Drug updated on 9/4/2024
| Dosage Form | Injection (intramuscular; 600 mg/3mL, 400 mg/2mL) |
| Drug Class | HIV-1 integrase strand transfer inhibitor and HIV-1 non-nucleoside reverse transcriptase inhibitor |
| Ongoing and Completed Studies | ClinicalTrials.gov |
Indication
- Indicated as a complete regimen for the treatment of HIV-1 infection in adults and adolescents 12 years of age and older and weighing at least 35 kg to replace the current antiretroviral regimen in those who are virologically suppressed (HIV-1 RNA <50 copies/mL) on a stable antiretroviral regimen with no history of treatment failure and with no known or suspected resistance to either cabotegravir or rilpivirine.
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Summary
- Cabenuva (cabotegravir/rilpivirine) is indicated as a complete regimen for the treatment of HIV-1 infection in adults and adolescents 12 years of age and older, weighing at least 35 kg, to replace the current antiretroviral regimen in those who are virologically suppressed (HIV-1 RNA <50 copies/mL) on a stable antiretroviral regimen, with no history of treatment failure and no known or suspected resistance to either cabotegravir or rilpivirine.
- This summary is based on the review of three systematic review(s)/meta-analysis(es). [1-3]
- Virological Suppression and HIV-1 Prevention: CAB-LA+RPV-LA maintained virological suppression similar to daily oral therapy at 48 and 96 weeks (91.43% vs 92.2%), with high suppression sustained over 5 years (80.9%). CAB-LA showed superior HIV-1 prevention efficacy compared to tenofovir disoproxil fumarate-emtricitabine (0.33% vs 1.46%).
- Comparison with Standard of Care (SoC): CAB-LA+RPV-LA administered every 8 weeks demonstrated non-inferior efficacy in maintaining virological suppression compared to daily oral SoC at Week 48 in virologically suppressed, treatment-experienced individuals.
- Population Types: The efficacy outcomes of CAB-LA+RPV-LA were consistent across both treatment-naive and treatment-experienced patients, with no significant differences observed in virological suppression across different baseline third active drug class subgroups.
- CAB-LA and RPV-LA had a comparable safety profile to placebo in terms of adverse event-related withdrawals, but CAB-LA+RPV-LA had a higher incidence of drug-related adverse events (81.6% vs 6.2%), mostly mild to moderate injection site reactions that decreased over time.
- CAB-LA+RPV-LA Q8W showed no significant differences in overall adverse events, serious adverse events, or grade 3-5 adverse events compared to daily oral SoC, and CAB-LA and RPV-LA were generally well-tolerated with safety profiles similar to placebo.
Product Monograph / Prescribing Information
| Document Title | Year | Source |
|---|---|---|
| Cabenuva (cabotegravir/rilpivirine) Prescribing Information. | 2023 | ViiV Healthcare, Research Triangle Park, NC |