Chance for HIV prevention administered once a year

• The drug lenacapavir has been approved by the European Medicines Agency (EMA) for sale in the EU for HIV pre-exposure prophylaxis
• It is currently the longest-acting form of PrEP available.
• Pre-exposure prophylaxis involves taking an antiretroviral drug by a person who is not infected with HIV but is at risk of infection.
• Recent progress has been enormous in the field of HIV prevention. In addition to the introduction of effective PrEP medications, new hopes for vaccines have emerged.

On August 26, 2025, lenacapavir, administered as a twice-yearly injection, was approved by the European Medicines Agency (EMA) for sale in the EU (as well as in Norway, Iceland, and Liechtenstein) for HIV pre-exposure prophylaxis. It is currently the longest-acting form of PrEP available.

In July 2025, WHO issued guidelines on the prophylactic use of lenacapavir.

Pre-exposure prophylaxis (PRP) involves taking an antiretroviral medication by an HIV-negative person at risk of infection. This is intended to prevent the development of HIV infection and further transmission of the virus. Until now, the longest-acting PrEP has been the antiviral drug cabotegravir, administered by injection once every eight weeks. Daily pills containing two antiviral drugs, emtricitabine and tenofovir, are also available.

A significant step towards ending the HIV epidemic

Experts believe that the approval of lenacapavir (sometimes incorrectly referred to in the media as a vaccine) for twice-yearly injections is a significant step toward halting the HIV epidemic. Annual injections would be an even more convenient form of PrEP, potentially leading to improved adherence and greater effectiveness.

Lenacapavir is an antiretroviral drug (HIV is a retrovirus) that targets several stages of the HIV-1 replication cycle, thereby inhibiting its multiplication in cells. In clinical trials—PURPOSE 1 and PURPOSE 2—the drug demonstrated efficacy of 100% and 99.9%, respectively. It was more effective than daily pill-based prophylaxis.

The ongoing PURPOSE-365 study will test whether annual administration of lenacapavir as part of PrEP is well-tolerated and safe. An earlier phase of the study, published in the Lancet in March 2025, showed promising results.

Recent progress has been enormous in the field of HIV prevention. In addition to the introduction of effective medications for PrEP, new hopes have emerged for vaccines that could protect against multiple strains of the virus. For decades, these vaccines have been elusive.

mRNA vaccines (based on the same technology as the mRNA vaccines for COVID-19) are currently being studied. Phase 1 studies indicate that this approach stimulates an early immune response to HIV and the production of broadly neutralizing antibodies (bNAbs).

According to infectious disease experts, the emergence of an effective HIV vaccine would further increase the chances of stopping the HIV/AIDS epidemic.

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