Pronunciation: doe-VAH-toe
Generic name: dolutegravir and lamivudine
Dosage form: oral tablet
Drug class: Antiviral combinations

Medically reviewed by Carmen Pope, BPharm. Last updated on Apr 9, 2024.

What is Dovato?

Dovato is an oral, once-daily, combination antiviral medicine that combines dolutegravir with lamivudine that may be given without other HIV-1 medicines, as a complete regimen, to treat HIV-1 infection in adults and adolescents aged 12 years and older and weighing at least 55 pounds (25kg):

• who have not received HIV-1 medicines in the past, or
• to replace their current HIV-1 medicines when their healthcare provider determines that they meet certain requirements (virologically suppressed, no history of treatment failure, no known substitutions associated with resistance).

Dovato is used to treat HIV, the virus that can cause the acquired immunodeficiency syndrome (AIDS). This medicine is not a cure for HIV or AIDS. Dovato works in two different ways to treat HIV-1. The first component, dolutegravir, is an integrase strand transfer inhibitor (INSTI) that inhibits an enzyme called HIV integrase that is essential for integration of HIV into DNA and the HIV replication cycle. The other component, lamivudine, is a nucleoside analog reverse transcriptase inhibitor (NRTI) that also prevents HIV from replicating, but it works differently, blocking an enzyme called reverse transcriptase.

Dovato was first FDA-approved on April 8, 2019. The approval was extended to include adolescents aged 12 years and older on April 5, 2024.

Warnings

Do not take Dovato if you have had an allergic reaction to Dovato, dolutegravir, lamivudine, or any of the inactive ingredients in the tablets. Symptoms may include a rash, hives, difficulty breathing, and swelling of your face, lips, tongue, or throat. Stop taking Dovato and talk to your healthcare provider immediately or seek emergency help if the symptoms are severe. 

You should not use Dovato if you are also taking dofetilide (Tikosyn). Taking them together may cause life-threatening side effects.

If you've ever had hepatitis B (HBV), it may become active and resistant to medication while you are taking Dovato. Hepatitis B may also get worse after you stop using this medicine. Your healthcare provider will test you for HBV before you start treatment and you may need regular liver function tests after you start treatment. 

Liver toxicity has also been reported with dolutegravir-containing medicines, such as Dovato. The risk is higher in those with underlying HBV or HBC. Your healthcare provider will monitor you for this. Not recommended in patients with severe hepatic impairment (Child-Pugh Score C) or with creatinine clearance less than 30 mL/min. 

Do not run out of Dovato or stop taking it without your doctor's advice. Refill your prescription or talk to your healthcare provider before it is all gone. If you do stop Dovato, you will need regular monitoring to check your health.

Other serious side effects including lactic acidosis, severe hepatomegaly with steatosis, and immune reconstitution syndrome have also been reported in patients treated with combination antiretroviral therapy. Talk to your healthcare provider for more information.

Taking Dovato during the first trimester of pregnancy may cause birth defects. Use effective birth control to prevent pregnancy while you are using this medicine.

It is not known if Dovato is safe and effective in children under the age of 12.

Before taking this medicine

You should not use Dovato if you are allergic to dolutegravir or lamivudine, or if you are also taking dofetilide (Tikosyn).

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
• are pregnant or plan to become pregnant
• are breastfeeding.

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 pregnancy is confirmed during the first 12 weeks of pregnancy.

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 the health of you and your baby. Talk with your healthcare provider about how you can take part in this registry.

Breastfeeding

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

• the HIV-1 virus may pass to your baby if your baby does not have HIV-1 infection.
• the HIV-1 virus may become harder to treat if your baby 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 on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

• The usual dosage of Dovato is one tablet, once a day
• You may take Dovato with or without food.
• You will need frequent medical tests.

Additional dosage information

Your healthcare provider may give you an additional 50mg of dolutegravir if you also take carbamazepine or rifampin. Take this separated from this combination product by 12 hours.

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.

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.

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

While Dovato can substantially reduce the risk of HIV transmission, there is still a chance the disease can spread. Do not have unprotected sex or share razors or toothbrushes. Talk with your doctor about safe ways to prevent HIV transmission during sex. Sharing drug or medicine needles is never safe, even for a healthy person.

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.

What are the side effects of Dovato?

Dovato can cause serious side effects.

Stop taking this medicine and get emergency medical help if you have signs of an allergic reaction to Dovato, such as fever, general ill feeling, trouble breathing, tiredness, joint or muscle pain, blisters or mouth sores, redness or swelling in your eyes; blistering or peeling skin, swelling of your face, lips, tongue, or throat.

You may develop lactic acidosis, a dangerous build-up of lactic acid in your blood. This may be more likely if you have other medical conditions, if you are overweight, or if you are a woman. Ask your doctor about your risk. Mild symptoms of lactic acidosis may worsen over time, and this condition can be fatal. Get emergency medical help if you have: unusual muscle pain, trouble breathing, stomach pain, vomiting, fast or irregular heart rate, dizziness, feeling cold, or feeling very weak or tired.

Other serious side effects include reactivation of HBV, severe hepatomegaly with steatosis, and immune reconstitution syndrome (see warnings above). 

Call your doctor at once if you have:

• the first sign of any skin rash, no matter how mild, including shingles or warts

• swollen lymph nodes

• liver problems - nausea, vomiting, loss of appetite, upper stomach pain, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Dolutegravir and lamivudine affect your immune system, which may cause certain side effects even weeks or months after you've stopped taking this medicine. Tell your doctor if you have:

• signs of a new infection - fever, night sweats, swollen glands, cold sores, cough, wheezing, diarrhea, weight loss;

• trouble speaking or swallowing, problems with balance or eye movement, weakness or prickly feeling; or

• swelling in your neck or throat (enlarged thyroid), menstrual changes, impotence.

Common Dovato side effects affecting 2% or more people include:

• headache

• tiredness

• nausea

• diarrhea

• anxiety

• sleep problems (insomnia).

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 FDA at 1-800-FDA-1088.

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).

Many drugs interact with dolutegravir and lamivudine. 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 and 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

ViiV Healthcare

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