The U.S. Food and Drug Administration has approved the world’s first twice-yearly injection to prevent HIV, a significant milestone in the global fight against the virus. The drug, called lenacapavir and manufactured by Gilead Sciences, offers a new option for those at high risk of infection.
Lenacapavir’s approval marks a breakthrough in HIV prevention, providing protection for six months with just two injections under the skin. This long-acting shot could be especially beneficial for people who struggle with daily pills or more frequent medical visits. In two groundbreaking studies, lenacapavir nearly eliminated new HIV infections among participants at high risk, outperforming the daily preventive pills that are currently standard.
“This is a game-changer in HIV prevention,” said experts familiar with the studies. “Having a long-acting option empowers individuals with more choices to protect themselves.”
While traditional methods like condoms and daily pre-exposure prophylaxis (PrEP) pills remain essential, lenacapavir adds a powerful tool to the arsenal against HIV. Its extended protection could appeal to many, particularly young people and women who need discreet options without a partner’s knowledge or consent.
Despite this advancement, global efforts to end the HIV pandemic by 2030 have stalled. There are still over 30,000 new infections in the U.S. annually and about 1.3 million worldwide. Access to preventive measures remains a challenge, especially in regions with limited healthcare resources.
In a study conducted in South Africa and Uganda, over 5,300 sexually active young women and teenage girls received either the twice-yearly lenacapavir injections or daily pills. The results were striking: none of those who received lenacapavir contracted HIV, while approximately 2% of the pill group did.
However, concerns remain regarding the accessibility of lenacapavir. Gilead Sciences has not yet announced the price, and issues such as healthcare funding cuts and challenges in foreign aid could impact the availability of this new prevention method, particularly in low-income countries.
Lenacapavir, already sold under the brand name Sunlenca for HIV treatment, will be marketed as Yeztugo for prevention. As the world anticipates its rollout, advocates hope it will play a key role in reducing new HIV infections and move us closer to ending the pandemic.
