Early results from the Phase 3 PURPOSE 1 trial reveal that an injectable antiretroviral drug, administered twice a year, can effectively prevent HIV infection in cisgender women. Professor Thesla Palanee-Phillips, director of clinical trials at Wits RHI, hailed the findings as historic, saying this is the first HIV prevention trial ever to show zero HIV infections with an intervention.
The trial involved over 5,300 adolescent girls and young women across 25 sites in South Africa and three in Uganda. Sub-Saharan Africa, home to 25.6 million people living with HIV, sees women and girls constituting 77% of new infections among youth aged 15-24. The study compared the effectiveness of the injectable drug lenacapavir with two oral drugs, Descovy and Truvada, taken daily.
Gilead, the pharmaceutical company behind lenacapavir, plans to present more detailed data from PURPOSE 1 at a future conference. The company noted that lenacapavir and Descovy for HIV prevention in cisgender women are still investigational and not yet approved globally.
New antiretroviral will change the approach to HIV pre-exposure prophylaxis
Gilead expects results from PURPOSE 2, which includes expanded populations such as cisgender men who have sex with men, transgender men, and transgender women, by late this year or early 2025. Regulatory approval filings will include findings from both PURPOSE 1 and PURPOSE 2.
Dr Flavia Matovu Kiweewa, director of research at Makerere University-Johns Hopkins University (MUJHU) Research Collaboration and Uganda’s national principal investigator for the study, said this is going to change the approach to HIV pre-exposure prophylaxis worldwide. She is confident that as governments continue to promote PrEP uptake and adherence, long-acting formulations like the six-monthly injection will address most of the challenges currently faced by young women and other populations.