Global Availability and Restrictions to Direct-Acting Antiviral Therapies for Hepatitis C Infection.

Author: Alison Marshall, Alex Willing, Abe Kairouz, Evan Cunningham, Alice Wheeler, Nicholas O'Brien, Vidura Perera, John Ward, Lindsey Hiebert, Louisa Degenhardt, Behzad Hajarizadeh, Samantha Colledge-Frisby, Matthew Hickman, Danielle Jawad, Jeffrey Lazarus, Gail Matthews, Nicholas Luhmann , Andrew Scheibe , Peter Vickerman, Gregory Dore, Jason Grebely

Theme: Clinical Research Year: 2023

Background: Since 2016, direct-acting antivirals (DAAs) for hepatitis C virus (HCV) infection have delivered high cure responses (>95%) leading to widespread uptake and cure. However, most people with HCV have yet to receive treatment suggesting challenges in access. We aimed to review the registration and reimbursement (government subsidised or free access) of HCV panogenotypic DAAs globally.

Methods: From November 2021 to December 2022, information was extracted from health regulatory and reimbursement websites and documents with the assistance of a newly formed multidisciplinary, international network of 155 HCV and HIV experts. Regulatory status was reviewed for: sofosbuvir-velapatsvir, sofosbuvir-velapatsvir-voxilaprevir, glecaprevir-pibrentasvir, and sofosbuvir-daclatasvir. We assessed whether there were any reimbursement restrictions based on: prescriber type (specialist-only), liver fibrosis stage, drug or alcohol use, and HCV retreatment.

Results: Of 209 countries, information was available for 159 (76%) countries. 144 (91%) countries registered at least one pangenotypic DAA and 105 (66%) countries reimbursed at least one panogenotypic DAA. Among countries that provide DAA therapy reimbursement (n=105), 62 (59%) countries had listed prescriber-type restrictions, three (3%) had liver disease stage restrictions, seven (7%) had illicit drug use restrictions, three (3%) had alcohol use restrictions and eight (8%) had retreatment restrictions. Some regions had considerably greater DAA access than others. For example, of countries with available information, 100% (18/18) in Eastern Europe and 96% (27/28) in Western Europe had reimbursed DAAs compared to 50% (2/4) in Central Asia, 25% (9/36) in sub-Saharan Africa, and none (0/2) in Pacific Island States.

Conclusion: While the price of DAAs has decreased, global access remains uneven. Low-and-middle income countries had comparatively limited DAA access. To meet WHO goals for HCV elimination, our findings suggest that more countries should register DAAs, remove reimbursement restrictions (particularly prescriber-type restrictions), and decentralise and task shift HCV care to non-specialised settings to assure universal access.

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