Understanding HIV Treatment | DOVATO (dolutegravir/lamivudine)

New to Treatment

HIV may be part of you, but it's not who you are

Learning about HIV is important when looking for the right treatment option for you

Having a grasp of HIV-related terminology can prove helpful in determining the next steps in your treatment journey. Here are some of the most frequently used terms you may encounter in discussions with your healthcare practitioner.

HIV 101

What is HIV?

HIV stands for Human Immunodeficiency Virus. This means the virus weakens your immune system and impairs its ability to fight other viruses or infections.
What is the difference between HIV and AIDS?

HIV and AIDS are different. AIDS stands for Acquired Immune Deficiency Syndrome and can lead to serious infections and other health risks. HIV doesn’t always result in AIDS. Today’s treatment can keep HIV under control.
How do you contract HIV?

HIV can be contracted through anal or vaginal sex, as well as through sharing needles, syringes, or other drug injection equipment.
What are some of the symptoms of HIV?

The most common symptoms of an HIV infection are very similar to those of a flu-like illness: fever, chills, rashes, fatigue, muscle aches, and swollen lymph nodes, among others.
What are CD4+ T-cells?

CD4⁺ T-cells are a type of white blood cell that helps fight infection by triggering your immune system.
Why is it important to monitor your CD4+ T-cell count?

Your CD4⁺ T-cell count is an indicator of your immune system’s health and helps your doctor forecast your condition moving forward.

Understanding U=U

What is undetectable?

Reaching and staying undetectable is the main goal of HIV treatment. Simply put, it means that the amount of HIV in the blood is below the level that can be measured by a lab test.
What does U=U mean?

U=U stands for Undetectable equals Untransmittable.
According to the Department of Health and Human Services, people living with HIV who reach and stay undetectable by taking their HIV medication as prescribed prevent transmitting HIV through sex. First, talk to your doctor about further risks of sexual HIV transmission.
How long does someone need to be on HIV treatment before the sexual transmission of HIV is prevented?

Achieving an undetectable viral load can take time. Taking HIV treatment as prescribed and getting to and staying undetectable for at least 6 months prevents transmitting HIV through sex. Viral load testing should be performed on a regular basis to confirm HIV remains at an undetectable level.
Should I still practice safe sex if I am undetectable?

Regardless of status, condoms can help you lead a healthy sexual life. Unlike HIV treatment, condoms can prevent other sexually transmitted infections (STIs) and pregnancy.

Figuring out your HIV treatment

What should I consider when evaluating an HIV treatment?
When evaluating an HIV treatment, consider the following:

Will it be effective to help you reach and/or stay undetectable?

The number of medicines in your daily HIV pill
Hint: the fewer medicines in your pill, the fewer medicines in your body over time >

Does it fit your lifestyle?

Could it be a part of your future health goals?
Why should I start HIV treatment early?

If you were recently diagnosed, you may be wondering, “When should I start HIV treatment?” The answer is that it’s important to start antiretroviral therapy (ART) soon after an HIV diagnosis rather than delaying therapy. That’s because treatment can help keep HIV under control, so the sooner you get started, the sooner you’ll be on the path to suppressing the virus.
Why should I stay on HIV treatment?

People living with HIV who start and stay on HIV treatment can now live longer lives compared with those who started treatment in earlier decades.^†

†Based on data (Lancet HIV, 2017) showing improvement in life expectancy between 1996 and 2013 among individuals starting antiretroviral therapy. Regimens in this study did not include DOVATO.
What else should I know about HIV treatment?

Staying informed about all of your treatment options is an important part of taking charge of your health, now and down the line. A good rule of thumb is to check in with your doctor regularly and bring any questions you may have.

“I used to take 2 pills, but now I
take only 1 pill with DOVATO.”

Armando
Switched to
DOVATO

Ask your doctor about a treatment option that may fit your needs

Asking the right questions can help you find the right HIV treatment. Use our virtual interactive guide before your next appointment.

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What is DOVATO?

DOVATO is a complete prescription regimen to treat HIV-1 in adults 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. One of the medicines in DOVATO (dolutegravir) may harm your unborn baby.
- Your healthcare provider may prescribe a different medicine than DOVATO if you are planning to become pregnant or if pregnancy is confirmed during the first 12 weeks of pregnancy.
- If you can become pregnant, your healthcare provider may perform a pregnancy test before you start treatment with DOVATO.
- If you can become pregnant, you and your healthcare provider should talk about the use of effective birth control (contraception) during treatment with 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.

are breastfeeding or plan to breastfeed. Do not breastfeed if you take DOVATO.
- You should not breastfeed if you have HIV-1 because of the risk of passing HIV-1 to your baby.
- DOVATO passes to your baby in your breast milk.
- Talk with your healthcare provider about the best way to feed your baby.

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.