loss surgery at Digestive Diseases: New Advances, held by Rutgers, the State University of New Jersey, and Global Academy for Medical Education.

“Bariatric surgery is associated with significant improvement not just in diabetes, dyslipidemia, hypertension, and other complications of metabolic disorders but for me more interestingly, it is effective for treating fatty liver disease where you can see a 90% improvement in steatosis,” reported Subhashini Ayloo, MD, chief of minimally invasive robotic hepato-pancreato-biliary surgery and liver transplantation at New Jersey Medical School, Newark.

Trained in both bariatric surgery and liver transplant, Dr. Ayloo predicts that these fields will become increasingly connected because of the obesity epidemic and the related rise in nonalcoholic fatty liver disease (NAFLD). Dr. Ayloo reported that bariatric surgery is already being used in her center to avoid a second liver transplant in obese patients who are unable to lose sufficient weight to prevent progressive NAFLD after a first transplant.

Courtesy of Wikimedia / Nephron / Creative Commons License


The emphasis Dr. Ayloo placed on the role of bariatric surgery in preventing progression of NAFLD to nonalcoholic steatohepatitis and the inflammatory process that leads to fibrosis, cirrhosis, and liver decompensation, was drawn from her interest in these two fields. However, she did not ignore the potential of protection from obesity control for other diseases.

“Obesity adversely affects every organ in the body,” Dr. Ayloo pointed out. As a result of weight loss achieved with bariatric surgery, there is now a large body of evidence supporting broad benefits, not just those related to fat deposited in hepatocytes.

“We have a couple of decades of experience that has been published [with bariatric surgery], and this has shown that it maintains weight loss long term, it improves all the obesity-associated comorbidities, and it is cost effective,” Dr. Ayloo said. Now with long-term follow-up, “all of the studies are showing that bariatric surgery improves survival.”

Although most of the survival data have been generated by retrospective cohort studies, Dr. Ayloo cited nine sets of data showing odds ratios associating bariatric surgery with up to a 90% reduction in death over periods of up to 10 years of follow-up. In a summary slide presented by Dr. Ayloo, the estimated mortality benefit over 5 years was listed as 85%. The same summary slide listed large improvements in relevant measures of morbidity for more than 10 organ systems, such as improvement or resolution of dyslipidemia and hypertension in the circulatory system, improvement or resolution of asthma and other diseases affecting the respiratory system, and resolution or improvement of gastroesophageal reflux disease and other diseases affecting the gastrointestinal system.

Specific to the liver, these benefits included a nearly 40% reduction in liver inflammation and 20% reduction in fibrosis. According to Dr. Ayloo, who noted that NAFLD is expected to overtake hepatitis C virus as the No. 1 cause of liver transplant within the next 5 years, these data are important for drawing attention to bariatric surgery as a strategy to control liver disease. She suggested that there is a need to create a tighter link between efforts to treat morbid obesity and advanced liver disease.

“There is an established literature showing that if somebody is morbidly obese, the rate of liver transplant is lower than when compared to patients with normal weight,” Dr. Ayloo said. “There is a call out in the transplant community that we need to address this and we cannot just be throwing this under the table.”

Because of the strong relationship between obesity and NAFLD, a systematic approach is needed to consider liver disease in obese patients and obesity in patients with liver disease, she said. The close relationship is relevant when planning interventions for either. Liver disease should be assessed prior to bariatric surgery regardless of the indication and then monitored closely as part of postoperative care, she said.

Dr. Ayloo identified weight control as an essential part of posttransplant care to prevent hepatic fat deposition that threatens transplant-free survival.
 

Global Academy and this news organization are owned by the same company. Dr. Ayloo reports no relevant financial relationships.

AGA Resource

The AGA Obesity Practice Guide provides tools for gastroenterologists to lead a multidisciplinary team of health-care professionals for the management of patients with obesity. Learn more at www.gastro.org/obesity.

 

– There is a long list of benefits from bariatric surgery in the morbidly obese, but prevention of end-stage liver disease and the need for a first or second liver transplant is likely to grow as an indication, according to an overview of weight loss surgery at Digestive Diseases: New Advances, held by Rutgers, the State University of New Jersey, and Global Academy for Medical Education.

“Bariatric surgery is associated with significant improvement not just in diabetes, dyslipidemia, hypertension, and other complications of metabolic disorders but for me more interestingly, it is effective for treating fatty liver disease where you can see a 90% improvement in steatosis,” reported Subhashini Ayloo, MD, chief of minimally invasive robotic hepato-pancreato-biliary surgery and liver transplantation at New Jersey Medical School, Newark.

Trained in both bariatric surgery and liver transplant, Dr. Ayloo predicts that these fields will become increasingly connected because of the obesity epidemic and the related rise in nonalcoholic fatty liver disease (NAFLD). Dr. Ayloo reported that bariatric surgery is already being used in her center to avoid a second liver transplant in obese patients who are unable to lose sufficient weight to prevent progressive NAFLD after a first transplant.

Courtesy of Wikimedia / Nephron / Creative Commons License


The emphasis Dr. Ayloo placed on the role of bariatric surgery in preventing progression of NAFLD to nonalcoholic steatohepatitis and the inflammatory process that leads to fibrosis, cirrhosis, and liver decompensation, was drawn from her interest in these two fields. However, she did not ignore the potential of protection from obesity control for other diseases.

