Biktarvy
Pronunciation: bik-TAR-vee
Generic name: bictegravir, emtricitabine, tenofovir
Dosage form: tablet (Bictegravir 50 mg/emtricitabine 200 mg/tenofovir alafenamide 25 mg), (Bictegravir 30 mg/emtricitabine 120 mg/tenofovir alafenamide 15mg)
Drug class: Antiviral combinations
What is Biktarvy?
Biktarvy is a complete HIV-1 treatment in once-a-day single tablet that contains the three antiviral medicines bictegravir, emtricitabine, and tenofovir. Biktarvy works by preventing the HIV from multiplying in your body and lowers HIV blood levels, which decreases your chance of developing acquired immunodeficiency syndrome (AIDS) and HIV-related illnesses, such as cancer or severe infections.
Biktarvy is a complete treatment and should not be used with any other HIV medicines. Human immunodeficiency virus type 1 (HIV-1) is the virus that causes acquired immune deficiency syndrome (AIDS).
Biktarvy is also called:
- BIC / FTC / TAF
- bictegravir sodium / emtricitabine / tenofovir alafenamide fumarate.
Biktarvy tablets are available in two different strengths:
- 30 mg bictegravir, 120 mg emtricitabine, 15 mg tenofovir alafenamide
- 50 mg bictegravir, 200 mg emtricitabine, 25 mg tenofovir alafenamide
Biktarvy FDA-approval was received on February 7, 2018, and no Biktarvy generic is available.
Who can take Biktarvy?
Biktarvy is an FDA-approved medicine used as a complete regimen for the treatment of HIV-1 infection in adults and pediatric patients who weigh at least 14 kg. Bikarvy can be used by patients who:
- who have not taken HIV-1 medicine in the past OR
- to replace their current HIV-1 medicine if they are virologically suppressed (HIV-1 RNA less than 50 copies per mL), on a stable antiretroviral regimen with no history of treatment failure and with no known substitutions associated with resistance to bictegravir or tenofovir.
How does Biktarvy work?
Biktarvy works as a combination antiviral medicine that stops viruses from multiplying to decrease the viral load in your body.
Biktarvy mechanism of action for the active ingredient bictegravir is as an integrase strand transfer inhibitor (INSTI). Biktarvy's mechanism of action for the active ingredients emtricitabine and tenofovir alafenamide is as nucleoside reverse transcriptase inhibitors (NRTIs). Bictegravir, emtricitabine, and tenofovir are antiviral medicines that stop the HIV virus from multiplying.
Biktarvy Side Effects
Common Biktarvy side effects
The most common Biktarvy side effects include:
- Diarrhea (6%)
- Nausea (6%)
- Headache (5%)
- Tiredness (3%)
- Abnormal dreams (3%)
- dizziness (2%)
- Sleep problems (2%)
- Bloating abdomen (2%)
These common side effects occurred in 2% or more of Biktarvy patients in clinical trial 1489.
Biktarvy's other side effects of abdominal pain, gas (flatulence), indigestion (dyspepsia), and vomiting occurred in less than 2% of patients in clinical trials 1489 and 1490.
Biktarvy side effects may also include laboratory abnormalities.
Serious Biktarvy side effects
If you are allergic to Biktarvy, get emergency medical help if you have signs of an allergic reaction, including rash, hives, shortness of breath, or swelling of your face, lips, tongue, or throat.
Biktarvy may cause other serious side effects. Call your doctor at once if you have:
- Kidney problems - little or no urination, swelling in your feet or ankles, feeling tired or short of breath;
- Lactic acidosis - muscle pain or weakness, numbness or cold feeling, trouble breathing, stomach pain, vomiting, irregular heart rate, dizziness, or feeling very weak or tired; or
- Liver problems - swelling around your midsection, upper stomach pain, unusual tiredness, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).
Biktarvy affects your immune system, which may cause certain side effects (even weeks or months after you've taken this medicine). Tell your doctor if you have:
- Signs of a new infection - fever, night sweats, swollen glands, cold sores, cough, wheezing, diarrhea, weight loss;
- Trouble speaking or swallowing, problems with balance or eye movement, weakness or prickly feeling; or
- Swelling in your neck or throat (enlarged thyroid), menstrual changes, impotence.
