World Hepatitis Day: 28 July 2013

News 26/07/2013

The European Medicines Agency supports World Hepatitis Day, which is taking place on Sunday 28 July 2013.

World Hepatitis Day is held every year on 28 July to provide international focus for patient groups and people living with hepatitis B and C. It aims to raise awareness and influence change in disease prevention and access to testing and treatment.

The World Hepatitis Alliance first launched World Hepatitis Day in 2008. The Alliance is a non-governmental organisation that represents hepatitis B and hepatitis C patient groups from around the world. The World Hepatitis Day is organised in partnership with the World Health Organisation (WHO).

Hepatitis B and C are caused by viruses that infect liver cells. Both diseases can lead to inflammation, scarring and cancer of the liver if left untreated. Viral hepatitis affects 500 million people worldwide and kills 1.4 million people every year.

The European Commission has authorised eight medicines for the treatment of chronic (long-term) hepatitis B and ten medicines for chronic hepatitis C on the recommendation of the Agency's Committee for Medicinal Products for Human Use (CHMP).

Among the medicines for hepatitis C recently authorised, two medicines in a new class called protease inhibitors attack the hepatitis C virus directly, in contrast to older medicines which work by stimulating the immune system to attack the virus.

The European Commission has also authorised ten vaccines for protection against hepatitis B infection for use in the European Union (EU).

The CHMP is currently evaluating the benefits and risks of a new vaccine for the protection against hepatitis B infection and two antivirals, a protease inhibitor and a polymerase inhibitor, for the treatment of chronic hepatitis C.

The Agency also publishes guidelines for pharmaceutical companies, describing how they should design and carry out studies of medicines for the treatment of hepatitis B and C. The Agency released a PDF icon draft guideline on the clinical evaluation of medicinal products for the treatment of chronic hepatitis C in 2011 and a PDF icon draft guideline on the clinical investigation of hepatitis-B immunoglobulins in 2012 for six-month public consultations. Comments received on these draft documents are currently under review.

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