Gilead presents new HIV research data at European AIDS Conference

Gilead (GILD) announced its upcoming participation in the 20th European AIDS Conference to be held in Paris, France from October 15-18. Gilead will provide an update on its strategic initiatives, key collaborations, and share new scientific data from its HIV research and development programs. Researchers will present the strategies that supported the recruitment of people in high-priority populations across France and the UK for the Phase 2 PURPOSE 5 trial, which is evaluating the persistence of twice-yearly lenacapavir among people who need or want PrEP but who have not previously engaged with existing HIV prevention options. Through collaboration with community advisory groups, thoughtful site selection and targeted recruitment goals for understudied populations, the study team achieved its enrollment goals and established a model for future HIV prevention studies. Further data from the PURPOSE 2 trial examined the concomitant use of lenacapavir by people also taking statins administered to lower cholesterol and PDE-5 inhibitors to treat erectile dysfunction. Lenacapavir is a moderate inhibitor of the enzyme CYP3A4 and could potentially increase levels of these classes of drugs. The accumulated data suggests that lenacapavir, like other moderate CYP3A4 inhibitors, can be co-administered with statins and PDE5 inhibitors with appropriate monitoring and dose adjustment. Long-term, real-world data were analyzed from individuals with HIV who were enrolled in Canada, France and Germany. The five-year outcomes are consistent with the results observed from multiple Phase 3 clinical trials evaluating the treatment responses of people with HIV on Biktarvy. In the group of BICSTaR study participants with 5 years of real-world follow-up, Biktarvy continued to demonstrate sustained viral suppression, a favorable safety and tolerability profile, and a high barrier to resistance. These benefits were seen in both treatment-naive and treatment-experienced people with HIV who have a high burden of co-morbidities. This could help inform treatment strategies for these groups. Data from an ongoing, randomized, open-label Phase 2 study demonstrate that switching to an investigational once-weekly combination regimen of islatravir and lenacapavir enabled people living with HIV to maintain viral suppression to two years. At 96 weeks, based on the Missing = Failure and Missing = Excluded analyses, respectively, 88.5% and 100% of adults treated with the novel investigation combination maintained an undetectable viral load demonstrating the potential of the combination, which could become the first weekly oral HIV treatment option. Two Phase 3 studies – ISLEND-1 and ISLEND-2 are ongoing. The Phase 2 open-label study from Gilead’s long-acting treatment pipeline demonstrated that twice-yearly lenacapavir in combination with bNAbs maintained viral suppression in people with HIV with susceptible viruses out to 52 weeks and was generally well tolerated. The investigational combination has the potential to be the first twice-yearly complete regimen. The treatment combination is now progressing to Phase 3 clinical development.