Dovato (Dolutegravir and Lamivudine) - Oral

Warning:

The United States Food and Drug Administration (FDA) has issued a boxed warning for Dovato. Boxed warnings are the agency’s strongest warnings for serious and potentially life-threatening risks.

The boxed warning:

  • All individuals with human immunodeficiency virus (HIV-1) should be tested for hepatitis B virus (HBV) before starting Dovato, as lamivudine-resistant HBV variants associated with lamivudine-present antiretroviral therapies (drugs that treat HIV-1) has been found in other people.
  • If Dovato is used in people co-infected with HIV-1 and HBV, additional treatment should be evaluated for appropriate treatment of chronic (long-lasting) HBV; otherwise, consider a different treatment. 
  • Severe worsening of HBV has been reported in individuals who are simultaneously infected with HIV-1 and HBV and have stopped lamivudine, a key ingredient found in Dovato.

What Is Dovato?

Dovato (dolutegravir and lamivudine) is an orally administered combination drug that treats human immunodeficiency virus type-1 (HIV-1) infections in adults aged 18 and older. HIV-1 is the virus that causes acquired immune deficiency syndrome (AIDS) and is the most widespread form of human immunodeficiency virus. Dovato works by helping the immune system to lessen the amount of HIV in the body.

Made up of two primary ingredients, lamivudine is in a class of medications called nucleoside analogue reverse transcriptase inhibitors (NRTIs). NRTIs are one of six classes of antiretroviral drugs (ARVs) used to treat HIV as part of antiretroviral therapy (ART). ARVs interfere with the ability of a virus to reproduce and are used to treat HIV infections.

Comparatively, dolutegravir is in a class of medications called integrase strand transfer inhibitors (INSTIs). INSTIs are oral antiretroviral medications used to treat HIV infections by preventing the virus from inserting its DNA into an infected cell.

While dolutegravir and lamivudine will not cure HIV-1, these medications may decrease your chance of developing AIDS and HIV-related illnesses such as serious infections or cancer.

Dovato is available as an orally administered tablet.

Drug Facts

Generic Name: Dolutegravir and lamivudine

Brand Name(s): Dovato

Drug Availability: Prescription

Administration Route: Oral

Therapeutic Classification: Antiretroviral agent

Available Generically: Yes

Controlled Substance: N/A

Active Ingredient: Dolutegravir sodium; lamivudine

Dosage Form(s): Tablet

What Is Dovato Used For?

The Food and Drug Administration (FDA) has approved Dovato — a combination of dolutegravir and lamivudine for the treatment of HIV-1 infection in adults with no ARV treatment history.

Additionally, Dovato is also approved to replace the current antiretroviral treatment in people who are virologically suppressed. This means that virologically suppressed individuals have current HIV-1 levels at an undetectable level, or that their HIV-1 RNA (meaning viral load) is less than 50 copies per milliliter (mL) on a healthy ARV regimen with no history of treatment failure and no known drug substitutions associated with resistance to the particular ingredients of Dovato.

HIV-1 is an immunodeficiency virus that attacks your body's immune system. The virus works to destroy CD4 cells (a type of white blood cell that helps the body defend against infection).

How to Take Dovato

Take Dovato once daily as directed by your healthcare provider. Take it with or without food two hours before or six hours after consuming:

  • Carafate (sucralfate)
  • Buffered medications (pills coated with a special substance that neutralizes stomach acid, reduces stomach pain, or increases the absorption of active ingredients)
  • Supplements containing iron or calcium

While the standard dose is 50 milligrams (mg) of dolutegravir and 300 milligrams of lamivudine, if you take Dovato simultaneously with Tegretol (carbamazepine) (a drug used as a mood stabilizer for bipolar disorder) or Xifaxan (rifaximin) (a drug used to treat diarrhea), your healthcare provider may prescribe one Dovato tablet once daily followed by an additional dolutegravir 50-milligram tablet, approximately 12 hours from the dose of Dovato.

