Kigali, Rwanda · 14 July 2025 — The World Health Organization (WHO) released new guidelines on Monday recommending the use of injectable lenacapavir (LEN) twice a year as an additional pre-exposure prophylaxis (PrEP) option for HIV prevention, in a landmark policy action announced at the 13th International AIDS Society Conference (IAS 2025) on HIV Science in Kigali, Rwanda.
LEN, the first twice-yearly injectable PrEP product, offers a highly effective, long-acting alternative to daily oral pills and other shorter-acting options. With just two doses per year, lenacapavir represents a significant shift in protecting people at risk of HIV — particularly those who face challenges with daily adherence, stigma, or access to health care.
A Transformative Prevention Tool
The recommendation was developed using WHO's rigorous guideline methodology, synthesizing clinical trial evidence from the PURPOSE trials, modeling studies, and implementation considerations. The PURPOSE 1 and PURPOSE 2 trials demonstrated lenacapavir's high efficacy for HIV prevention across diverse populations.
Dr Tedros Adhanom Ghebreyesus, WHO Director-General, framed the significance of the announcement:
"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. 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."
The U.S. Food and Drug Administration had approved lenacapavir for HIV prevention on 19 June 2025, paving the way for the WHO's global recommendation. The U.S. Centers for Disease Control and Prevention subsequently issued clinical guidance recommending injectable lenacapavir as a PrEP option for people who would benefit and who weigh at least 35 kg, administered every six months.
Simplified Testing: Removing a Major Barrier
A critical component of the new guidelines is WHO's recommendation for a public health approach to HIV testing. The guidelines recommend using HIV rapid diagnostic tests (RDTs) for people initiating or continuing any form of long-acting injectable PrEP, including both lenacapavir and cabotegravir (CAB-LA).
This simplified testing recommendation removes a major access barrier by eliminating complex, costly procedures and enabling community-based delivery of long-acting PrEP through pharmacies, clinics, and tele-health services. The approach is designed to expand access beyond traditional clinical settings, particularly in resource-limited contexts.
IAS 2025: Science Amid a Funding Crisis
The 13th IAS Conference on HIV Science, held from 13 to 17 July 2025 in Kigali, brought together approximately 4,000 delegates in person and virtually. The conference featured over 142 oral abstract presentations and more than 1,400 posters, sharing innovations from the African continent and globally.
The conference was defined by a stark contrast between significant scientific advancements and an urgent global funding crisis. Data presented at the conference highlighted the immediate consequences of reduced international funding, particularly shifts in U.S. global health aid:
| Impact Area | Finding |
|---|---|
| Mozambique and South Africa | Sharp declines in HIV testing, diagnoses, and ART initiations following funding withdrawals |
| Latin America and the Caribbean | 87% of surveyed organizations experienced funding suspensions; over 156,000 beneficiaries lost access to HIV services |
| Global new infections | 1.3 million in 2024, with disproportionate impact among key and priority populations |
The conference concluded with the release of the "Kigali Declaration," signed by scientists, advocates, and health leaders to reaffirm commitments to the HIV response.
Additional Guideline Updates
Beyond lenacapavir, WHO announced several other important updates at IAS 2025:
- Long-acting ART: For the first time, WHO's treatment guidelines include a recommendation for long-acting injectable cabotegravir and rilpivirine (CAB/RPV) as an alternative switching option for adults and adolescents who have achieved full viral suppression on oral ART and do not have active hepatitis B infection.
- Service integration: Updated guidelines recommend integrating HIV services with noncommunicable diseases such as hypertension and diabetes, as well as mental health care for depression, anxiety, and alcohol use disorders.
- STI management: New guidelines recommend screening for gonorrhoea and chlamydia in key and priority populations.
- Mpox and HIV: For people living with HIV who have mpox and are either ART naive or have experienced prolonged ART interruption, rapid initiation of ART is strongly recommended.
- Sustaining services: WHO issued operational guidance on sustaining priority HIV services in a changing funding landscape, providing a stepwise framework for countries to prioritize services, assess risks, and monitor disruptions.
The Access Challenge
While the WHO recommendation provides the normative framework, the organization highlighted the critical need for affordable pricing, transparent production costs, and regulatory approval at the country level to ensure equitable access. Several African countries already have access to lenacapavir through the Global Fund, but widespread rollout requires significant political and financial commitment.
Dr Meg Doherty, Director of WHO's Department of Global HIV, Hepatitis and STI Programmes, and incoming Director of Science, Research, Evidence and Quality for Health, stated:
"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."
A Growing Arsenal of Prevention Tools
Lenacapavir joins other WHO-recommended PrEP options as part of a growing toolkit to end the HIV epidemic:
- Daily oral PrEP — the original standard, available generically in many countries
- Injectable cabotegravir (CAB-LA) — bimonthly injectable PrEP
- Dapivirine vaginal ring — monthly user-controlled option
- Lenacapavir (LEN) — twice-yearly injectable, the longest-acting option
The diversification of PrEP modalities reflects a fundamental shift in HIV prevention philosophy: offering people choices that fit their lives, rather than a one-size-fits-all approach. Mathematical modeling cited in the WHO guidance suggests that widespread, scaled-up use of lenacapavir has the potential to significantly avert new HIV infections.
The International AIDS Society has directed its focus toward the 26th International AIDS Conference (AIDS 2026), scheduled to be held in Rio de Janeiro, Brazil.
Sources
- WHO, "WHO recommends injectable lenacapavir for HIV prevention," 14 July 2025 —
- WHO, "Guidelines on lenacapavir for HIV prevention and testing strategies for long-acting injectable pre-exposure prophylaxis," 2025 —
- WHO, "FDA approval of injectable lenacapavir marks progress for HIV prevention," 19 June 2025 —
- IAS, "13th IAS Conference on HIV Science," July 2025 —
- IAVI, "IAS 2025 Kigali: Reaffirms what it will take to keep HIV progress from sliding back," July 2025 —
- UNAIDS, HIV data and estimates, 2024 —
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