“Obesity adversely affects every organ in the body,” Dr. Ayloo pointed out. As a result of weight loss achieved with bariatric surgery, there is now a large body of evidence supporting broad benefits, not just those related to fat deposited in hepatocytes.

“We have a couple of decades of experience that has been published [with bariatric surgery], and this has shown that it maintains weight loss long term, it improves all the obesity-associated comorbidities, and it is cost effective,” Dr. Ayloo said. Now with long-term follow-up, “all of the studies are showing that bariatric surgery improves survival.”

Although most of the survival data have been generated by retrospective cohort studies, Dr. Ayloo cited nine sets of data showing odds ratios associating bariatric surgery with up to a 90% reduction in death over periods of up to 10 years of follow-up. In a summary slide presented by Dr. Ayloo, the estimated mortality benefit over 5 years was listed as 85%. The same summary slide listed large improvements in relevant measures of morbidity for more than 10 organ systems, such as improvement or resolution of dyslipidemia and hypertension in the circulatory system, improvement or resolution of asthma and other diseases affecting the respiratory system, and resolution or improvement of gastroesophageal reflux disease and other diseases affecting the gastrointestinal system.

Specific to the liver, these benefits included a nearly 40% reduction in liver inflammation and 20% reduction in fibrosis. According to Dr. Ayloo, who noted that NAFLD is expected to overtake hepatitis C virus as the No. 1 cause of liver transplant within the next 5 years, these data are important for drawing attention to bariatric surgery as a strategy to control liver disease. She suggested that there is a need to create a tighter link between efforts to treat morbid obesity and advanced liver disease.

“There is an established literature showing that if somebody is morbidly obese, the rate of liver transplant is lower than when compared to patients with normal weight,” Dr. Ayloo said. “There is a call out in the transplant community that we need to address this and we cannot just be throwing this under the table.”

Because of the strong relationship between obesity and NAFLD, a systematic approach is needed to consider liver disease in obese patients and obesity in patients with liver disease, she said. The close relationship is relevant when planning interventions for either. Liver disease should be assessed prior to bariatric surgery regardless of the indication and then monitored closely as part of postoperative care, she said.

Dr. Ayloo identified weight control as an essential part of posttransplant care to prevent hepatic fat deposition that threatens transplant-free survival.
 

Global Academy and this news organization are owned by the same company. Dr. Ayloo reports no relevant financial relationships.

AGA Resource

The AGA Obesity Practice Guide provides tools for gastroenterologists to lead a multidisciplinary team of health-care professionals for the management of patients with obesity. Learn more at www.gastro.org/obesity.

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AT DIGESTIVE DISEASES: NEW ADVANCES

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Eliminating hepatitis in the United States: A road map

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An ambitious new report by the National Academies of Sciences, Engineering, and Medicine lays out a detailed path by which some 90,000 deaths from hepatitis B and C infection could be prevented by 2030.

 

 

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An ambitious new report by the National Academies of Sciences, Engineering, and Medicine lays out a detailed path by which some 90,000 deaths from hepatitis B and C infection could be prevented by 2030.

 

 

 

An ambitious new report by the National Academies of Sciences, Engineering, and Medicine lays out a detailed path by which some 90,000 deaths from hepatitis B and C infection could be prevented by 2030.

 

 

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FROM THE NATIONAL ACADEMIES OF SCIENCES, ENGINEERING, AND MEDICINE

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Doubt expressed about potential of any single regimen to treat all hep C

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– Despite combination therapies for hepatitis C virus (HCV) that are now showing high rates of sustained viral remission (SVR) across all genotypes, a one-size-fits-all treatment will not be practical in the near future, according to a review of current and coming HCV therapies at Digestive Diseases: New Advances meeting held by Rutgers, the State University of New Jersey, and Global Academy for Medical Education. Global Academy and this news organization are owned by the same company.

 

 

Courtesy US. Dept of Veterans Affairs
Hepatitis C virus is magnified.
There is no question that the most effective one-pill combinations of direct–acting antiviral (DAA) agents are simplifying treatment strategies. “Many of the special populations have dissolved into what I would now consider to be special considerations,” according to Dr. Brown. However, she cautioned that HCV management still requires skills for individualizing care.

The presence of cirrhosis in some patients demonstrates the need for this care, for example. Many of the most effective single-pill DAA combinations are demonstrating high SVR rates for HCV patients with cirrhosis, but Dr. Brown said that identification of cirrhosis prior to HCV treatment “remains imperative.” Some pangenotypic therapies require a longer duration of treatment when cirrhosis is present, and patients with cirrhosis require posttreatment monitoring for decompensation and hepatocellular carcinoma (HCC). Patients who have failed a prior anti-HCV regimen or who are in renal failure also require more individualized care.

“There is no current therapy in my opinion that allows for one combination, for one length of treatment, without consideration of any patient characteristics,” Dr. Brown said at the meeting. Although several newer combination drugs with pangenotypic properties are likely to be approved for HCV in 2017, Dr. Brown believes that the one-size-fits-all ideal is not going to be fulfilled “anytime soon.”

