The U.S. Food and Drug Administration has approved the drug lenacapavir as a twice-yearly injection to prevent HIV.
The drug, called Yeztugo from company Gilead Sciences, was approved Wednesday based on data from clinical trials that showed 99.9% of participants who received it remained HIV negative.
Daniel O’Day, Gilead’s chairman and chief executive officer, called the approval a “milestone moment in the decades-long fight against HIV.”
“Yeztugo will help us prevent HIV on a scale never seen before. We now have a way to end the HIV epidemic once and for all,” O’Day said in a news release.
According to the Centers for Disease Control and Prevention, there were 31,800 estimated new HIV infections in the United States in 2022, the most recent year with available data.
While the drug’s approval meets an existing need, the Trump administration’s funding decisions have rolled back progress for a vaccine.
Last month, the administration moved to end funding for a broad swath of HIV vaccine research, saying current approaches are enough to counter the virus.
Dr. Barton Ford Haynes, the director of the Duke Human Vaccine Institute, recently told CBS News lenacapavir is a “wonderful development for the field,” but said there was still a need for a vaccine.
“For HIV vaccine design and development, we’ve begun to see light at the end of the tunnel after many years of research,” Dennis Burton, an immunology professor at Scripps Research, previously told CBS News. “This is a terrible time to cut it off. We’re beginning to get close. We’re getting good results out of clinical trials.”
Burton warned that their HIV vaccine research could not simply be turned back on, even if a future administration decided to change course on HIV funding. He said ongoing experiments would be shuttered, and researchers assembled to study the issue would be forced to refocus their careers on other topics.
“This is a decision with consequences that will linger. This is a setback of probably a decade for HIV vaccine research,” Burton said.
Dr. Céline Gounder and
Alexander Tin
contributed to this report.
