Dolutegravir

TIVICAY

Open Dolutegravir in the interactive console ↗

What it isHIV integrase strand-transfer inhibitor; a preferred anchor for initial and treatment-experienced regimens.

Why this oneIts unusually high barrier to resistance distinguishes it from earlier integrase inhibitors.

What limits itPolyvalent cations block absorption—separate antacids and supplements. It raises creatinine by blocking tubular secretion without lowering GFR; weight gain.

FDA-approved for

HIV infection (2013)

FDA label

Read the full label on DailyMed ↗

FDA dosing	Population	Start	Target	Max
HIV-1 (INSTI-naive or virologically suppressed)	Adults	50 mg QD	50 mg QD	50 mg QD
HIV-1 with UGT1A/CYP3A inducers or INSTI resistance	Adults	50 mg BID	50 mg BID	50 mg BID
HIV-1 (weight-based, Tivicay PD)	Peds ≥4 wk & ≥3 kg	5 mg QD (3–<6 kg)	weight-based QD	30 mg QD (≥20 kg)

Renal No adjustment for INSTI-naive (mild–severe); caution in INSTI-experienced with severe impairment (reduced levels)

Hepatic No adjustment mild–moderate (Child-Pugh A/B); not recommended in severe (C)

Instructions

May be taken with or without food.
Tivicay and Tivicay PD are not bioequivalent and not substitutable on a mg-per-mg basis.

Contraindications

Coadministration with dofetilide

Cautions

Hypersensitivity reactions (rash, constitutional findings, organ/liver injury) — discontinue immediately
Hepatotoxicity, esp. with underlying hepatitis B/C
Immune reconstitution syndrome

Adverse reactions

Insomnia
Fatigue
Headache

Pregnancy Pregnancy exposure registry; surveillance data do not show increased neural tube defects vs comparators; human data insufficient for definitive assessment

Lactation Undefined

NO BOXED WARNINGS

Principal riskCations block absorption; weight gain

Cost, est. cash$300–$2,000/month

Generic entry2030 est.