However, Dr. Brown does believe that HCV care can and should be shifted to trained primary care providers in order to increase the proportion of infected patients who are treated. She indicated that the pangenotypic drugs are making this easier to accomplish and cited a study from the most recent annual meeting of the American Society for the Study of Liver Diseases that showed comparable SVR rates for primary care physicians, nurse practitioners, and specialists when the primary care clinicians underwent a uniform 3-hour training program (Emmanuel B. et al. AASLD 2016;Abstract 22).

“There is an evidence basis for shifting care to primary care providers in order to expand treatment, but, certainly, these providers must have an interest,” Dr. Brown said. She also said that treatment from a primary care provider must be accompanied by follow-up care, which, for example, might include clinics specializing in alcohol or drug dependency.

In treatment-naive patients with uncomplicated HCV, nearly 100% of patients will achieve an SVR on 8-12 weeks of therapy, regardless of genotype, with the newest and most potent DAA regimens, according to data cited by Dr. Brown. However, she cautioned that, even in these patients, it would be inaccurate to conclude that one-size-fits-all therapy is sufficient.

One relatively recent concern is HBV activation. “The reactivation of HBV appears to be temporally related to use of DAAs, and this seems to be independent of HCV genotype, type of DAA received, or [the patient’s] HCV parameters,” Dr. Brown reported, citing data from the Food and Drug Administration. “The clinical implications for this are that HBV DNA must now be monitored, so this is another level of complexity for our care providers.”

Other considerations for care of HCV despite achieving SVR with current treatments include monitoring for HCC and preventing reinfection. Dr. Brown cautioned that the risk of HCC, although greatly reduced after SVR, is not eliminated, and specific monitoring strategies are particularly important for those with fibrosis or cirrhosis prior to SVR.

In addition, the same risks for primary HCV are relevant for reinfection, according to Dr. Brown. She pointed out that these reinfection rates can be substantial in populations that persist in behaviors that result in HCV exposure.

“We are getting very close to the ideal of a one-size-fits-all treatment regimen for HCV, which would include no need to check genotype, no contraindications, no need for close monitoring, and no need to document cirrhosis, but we are not there yet,” Dr. Brown said. Even if such a regimen does emerge, she indicated that clinicians are not likely to ever be absolved from important management decisions that ensure an optimal long-term outcome.
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– Despite combination therapies for hepatitis C virus (HCV) that are now showing high rates of sustained viral remission (SVR) across all genotypes, a one-size-fits-all treatment will not be practical in the near future, according to a review of current and coming HCV therapies at Digestive Diseases: New Advances meeting held by Rutgers, the State University of New Jersey, and Global Academy for Medical Education. Global Academy and this news organization are owned by the same company.

 

 

Courtesy US. Dept of Veterans Affairs
Hepatitis C virus is magnified.
There is no question that the most effective one-pill combinations of direct–acting antiviral (DAA) agents are simplifying treatment strategies. “Many of the special populations have dissolved into what I would now consider to be special considerations,” according to Dr. Brown. However, she cautioned that HCV management still requires skills for individualizing care.

The presence of cirrhosis in some patients demonstrates the need for this care, for example. Many of the most effective single-pill DAA combinations are demonstrating high SVR rates for HCV patients with cirrhosis, but Dr. Brown said that identification of cirrhosis prior to HCV treatment “remains imperative.” Some pangenotypic therapies require a longer duration of treatment when cirrhosis is present, and patients with cirrhosis require posttreatment monitoring for decompensation and hepatocellular carcinoma (HCC). Patients who have failed a prior anti-HCV regimen or who are in renal failure also require more individualized care.

“There is no current therapy in my opinion that allows for one combination, for one length of treatment, without consideration of any patient characteristics,” Dr. Brown said at the meeting. Although several newer combination drugs with pangenotypic properties are likely to be approved for HCV in 2017, Dr. Brown believes that the one-size-fits-all ideal is not going to be fulfilled “anytime soon.”

However, Dr. Brown does believe that HCV care can and should be shifted to trained primary care providers in order to increase the proportion of infected patients who are treated. She indicated that the pangenotypic drugs are making this easier to accomplish and cited a study from the most recent annual meeting of the American Society for the Study of Liver Diseases that showed comparable SVR rates for primary care physicians, nurse practitioners, and specialists when the primary care clinicians underwent a uniform 3-hour training program (Emmanuel B. et al. AASLD 2016;Abstract 22).

“There is an evidence basis for shifting care to primary care providers in order to expand treatment, but, certainly, these providers must have an interest,” Dr. Brown said. She also said that treatment from a primary care provider must be accompanied by follow-up care, which, for example, might include clinics specializing in alcohol or drug dependency.

In treatment-naive patients with uncomplicated HCV, nearly 100% of patients will achieve an SVR on 8-12 weeks of therapy, regardless of genotype, with the newest and most potent DAA regimens, according to data cited by Dr. Brown. However, she cautioned that, even in these patients, it would be inaccurate to conclude that one-size-fits-all therapy is sufficient.

One relatively recent concern is HBV activation. “The reactivation of HBV appears to be temporally related to use of DAAs, and this seems to be independent of HCV genotype, type of DAA received, or [the patient’s] HCV parameters,” Dr. Brown reported, citing data from the Food and Drug Administration. “The clinical implications for this are that HBV DNA must now be monitored, so this is another level of complexity for our care providers.”

