DOVATO

Combination product

Pronunciation: doe-loo-TEG-ra-veer and la-MI-vyoo-deen (doe-VAH-toe)

Combination of Dolutegravir and Lamivudine.

Each component keeps its own pharmacology page; the combination itself adds no new mechanism.

Components (2)

Dolutegravir ballicule — decagon mechanism diagram — Dolutegravir

Lamivudine ballicule — decagon mechanism diagram — Lamivudine

FDA label

Read the full label on DailyMed ↗

BOXED WARNING Patients co-infected with HBV and HIV-1: emergence of lamivudine-resistant HBV and severe acute exacerbations of HBV on discontinuation; test for HBV before initiating and monitor hepatic function.

FDA dosing	Population	Start	Target	Max
HIV-1 infection (complete regimen; treatment-naive or replacing a suppressive regimen)	Adults and adolescents ≥12 yr and ≥25 kg	1 tablet (dolutegravir 50 mg / lamivudine 300 mg) QD	1 tablet QD	1 tablet QD

Renal Not recommended if creatinine clearance <30 mL/min (fixed-dose, cannot adjust); at CrCl 30-49 mL/min monitor for hematologic toxicity

Hepatic No adjustment for mild or moderate impairment (Child-Pugh A or B); not recommended in severe (Child-Pugh C)

Instructions

One tablet once daily with or without food
Test for HBV infection before or when initiating
With carbamazepine or rifampin, take an additional dolutegravir 50-mg tablet ~12 hours after the DOVATO dose

Available strengths

tab 50/300 mg

Contraindications

Coadministration with dofetilide (risk of increased dofetilide concentrations and serious/life-threatening events)

Cautions

Hypersensitivity reactions (rash, constitutional findings, organ dysfunction including liver injury) — discontinue immediately
Hepatotoxicity (esp. with underlying hepatitis B or C)
Lactic acidosis and severe hepatomegaly with steatosis (nucleoside analogues)
Immune reconstitution syndrome
HBV: lamivudine-resistant HBV and posttreatment exacerbations

Adverse reactions

Headache, nausea, diarrhea, insomnia, fatigue, anxiety

Pregnancy Surveillance data show similar prevalence of neural tube defects vs comparators; human data insufficient to definitively assess risk; pregnancy registry available

Lactation Dolutegravir and lamivudine present in human milk; breastfeeding not recommended (HIV-1 transmission risk and other risks)

Cost

DOVATO

What pharmacies pay · NADAC 9/30/26

Strength		#/mo	generic $/mo	brand $/mo	CostPlus
50/300 mg	tab	30 qd	—	$3,156.74	not offered

Clinical profile

Therapeutic safety burden2 / 4

Overdose danger1 / 4

Weight-gain liability1 / 4

Sedation liability1 / 4

QT / Torsades0 / 4

Direct muscarinic antagonism0 / 4

Embryofetal risk1 / 4

Defining liabilityHBV resistance/reactivation and hepatic toxicity

Part D rank #403.

Self-check

Is dolutegravir–lamivudine listed as a complete HIV-1 regimen?
Yes.
What HBV/HIV coinfection risks are boxed?
Lamivudine-resistant HBV and HBV exacerbations.

All drugs · Open DOVATO in the interactive console ↗