Bictegravir, Emtricitabine, and Tenofovir Alafenamide
Bictegravir, emtricitabine, and tenofovir alafenamide is a three-drug combination antiretroviral used to treat HIV-1 infection in adults and children weighing at least 14 kg.
🧬 Where this information comes from Click to expand
The clinical label records used on this page are FDA-filed Structured Product Labeling (SPL) retrieved through openFDA. We identified 2 clinical label sets within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. Forms, routes, brands, labelers, strengths, and NDC product-record counts are built separately from matching FDA National Drug Code Directory records. The linked DailyMed document is a representative official source for verification, not the page’s only clinical source. View the linked label on DailyMed →
⚠️ FDA Boxed Warning — the FDA’s strongest safety alert ▾
Important warning for people with both HIV and hepatitis B (HBV): If you have HIV and hepatitis B at the same time, stopping Biktarvy can cause a sudden, severe worsening of hepatitis B — sometimes leading to liver failure. This has happened with medicines similar to those in Biktarvy and may happen with Biktarvy too. If you stop taking Biktarvy, your doctor will need to monitor your liver closely — with blood tests and check-ups — for at least several months. Do not stop taking Biktarvy without talking to your doctor first. You may need additional hepatitis B treatment, particularly if you have advanced liver disease.
📖 Bictegravir, Emtricitabine, and Tenofovir Alafenamide: Patient Information Guide
A plain-language walkthrough of Bictegravir, Emtricitabine, and Tenofovir Alafenamide — what it treats, how it works, how it’s taken, side effects, warnings and interactions. Tap any section to expand it.
🎯What it's used for▾
Bictegravir, emtricitabine, and tenofovir alafenamide is a fixed-dose combination antiretroviral used to treat HIV-1 infection. All current approved uses are specific to Biktarvy, the oral tablet formulation.
- Biktarvy is approved to treat HIV-1 infection in adults and pediatric patients weighing at least 14 kg who have no prior antiretroviral treatment history and no known resistance to its components
- Biktarvy is approved for adults and children (at least 14 kg) who are currently on HIV treatment but not virologically suppressed, provided they have no known resistance to integrase inhibitors, emtricitabine, or tenofovir
- Biktarvy is approved to replace an existing antiretroviral regimen in patients who are already virologically suppressed (HIV undetectable) on a stable regimen with no known resistance to bictegravir or tenofovir
- Biktarvy (higher-strength tablet) is approved for virologically-suppressed adults with end-stage kidney disease who are receiving chronic hemodialysis
⚙️How it works▾
Biktarvy combines three drugs that disrupt the HIV life cycle at two key steps. Bictegravir blocks an enzyme called integrase, preventing HIV from inserting its genetic code into the DNA of human immune cells. Emtricitabine and tenofovir alafenamide both block reverse transcriptase, another enzyme HIV relies on to replicate. By targeting two different steps in the replication process, the combination keeps HIV levels very low and reduces the chance of the virus developing resistance.
Tenofovir alafenamide (TAF) is a prodrug — meaning it converts into its active form inside cells, allowing it to act with a lower circulating dose compared to older tenofovir formulations.
💊How it's taken▾
Biktarvy is taken as one tablet by mouth once a day, with or without food. The tablet strength differs based on the patient's weight — a higher-strength tablet is used for adults and children weighing at least 25 kg, and a lower-strength tablet is used for children weighing 14 kg to less than 25 kg. For adults on chronic hemodialysis, the daily dose should be taken after the dialysis session is complete.