Other considerations for care of HCV despite achieving SVR with current treatments include monitoring for HCC and preventing reinfection. Dr. Brown cautioned that the risk of HCC, although greatly reduced after SVR, is not eliminated, and specific monitoring strategies are particularly important for those with fibrosis or cirrhosis prior to SVR.

In addition, the same risks for primary HCV are relevant for reinfection, according to Dr. Brown. She pointed out that these reinfection rates can be substantial in populations that persist in behaviors that result in HCV exposure.

“We are getting very close to the ideal of a one-size-fits-all treatment regimen for HCV, which would include no need to check genotype, no contraindications, no need for close monitoring, and no need to document cirrhosis, but we are not there yet,” Dr. Brown said. Even if such a regimen does emerge, she indicated that clinicians are not likely to ever be absolved from important management decisions that ensure an optimal long-term outcome.

 

– Despite combination therapies for hepatitis C virus (HCV) that are now showing high rates of sustained viral remission (SVR) across all genotypes, a one-size-fits-all treatment will not be practical in the near future, according to a review of current and coming HCV therapies at Digestive Diseases: New Advances meeting held by Rutgers, the State University of New Jersey, and Global Academy for Medical Education. Global Academy and this news organization are owned by the same company.

 

 

Courtesy US. Dept of Veterans Affairs
Hepatitis C virus is magnified.
There is no question that the most effective one-pill combinations of direct–acting antiviral (DAA) agents are simplifying treatment strategies. “Many of the special populations have dissolved into what I would now consider to be special considerations,” according to Dr. Brown. However, she cautioned that HCV management still requires skills for individualizing care.

The presence of cirrhosis in some patients demonstrates the need for this care, for example. Many of the most effective single-pill DAA combinations are demonstrating high SVR rates for HCV patients with cirrhosis, but Dr. Brown said that identification of cirrhosis prior to HCV treatment “remains imperative.” Some pangenotypic therapies require a longer duration of treatment when cirrhosis is present, and patients with cirrhosis require posttreatment monitoring for decompensation and hepatocellular carcinoma (HCC). Patients who have failed a prior anti-HCV regimen or who are in renal failure also require more individualized care.

“There is no current therapy in my opinion that allows for one combination, for one length of treatment, without consideration of any patient characteristics,” Dr. Brown said at the meeting. Although several newer combination drugs with pangenotypic properties are likely to be approved for HCV in 2017, Dr. Brown believes that the one-size-fits-all ideal is not going to be fulfilled “anytime soon.”

However, Dr. Brown does believe that HCV care can and should be shifted to trained primary care providers in order to increase the proportion of infected patients who are treated. She indicated that the pangenotypic drugs are making this easier to accomplish and cited a study from the most recent annual meeting of the American Society for the Study of Liver Diseases that showed comparable SVR rates for primary care physicians, nurse practitioners, and specialists when the primary care clinicians underwent a uniform 3-hour training program (Emmanuel B. et al. AASLD 2016;Abstract 22).

“There is an evidence basis for shifting care to primary care providers in order to expand treatment, but, certainly, these providers must have an interest,” Dr. Brown said. She also said that treatment from a primary care provider must be accompanied by follow-up care, which, for example, might include clinics specializing in alcohol or drug dependency.

In treatment-naive patients with uncomplicated HCV, nearly 100% of patients will achieve an SVR on 8-12 weeks of therapy, regardless of genotype, with the newest and most potent DAA regimens, according to data cited by Dr. Brown. However, she cautioned that, even in these patients, it would be inaccurate to conclude that one-size-fits-all therapy is sufficient.

One relatively recent concern is HBV activation. “The reactivation of HBV appears to be temporally related to use of DAAs, and this seems to be independent of HCV genotype, type of DAA received, or [the patient’s] HCV parameters,” Dr. Brown reported, citing data from the Food and Drug Administration. “The clinical implications for this are that HBV DNA must now be monitored, so this is another level of complexity for our care providers.”

Other considerations for care of HCV despite achieving SVR with current treatments include monitoring for HCC and preventing reinfection. Dr. Brown cautioned that the risk of HCC, although greatly reduced after SVR, is not eliminated, and specific monitoring strategies are particularly important for those with fibrosis or cirrhosis prior to SVR.

In addition, the same risks for primary HCV are relevant for reinfection, according to Dr. Brown. She pointed out that these reinfection rates can be substantial in populations that persist in behaviors that result in HCV exposure.

“We are getting very close to the ideal of a one-size-fits-all treatment regimen for HCV, which would include no need to check genotype, no contraindications, no need for close monitoring, and no need to document cirrhosis, but we are not there yet,” Dr. Brown said. Even if such a regimen does emerge, she indicated that clinicians are not likely to ever be absolved from important management decisions that ensure an optimal long-term outcome.
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AT DIGESTIVE DISEASES: NEW ADVANCES MEETING

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Key clinical point: Pangenotypic efficacy is not sufficient to create a one-size-fits-all regimen for HCV treatment, according to an assessment of evolving options.

Major finding: More-effective pills have moved the focus for progress in hepatitis C to more effective delivery of care.

Data source: A research review of current and coming HCV therapies.

Disclosures: Dr. Brown reported financial relationships with AbbVie, Bayer, Bristol-Myers Squibb, Gilead, Merck, and Novartis.

