A lead researcher from Gilead’s flagship human immunodeficiency virus (HIV) PURPOSE programme has highlighted the importance of sponsors better considering trial design when recognising and addressing global health inequalities.
Ahead of World AIDS day on 1 December, Moupali Das, executive director of HIV Clinical Research at Gilead, said that the inclusion of patients who are most impacted by disease are included in studies.
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“Whenever we study an innovation, we must be intentional about both the scientific and health equity aspects of it to ensure that it doesn’t exacerbate existing disparities,” Moupali said. “Based on this approach, it’s critical to ensure that we include people in our trials who are most disproportionately affected by HIV and who most need new choices for PrEP.”
Das specifically addressed the PURPOSE 1 trial (NCT04994509), which studied the safety and efficacy of the company’s twice-yearly, subcutaneous drug lenacapavir for pre-exposure prophylaxis (PrEP) for HIV. The trial was one of the first Phase III HIV study to include pregnant and lactating women – a hugely underrepresented patient population. In guidance released earlier this year, the World Health Organization (WHO) highlighted the importance of including this patient population in studies.
The trial included more than 5,300 cisgender women and adolescent girls in Sub-Saharan Africa, where around 3,100 women contract HIV every week. The participants are between the ages of 16 and 25 and are spread across 25 sites in South Africa and three sites in Uganda.
In June, Gilead announced positive results for the PURPOSE 1 trial for HIV, with the drug demonstrating 100% efficacy while boasting a twice yearly dosing schedule, improving adherence in comparison to daily oral pills for PrEP.
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By GlobalData“As a researcher, you dream of these ‘pinch-me’ moments that help provide a pathway toward new opportunities,” said Das.
PURPOSE 2 (NCT04925752) has enrolled cisgender men, transgender women, transgender men, and gender non-binary individuals who have sex with partners assigned male at birth, in the US, South Africa, Peru, Brazil, Argentina, Mexico, and Thailand. PURPOSE 2 did not hit perfect efficacy but touted a very impressive 99.9% prevention rate.
Currently, there are a total of five PURPOSE clinical trials.
“I’m filled with such hope as I think about what the PURPOSE programme 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.”
Research by the Clinical Trials Arena investigated whether anti-homosexuality bills in sub-Saharan Africa would impede access to HIV research for already underrepresented patient populations.