- Children who cannot swallow the tablet whole may split it and take each piece within about 10 minutes
- Antacids or supplements containing aluminum, magnesium, calcium, or iron require careful timing around Biktarvy doses — ask your pharmacist or prescriber for specific guidance
- Do not skip doses; always follow your prescriber's instructions and never stop taking Biktarvy without medical guidance, especially if you also have hepatitis B
🤒Side effects — in detail▾
The most commonly reported side effects with Biktarvy are mild to moderate and include:
- Diarrhea
- Nausea
- Headache
- Fatigue
- Abnormal dreams
- Small, stable increases in serum creatinine (a kidney marker) — this is an expected effect of bictegravir on lab values, not a sign of true kidney damage
- Mild increases in bilirubin (a liver marker) — usually low-grade and not a reason to stop treatment
Serious but rare reactions include acute kidney injury, Fanconi syndrome (a kidney tubule disorder), lactic acidosis (acid buildup in the blood), severe hepatitis B flare after stopping the drug, Stevens-Johnson syndrome (a severe skin reaction), and angioedema (swelling under the skin). Seek medical attention immediately if you develop any of these.
⚠️Warnings & precautions▾
- Hepatitis B flare after stopping: People co-infected with HIV and hepatitis B (HBV) face a serious risk of sudden, severe hepatitis B worsening if Biktarvy is stopped — potentially leading to liver failure. Do not stop this medication without medical supervision, and expect close liver monitoring for months afterward.
- Kidney problems: New or worsening kidney impairment, including serious conditions like proximal renal tubulopathy and Fanconi syndrome, has been reported with TAF-containing products. Kidney function should be checked before and during treatment.
- Lactic acidosis and liver enlargement: A rare but potentially fatal buildup of lactic acid in the blood has been reported with nucleoside analog drugs like those in Biktarvy. Stop treatment and seek immediate care if you experience unusual muscle pain, trouble breathing, stomach pain, or extreme fatigue.
- Immune reconstitution syndrome: As your immune system recovers after starting HIV treatment, it may overreact to hidden infections or trigger inflammatory conditions — notify your doctor if you develop new or worsening symptoms after starting Biktarvy.
- Drug interactions: Biktarvy has several serious drug interactions, including two absolute contraindications (dofetilide and rifampin). Always tell every provider about all medicines you take.
🔀What it interacts with▾
Biktarvy interacts with several common medications — some combinations are dangerous and must be avoided entirely.
- Dofetilide (heart rhythm drug): Contraindicated — Biktarvy increases dofetilide blood levels, risking life-threatening heart arrhythmias
- Rifampin (antibiotic): Contraindicated — significantly lowers bictegravir levels, risking treatment failure and drug resistance
- Rifabutin and rifapentine (antibiotics): Not recommended — also lower bictegravir and tenofovir levels
- Anti-seizure drugs (carbamazepine, oxcarbazepine, phenobarbital, phenytoin): Can lower Biktarvy levels — alternative anticonvulsants should be considered
- St. John's wort (herbal supplement): Not recommended — can reduce Biktarvy levels and lead to treatment failure
- Antacids or supplements with aluminum, magnesium, calcium, or iron: Can reduce bictegravir absorption — specific timing rules apply depending on whether food is taken
- Metformin (diabetes drug): Biktarvy may raise metformin levels — consult your prescriber about risks and benefits
- NSAIDs and drugs affecting kidney function (e.g., acyclovir, ganciclovir, aminoglycosides): Can increase kidney-related side effects when combined with Biktarvy
- Other antiretroviral HIV medicines: Should not be added to Biktarvy — it is already a complete HIV regimen
This is not a complete list of interactions. Always talk with your doctor or pharmacist before starting, stopping, or changing any medication.
