47th European Association for the Study of the Liver (EASL)/The International Liver Conference.

A phase 2 study of an interferon-free combination daclatasvir (BMS-790052, Bristol-Meyers Squibb) plus GS-7977 (formerly PSI-7977, Pharmasset/Gilead), with or without ribavirin, showed that this regimen was well tolerated and that treatmentnaive patients with hepatitis C virus (HCV) genotype 1, 2, and 3 infection achieved high rates of early sustained virological responses (SVRs). Investigators enrolled treatment-naive adults without cirrhosis who had chronic HCV infection type 1, 2, or 3 (n = 88). The patients were randomly assigned to three treatment cohorts for 24 weeks. Subjects in cohort A (n = 31) received GS7977 400 mg once daily for 7 days, then daclatasvir 60 mg once daily. Subjects in group B (n = 28) received GS-7977 400 mg once daily plus daclatasvir 60 mg once daily. Subjects in group C (n = 29) received the same regimen as group B plus ribavirin 1,000 to 1,200 mg once daily according to weight (HCV genotype 1) or 800 mg once daily (HCV genotype 2 or 3). In this interim analysis, researchers evaluated data for the secondary endpoint of SVRs at week 4 (SVR4), defined as HCV–RNA counts below the lower limit of quantification (25 IU/mL). They reported that all genotype 1 subjects in groups A, B, and C achieved SVR4 at a rate of 100%. Patients with HCV genotypes 2 and 3 achieved SVR4 at rates of 88% for cohort A, 100% for cohort B, and 86% for cohort C. “Overall sustained virological responses at week 4 were 95.5% across genotypes 1, 2, and 3,” said Dr. Thurz at the opening EASL press briefing. “There was no difference in sustained virological response at 4 weeks by the hepatitis C genotype 1 subtype or by the interleukin-28B genotype. Ribavirin did not increase the magnitude of hepatitis C RNA decline or influence sustained virological response.” Interferon-Free Therapy for Hepatitis C: CO-PILOT, Phase 2 • Fred Poordad, MD, Chief of Hepatology and Liver Transplantation, Cedars–Sinai Medical Center, Los Angeles, Calif.