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Efficient regulatory approval of two novel HIV prevention interventions in a resource-limited setting: experiences from Zimbabwe

The global burden of HIV remains unacceptably high despite significant progress made in HIV treatment and prevention. There is an urgent need to scale up the comprehensive HIV prevention strategies that include pre-exposure prophylaxis (PrEP). Oral PrEP is highly effective in preventing HIV acquisit...

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Autores principales: Murombedzi, Caroline, Chirinda, Libert, Chareka, Gift T., Chirenje, Z. Mike, Mgodi, Nyaradzo M.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Frontiers Media S.A. 2023
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10682080/
https://www.ncbi.nlm.nih.gov/pubmed/38034413
http://dx.doi.org/10.3389/frph.2023.1279124
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author Murombedzi, Caroline
Chirinda, Libert
Chareka, Gift T.
Chirenje, Z. Mike
Mgodi, Nyaradzo M.
author_facet Murombedzi, Caroline
Chirinda, Libert
Chareka, Gift T.
Chirenje, Z. Mike
Mgodi, Nyaradzo M.
author_sort Murombedzi, Caroline
collection PubMed
description The global burden of HIV remains unacceptably high despite significant progress made in HIV treatment and prevention. There is an urgent need to scale up the comprehensive HIV prevention strategies that include pre-exposure prophylaxis (PrEP). Oral PrEP is highly effective in preventing HIV acquisition when taken regularly, but this remains a challenge for some at-risk individuals. Therefore, there is a need for other HIV prevention options. The dapivirine vaginal ring (DVR) and long-acting injectable cabotegravir (CAB-LA) are novel biomedical interventions that are safe and efficacious for HIV pre-exposure prophylaxis, as demonstrated in recently completed clinical trials. Timely roll-out and scalability of efficacious interventions depend on the registration process with the national medicine regulatory authorities (NMRAs). The Medicines Control Authority of Zimbabwe (MCAZ) was the first NMRA globally to approve the DVR in July 2021 and the first in Africa to approve CAB-LA for HIV prevention in July 2022. The regulatory review process for DVR and CAB-LA by MCAZ took 4.5 and 5.5 months, respectively. This efficient review process of the two interventions by MCAZ, a regulatory body in a resource-limited setting, provides important lessons to shorten timelines between the completion of the clinical development process and the registration of essential medicines.
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spelling pubmed-106820802023-11-30 Efficient regulatory approval of two novel HIV prevention interventions in a resource-limited setting: experiences from Zimbabwe Murombedzi, Caroline Chirinda, Libert Chareka, Gift T. Chirenje, Z. Mike Mgodi, Nyaradzo M. Front Reprod Health Reproductive Health The global burden of HIV remains unacceptably high despite significant progress made in HIV treatment and prevention. There is an urgent need to scale up the comprehensive HIV prevention strategies that include pre-exposure prophylaxis (PrEP). Oral PrEP is highly effective in preventing HIV acquisition when taken regularly, but this remains a challenge for some at-risk individuals. Therefore, there is a need for other HIV prevention options. The dapivirine vaginal ring (DVR) and long-acting injectable cabotegravir (CAB-LA) are novel biomedical interventions that are safe and efficacious for HIV pre-exposure prophylaxis, as demonstrated in recently completed clinical trials. Timely roll-out and scalability of efficacious interventions depend on the registration process with the national medicine regulatory authorities (NMRAs). The Medicines Control Authority of Zimbabwe (MCAZ) was the first NMRA globally to approve the DVR in July 2021 and the first in Africa to approve CAB-LA for HIV prevention in July 2022. The regulatory review process for DVR and CAB-LA by MCAZ took 4.5 and 5.5 months, respectively. This efficient review process of the two interventions by MCAZ, a regulatory body in a resource-limited setting, provides important lessons to shorten timelines between the completion of the clinical development process and the registration of essential medicines. Frontiers Media S.A. 2023-11-14 /pmc/articles/PMC10682080/ /pubmed/38034413 http://dx.doi.org/10.3389/frph.2023.1279124 Text en © 2023 Murombedzi, Chirinda, Chareka, Chirenje and Mgodi. https://creativecommons.org/licenses/by/4.0/This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY) (https://creativecommons.org/licenses/by/4.0/) . The use, distribution or reproduction in other forums is permitted, provided the original author(s) and the copyright owner(s) are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.
spellingShingle Reproductive Health
Murombedzi, Caroline
Chirinda, Libert
Chareka, Gift T.
Chirenje, Z. Mike
Mgodi, Nyaradzo M.
Efficient regulatory approval of two novel HIV prevention interventions in a resource-limited setting: experiences from Zimbabwe
title Efficient regulatory approval of two novel HIV prevention interventions in a resource-limited setting: experiences from Zimbabwe
title_full Efficient regulatory approval of two novel HIV prevention interventions in a resource-limited setting: experiences from Zimbabwe
title_fullStr Efficient regulatory approval of two novel HIV prevention interventions in a resource-limited setting: experiences from Zimbabwe
title_full_unstemmed Efficient regulatory approval of two novel HIV prevention interventions in a resource-limited setting: experiences from Zimbabwe
title_short Efficient regulatory approval of two novel HIV prevention interventions in a resource-limited setting: experiences from Zimbabwe
title_sort efficient regulatory approval of two novel hiv prevention interventions in a resource-limited setting: experiences from zimbabwe
topic Reproductive Health
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10682080/
https://www.ncbi.nlm.nih.gov/pubmed/38034413
http://dx.doi.org/10.3389/frph.2023.1279124
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