FDA Approves First Injectable Treatment for #HIV Pre-Exposure Prevention (PrEP)

On December 10, 2021, the U.S. Food and Drug Administration approved Apretude (cabotegravir extended-release injectable suspension) for use in at-risk adults and adolescents weighing at least 35 kilograms (77 pounds) for pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV. Apretude is given first as two initiation injections administered one month apart, and then every two months thereafter. Patients can either start their treatment with Apretude or take oral cabotegravir (Vocabria) for four weeks to assess how well they tolerate the drug.
Read full FDA announcement here.

FDA Grants New Indication for Cabenuva for Every-8–Week Dosing

On February 1, 2022, the FDA announced the time between shots of cabotegravir plus rilpivirine (CAB/RPV; Cabenuva, ViiV Healthcare) has been extended to every two months to treat HIV-1 infection in virologically suppressed adults, according to the IDSE. Patients must have no history of treatment failure and be on a stable regimen without a known or suspected resistance to cabotegravir or rilpivirine. This new indication allows CAB/RPV to be administered every four or eight weeks.
Read full article here.

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