World Hepatitis Day: Recent steps toward reaching all patients

This year for World Hepatitis Day, the theme is “Find the Missing Millions.” Hundreds of millions of people living with viral hepatitis are unaware of their infection and many people are also unaware of the available treatments, especially the high efficacy and safety of available direct-acting antivirals.

Patient groups that are often missed include difficult-to-reach populations such as injection drug users along with children younger than 12 years who previously had to wait until they were old enough to receive treatment.

Healio Gastroenterology and Liver Disease presents several recent study results that showed the success of telemedicine models to reach injection drug users, an HCV micro-elimination program focused on curing a highly effected country in Kentucky, and three different DAAs that have showed high rates of sustained virologic response in children younger than 12 years with significant safety profiles.

Telemedicine takes focus in study of HCV treatment in methadone centers

With $7 million from the Patient-Centered Outcomes Research Institute, seven opioid treatment programs announced entry into an ongoing study of telemedicine for treatment of hepatitis C.

“The concept of the telemedicine model is that we are taking advantage of the ambience of the environment within the methadone programs, where patients generally feel more comfortable than conventional health care settings,” Andrew H. Talal, MD, from the Jacobs School of Medicine and Biomedical Sciences at the University at Buffalo, told Healio Gastroenterology and Liver Disease. “We’re taking advantage of that to integrate HCV treatment into that already existing relationship.” Read more

HCV micro-elimination program seeks to cure high-risk Kentucky county

Intent Solutions announced a partnership with the University of Kentucky in a $15 million federal grant program aimed at eliminating hepatitis C in an eastern Kentucky county that has particularly high rates of chronic infection, according to a press release.

The Kentucky Viral Hepatitis Treatment Study, known as KeY Treat, is part of the contract between the company and university because the study’s design is intended to manage the dispensation of HCV medications to 900 individuals in the program. Gilead Sciences donated the medications to be used with a value of approximately $20 million. Read more

Universal pregnancy screening for HCV could eliminate transmission in Canada

In a recently published commentary, Chelsea Elwood, MD, from the University of British Columbia, and colleagues advised that Canadian guidelines should recommend universal screening for hepatitis C in pregnant women as they do for hepatitis B and HIV to reduce the risk for vertical transmission.

“More years of life are lost because of HCV than any other infectious disease in Canada,” they wrote. “Hepatitis C virus infection does not appear to worsen maternal health; however, rates of preterm birth, low birth weight, obstetrical cholestasis and adverse neonatal outcomes, such as admission to a neonatal intensive care unit, are increased for pregnancies complicated by HCV infection.” Read more

Harvoni joins growing DAA options for younger patients with HCV

Harvoni joins other direct-acting antivirals in demonstrating safety and high efficacy in younger pediatric patients with chronic hepatitis C, specifically those aged 3 years to younger than 6 years, according to results published in Hepatology.

“In children who become chronically infected, the course of infection is usually slower than in adults; however, liver disease can progress during early life, and cases of cirrhosis, hepatocellular carcinoma, and end-stage liver disease requiring liver transplantation in childhood have been reported,” Kathleen B. Schwarz, MD, from Johns Hopkins Hospital in Maryland, and colleagues wrote. “The availability of an all-oral, direct-acting antiviral regimen for young children with chronic HCV infection would represent a significant advance in the care of patients who currently have limited treatment options.” Read more

Mavyret cures 100% of adolescents with HCV in first of two-part pediatric study

The pangenotypic direct-acting antiviral Mavyret demonstrated 100% sustained virologic response in adolescent patients aged 12 years to 17 years with a safety profile consistent with adult patients, according results from part one of the DORA study.

Researchers designed the DORA study to evaluate the pharmacokinetics, safety, and efficacy of Mavyret (glecaprevir/pibrentasvir, AbbVie) in pediatric patients with chronic HCV infection. The second part of the study will evaluate pediatric formulation for patients aged 3 years to 11 years. Read more

FDA approves Mavyret for all HCV genotypes in children

The FDA approved Mavyret to treat all six genotypes of hepatitis C in pediatric patients aged 12 years to 17 years, according to a press release from the organization.

“Direct-acting antiviral drugs reduce the amount of HCV in the body by preventing the virus from multiplying, and in most cases, they cure HCV infection,” Jeffrey Murray, MD, MPH, deputy director of the Division of Antiviral Products in the FDA’s Center for Drug Evaluation and Research, said in the release. “Today’s approval represents another treatment option for children and adolescents with HCV infection, but for the first time, in all genotypes of HCV.” Read more

Sovaldi with ribavirin safe, effective for children aged 3 years to 12 years

Treatment with Sovaldi and ribavirin was well-tolerated and highly effective in children aged 3 years to less than 12 years in pediatric patients with hepatitis C genotype 2 or genotype 3, according to a study published in Hepatology.

Previously, the only approved HCV treatment for patients aged younger than 12 years was pegylated interferon with ribavirin, which is “undesirable due to safety concerns, poor tolerability, and its parenteral route of administration,” according to Philip Rosenthal, MD, from the university of California San Diego, and colleagues. “Concern for the effects of pegylated interferon and ribavirin on growth and development in this age group also limits their use.” Read more

This year for World Hepatitis Day, the theme is “Find the Missing Millions.” Hundreds of millions of people living with viral hepatitis are unaware of their infection and many people are also unaware of the available treatments, especially the high efficacy and safety of available direct-acting antivirals.

