Early results from an HIV prevention trial show that an injectable antiretroviral drug given twice a year can prevent infection in cisgender women. 

“This is the first HIV prevention trial ever in history to show zero HIV infections with an intervention,” says Professor Thesla Palanee-Phillips, director of clinical trials at Wits RHI in a statement. 

The trial, known as the Phase 3 PURPOSE 1 trial, was conducted among more than 5 300 adolescent girls and young women in 25 sites in South Africa and three in Uganda. Palanee-Phillips is a lead researcher on the trial who co-managed the Wits RHI Research Centre Clinical Research site in Hillbrow Johannesburg where more than 200 young women were enrolled. 

Sub-Saharan Africa is home to two thirds (25.6 million) of people living with HIV. Women and girls make up 77% of new infections among youth aged 15-24 in the region. 

“After over a decade of working on HIV PrEP trials, it’s extremely fulfilling to get such amazing results from the PURPOSE1 study,” says Dr Flavia Matovu Kiweewa, director of research at Makerere University –Johns Hopkins University (MUJHU) Research Collaboration. 

Kiweewa is also the Uganda national principal investigator for the study. The study tested the effectiveness of the injectable lenacapavir versus two oral drugs that must be taken once a day: Descovy and Truvada. 

“I’m overwhelmed. It’s difficult catching any sleep over the past two nights, thinking of how far we have come with the PURPOSE 1 study, the amount of effort by study teams, how well the study has been executed, and what these results mean to the HIV prevention field,” she says. 

Gilead, the pharmaceutical company behind the drug, says more detailed data from PURPOSE 1 will be presented at a future conference. 

“The use of lenacapavir and the use of Descovy for the prevention of HIV in cisgender women are investigational and have not been determined to be safe or efficacious and are not approved anywhere globally,” the company says in a statement.  

The company says late this year or early 2025 it’s expecting the results from the PURPOSE 2 which is assessing lenacapvir among expanded population groups including cisgender men who have sex with men, transgender men, transgender women. Filing for regulatory approval of the drug will include findings from PURPOSE 1 & 2. 

“This is going to change the approach to HIV pre-exposure prophylaxis worldwide. I’m confident that as we continue to promote PrEP uptake and adherence in our setting, long-acting formulations like the six-monthly injection will address most of the challenges currently faced by young women and other populations,” says Kiweewa. – Health-e News