Breakthrough as HIV prevention drug records 100% success

In a release signed by Kay Marshall, Senior Communications Advisor for AVAC, the organization welcomes the groundbreaking results of the PURPOSE 1 study which enrolled over 5,300 cisgender adolescent girls and young women ages between the age of 16 and 26 in South Africa and Uganda.

The study evaluated injectable lenacapavir for PrEP and daily oral emtricitabine/tenofovir alafenamide (F/TAF) for PrEP.

An independent data and safety monitoring board (DSMB), at a scheduled review of the trial data, found the regimen to be safe and highly effective, with no infections seen among trial participants who received injectable lenacapavir.

Regulation

HIV prevention advocate and AVAC’s executive director, Mitchell Warren hails the lenacapavir trial results as a significant advancement. He emphasized the potential of long-acting injectables to increase adherence, improve access, and reduce strain on healthcare systems.

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“We expect to see a timeline that takes into account a full analysis of PURPOSE 1 data and the coming data from PURPOSE 2 from Gilead as soon as possible, and we urge regulatory agencies to prepare to fast track regulatory review.

“We look forward to working with civil society partners, Gilead, international donors, normative agencies and national governments to ensure that this groundbreaking HIV prevention option is made available as quickly as possible and that we don’t squander this opportunity to drive down new HIV infections,” Warren said.

The Regional Stakeholder Engagement Manager for AVAC, and a member of the PURPOSE 1 Global Community Advisory Group, Nandisile Sikwana said, “We are incredibly excited about this result, especially about what it can mean for women in Africa. We applaud Gilead’s commitment to Good Participatory Practice in this and the other PURPOSE studies.

“While we wait for full data from the study, including adherence data of oral F/TAF, it is imperative that planning for rollout of lenacapavir be accelerated. We know that even with the most ambitious timeline, it will take time for lenacapavir to be rolled out”.