Another feather in the cap of treatment as HIV prevention
- A Groundbreaking HIV Prevention Option -
SHOBHA SHUKLA - CNS
Remove access barriers so that all of us can access medicines and disease prevention services equitably
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Results of a phase 3 PURPOSE 1 HIV prevention study done among adolescent girls and young women in South Africa and Uganda show that there were no HIV infections in HIV-negative women who received 6 monthly (twice yearly) injectable investigational drug Lenacapavir - an injectable form of PrEP (pre-exposure prophylaxis) drug developed by Gilead Sciences. In other words, an HIV-negative woman will need just two injections a year of this long-acting drug to remain safe from acquiring HIV through the sexual route.
An independent Data and Safety Monitoring Committee found this new regimen to be safe and 100% effective, with no infections seen among study participants, and recommended that Gilead stop the blinded phase of the trial and offer open-label lenacapavir to all participants.
Mitchell Warren, Executive Director of AVAC, calls this as one of the most important results we have seen to date in an HIV prevention study. "Adding additional HIV prevention options means more people may find an option that is right for them. Beyond expanded choice, a twice-yearly injection has the potential to transform the way we deliver HIV prevention to people who need and want it most - from an easier to follow regimen for individuals to a decreased burden on healthcare systems that are stretched to the limit," he said.
PURPOSE 1 is a phase-3, double-blinded, multi-centre, randomised study to evaluate safety and efficacy of twice yearly long-acting injectable lenacapavir, and daily oral Descovy (emtricitabine and tenofovir alafenamide) for pre-exposure prophylaxis in adolescent girls and young women at risk of HIV infection.
The study enrolled over 5,300 cis-gender adolescent girls and young women aged 16-26 years across 25 sites in South Africa and 3 sites in Uganda. The participants were randomised into 3 groups in a 2:2:1 ratio.
- The 1st group received twice-yearly Lenacapavir,
- The 2nd group took once-daily oral Descovy (emtricitabine and tenofovir alafenamide), and
- The 3rd group was given once-daily oral Truvada (emtricitabine and tenofovir disoproxil fumarate).
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