From: Fierce Pharma
Image: AI ©Gay Globe
For the first time, a potential PrEP medication for HIV has shown zero infections in a Phase 3 trial. The result comes from the PURPOSE 1 trial evaluating Gilead Sciences’ semi-annual subcutaneous lenacapavir in cisgender women and adolescents aged 16 to 25. Lenacapavir, a capsid inhibitor, is already FDA-approved under the brand name Sunlenca for use with other antiretroviral drugs in treating HIV in certain difficult cases. The trial enrolled over 5,300 participants at 28 sites to receive either lenacapavir or one of Gilead’s daily oral PrEP medications, Descovy and Truvada. While no infections occurred during the trial period among over 2,000 women in the lenacapavir group, the Descovy group had an incidence rate of 2.02 per 100 person-years and the Truvada group had an incidence rate of 1.69 per 100 person-years. On the primary endpoint of the trial, which compared lenacapavir to a reference incidence rate of 2.41 per 100 person-years, Gilead’s drug proved significantly better. The drug also demonstrated superiority over Truvada, a secondary comparator.
As a result, an independent data monitoring committee recommended that Gilead end the blinded phase of the PURPOSE 1 trial at this interim analysis and offer lenacapavir to all participants as open access. Gilead is conducting several trials for lenacapavir under the PURPOSE program. The PURPOSE 2 trial evaluates the long-acting drug for PrEP primarily in cisgender men who have sex with men, as well as in transgender men and women in Argentina, Brazil, Mexico, Peru, South Africa, Thailand, and the United States. Results from this study are expected by late 2024 or early 2025. Gilead plans to combine data from the two pivotal trials for FDA approval.
If approved, the biannual drug could « provide a crucial new choice for HIV prevention, » said Bekker. The success of lenacapavir with a dosing schedule of once every six months poses a significant threat to GSK’s Apretude, an injection that, so far, can only be administered every two months. While ViiV Healthcare, GSK’s HIV-focused subsidiary, was the first to introduce a long-acting PrEP option, it lags behind Gilead in ultra-long-duration treatments.