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Title: [Effectiveness and safety of sofosbuvir/velpatasvir combination ± ribavirin in the treatment of Chinese adults with chronic hepatitis C virus infection].
Author: Li JP, Chen XF, Yan Q, Zhang YJ, Xie ZW, Xia Y, Guan YJ.
Journal: Zhonghua Gan Zang Bing Za Zhi; 2020 Oct 20; 28(10):831-837. PubMed ID: 33105927.
Abstract:
Objective: To understand the effectiveness and safety sofosbuvir/velpatasvir (SOF/VEL) combination ±ribavirin in the treatment of chronic hepatitis C virus (HCV) infection in China. Methods: A total of 96 Chinese adults with chronic HCV infection who were treated with SOF/VEL combination ± ribavirin for 12 weeks between July 2018 and February 2020 were selected. HCV RNA, routine blood test, liver, kidney and coagulation function, abdominal Color Doppler ultrasound or CT and liver stiffness were detected at baseline, 4 weeks of treatment, end of treatment and 12 weeks of follow-up. Adverse events and laboratory abnormalities during the treatment were recorded. A t-test was used to compare the measurement data between the two groups, and the analysis of variance was used for multiple group comparison. Results: A total of 93 cases (96.9%) achieved sustained virological response (SVR12), of which 3 cases had relapsed. 88 cases (91.7%, 88/96) had achieved rapid virological response (RVR). 96 cases (100%) had achieved virological response by the end of treatment (EOT). In patients with decompensated liver cirrhosis, the average baseline Child-Pugh score and Model for End-Stage Liver Disease score was 7.4±1.0, and 11.4±1.7, respectively. Among them, 12 cases of the SOF/VEL combined with RBV treatment had achieved SVR12 (100%) at 12 weeks, while only 3 of the 5 cases of single-tablet regimen of SOF/VEL had achieved SVR12 (60%). There was no significant difference between creatinine levels and baseline during or 12 weeks after treatment. The incidence of adverse events in patients with chronic hepatitis C and compensated cirrhosis was 6.3% (5/79), while that in patients with decompensated cirrhosis was 35.3% (6/17). The most common adverse events were hyperbilirubinemia, fatigue and anemia. There were no serious adverse events, deaths or discontinuation of treatment due to adverse events. Conclusion: SOF/VEL combination ± ribavirin in the treatment of various common genotypes of chronic hepatitis C, compensated cirrhosis, decompensated cirrhosis and hepatocellular carcinoma has higher SVR12 in China, and the tolerance and safety are good. 目的： 了解索磷布韦维帕他韦（SOF/VEL）联合或不联合利巴韦林治疗中国慢性丙型肝炎病毒（HCV）感染者的有效性和安全性。 方法： 收集2018年7月至2020年2月就诊并使用SOF/VEL联合或不联合利巴韦林12周治疗的96例中国成年慢性HCV感染者。检测患者基线、治疗4周、疗程结束和随访12周的HCV RNA、血常规、肝肾功能、凝血功能及腹部彩色超声或CT，检测患者基线及随访12周的肝脏硬度。记录治疗过程的不良事件和实验室异常，计量资料两组间比较用t检验，多组间比较用方差分析。 结果： 共有93例患者（96.9%）达到持续病毒学应答（SVR12），其中3例复发。88例快速病毒学应答（RVR）（91.7％，88/96），并且到治疗结束时（EOT）96例（100％）均达到了病毒学应答。在失代偿性肝硬化患者中，基线平均Child-Pugh评分为7.4±1.0，平均终末期肝病模型评分为11.4±1.7，其中12例患者SOF/VEL联合RBV 12周治疗均获得SVR12（100%），5例患者单药SOF/VEL治疗12周仅3例获得SVR12（60%）。在治疗期间或治疗后12周，肌酐水平与基线无明显差异。慢性丙型肝炎和代偿性肝硬化患者的不良反应发生率为6.3％（5/79），而失代偿性肝硬化患者为35.3％（6/17）。最常见的不良反应是胆红素升高、疲劳和贫血。没有发生因不良反应引起的严重不良事件、死亡或中止治疗的情况。 结论： 以SOF/VEL联合或不联合利巴韦林治疗中国各常见基因型初治和经治慢性丙型肝炎、代偿性肝硬化、失代偿性肝硬化及肝细胞癌的HCV感染者，均有较高SVR12，且耐受性和安全性良好。.

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