Open-Label Study to Evaluate the Safety & Tolerability of Telaprevir in Combination With Sofosbuvir in Naive Subjects Infected With Hepatitis C Virus Genotype 1

Abstract

AIMS: Sofosbuvir is a potent hepatitis C Virus (HCV) NS5B RNA polymerase inhibitor that has led to high-sustained viral response rates when combined with other direct-acting antivirals. To date, no data exists on the combination of sofosbuvir with the NS3 protease inhibitor, telaprevir. The safety, tolerability, and efficacy of an all-oral 12-week regimen of telaprevir in combination with sofosbuvir were evaluated in this open-label, phase 2 study. METHODS: Twenty adults with HCV genotype 1 infection who were non-cirrhotic and naïve to therapy received telaprevir 1125 mg orally twice-daily plus sofosbuvir 400 mg once daily for 12 weeks. RESULTS: Telaprevir plus sofosbuvir was generally well tolerated, with all 20 subjects completing treatment. The five most common adverse events were nausea, rash, headache, ano-rectal symptoms, and pruritus. Two subjects required discontinuation of telaprevir after week 4 but were maintained on sofosbuvir till the end of treatment. Sustained virologic response 12 weeks after the end of treatment was 95%. CONCLUSION: The results provide valuable information regarding the safety, tolerability and efficacy of telaprevir combined with sofosbuvir as dual therapy in naïve non- cirrhotic HCV genotype 1 infected patients.