bictegravir/emtricitabine/tenofovir
Brand names: Biktarvy
Biktarvy is a complete HIV-1 treatment for adults and children who weigh at least 31 pounds. It combines three medicines into one tablet to help control the virus.
Drug Pricing (NADAC)
Brand Price
$128.87/unit
Generic Available
No
GILEAD SCIENCES INC
Pricing data from NADAC (CMS), effective December 18, 2024. Compare all drug costs →
What it does
Biktarvy treats Human Immunodeficiency Virus type 1 (HIV-1) in adults and children weighing at least 31 pounds.
Common side effects
Diarrhea, Nausea, Headache
Key warnings
If you have both HIV and hepatitis B, stopping Biktarvy can cause your hepatitis B to suddenly get worse.
How It Works
Biktarvy contains three drugs that each block HIV in different ways. Bictegravir stops HIV from inserting its DNA into your cells. Emtricitabine and tenofovir alafenamide interfere with an enzyme HIV needs to make copies of itself.
How to Take It
Take one Biktarvy tablet once a day. You can take it with or without food. If you are on hemodialysis, take Biktarvy after your dialysis treatment. For children unable to swallow a whole tablet, the tablet can be split and each part taken separately as long as it is all taken within approximately 10 minutes.
Pregnancy & Breastfeeding
There is a pregnancy registry to track outcomes in women who take Biktarvy during pregnancy. Talk to your doctor about the risks and benefits of taking Biktarvy if you are pregnant or planning to become pregnant. There is not enough data to assess the risk of major birth defects.
Missed Dose
If you miss a dose of Biktarvy, take it as soon as you remember. If it is almost time for your next dose, skip the missed dose and take your next dose at the regular time.
Storage
Store Biktarvy at room temperature.
Serious Warnings
If you have both HIV and hepatitis B, stopping Biktarvy can cause your hepatitis B to suddenly get worse. Your doctor will need to monitor your liver closely for several months after you stop taking Biktarvy. You may need to take medicine for hepatitis B.
Known Drug Interactions
Antimycobacterials: rifabutin rifampin , Strong inducer of CYP3Aand P-gp, and inducer of UGT1A1. rifapentine ↓ BIC ↓ TAF Coadministration with rifampin is contraindicated due to the effect of rifampin on the BIC component of BIKTARVY [see Contraindications (4) ] .
Mechanism: Rifampin speeds up how fast your body breaks down the HIV medicine, which makes the HIV medicine less effective. This can cause the HIV virus to become harder to treat.
What to do: Do not take these two medications together. Your doctor will need to find a different antibiotic that does not interfere with your HIV treatment.
Coadministration of BIKTARVY with drugs that are substrates of OCT2 and MATE1 (e.g., dofetilide) may increase their plasma concentrations (see Table 3 ). Clinical Comment Antiarrhythmics: dofetilide ↑ Dofetilide Coadministration is contraindicated due to the potential for serious and/or life-threatening events associated with dofetilide therapy [see Contraindications (4) ] .
Mechanism: The HIV medicine blocks the way your body removes the heart medicine dofetilide, causing it to build up to dangerous levels. High levels of dofetilide can cause life-threatening heart rhythm problems.
What to do: These drugs must not be used together. Your doctor will need to find an alternative treatment to avoid serious heart risks.
Metformin ↑ Metformin Refer to the prescribing information of metformin for assessing the benefit and risk of concomitant use of BIKTARVY and metformin.
Mechanism: This HIV medication can increase the amount of metformin that stays in your blood. This happens because the medicine interferes with how metformin is cleared from your system.
What to do: Your doctor should watch you closely for metformin side effects and may need to lower your metformin dose.
7.6 Drugs without Clinically Significant Interactions with BIKTARVY Based on drug interaction studies conducted with BIKTARVY or the components of BIKTARVY, no clinically significant drug interactions have been observed when BIKTARVY is combined with the following drugs: ethinyl estradiol, ledipasvir/sofosbuvir, midazolam, norgestimate, sertraline, sofosbuvir, sofosbuvir/velpatasvir, and sofosbuvir/velpatasvir/voxilaprevir.
