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dolutegravir/lamivudine

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Brand names: Dovato

Integrase Inhibitor / NRTI Combination Rx

Dovato is a complete HIV-1 treatment that combines two medicines into one tablet. It is used for adults and adolescents who weigh at least 55 pounds.

Drug Pricing (NADAC)

Brand Price

$96.17/unit

Generic Available

No

Pricing data from NADAC (CMS), effective December 18, 2024. Compare all drug costs →

What it does

Dovato is used to treat HIV-1 infection in adults and adolescents (12 years and older, weighing at least 55 pounds).

Common side effects

Headache, Nausea, Diarrhea

Key warnings

If you have both HIV-1 and hepatitis B, you should be tested for hepatitis B before starting Dovato.

How It Works

Dovato contains two drugs: dolutegravir and lamivudine. Dolutegravir blocks HIV-1 integrase, an enzyme the virus needs to multiply. Lamivudine blocks reverse transcriptase, another enzyme HIV-1 needs to make copies of itself.

How to Take It

Take one Dovato tablet once a day. You can take it with or without food. If you take carbamazepine or rifampin, you may need to take an extra 50mg dolutegravir tablet about 12 hours after taking Dovato. Do not crush, chew, or break the tablet.

Pregnancy & Breastfeeding

There is a pregnancy registry to monitor outcomes in people exposed to Dovato during pregnancy. Talk to your doctor if you are pregnant or plan to become pregnant. There may be a risk of neural tube defects if dolutegravir is taken at the time of conception.

Missed Dose

If you miss a dose of Dovato, take it as soon as you remember. If it is almost time for your next dose, skip the missed dose and take your next dose at the regular time.

Storage

Store Dovato tablets below 86°F (30°C).

Side Effects (from patient reports)

Based on 8,059 FDA adverse event reports.

Pain
1,425
Anxiety
1,051
Emotional Distress
1,048
Anhedonia
942
Chronic Kidney Disease
701
Fatigue
628
Exposure During Pregnancy
606
Headache
566
Off Label Use
553
Renal Failure
539

Serious Warnings

If you have both HIV-1 and hepatitis B, you should be tested for hepatitis B before starting Dovato. Using Dovato can cause the hepatitis B virus to become resistant to lamivudine. Stopping Dovato can also cause a severe worsening of hepatitis B. Your liver function should be checked regularly.

Known Drug Interactions

7.2 Potential for DOVATO to Affect Other Drugs Dolutegravir, a component of DOVATO, inhibits the renal organic cation transporters (OCT)2 and multidrug and toxin extrusion transporter (MATE)1; thus, it may increase plasma concentrations of drugs eliminated via OCT2 or MATE1 such as dofetilide, dalfampridine, and metformin [see Contraindications ( 4 ), Drug Interactions ( 7.4 ), Clinical Pharmacology ( 12.3 )]. Coadministered Drug Class: Drug Name Effect on Concentration Clinical Comment Antiarrhythmic: Dofetilide ↑Dofetilide Coadministration is contraindicated with DOVATO [see Contraindicat...

Mechanism: One of the medicines in this combination blocks the pathways your kidneys use to get rid of dofetilide. This can lead to dangerously high levels of dofetilide in your system.

What to do: This combination should not be used. Talk to your healthcare provider about using a different medication.

moderate metformin

7.2 Potential for DOVATO to Affect Other Drugs Dolutegravir, a component of DOVATO, inhibits the renal organic cation transporters (OCT)2 and multidrug and toxin extrusion transporter (MATE)1; thus, it may increase plasma concentrations of drugs eliminated via OCT2 or MATE1 such as dofetilide, dalfampridine, and metformin [see Contraindications ( 4 ), Drug Interactions ( 7.4 ), Clinical Pharmacology ( 12.3 )]. Antidiabetic: Metformin a ↑Metformin Refer to the prescribing information for metformin for assessing the benefit and risk of concomitant use of DOVATO and metformin.

Mechanism: Dolutegravir blocks the proteins that help your kidneys remove metformin, which can lead to higher levels of metformin in your blood.

What to do: Talk to your doctor about the risks of this combination, as they may need to adjust your metformin treatment.

Anticonvulsants: Oxcarbazepine Phenytoin Phenobarbital ↓Dolutegravir Avoid coadministration with DOVATO because there are insufficient data to make dosing recommendations.

Mechanism: Oxcarbazepine lowers the amount of dolutegravir in your body, which could make your HIV treatment less effective.

What to do: You should avoid taking these two medications together because there is not enough information to determine a safe dose.

moderate phenytoin

Anticonvulsants: Oxcarbazepine Phenytoin Phenobarbital ↓Dolutegravir Avoid coadministration with DOVATO because there are insufficient data to make dosing recommendations.

