Lenacapavir Demonstrates 100% Efficacy in Preventing HIV in Women 

United States: Young women and adolescent girls in Africa received two shots per year of a drug that is now addressing HIV infections, controlling the infections with dramatic efficiency. 

More about the news 

A two-delivery injection of a drug per year called lenacapavir to combat HIV infections can offer a complete shield, and it has a zero percent failure rate, as seen from drug maker Gilead’s Phase 3 studies made public Wednesday in the New England Journal of Medicine. 

Over the years, most consumers have used prevention tools that are commonly referred to as PrEP, including a daily pill called Truvada that may prevent infections of the human immunodeficiency virus or HIV. 

Recently, Apretude, which some individuals have begun receiving two shots one month apart from one another and then every two months afterward, in a bid to prevent HIV infections, as CNN Health reported. 

Two injections a year of lenacapavir could become another weapon in the fight against HIV infections. 

Effectiveness of the drug 

Specifically, none of those five thousand women and adolescent girls with HIV-negative status from Africa receiving twice-yearly lenacapavir became infected by HIV during the trial, concluding that the compound was safe and effective in blocking virus infection; the researchers concluded in their study also that a presentation to the International AIDS Conference in Munich. 

According to Linda-Gail Bekker, director of the Desmond Tutu HIV Center at the University of Cape Town in South Africa and former President of the International AIDS Society, “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,” as CNN Health reported. 

The research, known as the PURPOSE 1 trial, enrolled adolescent girls and young women living with HIV in South Africa and Uganda who were randomly assigned to either receive lenacapavir injections every 26 weeks or a daily HIV oral regimen; either emtricitabine–tenofovir alafenamide or emtricitabine–tenofovir disoproxil fumarate. 

Regarding the study design, it was a double-blind trial, and the participants did not know their assigned group. 

Moreover, most of the adverse reactions in the women and girls who received lenacapavir concerned reactions at the injection site and affected 69 percent of the patients, whereas 35 percent of the patients in the placebo injection group reported the same, but the researchers raised no safety issues. 

What more are the experts saying? 

According to Dr. Dan Barouch, the director of the Center for Virology and Vaccine Research at Beth Israel Deaconess Medical Center, the finding suggesting that lenacapavir has a hundred percent efficacy for HIV prevention in women “is an important advance for the field, and I think that the field will welcome it as an additional prevention option,” as CNN Health reported. 

He added, “But I do think it’s important to realize that these data are only in prevention in young women. There is another study that’s still ongoing, that hasn’t been read out yet, in men,” and, “So, we await more data to learn about the prevention efficacy in men as well.” 

Several clinical trials with lenacapavir are ongoing. The latest Phase 3 results are also from GILEAD’s PURPOSE, a program of HIV prevention investigations that includes five investigations worldwide. 

Gilead stated in a news release Wednesday that the firm expects an outcome later this year, also in early 2025, the other program’s pivotal trial, PURPOSE 2, also evaluates bi-annual lenacapavir for the prevention of HIV infection in men, transwomen, and gender non-binary people from Argentina, Brazil, Mexico, Peru, South Africa, Thailand as well as the United States, who have sexual contact with male partners. 

According to the company statement, which referred to seeking lenacapavir as an HIV prevention tool, “The regulatory filing for lenacapavir for PrEP will include the results of both PURPOSE 1 and PURPOSE 2, if positive, to ensure lenacapavir for PrEP can be approved for multiple populations and communities most in need of additional HIV prevention options,” CNN Health reported.