FDA Approves First Twice‑Yearly HIV Prevention Injection
Gilead Sciences recently announced that the FDA has authorized a very effective new HIV-prevention medicine, according to reports. Per clinical studies, the medication essentially eradicated HIV transmission among persons who received an injection every six months.
Known as Yeztugo, the medication has sparked feverish anticipation among HIV prevention campaigners. The aim is that the treatment may hasten the chronically slow drop in HIV transmission in the US.
"This is the single best opportunity in 44 years of HIV prevention," said Mitchell Warren, executive director of AVAC, an HIV advocacy nonprofit organization, in an interview with NBC News.
Yeztugo (generic name lenacapavir), which is administered by health care workers in clinics, is much more effective than existing oral HIV-prevention medications, according to experts, because it appears to solve the difficulties of adhering to a daily pill regimen for those at high risk of HIV.
Daniel O'Day, Gilead's chairman and CEO, said in a statement Wednesday that the treatment might "end the HIV epidemic once and for all."
It was approved following impressive results from Gilead's clinical trials of the medication.
The trials randomly allocated persons at risk of HIV to either six-monthly lenacapavir injections or daily Truvada, a pill form of pre-exposure prophylaxis, or PrEP. Per the NBC News report, the Yeztugo group had an 89% lower HIV rate than the Truvada group and a 96% lower rate than Gilead projected would be expected in the absence of PrEP.
The outlet reports that in a similar trial involving cisgender women in Sub-Saharan Africa, none of those who got Yeztugo developed HIV.
The shot is the first of a new generation of antiretrovirals that prevent HIV from infecting and replicating inside the immune cells it targets. Lenacapavir was initially licensed in 2022, under the brand name Sunleca, for use in combination with other drugs to treat highly drug-resistant viral strains.