What is the generic name for Biktarvy?

Key Points

The generic name for Biktarvy is bictegravir, emtricitabine and tenofovir alafenamide. It's is a 3-drug combination given as once-daily, oral, single tablet regimen for HIV treatment. Biktarvy is not used for HIV prevention.

In 2018, the FDA first 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. 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.

Related: View Biktarvy in the Drugs.com Pill Identifier

What is Biktarvy approved for?

Biktary is FDA-approved for the treatment of HIV-1 infection in people:

• who have not received HIV-1 medicines in the past, OR
• to replace current HIV-1 medicines for people whose healthcare provider determines that they are virologically suppressed (HIV-1 RNA less than 50 copies per mL) on a stable antiretroviral regimen with no known or suspected substitutions associated with resistance to bictegravir or tenofovir.

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.

Related questions

• Which medicines should not be taken with Biktarvy?
• Can Biktarvy be used for PrEP or PEP?
• What if I miss a dose of Biktarvy?

Biktarvy Use in Patients with Resistance

Biktarvy (bictegravir 50 mg / emtricitabine 200 mg / tenofovir alafenamide 25 mg) was approved by the FDA in February 2024 for the treatment of people with HIV who have a known or suspected M184V/I mutation, a common form of treatment resistance.

• Biktarvy was studied In a 48-week long Phase 3 study (Study 4030) in people with HIV-1 with or without pre-existing NRTI resistance, including those with the M184V/I resistance.
• Participants were randomized to switch to Biktarvy (N=284) or to continue their prior treatment regimen, DTG+ F/TAF (N=281). Of the subjects receiving Biktarvy, 47 had HIV-1 with pre-existing M184V or I resistance substitutions
• Results showed that 89% (42/47) of people receiving Biktarvy (bictegravir 50 mg / emtricitabine 200 mg / tenofovir alafenamide 25 mg) with preexisting M184V/I resistance substitutions remained virally suppressed (HIV-1 RNA < 50 copies/mL) at Week 48 of the study.
• In addition, no cases of treatment-emergent resistance to Biktarvy were shown, regardless of M184V/I resistance status.

Side Effects

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.

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