However, you may take Dovato and supplements containing calcium or iron together with food. Try not to miss doses, and do not stop taking it even if you feel better.

Storage

Store Dovato in a secure, dry place at room temperature. Do not store it in your bathroom. Keep your medicine away from children and pets. 

Discard any unused or expired drugs. Do not throw down the drain, sink, or toilet. Speak to your pharmacist about the best ways to discard your medicine. Check out local take-back programs in your area.

How Long Does Dovato Take to Work?

It takes Dovato about two to three hours to peak once you take dolutegravir/lamivudine.

Your body quickly absorbs lamivudine, but it takes 30 minutes up to four hours to peak. The time this drug takes to a peak depends on factors such as age, weight, or how recently/how much you have eaten before taking Dovato.

What Are the Side Effects of Dovato?

This is not a complete list of side effects, and others may occur. A healthcare provider can advise you on side effects. If you experience other effects, contact your pharmacist or a healthcare provider. You may report side effects to the FDA at fda.gov/medwatch or 800-FDA-1088.

As with all medications, Dovato can cause side effects. Tell your healthcare provider about any side effects you experience while taking this medication.

Common Side Effects

Tell your healthcare provider if any of these side effects or symptoms do not go away or bother you. Common side effects of Dovato include:

Severe Effects

The FDA has issued a boxed warning for Dovato. Boxed warnings are the agency’s strongest warnings for serious and potentially life-threatening risks.

The boxed warning:

  • All individuals with human immunodeficiency virus (HIV-1) should be tested for hepatitis B virus (HBV) before starting Dovato, as lamivudine-resistant HBV variants associated with lamivudine-present antiretroviral therapies (drugs that treat HIV-1) has been found in other people.
  • If Dovato is used in people co-infected with HIV-1 and HBV, additional treatment should be evaluated for appropriate treatment of chronic (long-lasting) HBV; otherwise, consider a different treatment. 
  • Severe worsening of HBV has been reported in individuals who are simultaneously infected with HIV-1 and HBV and have stopped lamivudine, a key ingredient found in Dovato.

Dovato may cause severe and sometimes deadly side effects. Get medical help right away if you experience:

Long-Term Side Effects

Dovato is meant to be used as a long-term treatment. If you and your healthcare provider determine that Dovato is safe and effective for you, you’ll likely take it indefinitely and will treat side effects as they arise.

Report Side Effects

Dovato may cause other side effects. Call your healthcare provider if you have any unusual problems while taking this medication.

If you experience a serious side effect, you or your healthcare provider may send a report to the FDA's MedWatch Adverse Event Reporting Program or by phone (800-332-1088).

Drug Dosage

Drug Content Provided and Reviewed by IBM Micromedex®

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

  • For oral dosage form (tablets):
    • For HIV infection:
      • Adults—One tablet once a day. Each tablet contains 50 milligrams (mg) dolutegravir and 300 mg lamivudine.
      • Children—Use and dose must be determined by your doctor.

Modifications

Users should be aware of the following before starting Dovato:

Dose adjustment: Your dose may be altered if you are currently taking Tegretol or Xifaxan. Be sure to make your healthcare provider aware of all drugs you currently take before beginning Dovato.

Pregnancy: Consult with a healthcare provider if you plan on becoming pregnant during your use of Dovato, as there stand potential risks for the unborn fetus, especially in the first trimester. Pregnancy testing is recommended before initiation of Dovato in people of childbearing potential.

Breastfeeding: Breastfeeding is not recommended due to the potential for HIV-1 transmission. Talk with your healthcare provider if you plan to breastfeed, and weigh the benefits and risks of taking Dovato while nursing and the different ways to feed your baby.

Adults over 65: Research trials of Dovato did not include sufficient numbers of people aged 65 and over to determine whether they respond differently from younger subjects. As a result, caution should be exercised in the administration of Dovato in older people reflecting the greater frequency of decreased hepatic (liver), renal (kidney), or cardiac (heart) function and of associated disease or other drug therapy.

