Open-Label Study to Evaluate the Safety & Tolerability of Telaprevir in Combination with Sofosbuvir in Naive Subjects with HCV Genotype 1 Short Title: Telaprevir & Sofosbuvir in HCV Genotype 1

Giuseppe Morelli, Roberto Firpi, Patrick Horne, Joy Peter, Lucy Askushevich, Monika Vainorius, Shelley George, Abel De La Rosa, G.Prabhakar Reddy, Taylor Evers, Richard F Arrendale, Tara L Kieffer, Varun Garg, Michael W Fried, David R Nelson


Background & Aims: Sofosbuvir is a potent hepatitis C NS5B 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 genotype 1 hepatitis C 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 genotype 1 patients.


antiviral agent, clinical trial, combination drug therapy, protease inhibitor, nucleotide polymerase inhibitor.


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