Drug updated on 12/11/2024
| Dosage Form | Tablet (oral; emtricitabine/rilpivirine/tenofovir alafenamide; 200 mg/25 mg/25 mg) |
| Drug Class | HIV nucleoside analog reverse transcriptase inhibitors (HIV NRTI) 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 patients weighing at least 35kg as initial therapy in those with no antiretroviral treatment history with HIV-1 RNA less than or equal to 100,000 copies per mL; or to replace a stable antiretroviral regimen in those who are virologicallysuppressed (HIV-1 RNA less than 50 copies per mL) for at least 6 months with no history of treatment failure and no known substitutions associated with resistance to the individual components of ODEFSEY.
Latest News
Summary
- This summary is based on the review of two systematic review(s)/meta-analysis(es). [1-2]
- Long-acting cabotegravir (CAB-LA) demonstrated superior efficacy in preventing human immunodeficiency virus (HIV)-1 infection compared to tenofovir disoproxil fumarate-emtricitabine, with a significantly lower incidence rate in the CAB-LA group (0.33%) versus the tenofovir group (1.46%), yielding a risk ratio (RR) of 0.21 (95% confidence interval (CI) 0.07-0.61).
- Virological suppression rates for CAB-LA+long-acting rilpivirine (RPV-LA) were comparable to daily oral treatments at 48 weeks (91.43%) and 96 weeks (92.2%) with RR 0.99 (95% CI 0.97-1.02). High suppression levels were maintained long-term, with 80.9% suppression after 5 years of long-acting antiretroviral (LA-ARV) use, showing similar efficacy in both treatment-naive (93.2%) and treatment-experienced (94%) patients (RR 0.99, 95% CI 0.96-1.02).
- Adverse Event-Related Withdrawal and Safety Profile: CAB-LA and RPV-LA displayed a safety profile comparable to the placebo, with most adverse events being mild or moderate injection site reactions that decreased over time.
- Drug-Related Adverse Events: CAB-LA+RPV-LA was associated with more drug-related adverse events (81.6%) compared to the placebo group (6.2%) with an RR of 12.50 (95% CI 3.98-39.23), primarily mild or moderate injection site reactions.
- There is no population types or subgroups information available in the reviewed studies.
Product Monograph / Prescribing Information
| Document Title | Year | Source |
|---|---|---|
| Odefsey (emtricitabine, rilpivirine, and tenofovir alafenamide) Prescribing Information. | 2021 | Gilead Sciences, Inc., Foster City, CA |
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 |
| Comparison of the design and methodology of Phase 3 clinical trials of bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF) and dolutegravir-based dual therapy (DTG) in HIV: a systematic review of the literature | 2023 | Expert Review of Anti-infective Therapy |
Clinical Practice Guidelines
| Document Title | Year | Source |
|---|---|---|
| Recommendations for the use of antiretroviral drugs during pregnancy and interventions to reduce perinatal HIV transmission in the United States | 2023 | National Institutes of Health |
| Guidelines for the use of antiretroviral agents in adults and adolescents with HIV | 2023 | National Institutes of Health |
| Clinical considerations in the selection of preexposure prophylaxis for HIV prevention in Canada | 2022 | The Canadian Journal of Infectious Diseases & Medical Microbiology |
| European AIDS clinical society guidelines v10.1 October 2020 | 2020 | European AIDS Clinical Society |