Long-acting injectable lenacapavir proves effective in HIV prevention for women

WHO welcomes the news that long-acting injectable lenacapavir as pre-exposure prophylaxis (PrEP) is highly effective in preventing HIV acquisition in women. This represents a significant breakthrough in HIV prevention.

The full results of the PURPOSE 1 trial, presented at the 25th International AIDS Conference, demonstrate the safety and efficacy of the long-acting injectable antiretroviral drug lenacapavir (LEN) for PrEP in HIV-negative cisgender women. LEN is a HIV-1 capsid inhibitor that is delivered by subcutaneous injection twice a year for HIV prevention. The PURPOSE 1 study showed zero new infections among those taking LEN.

Women in countries where the PURPOSE 1 trial was conducted, and across East and southern Africa, continue to experience high HIV incidence. Additional effective and acceptable HIV prevention choices for women are needed, including PrEP choices.

WHO is eagerly awaiting the results from PURPOSE 2, which is evaluating lenacapavir for PrEP among cisgender men, transgender men, transgender women and gender non-binary individuals. Having these data will allow WHO to convene experts, ministries, partners and communities to develop and issue guidelines and to prepare for stringent regulatory authorities (SRAs) and WHO pre-qualification.

WHO has recommended a range of options for women who could benefit from PrEP, including oral PrEP containing TDF (2015), the dapivirine ring (DVR) (2021) and long-acting cabotegravir (CAB-LA) (2022). WHO has also developed implementation tools to support safe, effective, and acceptable implementation of these products.