FDA approves Gilead’s twice-yearly HIV prevention Injection

The U.S. Food and Drug Administration approved Gilead Sciences’ new HIV prevention drug, lenacapavir, branded as Yeztugo. This long-acting injectable requires only two doses per year and introduces a major advancement in HIV prevention.

Unlike daily oral PrEP methods, Yeztugo provides a convenient alternative. Clinical trials showed it reduced HIV transmission risk by over 99.9% in adults and adolescents. One study in sub-Saharan Africa found 100% effectiveness among women and adolescent girls.

Gilead’s chairman and CEO, Daniel O’Day, called the approval a historic step in combating HIV. The company spent nearly two decades researching and developing lenacapavir. Public health advocates now consider the injection a breakthrough for those who face stigma or struggle with daily pill routines.

Cost concerns remain. Gilead hasn’t announced official pricing, but projections suggest an annual cost of $25,000 similar to other PrEP options. Activists continue to urge the company to lower the price, especially for low-income regions where HIV persists as a major threat.

This approval also intersects with ongoing political debate. The current U.S. administration has cut funding for HIV prevention and vaccine research. Experts emphasize the need to pair this new drug with efforts to expand care access and develop a vaccine.

Lenacapavir offers a promising addition to HIV prevention tools. Two injections a year could help protect millions and move public health closer to ending the epidemic.