Efficacy and safety of a two‐drug direct‐acting antiviral agent regimen ruzasvir 180 mg and uprifosbuvir 450 mg for 12 weeks in adults with chronic hepatitis C virus genotype 1, 2, 3, 4, 5 or 6

• DOI: 10.1111/jvh.13132
• Publication Date: 2019-05-20T17:58:19Z
• Authors: Eric Lawitz; Edward Gane; Jordan J. Feld; Maria Buti; Graham R. Foster; Mordechai Rabinovitz; Eduard Burnevich; Helena Katchman; Krzysztof Tomasie...; Fred Lahser; Beth Jackson; Melissa Shaughnessy; Stephanie Klopfer; Wendy W. Yeh; Michael N. Robertson; George J. Hanna; Eliav Barr; Heather L. Platt
• Keywords: Tolerability; Regimen; Hepatitis C

Abstract Ruzasvir ( MK ‐8408, an NS 5A inhibitor) and uprifosbuvir ‐3682, a nonstructural protein 5B nucleotide are highly potent direct‐acting antiviral agents for the treatment of hepatitis C virus HCV ) infection. A phase III clinical trial evaluating two‐drug combination ruzasvir 60 mg plus 450 suggested suboptimal efficacy in certain genotypes (C‐ BREEZE 1; NCT 02759315). The aim present study was to evaluate safety with administered at higher dose than that assessed earlier 2: 02956629/Merck protocol PN 041). Treatment‐naïve or interferon (with without ribavirin)‐experienced participants compensated cirrhosis were enrolled. All received 180 once daily 12 weeks. primary objectives proportion RNA <15 lU/mL weeks after end therapy SVR 12), tolerability drug. Overall, 282 (n/N) 91.3% (42/46) infected genotype GT 1a; 1b, 96.7% (29/30); 2, 91.5% (43/47); 3, 73.8% (45/61); 4, 98.2% (55/56); 5, 100.0% (18/18); 6, 90.9% (20/22). Adverse events AE s) reported by 61.3% participants; drug‐related s 33.3%. most frequent (≥5% participants) all fatigue (7.8%) headache (7.4%). In conclusion, effective well tolerated 1, 5 lower 3‐infected persons.