Of six milestones, only two left on route to hep B cure

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– The road to absolute cure of hepatitis B virus (HBV) is so well understood that the strategies now being actively pursued may conceivably eliminate this infection from the human population, according to a summary of progress presented at Digestive Diseases: New Advances.

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– The road to absolute cure of hepatitis B virus (HBV) is so well understood that the strategies now being actively pursued may conceivably eliminate this infection from the human population, according to a summary of progress presented at Digestive Diseases: New Advances.

 

– The road to absolute cure of hepatitis B virus (HBV) is so well understood that the strategies now being actively pursued may conceivably eliminate this infection from the human population, according to a summary of progress presented at Digestive Diseases: New Advances.

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EXPERT ANALYSIS FROM DIGESTIVE DISEASES: NEW ADVANCES

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Therapeutic window is narrow for steroids in alcoholic hepatitis

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– The main lesson for discordant data regarding the benefit of corticosteroids for alcoholic hepatitis is that mortality reductions accrue only to those patients who have advanced hepatitis but have not yet developed end-stage disease, according to a detailed look at published studies presented at Digestive Diseases: New Advances, held by Rutgers, the State University of New Jersey, and Global Academy for Medical Education.

Dr. Kevin D. Mullen


These calculations were extrapolated from a long list of studies published over the last 45 years, some of the largest of which concluded that steroids are ineffective, according to Dr. Mullen. The likely source of the conflicting data is the timing of steroids over the course of the disease and the disparity in the scales used to define severity.

Of the scales employed to select candidates for steroid therapy, the Maddrey Discriminant Function (MDF) may be the best supported, according to Dr. Mullen. He suggested that other options, such as the MELD (Model for End-Stage Liver Disease) score and the presence or absence of hepatic encephalopathy are also likely to have discriminatory value in selecting patients for steroid therapy, but these have been largely evaluated in retrospective studies using disparate methodologies.

“The problem arises from so many trials using different criteria for patient selection,” Dr. Mullen explained.

Nevertheless, drawing on the preponderance of data, Dr. Mullen concluded that there is likely to be a therapeutic window within which steroids are beneficial. Using one prednisolone study that stratified patients by MDF score to illustrate this point, he noted that 6-month survival on active therapy was no better than placebo in patients with an MDF less than 25 and numerically but not necessarily clinically significantly better in those scoring 25-34. In the groups with an MDF score of 35-44 or 44-54, the survival at 6 months was several times higher (greater than 60% vs. less than 20%), but there was no advantage with scores greater than 54. In this latter group, the mortality rate at 6 months was 100% in those receiving steroids but only 80% among those given placebo.

“In my mind, there is no question that steroids can be of benefit, but it is a question of picking the right patient. If steroids are given too late in the disease process, it can exacerbate end-stage problems, leading to death,” Dr. Mullen said.

The potential mechanisms of benefit from steroids in alcoholic hepatitis include a reduction in collagen formation and an increase in albumin production, according to Dr. Mullen. In addition, steroids have the potential to suppress the cytokine-mediated inflammation that drives progressive liver dysfunction. However, steroids also have the potential of exacerbating existing infections by suppressing immune function. Moreover, he cautioned that steroids are contraindicated in patients with gastrointestinal bleeding or pancreatitis.

Importantly, patients with alcoholic hepatitis who are going to respond to steroids typically demonstrate a reduction in bilirubin within the first week, according to Dr. Mullen. He cautioned that continuing steroids in the absence of a change in bilirubin should be weighed again potential harms, including the exacerbation of liver disease or comorbidities. Even in responders, he recommended no more than 3 weeks to preserve a favorable benefit-to-risk ratio.

“Four weeks may be too long,” Dr. Mullen advised, but he also suggested that the management of advanced alcoholic hepatitis may be best left to specialists.

“Patients with severe alcoholic hepatitis should be referred and the referral should be to a hepatologist accustomed to managing these patients,” said Dr. Mullen, who cautioned that this is a challenging disease. “We have not been making a huge amount of progress” in the treatment of alcoholic hepatitis, which can be a frustrating disease because of alcoholic recidivism and poor prognosis in advanced stages, he said.

“I would argue that severe alcoholic liver disease has been one of the barriers for recruiting physicians into hepatology, because it is a very arduous group of people to look after, they get very sick, and the treatments are often not very successful,” he noted.

Global Academy and this news organization are owned by the same company. Dr. Mullen had no disclosures to report.
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– The main lesson for discordant data regarding the benefit of corticosteroids for alcoholic hepatitis is that mortality reductions accrue only to those patients who have advanced hepatitis but have not yet developed end-stage disease, according to a detailed look at published studies presented at Digestive Diseases: New Advances, held by Rutgers, the State University of New Jersey, and Global Academy for Medical Education.

Dr. Kevin D. Mullen


These calculations were extrapolated from a long list of studies published over the last 45 years, some of the largest of which concluded that steroids are ineffective, according to Dr. Mullen. The likely source of the conflicting data is the timing of steroids over the course of the disease and the disparity in the scales used to define severity.

Of the scales employed to select candidates for steroid therapy, the Maddrey Discriminant Function (MDF) may be the best supported, according to Dr. Mullen. He suggested that other options, such as the MELD (Model for End-Stage Liver Disease) score and the presence or absence of hepatic encephalopathy are also likely to have discriminatory value in selecting patients for steroid therapy, but these have been largely evaluated in retrospective studies using disparate methodologies.

