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)

Doravirine

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

Doravirine (DOR, Pifeltro)
Doravirine (DOR, Pifeltro)
Formulations
Tablet: 100 mg

Fixed-Dose Combination Tablets:
  • [Delstrigo] Doravirine 100 mg/lamivudine 300 mg/tenofovir disoproxil fumarate 300 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
Child and Adolescent Dose:
  • Doravirine (DOR) is not approved for use in children or adolescents aged <18 years.
Adult (Aged ≥18 Years) Dose:
  • DOR 100 mg once daily in antiretroviral (ARV)-naive patients and ARV-experienced patients who have been virologically suppressed (HIV RNA <50 copies/mL) on a stable ARV regimen with no history of treatment failure and no known mutations associated with resistance to DOR.
[Delstrigo] Doravirine/Lamivudine/Tenofovir Disoproxil Fumarate (TDF)
Adult (Aged ≥18 Years) Dose:
  • One tablet once daily in ARV-naive patients and ARV-experienced patients who have been virologically suppressed (HIV RNA <50 copies/mL) on a stable ARV regimen with no history of treatment failure and no known mutations associated with resistance to DOR.
  • Nausea
  • Abdominal pain
  • Diarrhea
  • Abnormal dreams
  • Insomnia, somnolence
Special Instructions
  • DOR can be taken with or without food.
  • Do not use DOR with other non-nucleoside reverse transcriptase inhibitors.
  • When DOR is coadministered with rifabutin, the dose should be increased from DOR 100 mg once daily to DOR 100 mg twice daily. When doravirine/lamivudine/TDF (DOR/3TC/TDF; Delstrigo) is coadministered with rifabutin, an additional 100-mg dose of freestanding DOR needs to be administered approximately 12 hours later.
  • Screen patients for hepatitis B virus (HBV) infection before using Delstrigo, which contains 3TC and TDF. Severe acute exacerbation of HBV can occur when 3TC or TDF are discontinued; therefore, hepatic function and hepatitis B viral load should be monitored for several months after halting therapy with 3TC or TDF.
Metabolism/Elimination
  • DOR is metabolized by the enzyme cytochrome P450 3A.
  • DOR has multiple interactions with several drugs (see text below).
Doravirine Dosing in Patients with Hepatic Impairment:
  • Dose adjustment is not required in patients with mild or moderate hepatic impairment. DOR has not been studied in patients with severe hepatic impairment.
Doravirine Dosing in Patients with Renal Impairment:
  • Dose adjustment is not required when using DOR in patients with mild, moderate, or severe renal impairment. DOR use has not been studied in patients with end-stage renal disease or in patients on dialysis.
  • DOR administered with 3TC and TDF as components of Delstrigo is not recommended in patients with estimated creatinine clearance <50 mL/min.

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