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One Pill, Once a Day

pill

Not actual size (15 mm x 8 mm)

What is BIKTARVY?

BIKTARVY is a complete HIV-1 treatment that combines 3 powerful medicines into 1 small pill, taken once a day with or without food.

BIKTARVY should not be taken with other HIV-1 medicines.

BIKTARVY is a prescription medicine for adults and children with HIV-1 who weigh at least 55 lbs and are either:

  • new to HIV-1 treatment OR
  • replacing their current regimen*

*For adults and children replacing their current regimen, their healthcare provider must determine if they meet certain requirements, including having an undetectable viral load (less than 50 copies/mL).

BIKTARVY does not cure HIV-1 or AIDS. HIV-1 is the virus that causes AIDS.

Ask if Biktarvy is right for you

Whether you are new to treatment or replacing your current HIV-1 medicine, ask your healthcare provider if BIKTARVY is right for you.

Built to Start Fast

The 3 powerful medicines in BIKTARVY were designed to attack the virus right away and to work together to lower the amount of HIV in your blood to undetectable levels. According to the U.S. Department of Health and Human Services (DHHS), many patients can get to undetectable in as quickly as 8 to 24 weeks, when taking their treatment as prescribed.

The 3 powerful medicines in BIKTARVY work quickly to fight the virus.

Reaching and Staying Undetectable

Whether you’re starting treatment or replacing your current HIV-1 treatment, BIKTARVY can help you reach important HIV-1 health goals.

Adults new to treatment:

  • Long-term viral suppression

    Three-year clinical studies showed that most patients taking BIKTARVY every day reached and stayed undetectable. Undetectable is when the amount of virus in your blood is below the level that can be measured in a lab test (less than 50 copies/mL).

  • Increase CD4 T-cell count

    BIKTARVY can help increase the number of CD4 T-cells in your blood. T-cells are an important part of your immune system because they help your body fight off infections.

Adults replacing their current treatment:

BIKTARVY can help you stay undetectable and maintain your CD4 T-cell count. Before taking BIKTARVY, your healthcare provider must determine that you meet certain requirements.

Studied in a Diverse Group of Adults

BIKTARVY was evaluated in 4 clinical trials, involving more than 2,400 adults living with HIV.

  • Two studies involved more than 1,200 adults new to HIV-1 treatment (634 new to BIKTARVY and 640 new to other treatments*) over a 3-year period.
  • Two additional studies involved more than 1,100 adults who replaced or continued their current treatment (572 replaced treatment with BIKTARVY and 568 continued their current treatment) over a 1-year period.

Results showed that BIKTARVY works in a diverse group of adults, regardless of age, sex, race, viral load, or CD4 T-cell count.

*The other treatments were TRIUMEQ® (abacavir, dolutegravir, lamivudine) or DESCOVY® (emtricitabine, tenofovir alafenamide) + TIVICAY® (dolutegravir).

The continued treatments were TRIUMEQ (abacavir, dolutegravir, lamivudine) or a combination of either EPZICOM® (abacavir, lamivudine) or TRUVADA® (emtricitabine, tenofovir disoproxil fumarate) + atazanavir or darunavir (with cobicistat or ritonavir).

IMPORTANT SAFETY INFORMATION

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

BIKTARVY may cause serious side effects:

  • Worsening of hepatitis B (HBV) infection. Your healthcare provider will test you for HBV. If you have both HIV-1 and HBV and stop taking BIKTARVY, your HBV may suddenly get worse. Do not stop taking BIKTARVY without first talking to your healthcare provider, as they will need to monitor your health, and may give you HBV medicine.

Who should not take BIKTARVY?

Do not take BIKTARVY if you take:

  • dofetilide
  • rifampin
  • any other medicines to treat HIV-1

What are the other possible side effects of BIKTARVY?

Serious side effects of BIKTARVY may also include:

  • Changes in your immune system. Your immune system may get stronger and begin to fight infections that may have been hidden in your body. Tell your healthcare provider if you have any new symptoms after you start taking BIKTARVY.
  • Kidney problems, including kidney failure. Your healthcare provider should do blood and urine tests to check your kidneys. If you develop new or worse kidney problems, they may tell you to stop taking BIKTARVY.
  • Too much lactic acid in your blood (lactic acidosis), which is a serious but rare medical emergency that can lead to death. Tell your healthcare provider right away if you get these symptoms: weakness or being more tired than usual, unusual muscle pain, being short of breath or fast breathing, stomach pain with nausea and vomiting, cold or blue hands and feet, feel dizzy or lightheaded, or a fast or abnormal heartbeat.
  • Severe liver problems, which in rare cases can lead to death. Tell your healthcare provider right away if you get these symptoms: skin or the white part of your eyes turns yellow, dark “tea-colored” urine, light-colored stools, loss of appetite for several days or longer, nausea, or stomach-area pain.

