(New England J Med; Apr 2010) In the treatment of chronic hepatitis C infection, it is common for Genotype 1 patients to experience non-response, breakthrough or relapse when treated with Peg-Interferon and Ribavirin for 48 weeks; SVR rates are as low as 40-50%. This study describes a new agent, telapravir, an orally bioavailable inhibitor of the nonstructural 3/4A HCV protease. It is trialed in HCV patients who had previously failed treatment.
The trial was a randomized, stratified, partially placebo-controlled, partially double-blind, phase 2 study. Telapravir was added to Peg-Interferon and Ribavirin for 12 of 24 weeks in one arm, and for 24 of 48 weeks in a second arm (total of 4 arms). Rates of SVR were about the same in these arms, 51 and 53%, respectively, and superior to the other two arms. Relapse rates were greater in the 12/24 arm. The most common adverse events with this new agent were rash and pruritus.
This is an exciting development in hepatology and especially for our patients with HCV who failed treatment in the past. For some additional information on this topic, refer to the Lecture on direct acting antivirals posted on Jan. 10, 2011.
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