Cabotegravir/rilpivirine

(Cabenuva®)

Cabotegravir/rilpivirine

Drug updated on 6/24/2024

Dosage FormInjection (intramuscular; 600 mg/3mL, 400 mg/2mL)
Drug ClassHIV-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
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  • Cabotegravir/Rilpivirine (Cabenuva) is indicated as a complete regimen for the treatment of HIV-1 infection in adults and adolescents 12 years of age and older, offering an alternative to current antiretroviral regimens for those who are virologically suppressed with no history of treatment failure or resistance to either drug.
  • Three systematic reviews/meta-analyses provided detailed comparison and analysis on the safety and effectiveness of Cabenuva compared to other drugs used for treating HIV-1 infection.
  • The first study revealed that Cabenuva demonstrated a better preventive effect against HIV-1 compared to tenofovir disoproxil fumarate-emtricitabine. It also showed similar efficacy outcomes in both treatment-na├»ve and experienced patients, suggesting broad applicability across different patient populations.
  • The second study suggested non-inferiority between every 8 weeks administration of Cabenuva versus daily oral standard care among virologically suppressed, treatment-experienced individuals. No significant differences were observed across subgroups defined by baseline third active drug class, indicating its effectiveness across diverse patient groups.
  • In the third study focusing on pre-exposure prophylaxis application, Cabotegravir/Rilpivirine was generally well-tolerated, with a safety profile comparable to placebo. Specific pharmacokinetic details provided for men suggest that tailored dosing strategies might be optimal for different patient groups.
  • Cabenuva offers an option with comparable efficacy to standard care options with manageable adverse events, primarily involving injection site reactions. Over 85% of participants preferred long-acting antiretroviral regimens like Cabenuva, highlighting potential better adherence and overall satisfaction from a patient perspective.