Children: Dovato is not recommended for children or any individual aged 18 or under.

People who smoke: Smoking can lower the effectiveness of Dovato. Try to stop smoking before starting Dovato, and avoid smoking while taking the medication. Your healthcare provider can help you with this goal.

Missed Dose

It is best to avoid missing your dose. However, take the missed dose once you remember. If it is too close to your next dose, skip the missed dose. Go back to your regular dosing frequency. Do not take extra or double the quantity.

If you are not sure what to do if you miss a dose, call your healthcare provider.

Overdose: What Happens If I Overdose on Dovato?

There is no known specific treatment for an overdose with Dovato. However, the individual should be monitored if an overdose occurs, and standard supportive treatment should be applied as required.

Common drug-related overdose symptoms include:

  • Nausea or vomiting
  • Appetite loss
  • Sweating
  • Bleeding
  • Bruising
  • Upper stomach pain
  • Yellowing of the skin or whites of the eyes (jaundice)

What Happens If I Overdose on Dovato

If you think you or someone else may have overdosed on Dovato, call a healthcare provider or the Poison Control Center (800-222-1222).

If someone collapses or isn't breathing after taking Dovato, call 911 immediately.

Precautions

Drug Content Provided and Reviewed by IBM Micromedex®

It is very important that your doctor check your progress at regular visits to make sure this medicine is working properly. Blood and urine tests may be needed to check for unwanted effects.

Do not use this medicine together with dofetilide (Tikosyn®). Using these medicines together may cause serious or life-threatening side effects.

It is important to tell your doctor if you are pregnant or planning to become pregnant before using this medicine. Using this medicine while you are pregnant can harm your unborn baby. If you are a woman who can get pregnant, your doctor may do tests to make sure you are not pregnant before starting treatment. Do not use this medicine during the first part of your pregnancy unless your doctor tells you to. Use an effective form of birth control to keep from getting pregnant.

Serious allergic reactions may occur while you are using this medicine. Check with your doctor right away if you have the following symptoms: a severe rash or rash with fever, blistering or peeling skin, diarrhea, nausea, vomiting, joint or muscle pain, sores in the mouth, swelling of the face, trouble breathing, unusual tiredness or weakness, or yellow eyes or skin.

Two rare but serious reactions to this medicine are lactic acidosis (too much acid in the blood) and liver toxicity, which includes an enlarged liver. These are more common if you are female, very overweight (obese), or have been taking anti-HIV medicines for a long time. Call your doctor right away if you have dark urine, decreased appetite, diarrhea, general feeling of discomfort, light-colored stools, muscle cramping or pain, nausea, stomach discomfort or cramping, unusual tiredness or weakness, trouble breathing, vomiting, or yellow eyes or skin.

Your immune system may get stronger when you start taking HIV medicines. Tell your doctor right away if you notice any changes in your health. Sometimes the immune system will start to fight infections that were hidden in your body, such as pneumonia or tuberculosis. Autoimmune disorders (eg, Graves' disease, polymyositis, or Guillain-Barré syndrome) may also occur.

This medicine will not keep you from giving HIV to your partner during sex. Make sure you understand this and practice safe sex, even if your partner also has HIV, by using a latex condom or other barrier method. This medicine will also not keep you from giving HIV to other people if they are exposed to your blood. Do not re-use or share needles with anyone.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal (eg, St. John's wort) or vitamin supplements.

What Are Reasons I Shouldn't Take Dovato?

Dovato is not appropriate for everyone. You should not take this medication if you are allergic to dolutegravir and lamivudine or any of the inactive ingredients in Dovato.

Dovato may be used with caution in some people only if the healthcare provider determines it is safe. This includes:

What Other Medications May Interact With Dovato?

Tell your healthcare provider about all of the medicines you take, including prescription and over-the-counter (OTC) medicines, and vitamins or supplements. 

