Drug updated on 12/11/2024
| Dosage Form | Tablet (oral; 200 mg of emtricitabine, 25 mg of rilpivirine, and 300 mg of tenofovir disoproxil fumarate) |
| Drug Class | Nucleoside analog HIV-1 reverse transcriptase inhibitors and non-nucleoside reverse transcriptase inhibitors |
| Ongoing and Completed Studies | ClinicalTrials.gov |
Indication
- Indicated for use as a complete regimen for the treatment of HIV-1 infection in patients weighing at least 35 kg (1) as initial therapy in those with no antiretroviral treatment history and with HIV-1 RNA less than or equal to 100,000 copies/mL at the start of therapy, or (2) or to replace a stable antiretroviral regiment in those who are virologically suppressed (HIV-1 RNA <50 copies/mL) on a stable antiretroviral regimen for at least 6 months with no treatment failure and no known substitutions associated with resistance to the individual components of COMPLERA.
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) significantly reduced human immunodeficiency virus (HIV)-1 infection rates (0.33%) compared to tenofovir disoproxil fumarate-emtricitabine (1.46%), with a risk ratio of 0.21 (95% confidence interval (CI) 0.07-0.61).
- CAB-LA+long-acting rilpivirine (RPV-LA) maintained high virological suppression at 48 and 96 weeks (80.9% at 5 years), with similar efficacy in treatment-naive (93.2%) and treatment-experienced (94%) patients.
- More than 85% of people living with HIV preferred long-acting antiretrovirals (LA-ARVs).
- Higher incidence of drug-related adverse events was observed with CAB-LA+RPV-LA (81.6%) compared to placebo (6.2%), with the most common adverse event being mild or moderate injection site reactions, which decreased over time.
- The safety profile of CAB-LA+RPV-LA was comparable to placebo in terms of adverse event-related withdrawals.
- There is no population types or subgroups information available in the reviewed studies.
Product Monograph / Prescribing Information
| Document Title | Year | Source |
|---|---|---|
| Complera (emtricitabine, rilpivirine, tenofovir disoproxil fumarate) Prescribing Information. | 2019 | Gilead Sciences, Inc. |
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 |