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# FDA Approves Viiv’s Apretude for HIV Pre-Exposure
- URL: https://www.fdaweb.com/fda-approves-viivs-apretude-for-hiv-pre-exposure/
- Published: 2022-01-03T12:00:00.000Z
- Updated: 2026-09-14T17:26:31.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5150841

FDA has approved Viiv’s Apretude (cabotegravir extended-release injectable suspension) for use in some at-risk adults and adolescents for pre-exposure prophylaxis (PrEP) to reduce the risk of sexually-acquired HIV. It is the first approved injectable PrEP drug.

An agency [statement](https://www.fda.gov/news-events/press-announcements/fda-approves-first-injectable-treatment-hiv-pre-exposure-prevention?ref=fdaweb.com) says Apretude is given first as two initiation injections administered one month apart and every two months thereafter. Patients can either start treatment with Apretude or take oral Vocabria (cabotegravir) for four weeks to assess how well they tolerate the drug, FDA says.

Apretude’s safety and efficacy were evaluated in two trials that compared it to Truvada, a once-daily oral medication for HIV PrEP. In each trial participants who took Apretude had less risk of infection with HIV than those who took Truvada, the statement says.

More frequent side effects noted in the two trials were injection site reactions, headache, fever, fatigue, back pain, myalgia, and rash. Apretude includes a Boxed Warning to not use it unless a negative HIV test is confirmed. The labeling also includes Warnings and Precautions about hypersensitivity reactions, hepatotoxicity, and depressive disorders.

FDA granted Apretude a priority review and breakthrough therapy designation.