Bon jour la toata lumea...
Am sa va pun aici un citat dinntr-un forum al Guvernului Canadian unde medicamentul antiviral Baraclude este adoptat in Februarie 2007 de catre Canada.
"Baraclude is indicated for the treatment of chronic hepatitis B virus (HBV) infection in adults with evidence of active viral replication and either evidence of persistent elevations in serum aminotransferases (ALT or AST) or histologically active disease. Baraclude has been shown to be an effective antiviral drug for the treatment of chronic HBV. The medicinal ingredient entecavir is phosphorylated to the active triphosphate form which exhibits selective activity against HBV polymerase, competes with the natural substrate deoxyguanosine triphosphate, and inhibits functional activities of the HBV polymerase."
Nu stiu daca este valabil si in Romania la ora actuala , insa puteti cauta pe goole mai multe. Se pare ca este mult mai bine tolerat de catre organism si da rezultate mai bune in comparatie cu Interferonul si Zeffix-ul
"Priority Review Status was granted for the evaluation of Baraclude as it appeared to provide a significant increase in efficacy for a serious, life-threatening, or severely debilitating illness not adequately managed by a drug marketed in Canada . Results presented suggested greater efficacy than existing treatments as well as effectiveness in patients whose virus is resistant to lamivudine, which represents an increasingly significant proportion of chronic HBV sufferers.
The market authorization was based on submitted data from quality control studies, preclinical, and clinical studies. Clinical efficacy and safety were studied in three pivotal active-controlled trials that included 1633 patients with chronic HBV infection accompanied by evidence of viral replication. Subjects had persistently elevated ALT levels (≥1.3 times the upper limit of normal) and chronic inflammation on liver biopsy compatible with a diagnosis of chronic viral hepatitis. The safety and efficacy were also evaluated in a study of 68 patients co-infected with HBV and HIV. All trials compared entecavir to an active control lamivudine. Entecavir was clearly efficacious and exhibited superiority to lamivudine.
Baraclude (entecavir) is presented in tablets (0.5 mg) and oral solution (0.05 mg/mL). The usual recommended dose of Baraclude for chronic HBV infection in adults and adolescents 16 years of age or older is 0.5 mg once daily. For adults and adolescents 16 years of age or older with a history of hepatitis B viremia while receiving lamivudine or with known lamivudine resistance mutations, the recommended dose of Baraclude is 1 mg (two 0.5 mg tablets) once daily. Dosing guidelines are available in the Product Monograph.
Baraclude is contraindicated in patients with a previously demonstrated hypersensitivity to entecavir or any component of the product. Baraclude should be administered under the conditions stated in the Product Monograph taking into consideration the potential risks associated with the administration of this drug product. Detailed conditions for the use of Baraclude are described in the Product Monograph.
Based on the Health Canada review of data on quality, safety, and effectiveness, Health Canada considers that the benefit/risk profile of Baraclude is favourable for the treatment of chronic HBV infection in adults with evidence of active viral replication and either evidence of persistent elevations in serum aminotransferases (ALT or AST) or histologically active disease."
