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FDA Approves Injectable Cabotegravir for PrEP

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Strategic Alliance Partners | <b>Fenway Health</b>

The therapy becomes the first injectable approved in the United States for this indication.

The Food and Drug Administration (FDA) announced today it has approved Apretude (cabotegravir extended-release injectable suspension) for pre-exposure prophylaxis (PrEP) for adults and adolescents to reduce the risk of HIV. Apretude is given first as 2 injections, 1 month apart, and then every 2 months thereafter.

Users can either start their treatment with injectable cabotegravir or take oral cabotegravir (Vocabria) for 4 weeks to decide how well they tolerate the drug.

This approval offers users another option that does not require daily adherence.

“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,” Debra Birnkrant, MD, director of the Division of Antivirals in the FDA’s Center for Drug Evaluation and Research, stated. “This injection, given every 2 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.”

Clinical Trials

The safety and efficacy of Apretude were evaluated in 2 trials that compared Apretude to tenofovir disoproxil fumarate with emtricitabine (TDF/FTC) (Truvada), a once daily oral medication for PrEP. The trials were randomized, double-blind studies. 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.

Participants who took Apretude started the trial with cabotegravir (oral, 30 mg tablet) and a placebo daily for up to 5 weeks, followed by Apretude 600mg injection at months 1 and 2, then every 2 months thereafter and a daily placebo tablet.

Participants who took Truvada started the trial taking oral Truvada and placebo daily for up to 5 weeks, followed by oral Truvada daily and placebo intramuscular injection at months 1 and 2 and every 2 months thereafter.

In Trial 1, 4566 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 2 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 Trial 2, 3224 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.

“This potent new PrEP option…is a terrific development in HIV prevention,” Douglas Krakower, MD, is Faculty in the Division of Infectious Diseases at Beth Israel Deaconess Medical Center, research scientist at The Fenway Institute, and Assistant Professor in Medicine and Population Medicine at Harvard Medical School, said.

Side effects occurred more frequently in participants who received Apretude compared to participants who received Truvada, and included injection site reactions, headache, fever, fatigue, back pain, myalgia and rash.

Positive Trend, Still Greater Initiation Needed

Over the last 5 years, significant strides towards greater PrEP initiation have been made. According to the Centers for Disease Control and Prevention, PrEP use in the United States is at approximately 25% of the 1.2 million people for whom it is recommended. And this increase is up from about 3% usage in 2015.

Still, there is a long way to go for greater initiation and communities disproportionately affected by HIV, such as injection drug users, trans people, and Black Americans, are not getting the message and typically have lower initiation rates compared to White men who have sex with men.

Krakower believes it can help reduce HIV rates in these other populations, but it is about how public health programs and individual providers reach them to disseminate messaging and the therapies. “If it is implemented in ways that are culturally-sensitive, patient-focused, and convenient,” Krakower explained. “This could include mobile van units to meet people where they live; embedding PrEP in community-based organizations that can improve trust in populations that have experiences discrimination in health care settings, such as LGBTQIA+ populations, Black and Latinx people, and people who inject drugs, among others.”