Drug updated on 10/25/2024
| Dosage Form | Injection (intramuscular; cabotegravir: 400 mg/2 mL [200 mg/mL], rilpivirine: 600 mg/2 mL [300 mg/mL]; cabotegravir: 600 mg/3 mL [200 mg/mL], rilpivirine: 900 mg/3 mL [300 mg/mL]) |
| Drug Class | Human immunodeficiency virus type 1 (HIV-1) integrase strand transfer inhibitors (INSTI) and HIV-1 non-nucleoside reverse transcriptase inhibitors (NNRTI) |
| 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.
Latest News
Summary
- This summary is based on the review of two systematic review(s)/meta-analysis(es). [1-2]
- CAB-LA (cabotegravir) demonstrated superior efficacy in preventing HIV-1 infection compared to tenofovir disoproxil fumarate-emtricitabine, with an infection rate of 0.33% (17/5161) versus 1.46% (75/5129) for tenofovir, resulting in a risk ratio (RR) of 0.21 (95% CI 0.07-0.61).
- CAB-LA combined with rilpivirine (RPV-LA) maintained high virological suppression rates at both 48 and 96 weeks (91.43% vs. 92.2%) with an RR of 0.99 (95% CI 0.97-1.02), showing long-term efficacy comparable to daily oral antiretrovirals.
- Efficacy outcomes were similar between treatment-naive patients (93.2%) and treatment-experienced patients (94%), demonstrating consistent effectiveness across both groups.
- CAB-LA and RPV-LA were generally well-tolerated, with adverse events comparable to placebo, including mild to moderate injection site reactions, which decreased over time.
- The overall rate of adverse event-related withdrawals for CAB-LA and RPV-LA was similar to placebo, indicating no significant safety concerns during the study.
- Specific pharmacokinetic findings showed superior dosing regimens for male participants, with CAB-LA 600 mg Q8W performing better than CAB-LA 800 mg Q12W. A high preference for long-acting antiretrovirals (over 85%) was observed among people living with HIV.
Product Monograph / Prescribing Information
| Document Title | Year | Source |
|---|---|---|
| Cabenuva (cabotegravir, rilpivirine) Prescribing Information. | 2024 | ViiV Healthcare, Research Triangle Park, NC |
Systematic Reviews / Meta-Analyses
| Document Title | Year | Source |
|---|---|---|
| Safety and Efficacy of Long-Acting Injectable Agents for HIV-1: Systematic Review and Meta-Analysis | 2023 | JMIR Public Health and Surveillance |
| Safety and Pharmacokinetic Profiles of Long-Acting Injectable Antiretroviral Drugs for HIV-1 Pre-Exposure Prophylaxis: A Systematic Review and Meta-analysis of Randomized Trials | 2021 | Frontiers in Pharmacology |