Statement from the Gilead’s Purpose 1 Global Community Accountability Board, The African Women’s Prevention Community Accountability Board, Our Partners and Community Partners

  • By admin.awpcab
  • June 21, 2024

We congratulate Gilead Sciences Inc. on achieving this remarkable milestone with the groundbreaking interim results from the PURPOSE 1 HIV Prevention Trial that is currently being conducted in Uganda and South Africa. The demonstration of 100% efficacy for Lenacapavir in preventing new HIV infections among cisgender women and adolescent girls aged 16-25 from an interim analysis marks a pivotal moment in our collective fight against HIV infections.

We must acknowledge and celebrate the crucial role of African women and communities in this study. Their active participation, resilience, and strong commitment have been instrumental in reaching this landmark achievement. This success is as much theirs as is Gilead’s.

As we move forward, we emphasise that choice in HIV prevention options for women and girls is paramount and must always be prioritised. Lenacapavir, if approved, will be a significant addition to the prevention toolkit, but it should complement what is in existencerather than coming in as a replacement.

We call on Gilead to demonstrate its commitment by immediately ensuring access through open-label extension studies. Clinical trial participants must receive priority access to the injection quickly to honor their contribution to this breakthrough.

Clear communication to the global health community regarding next steps is essential and we urge Gilead to outline a transparent roadmap for regulatory approvals, manufacturing scale-up, and distribution plans.

In all actions moving forward, we insist that Gilead act with a lens that centres women and girls, who continue to bear a disproportionate burden of new HIV infections. The company’s approach must reflect the urgency of their needs.

As speed is of the essence, we call on Gilead to act quickly in translating these trial results into real-world access whilst ensuring a pragmatic approach to ensuring manufacturing quality control. However, this urgency must not come at the expense of thorough safety monitoring and community engagement.

Partnership with women and communities, as demonstrated during the study, must continue to be a cornerstone of Gilead’s approach. We expect ongoing, meaningful collaboration in decision-making processes regarding access and implementation. The principles of GPP still remain a mandate for Gilead to uphold.

We urge Gilead to act swiftly in ensuring equitable, sustainable, broad access, particularly in markets with the highest need. This includes developing a robust plan licensing plan to fast track access, prioritising technology transfer and capacity building in affected regions.

Finally, we call on Gilead to implement equitable pricing strategies that ensure Lenacapaviris accessible to all who need it, regardless of economic status or geographic location.

The promise of Lenacapavir brings hope, but its true impact will be measured by how quickly and equitably it reaches those who need it most. We stand ready to partner with Gilead in turning this scientific achievement into a real-world victory in HIV prevention. 

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