Twice-a-Year HIV Injection Reduces Risk of Infection by 96%

A new twice-a-year HIV injection drug reduced the risk of infection by 96% in a second Phase 3 clinical trial. Gilead Sciences is the biopharmaceutical company behind this HIV prevention drug, lenacapavir.

Gilead shared a press release to announce this exciting new healthcare innovation. The advancement will help with HIV prevention and reduce HIV infections for patients experiencing symptoms.

The release states, “Gilead Sciences, Inc. today announced the results of an interim analysis from a second pivotal Phase 3 clinical trial investigating the use of the company’s twice-yearly injectable HIV-1 capsid inhibitor, lenacapavir. Lenacapavir reduced HIV infections by 96% compared to background HIV incidence.”9

The statement continues, “There were 2 incident cases among 2,180 participants, corresponding to 99.9% of participants not acquiring HIV infection in the lenacapavir group. Twice-yearly lenacapavir also demonstrated superiority to once-daily Truvada.”

In a statement within the press release, Daniel O’Day, chairman and chief executive officer of Gilead, said, “With such remarkable outcomes across two Phase 3 studies, lenacapavir has demonstrated the potential to transform the prevention of HIV and help to end the epidemic.”

“Now that we have a comprehensive dataset across multiple study populations, Gilead will work urgently with regulatory, government, public health and community partners to ensure that, if approved, we can deliver twice-yearly lenacapavir for PrEP worldwide, for all those who want or need PrEP,” he continued.

“In the United States, the stubbornly high rate of HIV diagnoses — especially in the U.S. South, and particularly among gay and bisexual men of color and transgender people — demands novel approaches to help people prevent HIV acquisition,” said Colleen Kelley, MD, MPH, professor of medicine at Emory University in a separate statement. “Because adherence to oral products can be challenging for some people, twice-yearly injectable lenacapavir for PrEP has the potential to be one of the most impactful interventions we could have to drive down new infections and bring us closer to ending the HIV epidemic in the United States.”

As reported by CNN, Gilead stated that it plans to leverage the trial data to initiate the drug approval process in several countries by year-end, with a focus on securing authorization in high-incidence, low-resource nations.

At present, there is no cure for HIV or AIDS.