New Hepatitis D treatment options still needed urgently
Scientists and doctors search for better treatment options for hepatitis patients.© German Liver Foundation
The largest trial on the treatment of aggressive hepatitis D (delta) worldwide was conducted at the German Liver Foundation’s HepNet Study House. It shows that an extension of treatment duration has positive impacts on the liver’s condition and can consequently prevent disease progression. However, significantly higher rates of cure were not found. The trial findings have been published in The Lancet Infectious Diseases.
Hepatitis D infection (HDV) leads to chronic liver disease with severe consequences. Frequently, the infected people develop liver cirrhosis and liver cell cancer. A liver transplant is often the last treatment resort for many patients. HDV is the smallest known virus that is able to infect humans. Only patients suffering from infections with hepatitis B can contract hepatitis D as the virus needs a membrane protein from the hepatitis B virus in order to replicate.
Currently, an estimated 15 to 25 million people worldwide and approximately 30,000 people in Germany have chronic HDV. Currently, the only treatment option available is with a modified tissue hormone, so-called pegylated interferon alfa, administered over a period of one year. However this treatment leads to relapses in the long-term. Up until now, it has been unclear as to whether the rates of cure can be increased by extending the duration of treatment or by combining the treatment with another drug to treat the co-existing hepatitis B infection.
Consequently, the largest study worldwide on antiviral treatment of chronic hepatitis D (Hep-Net International Delta Hepatitis Interventional Trial, HIDIT-II) was conducted at the German Liver Foundation’s HepNet Study House in collaboration with the Hannover Medical School and the company Roche Pharma. The HepNet Study House is an associate partner of the DZIF. In this trial, 120 patients were treated with either PEG interferon alfa-2a and tenofovir disoproxil (a drug which is approved for hepatitis B treatment) or with PEG interferon alfa-2a and a placebo in participating centres in Germany, Greece, Romania and Turkey over a period of 96 weeks.
Trial Findings
A significant trial finding is the marked reduction of liver scarring, i.e. an improvement of liver’s condition and function towards the end of the extended period of treatment. “This finding has been documented in this form for the first time worldwide, and it is highly significant for a patients’ long-term prognosis,” says Professor Heiner Wedemeyer, coordinator of the trial and Director of the Clinic of Gastroenterology und Hepatology at the University Hospital Essen. “Consequently, the likelihood of complications such as liver cirrhosis and liver cell cancer are significantly reduced.” An additional important finding is that the extended treatment is well tolerated, even through interferons have flu-like side effects or cause changes in the blood work findings.
However, relapses after the end of treatment were not prevented following the extended period of treatment of two years. Professor Cihan Yurdaydin from the Department of Gastroenterology of Ankara University, who is the responsible principal investigator for Turkey, explains that an extension of the duration of treatment to two years cannot be generally recommended based on these HIDIT-II trial findings. “However, this trial is very important for clinical practice and does show that an extension of treatment could indeed be taken into consideration for patients who respond well to treatment,” he clarifies.
“This trial, initiated by the HepNet Study-House was a logistical masterpiece conducted over almost ten years. It resulted unique findings worldwide and was only made possible due to the HepNet Study House’s infrastructure, international collaboration as well as with the support from the Hannover Clinical Trial Center (HCTC),” emphasises Professor Michael P. Manns. He is Director of the Department of Gastroenterology, Hepatology and Endocrinology of the Hannover Medical School and Chairman of the German Liver Foundation’s Executive Board.
The trial was funded by the companies Roche Pharma AG and Gilead Sciences GmbH. The HepNet Study House is funded by the DZIF.
The German Liver Foundation focuses on the liver, liver disease and its treatment. It aims to improve patient care by funding research and conducting its own scientific projects. Through intensive public relations work, the Foundation increases public awareness for liver diseases so that these can be diagnosed and cured earlier. In addition, the German Liver Foundation offers information and consultation services for patients and relatives as well as for doctors and pharmacists with regard to medical matters. Further information can be found at www.deutsche-leberstiftung.de.
