Infectious Disease

FDA approves first long-acting solution for injection for HIV prevention

December 20, 2021

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Birnkrant does not report any relevant financial information. Waterhouse is employed by ViiV Healthcare.

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The FDA on Monday approved ViiV Healthcare’s cabotegravir as the first long-acting solution for injection for HIV-PrEP.

The drug known as Apretude is given every 2 months after two initial injections 1 month apart. The FDA has approved it for vulnerable adults and adolescents weighing at least 77 pounds.

FDA approval

The FDA has approved ViiV Healthcare’s cabotegravir as the first long-acting injectable regimen for HIV-PrEP. Source: Adobe Stock

Debra Birnkrant, MD, who heads the antiviral drug division at the FDA’s Center for Drug Evaluation and Research, said the approval “adds an important tool to ending the HIV epidemic by providing the first option to prevent HIV that doesn’t involve ingestion daily pill includes “.

“This injection … will be critical to tackling the HIV epidemic in the US, including helping high-risk people and specific groups where adherence to daily medication has been a great challenge or not a realistic option,” Birnkrant said in a press release.

Pending approval, the CDC has included a prescribing section for cabotegravir in its updated HIV-PrEP clinical practice guidelines published 2 weeks ago. The CDC also recommended for the first time clinicians to tell all sexually active adult and adolescent patients about HIV-PrEP, as it has been shown that only about 25% of the 1.2 million people in the United States who will be indicated for it in 2020 Met PrEP, got it prescribed.

The FDA approval was based on study results showing that cabotegravir, given every 8 weeks, prevented HIV infection. Two studies provided the data: one that was done on transgender women and cis men who have sex with men, and a second study that only included cis women.

“People susceptible to HIV infection, especially those in black and Latinx communities who are disproportionately affected in the US, may want alternatives beyond the daily oral pills. For this reason, ViiV Healthcare is proud to have apretude featured in one of the most diverse and comprehensive HIV prevention study programs to date, including some of the largest numbers of transgender women and black men who have sex with men ever developed HIV disease. Prevention Participated Trial, ”ViiV CEO Deborah water house said in a statement.

Cabotegravir was part of the first FDA-approved long-acting injectable regimen for HIV treatment, Cabenuva, which also contains rilpivirine.

References:

CDC. PrEP for HIV prevention in the US. https://www.cdc.gov/nchhstp/newsroom/fact-sheets/hiv/PrEP-for-hiv-prevention-in-the-US-factsheet.html#anchor_1637678358. Accessed December 20, 2021.

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