📋Before taking it▾
- Hepatitis B co-infection: Get tested for hepatitis B before or when starting Biktarvy — stopping the drug can trigger a dangerous HBV flare
- Kidney disease: Biktarvy is not recommended for patients with severe renal impairment or end-stage kidney disease who are not on hemodialysis, or for treatment-naive patients with end-stage kidney disease on hemodialysis
- Severe liver disease: Biktarvy is not recommended for patients with severe hepatic (liver) impairment (Child-Pugh Class C)
- Pregnancy: Drug levels of Biktarvy can be lower during pregnancy, so viral load should be monitored closely; discuss benefits and risks with your prescriber, particularly around the time of conception, given data on other integrase inhibitors and neural tube defects
- Breastfeeding: Breastfeeding is generally not recommended due to the risk of passing HIV to the baby and potential drug exposure through breast milk
- Children under 14 kg: Biktarvy is not approved for use in patients weighing less than 14 kg
- All current medications: Tell your doctor and pharmacist about every prescription, over-the-counter drug, supplement, and herbal product you take — Biktarvy has many clinically important interactions
🚑If you take too much▾
There is no specific clinical data on Biktarvy overdose in patients. If an overdose is suspected, the approach is supportive care — monitoring vital signs and overall clinical status. Hemodialysis can remove a meaningful portion of the emtricitabine and tenofovir components, though it is not known whether it can fully reverse an overdose.
📡Pharmacodynamics — effects in the body▾
Bictegravir, at doses well above the recommended amount, did not cause changes in the heart's electrical rhythm (QT/QTc interval) in clinical testing, and neither did tenofovir alafenamide. The effect of emtricitabine on heart rhythm is not fully known. Bictegravir does cause a small, predictable increase in measured serum creatinine — a lab marker for kidney function — but this reflects an effect on how creatinine is cleared from the blood, not actual kidney damage; true kidney filtration rate is not meaningfully affected.
🔬Pharmacokinetics — how your body processes it▾
After an oral dose of Biktarvy, each component is absorbed at somewhat different speeds — bictegravir reaches peak blood levels in about 2 to 4 hours, emtricitabine in about 1.5 to 2 hours, and tenofovir alafenamide in as little as 30 minutes to 2 hours. A high-fat meal increases the absorption of bictegravir and tenofovir alafenamide to some degree but has minimal effect on emtricitabine; however, Biktarvy can be taken with or without food. Bictegravir is highly protein-bound (more than 99%), meaning it attaches tightly to proteins in the blood. Tenofovir alafenamide is a prodrug that is rapidly converted inside cells to its active form, allowing it to concentrate where it is needed most.
📦How to store it▾
Store bottle below 30 °C (86 °F). Store blister pack at 25 °C (77 °F), excursions permitted to 15–30 °C (59–86 °F) (see USP Controlled Room Temperature).
📄 Written from Bictegravir, Emtricitabine, and Tenofovir Alafenamide’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Every point is grounded in that labeling — nothing is invented. How we use AI →
Supplements & herbs that interact with Bictegravir, Emtricitabine, and Tenofovir Alafenamide
148 supplements and herbal products have documented interactions with Bictegravir, Emtricitabine, and Tenofovir Alafenamide in the licensed clinical database we use. Most are manageable — but your pharmacist should know about everything you take, including vitamins and herbals.
- Major · 3
- Moderate · 107
- Minor · 38
Educational information from a licensed clinical database (Natural Medicines) — see our data sources & update cadence. Not medical advice: an interaction being documented does not mean it will happen to you; do not start or stop medications or supplements without professional guidance.
🩺 Pharmacist Counseling Corner
Quick, plain-English answers to the questions patients ask most about Bictegravir, Emtricitabine, and Tenofovir Alafenamide — the kind of thing our pharmacy team would talk through with you at the counter.
What exactly does Biktarvy do — does it cure HIV? ▾
Does it matter what time of day I take Biktarvy, and do I need to take it with food? ▾
What side effects should I expect, and what side effects mean I need to call my doctor? ▾
I also have hepatitis B. Is it safe to take Biktarvy, and what happens if I need to stop? ▾
Are there any medicines, supplements, or herbal products I should avoid while taking Biktarvy? ▾
Is Biktarvy safe to take during pregnancy? ▾
Is Bictegravir, Emtricitabine, and Tenofovir Alafenamide available over the counter? ▾
When was Bictegravir, Emtricitabine, and Tenofovir Alafenamide first available? ▾
Who makes Bictegravir, Emtricitabine, and Tenofovir Alafenamide? ▾
💬 Answers drafted from Bictegravir, Emtricitabine, and Tenofovir Alafenamide’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Grounded in that labeling — nothing is made up. How we use AI →
🧰 Keep exploring
💊 How Bictegravir, Emtricitabine, and Tenofovir Alafenamide comes
Bictegravir, Emtricitabine, and Tenofovir Alafenamide is available in 1 form. Different forms and brands can have different approved uses, doses, schedules, and directions. Follow the instructions for your exact product, and do not switch forms without guidance from your prescriber or pharmacist.
