Vertex announces positive interim data from INCIVEK Phase 2 combination trial on HIV, HCV

Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced positive interim results from an ongoing Phase 2 study designed to evaluate the safety and tolerability of INCIVEK™ (telaprevir) tablets in combination with pegylated-interferon and ribavirin in people who are co-infected with chronic genotype 1 hepatitis C (HCV) and human immunodeficiency virus (HIV). Data showed 74 percent (28/38) of patients who were treated with INCIVEK (in-SEE-veck) combination therapy had undetectable hepatitis C virus (HCV RNA) at Week 24 of treatment compared to 55 percent (12/22) who were treated with pegylated-interferon and ribavirin alone. Changes in CD4 counts were similar between the treatment groups and no HIV viral load breakthroughs were observed in either treatment group during the study. Adverse events that occurred more frequently (≥10 percent difference) in the INCIVEK arms compared to placebo were abdominal pain, vomiting, nausea, fever, dizziness, depression and itchiness. No severe rashes were reported through 24 weeks. Interim results from this study are being presented at The Liver Meeting®, the 62nd Annual Meeting of the American Association for the Study of Liver Diseases (AASLD), November 4-8, 2011 in San Francisco.

"Treating hepatitis C in people who also have HIV is particularly challenging as only about 30 percent of people clear the virus after undergoing nearly a year of treatment with currently available medicines," said Robert Kauffman, M.D., Ph.D., Senior Vice President and Chief Medical Officer at Vertex. "As we prepare for our new Phase 3 study to evaluate INCIVEK combination therapy in a much larger group of people who are co-infected, data from this study give us hope that in the future we'll be able to help more co-infected patients clear the virus."

There are two parts to this study: Part A is evaluating people who are not currently being treated with antiretroviral therapy for HIV infection and Part B is evaluating those who are taking an Atripla® or Reyataz®-based regimen for HIV. This study enrolled patients who were new to hepatitis C treatment. Interim data also showed 63 percent (24/38) of patients treated with INCIVEK combination therapy in this study had an extended rapid hepatitis C viral response (eRVR, measured as undetectable HCV RNA at weeks 4 and 12 of treatment) compared to approximately 5 percent (1/22) who received pegylated-interferon and ribavirin alone.

"Complications associated with hepatitis C such as scarring of the liver typically develop much faster in people infected with both hepatitis C and HIV," said Kenneth Sherman, M.D., Ph.D., Professor of Medicine at the University of Cincinnati College of Medicine, Director of the Division of Digestive Diseases for UC Health and Principal Investigator of the trial. "As HIV treatments have improved, liver disease associated with hepatitis C has become a leading cause of death among people who are co-infected, so offering patients a better chance at a cure for hepatitis C while maintaining their suppression of HIV would be a major advance in treatment."


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