Gilead Sciences is prioritizing inclusive clinical trial designs in its PURPOSE program to address global health inequities in HIV prevention. The program's lead researcher, Moupali Das, emphasized the importance of including patients most impacted by the disease in studies to ensure new innovations do not exacerbate existing disparities.
The PURPOSE 1 trial (NCT04994509) specifically focused on cisgender women and adolescent girls in Sub-Saharan Africa, a population disproportionately affected by HIV, with approximately 3,100 new infections occurring weekly. This Phase 3 trial was also one of the first HIV prevention studies to include pregnant and lactating women, a historically underrepresented group in clinical research. The trial enrolled over 5,300 participants aged 16 to 25 across 25 sites in South Africa and three sites in Uganda.
The investigational medication studied in PURPOSE 1 was lenacapavir, a PrEP (pre-exposure prophylaxis) drug administered via subcutaneous injection once every six months. In June, Gilead announced positive results from the trial, demonstrating 100% efficacy in preventing HIV infection. This twice-yearly dosing schedule offers a significant advantage over daily oral PrEP pills, potentially improving adherence and overall effectiveness.
"Whenever we study a new innovation, we must be intentional about both the scientific and health equity aspects of it to ensure that it doesn't exacerbate existing disparities," said Moupali Das, Executive Director of HIV Clinical Research at Gilead.
PURPOSE 2 (NCT04925752) expanded the scope of the program to include cisgender men, transgender women, transgender men, and gender non-binary individuals who have sex with partners assigned male at birth, in multiple countries. While PURPOSE 2 did not achieve perfect efficacy, it demonstrated a 99.9% prevention rate.
Currently, there are five PURPOSE clinical trials underway, making it the most comprehensive and diverse program for an investigational HIV prevention medication ever conducted. The program reflects Gilead's commitment to a person-centric approach, reaching underserved communities and groups around the world.
"I'm filled with such hope as I think about what the PURPOSE program could mean for people who are members of groups that are disproportionally affected by HIV," Das said. "Potential new PrEP choices could be a key resource in helping to end the epidemic."