“The problem arises from so many trials using different criteria for patient selection,” Dr. Mullen explained.

Nevertheless, drawing on the preponderance of data, Dr. Mullen concluded that there is likely to be a therapeutic window within which steroids are beneficial. Using one prednisolone study that stratified patients by MDF score to illustrate this point, he noted that 6-month survival on active therapy was no better than placebo in patients with an MDF less than 25 and numerically but not necessarily clinically significantly better in those scoring 25-34. In the groups with an MDF score of 35-44 or 44-54, the survival at 6 months was several times higher (greater than 60% vs. less than 20%), but there was no advantage with scores greater than 54. In this latter group, the mortality rate at 6 months was 100% in those receiving steroids but only 80% among those given placebo.

“In my mind, there is no question that steroids can be of benefit, but it is a question of picking the right patient. If steroids are given too late in the disease process, it can exacerbate end-stage problems, leading to death,” Dr. Mullen said.

The potential mechanisms of benefit from steroids in alcoholic hepatitis include a reduction in collagen formation and an increase in albumin production, according to Dr. Mullen. In addition, steroids have the potential to suppress the cytokine-mediated inflammation that drives progressive liver dysfunction. However, steroids also have the potential of exacerbating existing infections by suppressing immune function. Moreover, he cautioned that steroids are contraindicated in patients with gastrointestinal bleeding or pancreatitis.

Importantly, patients with alcoholic hepatitis who are going to respond to steroids typically demonstrate a reduction in bilirubin within the first week, according to Dr. Mullen. He cautioned that continuing steroids in the absence of a change in bilirubin should be weighed again potential harms, including the exacerbation of liver disease or comorbidities. Even in responders, he recommended no more than 3 weeks to preserve a favorable benefit-to-risk ratio.

“Four weeks may be too long,” Dr. Mullen advised, but he also suggested that the management of advanced alcoholic hepatitis may be best left to specialists.

“Patients with severe alcoholic hepatitis should be referred and the referral should be to a hepatologist accustomed to managing these patients,” said Dr. Mullen, who cautioned that this is a challenging disease. “We have not been making a huge amount of progress” in the treatment of alcoholic hepatitis, which can be a frustrating disease because of alcoholic recidivism and poor prognosis in advanced stages, he said.

“I would argue that severe alcoholic liver disease has been one of the barriers for recruiting physicians into hepatology, because it is a very arduous group of people to look after, they get very sick, and the treatments are often not very successful,” he noted.

Global Academy and this news organization are owned by the same company. Dr. Mullen had no disclosures to report.

 

– The main lesson for discordant data regarding the benefit of corticosteroids for alcoholic hepatitis is that mortality reductions accrue only to those patients who have advanced hepatitis but have not yet developed end-stage disease, according to a detailed look at published studies presented at Digestive Diseases: New Advances, held by Rutgers, the State University of New Jersey, and Global Academy for Medical Education.

Dr. Kevin D. Mullen


These calculations were extrapolated from a long list of studies published over the last 45 years, some of the largest of which concluded that steroids are ineffective, according to Dr. Mullen. The likely source of the conflicting data is the timing of steroids over the course of the disease and the disparity in the scales used to define severity.

Of the scales employed to select candidates for steroid therapy, the Maddrey Discriminant Function (MDF) may be the best supported, according to Dr. Mullen. He suggested that other options, such as the MELD (Model for End-Stage Liver Disease) score and the presence or absence of hepatic encephalopathy are also likely to have discriminatory value in selecting patients for steroid therapy, but these have been largely evaluated in retrospective studies using disparate methodologies.

“The problem arises from so many trials using different criteria for patient selection,” Dr. Mullen explained.

Nevertheless, drawing on the preponderance of data, Dr. Mullen concluded that there is likely to be a therapeutic window within which steroids are beneficial. Using one prednisolone study that stratified patients by MDF score to illustrate this point, he noted that 6-month survival on active therapy was no better than placebo in patients with an MDF less than 25 and numerically but not necessarily clinically significantly better in those scoring 25-34. In the groups with an MDF score of 35-44 or 44-54, the survival at 6 months was several times higher (greater than 60% vs. less than 20%), but there was no advantage with scores greater than 54. In this latter group, the mortality rate at 6 months was 100% in those receiving steroids but only 80% among those given placebo.

“In my mind, there is no question that steroids can be of benefit, but it is a question of picking the right patient. If steroids are given too late in the disease process, it can exacerbate end-stage problems, leading to death,” Dr. Mullen said.

The potential mechanisms of benefit from steroids in alcoholic hepatitis include a reduction in collagen formation and an increase in albumin production, according to Dr. Mullen. In addition, steroids have the potential to suppress the cytokine-mediated inflammation that drives progressive liver dysfunction. However, steroids also have the potential of exacerbating existing infections by suppressing immune function. Moreover, he cautioned that steroids are contraindicated in patients with gastrointestinal bleeding or pancreatitis.

Importantly, patients with alcoholic hepatitis who are going to respond to steroids typically demonstrate a reduction in bilirubin within the first week, according to Dr. Mullen. He cautioned that continuing steroids in the absence of a change in bilirubin should be weighed again potential harms, including the exacerbation of liver disease or comorbidities. Even in responders, he recommended no more than 3 weeks to preserve a favorable benefit-to-risk ratio.

