Evigrade
DrugsCosmetic ingredientsCalculatorsInteractionsEvigrade SkinEvigrade Meds ↗
ConditionsJournalMethodologyPro for practitioners
ESRU

Entecavir

AEMPS

Guanosine nucleoside analogue, anti-HBV agent

ATC code: J05AF10

Brand names: Baraclude

Updated · Methodology

Indications

A

Chronic hepatitis B

First line

First-line therapy for chronic hepatitis B in adults with compensated or decompensated liver disease, naïve to nucleos(t)ide analogues. 2017 and the Spanish AEEH 2020 consensus position entecavir (0.5 mg/day) and tenofovir as equivalent first-line options in patients without lamivudine resistance. In lamivudine-resistant disease – switch to tenofovir rather than escalate entecavir. Therapy targets undetectable HBV-DNA and ALT normalisation; HBsAg seroconversion is rare.

Sources

  1. AEMPS: Ficha técnica de Entecavir (2023)
  2. EASL: Clinical Practice Guidelines on the management of hepatitis B virus infection (2017)

ICD-10: B18.1 · ICD-11: 1E51.0

How to read tiers A–F
  • AStrong evidence – first or second line in international guidelines
  • BRecommended in selected cases
  • CStudy data contradict each other
  • DBenefit not proven, no documented harm
  • FDocumented harm, or risk without benefit

Mechanism of action

Phosphorylated intracellularly to the active triphosphate. Competes with endogenous deoxyguanosine triphosphate for incorporation into nascent viral DNA. Suppresses three key HBV reverse transcriptase activities: priming, reverse transcription of pregenomic RNA and DNA-dependent DNA synthesis. Selectivity for HBV is high, anti-HIV activity is minimal (risk of HIV resistance selection in coinfected patients – monotherapy contraindicated). High barrier to resistance: monoresistance is rare in the first 5 years of therapy.

Safety

Contraindications

  • Hypersensitivity to entecavir
  • Monotherapy in HIV-coinfected patients without effective ART (risk of selecting HIV resistance)

Serious adverse effects

  • Severe hepatitis B flare on abrupt discontinuation
  • Lactic acidosis and severe hepatomegaly with steatosis (NRTI class effect)
  • Anaphylactoid reactions (rare)

Common adverse effects

  • Headache
  • Fatigue
  • Nausea
  • Diarrhoea
  • Insomnia
  • Dizziness

Pregnancy: can you take Entecavir?

AEMPS summary of product characteristics (section 4.6): there are not enough data on entecavir use in pregnant women; animal studies have shown reproductive toxicity at high doses, and the potential risk for humans is unknown. Women of childbearing potential should use effective contraception, and entecavir should not be used during pregnancy unless clearly necessary. There are no data on the effect of entecavir on mother-to-newborn transmission of hepatitis B virus, so appropriate measures should be taken to prevent infection in the newborn.

Breastfeeding: can you take Entecavir?

Limited data. Hale L3. Excreted in animal milk; human data are scarce. EASL 2017 considers switching breastfeeding patients from entecavir to tenofovir (L2) or discontinuing breastfeeding. Decision individualised according to HBV activity.

Calculate RID

Reference information, not a clinical decision. Discuss feeding pauses or changes with your physician or an IBCLC.

Check interaction with another drug

Opens the checker prefilled with this drug. Pick the second one from your regimen.

Open checker

Summary of a multi-drug list →

Medicine list: everything you take in one place →

Frequently asked

What is Entecavir used for?

Entecavir is evaluated for the following indications with varying evidence strength: Chronic hepatitis B (evidence tier A). See the full indication matrix with dosing and citations above on this page.

What are the side effects of Entecavir?

Common side effects of Entecavir (≥ 1 in 100): Headache, Fatigue, Nausea, Diarrhoea, Insomnia, Dizziness. See the Safety section for uncommon and serious reactions.

Is Entecavir safe during pregnancy?

AEMPS summary of product characteristics (section 4.6): there are not enough data on entecavir use in pregnant women; animal studies have shown reproductive toxicity at high doses, and the potential risk for humans is unknown. Women of childbearing potential should use effective contraception, and entecavir should not be used during pregnancy unless clearly necessary. There are no data on the effect of entecavir on mother-to-newborn transmission of hepatitis B virus, so appropriate measures should be taken to prevent infection in the newborn.

Is Entecavir compatible with breastfeeding?

Limited data. Hale L3. Excreted in animal milk; human data are scarce. EASL 2017 considers switching breastfeeding patients from entecavir to tenofovir (L2) or discontinuing breastfeeding. Decision individualised according to HBV activity.

Who should not take Entecavir?

Entecavir is contraindicated in: Hypersensitivity to entecavir; Monotherapy in HIV-coinfected patients without effective ART (risk of selecting HIV resistance). Full list in the Safety section.

Official sources

Direct links to regulator labels. Open in a new tab.

Other drugs in this group

Famciclovir, Inosine pranobex, Kagocel, Lactoferrin, Oseltamivir, Valacyclovir, Atazanavir, Meglumine acridone acetate