Let’s be honest,

this site is best viewed in portrait mode on mobile devices.

Please rotate your device.

Please rotate your device to portrait mode
 

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 12 years of age and older and weighing 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 together with other antiretroviral medicines to treat Human Immunodeficiency Virus (HIV‑1) infection in adults and children who weigh at least 66 pounds. 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.

TIVICAY does not cure HIV‑1 infection or AIDS.
You must stay on continuous HIV‑1therapy to
control the HIV‑1 infection and decrease HIV-related
illnesses.

IMPORTANT SAFETY INFORMATION

What is the most important information I should know about 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
      • extreme tiredness
      • muscle or joint aches
      • blisters or sores in mouth
      • blisters or peeling of the skin
      • redness or swelling in the eyes
      • swelling of the mouth, face, lips or tongue
      • problems breathing
    • 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
      • loss of appetite for several days or longer
      • pain, aching, or tenderness on the right side of your stomach area

Who should not take TIVICAY?

  • Do not take TIVICAY if you:
    • have ever had an allergic reaction to a
      medicine that contains dolutegravir (TIVICAY, TRIUMEQ®).
    • take dofetilide (Tikosyn®).

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

  • Changes in liver tests. People with a history of hepatitis B or C virus may havean increased risk of developing new or worsening changes in certain liver tests
    during treatment with TIVICAY. Your healthcare provider may do tests to check
    your liver function before and during treatment with TIVICAY.
  • Changes in body fat can happen in people who take HIV‑1 medicines.
  • Changes in your immune system. 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.

Tell your healthcare provider about any side effect that bothers you or that does not goaway. These are not all the possible side effects of TIVICAY.

What should I tell my healthcare provider before taking TIVICAY?

Before you take TIVICAY, tell your healthcare provider if you:

  • have ever had an allergic reaction to TIVICAY.
  • have had liver problems, including hepatitis B or C.
  • have any other medical condition.
  • are pregnant or plan to become pregnant. It is not known if TIVICAY will harmyour unborn baby.
  • are breastfeeding (nursing) or plan to breastfeed. Do not breastfeed. HIV‑1 can be passed to the baby in breast milk. It is not known if TIVICAY passes into your breast milk.

Tell your healthcare provider about the medicines you take

  • Keep a list that includes all prescription and over-the-counter medicines, vitamins, and herbal supplements and share it with your healthcare provider and pharmacist.
  • Ask your healthcare provider or pharmacist about medicines that should not be taken with TIVICAY. Some medicines interact with TIVICAY. Do not start taking a new medicine without telling your healthcare provider.
  • Over-the-counter medicines that interact with TIVICAY include:
    • St. John's wort (Hypericum perforatum). Avoid the use of St. John’s wort with TIVICAY.
    • antacids, laxatives, or other medicines that contain aluminum, magnesium, sucralfate (Carafate®), or buffered medicines. TIVICAY should be taken at least 2 hours before or 6 hours after you take these medicines.
    • iron or calcium supplements taken by mouth. Supplements (including multivitamins) containing calcium or iron may be taken at the same time with TIVICAY if taken with food. Otherwise, TIVICAY should be taken at least 2 hours before or 6 hours after you take these 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.

TIVICAY and TRIUMEQ are registered trademarks of ViiV Healthcare.

Other brands listed are trademarks of their respective owners and are not trademarks of ViiV Healthcare. The makers of these brands are not affiliated with and do not endorse ViiV Healthcare or its products.

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