Lenacapavir: WHO Recommends New Drug to Prevent HIV

MEXICO CITY (apro).— The World Health Organization (WHO) has recommended the use of Lenacapavir, a long-acting injectable antiretroviral drug, as an additional option for the prevention of the Human Immunodeficiency Virus (HIV). This endorsement was announced on July 14, 2025, at the 13th International AIDS Society Conference (IAS 2025) in Kigali.

Administered via a subcutaneous injection every six months, Lenacapavir offers an alternative to existing pre-exposure prophylaxis (PrEP) methods, such as daily oral pills. This WHO recommendation is based on clinical trial evidence demonstrating the drug’s high effectiveness in reducing the risk of HIV acquisition.

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WHO Director-General, Tedros Adhanom Ghebreyesus, stated in a press release that while an HIV vaccine remains elusive, “lenacapavir is the best alternative.” This step is considered a significant advancement in expanding the tools available for the global response to the epidemic.

How Does Lenacapavir Work and Its Efficacy?

Lenacapavir is a first-of-its-kind HIV capsid inhibitor, working by interfering with multiple stages of the virus’s lifecycle to prevent its replication. This sets it apart from other classes of currently approved antiretrovirals.

The results from large-scale clinical trials, known as PURPOSE, have been pivotal for this recommendation. PURPOSE 1, focused on cisgender women in Sub-Saharan Africa, reported a 100% efficacy rate as no HIV infections were recorded among participants who received Lenacapavir.

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Meanwhile, PURPOSE 2, which included cisgender men, transgender men and women, and non-binary individuals across various global regions, showed that Lenacapavir was superior to daily oral PrEP with emtricitabine/tenofovir disoproxil fumarate (F/TDF). In this study, 99.9% of participants in the Lenacapavir group did not acquire HIV.

A New Landscape for Prevention

In 2024, there were 1.3 million new HIV infections, disproportionately affecting key populations such as sex workers, men who have sex with men, transgender people, and people who inject drugs.

The option of a long-acting injectable can help overcome barriers such as adherence to daily treatment and the stigma associated with taking medications. The WHO has also simplified its HIV testing guidelines, advocating for the use of rapid tests to facilitate the initiation of injectable PrEP, which could allow for its administration in community settings like pharmacies and clinics.

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This new tool adds to other PrEP options recommended by WHO, including oral PrEP, long-acting injectable cabotegravir, and the dapivirine vaginal ring.

Access and Cost Are Critical

Prior to the WHO’s endorsement, the United States Food and Drug Administration (FDA) approved the use of Lenacapavir for HIV prevention in June 2025.

Organizations such as UNAIDS and Doctors Without Borders (MSF) have emphasized the importance of making the drug affordable and accessible globally. The initial list price in the United States has raised concerns about its availability in low- and middle-income countries.

In response, Gilead Sciences, the pharmaceutical company manufacturing the drug, has entered into an agreement with the Global Fund to Fight AIDS, Tuberculosis and Malaria to supply Lenacapavir at a non-profit rate in high-incidence, resource-limited countries. Additionally, it has signed voluntary licensing agreements with generic manufacturers to facilitate the production and distribution of more affordable versions in 120 countries.

Despite these efforts, some middle-income countries, including several in Latin America that participated in the clinical trials, are not covered by the initial agreements, posing a challenge for equitable access in these regions. The WHO has urged governments, donors, and partners to begin implementing Lenacapavir in national prevention programs, while continuing to gather data on its adoption and impact in clinical practice.