Mechanism: Phenytoin causes your body to clear dolutegravir more quickly, which reduces the amount of medicine available to fight the virus.

What to do: Avoid using these drugs at the same time since there are no clear instructions on how to adjust the dosage safely.

Anticonvulsants: Oxcarbazepine Phenytoin Phenobarbital ↓Dolutegravir Avoid coadministration with DOVATO because there are insufficient data to make dosing recommendations.

Mechanism: Phenobarbital speeds up the breakdown of dolutegravir in your system, which can prevent the medication from working properly.

What to do: This combination should be avoided because there is not enough research to provide a safe dosing plan.

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Common Questions

Can I take Dovato with other HIV medicines?
No, Dovato is a complete treatment for HIV-1. Do not take it with other HIV medicines.
What should I do if I have a rash after starting Dovato?
Stop taking Dovato and contact your doctor right away. A rash could be a sign of a serious allergic reaction.
Can Dovato cause liver problems?
Yes, Dovato can cause liver problems. Your doctor may monitor your liver function while you are taking Dovato.
Is Dovato safe for people with kidney problems?
Dovato is not recommended if your creatinine clearance is less than 30 mL/min.
Is Dovato safe for people with liver problems?
Dovato is not recommended if you have severe hepatic impairment (Child-Pugh Score C).
Can Dovato interact with other medicines I am taking?
Yes, Dovato can interact with other medicines. Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
What if I am co-infected with HIV and Hepatitis B?
All patients with HIV-1 should be tested for HBV prior to or when starting DOVATO. You may need additional treatment for Hepatitis B.
Can Dovato cause hypersensitivity reactions?
Yes, hypersensitivity reactions have been reported with dolutegravir, a component of DOVATO. Stop DOVATO immediately if signs or symptoms of hypersensitivity reactions develop.
What are the ingredients in Dovato?
Each tablet contains 50 mg of dolutegravir and 300 mg of lamivudine.
What does Dovato look like?
Dovato tablets are oval, biconvex, white, film-coated tablets, debossed with “SV 137” on one face.
What are the common side effects of dolutegravir/lamivudine?
The most commonly reported side effects of dolutegravir/lamivudine include Headache, Nausea, Diarrhea, Trouble sleeping (insomnia), Tiredness (fatigue). Based on 8,059 FDA adverse event reports. Always consult your healthcare provider about potential side effects.
Does dolutegravir/lamivudine interact with other medications?
Yes, dolutegravir/lamivudine has 9 known drug interactions. Notable interactions include dofetilide, metformin, oxcarbazepine. Always inform your doctor about all medications you are taking.
What drug class is dolutegravir/lamivudine?
dolutegravir/lamivudine belongs to the Integrase Inhibitor / NRTI Combination drug class. It requires a prescription (Rx). Dovato is used to treat HIV-1 infection in adults and adolescents (12 years and older, weighing at least 55 pounds).
Is dolutegravir/lamivudine safe during pregnancy?
There is a pregnancy registry to monitor outcomes in people exposed to Dovato during pregnancy. Talk to your doctor if you are pregnant or plan to become pregnant. Always consult your healthcare provider before using any medication during pregnancy or breastfeeding.

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What the FDA Data Shows for dolutegravir/lamivudine

The FDA label for dolutegravir/lamivudine (sold under brand names such as Dovato) classifies it as a prescription-only medication in the Integrase Inhibitor / NRTI Combination class. Dovato is used to treat HIV-1 infection in adults and adolescents (12 years and older, weighing at least 55 pounds). Official labeling lists 6 commonly reported side effects, including Headache, Nausea, Diarrhea.

Post-market surveillance from the FDA Adverse Event Reporting System (FAERS) captures real-world experience. For this drug, FAERS contains 8,059 voluntary reports. The database also lists 9 documented drug interactions derived from FDA labeling, with the top-flagged interaction rated major severity. NADAC pricing from CMS.

Report counts do not establish causation — a FAERS entry documents a temporal association, not proof that the drug produced the outcome. Widely prescribed medications naturally accumulate more reports than niche therapies, so raw totals must be interpreted alongside total exposure. Shortage status, recall history, and patent information further shape supply and switching decisions. This page summarizes public FDA data for educational purposes only and is not a substitute for professional medical advice — always consult a licensed healthcare provider before starting, stopping, or changing any medication.

Data Sources

Drug labeling: FDA Drug Labels (SPL/DailyMed). Adverse events: FDA Adverse Event Reporting System (FAERS). Pricing: CMS National Average Drug Acquisition Cost (NADAC).

FAERS reports are voluntary and do not establish causation. Drug interactions are derived from FDA labeling and clinical references. Always consult a healthcare professional before making medication decisions.

Last updated: October 29, 2025

All federal data sources used on this page