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- Title
Efficacy and Safety of Sofosbuvir/Velpatasvir Plus Ribavirin in Patients with Hepatitis C Virus-Related Decompensated Cirrhosis.
- Authors
Flamm, Steven; Lawitz, Eric; Borg, Brian; Charlton, Michael; Landis, Charles; Reddy, K. Rajender; Shiffman, Mitchell; Alsina, Angel; Chang, Charissa; Ravendhran, Natarajan; Hernandez, Candido; Hézode, Christophe; Scherbakovsky, Stacey; Mercier, Renee-Claude; Samuel, Didier
- Abstract
A fixed-dose combination of sofosbuvir/velpatasvir (SOF/VEL) plus weight-based ribavirin (RBV) for 12 weeks is recommended for the treatment of patients with hepatitis C virus (HCV)-associated decompensated cirrhosis. However, large global studies, while confirming the effectiveness of SOF/VEL in a broad range of patients, often exclude these patients. This Phase 2, single-arm, open-label study in adult patients with HCV-associated decompensated cirrhosis in France and the USA aimed to provide further data on the safety and efficacy of SOF/VEL plus RBV for 12 weeks in this population. Patients were treated with a fixed-dose combination of SOF 400 mg/VEL 100 mg plus weight-based RBV once daily for 12 weeks. The inclusion criteria were chronic HCV infection (≥6 months), quantifiable HCV RNA at screening, Child–Turcotte–Pugh class B or C cirrhosis, and liver imaging within 6 months of Day 1 to exclude hepatocellular carcinoma. Among 32 patients who initiated treatment, 78.1% achieved sustained virologic response 12 weeks after the end of treatment (SVR12). Failure to achieve SVR12 was due to non-virologic reasons (investigator discretion, n = 1; death, n = 6). All 25 patients in the per-protocol population achieved SVR12 and all but one achieved sustained virologic response 24 weeks after the end of treatment. Adverse events (AEs) were as expected for a patient population with advanced liver disease. All Grade 3–4 and serious AEs and deaths were deemed unrelated to treatment. In patients with HCV-associated decompensated cirrhosis, SOF/VEL plus RBV achieved high SVR12 rates and was generally well tolerated.
- Subjects
FRANCE; HEPATITIS C; RIBAVIRIN; HEPATITIS C virus; END of treatment; CIRRHOSIS of the liver
- Publication
Viruses (1999-4915), 2023, Vol 15, Issue 10, p2026
- ISSN
1999-4915
- Publication type
Article
- DOI
10.3390/v15102026