This is not a complete list of side effects, and others may occur. Talk to your doctor, pharmacist, or healthcare provider for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
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Warnings
Worsening of hepatitis B virus (HBV) infection. If you've ever had hepatitis B, it may become active or get worse after you stop using this medicine. You should have liver function tests with both clinical and laboratory follow-up before treatment and for several months after treatment to determine if they need to give you medicine to treat hepatitis B. Always tell your prescriber about any new or unusual symptoms you may have after you stop taking this medicine.
Biktarvy is not recommended in patients with severe renal impairment or patients with end-stage renal disease who are not receiving chronic hemodialysis, or patients with no antiretroviral treatment history and end-stage renal disease (ESRD) who are receiving chronic hemodialysis
Do not run out of these tablets. Before your tablets are finished, you should refill your prescription or talk to your healthcare provider.
You should not stop taking these tablets without first talking to your doctor.
Before taking this medicine
You should not use this medicine if you are allergic to antiviral medicines bictegravir, emtricitabine, or tenofovir contained in medicines such as Atripla, Complera, Emtriva, Descovy, Genvoya, Odefsey, Stribild, or Truvada.
Some medicines can cause unwanted or dangerous effects when used with Biktarvy, and your doctor may need to change your treatment plan. Do not take Biktarvy if you also take a medicine that contains:
- dofetilide; or
- rifampin.
Tell your doctor if you have or ever had:
- liver disease (especially cirrhosis)
- hepatitis B virus (HBV)
- kidney disease
Before starting treatment with this medicine, you will be tested for hepatitis B virus infection.
Before starting treatment and during treatment, your serum creatinine, estimated creatinine clearance, urine glucose, and urine protein will be monitored as clinically appropriate. In patients with chronic kidney disease, serum phosphorus will also be assessed.
Pregnancy
Tell your healthcare provider if you are pregnant or plan to become pregnant during treatment with this medicine. There is a pregnancy registry for women who take this medicine during pregnancy. The purpose of this registry is to collect information about your and your baby's health. Talk with your healthcare provider about how you can take part in this registry by calling the Antiretroviral Pregnancy Registry (APR) at 1-800-258- 4263.
Breastfeeding
Tell your healthcare provider if you are breastfeeding or planning to breastfeed. This medicine passes to your baby in your breast milk. Talk to your healthcare provider about the following risks to your baby from breastfeeding during treatment with this medicine:
- The HIV-1 virus may pass to your baby if your baby does not have HIV-1 infection.
- The HIV-1 virus may become harder to treat if your baby has HIV-1 infection.
- Your baby may get side effects from these tablets.
Talk with your healthcare provider about the best way to feed your baby.
How should I take Biktarvy?
- Take one tablet once a day, it can be taken with or without food.
- Children who have difficulty swallowing a whole tablet can have the tablet split in half and then swallow each part separately, as long as all parts are swallowed within about 10 minutes.
- You should not change your dose or stop taking this medicine without first talking with your healthcare provider. Stay under a healthcare provider's care during treatment with this medicine.
- If you take other medicines, such as antacids or supplements, see the drug interaction section for specific advice.
- For patients who are on dialysis, you should take your tablet following dialysis.
- Do NOT let your tablets run out. When your medicine supply starts to run low, get more from your healthcare provider or pharmacy before you run out. If the medicine is stopped for even a short time, the amount of virus in your blood may increase, and the virus may develop resistance to this medicine and become harder to treat.
- You will need frequent medical tests.
- Do not miss a dose of Biktarvy.
Take Biktarvy exactly as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.
Biktarvy is a complete HIV-1 treatment regimen. You should not take it with other HIV-1 medicines.
Biktarvy Copay Card
You may pay as little as $0 out-of-pocket if you qualify for the Biktarvy copay card. if you have commercial or private insurance, a valid prescription for Aimovig, and live in the US, Puerto Rico, or US territories.
