WHO recommends twice-yearly lenacapavir injection for HIV prevention

The World Health Organization (WHO) formally recommended twice-yearly injectable lenacapavir (LEN) for HIV prevention on 14 July 2025. Issued during the 13th International AIDS Society Conference in Kigali, Rwanda, the guideline positions the drug as a critical addition to the global arsenal against HIV, alongside daily oral pre-exposure prophylaxis (PrEP), the dapivirine vaginal ring, and injectable cabotegravir (CAB-LA).

Administered as two injections into the abdomen per year, lenacapavir provides an alternative for individuals who struggle with the adherence requirements of daily medication or face stigma associated with carrying pill bottles. While clinical trials showed the drug to be highly effective at preventing transmission among high-risk populations, its rollout remains the subject of intense debate regarding global equity, pricing, and infrastructure.

Implementation and Early Adoption

As of 14 April 2026, the Global Fund and the United States have scaled up a joint commitment to provide lenacapavir to 3 million people through 2028. Early distribution has already reached nine African nations: Eswatini, Kenya, Lesotho, Mozambique, Nigeria, South Africa, Uganda, Zambia, and Zimbabwe. According to the Global Fund, early program data show strong uptake among adolescent girls, young women, and pregnant or breastfeeding individuals.

To support broader access, the Global Fund has extended introduction support to 12 additional countries, including Fiji, Haiti, Indonesia, and Thailand. Despite this, the rollout faces logistical hurdles. Experts warn that the effectiveness of the drug depends on robust healthcare systems capable of ensuring patients return for their semi-annual doses—a challenge complicated by reported cuts to public health agencies and international HIV funding in the United States.

The Debate Over Access and Ethics

The manufacturer, Gilead Sciences, has faced significant criticism from organizations like Médecins Sans Frontières (MSF) and Public Citizen regarding its allocation strategies. Gilead currently sells lenacapavir for HIV treatment under the brand name Sunlenca, while the prevention product is branded as Yeztugo. In the United States, the list price is set at $28,218 per person per year. While Gilead has signed licensing agreements with six generic manufacturers to produce lower-cost versions for 120 countries, these generic options are not expected until 2027.

Critics point to a disparity in access for middle-income countries, including several in Latin America that hosted clinical trials for the drug but remain largely excluded from the current low-cost licensing agreements. Furthermore, MSF has expressed frustration over Gilead’s refusal to sell the drug directly to the organization outside of the Global Fund’s capped allocation. In response, Gilead maintains that it is committed to broad, sustainable access in resource-limited settings and is providing doses at no profit until generic versions become available.

Broader Context

The introduction of lenacapavir comes at a time when global HIV prevention progress has plateaued. An estimated 1.3 million new HIV infections occurred in 2024, and the global funding landscape remains volatile. In conjunction with the new guidelines, the WHO has issued updated operational frameworks to help countries integrate HIV services with mental health care, diabetes and hypertension management, and STI screening.

As the international community moves toward 2027, the focus remains on accelerating the arrival of generic production. Researchers and activists alike emphasize that scientific innovation, such as the high efficacy of lenacapavir, is only effective when paired with the infrastructure to deliver it to the most vulnerable. As Peter Mugyenyi, an HIV/AIDS researcher, observed, the challenge remains ensuring that the tools are physically available where the disease burden is highest.