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Direct-acting antiviral therapies for hepatitis C infection: global registration, reimbursement, and restrictions |
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Lancet Gastroenterol Hepatol. 2024 Feb 14:S2468-1253(23)00335-7.doi: 10.1016/S2468-1253(23)00335-7. Online ahead of print.
Alison D Marshall 1, Alex R Willing 2, Abe Kairouz 2, Evan B Cunningham 2, Alice Wheeler 2, Nicholas O'Brien 3, Vidura Perera 3, John W Ward 4, Lindsey Hiebert 4, Louisa Degenhardt 5, Behzad Hajarizadeh 2, Samantha Colledge 6, Matthew Hickman 7, Danielle Jawad 8, Jeffrey V Lazarus 9, Gail V Matthews 10, Andrew Scheibe 11, Peter Vickerman 7, Gregory J Dore 2, Jason Grebely 2; Global HCV and HIV Treatment Restrictions Group
Collaborators
Global HCV and HIV Treatment Restrictions Group:
N Sargsyants, L Suleymanova, N Salkic, M Simonova, T Nemeth-Blazic, V Mravcik, K Kivimets, R Salupere, M Butsashvili, G Soselia, M Makara, I Tolmane, L Jancoriene, S Stratulat, R Flisiak, L Gheorghe, R Cernat, A Lakhov, O Stanevich, P Jarcuska, M Peck-Radosavljevic, G Robaeys, A Øvrehus, G Foster, J Sutinen, M Farkkila, H Rautiainen, S Vuoti, D Nikolova, J M Pawlotsky, J Rockstroh, V Sypsa, G Papatheodoridis, S Olafsson, E Feeney, E Teti, C Seguin-Devaux, J Pocock, S Reiff, N McDougall, M Van der Valk, O Dalgard, R Tato Marinho, J Dillon, E Peters, K Bojovic, M Maticic, M Kåberg, P Bruggmann, B Healy, V H Chong, S Yi, J Tucker, L R Pasaribu, J Tanaka, E A Ashley, M R Abu Hassan, N S Mohammed, H K Chan, S Gidaagaya, K P Kyi, K Hyung Joon, B Chin, P C Baladjay, J H Kao, T Wansom, B da Cruz, B Flower, E Ehsan, M Al Mahtab, L Khandu, A S Bhadoria, M Alavi, P Kc, S Hamid, S Biryukov, D Alymbaeva, A Alaei, S Bakieva, D Flichman, R F Carmo, E Valdez, C P Cortes, F Contreras, E Teran, P Velez-Moller, T Jagnarine, M Mills, D Goodman-Meza, J Sánchez, J J Montenegro-Idrogo, A M Lugo Canales, J Davy, A Alexander, S Gerona, R Perazzo, D Balak, A Kelly-Hanku, A Fineanganofo, E Gane, N Raymond, N Debzi, K Sridharan, I Waked, D Turner, O Shibolet, A Al Muzaini, M El Nakib, D S Sheriff, T Brahni, T Essayagh, S Essayagh, D Hjaija, K Al-Naamani, F M Sanai, H Pasquale, S Bedri, M Chakroun, A Ghrabi, U S Akarca, V Falcao, S Edmond Gbedo, S Ouoba, F Nyabenda, M Rocher Mbella, A Mahamat Moussa, T Youssouf, Y Boniface, T Akilimali Shindano, M E Hamida, A Mongo, C Mapapa, H Desalegn, E L A Embinga, G Ndow, Y Nartey, M Cisse, M A Djalo, M Mugambi, M Nyakowa, M K Jeuronlon, J Ngoma, R Manitrala Ramanampamonjy, K Naik, M D Soyjaudah, E Filipe, E Nnakelu, J Serumondo, M Mbodj, M Patino, M K Aalto, P Waweru, A Dagnra, P Ocama, A Maghimbi, B M Hamooya, L Katsidzira, C Rios, M Thormann, N Al Marzooqi,
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Author information
1Viral Hepatitis Clinical Research Program, The Kirby Institute, University of New South Wales, Sydney, NSW, Australia; Centre for Social Research in Health, University of New South Wales, Sydney, NSW, Australia. Electronic address: amarshall@kirby.unsw.edu.au.
2Viral Hepatitis Clinical Research Program, The Kirby Institute, University of New South Wales, Sydney, NSW, Australia.
3Macquarie University, Sydney, NSW, Australia.
4Coalition for Global Hepatitis Elimination, Task Force for Global Health, Decatur, GA, USA.
5National Drug and Alcohol Research Centre, University of New South Wales, Sydney, NSW, Australia.
6National Drug Research Institute, Curtin University, Perth, WA, Australia.
7Population Health Sciences, Bristol Medical School, University of Bristol, Bristol, UK.
8Sydney School of Public Health, Faculty of Medicine and Health, The University of Sydney, Sydney, NSW, Australia.
9Barcelona Institute for Global Health (IS Global), Hospital Clinic, University of Barcelona, Barcelona, Spain; CUNY Graduate School of Public Health and Health Policy, New York, NY, USA.
10Therapeutic and Vaccine Research Program, The Kirby Institute, University of New South Wales, Sydney, NSW, Australia; St Vincent's Hospital, Darlinghurst, Sydney, NSW, Australia.
11TB HIV Care, Cape Town, South Africa; Community Orientated, Primary Care Research Unit, Department of Family Medicine, University of Pretoria, Pretoria, South Africa.
Abstract
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.
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