Guidelines for the Use of Antiretroviral Agents in Pediatric HIV Infection

The information in the brief version is excerpted directly from the full-text guidelines. The brief version is a compilation of the tables and boxed recommendations.

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Non-Nucleoside Analogue Reverse Transcriptase Inhibitors (NNRTIs)

Rilpivirine

Last Updated: April 14, 2020; Last Reviewed: April 14, 2020

Rilpivirine (RPV, Edurant)
Rilpivirine (RPV, Edurant)
Formulations
Tablets: 25 mg

Fixed-Dose Combination Tablets:
  • [Complera] Emtricitabine 200 mg/rilpivirine 25 mg/tenofovir disoproxil fumarate 300 mg
  • [Juluca] Dolutegravir 50 mg/rilpivirine 25 mg
  • [Odefsey] Emtricitabine 200 mg/rilpivirine 25 mg/tenofovir alafenamide 25 mg
When using fixed-dose combination (FDC) tablets, refer to other sections of the Drug Appendix for information about the individual components of the FDC. See also Appendix A, Table 2. Antiretroviral Fixed-Dose Combination Tablets: Minimum Body Weights and Considerations for Use in Children and Adolescents

For additional information, see Drugs@FDA or DailyMed.
Dosing Recommendations Selected Adverse Events
Neonate and Infant Dose:
  • Rilpivirine (RPV) is not approved for use in neonates or infants.
Children Aged <12 Years:
  • RPV is not approved for use in children aged <12 years (for more information, see the Pharmacokinetics section below).
Child and Adolescent (Aged ≥12 Years and Weighing ≥35 kg) and Adult Dose:
  • RPV 25 mg once daily with a meal in antiretroviral therapy (ART)-naive patients who have HIV RNA ≤100,000 copies/mL or in patients who are virologically suppressed (HIV RNA <50 copies/mL) with no history of virologic failure or resistance to RPV and other antiretroviral (ARV) drugs in the new regimen.
[Complera] Emtricitabine/Rilpivirine/Tenofovir Disoproxil Fumarate (TDF)
Child and Adolescent (Aged ≥12 Years and Weighing ≥35 kg) and Adult Dose: 
  • One tablet once daily with a meal in ART-naive patients with baseline viral loads ≤100,000 copies/mL. One tablet once daily can also be used to replace the current ARV regimen in patients who are currently on their first or second regimen and who have been virologically suppressed (HIV RNA <50 copies/mL) for at least 6 months with no history of treatment failure and no known mutations associated with resistance to the individual components of Complera.
[Juluca] Dolutegravir/Rilpivirine
Adult Dose:
  • One tablet once daily with a meal as a complete regimen to replace the current ARV regimen in patients who have been virologically suppressed (HIV RNA <50 copies/mL) on a stable ARV regimen for at least 6 months with no history of treatment failure and no known mutations associated with resistance to the individual components of Juluca.
  • Not approved for use in children or adolescents (see Simplification of Treatment section below).
[Odefsey] Emtricitabine/Rilpivirine/Tenofovir Alafenamide (TAF)
 Child and Adolescent (Aged ≥12 Years and Weighing ≥35 kg) and Adult Dose:
  •  One tablet once daily with a meal in ART-naive patients with HIV RNA ≤100,000 copies/mL. One tablet once daily can also be used to replace a stable ARV regimen in patients who have been virologically suppressed (HIV RNA <50 copies/mL) for at least 6 months with no history of treatment failure and no known mutations associated with resistance to the individual components of Odefsey.
  • Depression
  • Insomnia
  • Headache
  • Rash (can be severe and include drug reaction [or rash] with eosinophilia and systemic symptoms)
  • Hepatotoxicity
  • Altered adrenocorticotropic hormone stimulation test of uncertain clinical significance
Special Instructions
  • Do not start RPV in patients with HIV RNA >100,000 copies/mL due to increased risk of virologic failure.
  • Patients must be able to take RPV with a meal of at least 500 calories on a regular schedule (a protein drink alone does not constitute a meal).
  • Do not use RPV with other non-nucleoside reverse transcriptase inhibitors.
  • Do not use RPV with proton pump inhibitors (e.g., omeprazole, pantoprazole).
  • Antacids should only be taken at least 2 hours before or at least 4 hours after RPV.
  • H2 receptor antagonists (e.g., cimetidine, famotidine) should only be administered at least 12 hours before or at least 4 hours after RPV.
  • Use RPV with caution when coadministering it with a drug that has a known risk of Torsades de Pointes (for more information, see CredibleMeds).
Metabolism/Elimination
  • Cytochrome P450 3A substrate.
Rilpivirine Dosing in Patients with Hepatic Impairment:
  • No dose adjustment is necessary in patients with mild or moderate hepatic impairment.
  • RPV decreases tubular secretion of creatinine and slightly increases measured serum creatinine, but it does not affect glomerular filtration.
Rilpivirine Dosing in Patients with Renal Impairment:
  • No dose adjustment is necessary in patients with mild or moderate renal impairment. However, RPV should be used with caution in patients with severe renal impairment or end-stage renal disease. These patients should be monitored more frequently for adverse events; renal dysfunction may alter drug absorption, distribution, and metabolism, leading to increased RPV concentrations.
  • The FDC tablet Complera should not be used in patients with creatinine clearance (CrCl) <50 mL/min, and the FDC tablet Odefsey should not be used in patients with CrCl <30 mL/min.
  • When using Complera, see the TDF section of the guidelines; when using Odefsey, see the TAF section.

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