Drug updated on 3/28/2024
| Dosage Form | Injection (intramuscular; 600 mg/3mL, 400 mg/2mL) |
| Drug Class | Antiviral combinations |
| Ongoing and Completed Studies | ClinicalTrials.gov |
Indication
- For the treatment of HIV-1 infection in adults to replace the current antiretroviral regimen in those who are virologically suppressed (HIV-1 RNA less than 50 copies per mL) on a stable antiretroviral regimen with no history of treatment failure and with no known or suspected resistance to either cabotegravir or rilpivirine.
Summary
- Cabotegravir/rilpivirine (Cabenuva) is indicated for the treatment of HIV-1 infection in adults who are virologically suppressed on a stable antiretroviral regimen with no history of treatment failure and no known or suspected resistance to either cabotegravir or rilpivirine.
- Two systematic reviews/meta-analyses were reviewed, which included studies that reported efficacy and safety data on long-acting antiretrovirals intervention in people living with HIV.
- The first review found that cabotegravir/rilpivirine demonstrated safety profiles comparable to those of placebo regarding adverse event-related withdrawal, suggesting it was well-tolerated by patients.
- In terms of effectiveness, this same review showed that cabotegravir had better effects on preventing HIV-1 than tenofovir disoproxil fumarate-emtricitabine; moreover, when combined with rilpivrine as Cabenuva, it maintained high levels (80.9%) of virological suppression even after 5 years use among both treatment-naive and experienced patients.
- According to questionnaires cited in the first review document more than 85% people living with HIV favored long acting antiretrovirals like Cabenuva over daily oral drugs due its convenience and sustained viral suppression ability.
- The second review also confirmed favorable safety profile for both CAB-LA and RPV-LA similar to placebo alongwith promising pharmacokinetic profiles indicating their potential preventive efficacy against HIV-1 infection currently being evaluated further in Phase 3 trials.
Product Monograph / Prescribing Information
| Document Title | Year | Source |
|---|---|---|
| Cabenuva (cabotegravir/rilpivirine) Prescribing Information. | 2023 | 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 |
| Cabotegravir with rilpivirine for treating HIV-1. | 2022 | NICE |
| Australian public assessment report for cabotegravir sodium and cabotegravir/rilpivirine. | 2021 | Australian Government: Department of Health |
| 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 |
| Clinical guidance report: cabotegravir tablets, cabotegravir extended-release injectable suspension and rilpivirine extended-release injectable suspension. | 2020 | CADTH |