FDA approves first injectable treatment for HIV pre-exposure prevention
pharmafile | December 21, 2021 | News story | Manufacturing and Production |
The FDA have approved Apretude (cabotegravir extended-release injectable suspension), for use in at-risk adults and adolescents weighing at least 35 kilograms (77 pounds) for pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV. The safety and efficacy of Apretude to reduce the risk of acquiring HIV were evaluated in two randomised, double-blind trials that compared Apretude to Truvada, a once daily oral medication for HIV PrEP.
Trial 1 investigating the safety and efficacy of Apretude included HIV-uninfected men and transgender women who have sex with men and fall into high-risk categories for HIV infection. Trial 2 included uninfected cisgender women at risk of acquiring HIV. In Trial 1, 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 HIV infection when compared to participants who took Truvada.
According to the CDC, notable gains have been made in increasing PrEP use for HIV prevention in the US. 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, interpersonal factors, such as substance use disorders, depression, poverty and efforts to conceal medication, can impact patient adherence. It is hoped that the availability of a long-acting injectable PrEP option will increase PrEP uptake in these groups.
“Today’s approval adds an important tool in the effort to end the HIV epidemic by providing the first option to prevent HIV that does not involve taking a daily pill,” said Debra Birnkrant, MD, director of the Division of Antivirals in the FDA’s Center for Drug Evaluation and Research. “This injection, given every two months, will be critical to addressing the HIV epidemic in the US, including helping high-risk individuals and certain groups where adherence to daily medication has been a major challenge or not a realistic option.”
Ana Ovey
