HIV-1 Treatment

• Oral Lead-in Dosing to Assess Tolerability of Cabotegravir
• PO (Adults and Children ≥12 yr and ≥35 kg): 30 mg once daily (taken with rilpivirine 25 mg once daily). Continue for ≥28 days to assess tolerability prior to initiating cabotegravir/rilpivirine extended-release injection (Cabenuva) therapy. The last dose of oral cabotegravir should be taken on the same day that cabotegravir/rilpivirine extended-release injection (Cabenuva) therapy is initiated.
• Oral Dosing to Replace Planned Missed Doses of Cabotegravir/Rilpivirine Extended-Release Injection (Cabenuva)
• PO (Adults and Children ≥12 yr and ≥35 kg): To replace planned missed cabotegravir/rilpivirine extended-release injections (Cabenuva) for patients on monthly dosing schedule (if patient plans to miss scheduled monthly injection by >7 days): 30 mg once daily (with rilpivirine 25 mg once daily) initiated at the same time as missed injection of cabotegravir/rilpivirine and then continued until day the cabotegravir/rilpivirine extended-release injection (Cabenuva) is restarted (oral replacement therapy can be continued for up to 2 mo). To replace planned missed cabotegravir/rilpivirine extended-release injections (Cabenuva) for patients on every-2-mo dosing schedule (if patient plans to miss scheduled every-2-mo injection by >7 days): 30 mg once daily (with rilpivirine 25 mg once daily) initiated the same time as missed injection of cabotegravir/rilpivirine and then continued until day the cabotegravir/rilpivirine extended-release injection (Cabenuva) is restarted (oral replacement therapy can be continued for up to 2 mo).

HIV-1 Pre-exposure Prophylaxis

• May initiate with cabotegravir oral lead-in therapy (to assess tolerability of cabotegravir) prior to cabotegravir IM injections or may precede directly to cabotegravir IM injections without oral lead-in.
• Oral Lead-in Therapy
• PO (Adults and Children ≥12 yr and ≥35 kg): 30 mg once daily. Continue for ≥28 days to assess tolerability prior to initiating IM therapy (see Initiation Injections section below).
• Initiation Injections
• IM (Adults and Children ≥12 yr and ≥35 kg): With oral lead-in therapy: 600 mg once monthly for 2 consecutive mo (2nd initiation injection may be administered up to 7 days before or after the date the individual is scheduled to receive the injection); then proceed with continuation injections. 1st initiation injection should be given on the last day of oral cabotegravir lead-in therapy or within 3 days of the last dose of oral cabotegravir lead-in therapy (see Oral Lead-in Therapy section above to assess tolerability of cabotegravir). Without oral lead-in therapy: 600 mg once monthly for 2 consecutive mo (2nd initiation injection may be administered up to 7 days before or after the date the individual is scheduled to receive the injection); then proceed with continuation injections.
• Continuation Injections
• IM (Adults and Children ≥12 yr and ≥35 kg): 600 mg every 2 mo starting 2 mo after the last initiation injection (injection may be administered up to 7 days before or after the date the individual is scheduled to receive the injection).
• Missed Doses of Injection
• PO (Adults and Children ≥12 yr and ≥35 kg): Planned missed injections: If a patient plans to miss a scheduled every-2-mo dose of cabotegravir extended-release injection (Apretude) by >7 days, use cabotegravir 30 mg once daily to replace one every-2-mo injection. The 1st dose of oral therapy should be taken approximately 2 mo after the last dose of cabotegravir extended-release injection (Apretude) and continued until the day that injection dosing is restarted or within 3 days of injection dosing being restarted. For oral PrEP durations >2 mo, use an alternative oral regimen for PrEP. Unplanned missed injections: If a scheduled injection visit is missed or delayed by >7 days and oral dosing has not been taken in the interim, clinically reassess to determine if injection therapy remains appropriate.