Patient groups that are often missed include difficult-to-reach populations such as injection drug users along with children younger than 12 years who previously had to wait until they were old enough to receive treatment.

Healio Gastroenterology and Liver Disease presents several recent study results that showed the success of telemedicine models to reach injection drug users, an HCV micro-elimination program focused on curing a highly effected country in Kentucky, and three different DAAs that have showed high rates of sustained virologic response in children younger than 12 years with significant safety profiles.

Telemedicine takes focus in study of HCV treatment in methadone centers

With $7 million from the Patient-Centered Outcomes Research Institute, seven opioid treatment programs announced entry into an ongoing study of telemedicine for treatment of hepatitis C.

“The concept of the telemedicine model is that we are taking advantage of the ambience of the environment within the methadone programs, where patients generally feel more comfortable than conventional health care settings,” Andrew H. Talal, MD, from the Jacobs School of Medicine and Biomedical Sciences at the University at Buffalo, told Healio Gastroenterology and Liver Disease. “We’re taking advantage of that to integrate HCV treatment into that already existing relationship.” Read more

HCV micro-elimination program seeks to cure high-risk Kentucky county

Intent Solutions announced a partnership with the University of Kentucky in a $15 million federal grant program aimed at eliminating hepatitis C in an eastern Kentucky county that has particularly high rates of chronic infection, according to a press release.

The Kentucky Viral Hepatitis Treatment Study, known as KeY Treat, is part of the contract between the company and university because the study’s design is intended to manage the dispensation of HCV medications to 900 individuals in the program. Gilead Sciences donated the medications to be used with a value of approximately $20 million. Read more

Universal pregnancy screening for HCV could eliminate transmission in Canada

In a recently published commentary, Chelsea Elwood, MD, from the University of British Columbia, and colleagues advised that Canadian guidelines should recommend universal screening for hepatitis C in pregnant women as they do for hepatitis B and HIV to reduce the risk for vertical transmission.

“More years of life are lost because of HCV than any other infectious disease in Canada,” they wrote. “Hepatitis C virus infection does not appear to worsen maternal health; however, rates of preterm birth, low birth weight, obstetrical cholestasis and adverse neonatal outcomes, such as admission to a neonatal intensive care unit, are increased for pregnancies complicated by HCV infection.” Read more

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Harvoni joins growing DAA options for younger patients with HCV

Harvoni joins other direct-acting antivirals in demonstrating safety and high efficacy in younger pediatric patients with chronic hepatitis C, specifically those aged 3 years to younger than 6 years, according to results published in Hepatology.

“In children who become chronically infected, the course of infection is usually slower than in adults; however, liver disease can progress during early life, and cases of cirrhosis, hepatocellular carcinoma, and end-stage liver disease requiring liver transplantation in childhood have been reported,” Kathleen B. Schwarz, MD, from Johns Hopkins Hospital in Maryland, and colleagues wrote. “The availability of an all-oral, direct-acting antiviral regimen for young children with chronic HCV infection would represent a significant advance in the care of patients who currently have limited treatment options.” Read more

Mavyret cures 100% of adolescents with HCV in first of two-part pediatric study

The pangenotypic direct-acting antiviral Mavyret demonstrated 100% sustained virologic response in adolescent patients aged 12 years to 17 years with a safety profile consistent with adult patients, according results from part one of the DORA study.

Researchers designed the DORA study to evaluate the pharmacokinetics, safety, and efficacy of Mavyret (glecaprevir/pibrentasvir, AbbVie) in pediatric patients with chronic HCV infection. The second part of the study will evaluate pediatric formulation for patients aged 3 years to 11 years. Read more

FDA approves Mavyret for all HCV genotypes in children

The FDA approved Mavyret to treat all six genotypes of hepatitis C in pediatric patients aged 12 years to 17 years, according to a press release from the organization.

“Direct-acting antiviral drugs reduce the amount of HCV in the body by preventing the virus from multiplying, and in most cases, they cure HCV infection,” Jeffrey Murray, MD, MPH, deputy director of the Division of Antiviral Products in the FDA’s Center for Drug Evaluation and Research, said in the release. “Today’s approval represents another treatment option for children and adolescents with HCV infection, but for the first time, in all genotypes of HCV.” Read more

Sovaldi with ribavirin safe, effective for children aged 3 years to 12 years

Treatment with Sovaldi and ribavirin was well-tolerated and highly effective in children aged 3 years to less than 12 years in pediatric patients with hepatitis C genotype 2 or genotype 3, according to a study published in Hepatology.

Previously, the only approved HCV treatment for patients aged younger than 12 years was pegylated interferon with ribavirin, which is “undesirable due to safety concerns, poor tolerability, and its parenteral route of administration,” according to Philip Rosenthal, MD, from the university of California San Diego, and colleagues. “Concern for the effects of pegylated interferon and ribavirin on growth and development in this age group also limits their use.” Read more