The U.S. Food and Drug Administration (FDA) and the European Medicines Agency have approved lenacapavir as pre-exposure prophylaxis (PrEP) for uninfected individuals at high risk. This antiretroviral drug is administered via subcutaneous injections every six months, providing an alternative to daily pills. The World Health Organization endorses its use in comprehensive prevention strategies.
Lenacapavir, developed by Gilead Sciences, is a capsid inhibitor of the human immunodeficiency virus (HIV) that interferes with its replication cycle. By destabilizing the structure protecting the virus's genetic material, it blocks its ability to multiply and spread in the body. This direct action sets it apart from traditional treatments that inhibit enzymes, positioning it as a promising prevention option.
Recently authorized in the United States and several European Union countries, the drug is indicated for individuals over 12 years old at high risk of infection, such as sex workers or serodiscordant couples. Unlike conventional PrEP, which has required a daily pill since 2019, lenacapavir needs only two injections per year, improving treatment adherence and reducing dropout rates among vulnerable groups.
Preliminary clinical trials have shown nearly total risk reduction, with few cases among thousands of participants. The WHO has incorporated lenacapavir into its guidelines, recommending it as a "very good option" for settings with limited access to daily treatments, according to Director-General Tedros Adhanom Ghebreyesus. Though not a vaccine—since it does not generate lasting immunity or stimulate antibodies—it provides continuous protection while present in the body.
This approval marks a significant advance in the fight against HIV, which weakens the immune system by attacking CD4 lymphocytes, potentially leading to AIDS if not prevented. Experts highlight benefits like greater privacy, ease for youth and communities facing healthcare barriers, and elimination of daily dose forgetfulness.
