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 16, 2019; Last Reviewed: April 16, 2019

Doravirine (DOR, Pifeltro)
Doravirine (DOR, Pifeltro)
For additional information see Drugs@FDA: https://www.accessdata.fda.gov/scripts/cder/daf/
Formulations
Tablet: 100 mg

Fixed-Dose Combination Tablet:
  • [Delstrigo] Doravirine 100 mg/lamivudine 300 mg/tenofovir disoproxil fumarate (TDF) 300 mg
Dosing Recommendations Selected Adverse Events
Child and Adolescent Dose:
  • Doravirine is not approved for use in children or adolescents aged <18 years.
Adult (Aged ≥18 Years) Dose
Antiretroviral-Naive Patients:
  • Doravirine 100 mg once daily
[Delstrigo] Doravirine/Lamivudine/TDF
Adult (Aged ≥18 Years) Dose:
  • One tablet once daily
  • Nausea
  • Abdominal pain
  • Diarrhea
  • Abnormal dreams
  • Insomnia, somnolence
Special Instructions
  • Doravirine can be taken with or without food.
  • Do not use doravirine with other non-nucleoside reverse transcriptase inhibitors.
  • When doravirine is coadministered with rifabutin, the dose of doravirine should be increased to 100 mg twice daily. When doravirine/lamivudine/TDF (Delstrigo) is coadministered with rifabutin, an additional dose of freestanding doravirine (Pifeltro) needs to be administered approximately 12 hours later.
  • Screen patients for hepatitis B virus (HBV) infection before using Delstrigo, which contains lamivudine and TDF. Severe acute exacerbation of HBV can occur when lamivudine or TDF is discontinued; therefore, hepatic function should be monitored for several months after halting therapy with lamivudine or TDF.
  • See the lamivudine and TDF sections of the Drug Appendix for special instructions and additional information about the individual drug components of Delstrigo.
Metabolism/Elimination
  • Doravirine is metabolized by the enzyme cytochrome P450 3A.
  • Doravirine 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. Doravirine has not been studied in patients with severe hepatic impairment.
Doravirine Dosing in Patients with Renal Impairment:
  • Dose adjustment is not required when using doravirine in patients with mild, moderate, or severe renal impairment. Doravirine use has not been studied in patients with end-stage renal disease and or in patients on dialysis.
  • Doravirine administered with lamivudine and TDF as components of Delstrigo is not recommended in patients with estimated creatinine clearance <50 mL/min.

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