You may be eligible for a Biktarvy Copay Card, Biktarvy Patient Assistance Program (PAP), or coupon. Refer to our Biktarvy price guide page for links to enrollment forms and more information about the cost of this medicine.
Click here for more information on “Who is eligible for the Biktarvy Copay Card?”.
The cost of prescription drugs varies depending on whether you have insurance, the type of insurance plan you have, and which pharmacy you use.
Biktarvy Dosage Information
Usual Biktarvy dose in adults and pediatric patients weighing at least 25 kg, or virologically-suppressed adults with estimated creatinine clearance below 15 mL/min receiving chronic hemodialysis:
- Biktarvy (Bictegravir 50 mg/emtricitabine 200 mg/tenofovir alafenamide 25 mg) one tablet once a day, with or without food.
Recommended Biktarvy dosage in pregnant individuals who are virologically suppressed (HIV-1 RNA less than 50 copies per mL) on a stable antiretroviral regimen with no known substitutions associated with resistance to the individual components of Biktarvy:
- Biktarvy (Bictegravir 50 mg/emtricitabine 200 mg/tenofovir alafenamide 25 mg) one tablet once a day, with or without food.
Usual Biktarvy dose pediatric (weighing 14 kg to less than 25 kg):
- Biktarvy (Bictegravir 30 mg/emtricitabine 120 mg/tenofovir alafenamide 15mg) one tablet once a day, with or without food.
Renal impairment: Biktarvy is not recommended in patients with an estimated creatinine clearance of 15 to below 30 mL/min, or below 15 mL/min who are not receiving chronic hemodialysis, or below 15 mL/min who have no antiretroviral treatment history.
Hepatic impairment: This medicine is not recommended in patients with severe hepatic impairment.
Comments:
For children who are at least 14 kg to less than 25 kg and are unable to swallow a whole tablet, the tablet can be split, and each part can be taken separately as long as all parts are ingested within about 10 minutes.
What happens if I miss a dose?
Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not use two doses at one time.
When your tablets supply starts to run low, get more from your healthcare provider or pharmacy. This is very important because the amount of virus in your blood may increase if the medicine is stopped for even a short time. The virus may develop resistance to this medicine and become harder to treat.
What happens if I overdose?
Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.
What other drugs will affect Biktarvy?
Sometimes, it is not safe to use certain medications at the same time as taking Biktarvy. Drugs can affect the blood levels of other drugs you take, which may increase side effects or make the medications less effective.
You should not take Biktarvy with
- dofetilide; or
- Rifampin.
It is not recommended to take Biktarvy with:
- Rifabutin
- Rifapentine
- St. John's wort
When taking Biktarvy, alternative anticonvulsants should be considered instead of:
- carbamazepine
- oxcarbazepine
- phenobarbital
- phenytoin.
Avoid taking these tablets with other medications that may also harm the kidneys. Serious side effects, such as acute renal failure, have been reported in postmarketing studies.
Antacids containing aluminium/magnesium:
- Biktarvy can be taken at least 2 hours before or 6 hours after taking antacids containing aluminium/magnesium.
Supplements or Antacids containing Calcium or Iron:
- Biktarvy and supplements or antacids containing calcium or iron can be taken together with food.
In pregnant individuals:
Antacids containing Al/Mg:
- Biktarvy can be taken at least 2 hours before or 6 hours after antacids containing aluminium/magnesium regardless of food intake.
Supplements or Antacids containing Calcium or Iron:
- Biktarvy and supplements or antacids containing calcium or iron can be taken together with food.
- When Biktarvy is taken on an empty stomach it should be taken at least 2 hours before or 6 hours after supplements or antacids containing calcium or iron.
General interaction information
Many drugs can interact with Biktarvy. This includes prescription, over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed here. Tell your doctor about all your current medicines and any medicine you start or stop using. T
Storage
- Store tablets in the original bottle below 86 °F (30 °C).
- Keep the bottle tightly closed.
- This medicine contains a desiccant packet to help keep your medicine dry (protect it from moisture). Keep the desiccant packet in the bottle. Do not eat the desiccant packet.
- Store the tablets blister pack at room temperature between 68 °F to 77 °F (20 °C to 25 °C).
