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The European Association for the Study of the Liver (EASL) will this week be announcing new recommendations on the management of hepatitis C (HCV) at the International Liver Congress (ILC). These EASL recommendations reflect the approval of three new direct-acting antivirals (DAAs) during 2014 by the European Medicines Agency.
It is estimated that approximately 185 million people are infected with HCV on a global scale, with approximately 150 million people living with chronic infection. In Europe, between 7.3 million and 8.8 million people are infected with HCV and approximately 3 million to 4 million people become newly infected each year.
Three new HCV DAAs that are more efficacious and better-tolerated, will be on the European market in the first half of 2014, for use as part of combination therapies for HCV infection. Sofosbuvir, a nucleotide analogue inhibitor of HCV ribonucleic acid (RNA)-dependent RNA polymerase, was approved in January 2014. Simeprevir, a second-wave, first-generation NS3/4A protease inhibitor will be approved in May 2014. Daclatasvir, an NS5A inhibitor, is likely to be approved in August or September 2014.
Coordinator of the recommendations and director of the French National Reference Centre for Viral Hepatitis, professor Jean-Michel Pawlotsky, says, "Since EASL published the HCV Clinical Practice Guidelines in 2013, the treatment paradigm for HCV has changed with three additional direct-acting antivirals -- sofosbuvir, simeprevir and daclatasvir – scheduled for approval this year for use in patients infected with HCV genotype 1."
"These groundbreaking drugs continue to revolutionise treatment for HCV patients, including those who failed to respond to previous therapies. The new recommendations provide essential information on the recommended use of these new compounds with and without interferon to help prescribers deliver optimal care for their HCV patients."
Based on a systematic review of existing literature, the new recommendations provide best practice on a number of key areas:
•Indications for treatment: who should be treated?
•Available drugs (approved by EMA before the end of 2014)
•Treatment of chronic hepatitis C
•Measures to improve treatment adherence
•Post-treatment follow-up of patients who achieve an SVR
•Retreatment of non-sustained virological responders
•Treatment of patients with severe liver disease
•Treatment of special groups
Commenting on the new recommendations, EASL governing board member and recommendation panel member, Dr. Alessio Aghemo, says, "These new EASL on-line recommendations on the management of HCV reflect how the treatment landscape has evolved for this disease, and will further help physicians and other healthcare providers optimise management of patients with acute and chronic HCV."
The new EASL recommendations will be presented during a session at the ILCTM in London on April 12, 2014.
1. World Health Organization. WHO Guidelines for the Screening, Care and Treatment of Persons with Hepatitis C Infection. 2014.
2. European Association for the Study of the Liver. Clinical Practice Guidelines - Update on the management of hepatitis C virus infection. Journal of Hepatology, 2014.
3. WebMD. Hepatitis Health Center. Available at http://www.webmd.com/hepatitis/