The Committee of Human Use Medicines (CHMP) of the European Medicines Agency (EMA) gave a favorable opinion at the end of July at the Lénacapavir in HIV prevention, as part of an accelerated procedure. For its part, the WHO recommended it, as an additional option of pre-exhibition prophylaxis (PREP) for HIV prevention.
Administration limited to two per year
The CHMP has recommended the use of Lenacapavir, the inhibitor of the HIV-1 injectable Gilead Sciences, in pre-exhibition prophylaxis (PREP) to reduce the risk of infection by HIV-1 in adults and adolescents with an increased risk of infection by HIV-1.
The final decision of the European Commission (EC) is expected during the year. In the event of approval, the Lénacapavir will be marketed in the European Union (EU) under the trade name Yeytuo®. In the United States, the drug has been approved by the FDA since the end of June.
The mechanism of action in several stages of the Lénacapavir is distinguished from other classes of antiviral agents currently approved. While most antivirals act only one stage of viral replication, the Lénacapavir is designed to inhibit HIV in several stages of its life cycle and has no known cross resistance in vitro to other classes of existing drugs. In addition, thanks to an administration limited to two per year, Lénacapavir should facilitate the adoption and observance of pre-exhibition prophylaxis (PREP), by raising the obstacles linked to the daily take of oral tablets for PREP and other shorter action options. The Revue Science has appointed the Lenacapavir as “breakthrough of the year” 2024.
The recommendation of the CHMP is based on the results of two randomized clinical trials, double blind, controlled by active treatment and carried out on a multinational scale. In the test PURPOSE 1Lenacapavir offered 100 % protection against HIV in 5,000 women aged 16 to 25 in South Africa and Uganda. In the test PURPOSE 2he offered almost complete protection in men and gender people who are 16 years old aged 16 or over having sex with assigned men’s partners at birth in Argentina, Brazil, Mexico, Peru, South Africa, Thailand and the United States. In the two tests, the participants were randomly distributed in a 2: 1 report to receive subcutaneous injections of Lénacapavir twice a year or a daily dose of Emtricitabine-Tenofovir by oral route.
Also recommended by WHO
For its part, the World Health Organization (WHO) recommended, on July 14, the use of Lenacapavir, twice a year as an additional option of pre-exhibition prophylaxis (PREP) for HIV prevention. According to WHO, this new system could help reshape the global response to HIV. “The injectable Lénacapavir offers a very effective and long -lasting alternative to daily oral pills and other short -acting options.
With only two doses per year, the injection represents “a decisive advance” in the protection of people exposed to the risk of HIV infection, in particular those facing problems of daily observance, stigmatization or access to health care “she considers.
“While a HIV vaccine remains out of reach, Lénacapavir is the best: an antiretroviral with prolonged action whose trials have shown that it made it possible to prevent almost all HIV infections in people at risk,” said the Dr Tedros Adhanom GhebreyesusManaging Director of WHO.
Back from the International Aids Society (IAS), 13e of the name, which was held from July 13 to 17 in Kigali, capital of Rwanda, Professor Pialoux, professor of infectious and tropical diseases at Tenon hospital and at Sorbonne University, considered in a video for Medscape France that the Lenacapavir was the “star of the Congress”.
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