Drug updated on 12/11/2024
| Dosage Form | Tablet (oral; 25 mg) |
| Drug Class | HIV-1 non-nucleoside reverse transcriptase inhibitors (NNRTI) |
| Ongoing and Completed Studies | ClinicalTrials.gov |
Indication
- Indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection in treatment-nave patients 12 years of age and older and weighing at least 35 kg with HIV-1 RNA less than or equal to 100,000 copies/mL
- Indicated in combination with VOCABRIA (cabotegravir), for short-term treatment of HIV-1 infection in adults who are virologically suppressed (HIV-1 RNA less than 50 copies/mL) on a stable 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 seven systematic review(s)/meta-analysis(es). [1-7]
- No significant differences in treatment failure or virological failure were observed between two-drug regimens, including dolutegravir/rilpivirine (DTG/RPV), and triple-drug regimens at 96 weeks in virosuppressed people living with human immunodeficiency virus (HIV) (PLWH) (relative risk (RR) 0.77; 95% confidence interval (CI) 0.53–1.13; P=0.182 for treatment failure; RR 0.79; 95% CI 0.48–1.29; P=0.341 for virological failure). Long-acting cabotegravir (CAB-LA) and long-acting rilpivirine (RPV-LA) showed comparable efficacy to daily oral drugs at both 48 and 96 weeks (RR 0.99; 95% CI 0.97–1.02).
- Virological suppression rates were higher for DTG, including DTG/RPV, compared to protease inhibitors (PIs), efavirenz (EFV), and elvitegravir/cobicistat (EVG/c) at 96 weeks, with similar suppression rates to rilpivirine (RPV), raltegravir (RAL), and bictegravir (BIC). High suppression rates (92.4%) were maintained at 48 weeks for DTG+RPV in virologically suppressed PLWH, with a pooled virological failure rate of 0.6%.
- DTG demonstrated higher virological suppression in patients with baseline viral load >100,000 copies/mL, while CAB-LA+RPV-LA displayed consistent efficacy in both treatment-naive and treatment-experienced individuals. Real-world evidence supported high virological suppression rates across diverse backgrounds for DTG+RPV in virologically suppressed PLWH.
- No significant differences were observed in adverse drug reactions leading to discontinuation (RR, 1.74; 95% CI, 0.73-4.17; P=0.215) or the appearance of mutation (RR, 2.48; 95% CI, 0.33-18.68; P=0.379) between two-drug and triple-drug regimens.
- CAB-LA+RPV-LA was associated with more drug-related adverse events (81.6% vs 6.2%; RR 12.50; 95% CI 3.98-39.23; I²=85%), primarily presenting as mild or moderate injection site reactions.
- Virosuppressed PLWH demonstrated no significant differences in treatment outcomes between two-drug and triple-drug regimens, with similar efficacy observed in both treatment-naive and treatment-experienced populations; DTG achieved higher virological suppression in patients with baseline VL > 100,000 copies/mL, and real-world data showed high virological suppression rates for DTG+RPV in diverse backgrounds.
Product Monograph / Prescribing Information
| Document Title | Year | Source |
|---|---|---|
| Edurant (rilpivirine) Prescribing Information. | 2024 | Janssen Products, LP., Titusville, NJ |