WHO announces lenacapavir as a groundbreaking HIV prevention method
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The World Health Organization (WHO) announced a landmark policy at the 13th International AIDS Society Conference (IAS 2025) on HIV Science in Kigali, Rwanda, releasing new guidelines that recommend injectable lenacapavir (LEN) as a twice-yearly pre-exposure prophylaxis (PrEP) option for HIV prevention.
This development has the potential to significantly reshape the global HIV response.
LEN is the first twice-yearly injectable PrEP product, offering a highly effective, long-acting alternative to daily oral pills and shorter-acting prevention methods. With just two doses a year, LEN marks a transformative step in HIV prevention, particularly for individuals who face challenges with daily adherence, stigma, or limited access to health care.
'While an HIV vaccine remains elusive, lenacapavir is the next best thing: a long-acting antiretroviral shown in trials to prevent almost all HIV infections among those at risk," said Dr Tedros Adhanom Ghebreyesus, WHO Director-General.
'The launch of WHO's new guidelines, alongside the FDA's recent approval, marks a critical step forward in expanding access to this powerful tool. WHO is committed to working with countries and partners to ensure this innovation reaches communities as quickly and safely as possible.'
The new guidelines come at a pivotal time, as global HIV prevention efforts have stalled, with 1.3 million new infections recorded in 2024. Key and priority populations — including sex workers, men who have sex with men, transgender individuals, people who inject drugs, those in prisons, as well as children and adolescents — continue to be disproportionately affected.
WHO's endorsement of LEN marks a significant step toward broadening and diversifying HIV prevention strategies, empowering people with more choices to protect their health in ways that align with their needs and circumstances.
WHO has recommended a simpler, more accessible approach to HIV testing using rapid tests to support the rollout of long-acting injectable PrEP like LEN and CAB-LA. This change removes a major barrier by cutting out complex, expensive procedures and allowing delivery through local clinics, pharmacies, and tele-health.
LEN now joins other WHO-approved HIV prevention options — including daily oral PrEP, injectable cabotegravir, and the dapivirine vaginal ring. Although access to LEN outside clinical trials is still limited, WHO is calling on governments and health partners to begin implementing it within national HIV prevention programmes while gathering data on its real-world use and impact.
For the first time, WHO now recommends long-acting injectable cabotegravir and rilpivirine (CAB/RPV) as an option for adults and adolescents who are already virally suppressed on oral antiretroviral therapy (ART) and don't have hepatitis B. This is especially helpful for people who struggle with daily pill-taking.
WHO also updated its guidance on integrating HIV care with other health services, such as treating high blood pressure, diabetes, mental health conditions (like depression, anxiety, and alcohol use disorders), and improving ART adherence. The organisation now recommends STI screening (gonorrhoea and chlamydia) for key and priority populations, even when no symptoms are present.
For people living with HIV who have or are at risk of mpox (formerly monkeypox), WHO strongly recommends starting ART quickly, especially if they've never started treatment or have had long interruptions. HIV and syphilis testing is also advised for anyone with suspected or confirmed mpox.
Given funding challenges facing global HIV programmes, WHO released new guidance to help countries maintain essential HIV services. This includes advice on how to prioritise services, manage risks, and keep health systems resilient.
Dr Meg Doherty, WHO's HIV programme director, emphasised the urgency of acting on these guidelines: 'We have the tools and the knowledge to end AIDS as a public health problem. What we need now is bold implementation of these recommendations, grounded in equity and powered by communities.'
HIV continues to be a major public health issue, with an estimated 40.8 million people living with the virus globally by the end of 2024. While treatment access is growing — 31.6 million people are now on ART — new infections and deaths remain high, particularly in the WHO African Region.
With these updated guidelines, WHO said it is offering countries practical tools to make HIV responses more efficient, equitable, and sustainable.
The focus now shifts to putting these strategies into action.
