Briefing note: entecavir (Baraclude)

SMC did not accept entecavir for the treatment of chronic hepatitis B virus (HBV) infection in
adults with decompensated liver disease.

• Hepatitis B is a virus that is transmitted by infected blood and body fluids. It can cause an infection with flu-like symptoms, but usually corrects itself without treatment. However, in some cases the virus can cause chronic illness that lasts for months and potentially for life, with symptoms that come and go. Hepatitis B can cause liver disease in which the liver cells are damaged from the hepatitis infection and cannot function normally (known as decompensated liver disease). Chronic hepatitis B infection can also cause cirrhosis and liver cancer.
   
• If chronic illness develops, antiviral treatment may be used to prevent cirrhosis and/or liver cancer. Entecavir is a new antiviral medicine that stops the hepatitis B virus from spreading. It can lessen or stop the symptoms of chronic liver disease (a phase called remission). It is given as a tablet or solution orally.
   
• SMC has previously accepted entecavir for the treatment of chronic HBV infection in adults with compensated liver disease. This submission relates to a licence extension to allow use in patients with decompensated disease. These patients have a significant risk of severe liver disease and death, due to the development of progressive liver failure and liver cancer.
   
• A study in adults with chronic HBV and decompensated liver disease has shown that entecavir more effectively reduced the amount of virus to a target level after 48 weeks of treatment, compared with another similar medicine. However, the case presented by the manufacturer did not compare entecavir with the medicine most commonly used in Scotland.
   
• In studies, entecavir was tolerated as well as a comparator antiviral medicine.
   
• SMC did not accept entecavir because there were weaknesses in the economic case presented by the manufacturer.