Uganda is poised to adopt Lenacapavir, a groundbreaking HIV prevention method, following promising results from Gilead Sciences’ PURPOSE 1 trial. The trial, conducted in Uganda and South Africa, demonstrated 100% effectiveness in preventing HIV transmission among women and adolescent girls.
Lenacapavir, an injectable treatment, could revolutionize HIV prevention by eliminating the need for daily medication and reducing the stigma associated with HIV. Once approved, it is expected to significantly ease the burden of HIV prevention efforts.
Dr. Diana Atwine, Permanent Secretary of the Ministry of Health, highlighted the importance of such innovations in strengthening Uganda’s National HIV Combination Prevention Strategy. She emphasized the need for continued support, acknowledging that while the initial cost may be high, partnerships will make it accessible to those who need it most.
“We have made significant progress, and even though these solutions seem costly at first, prices typically decrease over time. With the help of partners, we will ensure that these treatments reach the people who need them the most,” Dr. Atwine stated.
Dr. Flavia Matovu Kiwewa, Director of Research at Makerere University-John Hopkins University (MU-JHU), revealed that the product is still under review in the second phase of the trial. The PURPOSE 1 and PURPOSE 2 studies will soon be filed for further evaluation.
“There were infections in the F/TAF and F/TDA groups, but those who were infected were not consistently using any prevention method. As a result, the committee recommended switching all participants in the PURPOSE 1 study to the Lenacapavir group. They will access it through the open-label extension phase,” Dr. Kiwewa explained.
Starting from July 8, girls returning to the clinic are being switched to Lenacapavir through this extension phase. This will help answer crucial scientific questions, such as the safety of Lenacapavir among breastfeeding mothers and its efficacy for those who return for treatment after extended periods.
Although Lenacapavir has shown promising results, Gilead is awaiting further data from the PURPOSE 2 study, which is focused on preventing HIV infection among men who have sex with men, transgender women, and non-binary populations. According to Dr. Kiwewa, global approval of the drug could be expected by the end of this year or early 2025.
“If the results are favorable, we can proceed with licensing the product and seeking approval from the Food and Drug Authority, followed by implementation of guidelines by the Ministry of Health,” Dr. Kiwewa added.
With over 3,000 girls worldwide becoming infected with HIV each week, Gilead has committed to working with generic manufacturers to reduce the cost of Lenacapavir, ensuring it is affordable and accessible to all.
The study initially focused on women, who are at higher risk of HIV infection, but the benefits of Lenacapavir are expected to extend across all genders.