Effectiveness of Elbasvir and Grazoprevir Combination and 1-year Follow-up Hepatic Function for HCV Genotype 1b Infection: Results From a Chinese Real-world Cohort.

Abstract Background: The treatment of chronic hepatitis C (CHC) has entered the interferon-free era since the approval of all-oral direct-acting antiviral (DAA) therapy in China. Twelve weeks of Elbasvir and Grazoprevir (EBR/GZR) has been demonstrated to be highly effective and well tolerated in phase III registration trials in Asia. However, real-world data on this regimen are lacking in mainland China. We aimed to evaluate the efficacy and safety of EBR/GZR and hepatic function during 1-year follow-up in real-world clinical practice with genotype 1b HCV infection.Methods: A prospective, multicenter, non-interventional cohort study was conducted in Tianjin Third Central Hospital and Tianjin Second People's Hospital of China. All patients diagnosed with HCV-1b infection and treated with EBR/GZR for 12 weeks were included. The sustained virological response (SVR) rate obtained 12 weeks posttreatment (SVR12) and week 48 posttreatment (SVR48), the liver function and safety were also evaluated in patients who received EBR/GZR.Results: A total of 251 patients were enrolled, 215 of whom completed the 12-week treatment and 107 completed the 48-week follow-up after treatment. 47 patients (21.9%) had compensatory cirrhosis. The overall rates at the end of treatment (EOT), SVR12 and SVR48 were 100%, 99.5% and 99.1%, respectively. Two cirrhosis patients relapsed at 12 weeks and 48 weeks posttreatment respectively. At 48 weeks posttreatment, the normalization rate of ALT and AST were increased significantly than that of baseline (97.2% and 95.3% vs 59.5% and 61.4%, P<0.01). The incidence of any adverse reactions was 18.1%, while most reactions were mild in severity. Conclusion: In a real-world cohort, treatment with EBR/GZR in Chinese patients with genotype 1b HCV infection appears to be well tolerated and achieves high SVR12 and SVR48 rates.Trial registration: ChiCTR, ChiCTR1900023747. Registered 10 June 2019, Retrospectively registered. http://www.chictr.org.cn/showproj.aspx?proj=39926