FDA approves breakthrough drug that reduces risk of contracting HIV by 96 percent

The Food and Drug Administration has approved a breakthrough medication that reduces the risk of contracting HIV by 96 percent.

Gilead's Yeztugo, generic name lenacapavir (LEN), has been approved for prevention after highly successful trials in September found that it nearly eliminated the spread of the virus among patients, showing a 96 percent relative risk reduction versus bHIV. The drug had already been approved for treatment of multidrug-resistant HIV.

The drug is meant to be given as an injection by health care workers in clinics every six months. It is currently priced at $14,109 per injection, or $2,352 per month, according to NBC News, making it unclear whether or not it will be covered by insurance.

“The approval of LEN is a much-needed boost for HIV prevention, given the strength of the science and the simultaneous disruption in HIV programs globally,” Mitchell Warren, executive director of AVAC, said in a statement. “But US FDA approval is just one in a series of steps needed to ensure that injectable LEN can help reduce the 1.3 million new HIV infections that occur each year."

"LEN for PrEP is poised to re-shape the HIV response, but only if today’s approval is accompanied by bold, strategic, effective and equitable rollout that reaches the populations that need access," Warren continued. "Otherwise, the world risks squandering this PrEP opportunity, as it has with other PrEP options too often over the past 12 years.” PrEP is pre-exposure prophylaxis, a strategy using drugs to prevent HIV-negative people from contracting the virus during sex.

Lenacapavir's trials, known as Purpose 1 and Purpose 2, examined the frequency at which patients contracted HIV without the use of PrEP. Purpose 1 took place in June and measured the effectiveness of lenacapavir among cisgender women in sub-Saharan Africa.

Purpose 2 included cisgender and transgender men, trans women, and nonbinary individuals who engage in sexual relations with partners assigned male at birth in Argentina, Brazil, Mexico, Peru, South Africa, Thailand, and the U.S. To compare effectiveness, 2,180 participants used lenacapavir and 1,087 participants used Truvada, another drug from Gilead approved for prevention. There were only two reported incidents of HIV in the lenacapavir test group versus nine in the Truvada group.

Ian L. Haddock, founder and executive director of the Normal Anomaly Initiative, participated in Purpose 2 as a trial subject. He said in a statement that he is "honored to be part of this journey, and even more excited to help our communities navigate what comes next.”

“Being a part of the PURPOSE 2 trial was about more than just my own health, it was about opening a door for others like me,” Haddock said. “In a region where stigma and systemic health inequities too often limit access to care, this injectable PrEP has the potential to transform how people protect themselves and reclaim agency over their sexual health."

This story has been updated with additional information.