TY - JOUR
T1 - Fixed-dose combination therapy with daclatasvir, asunaprevir, and beclabuvir for noncirrhotic patients with HCV genotype 1 infection
AU - Poordad, F.
AU - Sievert, W.
AU - Mollison, Lindsay
AU - Bennett, M.
AU - Tse, E.
AU - Bräu, N.
AU - Levin, J.
AU - Sepe, T.
AU - Lee, S.S.
AU - Angus, P.
AU - Conway, B.
AU - Pol, S.
AU - Boyer, N.
AU - Bronowicki, J.P.
AU - Jacobson, I.
AU - Muir, A.J.
AU - Reddy, K.R.
AU - Tam, E.
AU - Ortiz-Lasanta, G.
AU - De Lédinghen, V.
AU - Sulkowski, M.
AU - Boparai, N.
AU - Mcphee, F.
AU - Hughes, E.
AU - Swenson, E.S.
AU - Yin, P.D.
PY - 2015
Y1 - 2015
N2 - Copyright 2015 American Medical Association. All rights reserved. IMPORTANCE: 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
AB - Copyright 2015 American Medical Association. All rights reserved. IMPORTANCE: 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
U2 - 10.1001/jama.2015.3860
DO - 10.1001/jama.2015.3860
M3 - Article
C2 - 25942723
SN - 0098-7484
VL - 313
SP - 1728
EP - 1735
JO - JAMA: The Journal of the American Medical Association
JF - JAMA: The Journal of the American Medical Association
IS - 17
ER -
