The U.S. Food and Drug Administration (FDA) approved the first injectable treatment for pre-exposure prophylaxis to reduce the risk of sexually acquired HIV.
The agency approved Apretude (cabotegravir extended-release injectable suspension) for use in at-risk adults and adolescents weighing at least 77 pounds. Apretude is given first as two initiation injections administered one month apart, and then every two months thereafter. Patients can either start their treatment with Apretude or take oral cabotegravir (Vocabria) for four weeks to assess how well they tolerate the drug.
Debra Birnkrant, MD, Director of the Division of Antivirals in the FDA’s Center for Drug Evaluation and Research, said, “This injection, given every two months, will be critical to addressing the HIV epidemic in the U.S., including helping high-risk individuals and certain groups where adherence to daily medication has been a major challenge or not a realistic option.”
According to the U.S. Centers for Disease Control and Prevention (CDC), gains have been made in increasing PrEP use for HIV prevention. Preliminary data show that in 2020, about 25% of the 1.2 million people for whom PrEP is recommended were prescribed it, compared to only about 3% in 2015.
However, PrEP requires high levels of adherence to be effective and certain high-risk individuals and groups, such as young men who have sex with men, are less likely to adhere to daily medication. Other interpersonal factors, such as substance use disorders, depression, poverty, and efforts to conceal medication also can impact adherence. It is hoped that the availability of a long-acting injectable PrEP option will increase PrEP uptake and adherence in these groups.
The safety and efficacy of Apretude to reduce the risk of acquiring HIV were evaluated in two randomized, double-blind trials that compared Apretude to Truvada, a once daily oral medication for HIV PrEP. Trial 1 included HIV-uninfected men and transgender women who have sex with men and have high-risk behavior for HIV infection. Trial 2 included uninfected cisgender women at risk of acquiring HIV.
In the first trial, 4,566 cisgender men and transgender women who have sex with men received either Apretude or Truvada. The trial measured the rate of HIV infections among trial participants taking daily cabotegravir followed by Apretude injections every two months compared to daily oral Truvada. The trial showed participants who took Apretude had 69% less risk of getting infected with HIV when compared to participants who took Truvada.
In the second trial, 3,224 cisgender women received either Apretude or Truvada. The trial measured the rate of HIV infections in participants who took oral cabotegravir and injections of Apretude compared to those who took Truvada orally. The trial showed participants who took Apretude had 90% less risk of getting infected with HIV when compared to participants who took Truvada.
The FDA granted the approval of Apretude to Viiv