Drug updated on 4/17/2024
| 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.
Summary
- Rilpivirine hydrochloride (Edurant) is indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection, specifically in treatment-naïve patients aged 12 and older who weigh at least 35 kg and have an HIV-1 RNA count less than or equal to 100,000 copies/mL. It's also used alongside VOCABRIA (cabotegravir) for short-term treatment of virologically suppressed adults.
- Five systematic reviews/meta-analyses compared Edurant to other antiretroviral agents regarding safety and efficacy. The studies focused on its use across various populations including aging individuals, those seeking long-lasting treatments, and first-time patients.
- Long-acting rilpivirine was favored by over 85% of individuals living with HIV due to convenience and a reduced need for daily dosing without compromising safety or effectiveness. However, there was a higher frequency of drug-related adverse events such as mild injection site reactions that tend to decrease over time.
- Aging may affect the pharmacokinetics of rilpivirine, but specific insights are not provided within these studies, indicating a gap in knowledge about how this population might handle rilpivirine compared to other antiretrovirals.
- While effective when included in non-nucleoside reverse transcriptase inhibitor-based regimens, integrase inhibitor-based regimens containing dolutegravir were generally more efficacious and safer, according to one study suggesting alternatives like dolutegravir may offer better outcomes, especially among first-time adult patients infected with HIV-1.
- Studies suggest that switching clinically suppressed patients onto a two-drug regimen consisting of dolutegravir plus rilpivirine results in low rates of virologic failure and high rates of suppression, affirming the proposed benefits of such a strategy, thus positioning it as a viable option for certain patient populations.
Product Monograph / Prescribing Information
| Document Title | Year | Source |
|---|---|---|
| Edurant (rilpivirine) Prescribing Information. | 2022 | Janssen Therapeutics, Titusville, NJ |