You may have heard about Biktarvy, a medicine approved by the FDA in 2018 to treat HIV. It may be used if you:
- Have never been treated for HIV before
- Are being treated for HIV but the virus is still detectable and is not resistant to Biktarvy
- Already have HIV under control
- Need to switch from another HIV medicine and your virus is not resistant to Biktarvy
Biktarvy contains three medicines in one pill: bictegravir (an integrase inhibitor), emtricitabine (an NRTI), and tenofovir alafenamide (an NRTI). Emtricitabine and tenofovir alafenamide have been used to treat HIV for many years.
How Does Biktarvy Treat HIV?
HIV is a virus that spreads through the body and damages the immune system. A weakened immune system makes it easier to get very sick from other infections.
The three medicines in Biktarvy work together to stop HIV from spreading in your body. This helps protect your immune system and may lower the chance of passing the virus to others.
Biktarvy is one pill taken once a day. You do not need to take several different pills at different times. Taking one pill makes it easier to stay on your treatment, which is very important for keeping HIV under control.
Biktarvy can help keep HIV under control, but it is not a cure. It also does not protect against other sexually transmitted infections (STIs) like herpes, gonorrhea, or chlamydia.
Important Safety Warnings
Warning: Hepatitis B (HBV) Flare-Up After Stopping Biktarvy
This is the most serious warning for Biktarvy. If you have both HIV and hepatitis B, stopping Biktarvy can cause your hepatitis B to suddenly get much worse. This can be life-threatening. Your doctor needs to test you for hepatitis B before you start Biktarvy. If you have hepatitis B, your liver must be checked regularly and for several months after you stop taking Biktarvy. Never stop Biktarvy without talking to your doctor first.
Warning: Lactic Acidosis and Serious Liver Problems
A rare but potentially fatal condition called lactic acidosis (too much lactic acid in the blood) has been reported with medicines like those in Biktarvy. Serious liver swelling (with fat buildup) has also been reported and can be fatal. Stop taking Biktarvy and get emergency care right away if you have any of these symptoms:
- Unusual muscle pain or weakness
- Trouble breathing
- Stomach pain with nausea or vomiting
- Cold or bluish hands or feet
- Dizziness or lightheadedness
- Fast or irregular heartbeat
- Yellowing of your skin or eyes
How Was It Studied for HIV?
Several clinical trials have tested whether Biktarvy is safe and effective for treating HIV.
Two large studies looked at people who had never been treated for HIV. Biktarvy was compared to another first-line HIV treatment recommended by the U.S. Department of Health and Human Services (HHS). Both studies lasted 144 weeks. Biktarvy worked just as well as the other treatment. No one in these studies developed resistance to Biktarvy.
Several other studies looked at people whose HIV was already under control. Some patients stayed on their current medicine, while others switched to Biktarvy. These studies lasted 24 to 48 weeks. Biktarvy kept HIV under control in all of these studies. No one developed resistance to Biktarvy.
Some studies continued for longer to look at long-term effects. Biktarvy has been studied since 2015 in people who had never been treated for HIV, and since 2017 in people already on HIV treatment.
Who Was Included in These Studies?
Biktarvy has been studied in a wide range of people, including:
- Adults (including those 65 and older), adolescents, and children
- Males and females
- Asian, Black, Hispanic/Latino, and White people
How Strong Is the Evidence?
The clinical studies show that Biktarvy is effective for treating HIV. However, like all medicines, it carries serious risks that you should know about (see the safety warnings above). The U.S. Department of Health and Human Services recommends Biktarvy as one of several first-line medicines for people who have never been treated for HIV.
How Is Biktarvy Taken?
Biktarvy is one tablet taken by mouth once a day. It can be taken at any time, with or without food. Taking it every day without missing doses is very important for keeping HIV under control.
If you miss a dose take it as soon as you remember. If it is almost time for your next dose, skip the missed dose. Do not take two doses at once.
Do not stop taking Biktarvy without talking to your doctor first, especially if you have hepatitis B (see the HBV warning above).
What Can I Do to Manage Side Effects?
The most common side effects with Biktarvy are diarrhea, nausea, and headache.
- Diarrhea: Drink plenty of fluids to stay hydrated.
- Nausea: Try taking Biktarvy with food or a light snack. Eating smaller, more frequent meals may also help.
- Headache: Get plenty of rest and drink enough water.
Over-the-counter or prescription medicines can also help with these side effects. Talk to your health care provider for advice.
Serious side effects are described in the safety warnings above. These are not all possible side effects. Tell your health care provider about any symptoms that bother you.
You can report side effects to the FDA at www.fda.gov/medwatch or by calling 1-800-FDA-1088. In Canada, report side effects to Health Canada at www.health.gc.ca/medeffect or by calling 1-866-234-2345.
What Drug Interactions Can Happen?
Some medicines must not be taken with Biktarvy:
- Dofetilide (Tikosyn), a heart rhythm medicine. Taking it with Biktarvy can raise dofetilide to dangerous levels in your blood and cause a life-threatening heart problem. Do not take Biktarvy if you take dofetilide.
- Rifampin (Rifadin, Rimactane), an antibiotic used to treat tuberculosis. Taking it with Biktarvy can make Biktarvy stop working, and may lead to the HIV virus becoming resistant to treatment. Do not take Biktarvy if you take rifampin.
Other medicines and supplements can also affect how well Biktarvy works:
- Antacids containing aluminum or magnesium: Take Biktarvy at least 2 hours before, or at least 6 hours after, taking these antacids.
- Calcium or iron supplements: Take Biktarvy with food if you also take calcium or iron supplements.
- St. John's Wort: This herbal supplement can reduce how well Biktarvy works. Tell your doctor if you take it.
Always tell your health care provider and pharmacist about all prescription medicines, over-the-counter medicines, vitamins, minerals, herbal products, and other supplements you take or have recently taken.
Are There Any Other Important Cautions?
Kidney (renal) problems: Biktarvy is not recommended for people with significant kidney disease (eGFR below 30 mL/min). If you have kidney disease or are on dialysis, talk to your doctor specifically about whether Biktarvy is right for your situation.
Immune reconstitution syndrome (IRIS): When you first start HIV treatment, your recovering immune system may react strongly to infections that were already in your body. This can cause new or worsening symptoms shortly after you start Biktarvy. Tell your doctor right away if you notice new symptoms after starting treatment.
Pregnancy: If you are pregnant or plan to become pregnant, tell your doctor. Biktarvy levels in the blood may be lower during pregnancy, so your doctor may watch your viral load more closely.
Breastfeeding: If you are breastfeeding or plan to breastfeed, talk to your doctor first. Biktarvy passes into breastmilk. Breastfeeding while taking Biktarvy carries three risks: passing HIV to your baby if your baby does not have HIV; making HIV harder to treat if your baby does have HIV; and exposing your baby to Biktarvy side effects.
How Do I Know If It Is Working?
Your health care provider will order routine tests while you are taking Biktarvy. One test is called an HIV viral load, which measures the amount of HIV in your blood. If you have never been treated before, your viral load may be high. Taking Biktarvy every day will help bring it down and keep HIV under control.
If your HIV is already under control and you are switching to Biktarvy, your viral load should stay under control as long as you take it every day.
Is There Any Cost Assistance Available?
Yes. The manufacturer offers a co-pay program that may allow you to pay $0 for your prescription. Whether you qualify depends on your insurance. You can learn more at www.biktarvy.com/resources/biktarvy-cost-support.
