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bictegravir/emtricitabine/tenofovir alafenamide

Biktarvy · ATC code J05AR20

Also known as: Bictegravir/Emtricitabin/Tenofoviralafenamid, Biktegravir/Emtrisitabin/Tenofovir alafenamid, Bictegravir / Emtricitabine / Tenofovir Alafenamide

Key facts
Active substance
bictegravir/emtricitabine/tenofovir alafenamide (INN: bictegravir / emtricitabine / tenofovir alafenamide)
Drug class
Efavirenz/lamivudine/tenofovir
ATC code
J05AR20
Authorisation
centrally authorised across the EU (EMA)
Dosage forms
Biktarvy 30 mg/120 mg/15 mg film-coated tablets / Biktarvy 50 mg/200 mg/25 mg film-coated tablets
Marketing authorisation holder
Gilead Sciences Ireland UC
Information as of
2026-10-28

Key facts

Bictegravir/emtricitabine/tenofovir alafenamide (Biktarvy) is a fixed-dose combination of an integrase inhibitor and two nucleoside/nucleotide reverse transcriptase inhibitors for treating HIV-1 infection.

What it is used for

  • Treatment of HIV-1 infection in adults and children at least 2 years of age weighing at least 14 kg, without present or past evidence of resistance to the integrase inhibitor class, emtricitabine or tenofovir.

Dosing

  • Adults and children weighing at least 25 kg: one 50 mg/200 mg/25 mg tablet once daily.
  • Children at least 2 years of age weighing 14 kg to less than 25 kg: one 30 mg/120 mg/15 mg tablet once daily.
  • With or without food; do not chew or crush because of the bitter taste.
  • No dose adjustment in mild or moderate hepatic impairment; not recommended in severe (Child-Pugh C).
  • No dose adjustment with CrCl ≥ 30 mL/min; avoid initiation with CrCl ≥15 to < 30 mL/min. In chronic haemodialysis generally avoid; if used, take after dialysis.
  • A dose missed by up to 18 hours should be taken as soon as possible; if vomiting within 1 hour, take another tablet.

Contraindications

  • Hypersensitivity to the active substances or any excipient.
  • Co-administration with rifampicin or St John's wort.

Important warnings

  • HIV/HBV co-infection: discontinuation may cause severe acute exacerbations of hepatitis; monitor for at least several months.
  • Increased risk of severe hepatic reactions in chronic hepatitis B or C; monitor liver function in pre-existing liver disease.
  • Immune reactivation syndrome, including autoimmune disorders such as Graves' disease, may occur.
  • Osteonecrosis, particularly in advanced HIV disease or long-term CART.
  • Weight and blood lipid and glucose levels may increase.

Side effects

  • Most frequent (treatment-naïve patients, Week 144): headache (5%), diarrhoea (5%) and nausea (4%).
  • Common: depression, abnormal dreams, dizziness, fatigue.
  • Uncommon: anaemia, suicidal ideation and suicide attempt (mainly with a psychiatric history), anxiety, sleep disorders, vomiting, angioedema, rash; rare: Stevens-Johnson syndrome.

Interactions

  • Not recommended with atazanavir, carbamazepine, ciclosporin, oxcarbazepine, phenobarbital, phenytoin, rifabutin, rifapentine or sucralfate; not with other antiretrovirals.
  • Antacids or supplements with magnesium/aluminium: take Biktarvy at least 2 hours before, or with food 2 hours after; iron/zinc: at least 2 hours before or together with food.
  • Do not combine with other HBV medicines (tenofovir, lamivudine, adefovir dipivoxil).

Pregnancy and breastfeeding

  • A large amount of data (more than 1,000 exposed outcomes) shows no malformative toxicity for emtricitabine and tenofovir alafenamide; may be used in pregnancy if the benefit justifies the risk, with close viral load monitoring.
  • Should not be used during breast-feeding.

Summary of the official product information, written with AI on 2026-10-29. Every number was checked automatically against the original text. Not reviewed by a physician – the full official text is authoritative.

Full official text →

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For patients

Package leaflet, verbatim

This product has no separate US patient information.

Authorisation and brand names by country

Medicines with exactly this active-substance composition, as listed in the national registers – alphabetical and without ranking. Whether a product is currently available is not shown here.

EU – centrally authorised (all member states)

  • BiktarvyGilead Sciences Ireland UC · EMEA/H/C/004449

Source: European Medicines Agency (EMA), product information

Turkey

  • BiktarvyGİLEAD SCİENCES İLAÇ TİC. LTD. ŞTİ. · 2 register entries

Source: TİTCK – Ruhsatlı Beşeri Tıbbi Ürünler Listesi, as of 2026-10-16

Brand names in 3 more European countries
Iceland
Biktarvy
Liechtenstein
Biktarvy
Norway
Biktarvy

EMA – Article 57 product data (EU/EEA), 2026-10-29

Medelix receives no money from pharmaceutical companies. Brand names are listed alphabetically and without ranking.

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Sources

  1. European Medicines Agency. Biktarvy – EPAR, Product Information. 2026-10-28. https://www.ema.europa.eu/en/documents/product-information/biktarvy-epar-product-information_en.pdf
  2. TİTCK – Ruhsatlı Beşeri Tıbbi Ürünler Listesi, 2026-10-16. https://www.titck.gov.tr/dinamikmodul/85
  3. Wikidata (CC0): ATC J05AR.

Editorial: Medelix editorial team · last updated 2026-10-28 · How these pages are made · Report an error

Source: European Medicines Agency (EMA), product information. Not advertising, not a treatment recommendation. For questions about your own treatment, ask your doctor or pharmacist.