The South African Medical Research Council contributed to an international multi-centre study that resulted in a 100% efficacy for HIV prevention injectable Pre-exposure prophylaxis (PrEP).
Durban — The SA Medical Research Council (SAMRC), through its five sites under HIV and Other Infectious Diseases Research Unit (Hidru), contributed to an international multi-centre study that resulted in a 100% efficacy for HIV prevention injectable Pre-exposure prophylaxis (PrEP).
The SAMRC Hidru’s five clinical trial sites contributed 13% of participants to the efficacy results, and one of the sites is in Verulam, KwaZulu-Natal.
In a statement, the council said the Independent Data Monitoring Committee (IDMC) recently recommended that Gilead Sciences, Inc (Nasdaq: GILD) stop the blinded phase of the Purpose 1 Trial at Interim Analysis and Offer Open-Label Lenacapavir to all participants with immediate effect.
Gilead announced the main results from an interim analysis of the Phase 3 Purpose 1 double-blind, randomised trial indicated that the company’s twice-yearly injectable HIV-1 capsid inhibitor, lenacapavir, demonstrated 100% efficacy (the power to produce a desired result) for the investigational use of HIV prevention in cisgender women.
A double-blind study is one in which neither the participants nor the experimenters know who is receiving a particular treatment.
The Purpose programme comprises five HIV prevention trials around the world that are focused on innovation in science, trial design, community engagement and health equity.
Purpose 1 was a trial evaluating the safety and efficacy of twice-yearly, two injections that are given in the abdomen (subcutaneous lenacapavir) for pre-exposure prophylaxis (PrEP) and once-daily oral Descovy® (emtricitabine 200mg and tenofovir alafenamide 25mg, F/TAF). It was administered in more than 5 300 cisgender, not transgender, women and adolescent girls aged 16 to 25 across 25 sites in South Africa and three sites in Uganda.
The study objectives of the Purpose 1 trial were achieved as the key efficacy endpoints of superiority of twice-yearly lenacapavir to once-daily oral Truvada® (emtricitabine 200mg and tenofovir disoproxil fumarate 300mg; F/TDF) and background HIV incidence (bHIV) were met.
In the trial, lenacapavir was well-tolerated and no significant or new safety concerns were identified.
These figures are the first data generated from Gilead’s landmark Purpose programme, which is the most comprehensive and diverse HIV prevention trial programme ever conducted.
Dr Nishanta Singh, one of the SAMRC Hidru principal investigators at the Verulam site said that this first-ever 100% efficacy result signified a positive step in the direction of HIV eradication and their participants and communities were extremely excited.
Investigator at the Botha’s Hill site, Dr Elizabeth Spooner, said that they were happy that young women would benefit from the injection.
“We are eternally grateful to our study volunteers for their contribution to these milestone results. We thank our research team members, community stakeholders, partners and collaborators for their ongoing support and dedication to the trial.”
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