Biktarvy

Pronunciation: bik-TAR-vee.

Generic name
bictegravir/emtricitabine/tenofovir alafenamide
Drug class
Complete antiretroviral regimen (HIV-1 integrase inhibitor + 2 NRTIs, fixed-dose combination)
Form
Film-coated tablet (50 mg/200 mg/25 mg; pediatric 30 mg/120 mg/15 mg)
Route
Oral
Legal status
Prescription-only, specialist-initiated (HIV/infectious disease)

Availability and supply rules vary by country

Trade names by country: United States · United Kingdom · Canada · Australia · New Zealand

Australia: Biktarvy (4) · Full directory

What bictegravir/emtricitabine/tenofovir alafenamide is and how it works

Biktarvy is a prescription-only, complete HIV-1 treatment regimen combining three medicines in one tablet, taken once a day. It is prescribed and monitored by an HIV/infectious disease specialist. (1)

Biktarvy is a complete regimen on its own and should not be combined with other HIV medicines unless your specialist specifically directs this. If you also have hepatitis B, stopping Biktarvy without your specialist's involvement can cause a serious flare of hepatitis B.

Mechanism of action: how bictegravir/emtricitabine/tenofovir alafenamide works

Bictegravir is an HIV-1 integrase strand transfer inhibitor (INSTI); emtricitabine and tenofovir alafenamide are nucleoside/nucleotide analog reverse transcriptase inhibitors (NRTIs). Together they block two distinct steps the virus needs to replicate. (1)

What bictegravir/emtricitabine/tenofovir alafenamide is used for

Treatment of HIV-1 infection

Used as a complete, standalone regimen for HIV-1 infection in adults and children weighing at least 14 kg who are newly starting treatment, who are on treatment but not yet virally suppressed (without certain resistance patterns), or who are virally suppressed and switching from a different regimen. (1)

Before taking bictegravir/emtricitabine/tenofovir alafenamide

Do not take / not appropriate for

  • Do not take Biktarvy together with dofetilide (a heart-rhythm medicine) -- this combination can cause serious, life-threatening heart problems. (all countries) (1)
  • Do not take Biktarvy together with rifampin (an antibiotic used for tuberculosis) -- it reduces Biktarvy's effectiveness and can lead to drug resistance. (all countries) (1)

Tell your clinician about

  • Whether you have hepatitis B, or have never been tested for it.
  • Any kidney problems, including reduced kidney function.
  • Any liver problems, including severe liver disease.
  • All other medicines you take, especially antacids or supplements containing calcium, iron, or magnesium, and metformin.
  • Whether you are taking, or have been advised to take, any other HIV medicine alongside this one.
  • Pregnancy, plans for pregnancy, or breastfeeding.
(1)

How to take bictegravir/emtricitabine/tenofovir alafenamide

  • Take one tablet by mouth once a day, with or without food, exactly as your specialist prescribes.
  • Take it at around the same time each day to help keep drug levels steady.
  • If you take an antacid or a supplement containing calcium, iron, or magnesium, separate it from Biktarvy by at least 2 hours before or 6 hours after.
(1)

Procedures and treatment changes

Tell the treating team before surgery, procedures, or any medicine change. Do not alter treatment without the responsible clinician. (1) (2) (3) (4) (5) (6)

Missed dose

If you miss a dose, take it as soon as you remember on the same day. If you do not remember until it is closer to your next dose, skip the missed dose and continue your normal schedule -- do not take a double dose. Contact your specialist if you miss doses often, as this can affect how well the medicine works.

Overdose

Seek urgent medical attention or contact your specialist if too much Biktarvy has been taken. (1)

Side effects

Side effects and their urgency vary; report severe, persistent, or concerning symptoms.

Diarrhoea, nausea, and headache are the most common side effects.

What to notice: Diarrhoea, nausea, and headache are the most common side effects.

What to do: Discuss persistent or troublesome symptoms with the treating clinician or pharmacist. (1)

Less commonly: tiredness, unusual dreams, dizziness, trouble sleeping, and bloating.

What to notice: Less commonly: tiredness, unusual dreams, dizziness, trouble sleeping, and bloating.

