Non-Nucleoside Analogue Reverse Transcriptase Inhibitors (NNRTIs)
Last Updated: April 14, 2020; Last Reviewed: April 14, 2020
Doravirine (DOR, Pifeltro)
|Doravirine (DOR, Pifeltro)
Tablet: 100 mg
Fixed-Dose Combination Tablets:
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.
- [Delstrigo] Doravirine 100 mg/lamivudine 300 mg/tenofovir disoproxil fumarate 300 mg
For additional information, see Drugs@FDA or DailyMed.
||Selected Adverse Events
|Child and Adolescent Dose:
Adult (Aged ≥18 Years) Dose:
- Doravirine (DOR) is not approved for use in children or adolescents aged <18 years.
[Delstrigo] Doravirine/Lamivudine/Tenofovir Disoproxil Fumarate (TDF)
- 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.
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.
- Abdominal pain
- Abnormal dreams
- Insomnia, somnolence
- 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.
Doravirine Dosing in Patients with Hepatic Impairment:
- DOR is metabolized by the enzyme cytochrome P450 3A.
- DOR 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. DOR has not been studied in patients with severe hepatic 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.