Tablet
How this form is used
- Biktarvy tablet is used as a complete regimen to treat HIV-1 infection in adults and children weighing at least 14 kg
- Biktarvy tablet is used in treatment-naive patients (those who have never taken HIV medicines) with no known resistance to its components
- Biktarvy tablet is used to replace a current antiretroviral regimen in virologically-suppressed patients with no known resistance to bictegravir or tenofovir
- Biktarvy tablet (larger strength) is approved for virologically-suppressed adults on hemodialysis, taken after each dialysis session
- Biktarvy tablet is taken once daily by mouth, with or without food
- Biktarvy tablet should be taken after completion of hemodialysis on dialysis days (for eligible adults on chronic hemodialysis)
- Biktarvy tablet may be split for children who cannot swallow it whole — all pieces must be taken within approximately 10 minutes
- Biktarvy tablet should be spaced carefully from antacids or supplements containing aluminum, magnesium, calcium, or iron — ask your pharmacist about timing
📊 Bictegravir, Emtricitabine, and Tenofovir Alafenamide across the U.S. market
How Bictegravir, Emtricitabine, and Tenofovir Alafenamide appears in the FDA’s National Drug Code Directory — including its dosage forms, strengths, brand names, manufacturers, and FDA-listed product records. These are directory records, not sales or prescription volume.
Share of FDA-listed product records by manufacturer — FDA National Drug Code Directory. Record counts are not sales or prescription volume.
📈 How widely Bictegravir, Emtricitabine, and Tenofovir Alafenamide is used
A general measure of how commonly Bictegravir, Emtricitabine, and Tenofovir Alafenamide is prescribed, based on Medicaid — one of the largest public drug programs. The figure below is prescriptions filled in Q1–Q4 2025, summed across every form and brand of the drug.
Think of this as a proxy for how widely Bictegravir, Emtricitabine, and Tenofovir Alafenamide is used, drawn from freely available public data. Medicaid is just one program — these numbers don’t include Medicare, other government coverage, or commercial and cash-pay prescriptions, so real-world use is higher than what’s shown here.
How commonly is Bictegravir, Emtricitabine, and Tenofovir Alafenamide prescribed? Of the 1,596 medications we measure, Bictegravir, Emtricitabine, and Tenofovir Alafenamide ranks #201 by Medicaid prescriptions — more than 87% of them.
Utilization by Bictegravir, Emtricitabine, and Tenofovir Alafenamide product
Pick a product to see its own Medicaid numbers. Each chip is one clinical product — a specific strength & dosage form as defined by RxNorm — with brand-name and generic versions combined.
bictegravir 50 MG / emtricitabine 200 MG / tenofovir alafenamide 25 MG Oral Tablet Most dispensed
Summed across the 2 of 8 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1999667
bictegravir 30 MG / emtricitabine 120 MG / tenofovir alafenamide 15 MG Oral Tablet
Summed across the 1 of 2 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 2584354
Shares are of the Medicaid prescriptions shown here. Product grouping follows RxNorm (the National Library of Medicine’s drug terminology), so “one product” means one strength & dosage form regardless of manufacturer. Dollar figures are gross Medicaid reimbursement before mandatory rebates — rebates (often large, especially for brand-name drugs) are confidential, so actual net cost to Medicaid is lower than shown.
