Efficacy and safety of ruzasvir 60 mg and uprifosbuvir 450 mg for 12 weeks in adults with chronic hepatitis C virus genotype 1, 2, 3, 4 or 6 infection. Issue 6 (12th March 2019)

• Record Type: Journal Article
• Authors: Lawitz, Eric; Poordad, Fred; Anderson, Leah J.; Vesay, Michelle; Kelly, Michelle M.; Liu, Hong; Gao, Wei; Fernsler, Doreen; Asante‐Appiah, Ernest; Robertson, Michael N.; Hanna, George J.; Barr, Eliav; Butterton, Joan; Kowdley, Kris V.; Hassanein, Tarek; Sahota, Amandeep; Gordon, Stuart C.; Yeh, Wendy W.
• Is Part Of: Journal of viral hepatitis. Volume 26:Issue 6(2019)
• Page Start: 675
• Page End: 684
• Publication Date: 2019-03-12
• Subjects: genotype -- hepatitis C virus -- NS5A protein -- NS5B polymerase -- safety; Hepatitis, Viral -- Periodicals; Hepatitis, Viral, Animal; Hepatitis, Viral, Human; 616.3623
• DOI: 10.1111/jvh.13079
• Languages: English
• ISSNs: 1352-0504

Abstract

Summary: In clinical trials, the three‐drug regimen of ruzasvir (RZR) 60 mg, uprifosbuvir (UPR) 450 mg and grazoprevir 100 mg, with or without ribavirin, has demonstrated promising efficacy and excellent tolerability across a wide range of hepatitis C virus (HCV)‐infected individuals. The present study assessed the efficacy and safety of the two‐drug combination of RZR 60 mg plus UPR 450 mg administered for 12 weeks in participants with HCV genotype (GT) 1‐6 infection. In this open‐label clinical trial, treatment‐naive or ‐experienced and cirrhotic or noncirrhotic participants with chronic HCV GT1‐6 infection received RZR 60 mg plus UPR 450 mg orally once daily for 12 weeks (NCT02759315/protocol PN035). The primary efficacy endpoint was sustained virologic response at 12 weeks after the end of therapy (SVR12). One hundred and sixty participants were enrolled. SVR12 rates were 96% (52 of 54) in participants with GT1a infection; 100% (15 of 15) in those with GT1b infection; 97% (28 of 29) in those with GT2 infection; 77% (30 of 39) in those with GT3 infection; 90% (18 of 20) in those with GT4 infection; and 67% (2 of 3) in those with GT6 infection. Drug‐related adverse events (AEs) reported by >5% of participants were fatigue (n = 10, 6.3%) and diarrhoea (n = 9, 5.6%). Five participants reported a total of 11 serious AEs, none considered drug‐related. One participant experienced on‐treatment alanine aminotransferase/aspartate aminotransferase elevations that resolved without intervention. Data from the present study indicate that the combination of RZR 60 mg plus UPR 450 mg once daily for 12 weeks was well tolerated overall but was effective only for certain genotypes.