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ANTIINFECTIVES FOR SYSTEMIC USE › ANTIVIRALS FOR SYSTEMIC USE › DIRECT ACTING ANTIVIRALS › Non-nucleoside reverse transcriptase inhibitors
doravirine
J05AG06
Adult Dosing
- 100 mg orally once daily
- May be taken with or without food
- If co-administered with rifabutin, increase frequency to 100 mg twice daily (approx. 12 hours apart)
Pediatric Dosing
- Pediatric patients weighing >= 35 kg: 100 mg orally once daily
- Safety and efficacy not established in pediatric patients weighing < 35 kg
Indications
- Treatment of HIV-1 infection in adults and pediatric patients weighing >= 35 kg with no prior antiretroviral treatment history
- Replacement for a stable antiretroviral regimen in virologically suppressed adults with no history of treatment failure and no known resistance to doravirine
Mechanism of Action
- Non-nucleoside reverse transcriptase inhibitor (NNRTI) of HIV-1
- Binds directly to HIV-1 reverse transcriptase, causing a disruption of the enzyme's catalytic function
- Inhibits RNA-dependent and DNA-dependent DNA polymerase activities
Contraindications
- Hypersensitivity to doravirine or any component of the formulation
- Co-administration with strong cytochrome P450 3A (CYP3A) inducers due to significant decreases in doravirine plasma concentrations and loss of virologic response (e.g., rifampin, carbamazepine, oxcarbazepine, phenobarbital, phenytoin, St. John's wort)
Adverse Reactions
- Nausea
- Dizziness
- Headache
- Fatigue
- Diarrhea
- Abdominal pain
- Abnormal dreams
- Insomnia
Drug Interactions
- Strong CYP3A inducers (e.g., rifampin, carbamazepine, phenytoin, St. John's wort): Significantly decrease doravirine concentrations; contraindication
- Moderate CYP3A inducers (e.g., rifabutin): Requires dose increase of doravirine to 100 mg twice daily
- CYP3A inhibitors: Do not significantly alter doravirine pharmacokinetics; no dose adjustment required
Curated Content: Needs Vetting Before Put to Clinical Use