Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced that new data from a Phase 3 study in people being treated for hepatitis C for the first time showed similar rates of viral cure (SVR12, HCV RNA levels < 25 IU/mL 12 weeks after the end of all treatment) when telaprevir was given twice daily compared to three times daily, the currently approved dosing schedule. Telaprevir is approved for use in combination with pegylated-interferon and ribavirin by the U.S. Food and Drug Administration (FDA) and Health Canada under the brand name INCIVEK ® (telaprevir) tablets for people with genotype 1 chronic hepatitis C virus (HCV) with compensated liver disease (some level of damage to the liver but the liver still functions), including cirrhosis (scarring of the liver). In addition, new data from a Phase 2 study demonstrated that approximately three of four people co-infected with HCV and HIV achieved an HCV viral cure (SVR24, HCV RNA levels < 25 IU/mL 24 weeks after the end of all treatment) with telaprevir combination treatment. These and other new data on Vertex’s medicines in development for hepatitis C were presented at The Liver Meeting ®, the 63rd Annual Meeting of the American Association for the Study of Liver Diseases (AASLD).
“INCIVEK is the most prescribed direct-acting antiviral for the treatment of hepatitis C with more than 50,000 people in the United States treated since its approval,” said Robert Kauffman, M.D., Ph.D., Senior Vice President and Chief Medical Officer at Vertex. “We’re encouraged by the new data presented at AASLD that show consistent and high viral cure rates, even when telaprevir is given twice instead of three times daily.”
“OPTIMIZE trial: Non-inferiority of twice-daily telaprevir versus administration every 8 hours in treatment-naïve, genotype 1 HCV infected patients.” Poster Presentation #LB-8 November 12, 2012, 8:00 a.m. – 5:30 p.m. EST
Results of a Phase 3 study showed that 74 percent (274/369) of people with HCV who were new to treatment and received twice-daily (BID) telaprevir in combination with pegylated-interferon and ribavirin achieved a viral cure (SVR12), compared to 73 percent (270/371) of people who received telaprevir three times a day (q8h). The study met its primary endpoint of non-inferiority. All study participants received the same total daily dose (2,250 mg) of telaprevir. Fourteen percent (103/740) of people in the study were cirrhotic at study entry, and 52 percent (53/103) of them achieved a viral cure. Adverse events were generally similar between treatment arms and consistent with the safety profile described in the U.S. prescribing information for telaprevir and included rash, anemia and pruritis (itchiness). Vertex plans to submit data supporting this new dosing regimen to the FDA in 2013 for potential inclusion in the U.S. telaprevir label.