Sofosbuvir/Velpatasvir plus Ribavirin for chronic hepatitis C virus genotype 3 infected cirrhotic patients with or without HIV or HBV coinfection: Real-world experience from Southwest China

Abstract

Abstract Background: Evidence of direct-acting antiviral (DAA) treatment for refractory chronic hepatitis C (CHC) patients was limited. We aimed to evaluate the effectiveness and safety of Sofosbuvir/Velpatasvir (SOF/VEL) plus Ribavirin (RBV) in cirrhotic patients with hepatitis C virus genotype 3 (GT3) with or without HIV or HBV coinfection. Methods: From June 2019 to December 2022, CHC GT3 patients who received SOF/VEL plus RBV (dosage of RBV depended on weight) for 12 weeks were enrolled. Liver cirrhosis was diagnosed by clinical presentation . The primary endpoint was sustained virologic response at 12 weeks off-therapy (SVR12). Adverse events (AE)were assessed during treatment. Results:In total, 285 treatment-naive patients were recruited at the Kunming Third People’s Hospital. Mean age was 48.18±8.27 years-old and 74.04% (211/285) were male. All patients had GT3 HCV infection including 44 patients with GT3a and 241 patients with hepatitis C virus genotype 3b (GT3b) . Among these patients, 39 with HCV/HIV,10 with HBV/HCV, and 1 with HBV/HCV/HIV coinfection. All patients had liver cirrhosis, and 46.67% (133/285) of patients had compensated cirrhosis (CC), while 53.33% (152/285) of patients had decompensated cirrhosis (DCC). 98.95% (282/285) patients achieved SVR12 with SOF/VEL plus RBV treatment for 12 weeks, including 97.72% (43/44) in GT3a and 99.17% (239/241) in GT3b. According to the condition for 285 patients with liver cirrhosis, the SVR12 rate in the CC group was : 99.25% (132/133), the SVR12 rate in the DCC group was: 98.68% (150/152). After 12 weeks of treatment, the APRI score and FIB-4 score in CC group and DCC group were improved, and the improvement in the compensated cirrhosis group was better than that in decompensated cirrhosis group (PAPRI=0.001, PFIB-4=0.001). Mean ALT (from 74±27.23U/L to 39.31±12.22U/L, p<0.05) and AST (from 73.98±25.54U/L to 44.17±15.56U/L, p<0.05) also significantly declined after treatment.1 patient had serious AE of hemolysis but recovered after 2-3 days of interruption of RBV. Most AEs were consistent with clinical sequelae of advanced liver disease or known toxicities of RBV. Conclusion： SOF/VEL combined with RBV for cirrhotic GT3 hepatitis C patients all obtained high SVR12 (>95%), improved liver function during treatment, and for cirrhotic GT3 hepatitis C patients treatment with SOF/VEL combined with RBV is recommended as early as possible.