Drug updated on 10/2/2024
Dosage Form | Tablet (oral; 25 mg) |
Drug Class | HIV-1-specific, nonnucleoside reverse transcriptase inhibitors |
Ongoing and Completed Studies | ClinicalTrials.gov |
Indication
- Indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection in treatment-naïve 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.
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Summary
- Edurant (rilpivirine hydrochloride) is indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection in treatment-naïve 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; and 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.
- This summary is based on the review of five systematic review(s)/meta-analysis(es). [1-5]
- CAB-LA in HIV-1 Prevention: CAB-LA demonstrated superior efficacy in preventing HIV-1 compared to TDF-FTC (0.33% vs 1.46%; RR 0.21, 95% CI 0.07-0.61).
- Efficacy in Treatment: CAB-LA+RPV-LA showed comparable virologic suppression to daily oral regimens at 48 and 96 weeks (91.43% vs 92.2%; RR 0.99, 95% CI 0.97-1.02), maintaining high suppression rates (80.9% after 5 years).
- Comparison of Regimens: Integrase inhibitor (INI)-containing regimens, particularly those with DTG, were generally more effective than regimens containing rilpivirine (RPV) or efavirenz (EFV), with DTG+RPV showing low viral failure (0.6%) and high virologic suppression (92.4%) at 48 weeks.
- CAB-LA+RPV-LA: The regimen had a higher incidence of drug-related adverse events compared to placebo (81.6% vs 6.2%; RR 12.50, 95% CI 3.98-39.23), predominantly mild or moderate injection site reactions, with comparable safety in terms of adverse event-related withdrawal.
- DTG+RPV: Discontinuations due to adverse events were reported at 7.2% at 48 weeks, with similar rates at 96 weeks, indicating stable tolerability.
- There is no population types or subgroups information available in the reviewed studies.
Product Monograph / Prescribing Information
Document Title | Year | Source |
---|---|---|
Edurant (rilpivirine) Prescribing Information. | 2022 | Janssen Therapeutics, Titusville, NJ |