iNDICA NEWS BUREAU-
A pioneering HIV-preventive medication developed in the United States has shown remarkable promise, potentially transforming global efforts to curb HIV transmission. The drug, Lenacapavir, created by California-based biopharmaceutical company Gilead Sciences, Inc., has demonstrated 100% effectiveness in preventing HIV infections among women in a large-scale clinical trial.
This significant advancement could usher in a new chapter in HIV prevention strategies, offering renewed hope to millions at risk of infection worldwide.
The phase-3 clinical trial, PURPOSE 1, was recently published in The New England Journal of Medicine. This extensive study involved 5,338 HIV-negative teenage girls and young women in South Africa and Uganda, regions significantly affected by the HIV epidemic. The trial compared Lenacapavir, administered as an injection every 26 weeks, with two daily oral pre-exposure prophylaxis (PrEP) medications: Descovy (F/TAF) and Truvada (F/TDF).
The results were striking. In the Lenacapavir group, which included 2,134 participants, there were zero HIV infections. The Descovy group, with 2,136 participants, saw 39 HIV infections, while the Truvada group, consisting of 1,068 participants, reported 16 HIV infections. These outcomes translate to a 100% efficacy rate for Lenacapavir, showcasing its potential as a game-changing tool in HIV prevention.
Lenacapavir offers several advantages over existing preventive treatments. As a long-acting formulation, it is administered as an injection only twice a year, potentially improving adherence and reducing the burden of daily pill-taking. The study demonstrated complete protection against HIV infection in the Lenacapavir group, highlighting its high efficacy. Additionally, no serious adverse effects were reported, although about 70% of participants experienced mild injection-site reactions, indicating a favorable safety profile.
The development of Lenacapavir represents a significant advancement in the fight against HIV/AIDS, particularly for women in high-risk areas. HIV, which spreads through body fluids and can lead to AIDS if untreated, remains a major global health concern. The World Health Organization estimates that 37.7 million people were living with HIV worldwide in 2020, with women and girls accounting for about half of all new infections.
Dr. Linda-Gail Bekker, Director of the Desmond Tutu HIV Center at the University of Cape Town and the study’s lead author, emphasized the potential impact of Lenacapavir. She stated, “These stellar results show that twice-yearly Lenacapavir for PrEP, if approved, could offer a highly effective, tolerable, and discreet choice that could potentially improve PrEP uptake and persistence, helping us to reduce HIV in cisgender women globally.”
While the results are promising, further research is ongoing. Gilead Sciences is conducting another trial, PURPOSE 2, which focuses on cisgender men, transgender men, transgender women, and gender non-binary individuals in various countries, including Latin American nations, South Africa, and Thailand. Results from this study are expected in late 2024 or early 2025.
Currently, Lenacapavir is not yet approved for use as a preventive medication. The data from the PURPOSE 1 trial will likely be submitted to regulatory agencies, including the U.S. Food and Drug Administration (FDA), for review and potential approval as a PrEP option.
