Biannual Injection Found to Be Completely Effective in Preventing HIV Infection: Study

A recent study has found that biannual injections of lenacapavir, a drug currently used to treat HIV, are highly effective in preventing infections among young women and adolescent girls in Africa. Data released by drugmaker Gilead and published in the New England Journal of Medicine revealed that lenacapavir demonstrated 100% efficacy in preventing HIV infections during a Phase 3 trial.

Traditionally, HIV prevention has relied on daily medications such as Truvada or bimonthly injections of Apretude. The introduction of lenacapavir, with its twice-yearly dosage, could revolutionize prevention methods, offering a new, highly effective option.

The PURPOSE 1 trial involved over 5,000 HIV-negative women and adolescent girls in South Africa and Uganda. Participants were randomly assigned to receive either lenacapavir injections every 26 weeks or daily HIV medications. In this double-blind study, none of the participants who received lenacapavir contracted HIV. These findings were also presented at the International AIDS Conference in Munich.

Linda-Gail Bekker, director of the Desmond Tutu HIV Center at the University of Cape Town, highlighted the significance of these results, stating, “These stellar results show that twice-yearly lenacapavir for PrEP, if approved, could offer a highly effective, tolerable, and discreet choice that could potentially improve PrEP uptake and persistence, helping us to reduce HIV in cisgender women globally.”

Although about 69% of those who received lenacapavir experienced reactions at the injection site compared to 35% in the placebo group, no significant safety concerns were reported. Over the 26-week trial period, 55 HIV infections were observed: zero in the lenacapavir group, 39 in the daily emtricitabine–tenofovir alafenamide group, and 16 in the daily emtricitabine–tenofovir disoproxil fumarate group.

While lenacapavir is not yet approved for HIV prevention anywhere in the world, it is approved by the US Food and Drug Administration (FDA) for treating HIV in adults, in combination with other antiretroviral medicines. The drug’s cost is estimated to be over $40,000 annually as a manufacturer’s list price, or around $39,000 annually as an average wholesale price. As lenacapavir continues to be studied for HIV prevention, questions about its cost and accessibility remain.