A drug previously used to treat certain HIV infections has now received landmark approval from the US Food and Drug Administration (FDA) for use in HIV prevention vaccine.
Gilead Sciences, the pharmaceutical company behind the drug, announced Wednesday that the FDA has approved lenacapavir—now branded as Yeztugo—as a twice-yearly injection for pre-exposure prophylaxis (PrEP).
In clinical trials, lenacapavir was shown to dramatically reduce the risk of HIV infection, offering near-total protection and outperforming existing PrEP options in both convenience and effectiveness.
Until now, PrEP therapy typically required a daily pill, such as Truvada, or a bimonthly injection like Apretude. With Yeztugo, patients can now opt for a more convenient regimen—just two injections per year—potentially transforming the landscape of HIV prevention.
“Yeztugo could be the transformative PrEP option we’ve been waiting for – offering the potential to boost PrEP uptake and persistence and adding a powerful new tool in our mission to end the HIV epidemic,” said Dr. Carlos del Rio, professor of medicine at Emory University and co-director of the Emory Center for AIDS Research.
Dr. del Rio added that the reduced dosing frequency could help overcome barriers such as stigma and medication adherence, which remain challenges for those on daily or more frequent PrEP regimens.
Research also shows that many individuals at risk for HIV prefer less frequent dosing, making Yeztugo a promising new option in the ongoing fight against the virus.