背景:欧洲肝脏研究协会(EASL)和美国肝病研究协会和美国传染病学会(AASLD-IDSA)指南都建议对符合条件的患者使用泛基因型sofosbuvir/velpatasvir或glecaprevir/pibrentasvir简化丙型肝炎病毒(HCV)治疗。这项观察性研究使用真实世界的数据来评估这些方案在符合条件的患者中的安全性,并开发一种算法来识别适合非专业人员简化治疗的患者。
方法:来自台湾丙型肝炎注册中心(TACR)的7,677名HCV感染患者接受了至少一剂索非布韦/velpatasvir或glecaprevir/pibrentasvir,并符合EASL/AASLD-IDSA标准的简化治疗进行分析。对患者特征和安全性数据进行多因素分析。
结果:总体而言,92.8%(7,128/7,677)的患者获得了持续的病毒学应答,只有1.9%(146/7,677)的患者经历了2-4级的关键肝功能参数实验室异常(丙氨酸转氨酶,天冬氨酸转氨酶,和总胆红素),只有18例患者(0.23%)经历3-4级异常。年龄>70岁,肝细胞癌的存在,总胆红素>1.2mg/dL,估计的肾小球滤过率<60mL/min/1.73m2,纤维化-4>3.25与2-4级异常的高风险相关.具有任何这些的患者的几率是没有发展为2-4级异常的患者的4.53倍(p<0.01)。
结论:来自台湾的真实世界数据证实,对泛基因型方案的合格患者进行简化的HCV治疗是有效且耐受性良好的。TACR算法,根据这项研究的结果开发,可以进一步确定可以通过非专科护理安全管理的患者。
BACKGROUND: Both European Association for the Study of the Liver (EASL) and American Association for the Study of Liver Diseases and the Infectious Diseases Society of America (AASLD-IDSA) guidelines recommend simplified hepatitis C virus (HCV) treatment with pan-genotypic sofosbuvir/velpatasvir or glecaprevir/pibrentasvir for eligible patients. This observational study used real-world data to assess these regimens\' safety in eligible patients and develop an algorithm to identify patients suitable for simplified treatment by non-specialists.
METHODS: 7,677 HCV-infected patients from Taiwan Hepatitis C Registry (TACR) who received at least one dose of sofosbuvir/velpatasvir or glecaprevir/pibrentasvir, and fulfilled the EASL/AASLD-IDSA criteria for simplified treatment were analyzed. Multivariate analysis was conducted on patient characteristics and safety data.
RESULTS: Overall, 92.8% (7,128/7,677) of patients achieved sustained virological response and only 1.9% (146/7,677) experienced Grades 2-4 laboratory abnormalities in key liver function parameters (alanine aminotransferase, aspartate aminotransferase, and total bilirubin), with only 18 patients (0.23%) experiencing Grades 3-4 abnormalities. Age > 70 years old, presence of hepatocellular carcinoma, total bilirubin > 1.2 mg/dL, estimated glomerular filtration rate < 60 mL/min/1.73 m2, and Fibrosis-4 > 3.25 were associated with higher risks of Grades 2-4 abnormalities. Patients with any of these had an odds of 4.53 times than that of those without in developing Grades 2-4 abnormalities (p < 0.01).
CONCLUSIONS: Real-world data from Taiwan confirmed that simplified HCV treatment for eligible patients with pan-genotypic regimens is effective and well tolerated. The TACR algorithm, developed based on this study\'s results, can further identify patients who can be safely managed by non-specialist care.