Drug updated on 7/25/2024
| 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
- Cabotegravir/rilpivirine (Cabenuva) is indicated for the treatment of HIV-1 infection in adults and adolescents aged 12 years and older who are virologically suppressed on a stable antiretroviral regimen.
- Three systematic reviews/meta-analyses were reviewed to gather information about Cabenuva's efficacy, safety, and population considerations.
- In comparison to other drugs like tenofovir disoproxil fumarate-emtricitabine, cabotegravir long-acting (CAB-LA) showed superior prophylactic efficacy with fewer incidences of HIV infection during prevention trials.
- CAB-LA+RPV-LA maintained similar levels of virological suppression as daily oral antiretrovirals over periods up to five years, making it an effective long-term treatment option for both treatment-naive and experienced populations.
- Safety profiles indicate that injection site reactions are common but tend to decrease over time. Overall safety was comparable to placebos and other regimens such as tenofovir disoproxil fumarate-emtricitabine.
- Subgroup analyses revealed consistent effectiveness across different baseline third active drug classes without significant differences in adverse events or virologic suppression rates.
Product Monograph / Prescribing Information
| Document Title | Year | Source |
|---|---|---|
| Cabenuva (cabotegravir/rilpivirine) Prescribing Information. | 2023 | ViiV Healthcare, Research Triangle Park, NC |