A groundbreaking study published in The New England Journal of Medicine has revealed promising results for a new HIV-preventive drug. Lenacapavir, an injectable medication administered twice a year, showed 100% efficacy and no safety concerns in a phase-3 trial conducted on teenage girls and young women in South Africa and Uganda. Developed by the US-based biopharmaceutical company Gilead Sciences, Inc., lenacapavir is a pre-exposure prophylaxis (PrEP) drug designed to prevent the spread of HIV infection in individuals not yet exposed to the virus.
The study, known as PURPOSE 1, enrolled 5,338 HIV-negative participants and divided them into three groups. The first group received lenacapavir injections every 26 weeks, the second group received the daily oral tablet Descovy (F/TAF), and the third group received the daily oral tablet Truvada (F/TDF).
The researchers, including those from the Desmond Tutu HIV Centre at the University of Cape Town, South Africa, observed a remarkable outcome. Out of the 55 total infections recorded, none occurred in the lenacapavir group, while 39 cases were observed in the Descovy group and 16 in the Truvada group.
“No participants receiving twice-yearly lenacapavir acquired HIV infection,” the study authors emphasized.
Although the most common adverse effects were injection-site reactions experienced by approximately 70% of the participants in the lenacapavir group, no serious injection-site reactions were reported.
“These stellar results show that twice-yearly lenacapavir for PrEP, if approved, could offer a highly effective, tolerable and discreet choice that could potentially improve PrEP uptake and persistence, helping us to reduce HIV in cisgender women globally,” stated Linda-Gail Bekker, Director of the Desmond Tutu HIV Center at the University of Cape Town, South Africa, and the study’s first author.
The results of the PURPOSE 2 trial, involving cisgender men, transgender men, transgender women, and gender non-binary individuals in countries including Latin America, South Africa, and Thailand, are anticipated in late 2024 or early 2025.
The groundbreaking success of lenacapavir in the PURPOSE 1 trial holds immense promise for the global fight against HIV. Its effectiveness, safety, and convenient administration regimen could significantly contribute to reducing HIV transmission, particularly among women, and provide a critical tool for public health initiatives.
