A Game-Changer in HIV Prevention: The Injectable PrEP
In a significant advancement in the fight against HIV, the FDA has approved Apretude (cabotegravir extended-release injectable suspension) for pre-exposure prophylaxis (PrEP) to prevent HIV infection. This approval marks a pivotal shift in HIV prevention strategies, offering a new option for those at risk of HIV that doesn’t require a daily pill.
The Breakthrough
Apretude is the first injectable treatment approved for PrEP, administered initially as two injections one month apart, followed by injections every two months. This regimen is designed to improve adherence, particularly among high-risk populations who struggle with daily medication routines. According to the FDA, this long-acting injectable option is expected to be critical in addressing the HIV epidemic in the U.S., especially for individuals for whom daily pills are not a realistic or effective solution.

Clinical Trials and Effectiveness
The approval of Apretude is based on the results from two major clinical trials. The first trial included HIV-uninfected men and transgender women who have sex with men, while the second focused on HIV-uninfected cisgender women. Participants who received Apretude had a significantly lower risk of acquiring HIV compared to those who took daily oral Truvada. Specifically, Apretude reduced the risk of HIV infection by 69% in the first trial and by 90% in the second trial, highlighting its effectiveness as a preventive measure.
Addressing Adherence Challenges
One of the main challenges with current PrEP options is adherence. The daily pill regimen can be difficult for some individuals to maintain consistently, especially for those facing various social and personal barriers. Apretude’s bi-monthly injection schedule aims to overcome these challenges, providing a more manageable and reliable method of HIV prevention. This approach is expected to increase PrEP uptake and adherence, thereby reducing HIV transmission rates.
The introduction of Apretude as a long-acting injectable PrEP marks a significant milestone in HIV prevention efforts. As healthcare providers and public health officials work to implement this new option, it is anticipated that it will play a crucial role in reducing HIV incidence and moving closer to ending the HIV epidemic.