Efficacy and Safety of Velpatasvir Plus Sofosbuvir With or Without Ribavirin in Hepatitis C Patients With Decompensated Cirrhosis: A Systematic Review and Meta-Analysis.

To assess the efficacy and safety of the Velpatasvir (VEL)/Sofosbuvir (SOF) with or without Ribavirin (RBV) in treating patients with decompensated hepatitis C cirrhosis. We searched multiple databases for studies published from October 2010 to September 2024. Outcomes of interest were sustained viral response at 12 weeks (SVR12) and the safety of VEL/SOF with and without RBV regimens in patients with decompensated hepatitis C virus (HCV) cirrhosis. All statistical analyses were performed using R Statistics (4.4.1). We included 13 studies that enrolled 872 adult patients with decompensated cirrhosis due to HCV. The addition of RBV to the VEL/SOF regimen neither significantly improved SVR12 after the last dose of treatment [95.0% (366/391, 95% CI: 89.0-99.0) vs. 94.0% (442/481, 95% CI: 90.0-97.0); p = 0.92] nor decreased virologic relapse [1.0% (2/158, 95% CI: 0.0-8.0) vs. 6.0% (12/197, 95% CI: 3.0-10.0); p = 0.15]. VEL/SOF plus RBV therapy had a significantly higher rate of adverse events [92.0% (261/287, 95% CI: 88.0-95.0) vs. 47.0% (167/348, 95% CI: 24.0-71.0); p < 0.01] and death [7.0% (20/287, 95% CI: 2.0-16.0) vs. 2.0% (8/366, 95% CI: 1.0-4.0); p = 0.05]. However, for patients with genotype 3, adding RBV to the VEL/SOF regimen significantly improved SVR12 [87.0% (26/30, 95% CI: 71.0-98.0) vs. 45% (7/15, 95% CI: 13.0-79.0); p < 0.01] and decreased virologic relapse [0.0% (0/10, 95% CI: 0.0-31.0) vs. 100% (1/1, 95% CI: 2.0-100.0); p = 0.02]. VEL/SOF based therapy is a safe and effective treatment for patients with decompensated cirrhosis due to HCV. The addition of RBV to VEL/SOF may increase toxicity without achieving improved efficacy overall. However, the addition of RBV significantly increased the SVR12 rate and reduced the virologic relapse in genotype 3 patients. Trial Registration: PROSPERO database: CRD42023491852.