Biannual Lenacapavir Prevents HIV in Young Women

In a study published online on July 24 in the New England Journal of Medicine, researchers found that the drug lenacapavir, administered every 26 weeks, is effective in preventing HIV infection among adolescent girls and young women. This research was released in conjunction with the 25th International AIDS Conference held from July 22 to 26 in Munich.

The phase 3 trial, led by Linda-Gail Bekker, M.B., Ch.B., Ph.D., from the Desmond Tutu HIV Centre at the University of Cape Town, South Africa, involved adolescent girls and young women. Participants were randomly assigned to receive either subcutaneous lenacapavir every 26 weeks, daily oral emtricitabine-tenofovir alafenamide (F/TAF), or daily oral emtricitabine-tenofovir disoproxil fumarate (F/TDF), which served as the active control. The study divided the participants in a 2:2:1 ratio, with 2,134 receiving lenacapavir, 2,136 receiving F/TAF, and 1,068 receiving F/TDF.

The researchers aimed to evaluate the relative efficacy of lenacapavir and F/TAF by comparing the incidence of HIV infections among the participants versus the estimated background incidence in the screened population. The screened population included 8,094 individuals. Additionally, the efficacy of lenacapavir and F/TAF was compared to that of F/TDF.

The study revealed 55 new HIV infections among the 5,338 participants who were initially HIV-negative. The rates were 0.0 infections per 100 person-years for the lenacapavir group, 2.02 infections per 100 person-years for the F/TAF group, and 1.69 infections per 100 person-years for the F/TDF group. In the screened population, the background HIV incidence was found to be 2.41 infections per 100 person-years.

The study's results indicated that the HIV incidence with lenacapavir was significantly lower than both the background HIV incidence and the HIV incidence with F/TDF. The incidence rate ratio for both comparisons was 0.00. No significant difference was observed between the HIV incidence with F/TAF and the background HIV incidence. Furthermore, no meaningful difference was found between the HIV incidences of F/TAF and F/TDF.

According to the authors, lenacapavir presents a promising option for pre-exposure prophylaxis among women. "Twice-yearly lenacapavir offers a highly efficacious and discreet choice to potentially improve preexposure prophylaxis use among women," the authors noted.

It is worth mentioning that several authors of the study disclosed affiliations with pharmaceutical companies, including Gilead Sciences, which manufactures lenacapavir and funded the study.