New Drug Allows Shorter Hepatitis C Therapy

All patients received telaprevir at a dose of 750 mg every 8 hours, peginterferon alfa-2a at a dose of 180 μg per week, and ribavirin at a dose of 1,000 mg to 1,200 mg per day, for 12 weeks (T12PR12), followed by peginterferon-ribavirin. Patients who had an extended rapid virologic response (ERVR) during the study were randomly assigned after week 20 to receive the dual therapy for 4 more weeks (T12PR24) or 28 more weeks (T12PR48).

The results showed that 352 (65%) of the patients had an ERVR, and the overall rate of sustained virologic response was 72%. Among the 322 patients with an ERVR that were randomly assigned to a study group, 149 (92%) in the T12PR24 group and 140 (88%) in the T12PR48 group had a sustained virologic response, establishing noninferiority; adverse events included rash and anemia. Discontinuation of all the study drugs was based on adverse events in 18% of patients overall, as well as in 1% of patients (all of whom were randomly assigned) in the T12PR24 group and 12% of the patients randomly assigned to the T12PR48 group. The study was published in the September 15, 2011, issue of the New England Journal of Medicine (NEJM).

“There was no benefit to extending telaprevir-based therapy to 48 weeks for the majority of people,” said lead author professor Kenneth Sherman, MD, PhD, director of the division of digestive diseases for UC Health. “Patients who had a rapid response to telaprevir-based regimens at weeks 4 and 12 had a high likelihood of achieving a cure with 24 weeks of total treatment, which may provide important information to motivate people to continue therapy.”

Telaprevir is an investigational HCV protease inhibitor used in combination with pegylated interferon and ribavirin, the standard HCV treatment. It is one of two new medications--the other is boceprevir--that target the virus directly, in contrast to the standard therapy, which boosts the immune system. Both the standard therapy and telaprevir are associated with a range of adverse events that can lead patients to stop therapy.

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