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The Global Fund's offer, however, is a way to get branded, 'bridging' doses from Gilead to South Africa while the world waits for cheaper generics to become available around 2027. 'We now stand at a moment of reckoning and a moment of choice,' Mitchell Warren, the executive director of the international advocacy organisation, Avac, told Bhekisisa at the 13th conference on HIV science in Kigali this week. 'While a lot of the choices over the last six months have been made by an American politician [Donald Trump] who doesn't care about the pandemic or science generally, our choice is to make decisions based on the science that we all now know. Which is that lenacapavir is our most potent opportunity.' Countries have to budget just under R600 per dose Jamaloodien, however, cautions further discussions with the Global Fund and Gilead will be needed about the governance around the pricing of the product. 'We have a transparent pricing system, guided by the Public Finance Management Act. Even if we procure medicine with Global Fund money, we have to follow the same rules that the Treasury requires us to follow with tenders, which includes revealing the price at which the medicine is bought,' Jamaloodien says. In a Global Fund letter sent in early July to the nine early roll-out countries (South Africa, Zimbabwe, Eswatini, Lesotho, Zambia, Mozambique, Kenya, Uganda and Nigeria) the fund asked the governments to budget for $60 (about R1,076) per patient per year ($30, or R576, per six-monthly dose), to buy lenacapavir. But in the document, which Bhekisisa has seen, the fund makes it clear that the amount 'reflects the country contribution only, to be used for budgeting purposes, and should not be considered the product price'. Jamaloodien has confirmed to Bhekisisa that the Health Department did receive such a letter. The letter also says that the gap between the price that the fund pays Gilead per patient per year and the $60 that countries will pay for with their Global Fund grants, will be covered by private sector funding, which Hui Yang, the fund's head of supply operations, confirmed to Bhekisisa will be paid for by a $150-million (about R2.68-billion) donation of the UK-based Children's Investment Fund Foundation to the Global Fund. Furthermore, says Jamaloodien, South Africa's letter instructs the country to submit its first order, for planning purposes, by 30 September under an 'agreed procurement mechanism'. Why does Gilead not want to talk about LEN's price? Lenacapavir, also referred to as LEN, was registered for HIV prevention – also called PrEP – by the US medicines regulator, the Food and Drug Administration, on 18 June and is sold in that country for $28,218 (about R505,269) per person per year under the trade name Yeztugo. The US is the only country in which LEN has been registered so far as PrEP. For low- and middle-income countries such as South Africa, Gilead, however, said it will have a 'not-for-profit' price such as the one they negotiated with the Global Fund, but isn't allowing the fund to make it public. Several scientists and activists at the HIV science conference have, however, told Bhekisisa the rumoured not-for-profit price that Gilead has negotiated with the fund is $100 per person per year, and Avac confirms it in its analysis of events. But neither Gilead or the Global Fund have confirmed this amount. If South Africa budgets for $60 per person per year, the $29.2-million that the Global Fund says we can use to buy lenacapavir translates to putting and keeping about 400,000 people on the medicine over three years (Global Fund grants run for three years at a time). Gilead argues that, because the not-for-profit price is based on the actual cost of making lenacapavir, and shipping it to countries, it can't declare that cost. 'Gilead doesn't publicly disclose manufacturing costs for any of our medications,' Caroline Almeida, Gilead's head of public affairs, told Bhekisisa in Kigali. But activists don't buy this argument. 'Gilead's secrecy will obstruct civil society activism for lower drug prices and keep prices high in middle-income countries [such as South Africa] where Gilead negotiates prices directly,' the Health Justice Initiative and other activist groups said last week. Avac has identified 16 top lenacapavir markets, of which South Africa is, by far, the largest because of the country's high number of new HIV infections. The country's 170,000 new infections in 2024 is 13% of the 1.3 million new HIV infections around the world in 2024. And research released by Wits RHI on Tuesday in Kigali shows South Africans are open to using the jab: 56% of just more than 1,700 participants in a survey in Tshwane, Mthatha and Gqeberha, who were already using public sector HIV prevention services, said they would take a lenacapavir shot. But for LEN to be affordable, activists argue, Gilead needs to be open about its price. 'Such secrecy undermines the power of buyers to negotiate affordable prices and violates the human rights of all people to access information and lifesaving tools,' activists said in last week's press release. Warren concludes: 'Pricing transparency has been a long-standing challenge, as companies try to balance their commercial pricing and marketing strategies with their global public health strategies. We clearly need a new model or compact for pricing that helps break the cycle of small thinking and limited impact.' DM
