FAQs | DOVATO (dolutegravir/lamivudine)

FAQs

Considering a switch or new to HIV treatment?

Either way, we have answers to questions you may have about DOVATO.

Learning about DOVATO

What is DOVATO?

DOVATO is an HIV medicine that controls HIV by helping people reach and/or stay undetectable with just 2 medicines in 1 pill.* No other complete HIV pill contains fewer medicines than DOVATO.

DOVATO is a one-pill, once-a-day complete treatment for people 12 years and older who weigh at least 55 lbs who are new to HIV-1 treatment or are replacing their current HIV-1 medicines. Take DOVATO exactly as your healthcare provider tells you.
Learn more about the DOVATO difference >

*GEMINI 1 & 2 and TANGO studies.

Results may vary.
What does “undetectable” mean?

Reaching and staying undetectable has always been a key goal of treatment. Simply put, it means this: the amount of HIV in the blood is below the level that can be measured by a lab test.
Learn more about living with HIV >
What is different about DOVATO and why does it matter?

With just 2 medicines in 1 pill, DOVATO was clinically proven to control HIV as effectively as an HIV treatment with 3 or 4 medicines by helping people reach and/or stay undetectable.^†

That means fewer medicines in your body, today and tomorrow.

^†Based on data from the GEMINI 1 & 2 studies (patients new to treatment) and TANGO study (patients replacing their current HIV treatment). DOVATO was compared with a regimen containing either 3 or 4 medicines, measuring either the percentage of patients with an undetectable viral load (<50 copies/mL) or the percentage of patients without an undetectable viral load (≥50 copies/mL).

GEMINI: dolutegravir + tenofovir disoproxil fumarate/emtricitabine.

TANGO: tenofovir alafenamide-based 3- or 4-drug regimen.
Do I have to be undetectable to get DOVATO?

DOVATO was proven to help people new to treatment reach and stay undetectable as effectively as a regimen containing 3 medicines.^‡ Talk to your doctor about whether DOVATO could work for you.
Check out the clinical studies >

^‡GEMINI 1 & 2 studies (patients new to treatment).
Can DOVATO help keep me undetectable?

DOVATO was proven to help people already on treatment stay undetectable as effectively as an HIV regimen containing 3 or 4 medicines.^§

^§TANGO study (patients replacing their current HIV treatment).
How long has DOVATO been around?

DOVATO was approved by the FDA in 2019.
What medicines make up DOVATO?

DOVATO includes just 2 medicines—dolutegravir and lamivudine. Both medicines together are proven to work as effectively as HIV treatments with 3 or 4 medicines.*

*GEMINI 1 & 2 and TANGO studies.

PMUS-DLLWCNT240023

What is DOVATO?

DOVATO is a complete prescription regimen to treat HIV-1 in people 12 years and older who weigh at least 55 lbs who have not received HIV-1 medicines in the past or to replace their current HIV-1 medicines when their doctor determines they meet certain requirements.

IMPORTANT SAFETY INFORMATION

What is the most important information I should know about DOVATO?

If you have both HIV-1 infection and Hepatitis B virus (HBV) infection, DOVATO can cause serious side effects, including:

Resistant HBV. 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 with DOVATO and become harder to treat (resistant). It is not known if DOVATO is safe and effective in people who have HIV-1 and HBV infection.
Worsening of HBV infection. If you have HBV infection and take DOVATO, your HBV may get worse (flare-up) if you stop taking DOVATO. 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 your DOVATO is all gone.
- Do not stop DOVATO 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 DOVATO.

For more information about side effects, see “What are the possible side effects of DOVATO?”

Who should not take DOVATO?

Do not take DOVATO if you:
- have ever had an allergic reaction to a medicine that contains dolutegravir or lamivudine.
- take dofetilide. Taking DOVATO and dofetilide can cause side effects that may be serious or life-threatening.

What are other possible side effects of DOVATO?

DOVATO can cause serious side effects, including:

See “What is the most important information I should know about DOVATO?”
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
- generally ill 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.
The most common side effects of DOVATO include:
- headache
- nausea
- diarrhea
- trouble sleeping
- tiredness
- anxiety

These are not all the possible side effects of DOVATO. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What should I tell my healthcare provider before taking DOVATO?

Before you take DOVATO, tell your healthcare provider about all of your medical conditions, including if you:

have or have had liver problems, including hepatitis B or C infection.
have kidney problems.
are pregnant or plan to become pregnant. Talk to your healthcare provider about the benefits and risks of taking DOVATO during pregnancy.
are breastfeeding or plan to breastfeed. 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:
- HIV may pass to your baby if your baby does not have HIV.
- HIV may become harder to treat if your baby has HIV.
- your baby may get side effects from DOVATO.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Some medicines interact with DOVATO. Keep a list of your medicines and show it to your healthcare provider and pharmacist when you get a new medicine.

You can ask your healthcare provider or pharmacist for a list of medicines that interact with DOVATO.
Do not start taking a new medicine without telling your healthcare provider. Your healthcare provider can tell you if it is safe to take DOVATO with other medicines.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

Please read the Patient Information for DOVATO and discuss it with your healthcare provider.

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