Vertex Pharmaceuticals announced data from its Phase 2 study of telaprevir in combination with pegylated-interferon and ribavirin compared to pegylated-interferon and ribavirin alone for the treatment of patients who are infected with both genotype 1 hepatitis C virus (HCV) and human immunodeficiency virus (HIV), also known as HCV-HIV co-infection. This trial is a two-part (A and B), randomized, double-blind, placebo-controlled, parallel group, multicenter study. Part A of the study is evaluating telaprevir in patients who are not currently being treated with antiretroviral therapy (ART) for HIV infection. Part B of the study is evaluating telaprevir in people receiving Atripla (efavirenz and emtricitabine; Bristol-Myers and Gilead) or a Reyataz (atazanavir, Bristol-Myers Squibb and Gilead) -based regimen for HIV.
The primary endpoint of the study is to evaluate the safety and tolerability of telaprevir-based combination therapy in patients with HCV-HIV co-infection. The interim analysis was conducted when all patients had reached week 4 of treatment. At that time, 70 percent (n=26/37) of people in the study (Parts A and B) who received telaprevir-based combination therapy had undetectable hepatitis C virus by week 4 (rapid viral response, RVR) compared to 5 percent (n=1/22) of people who received pegylated-interferon and ribavirin alone. HIV viral load and CD4 counts were stable among patients receiving a telaprevir-based regimen.
Telaprevir is an investigational, oral inhibitor that acts directly on the HCV protease, an enzyme essential for viral replication.
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