Dolutegravir and lamivudine

Pronunciation: DOE-loo-TEG-ra-vir and la-MIV-ue-deen
Generic name: dolutegravir and lamivudine
Brand name: Dovato
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 dolutegravir and lamivudine?

Dolutegravir/lamivudine 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 dolutegravir and lamivudine tablets gained FDA approval on April 8, 2019, under the brand Dovato). There is no generic.

FDA approvals and indications

Dolutegravir/lamivudine is approved as a complete regimen for the treatment of HIV-1 infection in adults and adolescents 12 years of age and older and 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

Dolutegravir/lamivudine 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 dolutegravir and lamivudine prevents HIV-1 from multiplying in the body.

Side effects

The most common side effects of dolutegravir and lamivudine are:

• headache

• tiredness

• nausea

• diarrhea

• anxiety

• sleep problems (insomnia).

Serious side effects and warnings

Dolutegravir and lamivudine 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 dolutegravir and lamivudine. 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 dolutegravir and lamivudine 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 dolutegravir and lamivudine, 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 dolutegravir and lamivudine. 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 dolutegravir and lamivudine, 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 dolutegravir and lamivudine 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 dolutegravir and lamivudine are 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 dolutegravir/lamivudine, 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 dolutegravir and lamivudine. You and your healthcare provider should talk about the use of effective birth control (contraception) while taking dolutegravir and lamivudine.

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 dolutegravir and lamivudine. There is a pregnancy registry for those who take dolutegravir and lamivudine 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

Dolutegravir and lamivudine pass 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 dolutegravir and lamivudine.

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 dolutegravir and lamivudine?

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

Follow all directions on the Dovato (dolutegravir and lamivudine) Package Insert. Use the medicine exactly as directed.

• 1 tablet of dolutegravir and lamivudine 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 dolutegravir and lamivudine 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 dolutegravir and lamivudine, 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 dolutegravir and lamivudine.

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

Do not run out of dolutegravir and lamivudine. 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 dolutegravir and lamivudine, you will need regular monitoring to check your health.

What other drugs will affect dolutegravir and lamivudine?

Some medicines can make dolutegravir and lamivudine 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 dolutegravir and lamivudine:

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

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

Only available as the brand Dovato.

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

Dolutegravir/lamivudine is manufactured by ViiV Healthcare under the brand Dovato. ViiV is a pharmaceutical company that specializes in HIV medications and is 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.

Popular FAQ

Further information

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

Medical Disclaimer