SMC approves Baraclude as HBV treatment for NHS in Scotland

US drugmaker Bristol-Myers Squibb says that it welcomes the decision by the Scottish Medicines Consortium, the agency that regulates the provision of drugs in the National Health Service in Scotland, to approve Baraclude (entecavir) as a treatment for chronic hepatitis B infection. The SMC guidance states that the agent is accepted for use in the treatment of HBV in adults with compensated liver disease and evidence of active viral replication, persistently elevated serum alanine amino transferase levels and histological evidence of active inflammation or fibrosis.

B-MS explained that viral load in HBV-infected individuals is an important prognostic indicator in terms of disease progression, which can lead to serious liver damage and liver cancer. The firm went on to say that Baraclude inhibits viral reproduction and therefore lowers viral load, in some cases to undetectable levels.

The company added that the results of three pivotal Phase III studies that compared Baraclude with lamivudine, showed that the agent had a comparable beneficial effect on the level of liver inflammation and fibrosis, brought about a greater reduction in viral load and conferred increased normalization of liver function and seroconversion. The firm also said that, among patients who had not received prior antiviral therapy, no resistance to the drug has emerged after 96 weeks of continuous treatment.