Bictegravir, Emtricitabine, and Tenofovir Alafenamide
Bictegravir, emtricitabine, and tenofovir alafenamide is a three-drug combination antiviral used to treat HIV-1 infection in adults and children.
🧬 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 who have both HIV and hepatitis B: If you stop taking Biktarvy and you are coinfected with HIV and hepatitis B virus (HBV), your hepatitis B can flare up severely and suddenly. This can lead to serious liver damage or liver failure. Your doctor must monitor your liver closely — with both lab tests and clinical check-ins — for at least several months after stopping Biktarvy. In some cases, treatment specifically for hepatitis B may be needed. Do not stop Biktarvy without talking to your doctor first.
📖 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 complete three-drug antiviral regimen used exclusively to treat HIV-1 infection. Biktarvy (the brand containing this combination as an oral tablet) is approved for:
- Adults and children weighing at least 14 kg who have never taken HIV medicine before
- Adults and children weighing at least 14 kg who are on HIV treatment but whose virus is not fully suppressed, provided there is no known resistance to the drug classes in Biktarvy
- Adults and children weighing at least 14 kg who are virologically suppressed (HIV-1 RNA below 50 copies/mL) on a stable regimen and want to switch to Biktarvy, as long as there is no known resistance to bictegravir or tenofovir
- Virologically suppressed adults receiving chronic hemodialysis (kidney dialysis)
⚙️How it works▾
Biktarvy works by blocking HIV at two different points in its life cycle. Bictegravir blocks an enzyme called integrase — this is the tool HIV uses to insert its genetic code into your own cells, making them produce more virus. Emtricitabine and tenofovir alafenamide work by mimicking the building blocks HIV needs to copy itself; when HIV tries to use them, the copying process gets jammed and stops. Together, these three drugs make it very difficult for HIV to replicate and spread.
Because the three components attack HIV in different ways, the combination is harder for the virus to work around than a single drug would be — reducing the chance of the virus developing resistance.
💊How it's taken▾
Biktarvy is taken as one tablet by mouth once a day, with or without food. The tablet strength depends on the patient's weight — a lower-strength tablet is used for children weighing 14 kg to less than 25 kg, and the standard-strength tablet is used for those weighing 25 kg or more and for adults. Children who cannot swallow a whole tablet can split it and take each piece separately, as long as all pieces are swallowed within about 10 minutes.
- Take it at roughly the same time each day to keep drug levels steady
- On hemodialysis days, take your dose after the dialysis session is finished
- If you take antacids or supplements with magnesium, aluminum, calcium, or iron, timing matters — ask your pharmacist for the correct spacing
- Always follow your prescriber's specific instructions
🤒Side effects — in detail▾
The most common side effects reported with Biktarvy are generally mild:
- Diarrhea
- Nausea
- Headache
- Fatigue
- Abnormal dreams
- Small, stable rises in creatinine on blood tests (usually not a sign of true kidney damage)
- Mild increases in bilirubin on liver panels
Seek medical attention promptly if you experience signs of lactic acidosis (unusual fatigue, muscle pain, trouble breathing, stomach pain, nausea/vomiting), severe liver symptoms, serious skin reactions such as blistering or peeling, or any signs of kidney problems like a major drop in urination.
⚠️Warnings & precautions▾
- Hepatitis B flare after stopping: People coinfected with HIV and hepatitis B face a serious risk of sudden liver worsening if Biktarvy is stopped. Liver function must be monitored for at least several months after stopping.
- Kidney function: Biktarvy can affect the kidneys. Kidney tests are required before and during treatment. It is not recommended in severe kidney impairment unless you are on chronic hemodialysis and your virus is already suppressed.
- Lactic acidosis and liver swelling: A rare but potentially fatal buildup of lactic acid in the blood, and severe liver enlargement with fat deposits, have been reported with drugs in this class. Discontinue Biktarvy if these are suspected.
- Immune reconstitution syndrome: After starting effective HIV treatment, the recovering immune system can overreact to hidden infections or trigger autoimmune conditions. Tell your doctor about any new symptoms after starting Biktarvy.
- Drug interactions: Certain medicines can make Biktarvy ineffective or cause dangerous side effects — see the interactions section.
