WHO approves injectable HIV drug lenacapavir for high-risk communities

The World Health Organization (WHO) has released updated guidelines to strengthen global HIV prevention efforts, recommending the use of lenacapavir — a newly approved, long-acting antiretroviral — for high-risk groups and in regions with high infection rates.

The recommendation was announced on 14 July at the 13th International AIDS Society Conference (IAS 2025) held in Kigali, Rwanda. It marks a milestone in HIV prevention, following the recent approval of lenacapavir by the United States Food and Drug Administration (FDA) as a twice-yearly injectable pre-exposure prophylaxis (PrEP) treatment.

Initially approved in 2022 for treating HIV, lenacapavir demonstrated strong efficacy in prevention trials, offering near-complete protection against infection. The drug has now become a central pillar of WHO’s revised prevention strategy.

What is Lenacapavir?

Lenacapavir (LEN) is a long-acting HIV medicine developed by New Delhi-based Gilead Sciences. It belongs to a new class of drugs known as capsid inhibitors, which work by disrupting multiple stages in the HIV replication cycle. Approved for treatment in 2022 and prevention in 2024, LEN is the first PrEP injection that can be administered just twice a year.

This long-acting injectable offers a powerful alternative to daily oral pills and other shorter-acting methods. With only two doses annually, LEN could be transformative, particularly for individuals facing challenges related to daily adherence, healthcare access, or stigma.

WHO supports LEN usage against AIDS

“While an HIV vaccine is still 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,” he said. He further reiterated WHO’s commitment to working with countries and partners to ensure this innovation reaches communities as quickly and safely as possible

WHO’s endorsement of LEN reflects a shift towards expanding and diversifying prevention tools in order to give individuals better choices.

Challenges ahead in HIV prevention

The updated guidelines come amid stagnation in global HIV prevention efforts, with an estimated 1.3 million new infections recorded in 2024. The impacted populations include sex workers, men who have sex with men, transgender people, injecting drug users, prisoners, children and adolescents.

Seeking simplified access through rapid testing

As part of the updated approach, WHO has also recommended a public health model that incorporates simplified HIV testing using rapid diagnostic kits. This will support broader access to long-acting injectable PrEP options such as lenacapavir and cabotegravir (CAB-LA). It will also facilitate community-based delivery via pharmacies, clinics and telehealth platforms.

Funding concerns as Trump cuts aid

The release of these guidelines coincides with growing concern over declining international aid for HIV programmes. According to the United Nations, around 80 per cent of prevention funding in low- and middle-income countries comes from foreign assistance.

In recent months, the United States has sharply reduced its support, including funding for the US Agency for International Development (USAID) and the President’s Emergency Plan for AIDS Relief (PEPFAR) — the largest commitment ever made by any nation towards tackling a single disease.

The impact of these cuts is already evident. In Nigeria, for instance, the number of people receiving PrEP dropped from roughly 40,000 late last year to fewer than 7,000 in April 2025, according to UNAIDS data.

A recent United Nations report warned that millions more could die of HIV-related causes by 2029 if current funding levels are not restored. Although 25 of 60 low- and middle-income countries surveyed intend to raise their domestic HIV budgets in the coming year, the report cautioned that these increases are unlikely to fully compensate for lost international support.

Gilead Science shows hope amid setbacks

In a promising development, Gilead Sciences announced an agreement with the Global Fund to Fight AIDS, Tuberculosis and Malaria to supply lenacapavir at cost, with no profit margin. This pricing model reflects only the cost of production and delivery, CNN reported.

In the United States — currently the only country where lenacapavir is approved for prevention — the drug carries an annual list price of $28,218, a figure comparable to existing PrEP treatments, according to the company.