Doravirine
PIFELTRO
What it isNon-nucleoside reverse transcriptase inhibitor; HIV.
Why this oneFewer CNS and lipid effects than efavirenz, and it works at high viral load where rilpivirine fails.
What limits itRifampin and other strong inducers are contraindicated. Once daily with or without food.
FDA-approved for
- HIV-1 infection (2018)
FDA label
Read the full label on DailyMed ↗
| FDA dosing | Population | Start | Target | Max |
|---|---|---|---|---|
| HIV-1 | Adults & peds ≥35 kg | 100 mg QD | 100 mg QD | 100 mg QD |
| HIV-1 with rifabutin | Adults & peds ≥35 kg | 100 mg BID | 100 mg BID | 100 mg BID |
Renal No adjustment (mild–severe); not studied in ESRD/dialysis
Hepatic No adjustment mild–moderate (Child-Pugh A/B); not studied in severe (C)
Instructions
- Take with or without food.
- With rifabutin, give the two daily doses about 12 hours apart.
Contraindications
- Coadministration with strong CYP3A inducers (e.g., carbamazepine, oxcarbazepine, phenobarbital, phenytoin, enzalutamide, rifampin, rifapentine, mitotane, St. John's wort)
Cautions
- Severe skin/hypersensitivity reactions incl. SJS/TEN and DRESS — discontinue immediately
- Loss of virologic response from drug interactions
- Immune reconstitution syndrome
Adverse reactions
- Nausea
- Dizziness
- Headache
- Fatigue
- Diarrhea
- Abdominal pain
- Abnormal dreams
Pregnancy Pregnancy exposure registry; no adequate human data; no adverse developmental effects in animals at ≥8× human exposure
Lactation Unknown if present in human milk; breastfeeding not recommended (HIV transmission risk)
NO BOXED WARNINGS
Principal riskStrong inducers such as rifampin are contraindicated
Cost, est. cash$300–$2,000/month
Generic entry2031 est.
Classes and tags
Clinical profile
Legacy pregnancy categoryNot assigned — PLLR-era drug
Defining liabilityAgent-specific renal, hepatic, hematologic, metabolic and drug-interaction toxicity.
Mechanism of action: Doravirine ballicule