What to do: Discuss persistent or troublesome symptoms with the treating clinician or pharmacist. (1)

Serious warnings

Signs of a hepatitis B flare after stopping Biktarvy — boxed_warning

Symptoms: Worsening tiredness, yellowing of the skin or eyes, dark urine, or stomach pain -- especially if you have both HIV and hepatitis B.

Action: If you have hepatitis B and need to stop Biktarvy, your specialist will monitor your liver closely for several months afterward and may start additional hepatitis B treatment. Do not stop Biktarvy on your own if you have hepatitis B. (1)

Signs of kidney problems — high caution

Symptoms: Reduced urination, swelling in the legs or ankles, or unusual muscle weakness.

Action: Your specialist will check your kidney function regularly with blood and urine tests; Biktarvy is not recommended for people with significantly reduced kidney function. (1)

Signs of lactic acidosis or severe liver problems — emergency

Symptoms: Unusual muscle pain, trouble breathing, stomach pain with nausea and vomiting, feeling very weak or tired, or yellowing of the skin/eyes.

Action: Seek urgent medical attention. Your specialist will decide whether Biktarvy needs to be stopped. (1)

New or worsening infection shortly after starting treatment (immune reconstitution) — high caution

Symptoms: New symptoms of infection or inflammation appearing as your immune system recovers.

Action: Tell your specialist promptly about any new symptoms in the weeks after starting Biktarvy. (1)

Interactions

  • Must not be combined with dofetilide or rifampin (see 'Do not take' above). (1)
  • Certain medicines that strongly affect drug breakdown (e.g. carbamazepine, phenytoin, rifabutin, rifapentine, St. John's Wort) can lower Biktarvy's effectiveness -- your specialist may need to choose a different combination. (1)
  • Antacids or supplements containing calcium, iron, or magnesium can reduce absorption -- separate dosing by several hours as directed. (1)
  • Biktarvy can raise metformin levels -- your specialist may need to monitor this if you take metformin for diabetes. (1)
  • Other medicines that affect the kidneys (such as regular NSAID painkiller use, or certain antiviral/antibiotic medicines) may increase side effects -- tell your specialist about all medicines you take. (1)
  • Should not be combined with other HIV antiretroviral medicines -- Biktarvy is a complete regimen by itself. (1)

Pregnancy, breastfeeding, kidney/liver function, age

Pregnancy

Available data have not shown an increased risk of birth defects. Biktarvy is only recommended in pregnancy for those already virally suppressed, with closer monitoring because drug levels can be lower during pregnancy. A pregnancy exposure registry exists to track outcomes. (1) (2) (3) (4) (5) (6)

Breastfeeding

Breastfeeding is not recommended, because HIV can be transmitted through breast milk and the medicine's components pass into milk. (1) (2) (3) (4) (5) (6)

Children

Approved for children weighing at least 14 kg, using a smaller-dose tablet below 25 kg. (1) (2) (3) (4) (5) (6)

Elderly

No specific dose adjustment based on age alone is described in the source reviewed. (1) (2) (3) (4) (5) (6)

Hepatic_impairment

No dose adjustment needed for mild-to-moderate liver impairment; not recommended for severe liver impairment. (1) (2) (3) (4) (5) (6)

Renal_impairment

Not recommended for significantly reduced kidney function (CrCl below 30 mL/min) or for kidney failure not treated with dialysis. (1) (2) (3) (4) (5) (6)

Monitoring

Before starting

  • Hepatitis B testing
  • Kidney function (creatinine, estimated clearance, urine tests)
  • Liver function
  • Current medicines, especially interacting ones

During treatment

  • Regular kidney function monitoring.
  • Liver function monitoring, especially if also hepatitis B positive.
  • HIV viral load and immune status monitoring as part of routine HIV care.
(1)

Storage

Store as directed on the product label supplied with your specific medicine; keep out of the reach of children.

Professional information

Clinician-facing context only, sourced from the current US FDA prescribing information; verify against the current full label before prescribing.

United States

Indication: HIV-1 treatment

Dose summary: Adults/pediatric >=25kg: 50/200/25 mg once daily. Pediatric 14-<25kg: 30/120/15 mg once daily (may split, both halves within ~10 min). Pregnancy (virologically suppressed only): 50/200/25 mg once daily with close viral-load monitoring. Contraindicated with dofetilide and rifampin.

