Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) announced today interim results from an ongoing, two-part (A and B), Phase 2 study evaluating telaprevir in combination with pegylated-interferon and ribavirin compared to pegylated-interferon and ribavirin alone in people who are infected with both genotype 1 hepatitis C virus (HCV) and human immunodeficiency virus (HIV), also known as HCV-HIV co-infection. All people in this study were new to hepatitis C treatment. Part A of the study is evaluating telaprevir in people 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® or a Reyataz®-based regimen for HIV. These initial HIV regimens were selected based on current HIV treatment guidelines and data from drug-drug interaction studies of telaprevir and commonly used ART medicines. Data from the co-infection study were presented today at the 18th Conference on Retroviruses and Opportunistic Infections (CROI) taking place February 27 to March 2, 2011 in Boston.
The primary endpoint of the study is to evaluate the safety and tolerability of telaprevir-based combination therapy in people co-infected with hepatitis C and HIV. The interim analysis was conducted when all patients had reached week 4 of treatment.
"Research in hepatitis C has shown that people who respond early to treatment have a higher likelihood of achieving a viral cure," said Robert Kauffman, M.D., Ph.D., Senior Vice President and Chief Medical Officer at Vertex. "These interim results are encouraging because they showed a high proportion of people in the study had a rapid viral response to telaprevir. We will use what we are learning from this study to inform the design of a Phase 3 co-infection study of telaprevir planned for the end of the year."
Interim Study Results
Sixty people were enrolled in this Phase 2 study. At the time of the analysis, all study participants had reached week 4 of treatment and 69 percent of patients.
The most common adverse events (≥15% of people) regardless of treatment arm were fatigue, pruritus, nausea, headache, dizziness, pyrexia, anorexia, vomiting, diarrhea and chills. Of these adverse events, pruritus, nausea, dizziness, pyrexia, anorexia and vomiting occurred more frequently in the telaprevir arms (≥10% difference) compared to placebo. The majority of adverse events were mild or moderate.