Pronunciation: doe VAH toe
Generic name: dolutegravir and lamivudine
Dosage form: oral tablet (dolutegravir 50 mg/lamivudine 300 mg)
Drug class: Antiviral combinations

Medically reviewed by Carmen Pope, BPharm. Last updated on Apr 17, 2025.

What is Dovato?

Dovato is used to treat HIV-1 infection in adults and children 12 years and older weighing at least 55 pounds (25 kg). It is a 2-drug combination antiviral tablet that is taken once a day.

Combination Dovato tablets gained FDA approval on April 8, 2019. There is no generic.

FDA approvals and indications

Dovato is approved as a complete regimen for the treatment of HIV-1 infection in the following adults and adolescents 12 years of age and older, weighing at least 25 kg:

• With no antiretroviral treatment history

Or

• To replace the current antiretroviral regimen in those who are virologically suppressed (HIV-1 RNA less than 50 copies/mL) on a stable antiretroviral regimen with no history of treatment failure and no known substitutions associated with resistance to dolutegravir or lamivudine.

Mechanism

Dovato contains 2 antiviral ingredients: dolutegravir and lamivudine. Each has a different mechanism of action.

• Dolutegravir is an integrase strand transfer inhibitor (INSTI) that blocks HIV integrase, an enzyme essential for HIV replication.
• Lamivudine is a nucleoside analog reverse transcriptase inhibitor (NRTI) that inhibits reverse transcriptase, an enzyme also crucial for viral replication.

The dual action of Dovato prevents HIV-1 from multiplying in the body.

Side effects

The most common side effects of Dovato are:

• headache

• tiredness

• nausea

• diarrhea

• anxiety

• sleep problems (insomnia).

Serious side effects and warnings

Dovato can cause the following serious side effects: 

• Resistant HBV (Boxed Warning). Your healthcare provider will test you for HBV infection before you start treatment with Dovato. If you have HIV-1 and hepatitis B, the HBV can change (mutate) during your treatment and become harder to treat (resistant). It is not known if Dovato are safe and effective in people who have HIV-1 and HBV infection.
• Worsening of HBV infection (Boxed Warning). If you have HBV and take Dovato, your HBV may get worse (flare-up) if you stop taking it. A “flare-up” is when your HBV infection suddenly returns in a worse way than before.
  • Do not run out of Dovato. Refill your prescription or talk to your healthcare provider before it is all gone.
  • Do not stop this medicine without first talking to your healthcare provider.

If you stop taking Dovato, your healthcare provider will need to check your health often and do blood tests regularly for several months to check your liver function and monitor your HBV infection. It may be necessary to give you a medicine to treat hepatitis B. Tell your healthcare provider about any new or unusual symptoms you may have after you stop taking this medicine.

• Allergic reactions. Call your healthcare provider right away if you develop a rash with Dovato. Stop taking Dovato and get medical help right away if you develop a rash with any of the following signs or symptoms:
  • fever
  • a generally unwell feeling
  • tiredness
  • muscle or joint aches
  • blisters or sores in mouth
  • blisters or peeling of the skin
  • redness or swelling of the eyes
  • swelling of the mouth, face, lips, or tongue
  • problems breathing.

• Liver problems. People with a history of hepatitis B or C virus may have an increased risk of developing new or worsening changes in certain liver tests during treatment with Dovato. Liver problems, including liver failure, have also happened in people without a history of liver disease or other risk factors. Your healthcare provider may do blood tests to check your liver. Tell your healthcare provider right away if you get any of the following signs or symptoms of liver problems:
  • your skin or the white part of your eyes turns yellow (jaundice)
  • dark or “tea-colored” urine
  • light-colored stools (bowel movements)
  • nausea or vomiting
  • loss of appetite
  • pain, aching, or tenderness on the right side of your stomach area.

• Too much lactic acid in your blood (lactic acidosis). Too much lactic acid is a serious medical emergency that can lead to death. Tell your healthcare provider right away if you get any of the following symptoms that could be signs of lactic acidosis:
  • feel very weak or tired
  • unusual (not normal) muscle pain
  • trouble breathing
  • stomach pain with nausea and vomiting
  • feel cold, especially in your arms and legs
  • feel dizzy or light-headed
  • have a fast or irregular heartbeat.

Lactic acidosis can also lead to severe liver problems, which can lead to death. Your liver may become large (hepatomegaly), and you may develop fat in your liver (steatosis). Tell your healthcare provider right away if you get any of the signs or symptoms of liver problems, which are listed above under “Liver problems”. You may be more likely to get lactic acidosis or severe liver problems if you are female or very overweight (obese).

• Changes in your immune system (Immune Reconstitution Syndrome) can happen when you start taking HIV-1 medicines. Your immune system may get stronger and begin to fight infections that have been hidden in your body for a long time. Tell your healthcare provider right away if you start having new symptoms after you start taking Dovato.

This is not a complete list of side effects, and others may occur. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Related/similar drugs

Before taking

Do not take Dovato if you:

• have had an allergic reaction to dolutegravir, lamivudine, Dovato, or any of the inactive ingredients in the tablets
• are also taking dofetilide (Tikosyn). Taking them together may cause life-threatening side effects
• are pregnant.

