The Food and Drug Administration has approved a highly effective new HIV-prevention medication, Gilead Sciences reported Wednesday. In clinical trials, the drug nearly eliminated HIV’s spread among people given an injection every six months.
Called Yeztugo, the highly effective drug has inspired feverish anticipation among advocates for HIV prevention. The hope is the medication could accelerate the stubbornly slow decline of HIV transmission in the United States.
“This is the single best opportunity in 44 years of HIV prevention,” said Mitchell Warren, executive director of the HIV advocacy nonprofit group AVAC.
Yeztugo (generic name lenacapavir), which is given by health care workers in clinics, is significantly more effective than the existing oral HIV-prevention drugs, experts said, because it appears to address the challenges of sticking to a daily pill regimen for people who are at high risk of HIV.
Gilead’s chairman and CEO, Daniel O’Day, suggested in a statement Wednesday that the drug could “end the HIV epidemic once and for all.”
It was approved after astounding results in Gilead’s large clinical trials of the drug. The trials randomly assigned people at risk of HIV to receive either lenacapavir injections every six months or daily Truvada, a pill form of pre-exposure prophylaxis, or PrEP. Among gay and bisexual men and transgender people, the Yeztugo group had an 89% lower HIV rate than a group taking Truvada and a 96% lower rate than Gilead estimated would have been expected absent any PrEP.
In a similar trial among cisgender women in sub-Saharan Africa, no one who received Yeztugo contracted HIV.
The shot is the first in a new class of antiretrovirals that block HIV from infecting and making new copies of itself inside the immune cells it targets. Lenacapavir was first approved in 2022, under the brand name Sunleca, for use with other medications to treat highly drug-resistant strains of the virus.
All forms of PrEP work in the same way: If enough of the drug is present in the body when a person is exposed to HIV, it’s highly effective at preventing the virus from taking hold and establishing a lifelong infection. Lenacapavir is so long-acting that it needs to be injected only twice a year.
However, Yeztugo’s use as PrEP against HIV emerges into a political climate that experts warn could derail progress against the virus’ spread. The Trump administration’s recent sweeping cancellations of research grants and its severe cuts to the Centers for Disease Control and Prevention’s staffing have dramatically affected the HIV-prevention field in particular. HIV experts are concerned that Yeztugo’s full potential might remain unrealized.
The shot is the first in a new class of antiretrovirals that block HIV from infecting and making new copies of itself inside the immune cells it targets.
At $14,109 per injection, or $2,352 per month, Yeztugo’s cost could be another hurdle.
Health insurers, at least in the near term, might decline to cover the shots in favor of other forms of PrEP, including the cheaper generic version of Truvada pills, which cost as little as $30 per month. Or insurers might impose higher copays for lenacapavir, said Elizabeth Kaplan, director of health care access at Harvard Law School’s Health Law and Policy Clinic.
