Studied in a Diverse Group of Adults
BIKTARVY® was evaluated in 5 clinical trials, involving more than 2,900 adults living with HIV for varying periods of time
- 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. At the end of 3 years, most adults who had either been taking BIKTARVY continued or who were taking other treatments switched to BIKTARVY, and these groups were studied for an additional 2 years. Together, these study periods examined BIKTARVY in adults new to treatment for a total of 5 years.
- 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.
BIKTARVY was studied even in some cases where the HIV virus had changed in certain ways
- Sometimes the HIV virus can mutate or change. Some mutations can cause drug resistance, which means your medicine may stop working and make the virus harder to treat.
- One additional study involved more than 560 adults. People in the study either replaced or continued their current treatment [284 replaced treatment with BIKTARVY and 281 stayed on or replaced their treatment with DESCOVY® (emtricitabine, tenofovir alafenamide) + TIVICAY® (dolutegravir)] over a 1-year period. Of the adults who switched to BIKTARVY, 47 out of 284 had an HIV virus that had changed in a certain way (a mutation called M184V/I) where it was resistant to emtricitabine, a medicine in BIKTARVY.
Results showed that BIKTARVY works in a diverse group of adults, regardless of age, sex, or race.
*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).
Reaching and Staying Undetectable
Starting BIKTARVY:
Long-term viral suppression
Both 3-year and 5-year clinical study timepoints showed that most adults new to treatment 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 infections.
Switching to BIKTARVY:
BIKTARVY can help adults stay undetectable and maintain your CD4 T-cell count. BIKTARVY can also help adults stay undetectable whose virus has changed in a certain way (a mutation called M184V/I) where it is resistant to emtricitabine, a medicine in BIKTARVY. Before taking BIKTARVY, your healthcare provider must determine that you meet certain requirements.
Starting or switching your HIV-1 treatment is an important decision. Your healthcare provider should always work with you to decide what medicine makes sense.
CD4, cluster of differentiation 4.
Zero Resistance Over 5 Years
It’s important to take your treatment as prescribed, because low levels of medicine in your blood may make it easier for the HIV virus to mutate, or change. Some mutations can cause drug resistance, which means your medicine may stop working and make the virus harder to treat.
A medicine’s barrier to resistance refers to how well it works, even when the virus has mutated. When a medicine has a high barrier to resistance, it means the medicine may still work even if the virus has mutated.
Taking a treatment that has a high barrier to resistance, like BIKTARVY, and taking your medication every day can help prevent drug resistance.
Zero adults new to treatment developed drug resistance to BIKTARVY through 5 years of clinical trials.
Talk to your healthcare provider about why resistance matters.
Starting or switching to BIKTARVY?
Download this brochure to learn more about BIKTARVY.
Looking for more Spanish resources? Visit the Spanish site
What is BIKTARVY®?
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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.
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. Tell your healthcare provider if you become pregnant while taking BIKTARVY.
- If you are breastfeeding (nursing) or plan to breastfeed. Talk to your healthcare provider about the risks of breastfeeding during treatment with BIKTARVY.
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 see Important Facts about BIKTARVY, including important warnings.
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. Tell your healthcare provider if you become pregnant while taking BIKTARVY.
- If you are breastfeeding (nursing) or plan to breastfeed. Talk to your healthcare provider about the risks of breastfeeding during treatment with BIKTARVY.
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 see Important Facts about BIKTARVY, including important warnings.
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.
