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: May 22, 2018; Last Reviewed: May 22, 2018

Rilpivirine (RPV, Edurant)
Rilpivirine (RPV, Edurant)
For additional information see Drugs@FDA: https://www.accessdata.fda.gov/scripts/cder/daf/
Formulations
Tablet: 25 mg

Fixed-Dose Combination Tablets:
  • [Complera] Emtricitabine 200 mg plus rilpivirine 25 mg plus tenofovir disoproxil fumarate (TDF) 300 mg
  • [Odefsey] Emtricitabine 200 mg plus rilpivirine 25 mg plus tenofovir alafenamide (TAF) 25 mg
  • [Juluca] Dolutegravir 50 mg plus rilpivirine 25 mg
Dosing Recommendations Selected Adverse Events
Neonate/Infant Dose:
  • Not approved for use in neonates or infants.
Children Aged <12 Years:
  • Not Food and Drug Administration-approved for use in children aged <12 years. For more information regarding consideration for use in children aged <12 years and weighing ≥35 kg, see the Pharmacokinetics section below.
Adolescent (Weighing ≥35 kg) and Adult Dose:
  • 25 mg once daily in antiretroviral (ARV)-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 rilpivirine and other ARV drugs in the new regimen.

Combination Tablets
[Complera] Emtricitabine plus Rilpivirine plus TDF
Adolescent (Weighing ≥35 kg) and Adult Dose:
  • One tablet once daily in treatment-naive patients with baseline viral load ≤100,000 copies/mL. One tablet once daily can also be used to replace a stable ARV regimen in patients who are currently on their first or second regimen and who have been virologically suppressed (HIV-1 RNA <50 copies per mL) for ≥6 months with no history of treatment failure and no known current or past substitutions associated with resistance to the individual components of Complera.
[Odefsey] Emtricitabine plus Rilpivirine plus TAF
Adolescent (Weighing ≥35 kg) and Adult Dose:
  • One tablet once daily with a meal as initial therapy in treatment-naive patients with HIV-1 RNA ≤100,000 copies per mL. One tablet once daily can also be used to replace a stable ARV regimen in patients who have been virologically suppressed (HIV-1 RNA <50 copies per mL) for ≥6 months with no history of treatment failure and no known current or past substitutions associated with resistance to the individual components of Odefsey.
[Juluca] Dolutegravir plus 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-1 RNA <50 copies per mL) on a stable ARV regimen for ≥6 months with no history of treatment failure and no known substitutions associated with resistance to the individual components of Juluca.
  • Not approved for children or adolescents. See Simplification of Treatment section below.
  • Depression
  • Insomnia
  • Headache
  • Rash (can be severe and include Drug Reaction/Rash with Eosinophilia and Systemic Symptoms)
  • Hepatotoxicity
  • Altered ACTH stimulation test of uncertain clinical significance
Special Instructions
  • Do not start rilpivirine in patients with HIV RNA >100,000 copies/mL due to increased risk of virologic failure.
  • Patients must be able to take rilpivirine with a meal of at least 500 calories on a regular schedule (a protein drink alone does not constitute a meal).
  • Do not use rilpivirine with other non-nucleoside reverse transcriptase inhibitors.
  • Do not use rilpivirine with proton pump inhibitors.
  • Antacids should only be taken at least 2 hours before or at least 4 hours after rilpivirine.
  • Use rilpivirine with caution when co-administered with a drug that has a known risk of Torsades de Pointes (for more information see CredibleMeds)
  • When using fixed-dose combination (FDC) tablets, see other sections of the Drug Appendix for special instructions and additional information about the individual components of the FDC.
Metabolism/Elimination
  • Cytochrome P450 (CYP) 3A substrate
Rilpivirine Dosing in Patients with Hepatic Impairment:
  • No dose adjustment is necessary in patients with mild or moderate hepatic impairment.
  • Rilpivirine 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.
  • The FDC drugs Complera and Odefsey should not be used in patients with creatinine clearance <50 or <30 mL/min, respectively, or in patients who require dialysis.
  • Use rilpivirine with caution in patients with severe renal impairment or end-stage renal disease. Rilpivirine concentrations may be increased in patients with severe renal impairment or end-stage renal disease, so monitoring for adverse effects is especially important in these patients.
  • When using Complera, see the TDF section of the guidelines; when using Odefsey, see the TAF section.

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