Non-Nucleoside Analogue Reverse Transcriptase Inhibitors (NNRTIs)
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/
|Tablet: 100 mg
Fixed-Dose Combination Tablet:
- [Delstrigo] Doravirine 100 mg/lamivudine 300 mg/tenofovir disoproxil fumarate (TDF) 300 mg
||Selected Adverse Events
|Child and Adolescent Dose:
Adult (Aged ≥18 Years) Dose
- Doravirine is not approved for use in children or adolescents aged <18 years.
- Doravirine 100 mg once daily
Adult (Aged ≥18 Years) Dose:
- Abdominal pain
- Abnormal dreams
- Insomnia, somnolence
- 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.
Doravirine Dosing in Patients with Hepatic Impairment:
- Doravirine is metabolized by the enzyme cytochrome P450 3A.
- Doravirine has multiple interactions with several drugs (see text below).
Doravirine Dosing in Patients with Renal 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.
- 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.