Effectiveness and safety of sofosbuvir/velpatasvir/voxilaprevir retreatment in hepatitis C patients with different genotypes with DAAs failure in East China

Abstract

Abstract Background and Aim: At present, DAAs are very effective in the treatment of HCV, but there are still a small number of patients with treatment failure. Sofosbuvir/velpatavir/voxilaprevir (SOF/VEL/VOX) is a first-line retreatment recommended by HCV guidelines. The sustained virological response rate at 12 weeks (SVR12) of phase Ⅲ clinical studies reached 97%. However, SOF/VEL/VOX was only allowed into the health insurance list in January 2022 in China. So there are few data on the effectiveness and safety of SOF/VEL/VOX in East China. Meanwhile, there is a lack of international data on genotype (GT)3b retreatment therapy. This is the first real-life cohort study evaluating effectiveness and safety of SOF/VEL/VOX in prior direct-acting antiviral failure HCV from multi-center of East China. The aim of this study was to evaluate the effectiveness and safety of SOF/VEL/VOX retreatment in HCV patients with DAAs failure. Methods: A total of 13 patients with HCV who failed treatment in multiple centers in East China from January 2022 to March 2022 were collected and received 12w SOF/VEL/VOX antiviral treatment. HCV RNA, blood routine, liver and kidney function, abdominal color ultrasound or CT were measured at baseline, 4 weeks, 8 weeks, 12weeks and follow-up of 12 weeks. Virological response rate was used to evaluate the direct antiviral efficacy. Results: A total of 13 previous DAA failure HCV patients received 12w SOF/VEL/VOX without Ribavirin (RBV) retreatment, with an average age of 44.2 ± 8.5 years, with male predominance (92.3%). There were 6 patients with genotype GT3b, 5 patients of GT6（4 GT6a and 1 GT6n）, 2 patients of GT1b. All patients are non-cirrhotic patients, including 2 patients with PWID. Previous treatment included Sofosbuvir + Velpatavir, Coblopasvir + Hydrochloride + Sofosbuvir, Elbasvir + Grazoprevir. The mean value of baseline HCV-RNA was 9.45*106copies/ml, ALT was 231.6±218.1U/L, and AST was 150.7±166.4U/L. SVR12 was 100%. The common adverse reactions were gastrointestinal reactions and dizziness, which were well tolerated by the patients. No serious adverse events, death or treatment discontinuation occurred due to adverse reactions. Conclusion: SOF/VEL/VOX is an effective and safe retreatment for patients with HCV who have failed on a previous DAA course in a real-life setting, and has a good virological response rate for HCV patients with different genotypes of treatment failure even for refractory GT3b.