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Gilead Announces 100% Efficacy in HIV Prevention for Cisgender Women with Lenacapavir in Aurum conducted trial

Gilead Announces 100% Efficacy in HIV Prevention for Cisgender Women with Lenacapavir in Aurum conducted trial

The Aurum Institute welcomes the announcement from Gilead on the provisional results of the Phase 3 PURPOSE 1 trial. The trial has demonstrated that Gilead's twice-yearly injectable HIV-1 capsid inhibitor, lenacapavir, has achieved 100% efficacy for HIV prevention in cisgender women. This marks a significant advancement in the field of HIV prevention and public health.

Dr William Brumskine, Principal Investigator for PURPOSE 1 at the Aurum Rustenburg Clinical Research Site, highlighted the importance of this achievement, stating, "The success of lenacapavir is crucial for women as it provides a discreet and convenient injectable option, helping them adhere to treatment plans and protect themselves against HIV."

This development aligns with Aurum's values of innovation and commitment to improving women's health to transform HIV prevention. Lenacapavir's effectiveness and convenience have the potential to alter our strategies, providing a more effective and user-friendly option that enhances adherence and health outcomes.

"This breakthrough underscores the critical importance of ongoing innovation in HIV treatment and prevention. It also reinforces our dedication to improving public health and empowering those most affected by HIV. By providing a more effective and convenient option, lenacapavir has the potential to significantly reduce HIV transmission rates and transform our strategies for combating this epidemic." said Brumskine. 

Dr Pearl Selepe, PI for Aurum Klerksdorp Clinical Research Site, Dr Mmatsie Manentsa, PI for Aurum Tembisa Clinical Research Site, and Dr Zwelethu Zwane, PI for Aurum Pretoria Clinical Research Site, all support these findings and the potential impact on public health.

Heeran Makkan, Aurum Senior Programme Manager for PURPOSE 1, added, "From the outset of this study, we have had intentional discussions and strategies to enable broad, sustainable access to lenacapavir globally. We understood that if we achieved superior results for lenacapavir, it would be essential to deliver it swiftly, ensure sustainable access, and provide it in sufficient volumes to meet global demand."

Globally, women and adolescent girls bear the heaviest burden of HIV, underscoring the urgent need for effective HIV prevention methods. In Sub-Saharan Africa, women and adolescent girls account for nearly 60% of all new HIV infections. Factors such as stigma, marginalisation, poverty, gender-based violence, and social inequalities have made women and adolescent girls particularly vulnerable to HIV.

PURPOSE 1, which includes cisgender women, will assess an investigational drug, lenacapavir, alongside an FDA-approved PrEP drug for people assigned male at birth, emtricitabine/tenofovir alafenamide, also known as F/TAF or DESCOVY for PrEP. This trial is being conducted in South Africa by The Aurum Institute across four sites in Rustenburg, Klerksdorp, Pretoria, and Tembisa. It is also being conducted in Uganda and has completed enrolment.

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