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Information about Baraclude

What is it and what is it used for?

Baraclude is an antiviral medicine that contains the active substance entecavir. It is available as tablets (0.5 mg and 1 mg) and as an oral solution (0.05 mg/ml).

Baraclude is 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.

The medicine can only be obtained with a prescription.

How Baraclude works
The active substance in Baraclude, 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.

How Baraclude is used
Treatment with Baraclude should be started by a doctor with experience in the management of chronic hepatitis B.

Baraclude 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 Baraclude (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 less than 32.6 kg should be given the oral solution, while those weighing 32.6 kg and above can also be given the 0.5 mg tablets. For more information on the use of the medicine in children, see the summary of product characteristics (also part of the EPAR).

What are the benefits?

The European Medicines Agency concluded that Baraclude’s benefits are greater than its risks and recommended that it be given marketing authorisation. Baraclude has been shown to be effective at suppressing the virus in adults with both compensated and decompensated liver disease.

Viral suppression has also been shown in children. The decision to start a child on treatment should be based on careful consideration of their individual needs, as not all children with chronic hepatitis B infection require treatment.

What are main side effects?

The most common side effects seen with Baraclude are headache (seen in 9% of patients), fatigue (tiredness, 6%), dizziness (4%) and nausea (feeling sick, 3%).

For the full list of side effects and restrictions with Baraclude, see the package leaflet.

Patients also need to know that they may also suffer a worsening of their liver disease. This can happen during the treatment, or after it has been stopped. Resistance to entecavir (when a virus becomes insensitive to the antiviral) has been seen in lamivudine-refractory patients.

What studies have been done?

In adults with compensated liver disease, Baraclude was more effective than lamivudine in patients who had not been treated with nucleoside analogues before: an improvement in the condition of the liver was seen in just over 70% of the patients treated with Baraclude, against just over 60% of the patients treated with lamivudine. Baraclude was also more effective than lamivudine in patients refractory to lamivudine: 55% of patients treated with Baraclude had improvements in the condition of their liver, against 28% of those treated with lamivudine. At the end of the study, 55% of the patients treated with Baraclude had both a normal ALT level and undetectable viral DNA in their blood, while 4% of those treated with lamivudine showed the same results.

In adults with decompensated liver disease, there was a greater reduction in viral DNA with Baraclude than with adefovir dipivoxil.

Baraclude was also shown to be effective in the children’s study: 24% of children in the Baraclude group achieved the primary goal of having a viral DNA level of less than 50 IU/ml plus production of antibody to e-antigen and no e-antigen in their blood compared with 2% of children in the placebo group.

Sources

Baraclude was first approved for use in the EU in 2006. It is manufactured by Bristol-Myers Squibb.

European Medicines Agency website page for Baraclude (accessed 17/07/18)

Links available in External Resources

Reporting of suspected adverse reactions

Reporting suspected adverse reactions (side effects) after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals or patients are asked to report any suspected adverse reactions via the Yellow Card Scheme at yellowcard.mhra.gov.uk or search for MHRA Yellow Card in the Google Play or Apple App Store.


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For the full list of side effects and restrictions, see the package leaflet (link to package leaflet available in External Resources).