To make sure Dovato is safe for you, tell your doctor if you:

• have kidney problems
• have liver disease or a liver infection, especially hepatitis B or C
• plan to become pregnant
• are breastfeeding.

It is not known if dolutegravir/lamivudine is safe and effective in children under the age of 12 weighing less than 55 pounds (25 kg).

Pregnancy

One of the medicines in Dovato, dolutegravir, may harm an unborn baby if you take the medicine at the time of conception or during the first 12 weeks of pregnancy. Your healthcare provider may prescribe a different medicine if you are planning to become pregnant or if a pregnancy is confirmed during the first 12 weeks of treatment.

If you can become pregnant, you may need to have a negative pregnancy test before starting treatment with Dovato. You and your healthcare provider should talk about the use of effective birth control (contraception) while taking Dovato.

Tell your healthcare provider right away if you are planning to become pregnant, you become pregnant, or think you may be pregnant during treatment with Dovato. There is a pregnancy registry for those who take Dovato during pregnancy that collects information about your health and that of your baby's. Talk with your healthcare provider about how you can take part in this registry.

Breastfeeding

Dovato can pass to your baby in breast milk. Talk with your healthcare provider about the following risks to your baby from breastfeeding during treatment, such as:

• HIV-1 may pass to your baby if your baby does not have an an HIV-1 infection
• HIV-1 may become harder to treat if your baby already has HIV-1 infection
• Your baby may get side effects from Dovato.

Women with HIV or AIDS should not breastfeed a baby. Even if your baby is born without HIV, the virus may be passed to the baby in your breast milk.

How should I take Dovato?

Before you start Dovato, your doctor may perform tests to make sure you do not have hepatitis B.

Follow all directions in the Dovato Package Insert. Use the medicine exactly as directed.

• 1 tablet of Dovato is taken 1 time a day.
• You can take it with or without food.

Keep all your medical appointments because you will need frequent medical tests while you are taking this medicine.

Do not change your dose or stop using Dovato without your doctor's advice. Every person with HIV should remain under the care of a doctor.

What happens if I miss a dose?

Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.

Get your prescription refilled before you run out of medicine completely.

What happens if I overdose?

If you take too much Dovato, call your healthcare provider or go to the nearest hospital emergency room right away. 

What to avoid

Avoid taking an herbal supplement containing St. John's wort. Talk to your healthcare provider about other medications that may interact with Dovato.

If you take antacids, laxatives, or other medicines that contain aluminum, magnesium, or buffered
medicines, you should take Dovato at least 2 hours before or 6 hours after you take these medicines.

Do not run out of Dovato. The virus in your blood may increase, and the virus may become harder to treat. When your supply starts to run low, get more from your healthcare provider or pharmacy. If you do stop Dovato, you will need regular monitoring to check your health.

What other drugs will affect Dovato?

Some medicines can make Dovato much less effective when taken at the same time. Tell your healthcare provider about all the medicines you take, including OTC medicines, supplements, herbals, or prescription medicines. Especially tell them about:

• antacids or laxatives that contain calcium, magnesium, or aluminum (such as Amphojel, Di-Gel Maalox, Milk of Magnesia, Mylanta, Pepcid Complete, Rolaids, Rulox, Tums, and others), or the ulcer medicine sucralfate (Carafate)

• buffered medicine

• carbamazepine

• rifampin

• St. Johns Wort

• vitamin or mineral supplements that contain calcium or iron (but if you take dolutegravir with food, you can take these supplements at the same time).

Your healthcare provider may give you an extra 50 mg of dolutegravir if you take some other medications, such as carbamazepine. 

If you need to take iron or calcium supplements, including multivitamins that contain iron or calcium, by
mouth during treatment with Dovato:

• You may take these supplements at the same time that you take Dovato with food.
• If you do not take these supplements at the same time as Dovato and food, take Dovato at least 2 hours before or 6 hours after you take these supplements.

Many drugs interact with Dovato. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed here. Tell your doctor about all your current medicines and any medicine you start or stop using. See the prescribing information for a complete list of interactions.

Storage

Store at room temperature away from moisture and heat.

Ingredients

Active ingredients: dolutegravir/lamivudine

Inactive ingredients: magnesium stearate, mannitol, microcrystalline cellulose, povidone K29/32, sodium starch glycolate, sodium stearyl fumarate.

Film-coating: hypromellose, polyethylene glycol, titanium dioxide.

Each Dovato tablet contains 50 mg of dolutegravir and 300 mg of lamivudine.

Manufacturer

Dovato is manufactured by ViiV Healthcare, a pharmaceutical company that specializes in HIV medications, based in London, United Kingdom. It was established in 2009 as a joint venture between GlaxoSmithKline (GSK) and Pfizer, with Shionogi joining later as a shareholder.

ViiV Healthcare focuses exclusively on HIV treatment and prevention, making it unique among pharmaceutical companies.

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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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