Daclatasvir, sofosbuvir, and ribavirin for hepatitis C virus genotype 3 and advanced liver disease: A randomized phase III study (ALLY-3 )
Vincent Leroy, Peter Angus, Jean-Pierre Bronowicki, Gregory J Dore, Christophe Hezode, Stephen Pianko, Stanislas Pol, Katherine Stuart, Edmund Tse, Fiona McPhee, Rafia Bhore, Maria Jesus Jimenez-Exposito, Alexander J Thompson
HEPATOLOGY | WILEY | Published : 2016
UNLABELLED: Patients with hepatitis C virus (HCV) genotype 3 infection, especially those with advanced liver disease, are a challenging population in urgent need of optimally effective therapies. The combination of daclatasvir (DCV; pangenotypic nonstructural protein 5A inhibitor) and sofosbuvir (SOF; nucleotide nonstructural protein 5B inhibitor) for 12 weeks previously showed high efficacy (96%) in noncirrhotic genotype 3 infection. The phase III ALLY-3+ study (N = 50) evaluated DCV-SOF with ribavirin (RBV) in treatment-naïve (n = 13) or treatment-experienced (n = 37) genotype 3-infected patients with advanced fibrosis (n = 14) or compensated cirrhosis (n = 36). Patients were randomized 1:..View full abstract
We thank Patricia Mendez and Melissa Harris for their contributions to the study conception, Kimberly Brown for contributing to the study execution, and Eric Y. Wong for contributing to the development of the manuscript. Editorial support was provided by Nick Fitch, Ph.D., of Articulate Science and was funded by Bristol-Myers Squibb.