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.
Competing Interests: Declaration of interests The Kirby Institute is funded by the Australian Government Department of Health and Aged Care. The views expressed in this publication do not necessarily represent the position of the Australian Government. GJD has received clinical trial grants from Gilead Sciences and AbbVie and has participated on a data safety monitoring board for a National Institutes of Health grant (unpaid). JG is supported by a National Health and Medical Research Council Investigator Grant (1176131); has received grants or contracts from AbbVie, bioLytical Laboratories, Camurus, Cepheid, Gilead Sciences, Hologic, Indivior, and Roche; and has received payment or honoraria from AbbVie, Cepheid, Gilead Sciences, and Roche. The Task Force for Global Health (JWW and LH) has received funds for the general support of the Coalition for Global Hepatitis Elimination from Abbott Laboratories, AbbVie, Cepheid, Gilead Sciences, John C Martin Foundation, Merck, Pharco, Roche, Siemens, the US Centers for Disease Control and Prevention, the US National Institutes of Health, VBI Vaccines, and Zydus-Cadila. All payments to the Task Force for Global Health were to directly support the general work of the Coalition. JVL (via the Barcelona Institute for Global Health) has received grants or contracts from AbbVie, FIND, Gilead Sciences, Merck Sharp and Dohme, and Roche Diagnostics. JVL has also received consulting fees from NovoVax and Roche Diagnostics; payment or honoraria from AbbVie, Echosens, Gilead Sciences, Intercept, Janssen, Moderna, and Novo Nordisk; has participated on a data safety monitoring board or advisory board for the QuickStart Study (unpaid); and is a member of the public health and policy committee of the European Association for the Study of the Liver (unpaid), an HIV Outcomes co-chair (unpaid), and coordinator for Healthy Livers, Healthy Lives (unpaid). All other authors declare no competing interests.
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