The FDA has announced the approval of Yeztugo (lenacapavir), a groundbreaking long-acting injectable medication for HIV prevention.
Yeztugo, developed by the biopharmaceutical company Gilead Sciences, represents a significant advancement in the fight against HIV as the first and only pre-exposure prophylaxis (PrEP) option administered just twice a year.
This new therapy is indicated to reduce the risk of sexually acquired HIV-1 infection in adults and adolescents weighing at least 35 kg who are at risk of contracting the virus.
A Paradigm Shift in HIV Prevention
Until now, PrEP options included daily pills or bimonthly injections. The arrival of Yeztugo, with its twice-yearly dosing schedule, promises to dramatically improve treatment adherence, one of the biggest challenges in HIV prevention.
“This is a historic day in the decades-long fight against HIV,” said Daniel O’Day, Chairman and CEO of Gilead Sciences. “Yeztugo is one of the most important scientific advances of our time and offers a very real opportunity to help end the HIV epidemic.”
How Does Yeztugo Work?
Yeztugo belongs to a new class of antiretroviral medications known as HIV-1 capsid inhibitors. Its mechanism of action involves blocking the capsid, a protein shell essential for protecting the virus’s genetic material and crucial for its replication. By interfering with multiple stages of the viral life cycle, Yeztugo prevents HIV from establishing itself in the body.
The medication is administered via two subcutaneous injections every six months.
Proven Efficacy in Clinical Trials
The FDA’s approval is based on robust results from Phase 3 clinical trials, PURPOSE 1 and PURPOSE 2. These studies demonstrated Yeztugo’s exceptional efficacy in preventing HIV infection. In the PURPOSE 1 trial, which included over 5,300 cisgender women and adolescents in South Africa and Uganda, no cases of HIV infection were recorded in the group receiving Yeztugo, translating to a 100% reduction in incidence. The PURPOSE 2 trial, which evaluated the drug in cisgender men, transgender women, transgender men, and nonbinary individuals who have sex with partners assigned male at birth, also showed efficacy exceeding 99%.
Availability and Next Steps
Gilead Sciences has announced that Yeztugo will be available in the United States soon. The company is also preparing approval applications in other countries that follow FDA decisions, including markets in Latin America such as Mexico and Argentina.
It is important to note that Yeztugo does not prevent other sexually transmitted infections, so its use should be part of a comprehensive prevention strategy that includes safer sexual practices.
Previously, the active ingredient in Yeztugo, lenacapavir, had already been approved under the brand Sunlenca for treating people with multidrug-resistant HIV. Today’s approval expands its use to the critical area of prevention.
