Objective: To study the real-world outcome of China FDA-approved Sofosbuvir (SOF)/Velpatasvir (VEL) in Northwest China. Methods: In this multicenter, prospective, real-world cohort study, we recruited patients from 10 sites from Northwest China, who were chronically infected with HCV GTs 1-6 from 06/2018 to 09/2019. Patients received SOF (400mg)/VEL (100mg) for 12 weeks, and with ribavirin 900-1200 mg for GT3 cirrhosis and for any genotype decompensated cirrhosis. The primary endpoint was sustained virological response at 12-weeks post-treatment (SVR12) and safety. The secondary endpoint was the change of liver function after the achievement of SVR12. Results: Totally, 143 patients were enrolled in the study, four patients were lost to follow-up and one died during the follow-up, 138 patients were included in per-protocol analysis. Of the 138 patients, the mean age 53 years, 53.6% male, 94.2% Han nationality, 53.6% liver cirrhosis, 10.1% HBsAg(+), 6.5% renal dysfunction, 5.1% treatment-experienced, and 16.7% patients received ribavirin treatment. The genotype distribution was as follows: 35.5% GT1, 42.8% GT2, 15.9% GT3, and 5.8% un-typed. The SVR12 rate was 96.5% (138/143, 95%CI: 93.5%-99.6%) for intention-to-treat analysis, and in per-protocol analysis, all 138 patients obtained SVR12 (100%). Compared with baseline, the serum total bilirubin, ALT and AFP levels decreased (all P < 0.05), as well as increased ALB and platelet count (all P < 0.001) at post-treatment 12-weeks. Overall adverse events (AEs) rate is 29.0%, and the most common AEs were anemia (14.5%) and fatigue (8.0%). Severe side effects (edema and fatigue) occurred in 2 patients, one of whom needed a short-term interruption of treatment due to fatigue. Conclusion: In this real-world cohort study, 12-week SOF/VEL regimen with or without ribavirin achieved high SVR12 rates (96.5%-100% overall) with excellent safety profile among patients with HCV GT1/2/3 infection including patients with GT3 and cirrhosis, and led to improvement of liver function.
目的： 探讨索磷布韦/维帕他韦（SOF/VEL）治疗西北地区慢性丙型肝炎（CHC）患者的疗效和安全性。 方法： 该项多中心、前瞻性、真实世界研究纳入中国西北地区10个研究中心CHC任何基因型接受SOF（400 mg）/VEL（100 mg）治疗12周患者,基因3型肝硬化和任何基因型失代偿期肝硬化患者联合利巴韦林（RBV）900~1 200 mg治疗。主要终点为治疗结束12周持续病毒学应答（SVR12）和安全性。次要终点是获得SVR12对肝脏生化指标的影响。 结果： 共纳入143例患者，4例失访，1例治疗结束随访期间死亡，最终138例纳入符合研究方案分析。中位年龄53岁，53.6%肝硬化，10.1% HBsAg阳性，6.5%合并肾损害，5.1%经治，16.7%患者联合RBV治疗。基因型分布：1型35.5%，2型42.8%，3型15.9%，5.8%未检测基因型。意向治疗分析，SVR12率为96.5% (138/143，95%CI: 93.5%~99.6%)；PP分析，138例患者均获得SVR12（100%）。与基线相比治疗结束后12周血清总胆红素、ALT和AFP水平明显降低（P值均< 0.05），血清白蛋白、血小板计数明显升高（P值均< 0.001）。任何不良事件发生率为29.0%，贫血（14.5%）和乏力（8.0%）最常见。2例患者出现严重不良反应（水肿和乏力），其中1例需要短暂中断治疗。 结论： 12周SOF/VEL单用或联合RBV治疗西北地区CHC患者可获得高的SVR12（96.5%~100%），抗病毒治疗安全性良好，获得SVR12患者肝脏生化指标明显改善。.
Keywords: Chronic hepatitis C; Effectiveness; Genotype 3; Liver cirrhosis; Real world; Ribavirin; Sofosbuvir; Velpatasvir.