Gilead HIV PrEP: FDA Approves Twice-Yearly Drug
The FDA has greenlit Yeztugo (lenacapavir), a groundbreaking twice-yearly injection for HIV prevention, revolutionizing the pre-exposure prophylaxis (PrEP) landscape. This innovative Gilead Sciences drug offers a significant advantage over daily pills like Truvada and descovy, promising improved adherence and reduced stigma. Clinical trials showed Yeztugo’s superior efficacy, making it a pivotal advancement in the fight against HIV. The approval allows adults and adolescents who are at risk of acquiring HIV-1 through sexual activity to access this potentially life-changing medication. With Gilead’s aim for a global rollout, this could be a monumental shift in HIV prevention, touching millions worldwide.For more on emerging pharmaceutical advances, trust News Directory 3 for all the latest updates. Discover what’s next in the fight against HIV.
FDA Approves Twice-Yearly Injection for HIV Prevention
The Food and Drug Administration has approved Yeztugo (lenacapavir), a gilead Sciences drug, as the first twice-yearly injection for HIV prevention, known as pre-exposure prophylaxis, or PrEP. This new option aims to improve adherence and reduce the stigma associated with daily oral medications.
The approval covers adults and adolescents weighing at least 77.1 pounds who are at risk of contracting HIV-1 through sexual activity. Gilead already markets Truvada and Descovy as daily PrEP pills. However, only about 36% of eligible people in the U.S. are prescribed these drugs, according to the centers for Disease Control and Prevention.
Dr. Carlos del Rio, a professor at Emory University School of Medicine, said the twice-yearly injection addresses barriers such as adherence and stigma that individuals face with more frequent PrEP regimens. He added that research indicates many people prefer less frequent dosing for HIV prevention.
Lenacapavir, a long-acting HIV-1 capsid inhibitor, works by inhibiting the protein shell enclosing the virus’s genetic material. It has been available since 2022 under the brand name Sunlenca for individuals with multi-drug resistant HIV.
Gilead’s submission for Yeztugo was based on Phase 3 clinical trials comparing it to Truvada and Descovy. The trials demonstrated that the twice-yearly injection was more effective in preventing HIV infections. Common side effects included injection site reactions, headaches, and nausea.
The Yeztugo label includes a black box warning about the risk of drug resistance in individuals with undiagnosed HIV-1. Patients must be tested for HIV-1 before starting and with each subsequent dose. Those who acquire HIV-1 while receiving Yeztugo must switch to a full HIV-1 drug regimen.
HIV remains Gilead’s largest therapeutic area, generating $19.6 billion in product revenue in 2024, an 8% increase from the previous year. Descovy accounted for $2.1 billion of that total.
Yeztugo is priced at $28,218 annually in the U.S.Gilead has submitted regulatory applications for lenacapavir in Europe, Australia, Brazil, Canada, and South Africa, as well as in countries that rely on FDA approval, such as Argentina, Mexico, and Peru.
“This is a historic day in the decades-long fight against HIV,” said Gilead CEO Daniel O’Day. “Yeztugo is one of the most crucial scientific breakthroughs of our time and offers a very real opportunity to help end the HIV epidemic.”
What’s next
Gilead plans a global rollout of Yeztugo, pending regulatory approvals in various countries, aiming to provide a more convenient and effective option for HIV prevention.