Cape Town, South Africa – June 21, 2024 – Gilead Sciences announced the groundbreaking results of the Phase 3 PURPOSE 1 study yesterday, which demonstrated that twice-yearly injections of Lenacapavir achieved 100% efficacy and superiority to daily Truvada (emtricitabine/tenofovir disoproxil fumarate) for HIV prevention in cisgender women.
The Desmond Tutu Health Foundation (DTHF) contributed to these important research findings through a number of their well-equipped clinical research sites and associated community partnerships. PURPOSE 1 focused on evaluating the effectiveness of long-acting, subcutaneous Lenacapavir compared to daily oral Emtricitabine/Tenofovir Alafenamide in at-risk adolescent girls and young women. DTHF remains committed seeing an end to the HIV epidemic in South Africa and is proud to have played a pivotal role in reaching this significant milestone, showcasing the potential of Lenacapavir as a pre-exposure prophylaxis (PrEP) as a highly effective and safe prevention option.
Treatment vs Prevention
While lenacapavir has been approved and is currently being used for the treatment of multidrug-resistant HIV-1 infection in several countries, its use as a prevention drug is still under investigation. The PURPOSE 1 trial has studied lenacapavir as a potential PrEP option, demonstrating promising results. However, regulatory approval for this specific use has not yet been granted in any country. This means that the drug will not be available for this purpose (i.e., PrEP) for some time, as it must undergo further regulatory processes beyond clinical trials, including market approval and distribution planning.
Urgent Call for Action
DTHF urges global and local health authorities, governments, and regulatory bodies to expedite the approval and distribution of Lenacapavir PrEP. Rapid and unrestrained access to this groundbreaking medication is crucial to harness its full potential in preventing new HIV infections, especially for populations in low- and middle-income countries, such as South Africa. Reproductive health has taught us that providing options for people results in better uptake and more effective use of interventions because people can match the intervention to their preference and lifestyle. Providing less frequently dosed injectable options alongside currently available shorter-acting HIV prevention methods such as daily oral PrEP (Pre-Exposure Prophylaxis), will result in overall better prevention outcomes.
Recently, the monthly dapivirine ring and a 2 monthly CAB-LA (long-acting injectable Cabotegravir) were approved in South Africa, and DTHF is proud to be among the first to offer these innovative options alongside oral PrEP in some of the communities we serve. To derive the most benefit from these innovations, we need to see greater affordability and accessibility, innovative funding as well as government support to ensure no one and no communities are left behind.
The success of Lenacapavir PrEP paves the way for broader implementation of PrEP choice, particularly in populations that face barriers to daily medication regimens and other challenges. DTHF remains committed to continuing its research and advocacy efforts to ensure these advancements reach those most in need.
Read Gilead’s press release here: Gilead’s Twice-Yearly Lenacapavir Demonstrated 100% Efficacy and Superiority to Daily Truvada® for HIV Prevention
For more details on the current status and ongoing studies, you can visit Gilead’s official page or PrEPWatch.
Watch our video that explains how Lenacapavir targets HIV:
Watch our video that explains the clinical trials process in South Africa:
For more detailed information, you can refer to:
