July 2024- 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 subcutaneous injection that inhibits the HIV-1 capsid and is administered twice a year for HIV prevention. The PURPOSE 1 study showed zero new infections among those taking LEN.
Women in countries conducting the PURPOSE 1 trial, as well as across East and southern Africa, continue to experience high HIV incidence. Women need additional effective and acceptable HIV prevention choices, including PrEP options.
LEN has the potential to further increase the range of effective and acceptable prevention choices available to women, overcome challenges including those related to effective use of oral tablets and improve uptake and use of prevention.
While WHO is excited by these results, there remain several important issues to address, including safety of LEN in pregnancy and breastfeeding, best approaches for HIV testing to confirm infection, potential drug resistance, safety and effectiveness among groups not included in PURPOSE 1, and the real-world implementation of LEN.
Also Read: Youth and the Future of HIV
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.
