What is the generic name for Biktarvy?
The generic name for Biktarvy is bictegravir, emtricitabine and tenofovir alafenamide. Biktary is a 3-drug combination used as a complete, once-daily, single tablet regimen for HIV treatment. Biktarvy is not a cure for HIV or AIDS and is not used for HIV prevention.
In 2018, the FDA approved Biktarvy from Gilead Sciences. Biktarvy contains bictegravir, an integrase strand transfer inhibitor (INSTI), and emtricitabine (FTC) and tenofovir alafenamide (TAF), both HIV-1 nucleoside analog reverse transcriptase inhibitors (NRTIs) used for the treatment of HIV-1 infection.
Biktary comes in an oral tablet form. Each tablet contains 50 mg of bictegravir (BIC), 200 mg of emtricitabine (FTC), and 25 mg of tenofovir alafenamide (TAF). It is given once a day with or without food in adults and children that weigh at least 14 kg (31 lb). Biktarvy should not be taken with other HIV-1 medications.
What is Biktarvy approved for?
Biktary is FDA-approved for the treatment of HIV-1 infection:
- in patients who have no antiretroviral treatment history, or
- to replace the current stable, HIV treatment regimen in those who are virologically-suppressed (HIV-1 RNA less than 50 copies per mL). Patients should have no history of treatment failure and no known resistance to Biktarvy components.
- Patients with certain levels of kidney or liver disease may not be able to use Biktarvy.
What are HIV and AIDS?
HIV (Human Immunodeficiency Virus) damages the cells of the immune system. Your immune system helps to protect you from infections and disease. HIV makes the body less able to fight infection and more susceptible to life threatening opportunistic infections that are more common in people with weakened immune systems. HIV-1 virus is the virus that causes AIDS.
AIDS (Acquired Immunodeficiency Syndrome) refers to the late stages of HIV infection. Most individuals infected with HIV will progress to AIDS if not treated with antiretroviral medications.
Biktarvy study results
- In four Phase 3 studies of 2,415 participants over 48 weeks, Biktarvy met its primary goal at the end of the study of non-inferiority (meaning Biktarvy was not worse than the active controls).
- Three-year long clinical studies showed that most patients taking Biktarvy every day reached and stayed undetectable(virus levels less than 50 copies/mL). Biktarvy can also help to increase the number of CD4 T-cells in your blood and help you fight off infections.
- No adults new to treatment in clinical studies developed resistance to Biktary over a 3-year period.
According to the U.S. Department of Health and Human Services, many patients can become undetectable in 8 to 24 weeks, when taking their treatment as prescribed.
Biktarvy does not require testing for the HLA-B5701 gene variant because it does not contain abacavir. Patients with the HLA-B5701 gene variant cannot take abacavir as they have a higher risk of developing a possible life-threatening reaction to the medicine. Abacavir is found in products like Triumeq and Trizivir.
The most common side effects in clinical studies with Biktarvy included diarrhea (6%), nausea (5%), and headache (5%).
Biktary can worsen a hepatitis B virus (HBV) infection. Your healthcare provider will test you for HBV infection before or when you start treatment. If you have HBV infection and take Biktarvy, your HBV infection may get worse (flare-up) if you stop taking this medicine.
Be sure to tell your doctor or other healthcare provider about all the medications you take, so they can check for Biktarvy drug interactions or other problems. This includes prescription and over-the-counter (OTC) medicines, antacids, laxatives, vitamins, and herbal supplements.
This is not all the information you need to know about Biktary (bictegravir, tenofovir, and emtricitabine) for safe and effective use and does not take the place of talking to your doctor about your treatment. Review the full Biktarvy information here, and discuss this information and any questions you have with your doctor or other health care provider.
- Biktarvy (bictegravir, emtricitabine and tenofovir alafenamide) [product information]. Gilead Sciences, Foster City, CA. Accessed Feb. 23, 2021 at https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/210251s007lbl.pdf
- Biktarvy.com. About Biktary (online). Gilead Sciences. Accessed Feb. 23, 2021 at https://www.biktarvy.com/about-biktarvy
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