Lenacapavir: HIV prevention drug shows 100% effectiveness in clinical trials

Injections twice a year lenacapavirhuman immunodeficiency virus (HIV) capsid inhibitor, worked with 100% effectiveness in preventing HIV infection.

This was announced by pharmaceutical company Gilead, which just presented topline results from an interim analysis of its late-stage clinical trial in women.

Study of lenacapavir for HIV prevention

More than 5,300 cisgender women and girls (whose gender identity and sex match) aged 16 to 25 years from South Africa and Uganda took part in the double-blind phase 3 study.

The purpose of the clinical trial, called Aim 1, was to evaluate the safety and effectiveness of lenacapavir administered semiannually for HIV pre-exposure prophylaxis (PrEP), as well as other previous drugs, two antiretroviral drugs (in combination with emtricitabine). and tenofovir, known by the trade name Truvada), administered orally once a day.

100% effective in preventing HIV

The analysis showed that among the 2,134 women in the lenacapavir group, there were no cases of HIV infection. By comparison, there were 39 and 16 infections in the two groups receiving other drugs. Lencapavir was also generally well tolerated, and no new or significant safety concerns were identified.

Based on these results, an independent data monitoring committee recommended that Gilead stop the blinded phase of the study and offer lenacapavir to all participants, the pharmaceutical company said in a statement.

“With zero infections and 100% effectiveness, twice-yearly lenacapavir has demonstrated its potential as a critical new treatment for preventing HIV infection,” said Mehrdad Parsi, chief medical officer of Gilead. “We look forward to further results from the ongoing Purpose clinical program and continued progress towards our goal of helping end the HIV epidemic for everyone, everywhere.”

Lenacapavir and HIV

It should be noted that the use of lenacapavir for HIV prevention in cisgender women is experimental and has not been found to be safe or effective, nor has it yet been approved by any medical authority in the world.

Remember that in some countries this drug is indicated in combination with other antiretroviral drugs to treat adults with multidrug-resistant HIV-1 infection for whom an alternative suppressive antiviral regimen is not available.

“Taking lenacapavir as PrEP twice a year, if approved, will be an important new HIV prevention option that fits into many people’s lives,” said Linda-Gail Becker, director of the Desmond Tutu University HIV Center in Cape Town and former. President of the International AIDS Society. “While we know that traditional HIV prevention options are very effective when taken as prescribed, taking lenacapavir twice a year as PrEP will help eliminate the stigma and discrimination that some people face when taking the oral pill, and also potentially promote increased adherence to treatment. given its six-month dosing schedule.”

Finally, the company plans to announce results from a second study of the drug, which is being tested in other populations, between the end of this year and early 2025.

Article originally published in WIRED Italia. Adaptation by Andrei Osornio.