🔀What it interacts with▾
Biktarvy has several important drug interactions that require attention before and during treatment:
- Dofetilide (Tikosyn): Contraindicated — Biktarvy raises dofetilide blood levels to potentially life-threatening levels
- Rifampin: Contraindicated — drastically lowers Biktarvy levels, risking treatment failure and drug resistance
- Rifabutin and rifapentine: Not recommended — also reduce Biktarvy levels significantly
- Seizure medicines (carbamazepine, oxcarbazepine, phenobarbital, phenytoin): Lower Biktarvy levels; alternative seizure medicines should be considered
- St. John's Wort: This herbal supplement lowers Biktarvy levels and is not recommended
- Antacids and supplements with magnesium, aluminum, calcium, or iron: Can reduce absorption of bictegravir; specific timing instructions apply depending on the type
- Metformin: Biktarvy may raise metformin blood levels; check with your prescriber about monitoring
- Other HIV medicines: Biktarvy is a complete regimen — adding other antiretrovirals for HIV is not recommended
- Drugs eliminated by the kidneys (e.g., acyclovir, aminoglycoside antibiotics, high-dose NSAIDs): May compete with Biktarvy components for kidney removal, potentially increasing side effect risk
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 coinfection: You must be tested for hepatitis B before starting Biktarvy — stopping the medicine can cause a dangerous hepatitis B flare
- Kidney problems: Tell your doctor about any kidney disease; dosing restrictions apply and monitoring is required throughout treatment
- Liver problems: Biktarvy is not recommended for people with severe liver impairment (Child-Pugh Class C)
- Pregnancy: Discuss risks and benefits with your doctor — lower drug exposures occur during pregnancy, so viral load needs closer monitoring; data on birth defect risk with bictegravir are still limited
- Breastfeeding: Not recommended — risk of passing HIV to the infant, and drug components may be present in breast milk
- Children under 14 kg: Biktarvy is not approved for children weighing less than 14 kg
- All medications and supplements: Share a complete list with your doctor and pharmacist, especially antacids, herbal products, seizure medicines, and heart medicines
🚑If you take too much▾
There are no specific data on Biktarvy overdose in patients. If an overdose is suspected, the main approach is supportive care — monitoring vital signs and watching for any signs of toxicity. Hemodialysis can remove a meaningful portion of the emtricitabine and tenofovir components, though it is not known whether it helps with bictegravir. Contact a poison control center or emergency services right away if an overdose occurs.
📡Pharmacodynamics — effects in the body▾
Bictegravir can cause a small, predictable rise in blood creatinine levels — a marker often used to estimate kidney function. This happens because bictegravir blocks a transporter in the kidneys that normally secretes creatinine, not because the kidneys are actually being harmed; studies confirm it does not meaningfully reduce true kidney filtration ability. This rise typically appears within the first four weeks and then stabilizes. Neither bictegravir nor tenofovir alafenamide, at recommended doses, appear to affect the heart's electrical conduction (QT or PR intervals).
🔬Pharmacokinetics — how your body processes it▾
After taking Biktarvy, peak blood levels of its three components are generally reached within about 30 minutes to 4 hours. A high-fat meal can notably increase the absorption of tenofovir alafenamide and modestly increase bictegravir absorption, though the medicine can be taken with or without food. Bictegravir is extensively bound to proteins in the blood (greater than 99%). The three drugs are processed and cleared through a combination of liver metabolism and kidney excretion, which is why dose adjustments and precautions apply in people with significant kidney or liver impairment.
📦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? ▾
Do I really have to take it every single day, even when I feel fine? ▾
What side effects should I expect, and what should make me call my doctor? ▾
I also have hepatitis B — is there anything special I need to know? ▾
Are there any common medicines or supplements I need to 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 to treat HIV-1 infection in adults and children weighing at least 14 kg who have no prior HIV treatment history
- Biktarvy tablet is used in adults and children weighing at least 14 kg who are on HIV treatment but whose virus is not yet fully suppressed, with no known drug resistance to its components
- Biktarvy tablet is used to replace a stable HIV regimen in adults and children weighing at least 14 kg whose virus is already well controlled (HIV-1 RNA below 50 copies/mL) with no known resistance to bictegravir or tenofovir
- Biktarvy tablet is taken once daily by mouth, with or without food
- Biktarvy tablet may be split for children unable to swallow it whole — take all pieces within about 10 minutes
- On hemodialysis days, take Biktarvy tablet after the dialysis session is complete
- If taking antacids containing aluminum or magnesium, take Biktarvy at least 2 hours before or 6 hours after — or take calcium/iron supplements or antacids together with food
📊 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 1,594 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. × 4 listings | NDA | View NDC → |
| BICTEGRAVIR SODIUM 50 mg/1; EMTRICITABINE 200 mg/1; TENOFOVIR ALAFENAMIDE FUMARATE 25 mg | Oral | Gilead Sciences, Inc. × 2 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 13 of 13 products — FDA National Drug Code Directory. See every product, package size and price: browse all 13 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.