Fixed-dose combination therapy with daclatasvir, asunaprevir, and beclabuvir for noncirrhotic patients with HCV genotype 1 infection

Fred Poordad, William Sievert, Lindsay Mollison, Michael Bennett, Edmund Tse, Norbert Brau, James M Levin, Thomas E Sepe, Samuel S Lee, Peter W Angus, Brian Conway, Stanislas B Pol, Nathalie Boyer, Jean-Pierre Bronowicki, Ira M Jacobson, Andrew J Muir, Kuchikula Rajender Reddy, Edward Tam, Grisell Ortiz-Lasanta, Victor de LedinghenMark S Sulkowski, Navdeep Boparai, Fiona McPhee, Eric A Hughes, E Scott Swenson, Philip D Yin

Research output: Contribution to journalArticleResearchpeer-review

85 Citations (Scopus)

Abstract

The antiviral activity of all-oral, ribavirin-free, direct-acting antiviral regimens requires evaluation in patients with chronic hepatitis C virus (HCV) infection. OBJECTIVE: To determine the rates of sustained virologic response (SVR) in patients receiving the 3-drug combination of daclatasvir (a pan-genotypic NS5A inhibitor), asunaprevir (an NS3 protease inhibitor), and beclabuvir (a nonnucleoside NS5B inhibitor). DESIGN, SETTING, AND PARTICIPANTS: This was an open-label, single-group, uncontrolled international study (UNITY-1) conducted at 66 sites in the United States, Canada, France, and Australia between December 2013 and August 2014. Patients without cirrhosis who were either treatment-naive (n = 312) or treatment-experienced (n = 103) and had chronic HCV genotype 1 infection were included. INTERVENTIONS: Patients received a twice-daily fixed-dose combination of daclatasvir, 30 mg; asunaprevir, 200 mg; and beclabuvir, 75 mg. MAIN OUTCOMES AND MEASURES: The primary study outcome was SVR12 (HCV-RNA
Original languageEnglish
Pages (from-to)1728 - 1735
Number of pages8
JournalJAMA
Volume313
Issue number17
DOIs
Publication statusPublished - 2015

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