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emtricitabine/rilpivirine/tenofovir alafenamide

Odefsey · ATC code J05AR19

Also known as: Emtricitabin/Rilpivirin/Tenofoviralafenamid, Emtrisitabin/Rilpivirin/Tenofovir alafenamid, Emtricitabine / Rilpivirine / Tenofovir Alafenamide

Key facts
Active substance
emtricitabine/rilpivirine/tenofovir alafenamide (INN: emtricitabine / rilpivirine / tenofovir alafenamide)
Drug class
Efavirenz/lamivudine/tenofovir
ATC code
J05AR19
Authorisation
centrally authorised across the EU (EMA)
Dosage forms
Odefsey 200 mg/25 mg/25 mg film-coated tablets
Marketing authorisation holder
Gilead Sciences Ireland UC
Information as of
2026-10-28

Key facts

Emtricitabine/rilpivirine/tenofovir alafenamide (Odefsey) is a single-tablet complete regimen of three antiretrovirals for treating HIV-1 infection in adults and adolescents.

What it is used for

  • Treatment of adults and adolescents (aged 12 years and older with body weight at least 35 kg) infected with HIV-1 without known resistance mutations to the NNRTI class, tenofovir or emtricitabine and with a viral load ≤ 100,000 HIV-1 RNA copies/mL.

Dosing

  • One tablet (200 mg/25 mg/25 mg) once daily with food; it should not be chewed, crushed or split.
  • Missed dose: if within 12 hours, take it with food as soon as possible; if more than 12 hours, skip it. If vomiting occurs within 4 hours, take another tablet with food.
  • Renal impairment: no adjustment with CrCl ≥ 30 mL/min; discontinue if CrCl declines below 30 mL/min. In end-stage renal disease on chronic haemodialysis generally avoided but may be used with caution, given after haemodialysis.
  • Hepatic impairment: no adjustment in mild or moderate impairment (caution in moderate); not recommended in severe impairment.
  • No adjustment in elderly patients.

Contraindications

  • Hypersensitivity to the active substances or to any of the excipients.
  • Co-administration with medicines that significantly decrease rilpivirine levels: carbamazepine, oxcarbazepine, phenobarbital, phenytoin; rifabutin, rifampicin, rifapentine; proton pump inhibitors (omeprazole, esomeprazole, dexlansoprazole, lansoprazole, pantoprazole, rabeprazole); dexamethasone except as a single dose; St John's wort.

Important warnings

  • Virologic failure and resistance are more likely with a baseline viral load > 100,000 HIV-1 RNA copies/mL; resistance testing should guide use, and data are insufficient after prior NNRTI failure.
  • Caution with medicines that have a known risk of Torsade de Pointes.
  • In patients co-infected with hepatitis B, stopping treatment may cause severe acute exacerbations of hepatitis; close monitoring for at least several months after stopping.
  • Patients with chronic hepatitis B or C are at increased risk of severe hepatic adverse reactions.

Side effects

  • Very common: insomnia, headache, dizziness, nausea, increased total and LDL cholesterol, increased pancreatic amylase, increased transaminases.
  • Common: depression, abnormal dreams, sleep disorders, somnolence, abdominal pain, vomiting, diarrhoea, dry mouth, rash, increased bilirubin, decreased appetite.
  • Uncommon: anaemia, immune reactivation syndrome, severe skin reactions.

Interactions

  • Intended as a complete regimen; not to be combined with other antiretrovirals.
  • Antacids only at least 2 hours before or at least 4 hours after Odefsey.
  • CYP3A inducers or inhibitors may affect rilpivirine clearance; P-gp and BCRP modulators may change tenofovir alafenamide absorption.
  • Medicines that decrease renal function or are eliminated by tubular secretion may increase emtricitabine concentrations.

Pregnancy and breastfeeding

  • Use should be accompanied by effective contraception; no adequate studies of Odefsey in pregnant women.

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)

Source: European Medicines Agency (EMA), product information

Turkey

  • OdefseyGİLEAD SCİENCES İLAÇ TİC. LTD. ŞTİ. · 1 register entry

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

Brand names in 3 more European countries
Iceland
Emtricitabine/Rilpivirine/Tenofovir Alafenamide Viatris, Odefsey
Liechtenstein
Emtricitabine/Rilpivirine/Tenofovir Alafenamide Viatris, Odefsey
Norway
Emtricitabine/Rilpivirine/Tenofovir Alafenamide Viatris, Odefsey

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. Odefsey – EPAR, Product Information. 2026-10-28. https://www.ema.europa.eu/en/documents/product-information/odefsey-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.