Drug Class: Antiviral combinations
Usual Adult Dose for HIV Infection
1 tablet orally once a day
Use: As a complete regimen, for the treatment of HIV-1 infection in patients with no prior antiretroviral treatment history or to replace the current antiretroviral regimen in patients virologically-suppressed (HIV-1 RNA less than 50 copies/mL) on a stable antiretroviral regimen with no history of treatment failure and no known substitutions associated with resistance to the components of this drug
Renal Dose Adjustments
Estimated CrCl less than 50 mL/min: Not recommended.
- If estimated CrCl falls below 50 mL/min during therapy: This drug should be discontinued.
Liver Dose Adjustments
Mild or moderate liver dysfunction (Child-Pugh A or B): No adjustment recommended.
Severe liver dysfunction (Child-Pugh C): Data not available
Dose Adjustments
Coadministration with rifabutin: An additional 100 mg/day of doravirine is recommended, separated from this combination product by about 12 hours, for the duration of rifabutin coadministration.
Precautions
US BOXED WARNING:
- POSTTREATMENT ACUTE EXACERBATIONS OF HEPATITIS B: Severe acute exacerbations of hepatitis B reported in patients coinfected with HBV and HIV-1 who have stopped lamivudine or tenofovir disoproxil fumarate, components of this drug. Hepatic function of HBV/HIV-1-coinfected patients should be monitored closely with clinical and laboratory follow-up for at least several months after stopping this drug. If appropriate and necessary, antihepatitis B therapy should be started.
CONTRAINDICATIONS:
- Coadministration with strong CYP450 3A inducers (may significantly decrease doravirine plasma levels, which may decrease the efficacy of this drug) including, but not limited to, carbamazepine, oxcarbazepine, phenobarbital, phenytoin, enzalutamide, rifampin, rifapentine, mitotane, St. John's wort
- Previous hypersensitivity reaction to lamivudine
Safety and efficacy have not been established in patients younger than 18 years.
Consult WARNINGS section for additional precautions.
Dialysis
Data not available
Other Comments
Administration advice:
- Test patients for HBV infection before or when starting this drug.
- In all patients, assess serum creatinine, estimated CrCl, urine glucose, and urine protein before or when starting this drug, and during therapy with this drug as clinically appropriate; in patients with chronic kidney disease, also assess serum phosphorus.
- May administer with or without food
- Consult the manufacturer product information regarding missed doses.
Storage requirements:
- Store at 20 to 25C (68F to 77F); excursions permitted to 15C to 30C (59F to 86F).
- Store in original bottle and do not remove desiccants; keep bottle tightly closed to protect from moisture.
General:
- Each 3-drug fixed-dose combination tablet contains doravirine 100 mg, lamivudine 300 mg, and tenofovir disoproxil fumarate 300 mg.
Monitoring:
- Hepatic: Hepatic function of HIV-1/HBV-coinfected patients with clinical and laboratory follow-up (for at least several months after stopping therapy)
- Infections/Infestations: For chronic HBV infection in all patients (before starting therapy)
- Metabolic: Serum phosphorus in patients with chronic kidney disease (before or when starting and as clinically appropriate during therapy)
- Musculoskeletal: Bone mineral density in patients with history of pathologic bone fracture or other risk factors for osteoporosis or bone loss
- Renal: Serum creatinine, estimated CrCl, urine glucose, and urine protein in all patients (before or when starting and as clinically appropriate during therapy)
Patient advice:
- Read the US FDA-approved patient labeling (Patient Information).
- Avoid taking this drug with concurrent/recent use of nephrotoxic agents.
- Notify healthcare provider at once of any symptoms of infection.
- Do not miss or skip doses as resistance may develop.
Frequently asked questions
- What drugs are contained in the HIV treatment Delstrigo?
