SC Connecticut News

A potential advancement in HIV prevention is emerging, as reported by the World Health Organization. An interim analysis from a Phase 3 clinical trial led by Gilead Sciences, Inc., has revealed that lenacapavir, an injectable drug administered twice a year, shows promise in preventing new HIV infections. Onyema Ogbuagu, MBBCh, associate professor of medicine and pharmacology at Yale School of Medicine and principal investigator of the study known as PURPOSE 2, discussed the trial's findings and the future implications for lenacapavir.

Lenacapavir operates by targeting the HIV capsid—a structure housing the virus's genetic material and proteins—thereby inhibiting replication within host cells. "Even if the virus evades this process," Ogbuagu explained, "lenacapavir also prevents HIV from forming mature virions [virus particles] that propagate the infection."

Current prevention methods include behavioral strategies and oral antiretroviral therapies requiring daily intake. However, adherence issues limit their effectiveness. The introduction of long-acting injectables like cabotegravir addressed some adherence challenges but required bi-monthly administration.

PURPOSE 2 evaluated lenacapavir among diverse groups worldwide who have sex with men. Participants included men, trans women, trans men, and gender non-binary individuals. Approximately 3,200 people participated in this study. Results showed that lenacapavir achieved a 96% prevention efficacy compared to background incidence rates and was 89% more effective than oral drugs.

"The World Health Organization has described lenacapavir as 'a significant breakthrough' in HIV prevention," noted Ogbuagu. "100%. This would be the longest-acting HIV prevention modality out there."

With regulatory approval anticipated by late 2025, efforts are underway to ensure affordability through agreements with generic manufacturers. Meanwhile, participants will have access to an open-label extension until availability expands globally.