Cabotegravir (Apretude (PrEP), Vocabria / Cabenuva (treatment, with rilpivirine))
Long-acting cabotegravir is used for HIV pre-exposure prophylaxis (Apretude) and, combined with long-acting rilpivirine (Cabenuva), for treatment of virologically suppressed HIV-1. Its 2021 PrEP approval followed HPTN 083/084; treatment approvals followed FLAIR/ATLAS/ATLAS-2M.
- Mechanism of action
- Inhibits HIV-1 integrase, preventing integration of viral DNA into the host genome. Available as a long-acting injectable formulation.
- Administration route
- Intramuscular injection (long-acting) for PrEP and for treatment in combination with rilpivirine; oral formulations used for lead-in/oral bridging.
FDA-approved indications (2026)
HIV pre-exposure prophylaxis
At-risk adults and adolescents ≥35 kg for PrEP (Apretude).
HIV-1 treatment
Virologically suppressed adults and adolescents on stable oral ART, in combination with long-acting rilpivirine (Cabenuva).
Dosing: adult, renal, and hepatic
| Population | Dose |
|---|---|
| PrEP | Optional oral lead-in 30 mg PO daily × 4 wk, then 600 mg IM at month 1, month 2, and every 2 months thereafter. |
| HIV treatment (with rilpivirine) | 600 mg cabotegravir IM + 900 mg rilpivirine IM monthly, or 400 mg + 600 mg every 2 months after initial injections. |
| Renal impairment | No adjustment in mild-moderate. Monitor in severe or ESKD. |
| Hepatic impairment | No dose adjustment in mild-moderate. Not recommended in severe hepatic impairment. |
Contraindications and boxed warnings
Contraindications
- Concomitant use with strong UGT1A1/1A9 inducers (e.g., rifampin, carbamazepine).
- Prior hypersensitivity to cabotegravir.
2026 guideline and pivotal trial position
2026 USPSTF and CDC PrEP guidance include long-acting cabotegravir as a preferred option for adults and adolescents at increased risk of HIV, particularly for those with adherence challenges on oral PrEP. DHHS HIV treatment guidelines endorse monthly or every-two-months LA cabotegravir + rilpivirine for maintenance ART in virologically suppressed, adherent patients without certain resistance mutations.
HPTN 083
Superior HIV prevention vs oral FTC/TDF in men who have sex with men and transgender women.
HPTN 084
Superior HIV prevention vs oral FTC/TDF in cisgender women in sub-Saharan Africa.
FLAIR / ATLAS / ATLAS-2M
Noninferior viral suppression with LA CAB + RPV (monthly or q2mo) vs oral ART.
Cross-system reasoning
Long-acting cabotegravir reframes HIV prevention and maintenance around an infectious-disease / primary-care delivery infrastructure for injections every 1–2 months. For a patient with HIV, chronic HBV, and renal disease, LA cabotegravir is suitable for HIV control but does not cover HBV; HBV therapy must be maintained. Drug-drug interactions with enzyme inducers (rifampin, carbamazepine, phenytoin) are critical; co-management with neurology or TB services requires explicit regimen review.
Key references
Related clinical reading
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This reference is for US-licensed physicians and is not a substitute for the full FDA prescribing information. Dosing in special populations, drug interactions, and emerging safety information should be verified against the current manufacturer label and society guidelines before prescribing.