Cabotegravir (Apretude®)

Coverage: Apretude (cabotegravir IM) is authorized only for FDA‑approved PrEP to reduce risk of sexually acquired HIV‑1 infection and is not covered for treatment of established HIV infection. Key requirements: approval (up to 12 months) requires weight ≥35 kg, a negative HIV‑1 test within 1 week and no signs of acute infection, prescription by or in consultation with an HIV specialist, use as part of a comprehensive prevention strategy, adherence to initiation (two 600 mg IM injections 1 month apart or with oral lead‑in given and injections on last day of lead‑in/within 3 days) and continuation dosing (600 mg IM every 2 months), plus documentation of all criteria.

"Apretude is indicated for pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV-1 infection."

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