The FDA has approved Gilead’s Yeztugo medication as “pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV in adults and adolescents.”
This approval makes Yeztugo “the first and only twice-yearly option available in the U.S. for people who need or want PrEP.” Over 99.9% of participants who received the drug in trials remained HIV negative.
The first PrEP medication was approved in the U.S. in 2012. Data from 2022 showed that “only about 1 in 3 (36%) people in the U.S. who met the CDC’s eligibility criteria for PrEP were prescribed” a form of it. Particular gaps remain in usage among women, Black / African American, and Hispanic / Latino people, and people in the U.S. South. Other barriers including “adherence challenges, stigma, and low awareness of existing PrEP options…contribute to this low uptake.”
In a PURPOSE 1 trial testing Yeztugo’s efficacy, zero HIV infections were detected among 2,134 participants in the group taking the drug. The drug also showed superiority of prevention of HIV infections compared with once-daily oral Truvada. In the PURPOSE 2 trial, “there were two HIV infections among 2,179 participants in the twice-yearly subcutaneous Yeztugo group.”
Gilead is working closely with insurers, healthcare systems, and other payers in the U.S. “with the goal of ensuring broad insurance coverage for Yeztugo.”
Matt MacKenzie | Associate Editor
Matt is Associate Editor for Healthcare Purchasing News.
