索磷布韦/维帕他韦类抗病毒药物在中国患者中根除丙型肝炎的有效性和安全性的真实世界研究。
Real-life study on the effectiveness and safety of sofosbuvir/velpatasvir-based antiviral agents for hepatitis C eradication in Chinese patients.
作者信息
Wang Jiayi, Du Lingyao, Zhang Dongmei, Zhou Chen, Zeng Yilan, Liu Miao, Cheng Xing, Song Xiaona, Chen Han, Han Ning, Chen Enqiang, Tang Hong
机构信息
Center of Infectious Diseases, West China Hospital of Sichuan University, Chengdu, 610041, China.
Laboratory of Infectious and Liver Diseases, Institution of Infectious Diseases, West China Hospital of Sichuan University, Chengdu, 610041, China.
出版信息
J Virus Erad. 2024 Dec 3;10(4):100571. doi: 10.1016/j.jve.2024.100571. eCollection 2024 Dec.
BACKGROUND
Hepatitis C virus (HCV) eradication with sofosbuvir/velpatasvir (SOF/VEL) represents a significant advancement, offering hope for eliminating the virus in diverse patient populations. But real-world data on its effectiveness and safety remains scarce for patients with chronic hepatitis C (CHC) in China, especially those with HCV GT3b, cirrhosis, hepato-cellular carcinoma (HCC), or HCV/hepatitis B (HBV), HCV/HIV, or HCV/HBV/HIV coinfection.
METHODS
In this real-world prospective observational study, we recruited patients from the West China Hospital and Public Health Clinical Center of Chengdu in China. Patients included adults with with CHC and any genotype (GT), with or without cirrhosis, hepatocellular carcinoma (HCC), HCV/HBV, HCV/HIV, or HCV/HBV/HIV coinfection. Patients were administered SOF/VEL (400/100 mg) ± ribavirin (RBV) once daily for 12 weeks. The primary efficacy endpoint was sustained virological response at post-treatment week 12 (SVR12). Adverse events (AEs) were evaluated during treatment.
RESULTS
The study included 483 patients with HCV genotypes 1, 2, 3, 6 and uncertain ones. Among them, 35.4 % (171/483, ITT) and 36.7 % (166/452, mITT) received SOF/VEL + RBV. At the end of treatment , 99.2 % (ITT, 479/483) and 99.1 % (mITT, 448/452) of patients had undetectable HCV RNA. SVR12 rates were 92.8 % [intention to treat (ITT), 448/483] and 99.1 % [modified ITT (mITT), 448/452]. In the mITT analysis, SVR12 for patients with HCV GT3b, those with cirrhosis or HCC, and those coinfected with HBV/HIV was 99.2 % (130/131), 99.4 % (168/169), and 97.6 % (40/41), respectively. The albumin-bilirubin (ALBI) (-3.01 -3.18 < 0.001), Fibrosis-4 (FIB4) Index (2.53 1.88, = 0.004) and AST to Platelet Ratio Index (APRI) (0.99 0.44, < 0.001) scores showed a significant decrease from baseline to SVR12. No patients experienced grade 3-5 AEs.
CONCLUSIONS
Although a high proportion of patients included in this study had HCV GT3b, cirrhosis, HCC, or HCV/HBV, HCV/HIV, or HCV/HBV/HIV coinfection, SOF/VEL ± RBV was highly effective and well tolerated in Chinese patients with CHC.
背景
使用索磷布韦/维帕他韦（SOF/VEL）根除丙型肝炎病毒（HCV）是一项重大进展，为在不同患者群体中消除该病毒带来了希望。但在中国，关于慢性丙型肝炎（CHC）患者，尤其是HCV GT3b、肝硬化、肝细胞癌（HCC）或HCV/乙型肝炎（HBV）、HCV/人类免疫缺陷病毒（HIV）或HCV/HBV/HIV合并感染患者的有效性和安全性的真实世界数据仍然匮乏。
方法
在这项真实世界前瞻性观察研究中，我们从中国成都的华西医院和公共卫生临床中心招募患者。患者包括患有CHC且具有任何基因型（GT）的成年人，有或无肝硬化、肝细胞癌（HCC）、HCV/HBV、HCV/HIV或HCV/HBV/HIV合并感染。患者每天一次接受SOF/VEL（400/100毫克）±利巴韦林（RBV）治疗，持续12周。主要疗效终点是治疗后第12周的持续病毒学应答（SVR12）。在治疗期间评估不良事件（AE）。
结果
该研究纳入了483例HCV基因型1、2、3、6及基因型不确定的患者。其中，35.4%（171/483，意向性分析人群）和36.7%（166/452，改良意向性分析人群）接受了SOF/VEL + RBV治疗。治疗结束时，99.2%（意向性分析人群，479/483）和99.1%（改良意向性分析人群，448/452）的患者HCV RNA检测不到。SVR12率分别为92.8%[意向性治疗（ITT），448/483]和99.1%[改良ITT（mITT），448/452]。在改良意向性分析中，HCV GT3b患者、肝硬化或HCC患者以及HBV/HIV合并感染患者的SVR12分别为99.2%（130/131）、99.4%（168/169）和97.6%（40/41）。白蛋白-胆红素（ALBI）（-3.01 -3.18，<0.001）、纤维化-4（FIB4）指数（2.53 1.88，=0.004）和天冬氨酸转氨酶与血小板比值指数（APRI）（0.99 0.44，<0.001）评分从基线至SVR12均显著下降。无患者发生3-5级不良事件。
结论
尽管本研究纳入的患者中很大一部分患有HCV GT3b、肝硬化、HCC或HCV/HBV、HCV/HIV或HCV/HBV/HIV合并感染，但SOF/VEL±RBV在中国CHC患者中具有高效性且耐受性良好。
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