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.

中文翻译：

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丙型肝炎感染的直接抗病毒疗法：全球注册、报销和限制

针对丙型肝炎病毒 (HCV) 感染的直接作用抗病毒药物 (DAA) 具有较高的缓解率 (>95%)，并简化了 HCV 治疗的管理，使非专家能够治疗没有晚期肝病的患者。我们收集并审查了有关丙肝治疗的注册和报销（政府补贴）的全球数据，包括报销限制。主要数据收集于 2021 年 11 月 15 日至 2023 年 7 月 24 日期间通过由 166 名 HCV 专家组成的全球网络的协助进行。我们检索了 209 个国家和地区中的 160 个国家和地区 (77%) 的数据。到 2023 年中期，145 个国家 (91%) 已注册至少一种以下 DAA 疗法：索磷布韦 - 维帕他韦、索磷布韦 - 维帕他韦 - 沃西拉瑞韦、格卡瑞韦 - 匹布伦他韦、索磷布韦 - 达拉他韦或索磷布韦。109 个国家 (68%) 报销了至少一种 DAA 治疗。在 102 个低收入和中等收入国家 (LMIC) 中，89 个国家 (87%) 注册了至少一种 HCV DAA 治疗，53 个国家 (52%) 报销了至少一种 DAA 治疗。在所有实行 DAA 治疗报销的国家中（n=109），66 个国家（61%）需要专家处方，8 个国家（7%）有再治疗限制，7 个国家（6%）有非法药物使用限制，5 个国家（5%）有限制饮酒，三人 (3%) 有肝病限制。全球获得 DAA 报销的机会仍然不平衡，与高收入国家相比，中低收入国家的报销相对较低。为了实现世卫组织消除丙肝病毒的目标，应努力协助各国，特别是中低收入国家，增加获得 DAA 报销的机会，并取消报销限制（尤其是处方者类型的限制），以确保普遍获得服务。