Biktarvy (Bictegravir/Emtricitabine/Tenofovir Alafenamide) 50mg/200mg/25mg*30's | HIV-1 | GLT

Generic Information: Biktarvy (United States)

Biktarvy is the originator fixed-dose combination of bictegravir 50 mg, emtricitabine 200 mg, and tenofovir alafenamide 25 mg, developed by Gilead Sciences and approved by the US FDA on 7 February 2018. It was the smallest integrase-inhibitor-based triple-therapy single-tablet regimen available at launch, packing one INSTI and two NRTIs into a single once-daily pill. This listing covers the United States version, the reference product against which every later generic and licensed copy is measured.

What Is Biktarvy Used For?

Biktarvy is a complete regimen for the treatment of HIV-1 infection in adults and in children weighing at least 14 kg, whether they are starting treatment for the first time or switching from a stable, virologically suppressed regimen. The US label has since been expanded to cover people with a known or suspected M184V/I mutation, a common resistance pattern that had previously restricted the drug's use. It is treatment, not prevention, and does not cure HIV.

How Does Biktarvy Work?

The three components attack the virus at two different points in its replication cycle. Bictegravir is an unboosted integrase strand transfer inhibitor that blocks the enzyme HIV uses to insert its DNA into a human cell's genome, while emtricitabine and tenofovir alafenamide are nucleoside reverse transcriptase inhibitors that stop the virus from copying its genetic material. Because the three drugs work together and neither bictegravir nor TAF requires a boosting agent, the whole regimen fits into one small tablet with no food requirement and no HLA-B*5701 testing.

Indications

Biktarvy is indicated as a complete regimen for HIV-1 infection in treatment-naive adults and pediatric patients weighing at least 14 kg, and as a switch option for those who are virologically suppressed on a stable regimen with no known resistance to its components. It is also approved for people with an M184V/I mutation. It should not be combined with other antiretrovirals, and it is not used for pre-exposure prophylaxis.

Dosage

The dose is one tablet once daily, with or without food, in patients weighing at least 14 kg. The tablet must not be chewed or crushed. Because bictegravir and TAF are affected by kidney function, Biktarvy is not recommended when estimated creatinine clearance is below 30 mL per minute, and it is not recommended in severe hepatic impairment. Patients should test for hepatitis B before starting, because stopping the drug in someone coinfected with HBV can trigger a severe hepatitis flare.

Side Effects

The most common adverse reactions, each reported in at least 5% of patients, are diarrhea, nausea, and headache. Bictegravir can raise serum creatinine without affecting true kidney function, because it blocks tubular secretion of creatinine; total bilirubin may also rise. The boxed warning concerns post-treatment acute exacerbation of hepatitis B, so liver function is monitored closely after discontinuation in coinfected patients. Rare but serious risks include lactic acidosis and immune reconstitution syndrome.

Storage

Store Biktarvy at room temperature, between 20°C and 25°C (with excursions permitted to 15–30°C), in the original container, away from moisture and out of reach of children. No refrigeration is required.

Why Choose the US Version of Biktarvy?

The US version is the exact reference formulation used in the pivotal Phase 3 program, and Biktarvy has become Gilead's top-selling medicine and a first-line standard of care worldwide. Its real draw for international buyers is the combination of a single small daily tablet, a high barrier to resistance, and no food or HLA testing burden. GLT helps buyers source the genuine US product with verified supply chains and proper export documentation.

How to Order

To source United States Biktarvy through GLT, message us on WhatsApp at +86 15234153837 or email [email protected]. Tell us the strength, pack size, and destination country, and we will confirm sourcing origin, current availability, and the import documentation you need. We serve both institutional purchasers and individual patients.

FAQ

Is Biktarvy a single-pill regimen? Yes. It combines bictegravir, emtricitabine, and tenofovir alafenamide in one tablet taken once daily, which is why it is called a single-tablet regimen.

Do I need to take Biktarvy with food? No. Biktarvy can be taken with or without food, and it does not require HLA-B*5701 testing because it does not contain abacavir.

What does the boxed warning mean? Patients coinfected with HIV and hepatitis B can experience a severe flare of hepatitis B if they stop Biktarvy, so hepatic function must be monitored after discontinuation.