
Defending Against Resistance Matters
What is resistance?
Sometimes, HIV can change or mutate. This change might make a medicine not work as well. This is called a resistance mutation or treatment resistance. When HIV becomes resistant, it’s tougher to treat. Resistance is permanent and not reversible, which means future treatment options could be limited. That’s why it’s important to understand ways to reduce the risk of resistance.
The importance of a high barrier to resistance
Medicines have low to high barriers to resistance, which tell us how many mutations would need to occur to stop the medicine from working. A medicine with a high barrier to resistance means it may still work even after several mutations. An important defense against drug resistance is taking your medication exactly as your healthcare provider prescribes and taking a treatment with a high barrier to resistance.
Taking your medication as prescribed and taking a treatment that has a high barrier to resistance, like BIKTARVY®, can help prevent drug resistance.
Make sure 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.
BIKTARVY has been proven effective in extensive clinical trials of people new to treatment.
Two studies involved more than 1200 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.
Both 3-year and 5-year clinical study time points showed that most adults new to treatment taking BIKTARVY as prescribed reached and stayed undetectable (less than 50 copies/mL). 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).
*The other treatments were TRIUMEQ® (abacavir, dolutegravir, lamivudine) or DESCOVY® (emtricitabine, tenofovir alafenamide) + TIVICAY® (dolutegravir).
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.
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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 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.