Source: Medicaid State Drug Utilization Data (CMS), aggregated by generic ingredient — summed across every NDC (all brands, strengths, salt forms and dosage forms) of Bictegravir, Emtricitabine, and Tenofovir Alafenamide, and across all states and both fee-for-service and managed-care claims. A general popularity signal; it excludes Medicare, commercial insurance and cash prescriptions, so it is not total U.S. use. Based on the 3 of 10 listed Bictegravir, Emtricitabine, and Tenofovir Alafenamide NDCs with Medicaid activity.
🔍 Compare Bictegravir, Emtricitabine, and Tenofovir Alafenamide products
A representative set of FDA-listed product records for Bictegravir, Emtricitabine, and Tenofovir Alafenamide — across manufacturers, strengths, and dosage forms, grouped by form with each product’s manufacturer and how the FDA approved it. The same medicine may be made and packaged by different companies, so a single drug can have many directory entries. (It’s also why a refill can look different — a new shape, color, or box — even though it contains the same medication.)
| Strength | Route | Manufacturer / Labeler | Category ⓘ | Details |
|---|---|---|---|---|
| 💊Tablet | ||||
| BICTEGRAVIR SODIUM 50 mg/1; EMTRICITABINE 200 mg/1; TENOFOVIR ALAFENAMIDE FUMARATE 25 mg | Oral | A-S Medication Solutions | NDA | View NDC → |
| 50; 200; 25 mg/1; mg/1; mg | Oral | A-S Medication Solutions | NDA | View NDC → |
| BICTEGRAVIR SODIUM 30 mg/1; EMTRICITABINE 120 mg/1; TENOFOVIR ALAFENAMIDE FUMARATE 15 mg | Oral | Gilead Sciences, Inc. × 6 listings | NDA | View NDC → |
| BICTEGRAVIR SODIUM 50 mg/1; EMTRICITABINE 200 mg/1; TENOFOVIR ALAFENAMIDE FUMARATE 25 mg | Oral | Gilead Sciences, Inc. × 3 listings | NDA | View NDC → |
| 30; 120; 15 mg/1; mg/1; mg | Oral | Gilead Sciences, Inc. | NDA | View NDC → |
| 50; 200; 25 mg/1; mg/1; mg | Oral | Gilead Sciences, Inc. | NDA | View NDC → |
| BICTEGRAVIR SODIUM 50 mg/1; EMTRICITABINE 200 mg/1; TENOFOVIR ALAFENAMIDE FUMARATE 25 mg | — | Patheon Inc. | DRUG FOR FURTHER PROCESSING | View NDC → |
| BICTEGRAVIR SODIUM 50 mg/1; EMTRICITABINE 200 mg/1; TENOFOVIR ALAFENAMIDE FUMARATE 25 mg | — | Rottendorf Pharma GmbH | DRUG FOR FURTHER PROCESSING | View NDC → |
| BICTEGRAVIR SODIUM 50 mg/1; EMTRICITABINE 200 mg/1; TENOFOVIR ALAFENAMIDE FUMARATE 25 mg | — | Takeda GmbH | DRUG FOR FURTHER PROCESSING | View NDC → |
Showing 16 of 16 products — FDA National Drug Code Directory. See every product, package size and price: browse all 16 Bictegravir, Emtricitabine, and Tenofovir Alafenamide NDCs →
📈 What people report — real-world data (FDA FAERS)
After a medicine reaches the market, patients, doctors and drugmakers can send the FDA reports of problems they think may be linked to it. Here’s what’s been reported for Bictegravir, Emtricitabine, and Tenofovir Alafenamide — a signal of what to watch for, not proof the drug caused it.
Source: openFDA, from the FDA Adverse Event Reporting System (FAERS). These are voluntary reports — they don’t prove the drug caused the effect, and counts reflect how often something was reported, not how often it actually happens. Reports also often name the very problem the medicine is taken for — a common reason to file one is that the drug didn’t help — so for a pain reliever you may see “pain” high on the list; that points to why the report was filed, not to the drug causing the symptom. This counts every report that lists Bictegravir, Emtricitabine, and Tenofovir Alafenamide in any role, so the total runs higher than the FDA’s official dashboard, which counts only cases where the drug is the suspect. For the authoritative figures, see the FDA FAERS Public Dashboard. Always talk to your pharmacist or doctor.
