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<p>Researchers hope this long-acting solution every will boost PrEP adherence rates among those at risk for contracting HIV.</p>

First Injectable Pre-Exposure Prophylaxis Receives FDA Approval

December 22, 2021

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By Jonathan Springston, Editor, Relias Media

The FDA this week approved cabotegravir extended-release injectable suspension, a first-of-its-kind pre-exposure prophylaxis (PrEP) to help at-risk adults lower the risk of acquiring HIV. Patients receive two initial injections, administered one month apart, then take an injection every two months.

Despite the expanded availability of PrEP, especially daily pills, data indicate only 25% of the more than 1 million patients eligible for PrEP even received a prescription for it in 2020. The FDA notes PrEP requires strict adherence to be effective; remembering to take a pill every day can be challenging. Efforts to conceal this medication, along with depression, poverty, and substance use disorders, also can affect PrEP adherence.

“Many people who are vulnerable to HIV have complex lives that can make taking a daily pill to prevent HIV a burden. This can include stigma, fears about accidental disclosure of their medicine, as well as general complications from daily living. Together, these issues may contribute to low rates of PrEP usage and the expansion of the HIV epidemic,” Gabriel Maldonado, MBA, executive director and CEO, of TruEvolution, said in a statement. “Our community has been in dire need of additional HIV prevention options that may address their evolving needs, and cabotegravir long-acting for PrEP represents an exciting new option to help them reduce their risk of acquiring HIV.”

The FDA based approval on two randomized, double-blind trials that compared the injection to Truvada, a once-daily PrEP oral medication. Trial 1 included 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. Participants who took the cabotegravir injection were 69% less likely to contract HIV in trial 1 and 90% less likely in trial 2.

For more on this and related subjects, be sure to read future issues of Infectious Disease Alert and Internal Medicine Alert.