The most common side effects of BIKTARVY in clinical studies were diarrhea (6%), nausea (6%), and headache (5%). Tell your healthcare provider if you have any side effects that bother you or don’t go away.

Another Reason to Keep Fighting

Getting to undetectable quickly is an important goal. But continuing to take your treatment and staying undetectable is just as important. The HIV virus can change and evolve, which means there’s a chance you can develop what’s called drug resistance. That’s when the virus mutates, making your treatment no longer effective.

0

Zero adults new to treatment developed drug resistance to BIKTARVY through 3 years in clinical trials.

When you keep taking BIKTARVY every day, the medicines keep fighting the virus to help prevent drug resistance.

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Download the BIKTARVY patient brochure for more information.

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What is BIKTARVY®?

BIKTARVY is a complete, 1-pill, once-a-day prescription medicine used to treat HIV-1 in adults and children who weigh at least 55 pounds. It can either be used in people who have never taken HIV-1 medicines before, or people who are replacing their current HIV-1 medicines and whose healthcare provider determines they meet certain requirements.

BIKTARVY does not cure HIV-1 or AIDS. HIV-1 is the virus that causes AIDS.

IMPORTANT SAFETY INFORMATION

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

BIKTARVY may cause serious side effects:

  • Worsening of hepatitis B (HBV) infection. Your healthcare provider will test you for HBV. If you have both HIV-1 and HBV and stop taking BIKTARVY, your HBV may suddenly get worse. Do not stop taking BIKTARVY without first talking to your healthcare provider, as they will need to monitor your health, and may give you HBV medicine.

Who should not take BIKTARVY?

Do not take BIKTARVY if you take:

  • dofetilide
  • rifampin
  • any other medicines to treat HIV-1

What are the other possible side effects of BIKTARVY?

Serious side effects of BIKTARVY may also include:

  • Changes in your immune system. Your immune system may get stronger and begin to fight infections that may have been hidden in your body. Tell your healthcare provider if you have any new symptoms after you start taking BIKTARVY.
  • Kidney problems, including kidney failure. Your healthcare provider should do blood and urine tests to check your kidneys. If you develop new or worse kidney problems, they may tell you to stop taking BIKTARVY.
  • Too much lactic acid in your blood (lactic acidosis), which is a serious but rare medical emergency that can lead to death. Tell your healthcare provider right away if you get these symptoms: weakness or being more tired than usual, unusual muscle pain, being short of breath or fast breathing, stomach pain with nausea and vomiting, cold or blue hands and feet, feel dizzy or lightheaded, or a fast or abnormal heartbeat.
  • Severe liver problems, which in rare cases can lead to death. Tell your healthcare provider right away if you get these symptoms: skin or the white part of your eyes turns yellow, dark “tea-colored” urine, light-colored stools, loss of appetite for several days or longer, nausea, or stomach-area pain.

The most common side effects of BIKTARVY in clinical studies were diarrhea (6%), nausea (6%), and headache (5%). Tell your healthcare provider if you have any side effects that bother you or don’t go away.

What should I tell my healthcare provider before taking BIKTARVY?

  • All your health problems. Be sure to tell your healthcare provider if you have or have had any kidney or liver problems, including hepatitis virus infection.
  • All the medicines you take, including prescription and over-the-counter medicines, antacids, laxatives, vitamins, and herbal supplements. BIKTARVY and other medicines may affect each other. Keep a list of all your medicines and show it to your healthcare provider and pharmacist, and ask if it is safe to take BIKTARVY with all of your other medicines.
  • If you are pregnant or plan to become pregnant. It is not known if BIKTARVY can harm your unborn baby. Tell your healthcare provider if you become pregnant while taking BIKTARVY.
  • If you are breastfeeding (nursing) or plan to breastfeed. Do not breastfeed. HIV-1 can be passed to the baby in breast milk.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call ‍1‑800‑FDA‑10881‑800‑FDA‑1088.

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