The global fight against HIV may be entering a transformative phase, as the U.S. Food and Drug Administration on Wednesday approved a revolutionary twice-yearly injection developed by Gilead Sciences to prevent HIV infection. The approval marks a major leap forward in efforts to end the decades-long epidemic.

Marketed under the name Yeztugo, the injectable drug demonstrated near-complete prevention of new HIV infections in two pivotal clinical trials conducted in 2024. When administered every six months, the drug was found to be significantly more convenient and equally, if not more, effective than current prevention options, such as Gilead’s daily PrEP pills and GSK’s bi-monthly injection.

“This is a breakthrough in convenience and protection,” said Gilead CEO Daniel O’Day. “Yeztugo has the potential to dramatically bend the curve of the epidemic, particularly in vulnerable communities around the world.”

According to the World Health Organization, an estimated 1.3 million people contracted HIV globally in 2023, and approximately 630,000 died from HIV-related causes. In the U.S. alone, around 700 new infections and 100 deaths occur each week, disproportionately affecting people of color, gay and bisexual men, and transgender women.

Despite its promise, the rollout of Yeztugo faces potential obstacles. One major concern is proposed cuts to federal HIV prevention funding under the Trump administration, which could hinder access and distribution, particularly in underserved populations.

Jeremiah Johnson, Executive Director of PrEP4All, an advocacy group dedicated to expanding access to HIV prevention tools, emphasized that the drug’s impact will hinge not only on its efficacy but on accessibility. “This approval is historic, but access must be equitable if it’s to reach its full potential,” he said.

Yeztugo’s active ingredient, Lenacapavir, comes with an annual list price of $28,218 in the U.S. before insurance, according to a Gilead spokesperson—comparable to other branded PrEP medications on the market.

Health experts say Yeztugo’s extended dosing schedule may offer a game-changing option for individuals at risk of HIV who struggle with adherence to daily pills or frequent clinic visits.

As global health agencies and advocacy organizations prepare for its rollout, many are hopeful that Yeztugo could mark the beginning of the end for one of the world’s most enduring public health crises.