Securing accelerated access to long‐acting injectable cabotegravir for HIV prevention in low‐ and middle‐income countries
Abstract Introduction Reductions in HIV acquisition have slowed, and the global community is significantly off track from global goals. Oral pre‐exposure prophylaxis (PrEP) alone cannot address the diverse needs of the millions of people at risk of HIV acquisition. Long‐acting injectable cabotegravi...
| Main Authors: | , , , , , , |
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| Format: | Article |
| Language: | English |
| Published: |
Wiley
2023-07-01
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| Series: | Journal of the International AIDS Society |
| Subjects: | |
| Online Access: | https://doi.org/10.1002/jia2.26101 |
| _version_ | 1797781802983620608 |
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| author | Sarah Y. Jenkins Danielle Resar Zachary Panos Alan Staple Melynda Watkins David Ripin Carolyn Amole |
| author_facet | Sarah Y. Jenkins Danielle Resar Zachary Panos Alan Staple Melynda Watkins David Ripin Carolyn Amole |
| author_sort | Sarah Y. Jenkins |
| collection | DOAJ |
| description | Abstract Introduction Reductions in HIV acquisition have slowed, and the global community is significantly off track from global goals. Oral pre‐exposure prophylaxis (PrEP) alone cannot address the diverse needs of the millions of people at risk of HIV acquisition. Long‐acting injectable cabotegravir (CAB‐LA) received United States Food and Drug Administration approval for HIV prevention in December 2021. When studied, CAB‐LA demonstrated high effectiveness, provides months of protection versus daily use, is preferred by some users and has the potential to achieve commodity cost reduction. These factors position CAB‐LA to catalyse transformation in HIV prevention. Significant work must be undertaken to ensure at‐scale uptake in low‐ and middle‐income countries. Leveraging decades of product introduction experience, Clinton Health Access Initiative (CHAI) has developed an innovative roadmap to support equitable CAB‐LA introduction, comprising tightly executed market‐shaping, product development, regulatory, and programmatic and implementation action. Discussion Proven models exist (e.g. long‐acting reversible contraceptives, paediatric tuberculosis treatment and antiretrovirals (ARVs), such as paediatric dolutegravir and tenofovir disoproxil fumarate, lamivudine, and dolutegravir) for partnership‐driven, accelerated, impactful product introduction. Based on learnings from these models and needs in the prevention space, CHAI developed a roadmap to maximize the near‐term impact of CAB‐LA and accelerate the development of, access to and impact of quality‐assured, low‐cost generic CAB‐LA. This roadmap is intended to inform introduction planning and investment decision‐making across a range of stakeholders, including donors, governments, manufacturers and other partners working in the HIV prevention space. Elements include (1) ensuring coordination and alignment across partners, and avoiding redundancy experienced during oral PrEP introduction; (2) preparing national programmes and providing support to maximize impact, including the development of national policies, guidelines and introduction plans; system strengthening; quantification and procurement; and addressing evidence needs, among other areas; (3) supporting community engagement, ensuring that demand generation and delivery approaches are person‐centred and community‐led; (4) incentivizing generic product development through, for example, milestone‐based commercialization incentives and product development cost‐sharing; and (5) expediting regulatory reviews. Conclusions Accelerating access to affordable, generic CAB‐LA can transform progress towards HIV epidemic control. This vision of impact at scale in prevention is achievable, if informed by results‐backed approaches to introduction. |
| first_indexed | 2024-03-13T00:02:07Z |
| format | Article |
| id | doaj.art-a33f71023518450db51a82f1e233c6d0 |
| institution | Directory Open Access Journal |
| issn | 1758-2652 |
| language | English |
| last_indexed | 2024-03-13T00:02:07Z |
| publishDate | 2023-07-01 |
| publisher | Wiley |
| record_format | Article |
| series | Journal of the International AIDS Society |
