Efficacy and safety of sofosbuvir/velpatasvir in a real world chronic hepatitis C genotype 3 cohort.

BACKGROUND & AIM Real-world data on sofosbuvir/velpatasvir with and without ribavirin (SOF/VEL ± RBV), particularly among patients with genotype 3 (GT3) decompensated cirrhosis, prior treatment, coinfection and hepatocellular carcinoma (HCC), are scarce. We aimed to assess the efficacy and safety of SOF/VEL ± RBV in a real-world setting that included both community and incarcerated GT3 HCV patients. METHODS We included all GT3 HCV patients treated with SOF/VEL ± RBV in our institution. The primary outcome measure was the overall sustained virological response 12 weeks after treatment (SVR12), reported in both intention-to-treat (ITT) and per-protocol (PP) analyses. The secondary outcome measures were SVR12 stratified by the presence of decompensated cirrhosis, prior treatment, HCC, HIV/HBV co-infection, and the occurrence rate of serious adverse events requiring treatment cessation or hospitalization. RESULTS A total of 779 HCV patients were treated with 12-week of SOF/VEL ± RBV, of which 85% were treated during incarceration. Among the 530 GT3 HCV patients, 31% had liver cirrhosis and 6% were treatment-experienced. The overall SVR12 for GT3 was 98.7% (95% CI: 97.3%, 99.5%) and 99.2% (95% CI: 98.1%, 99.8%), in ITT and PP analysis, respectively. High SVR12 was also seen in ITT analysis among GT3 HCV patients with decompensated cirrhosis (88%), prior treatment (100%), HCC (100%) and HIV/HBV coinfection (100%). Apart from 1 patient who developed myositis, no other serious adverse events were observed. CONCLUSION SOF/VEL ± RBV is a safe and efficacious treatment option for GT3 HCV patients in a real-world setting. SOF/VEL with RBV may be considered for decompensated GT3 HCV patients.