THE INDEPENDENT MONTHLY NEWSPAPER FOR GASTROENTEROLOGISTS
Last Update: December 04, 2015
Hepatology in FocuS
ISSUE: OCTOBER 2015 | VOLUME: 66:10
by Bridget M. Kuehn
Recently Mark S. Sulkowski, MD, of the John Hopkins University School of Medicine, in Baltimore, saw a teenage patient who had contracted hepatitis C after starting to shoot up as a 12-year-old.
The case is but one in a spike of new infections with the hepatitis C virus (HCV) being driven largely by an epidemic of injection drug use, particularly among adolescents and young adults, according to the Centers for Disease Control and Prevention.
“Sadly, with the heroin epidemic, I’m increasingly seeing teenagers in my practice,” Dr. Sulkowski said earlier this year at the inaugural midyear meeting of the American Association for the Study of Liver Diseases.
Although mother-to-child transmission remains the primary source of HCV infection for children, injection drug use is a common source of infection for adolescents (Clin Liver Dis 2014;5:14-16). Managing young patients is challenging for clinicians, who may not be accustomed to treating pediatric patients and who have little data to guide their treatment decisions.
“This is a patient population for whom data is lacking,” Dr. Sulkowski said.
Dr. Sulkowski said there was a nine-year gap between the publication of the first clinical trials of pegylated interferon and ribavirin in adults and similar studies in children (N Engl J Med 2002;347:975-982; Gastroenterology 2011;140:450-458). As a result, investigators were uncertain of a safe dose and whether the medications would affect growth or pose other risks to children, he said. However, eventually results suggested that the combination also worked in children.
Clinical trials of the protease inhibitors telaprevir (Incivek, Vertex) and boceprevir (Victrelis, Merck) were abandoned in children when data on the use of newer direct-acting antiviral agents in adults indicated that these drugs might provide effective and less toxic options for young patients.
Studies of direct-acting antiviral agents are underway in pediatric populations, but none has been published so far, said Maureen Jonas, MD, clinical director of the Center for Childhood Liver Disease at Boston Children’s Hospital. Pediatric trials are more complicated because appropriate doses for children of different ages and sizes must be determined, Dr. Jonas said. Children also may be unable to swallow large pills, requiring a different means of administration.
So far, Dr. Jonas said there is no reason to believe that children will not experience cure rates above 90% with 12 weeks of direct-acting antivirals, as do adults. That prospect makes the currently available drugs, which may require a yearlong regimen and only cure about half of patients, an unappealing option for pediatric patients, she said.
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