| spelling | doaj.art-a33f71023518450db51a82f1e233c6d02023-07-13T09:32:37ZengWileyJournal of the International AIDS Society1758-26522023-07-0126S2n/an/a10.1002/jia2.26101Securing accelerated access to long‐acting injectable cabotegravir for HIV prevention in low‐ and middle‐income countriesSarah Y. Jenkins0Danielle Resar1Zachary Panos2Alan Staple3Melynda Watkins4David Ripin5Carolyn Amole6Clinton Health Access Initiative Boston Massachusetts USAClinton Health Access Initiative Boston Massachusetts USAClinton Health Access Initiative Boston Massachusetts USAClinton Health Access Initiative Boston Massachusetts USAClinton Health Access Initiative Boston Massachusetts USAClinton Health Access Initiative Boston Massachusetts USAClinton Health Access Initiative Boston Massachusetts USAAbstract Introduction Reductions in HIV acquisition have slowed, and the global community is significantly off track from global goals. Oral pre‐exposure prophylaxis (PrEP) alone cannot address the diverse needs of the millions of people at risk of HIV acquisition. Long‐acting injectable cabotegravir (CAB‐LA) received United States Food and Drug Administration approval for HIV prevention in December 2021. When studied, CAB‐LA demonstrated high effectiveness, provides months of protection versus daily use, is preferred by some users and has the potential to achieve commodity cost reduction. These factors position CAB‐LA to catalyse transformation in HIV prevention. Significant work must be undertaken to ensure at‐scale uptake in low‐ and middle‐income countries. Leveraging decades of product introduction experience, Clinton Health Access Initiative (CHAI) has developed an innovative roadmap to support equitable CAB‐LA introduction, comprising tightly executed market‐shaping, product development, regulatory, and programmatic and implementation action. Discussion Proven models exist (e.g. long‐acting reversible contraceptives, paediatric tuberculosis treatment and antiretrovirals (ARVs), such as paediatric dolutegravir and tenofovir disoproxil fumarate, lamivudine, and dolutegravir) for partnership‐driven, accelerated, impactful product introduction. Based on learnings from these models and needs in the prevention space, CHAI developed a roadmap to maximize the near‐term impact of CAB‐LA and accelerate the development of, access to and impact of quality‐assured, low‐cost generic CAB‐LA. This roadmap is intended to inform introduction planning and investment decision‐making across a range of stakeholders, including donors, governments, manufacturers and other partners working in the HIV prevention space. Elements include (1) ensuring coordination and alignment across partners, and avoiding redundancy experienced during oral PrEP introduction; (2) preparing national programmes and providing support to maximize impact, including the development of national policies, guidelines and introduction plans; system strengthening; quantification and procurement; and addressing evidence needs, among other areas; (3) supporting community engagement, ensuring that demand generation and delivery approaches are person‐centred and community‐led; (4) incentivizing generic product development through, for example, milestone‐based commercialization incentives and product development cost‐sharing; and (5) expediting regulatory reviews. Conclusions Accelerating access to affordable, generic CAB‐LA can transform progress towards HIV epidemic control. This vision of impact at scale in prevention is achievable, if informed by results‐backed approaches to introduction.https://doi.org/10.1002/jia2.26101cabotegravirlong‐actingHIV preventionaccessLMICsPrEP |
| spellingShingle | Sarah Y. Jenkins Danielle Resar Zachary Panos Alan Staple Melynda Watkins David Ripin Carolyn Amole Securing accelerated access to long‐acting injectable cabotegravir for HIV prevention in low‐ and middle‐income countries Journal of the International AIDS Society cabotegravir long‐acting HIV prevention access LMICs PrEP |
| title | Securing accelerated access to long‐acting injectable cabotegravir for HIV prevention in low‐ and middle‐income countries |
| title_full | Securing accelerated access to long‐acting injectable cabotegravir for HIV prevention in low‐ and middle‐income countries |
| title_fullStr | Securing accelerated access to long‐acting injectable cabotegravir for HIV prevention in low‐ and middle‐income countries |
| title_full_unstemmed | Securing accelerated access to long‐acting injectable cabotegravir for HIV prevention in low‐ and middle‐income countries |
| title_short | Securing accelerated access to long‐acting injectable cabotegravir for HIV prevention in low‐ and middle‐income countries |
| title_sort | securing accelerated access to long acting injectable cabotegravir for hiv prevention in low and middle income countries |
| topic | cabotegravir long‐acting HIV prevention access LMICs PrEP |
| url | https://doi.org/10.1002/jia2.26101 |
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