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About
TIVICAY®
(dolutegravir)

Why it might be
right for you

When taken in combination with other HIV-1 medicines, TIVICAY can help provide effective
HIV-1 treatment in adults and children who weigh at least 66 pounds.

TIVICAY, taken in combination with other HIV-1 medications, may also help lower your viral load and increase your CD4 count. See results from two clinical studies below.

study 1(click here)
study 2(click here)

In one clinical study, called SINGLE, with 833 adult patients who had never taken HIV-1 treatment before, more patients got to less than 50 copies of HIV-1 RNA per milliliter of blood with TIVICAY 50 mg once daily and abacavir + lamivudine than with Atripla® at 144 weeks. The difference in results was driven primarily by the rates of discontinuation due to adverse events.

Individual results may vary.

Results at 144 weeks

Took TIVICAY + ABC/3TC*

Took Atripla

% of Patients
< 50 copies/mL

71% 63%

Average CD4
Cell Count
Increase from
Study Start

378
CD4 cells/mm3†
332
CD4 cells/mm3†

% of Patients Who
Stopped Treatment
Due to Side Effects

4% 14%
  • From 96 weeks to 144 weeks, patients knew which drug they were taking.
  • *ABC/3TC = abacavir/lamivudine.
  • The number of CD4 T-cells per cubic millimeter of blood.
  • "Treatment" means HIV‑1 medicines being given in the study.

Side effects through 144 weeks

Took TIVICAY

Took Atripla

Most common
medium to
severe side
effects

3% of patients
had trouble sleeping.
2% of patients
experienced headaches.
2% of patients
experienced tiredness.
3% of patients
had trouble sleeping.
2% of patients
experienced headaches.
2% of patients
experienced tiredness.

Most common
mild side effect

7% of patients
had trouble sleeping.
4% of patients
had trouble sleeping.
Study 1 Side Effects

Of course, your experience may be different. If it is, make sure you tell your healthcare provider.

Study 2

Ready to find out if TIVICAY might be an HIV-1 treatment option for you? Check out the Talk About Treatment page for questions to help you start a conversation with your healthcare provider about HIV-1 treatment.

In another clinical study, called SPRING-2, with 822* adult patients who had never taken HIV-1 treatment before, TIVICAY worked as well as raltegravir in getting patients to less than 50 copies of HIV-1 RNA in a milliliter of blood when taken with either abacavir/lamivudine or emtricitabine/tenofovir.

Individual results may vary.

Results at 96 weeks

Took TIVICAY

Took Raltegravir

% of Patients
< 50 copies/mL

82% 78%

Median CD4
Cell Count
Increase from
Study Start

276
CD4 cells/mm3‡
264
CD4 cells/mm3‡

% of Patients Who
Stopped Treatment§
Due to Side Effects

2% 2%
  • *808 patients were included in the study results.
  • Taken with either abacavir/lamivudine or emtricitabine/tenofovir.
  • The number of CD4 T-cells per cubic millimeter of blood.
  • §"Treatment" means HIV‑1 medicines being given in the study.

Side effects through 96 weeks

Took TIVICAY

Took Raltegravir

Most common
medium to
severe side
effect

1% of patients experienced nausea.
1% of patients experienced nausea.

Most common
mild side effect

1% of patients
had trouble sleeping.
<1% of patients
had trouble sleeping.

Of course, your experience may be different. If it is, make sure you tell your healthcare provider.

Study 1

Ready to find out if TIVICAY might be an HIV-1 treatment option for you? Check out the Talk About Treatment page for questions to help you start a conversation with your healthcare provider about HIV-1 treatment.

What is TIVICAY?

TIVICAY is a prescription medicine that is used to treat Human Immunodeficiency Virus‑1 (HIV‑1) infection together with:

  • other antiretroviral medicines in adults and children who weigh at least 66 pounds.
  • rilpivirine in adults to replace their current anti-HIV-1 medicines when their healthcare provider determines that they meet certain requirements.

HIV‑1 is the virus that causes Acquired Immune Deficiency Syndrome (AIDS). It is not known if TIVICAY is safe and effective in children who weigh less than 66 pounds or in children who have received certain types of medicine for HIV-1 infection.

IMPORTANT SAFETY INFORMATION

Who should not take TIVICAY?

  • Do not take TIVICAY if you:
    • have ever had an allergic reaction to a medicine that contains dolutegravir.
    • take dofetilide.

What are the possible side effects of TIVICAY?
TIVICAY can cause serious side effects including:

  • Allergic reactions. Call your healthcare provider right away if you develop a rash with TIVICAY. Stop taking TIVICAY and get medical help right away if you develop a rash with any of the following signs or symptoms:
    • fever
    • general 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 TIVICAY. 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. Call your healthcare provider right away if you develop any of the following signs or symptoms of liver problems:
    • your skin or the white part of your eyes turn yellow
    • 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
  • 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. Tell your healthcare provider right away if you start having new symptoms after you start taking TIVICAY.
  • The most common side effects of TIVICAY include: trouble sleeping, tiredness, and headache.

These are not all the possible side effects of TIVICAY. Call your doctor for medical advice about side effects.

What should I tell my healthcare provider before taking TIVICAY?

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

  • have ever had an allergic reaction to dolutegravir.
  • have had liver problems, including hepatitis B or C.
  • are pregnant or plan to become pregnant. It is not known if TIVICAY will harmyour unborn baby.
  • are breastfeeding or plan to breastfeed. Do not breastfeed if you take TIVICAY. It is not known if TIVICAY can pass 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 the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Some medicines interact with TIVICAY. 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 TIVICAY. Do not start taking a new medicine without telling your healthcare provider. Your healthcare provider can tell you if it is safe to take TIVICAY 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 TIVICAY and discuss it with your healthcare provider.

Trademarks are owned by or licensed to the ViiV Healthcare group of companies.

To learn about another prescription product for HIV‑1, CLICK HERE.