“Four weeks may be too long,” Dr. Mullen advised, but he also suggested that the management of advanced alcoholic hepatitis may be best left to specialists.

“Patients with severe alcoholic hepatitis should be referred and the referral should be to a hepatologist accustomed to managing these patients,” said Dr. Mullen, who cautioned that this is a challenging disease. “We have not been making a huge amount of progress” in the treatment of alcoholic hepatitis, which can be a frustrating disease because of alcoholic recidivism and poor prognosis in advanced stages, he said.

“I would argue that severe alcoholic liver disease has been one of the barriers for recruiting physicians into hepatology, because it is a very arduous group of people to look after, they get very sick, and the treatments are often not very successful,” he noted.

Global Academy and this news organization are owned by the same company. Dr. Mullen had no disclosures to report.
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HCV ‘cure’ within the VA appears likely

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The number of Veterans Affairs patients with hepatitis C who have achieved a sustained virologic response to antiviral therapy has escalated so rapidly and reached such a height that the disease may well be eradicated in that health care system within a few years, according to a report in Alimentary Pharmacology and Therapeutics.

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The number of Veterans Affairs patients with hepatitis C who have achieved a sustained virologic response to antiviral therapy has escalated so rapidly and reached such a height that the disease may well be eradicated in that health care system within a few years, according to a report in Alimentary Pharmacology and Therapeutics.

 

The number of Veterans Affairs patients with hepatitis C who have achieved a sustained virologic response to antiviral therapy has escalated so rapidly and reached such a height that the disease may well be eradicated in that health care system within a few years, according to a report in Alimentary Pharmacology and Therapeutics.

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FROM ALIMENTARY PHARMACOLOGY AND THERAPEUTICS

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Key clinical point: The number of VA patients with hepatitis C virus who have achieved a sustained virologic response has escalated so rapidly and so high that the disease may be eradicated in that health care system within a few years.

Major finding: SVR rates rose from less than 25% at the beginning of the study period to a “remarkable” 90.5% at the end; the number of patients achieving SVR increased 21-fold from 1,313 in 2010 to an estimated 28,084 in 2015.

Data source: A retrospective cohort study examining all 105,369 antiviral regimens administered within the VA in 1999-2016.

Disclosures: The VA Office of Research and Development funded the study. Dr. Moon and his associates reported having no relevant financial disclosures.

HCV testing stagnant among baby boomers

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Despite the urging of the United States Preventive Services Task Force and other organizations in 2013, the percentage of baby boomers who underwent testing for hepatitis C (HCV) infection had barely changed 2 years later – from 12.3% in 2013 to 13.8% in 2015.

Jarun011/Thinkstock
New guidelines often take time to get adopted by public health and medical communities, but the authors expected some increase. “But there wasn’t. It just remained pretty low. It was a little bit surprising,” said study coauthor Stacey Fedewa, PhD, strategic director of risk factors and screening surveillance at the American Cancer Society.

Other reactions were more forceful. “Kind of pathetic, isn’t it?” said John D. Scott, MD, assistant director of the Hepatitis and Liver Clinic at Harborview Medical Center, and an associate professor of medicine at the University of Washington, Seattle.

The researchers analyzed 2013 and 2015 data from the National Health Interview Survey, which included records for 21,827 baby boomers with HCV testing data.

The slight increase overall of 12.3% to 13.8% was small but also statistically significant (P = .013). Some populations fared better: Compared with the privately insured, those with Medicare plus Medicaid were more likely to have been tested (prevalence ratio, 1.83; 95% confidence interval, 1.32-2.53), as were those only on Medicaid (PR, 1.35; 95% CI, 1.04-1.76), and those with military insurance (PR, 1.62; 95% CI, 1.16-2.26).

The study could be subject to recall bias, since it relied on participants’ self-reports.

The authors speculate that the higher prevalence of testing in those with military insurance may reflect efforts by the Veterans Health Administration to reduce the high prevalence of HCV-associated disease among veterans.

It’s entirely possible to increase testing rates, according to Dr. Scott, who has a grant from the Centers for Disease Control and Prevention to study ways to increase uptake. “Probably the easiest thing to do is just incorporate this information into your electronic medical record and make it part of your alerts and standard preventative practices. Try to automate a lot of this rather than remind a very busy primary care doctor of all the things they have to do,” he said.

For example, one strategy that Seattle’s King County has employed is to automatically notify the testing laboratory if an antibody test is positive. “The lab knows to keep that blood and run a second (nucleic acid) test without the patient having to come back. That has helped to get our confirmatory rates up,” said Dr. Scott.

More broadly, the importance of testing needs to be emphasized, according to Paul J. Thuluvath, MD, medical director at the Institute of Digestive Health and Liver Disease at Mercy Medical Center, Baltimore, and a professor of medicine and surgery at the University of Maryland. “We need everybody to buy into this: the primary care physicians, internists, and gynecologists. If they are not convinced of the importance of this, it’s not going to happen. And I don’t think many primary care physicians and internists are convinced yet,” he said.

