Entecavir Accord
Authorised
This medicine is authorised for use in the European Union
entecavir
MedicineHumanAuthorised
Overview
This is a summary of the European public assessment report (EPAR) for Entecavir Accord. It explains how the Agency assessed the medicine to recommend its authorisation in the EU and its conditions of use. It is not intended to provide practical advice on how to use Entecavir Accord.
For practical information about using Entecavir Accord, patients should read the package leaflet or contact their doctor or pharmacist.
Entecavir Accord is a medicine used to treat chronic (long-term) hepatitis B (an infectious disease of the liver, caused by the hepatitis B virus).
It is used in adults with signs of ongoing liver injury (such as inflammation and fibrosis) when the liver is still working properly (compensated liver disease) and also when the liver is no longer working properly (decompensated liver disease).
It can also be considered for children aged from 2 to 18 years but only in those with compensated liver disease.
Entecavir Accord contains the active substance entecavir and is a ‘generic medicine’. This means that Entecavir Accord contains the same active substance and works in the same way as a ‘reference medicine’ already authorised in the European Union (EU) called Baraclude.
Entecavir Accord can only be obtained with a prescription and is available as tablets (0.5 mg and 1 mg). Treatment with Entecavir Accord should be started by a doctor with experience in the management of chronic hepatitis B.
Entecavir Accord is taken once a day. For adults with compensated liver disease, the dose depends on whether or not the patient has been previously treated with a medicine in the same group as Entecavir Accord (a nucleoside analogue, such as lamivudine). Patients who have not been treated before with a nucleoside analogue receive a 0.5 mg dose, while those who have received lamivudine before but whose infection is no longer responding to it are given a 1 mg dose. The 0.5 mg dose can be taken with or without food, but the 1 mg dose must be taken at least 2 hours before or 2 hours after a meal. The treatment duration is determined by how the patient responds.
The 1 mg daily dose is also used in adults with decompensated liver disease and stopping treatment is not recommended in these patients.
When treatment is considered appropriate in children, the dose depends on their body weight. Children weighing 32.6 kg and above can be given the 0.5 mg tablets, while an oral solution of entecavir may be available for children weighing less than 32.6 kg. For further information, see the package leaflet.
The active substance in Entecavir Accord, entecavir, is an antiviral belonging to the class of the nucleoside analogues. Entecavir interferes with the action of a viral enzyme, DNA polymerase, which is involved in the formation of viral DNA. Entecavir stops the virus making DNA, and prevents it from multiplying and spreading.
Studies on the benefits and risks of the active substance in the approved uses have already been carried out with the reference medicine, Baraclude, and do not need to be repeated for Entecavir Accord.
As for every medicine, the company provided studies on the quality of Entecavir Accord. The company also carried out a study that showed that it is ‘bioequivalent’ to the reference medicine. Two medicines are bioequivalent when they produce the same levels of the active substance in the body and are therefore expected to have the same effect.
Because Entecavir Accord is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine’s.
The European Medicines Agency concluded that, in accordance with EU requirements, Entecavir Accord has been shown to have comparable quality and to be bioequivalent to Baraclude. Therefore, the Agency’s view was that, as for Baraclude, the benefit outweighs the identified risk. The Agency recommended that Entecavir Accord be approved for use in the EU.
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Entecavir Accord have been included in the summary of product characteristics and the package leaflet.
The European Commission granted a marketing authorisation valid throughout the European Union for Entecavir Accord on 26 September 2017.
For more information about treatment with Entecavir Accord, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Product information
Latest procedure affecting product information: R/0011
01/07/2022
This medicine’s product information is available in all official EU languages.
Select 'available languages' to access the language you need.
Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
Product details
- Name of medicine
- Entecavir Accord
- Active substance
- Entecavir
- International non-proprietary name (INN) or common name
- entecavir
- Therapeutic area (MeSH)
- Hepatitis B, Chronic
- Anatomical therapeutic chemical (ATC) code
- J05AF10
Pharmacotherapeutic group
Antivirals for systemic useTherapeutic indication
Entecavir Accord is indicated for the treatment of chronic hepatitis B virus (HBV) infection in adults with:
- compensated liver disease and evidence of active viral replication, persistently elevated serum alanine aminotransferase (ALT) levels and histological evidence of active inflammation and/or fibrosis.
- decompensated liver disease.
For both compensated and decompensated liver disease, this indication is based on clinical trial data in nucleoside naive patients with HBeAg positive and HBeAg negative HBV infection. With respect to patients with lamivudine-refractory hepatitis B.
Entecavir Accord is also indicated for the treatment of chronic HBV infection in nucleoside naive paediatric patients from 2 to <18 years of age with compensated liver disease who have evidence of active viral replication and persistently elevated serum ALT levels, or histological evidence of moderate to severe inflammation and/or fibrosis. With respect to the decision to initiate treatment in paediatric patients.
News on Entecavir Accord
This page was last updated on