Observation On The Efficacy And Safety Of Sofosbuvir/Velpatasvir In The Treatment Of Patients With Hepatitis C:A Single-center Real-world Retrospective Analysis

Objective The aim of this study was working on the safety and effectiveness of sofosbuvir/velpatasvir(SOF/VEL)in real-world study(RWS)in a single centre from Northwest in China.Method Initial or PR treated patients with hepatitis C were recruited from May 2018 to Apr 2020.Group divided according to clinical cirrhosis state(LC): group of CHC(non-LC),group of chronic hepatitis C related compensated liver cirrhosis(CHC-CLC),group of chronic hepatitis C related decompensated liver cirrhosis(CHC-DLC).Both groups patients in CHC and CHC-CLC initiated on SOF/VEL-RBV 12weeks;Patients in CHC-DLC group initiated on SOF/VEL + RBV 12 weeks.Data on follow-up SVR12/SVR24 outcomes and adverse events(AE)were analysed in three group patients after cessation of treatment(SVR12)information overall and by subgroups.Results(1)Baseline characteristics:Total 99 patients have been recruited,in which 32 cases in CHC group,36 cases in CHC-CLC group,31 cases in CHC-DLC group.There was no difference in HCVRNA among the three groups at baseline.GT 2a(55.6%)and GT1b(34.3%)were the main genotypes(GT)in the three groups.(2)Main endpoint:Among three groups,SVR12 was 100%,100% and 92.9% separately;further,SVR24 was 100%,100% and 93.1% separately.There were no significant difference SVR12 and SVR24 among the three groups(P(27)0.05).Overall,SVR12 and SVR24 in GTS patients were 97.8% and 97.7% separately,and SVR12/SVR24 in all GTs patients were100%,except GT3 b.(3)Secondary endpoint:Compared with the baseline,the serum level of ALT,AST,ALB and the APRI LSM in three groups were significantly improved after treatment.(4)The total AE was 12.1%.All patients were well tolerated,no serious AEs were observed,no patients drug withdrawal and death due to AE.Conclusion SVR12/SVR24 were achieved in 100% of patients on SOF/VEL ±RBV12 weeks independent of HCV GT(2a、1b、3a、2a+6a、1b+2a、undetermined genotype,except 3b),PR treatment history,or cirrhosis status in a single centre from Northwest in China.