Various antivirals are approved for chronic viral hepatitis treatment in Europe. A centralised approval system for pharmaceutical innovations for viral diseases exists in Europe in the form of the European Medicines Agency (EMA). Applications are appraised by scientific committees to grant approval (or not) for single marketing authorisation in all EU countries although decisions on pricing and reimbursement are generally made at the national level.
Chronic hepatitis B treatment advances
The 2012 Clinical Practice Guidelines for the management of chronic hepatitis B (CHB) infection published in 2012 by the European Association for the Study of the Liver (EASL), drugs available for the treatment of CHB include interferon (IFN), PEG-IFN and six nucleotide/nucleoside analogues (NAs) . NAs for HBV therapy can be classified into nucleosides (lamivudine, telbivudine, emtricitabine, entecavir) and nucleotides (adefovir and tenofovir). PEG-IFN-2b and emtricitabine are not licensed for HBV treatment in most European countries. Lamivudine, adefovir, entecavir, telbivudine and tenofovir have been approved in Europe for HBV treatment, and the combination of tenofovir and emtricitabine in one tablet has been licensed for the treatment of human HIV infection.
Read more in the EASL Clinical Practice Guidelines for the management of chronic hepatitis B (CHB) infection http://www.easl.eu/assets/application/files/ef520780b91cf4f_file.pdf
Chronic hepatitis C treatment advances
Until 2011, the combination of pegylated interferon (IFN)-α and ribavirin for 24 or 48 weeks was the only approved treatment for chronic hepatitis C. In 2011, telaprevir and boceprevir were licensed for use in HCV genotype 1 infection. These two drugs are first-wave, first-generation direct-acting antivirals (DAAs). Both target the HCV NS3/4A serine protease and are thus referred to as protease inhibitors. Both telaprevir and boceprevir must be administered in combination with pegylated IFN-α and ribavirin. Three new HCV DAAs have been licenced in the EU in the first half of 2014, for use as part of combination therapies for HCV infection: sofosbuvir, a nucleotide analogue inhibitor of HCV RNA-dependent RNA polymerase, simeprevir, a second-wave, first-generation NS3/4A protease inhibitor and daclatasvir, an NS5A inhibitor.
Read more in the EASL Recommendations for the Treatment of Hepatitis C: http://www.easl.eu/_newsroom/latest-news/easl-recommendations-on-treatment-of-hepatitis-c-2014