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Abstract Details
All-Oral Combination of Ledipasvir, Vedroprevir, Tegobuvir, and Ribavirin in Treatment-Naive Patients with Genotype 1 HCV Infection
Wyles DL1, Rodriguez-Torres M, Lawitz E, Shiffman ML, Pol S, Herring RW, Massetto B, Kanwar B, Trenkle JD, Pang PS, Zhu Y, Mo H, Brainard DM, Subramanian GM, McHutchison JG, Habersetzer F, Sulkowski MS. Hepatology. 2014 Feb 5. doi: 10.1002/hep.27053. [Epub ahead of print]
Author information
1University of California, San Diego, La Jolla, CA.
Abstract
This phase 2 trial assessed the efficacy and safety of a combination regimen of the NS5A inhibitor ledipasvir (LDV), NS3 protease inhibitor vedroprevir (VDV), nonnucleoside NS5B inhibitor tegobuvir (TGV), and ribavirin (RBV) in treatment-naive patients with chronic hepatitis C virus (HCV) genotype 1 without cirrhosis. Patients were randomized 1:2 to LDV 30 mg once daily (QD) (Arm 1; n = 46) or LDV 90 mg QD (Arm 2; n = 94); patients in both arms also received VDV 200 mg QD, TGV 30 mg twice daily, and RBV 1000-1200 mg/day. Patients in Arm 2 with vRVR, defined as HCV RNA