Direct-acting antiviral therapies for hepatitis C infection: global registration, reimbursement, and restrictions

Direct-acting antivirals (DAAs) for hepatitis C virus (HCV) infection have delivered high response rates (>95%) and simplified the management of HCV treatment, permitting non-specialists to manage patients without advanced liver disease. We collected and reviewed global data on the registration and reimbursement (government subsidised) of HCV therapies, including restrictions on reimbursement. Primary data collection occurred between Nov 15, 2021, and July 24, 2023, through the assistance of a global network of 166 HCV experts. We retrieved data for 160 (77%) of 209 countries and juristrictions. By mid-2023, 145 (91%) countries had registered at least one of the following DAA therapies: sofosbuvir–velpatasvir, sofosbuvir–velpatasvir–voxilaprevir, glecaprevir–pibrentasvir, sofosbuvir–daclatasvir, or sofosbuvir. 109 (68%) countries reimbursed at least one DAA therapy. Among 102 low-income and middle-income countries (LMICs), 89 (87%) had registered at least one HCV DAA therapy and 53 (52%) reimbursed at least one DAA therapy. Among all countries with DAA therapy reimbursement (n=109), 66 (61%) required specialist prescribing, eight (7%) had retreatment restrictions, seven (6%) had an illicit drug use restriction, five (5%) had an alcohol use restriction, and three (3%) had liver disease restrictions. Global access to DAA reimbursement remains uneven, with LMICs having comparatively low reimbursement compared with high-income countries. To meet WHO goals for HCV elimination, efforts should be made to assist countries, particularly LMICs, to increase access to DAA reimbursement and remove reimbursement restrictions—especially prescriber-type restrictions—to ensure universal access.

丙型肝炎病毒（hepatitis C virus, HCV）感染的直接抗病毒药物（direct-acting antivirals, DAAs）实现了超过95%的高病毒学应答率，简化了丙型肝炎治疗的管理流程，使得非专科医师可对无晚期肝病的患者进行诊疗管理。本研究收集并系统梳理了全球范围内丙型肝炎治疗药物的注册与医保报销（政府补贴类）数据，包括报销限制条款。本次原始数据采集工作开展于2021年11月15日至2023年7月24日期间，依托由166名HCV专家组成的全球协作网络完成。最终从209个国家及司法管辖区中，获取到160个（占比77%）地区的有效数据。截至2023年中期，已有145个（占比91%）国家至少注册了以下任意一种DAA治疗方案：索磷布韦维帕他韦、索磷布韦维帕他韦伏西瑞韦、格卡瑞韦哌仑他韦、索磷布韦达拉他韦，或索磷布韦单药制剂。其中109个（占比68%）国家将至少一种DAA治疗方案纳入医保报销范围。在102个低收入和中等收入国家（Low- and Middle-Income Countries, LMICs）中，89个（占比87%）至少注册了一种HCV的DAA治疗方案，53个（占比52%）将至少一种DAA治疗方案纳入报销范畴。在已实现DAA治疗报销的109个国家中，66个（占比61%）要求需由专科医师开具处方，8个（占比7%）设置了复治限制，7个（占比6%）存在违禁药物使用限制，5个（占比5%）存在酒精使用限制，3个（占比3%）存在肝病相关限制。全球范围内DAA报销的可及性仍存在显著不均衡性，低收入和中等收入国家的报销覆盖率远低于高收入国家。为达成世界卫生组织（World Health Organization, WHO）提出的HCV消除目标，应助力各国尤其是低收入和中等收入国家提升DAA报销的可及性，并移除报销限制条款——尤其是处方医师资质类限制——以保障全民可及。