Certain medications interact with Dovato, causing more side effects or lowering how well the drugs work. Avoid taking these medications with Dovato:

Other drug interactions may occur with Dovato. Consult your healthcare provider for a complete list of drug interactions.

What Medications Are Similar?

Other medications used to treat HIV-1 infections similar to Dovato include:

Dovato is considered cheaper than most other drugs. Hence, a more cost-effective option for HIV treatment.

This list is a list of drugs also prescribed for HIV-1. It is NOT a list of drugs recommended to take with Dovato. In fact, you should not take these drugs together. Ask your pharmacist or a healthcare provider if you have questions regarding combinational treatments for HIV-1.

Frequently Asked Questions

  • What is Dovato used to treat?

    Dovato is used to treat HIV-1 infections in adults with no ARV treatment history or to replace the current antiretroviral treatment in those who are virologically suppressed (HIV-1 levels are at an undetectable level, or HIV-1 RNA (meaning viral load) is less than 50 copies per milliliter) on a stable ARV regimen with no history of treatment failure and no known drug substitutions associated with resistance to the individual ingredients of Dovato.

  • What should I do if I miss a dose of Dovato?

    Take the missed dose as soon as you remember. If it is too close to your next dose, skip the missed dose. Do not double up or take extra amounts. Your healthcare provider can help you develop ways to consistently remember to take your medications.

  • How should I store Dovato?

    Store this drug in a secure, dry place at room temperature. Do not store it in a bathroom. Keep Dovato away from children and pets, preferably in a lockbox if possible.

How Can I Stay Healthy While Taking Dovato?

Staying healthy while living with HIV-1 is very important, especially since the virus is trying to lower your immune system. Make sure that you:

  • Always have protected sex (with a latex or polyurethane condom).
  • Do not share things like razors, needles, or toothbrushes.
  • Do not miss taking your medicine.
  • Do not share your medicine with someone or take another person's medicine.
  • Tell your healthcare provider immediately if you feel like your medicine is not working or you feel worse.

Also, being part of a support group may be helpful for you. Learning about the journeys of others can help you know that you are not alone. 

Medical Disclaimer

Verywell Health's drug information is meant for educational purposes only and is not intended to replace medical advice, diagnosis, or treatment from a healthcare provider. Consult your healthcare provider before taking any new medication(s). IBM Watson Micromedex provides some of the drug content, as indicated on the page.

12 Sources
Verywell Health uses only high-quality sources, including peer-reviewed studies, to support the facts within our articles. Read our editorial process to learn more about how we fact-check and keep our content accurate, reliable, and trustworthy.
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  2. HIV.gov. What are HIV and AIDS?

  3. MedlinePlus. Lamivudine.

  4. Clinical Info. HIV.gov. Nucleoside reverse transcriptase inhibitor (NRTI).

  5. MedlinePlus. Dolutegravir.

  6. Clinical Info. HIV.gov. Integrase Strand Transfer Inhibitor (INSTI).

  7. Centers for Disease Control and Prevention. HIV treatment as prevention.

  8. Lehavot K, Huh D, Walters KL, King KM, Andrasik MP, Simoni JM. Buffering effects of general and medication-specific social support on the association between substance use and HIV medication adherence. AIDS Patient Care STDS. 2011;25(3):181-189. doi:10.1089/apc.2010.0314

  9. Prescribers’ Digital Reference. Dolutegravir/lamivudine - drug summary.

  10. Clinical Info. HIV.gov. HIV overview. FDA-approved HIV medicines.

  11. Clinical Info. HIV.gov. Limitations to treatment safety and efficacy. Cost considerations and antiretroviral therapy.

  12. Centers for Disease Control and Prevention. Healthy living with HIV.

By Queen Buyalos, PharmD
Queen Buyalos is a pharmacist and freelance medical writer. She takes pride in advocating for cancer prevention, overall health, and mental health education. Queen enjoys counseling and educating patients about drug therapy and translating complex ideas into simple language.