A Treatment Studied With You in Mind
BIKTARVY® has been thoroughly tested in 9 clinical trials with over 3600 participants.
HIV can affect anyone. BIKTARVY was studied in people from many different backgrounds, such as:
People new
to starting
treatment
People who
switched after being undetectable on
another treatment
Various races
and ethnicities
People aged 3
to 80 years old
Pregnant
people
People with
high amounts of
HIV in the blood
People with a
low CD4 count
People whose
HIV had
changed in
certain ways
Proven by Experience in Clinical Trials
New to Treatment
BIKTARVY has been proven effective in extensive clinical trials of people new to treatment.
Clinical Trials
Study 1489 and Study 1490 | 5 Years
Overview
At the end of 3 years, most adults who had been taking BIKTARVY continued, and many who were taking other treatments switched to BIKTARVY.
Together, these studies examined BIKTARVY in adults new to HIV treatment for a total of 5 years, including over 120 women.
*The other treatments were TRIUMEQ® (abacavir, dolutegravir, lamivudine) or DESCOVY® (emtricitabine, tenofovir alafenamide) + TIVICAY® (dolutegravir).
Results
Both 3-year and 5-year clinical study time points 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.
Click below to learn more about the 1- and 3-year time points.
About 9 out of 10 people living with HIV who were new to treatment on BIKTARVY reached undetectable levels.
- Study 1489: 92% (290 out of 314) of people on BIKTARVY reached undetectable compared to 93% (293 out of 315) of people on TRIUMEQ® (abacavir, dolutegravir, lamivudine).
- Study 1490: 89% (286 out of 320) of people on BIKTARVY reached undetectable compared to 93% (302 out of 325) of people on DESCOVY (emtricitabine, tenofovir alafenamide) + TIVICAY (dolutegravir).
8 out of 10 people living with HIV who were new to treatment on BIKTARVY reached undetectable levels.
- Study 1489: 82% (256 out of 314) of people on BIKTARVY reached undetectable compared to 84% (265 out of 315) of people on TRIUMEQ (abacavir, dolutegravir, lamivudine).
- Study 1490: 81% (262 out of 320) of people on BIKTARVY reached undetectable compared to 84% (273 out of 325) of people on DESCOVY (emtricitabine, tenofovir alafenamide) + TIVICAY (dolutegravir).
Starting your HIV-1 treatment is an important decision. Your healthcare provider should always work with you to decide what medicine makes sense.
Switching Treatment
More people have switched to BIKTARVY than any other HIV treatment.
Source: IQVIA LAAD, July 2018 through July 2024.†
†This information is an estimate derived from the use of information under license from the following IQVIA information service: IQVIA LAAD, for the period July 2018 through July 2024. IQVIA expressly reserves all rights, including rights of copying, distribution, and republication.
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.
Read about the clinical trials and results below.
Clinical Trials
Study 1844 | 3 years
Overview
‡The continued treatment was TRIUMEQ (abacavir, dolutegravir, lamivudine).
Results
Both 1-year and 3-year time points showed that most adults who replaced their current treatment with BIKTARVY and took their treatment as prescribed stayed undetectable.
At 1 year, about 9 out of 10 people (94%, 264 out of 282) who were undetectable on another treatment stayed undetectable when they switched to BIKTARVY. Of the people who continued their current treatment, about 9 out of 10 (95%, 267 out of 281) stayed undetectable at 1 year.
Study 1878 | 2 years
Overview
§ The continued treatments were a combination of either EPZICOM® (abacavir, lamivudine) or TRUVADA® (emtricitabine, tenofovir disoproxil fumarate) + atazanavir or darunavir (with cobicistat or ritonavir).
Results
Both 1-year and 2-year time points showed that most adults who replaced their current treatment with BIKTARVY and took their treatment as prescribed stayed undetectable.
At 1 year, about 9 out of 10 people (92%, 267 out of 290) who were undetectable on another treatment stayed undetectable when they switched to BIKTARVY. Of the people who continued their current treatment, about 9 out of 10 (89%, 255 of 287) stayed undetectable at 1 year.
Switching your HIV-1 treatment is an important decision. Your healthcare provider should always work with you to decide what medicine makes sense.
Studied With Resistance in Mind
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 in these studies showed that BIKTARVY works in a diverse group of adults, including those of different ages, sexes, or races.
CD4, cluster of differentiation 4.
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 31 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 31 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 31 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 31 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.