🏛️ The road to your pharmacy
How Bictegravir, Emtricitabine, and Tenofovir Alafenamide went from FDA review to the pharmacy shelf — the key milestones in its regulatory journey.
Source: Drugs@FDA.
🚨 Recall history
A recall is when a specific batch of a medicine is pulled from the market — usually a manufacturing issue, not a problem with the drug itself. Class I is most serious, Class III least.
Source: openFDA drug enforcement (recall) reports.
RxNorm Concept Web — From Ingredient to Every Form and Strength
This page starts with one exact multiple-ingredient concept (MIN). The branches below show its dose-form concepts (SCDF), then the available clinical drug and strength concepts (SCD). A product with a different ingredient combination belongs on a different page.
RxCUI 1996259 1 dose form · 2 strengths
-
Dose form (SCDF) Oral Tablet RxCUI 1999666In current FDA listingsClinical drug / strength (SCD) bictegravir 30 MG / emtricitabine 120 MG / tenofovir alafenamide 15 MGRxCUI 2584354bictegravir 50 MG / emtricitabine 200 MG / tenofovir alafenamide 25 MGRxCUI 1999667
Look up RxCUI 1996259 in the RxCUI Atlas →
RxNorm is the U.S. National Library of Medicine’s normalized drug vocabulary. Its concept hierarchy can include forms that are not currently marketed; the status on each branch compares that concept with current FDA listings. RxCUIs identify vocabulary concepts, not individual packages or manufacturers.
📦 Supply & shortage status
Whether Bictegravir, Emtricitabine, and Tenofovir Alafenamide is in short supply in the U.S. right now, plus any shortage history the FDA has on record. A shortage usually reflects a manufacturing or demand issue — not a safety problem with the drug.
Source: openFDA, from the FDA Drug Shortages database.
🏷️ Sold under these brand names
🏭 Manufacturers & labelers
RxNorm drug class
Bictegravir, Emtricitabine, and Tenofovir Alafenamide belongs to the Nucleoside and nucleotide reverse transcriptase inhibitors class.
Classified by RxNorm RxClass — the U.S. National Library of Medicine's standardized drug-classification service (Established Pharmacologic Class from the FDA, the ATC drug family from the WHO, and mechanism of action). Reference only, not medical advice.
🔬 Where this comes from
Core label, product, RxNorm, safety, and utilization data on this page come from the sources identified below. AI-written, editorial, and licensed sections are labeled separately.
How we combine label and product data
HelloPharmacist combines public FDA and NLM records; we don’t author the underlying clinical facts. We identified 2 FDA-filed SPL label sets within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. The representative label is the starting point for the displayed reference monograph; the 12 largest stored in-scope SPL records, which may include that representative, are compared section by section, and the longest available version of each section is retained. Forms, routes, brands, labelers, product-listed strengths, and product-record counts are aggregated separately from ingredient-matched FDA NDC Directory records; package records listed above are associated with the linked SPL; and the normalized concept hierarchy comes from NLM RxNorm.
For canonical ingredient pages, bounded product-attributed indication and administration excerpts may be added to the AI evidence, and the generator is instructed to preserve available product, brand, route, and form qualifiers instead of treating one label as universal. Where a section is identified as AI-written, its plain-language text is generated from bounded label evidence. New draft drug pages remain in the admin review queue before first publication. Gilead Sciences, Inc. is the representative DailyMed label linked for verification and dates; it is not the sole source used for the page.
This is general education, not medical advice — always consult your doctor or pharmacist about your medications and any medical condition. For the exact wording of the linked representative label, view that label on DailyMed; some displayed composite sections may come from other in-scope SPL labels. Learn how we use AI and our data sources & update cadence.