Renal context: Not recommended for CrCl 15-<30 mL/min or dialysis-free ESRD; monitor serum creatinine, eGFR, urine glucose/protein at baseline and during therapy; assess serum phosphorus in CKD. (1)

Mechanism of action

Hepatic guidance

No adjustment needed for mild-to-moderate hepatic impairment; not recommended for severe impairment (Child-Pugh C).

Overdose note

No specific antidote described in the source reviewed; manage supportively and seek urgent specialist guidance for suspected overdose. (1)

Frequently asked questions

Is Biktarvy available in the US, UK, Europe, Canada, Australia, and New Zealand?

Yes. Biktarvy is approved by regulators in all of these regions, including the European Union (all member states plus Norway, Iceland, and Liechtenstein). (1) (2) (3) (4) (5) (6)

Can I stop taking Biktarvy if I also have hepatitis B?

Do not stop Biktarvy on your own if you have both HIV and hepatitis B. Stopping can cause a serious hepatitis B flare, so your specialist needs to closely monitor your liver for several months after any planned stop and may start additional hepatitis B treatment. (1)

Can I take Biktarvy with other HIV medicines?

No. Biktarvy is designed as a complete regimen on its own and should not be combined with other antiretroviral medicines unless your HIV specialist specifically directs otherwise. (1)

What is the mechanism of action of bictegravir/emtricitabine/tenofovir alafenamide?

Bictegravir is an HIV-1 integrase strand transfer inhibitor (INSTI); emtricitabine and tenofovir alafenamide are nucleoside/nucleotide analog reverse transcriptase inhibitors (NRTIs). Together they block two distinct steps the virus needs to replicate. (1)

What is the generic name of Biktarvy?

The generic name is bictegravir/emtricitabine/tenofovir alafenamide. (1)

What class of drug is bictegravir/emtricitabine/tenofovir alafenamide?

Biktarvy is classed as: Complete antiretroviral regimen (HIV-1 integrase inhibitor + 2 NRTIs, fixed-dose combination). (1)

References

  1. BIKTARVY (bictegravir/emtricitabine/tenofovir alafenamide) -- full prescribing informationU.S. Food and Drug Administration / DailyMed (NIH), full prescribing information, Gilead Sciences, Inc. · United States · accessed 2026-07-29 · source 1
  2. European Commission Marketing Authorization for BiktarvyEuropean Commission / Gilead press releases · European Union · accessed 2026-07-29 · source 2
  3. Health Canada Notice of Compliance for BiktarvyHealth Canada · Canada · accessed 2026-07-29 · source 3
  4. BIKTARVY -- ARTG registrationTherapeutic Goods Administration (TGA), Australia · Australia · accessed 2026-07-29 · source 4
  5. Biktarvy 50mg/200mg/25mg film-coated tablets -- Patient Information Leafletelectronic medicines compendium (emc), United Kingdom -- Gilead Sciences · United Kingdom · accessed 2026-07-29 · source 5
  6. BIKTARVY New Zealand Data SheetMedsafe (New Zealand regulator) · New Zealand · accessed 2026-07-29 · source 6

Brand names by country

Single-ingredient bictegravir/emtricitabine/tenofovir alafenamide names are shown separately by country. Product availability, strengths, and supply rules can change; combination products are not included here.

Priority countries

United States

  • Biktarvy (1)FDA approved currently labeled · 50 mg/200 mg/25 mg, 30 mg/120 mg/15 mg · Gilead Sciences, Inc.

United Kingdom

  • Biktarvy (5)MHRA licensed confirmed · 50 mg/200 mg/25 mg · Gilead Sciences

Canada

  • Biktarvy (3)Health Canada Notice of Compliance confirmed · not specified in fetched source · Gilead Sciences Canada, Inc.

Australia

  • Biktarvy (4)TGA ARTG registered 2018-07-12 · 50 mg/200 mg/25 mg · Gilead Sciences Pty Ltd

New Zealand

  • Biktarvy (6)Medsafe approved 2019 · not specified in fetched source · Gilead Sciences
View brands in additional countries.

European Union

Biktarvy (2)

This page provides general reference information about Biktarvy and is not a substitute for advice from the HIV/infectious disease specialist managing your treatment. Biktarvy has a boxed warning for hepatitis B flare risk; all dosing and treatment decisions should be made with your specialist.

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