TY - JOUR
T1 - Fixed-dose combination therapy with daclatasvir, asunaprevir, and beclabuvir for noncirrhotic patients with HCV genotype 1 infection
AU - Poordad, Fred
AU - Sievert, William
AU - Mollison, Lindsay
AU - Bennett, Michael
AU - Tse, Edmund
AU - Brau, Norbert
AU - Levin, James M
AU - Sepe, Thomas E
AU - Lee, Samuel S
AU - Angus, Peter W
AU - Conway, Brian
AU - Pol, Stanislas B
AU - Boyer, Nathalie
AU - Bronowicki, Jean-Pierre
AU - Jacobson, Ira M
AU - Muir, Andrew J
AU - Reddy, Kuchikula Rajender
AU - Tam, Edward
AU - Ortiz-Lasanta, Grisell
AU - de Ledinghen, Victor
AU - Sulkowski, Mark S
AU - Boparai, Navdeep
AU - McPhee, Fiona
AU - Hughes, Eric A
AU - Swenson, E Scott
AU - Yin, Philip D
PY - 2015
Y1 - 2015
N2 - 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 - 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
UR - http://jama.jamanetwork.com/article.aspx?articleid=2281704
U2 - 10.1001/jama.2015.3860
DO - 10.1001/jama.2015.3860
M3 - Article
VL - 313
SP - 1728
EP - 1735
JO - JAMA
JF - JAMA
SN - 0098-7484
IS - 17
ER -