| Fact Table | |
|---|---|
| Formula | C21H18F3N3O5 / C8H10FN3O3S / C21H29N6O5P |
| License | FDA approved (February 7, 2018) |
| Bioavailability | Bictegravir: not determined; emtricitabine: ~93%; tenofovir alafenamide: not established for the fixed-dose product |
| Legal status | Prescription only (Rx) |
| Chemical Name | Bictegravir / Emtricitabine / Tenofovir alafenamide |
| Elimination half-life | Bictegravir: ~17.3 hours; emtricitabine: ~10 hours; tenofovir alafenamide: ~0.5 hours (plasma) |
| Dosage (Strength) | Tablets: 30 mg/120 mg/15 mg and 50 mg/200 mg/25 mg; usual adult dose: 50 mg/200 mg/25 mg once daily |
| Pregnancy | Use in pregnancy is supported in current labeling; recommended dose is unchanged, with close viral load monitoring during pregnancy |
| Brands | Biktarvy |
| Protein binding | Bictegravir: >99%; emtricitabine: <4%; tenofovir alafenamide: ~80% |
| PubChem CID | 129626368 |
| MedlinePlus | a618012 |
| ChEBI | 172943 / 37598 / 134990 |
| ATC code | J05AR20 |
| DrugBank | DB11799 / DB00879 / DB09299 |
| KEGG | D11039 |
| Routes of administration | By mouth (oral tablets) |
Biktarvy is a single pill that combines three drugs to treat HIV-1 infection. Bictegravir works as an integrase strand transfer inhibitor (INSTI), while emtricitabine and tenofovir alafenamide work as nucleoside analog reverse transcriptase inhibitors (NRTIs). Each drug works in a different way to block the virus from making copies of itself, which helps control HIV in the body. Although some people may have both HIV and hepatitis B, Biktarvy is not used to treat hepatitis B infection.
Biktarvy is taken orally as one tablet once daily with or without food. Swallow the tablet whole and not crush, chew, or split it.
The standard dose contains 50 mg of bictegravir, 200 mg of emtricitabine, and 25 mg of tenofovir alafenamide in a single combination tablet. The exact dosage may depend on a person's age, weight, and kidney function.
If a dose is missed and it's been less than 18 hours since the usual dosing time, take the missed dose as soon as possible and then resume the regular schedule. However, if more than 18 hours have passed, do not take the missed dose and wait until the next scheduled time. It's important not to take more than one dose at a time to make up for a missed tablet.
Before starting Biktarvy, patients may need testing for hepatitis B virus since stopping the medication may cause severe liver problems in people with HBV infection.
The active ingredients in Biktarvy are bictegravir sodium, emtricitabine, and tenofovir alafenamide fumarate.
Before using this medication, you may want to consult a healthcare provider about the following:
Hepatitis B can worsen if treatment is stopped. If you have both HIV and hepatitis B, stopping Biktarvy may cause serious liver problems.
Drug interactions may reduce effectiveness or increase side effects. Some medications can make Biktarvy work less well or raise the risk of harmful reactions. Tell a provider about all prescription drugs, over-the-counter medicines, and supplements you take.
Immune reconstitution syndrome may occur. As your immune system gets stronger on treatment, it may react to hidden infections, causing inflammation. Autoimmune conditions may also develop months after starting therapy.
Kidney problems can develop or worsen. Biktarvy may affect kidney function, especially in people with existing kidney disease or those taking certain medications like NSAIDs.
Severe liver problems and lactic acidosis are rare but serious risks. Symptoms may include unusual weakness, stomach pain, trouble breathing, or yellowing of the skin or eyes.
Avoid taking or using this medication if any of the following apply:
Common side effects of Biktarvy include:
These side effects are usually mild and tend to improve after adjusting to treatment. Some people may also notice tiredness or stomach discomfort. Let a healthcare provider know if side effects bother you or do not go away.
Biktarvy can also cause serious side effects, although these are less common. These include immune reconstitution syndrome (when your recovering immune system starts fighting hidden infections), new or worsening kidney problems, lactic acidosis, and severe liver problems.
Get medical help if you develop yellowing of the skin or eyes, dark urine, unusual muscle pain, trouble breathing, severe weakness, or ongoing stomach pain.
What is Biktarvy used for?
Biktarvy is a once-daily prescription medicine used to treat HIV-1 infection. It combines three antiviral drugs in one tablet: bictegravir, emtricitabine, and tenofovir alafenamide. It helps lower the amount of HIV in the body, but it does not cure HIV.
How is Biktarvy taken?
Biktarvy is usually taken by mouth once daily, with or without food. It should be taken exactly as prescribed and not skipped, because missed doses can allow the virus to multiply and may increase the risk of resistance.
Is Biktarvy a complete HIV treatment by itself?
Yes. Biktarvy is considered a complete HIV regimen, so it is generally not taken with other HIV medicines unless a clinician specifically directs it. Taking extra antiretrovirals without guidance can increase side effects or interactions.
What are the most common side effects of Biktarvy?
Common side effects include diarrhea, nausea, headache, and tiredness. Some people also notice changes in weight over time. Many side effects are mild, but persistent or severe symptoms should be discussed with a healthcare professional.
Are there serious warnings with Biktarvy?
Yes. A major warning involves hepatitis B. If someone has both HIV and hepatitis B, stopping Biktarvy can cause hepatitis B to flare up and worsen suddenly. Liver problems, kidney problems, and rare buildup of lactic acid are also important safety concerns.
Can Biktarvy be taken with antacids or supplements?
It can interact with products that contain aluminum, magnesium, calcium, or iron. These can affect how bictegravir is absorbed. Depending on the product, timing may matter, so people should follow the specific instructions given by their prescriber or pharmacist.
What medicines should not be taken with Biktarvy?
Some drugs can cause major interactions, including certain seizure medicines, rifampin, and dofetilide. Herbal products such as St. John’s wort may also reduce Biktarvy levels. Patients should have all prescription drugs, over-the-counter products, and supplements reviewed before starting it.
Is Biktarvy safe for people with kidney or liver problems?
Biktarvy may not be appropriate for everyone with significant kidney or liver disease. Kidney function and liver health are often checked before treatment and monitored during therapy. This is especially important in people with hepatitis B or other existing liver conditions.
Can Biktarvy be used during pregnancy?
Biktarvy may be used in pregnancy in certain situations, but treatment decisions are individualized. A clinician will consider viral suppression, prior treatment history, and overall maternal and fetal health when deciding whether to continue or start it.
What should someone do if they miss a dose of Biktarvy?
The missed dose should usually be taken as soon as remembered unless it is almost time for the next dose. In that case, the person should skip the missed dose and return to the regular schedule. Two doses should not be taken at the same time.
A generic drug is a copy of the brand-name drug with the same dosage, safety, strength, quality, consumption method, performance, and intended use. Before generics become available on the market, the generic company must prove it has the same active ingredients as the brand-name drug and works in the same way and in the same amount of time in the body.
The only differences between generics and their brand-name counterparts is that generics are less expensive and may look slightly different (e.g., different shape or color), as trademark laws prevent a generic from looking exactly like the brand-name drug.
Generics are less expensive because generic manufacturers don't have to invest large sums of money to develop a drug. When the brand-name patent expires, generic companies can manufacture a copy of the brand-name and sell it at a substantial discount.