What is Baraclude?
Baraclude contains the active ingredient entecavir. Baraclude is available as tablets
(white: 0.5 mg, pink: 1 mg) or oral solution (0.05 mg / ml).
What is Baraclude used for?
Baraclude is indicated for the treatment of chronic hepatitis B (a persistent liver infection caused by the hepatitis B virus) in adults. It is used in patients suffering from compensated liver disease (in which the liver functions normally, despite being damaged), in which signs are observed that the virus continues to reproduce (high levels of the liver enzyme) and signs of liver damage (detected under a microscope ).
The medicine can only be obtained with a prescription.
How is Baraclude used?
Baraclude therapy should be started by a doctor experienced in treating chronic hepatitis B virus infection.
Baraclude should be taken once a day. The dose changes depending on whether the patient was previously treated for chronic hepatitis B with a medicine from the same group as Baraclude (a nucleoside analogue such as lamivudine). In patients who have not previously been treated with a nucleoside analogue, the recommended dose is 0.5 mg, while the 1 mg dose is used in patients who have been previously treated with lamivudine and who have developed "resistance" ( no longer respond to this substance. The 0.5 mg dose can be taken with or without food; the 1 mg dose should be taken at least 2 hours before or 2 hours after a meal. In patients with kidney problems the doses decrease; in these patients the use of the oral solution is possible. The duration of treatment depends on the patient's response.
How Baraclude works
The active substance in Baraclude, entecavir, is an antiviral that belongs to the class of analogues
nucleoside. Entecavir interferes with the action of a viral enzyme, DNA polymerase, which is involved in the formation of virus DNA. Entecavir stops producing DNA by
of the virus, thus preventing it from multiplying and spreading.
What studies have been carried out on Baraclude?
Before being studied in humans, the effects of Baraclude were analyzed in experimental models. The effectiveness of Baraclude in the treatment of chronic hepatitis B has been compared to that of lamivudine in 3 important clinical studies. Patients, predominantly male, aged between 35 and 44, were treated for at least a year with Baraclude or lamivudine.
Two studies (1 363 patients) were performed on nucleoside-naive patients (ie on patients who were not previously treated with nucleoside analogues). The third study (293 patients) was conducted on patients who developed resistance to lamivudine therapy. The studies measured the effectiveness of the treatment by recording the evolution of liver damage during 48 weeks of therapy (by means of a liver biopsy, with which a sample of liver tissue is taken to examine it under a microscope) as well as other signs of the disease, such as levels of a liver enzyme (ALT) or viral DNA circulating in patients' blood.
What benefits has Baraclude revealed during your studies?
Baraclude was more effective than lamivudine in the treatment of naive patients: an improvement in liver conditions was observed in just over 70% of patients treated with Baraclude compared to just over 60% of subjects treated with lamivudine. These results were obtained both in the so-called "HBeAg positive" patients (infected with the common hepatitis B virus) and in the so-called "HBeAg negative" patients (infected with a mutated virus, which caused a more difficult form of chronic hepatitis B by treat).
Baraclude was more effective than lamivudine even in refractory (resistant) patients a
this medicine: an improvement in the condition of the liver was observed in 55% of subjects treated with Baraclude compared to 28% of subjects treated with lamivudine. At the end of the study, 55% of patients treated with Baraclude showed a normal level of ALT and no signs of the presence of viral DNA in the blood compared to 4% of patients treated with lamivudine.
What are the risks associated with Baraclude?
In clinical studies the most common side effects (found in 9% of patients) were fatigue (6%), drowsiness (4%) and nausea (3%). For the complete list of side effects
detected with Baraclude, see the package leaflet. Baraclude should not be used in patients who may be hypersensitive (allergic) to entecavir or any of the other ingredients.
Patients and doctors must be aware of the fact that Baraclude belongs to a group of medicines, nucleoside analogues, which can cause "lactic acidosis", ie an abnormal increase in the level of chemical lactic acid in the blood, with symptoms such as nausea, vomiting and pain in the stomach. Patients must also be aware of the fact that liver disease could get worse. This could happen during the treatment or at the end of the same. In lamivudine-refractory patients, entecavir resistance was observed (due to the fact that the virus becomes insensitive to antiviral). Since resistance may affect efficacy, the latter is monitored closely in long-term follow-up.
Why has Baraclude been approved?
The Committee for Medicinal Products for Human Use (CHMP) concluded that Baraclude was shown to be just as effective or more effective than the medicine currently used to treat infections caused by the hepatitis B virus. The CHMP decided that Baraclude's benefits are greater than its risks in the treatment of chronic hepatitis B patients with compensated liver disease and therefore recommended that it be given marketing authorization.
More information on Baraclude:
On 26 June 2006, the European Commission granted a marketing authorization valid for the entire European Union to Baraclude to BRISTOL-MYERS SQUIBB PHARMA EEIG.
For the full version of the evaluation (EPAR), click here.
Last update of this summary: 05-2006
