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FDA Approves First Monthly Injectable Regimen for HIV

FRIDAY, Jan. 22, 2021 -- The U.S. Food and Drug Administration approved the first monthly injectable, complete regimen for HIV-infected adults, the agency announced Thursday.

Cabenuva (cabotegravir and rilpivirine, injectable formulation) is a complete regimen for treatment of HIV-1 and offers an alternative to the current daily oral antiretroviral regimen. It is indicated for patients who are virologically suppressed on a stable antiretroviral regimen and who have no history of treatment failure and no known or suspected resistance to cabotegravir or rilpivirine. With this approval, the FDA also approved Vocabria (cabotegravir, tablet formulation). Patients should take Vocabria with oral rilpivirine (Edurant) for one month before initiation of Cabenuva to ensure they can tolerate the medications before switching to the extended-release injectable formulation.

Approval was based on data from the Phase 3 ATLAS and FLAIR studies, two randomized, open-label, controlled clinical trials in 1,182 HIV-infected adults. Before initiating Cabenuva treatment, study participants were virologically suppressed (HIV-1 RNA <50 copies/mL). After 48 weeks of treatment, a comparable number of patients receiving Cabenuva and patients who continued their daily current antiretroviral regimen continued to show virologic suppression. Researchers found no clinically relevant change from baseline in CD4+ cell counts.

The most commonly reported adverse reactions were injection site reactions, fever, fatigue, headache, musculoskeletal pain, nausea, sleep disorders, dizziness, and rash.

Approval of Cabenuva and Vocabria was granted to ViiV Healthcare.

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Posted: January 2021

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