Jiayi Wang, Lingyao Du, Dongmei Zhang, Chen Zhou, Yilan Zeng, Miao Liu, Xing Cheng, Xiaona Song, Han Chen, Ning Han, Enqiang Chen, Hong Tang
{"title":"基于索非布韦/维帕他韦的抗病毒药物在中国丙型肝炎患者根除中的有效性和安全性的现实研究。","authors":"Jiayi Wang, Lingyao Du, Dongmei Zhang, Chen Zhou, Yilan Zeng, Miao Liu, Xing Cheng, Xiaona Song, Han Chen, Ning Han, Enqiang Chen, Hong Tang","doi":"10.1016/j.jve.2024.100571","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>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.</p><p><strong>Methods: </strong>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.</p><p><strong>Results: </strong>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 <i>vs.</i> -3.18 <i>P</i> < 0.001), Fibrosis-4 (FIB4) Index (2.53 <i>vs.</i> 1.88, <i>P</i> = 0.004) and AST to Platelet Ratio Index (APRI) (0.99 <i>vs.</i> 0.44, <i>P</i> < 0.001) scores showed a significant decrease from baseline to SVR12. No patients experienced grade 3-5 AEs.</p><p><strong>Conclusions: </strong>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.</p>","PeriodicalId":17552,"journal":{"name":"Journal of Virus Eradication","volume":"10 4","pages":"100571"},"PeriodicalIF":3.5000,"publicationDate":"2024-12-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11681871/pdf/","citationCount":"0","resultStr":"{\"title\":\"Real-life study on the effectiveness and safety of sofosbuvir/velpatasvir-based antiviral agents for hepatitis C eradication in Chinese patients.\",\"authors\":\"Jiayi Wang, Lingyao Du, Dongmei Zhang, Chen Zhou, Yilan Zeng, Miao Liu, Xing Cheng, Xiaona Song, Han Chen, Ning Han, Enqiang Chen, Hong Tang\",\"doi\":\"10.1016/j.jve.2024.100571\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Background: </strong>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.</p><p><strong>Methods: </strong>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.</p><p><strong>Results: </strong>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 <i>vs.</i> -3.18 <i>P</i> < 0.001), Fibrosis-4 (FIB4) Index (2.53 <i>vs.</i> 1.88, <i>P</i> = 0.004) and AST to Platelet Ratio Index (APRI) (0.99 <i>vs.</i> 0.44, <i>P</i> < 0.001) scores showed a significant decrease from baseline to SVR12. No patients experienced grade 3-5 AEs.</p><p><strong>Conclusions: </strong>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.</p>\",\"PeriodicalId\":17552,\"journal\":{\"name\":\"Journal of Virus Eradication\",\"volume\":\"10 4\",\"pages\":\"100571\"},\"PeriodicalIF\":3.5000,\"publicationDate\":\"2024-12-03\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11681871/pdf/\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Journal of Virus Eradication\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.1016/j.jve.2024.100571\",\"RegionNum\":4,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"2024/12/1 0:00:00\",\"PubModel\":\"eCollection\",\"JCR\":\"Q2\",\"JCRName\":\"IMMUNOLOGY\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Journal of Virus Eradication","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1016/j.jve.2024.100571","RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"2024/12/1 0:00:00","PubModel":"eCollection","JCR":"Q2","JCRName":"IMMUNOLOGY","Score":null,"Total":0}
引用次数: 0
摘要
背景：索非布韦/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病毒提供了希望。但在中国慢性丙型肝炎（CHC）患者，特别是HCV GT3b、肝硬化、肝细胞癌（HCC）、HCV/乙型肝炎（HBV）、HCV/HIV或HCV/HBV/HIV合并感染的患者，其有效性和安全性的真实数据仍然很少。方法：在这项现实世界的前瞻性观察研究中，我们从中国成都华西医院和公共卫生临床中心招募了患者。患者包括患有CHC和任何基因型（GT）的成年人，伴有或不伴有肝硬化、肝细胞癌（HCC）、HCV/HBV、HCV/HIV或HCV/HBV/HIV合并感染。患者给予SOF/VEL （400/100 mg）±利巴韦林（RBV），每日1次，连续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：纳入HCV基因型1、2、3、6及不确定型患者483例。其中，35.4% （171/483，ITT）和36.7% （166/452,mITT）接受了SOF/VEL + RBV治疗。在治疗结束时，99.2% （ITT, 479/483）和99.1% （mITT, 448/452）的患者无法检测到HCV RNA。SVR12率为92.8%[意向治疗（ITT）， 448/483]和99.1%[改良ITT (mITT), 448/452]。在mITT分析中，HCV GT3b患者、肝硬化或HCC患者和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 vs. -3.18 P vs. 1.88, P = 0.004）和AST /血小板比值指数（APRI） （0.99 vs. 0.44， P）结论：尽管本研究中有很高比例的患者患有HCV GT3b、肝硬化、HCC或HCV/HBV、HCV/HIV或HCV/HBV/HIV合并感染，SOF/VEL±RBV对中国CHC患者非常有效且耐受性良好。
Real-life study on the effectiveness and safety of sofosbuvir/velpatasvir-based antiviral agents for hepatitis C eradication in Chinese patients.
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 vs. -3.18 P < 0.001), Fibrosis-4 (FIB4) Index (2.53 vs. 1.88, P = 0.004) and AST to Platelet Ratio Index (APRI) (0.99 vs. 0.44, P < 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.
期刊介绍：
The Journal of Virus Eradication aims to provide a specialist, open-access forum to publish work in the rapidly developing field of virus eradication. The Journal covers all human viruses, in the context of new therapeutic strategies, as well as societal eradication of viral infections with preventive interventions.
The Journal is aimed at the international community involved in the prevention and management of viral infections. It provides an academic forum for the publication of original research into viral reservoirs, viral persistence and virus eradication and ultimately development of cures.
The Journal not only publishes original research, but provides an opportunity for opinions, reviews, case studies and comments on the published literature. It focusses on evidence-based medicine as the major thrust in the successful management of viral infections.The Journal encompasses virological, immunological, epidemiological, modelling, pharmacological, pre-clinical and in vitro, as well as clinical, data including but not limited to drugs, immunotherapy and gene therapy. It is an important source of information on the development of vaccine programs and preventative measures aimed at virus eradication.
京公网安备 11010802042870号
京ICP备2023020795号-1
分享
求助内容：
应助结果提醒方式：
扫码关注我们
