Kigali, Rwanda: Doctors Without Borders/Médecins Sans Frontières (MSF) welcomes the release of the World Health Organization’s (WHO) HIV prevention guidelines for lenacapavir at the International AIDS Society Conference in Kigali, Rwanda. Lenacapavir has the potential to transform the HIV prevention landscape.
Current medical HIV prevention options include oral pre-exposure prophylaxis (PrEP), the dapivirine vaginal ring and cabotegravir (an injection every two months). Oral PrEP, requiring frequent pill-taking, can be difficult to adhere to, potentially leading to poor effectiveness. Lenacapavir, on the other hand, requiring only twice-yearly injections, has been proven to be 100% effective in preventing HIV infection among cisgender women and girls, and reduced HIV risk by 96% in a gender-diverse group including cis- and transgender men and non-binary individuals, making it at least 89% more effective than daily oral medicine. The release of the WHO guidelines, ‘Lenacapavir for HIV prevention and testing strategies for long-acting injectable pre-exposure prophylaxis’, therefore offers a path towards an HIV-free world at this critical period for global health.
MSF is already supporting the rollout of long-acting cabotegravir (CAB-LA) for PrEP in Eswatini, Malawi, Mozambique, and Zimbabwe, and offers other forms of PrEP (oral and ring) and broader HIV prevention strategies in many regions, including in countries in Africa and Latin America. Expanding the range of available tools, such as by including lenacapavir, is a key priority however, as individual choice and agency are central tenets of HIV prevention, ones by which MSF operates.
However, the current patent licensing agreement signed by lenacapavir’s developer, Gilead Sciences (Gilead), includes restrictive conditions that hinders access to generic lenacapavir in countries excluded from the license. These conditions further restrict the scope of generic competition at the global level and limit broader access to more affordable generic options of this groundbreaking tool.
While MSF welcomes the recent strategic partnership agreement between Gilead and the Global Fund to Fight AIDS, TB and Malaria (the Global Fund), the agreed pricing and supply needs to be transparent to facilitate negotiations for affordable sustainable access to this critical HIV prevention tool outside of the Global Fund agreement.
Recent studies have shown that with sufficient demand and additional competition, generic versions of lenacapavir could be produced at about US$40 a year, which is comparable to current prices for oral PrEP. Gilead has not made price information for LMICs publicly available. The price offered in the US market is US$42,250 per year for treatment and $28,218 for PrEP. Global health funding cuts, massively impacting on HIV prevention services for key populations and vulnerable communities, threaten the ability of programmes to buy lenacapavir.
While the Global Fund has a stated aim of reaching 2 million people with lenacapavir, this would represent only a fraction of the missed UNAIDS target of 21 million by 2025, and the organisation is itself facing major funding shortfalls. Funding gaps, the removal of restrictive licensing conditions and facilitating generic competition must all be addressed to ensure larger communities can be reached with lenacapavir. This would subsequently drive down the price of the drug and allow for its greatest possible use.
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Related:
- advanced HIV
- HIV
- HIV prevention
- HIV/AIDS
