Doravirine

PIFELTRO

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Pronunciation: dor-a-VIR-een (pi-FEL-troe)

Doravirine ballicule: receptor binding, kinetics and half-life diagram — Mechanism of action: Doravirine ballicule

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.

Doravirine molecular structure (skeletal formula) — Molecular structure: Doravirine

Doravirine prescription history

Animated chart of estimated U.S. prescriptions per year, HIV antiretrovirals (1987–2026). Doravirine enters in 2018 (estimated).

FDA-approved for

HIV-1 infection (2018)

Principal riskStrong inducers such as rifampin are contraindicated

Classes and tags

Clinical profile

Therapeutic safety burden2 / 4

Overdose danger2 / 4

Weight-gain liability0 / 4

Sedation liability0 / 4

QT / Torsades0 / 4

Direct muscarinic antagonism0 / 4

Embryofetal risk2 / 4

Legacy pregnancy categoryNot assigned — PLLR-era drug

Defining liabilityAgent-specific renal, hepatic, hematologic, metabolic and drug-interaction toxicity.

FDA label

Read the full label on DailyMed ↗

NO BOXED WARNINGS

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.

Available strengths

tab 100 mg

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)

Cost

Doravirine (PIFELTRO)

What pharmacies pay · NADAC 9/30/26

Strength		#/mo	generic $/mo	brand $/mo	CostPlus
100 mg	tab	30 qd	—	$1,823.61	not offered

Available combined with: Islatravir

Generic entry2031 est.

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Self-check

Which antibiotic is contraindicated with doravirine?
Rifampin.
Must doravirine be taken with food?
No; with or without food.