- Keep tablets in its original bottle or blister pack.
- Biktarvy comes in a child-resistant package.
Ingredients
Active ingredients: bictegravir, emtricitabine, and tenofovir alafenamide.
Inactive ingredients: croscarmellose sodium, magnesium stearate, and microcrystalline cellulose.
The tablets are film-coated with a coating material containing iron oxide black, iron oxide red, polyethylene glycol, polyvinyl alcohol, talc, and titanium dioxide.
Manufacturer
Gilead Sciences, Inc. Foster City, CA 94404
Popular FAQ
Does Biktarvy have a copay card?
Yes, the Gilead Advancing Access copay program can help eligible patients who need financial assistance with their copays. The Biktarvy copay card is for commercially insured patients only. If you’re eligible, you may be able to pay as little as $0 for your co-pay. Contact Gilead Sciences at 1-800-226-2056 M–F, 9am–8pm ET for more information.
Which medicines should not be taken with Biktarvy?
- Biktarvy is a complete regimen and use with other antiretroviral medications for the treatment of HIV-1 infection is not recommended.
- Biktarvy is associated with many drug interactions as it contains three different medicines, increasing your risk for interactions. Have your health care provider check for possible interactions with other prescription medicines, OTCs or herbal you take.
- You should not take Biktarvy with dofetilide (Tikosyn), a drug used for heart rhythm disorders or rifampin (Rifadin), a medicine for tuberculosis (TB). These drugs are contraindicated with the use of Biktarvy.
Can Biktarvy be used for PrEP or PEP?
Biktarvy (bictegravir, tenofovir, and emtricitabine) is not FDA approved for use as an HIV-1 preventive for pre-exposure prophylaxis (PrEP) or as a post-exposure prophylaxis (PEP) treatment. Biktarvy is used for HIV treatment (not for prevention) as a once-daily, oral complete regimen in adults and children.
Medications approved by the FDA for use in PrEP are emtricitabine plus tenofovir alafenamide (oral Descovy), emtricitabine plus tenofovir disoproxil (oral Truvada) and the long-acting injection cabotegravir (Apretude). Continue reading
What if I miss a dose of Biktarvy?
If you miss one dose of Biktarvy (bictegravir, tenofovir, and emtricitabine), take the missed dose as soon as you remember it. If it is almost time for your next dose, just skip the missed dose and take your next dose at the regular time. Try not to miss doses. Taking your medicine as prescribed will help you to keep your HIV under control and help prevent drug resistance. Continue reading
Does Biktarvy cause weight gain?
Weight gain is a side effect with Biktarvy, but it was reported after the drug was approved and it's not known if it was caused by the drug. Studies have shown a weight gain of between 1 and 4 kg (2.2 to 8.8 lbs) over 2 years with integrase inhibitors. Continue reading
Do you have to take Biktarvy forever?
Biktarvy antiretroviral therapy (ART) is taken indefinitely for HIV-1 infection as it is a complete regimen for both initial and long-term treatment. Stopping ART can increase blood levels of the HIV virus, lead to resistance, increase your risk for HIV infections and complications and increase the chance that you may transmit the infection to others. Continue reading
Does Dovato cause weight gain?
Studies have shown that weight gain with Dovato can range from 2.4 to 6 kg (5.3 to 13.2 lb) or more after one year of treatment. Integrase inhibitors have been associated with significant weight gain in people living with HIV, although the exact mechanism is not fully understood. Continue reading
Is Biktarvy covered by insurance?
Most commercial and government health insurance plans in the U.S. cover some portion of the cost for Biktarvy. Typically a person taking Biktarvy pays between $0 and $5 per month. A co-pay card program for Biktarvy offers up to $7,200 in cost-sharing assistance per year with no monthly limit. Continue reading
Can I drink alcohol while taking Biktarvy?
There is not a specific warning in the product label against alcohol (ethanol) consumption with Biktarvy, a medication used for HIV treatment. But drinking too much alcohol can damage your liver. Ask your doctor if it is safe and how much alcohol you can drink while taking Biktarvy. Continue reading
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