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Despite the urging of the United States Preventive Services Task Force and other organizations in 2013, the percentage of baby boomers who underwent testing for hepatitis C (HCV) infection had barely changed 2 years later – from 12.3% in 2013 to 13.8% in 2015.

Jarun011/Thinkstock
New guidelines often take time to get adopted by public health and medical communities, but the authors expected some increase. “But there wasn’t. It just remained pretty low. It was a little bit surprising,” said study coauthor Stacey Fedewa, PhD, strategic director of risk factors and screening surveillance at the American Cancer Society.

Other reactions were more forceful. “Kind of pathetic, isn’t it?” said John D. Scott, MD, assistant director of the Hepatitis and Liver Clinic at Harborview Medical Center, and an associate professor of medicine at the University of Washington, Seattle.

The researchers analyzed 2013 and 2015 data from the National Health Interview Survey, which included records for 21,827 baby boomers with HCV testing data.

The slight increase overall of 12.3% to 13.8% was small but also statistically significant (P = .013). Some populations fared better: Compared with the privately insured, those with Medicare plus Medicaid were more likely to have been tested (prevalence ratio, 1.83; 95% confidence interval, 1.32-2.53), as were those only on Medicaid (PR, 1.35; 95% CI, 1.04-1.76), and those with military insurance (PR, 1.62; 95% CI, 1.16-2.26).

The study could be subject to recall bias, since it relied on participants’ self-reports.

The authors speculate that the higher prevalence of testing in those with military insurance may reflect efforts by the Veterans Health Administration to reduce the high prevalence of HCV-associated disease among veterans.

It’s entirely possible to increase testing rates, according to Dr. Scott, who has a grant from the Centers for Disease Control and Prevention to study ways to increase uptake. “Probably the easiest thing to do is just incorporate this information into your electronic medical record and make it part of your alerts and standard preventative practices. Try to automate a lot of this rather than remind a very busy primary care doctor of all the things they have to do,” he said.

For example, one strategy that Seattle’s King County has employed is to automatically notify the testing laboratory if an antibody test is positive. “The lab knows to keep that blood and run a second (nucleic acid) test without the patient having to come back. That has helped to get our confirmatory rates up,” said Dr. Scott.

More broadly, the importance of testing needs to be emphasized, according to Paul J. Thuluvath, MD, medical director at the Institute of Digestive Health and Liver Disease at Mercy Medical Center, Baltimore, and a professor of medicine and surgery at the University of Maryland. “We need everybody to buy into this: the primary care physicians, internists, and gynecologists. If they are not convinced of the importance of this, it’s not going to happen. And I don’t think many primary care physicians and internists are convinced yet,” he said.

 

Despite the urging of the United States Preventive Services Task Force and other organizations in 2013, the percentage of baby boomers who underwent testing for hepatitis C (HCV) infection had barely changed 2 years later – from 12.3% in 2013 to 13.8% in 2015.

Jarun011/Thinkstock
New guidelines often take time to get adopted by public health and medical communities, but the authors expected some increase. “But there wasn’t. It just remained pretty low. It was a little bit surprising,” said study coauthor Stacey Fedewa, PhD, strategic director of risk factors and screening surveillance at the American Cancer Society.

Other reactions were more forceful. “Kind of pathetic, isn’t it?” said John D. Scott, MD, assistant director of the Hepatitis and Liver Clinic at Harborview Medical Center, and an associate professor of medicine at the University of Washington, Seattle.

The researchers analyzed 2013 and 2015 data from the National Health Interview Survey, which included records for 21,827 baby boomers with HCV testing data.

The slight increase overall of 12.3% to 13.8% was small but also statistically significant (P = .013). Some populations fared better: Compared with the privately insured, those with Medicare plus Medicaid were more likely to have been tested (prevalence ratio, 1.83; 95% confidence interval, 1.32-2.53), as were those only on Medicaid (PR, 1.35; 95% CI, 1.04-1.76), and those with military insurance (PR, 1.62; 95% CI, 1.16-2.26).

The study could be subject to recall bias, since it relied on participants’ self-reports.

The authors speculate that the higher prevalence of testing in those with military insurance may reflect efforts by the Veterans Health Administration to reduce the high prevalence of HCV-associated disease among veterans.

It’s entirely possible to increase testing rates, according to Dr. Scott, who has a grant from the Centers for Disease Control and Prevention to study ways to increase uptake. “Probably the easiest thing to do is just incorporate this information into your electronic medical record and make it part of your alerts and standard preventative practices. Try to automate a lot of this rather than remind a very busy primary care doctor of all the things they have to do,” he said.

For example, one strategy that Seattle’s King County has employed is to automatically notify the testing laboratory if an antibody test is positive. “The lab knows to keep that blood and run a second (nucleic acid) test without the patient having to come back. That has helped to get our confirmatory rates up,” said Dr. Scott.

More broadly, the importance of testing needs to be emphasized, according to Paul J. Thuluvath, MD, medical director at the Institute of Digestive Health and Liver Disease at Mercy Medical Center, Baltimore, and a professor of medicine and surgery at the University of Maryland. “We need everybody to buy into this: the primary care physicians, internists, and gynecologists. If they are not convinced of the importance of this, it’s not going to happen. And I don’t think many primary care physicians and internists are convinced yet,” he said.

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FROM AMERICAN JOURNAL OF PREVENTIVE MEDICINE

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