Mechanism: These two medications do not have any meaningful effect on how the other is processed by the body.
What to do: You can safely take these medications together without any special dose changes.
7.6 Drugs without Clinically Significant Interactions with BIKTARVY Based on drug interaction studies conducted with BIKTARVY or the components of BIKTARVY, no clinically significant drug interactions have been observed when BIKTARVY is combined with the following drugs: ethinyl estradiol, ledipasvir/sofosbuvir, midazolam, norgestimate, sertraline, sofosbuvir, sofosbuvir/velpatasvir, and sofosbuvir/velpatasvir/voxilaprevir.
Mechanism: Clinical studies show that these drugs do not interfere with each other when taken at the same time.
What to do: No adjustments to your treatment are needed when using these two drugs together.
Common Questions
Can I take Biktarvy with other HIV medicines?
What tests should I have before starting Biktarvy?
Can Biktarvy affect my kidneys?
What are the symptoms of lactic acidosis?
Can Biktarvy cause liver problems?
Can I take Biktarvy if I have severe liver problems?
What drugs should I avoid while taking Biktarvy?
Can Biktarvy be used in children?
How will I know if Biktarvy is working?
What should I do if I think I have a side effect from Biktarvy?
What are the common side effects of bictegravir/emtricitabine/tenofovir?
Does bictegravir/emtricitabine/tenofovir interact with other medications?
What drug class is bictegravir/emtricitabine/tenofovir?
Is bictegravir/emtricitabine/tenofovir safe during pregnancy?
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What the FDA Data Shows for bictegravir/emtricitabine/tenofovir
The FDA label for bictegravir/emtricitabine/tenofovir (sold under brand names such as Biktarvy) classifies it as a prescription-only medication in the Integrase Inhibitor / NRTI Combination class. Biktarvy treats Human Immunodeficiency Virus type 1 (HIV-1) in adults and children weighing at least 31 pounds. Official labeling lists 3 commonly reported side effects, including Diarrhea, Nausea, Headache.
Post-market surveillance from the FDA Adverse Event Reporting System (FAERS) captures real-world experience. Voluntary reports accumulate over the lifetime of a drug and reflect wide-ranging clinical use. The database also lists 19 documented drug interactions derived from FDA labeling, with the top-flagged interaction rated major severity. NADAC pricing from CMS.
Report counts do not establish causation — a FAERS entry documents a temporal association, not proof that the drug produced the outcome. Widely prescribed medications naturally accumulate more reports than niche therapies, so raw totals must be interpreted alongside total exposure. Shortage status, recall history, and patent information further shape supply and switching decisions. This page summarizes public FDA data for educational purposes only and is not a substitute for professional medical advice — always consult a licensed healthcare provider before starting, stopping, or changing any medication.
Data Sources
Drug labeling: FDA Drug Labels (SPL/DailyMed). Adverse events: FDA Adverse Event Reporting System (FAERS). Pricing: CMS National Average Drug Acquisition Cost (NADAC).
FAERS reports are voluntary and do not establish causation. Drug interactions are derived from FDA labeling and clinical references. Always consult a healthcare professional before making medication decisions.
Last updated: April 30, 2024
Read our methodology — how this data is sourced, computed, and verified.
All federal data sources used on this page
- FDA Orange Book — approved drug products with therapeutic equivalence. accessdata.fda.gov/cder/ob
- FDA DailyMed — NIH-hosted drug labeling for FDA-approved meds. dailymed.nlm.nih.gov
- FDA Adverse Event Reporting System (FAERS) — post-marketing safety surveillance. fda.gov/drugs/faers
- NLM RxNorm — standardized clinical drug nomenclature. nlm.nih.gov/research/umls/rxnorm
- CMS Medicare Part B Drug Average Sales Price Files — federal drug pricing data. cms.gov/medicare/part-b-drugs/asp
- FDA Drug Shortages Database — current and resolved drug shortage tracking. accessdata.fda.gov/drugshortages