German Liver Foundation launches registry to improve hepatitis C therapy

15.10.2014 12:57

Chronic hepatitis C can now be easily treated. However, especially for the new drugs, further data is required in order to optimize patient treatment. So that this information can be collected, the German Liver Foundation is launching the “German Hepatitis C Register”.

Up to 170 million people worldwide are infected with the hepatitis C virus (HCV); In Germany alone, around 300,000 to 600,000 people are probably affected. Chronic hepatitis C leads to liver cirrhosis and then to hepatocellular carcinoma in many patients. Treatment is therefore absolutely necessary.

There are now new, interferon-free therapies with very good chances of recovery for hepatitis C patients. Some new substances have already been approved, others are about to be approved.

So that the new therapies for hepatitis C can actually benefit all those affected, further information must be collected after the drugs have been approved - for example, to determine whether the drugs are also suitable for patients with other diseases in addition to hepatitis C or to determine whether what side effects can occur with widespread use. It is also important to know how common hepatitis C actually is, how much the disease costs and how much it costs to treat. Only with this knowledge can the new drugs be used optimally.

The German Liver Foundation has therefore decided to cooperate with the Professional Association of Resident Gastroenterologists in Germany. V. (bng) to maintain the German Hepatitis C Register. The foundation can rely on an already established register. This registry records over 40,000 patients suffering from chronic hepatitis C. Over 600 centers in Germany, bng practices, clinics, university hospitals, HIV practices and addiction medicine specialists, were involved in data collection.

In the future, all forms of therapy for hepatitis C can be included in the new registry. This has already been provided for medications that have not yet been approved, so that the register can be expanded immediately after approval.

In order to keep the register, the German Liver Foundation has founded a GmbH, of which it is the sole shareholder. The “Leberstiftungs-GmbH Deutschland” is responsible for the German Hepatitis C Register. The register is carried out in cooperation with the bng. The scientific director of the registry is Dr. Dietrich Hüppe, Herne. For the Leberstiftung GmbH Germany, Prof. Dr. Heiner Wedemeyer runs the register as medical director.

The registry is financially supported by the companies AbbVie Deutschland GmbH & Co. KG, Bristol-Myers Squibb GmbH & Co.KGaA, Gilead Sciences GmbH, Janssen-Cilag GmbH, MSD Sharp & Dohme GmbH and Roche Pharma AG.

“We would like to thank everyone involved for the great opportunity to establish one of the largest prospective registers for documenting new therapies in the world and to enable a broad retrospective scientific evaluation by passing on the existing data sets,” says Prof. Dr. Michael P. Manns, Chairman of the Board of the German Liver Foundation, highlighted the importance of the register. And Dr. Dietrich Hüppe emphasizes for the bng: “With the continuation and expansion of the register, we have a unique opportunity to document the new therapies in a proven manner right from the start. This means that the centers that have long been involved in non-interventional studies can continue to make an important contribution to health services research and to improving hepatitis C therapy.”