Hepatitis D virus infection causes the most severe form of chronic viral hepatitis disease. About ten to 20 million people worldwide are affected. There is currently no cure for the disease, and in the end the only treatment option is often a liver transplant.
However, an international team led by Prof. Wedemeyer and Prof. Cornberg has now been able to prove in a multicentre phase 3 study with 150 participants that the active substance Bulevirtide prevents hepatitis D viruses (HDV) from entering the liver. “This means that the prerequisites for full approval of the drug have been fulfilled and we can finally give all treating physicians a sharp sword against hepatitis D,” says a pleased Prof. Wedemeyer, head of the study. The results were published in the internationally renowned medical journal New England Journal of Medicine.
Based on the positive results of an earlier study, the European Medicines Agency (EMA) had already provisionally approved the drug. “This is extremely unusual because the requirements for full approval are only met with the phase 3 clinical trial. This shows how urgently an effective drug is needed for this severe liver disease,” emphasises Prof. Wedemeyer. In the current study, the drug was tested on a larger number of patients to see if efficacy and safety could be confirmed, and possible interactions with other drugs were investigated.
Bulevirtide was developed at Heidelberg University Hospital and the German Centre for Infection Research (DZIF). It blocks the docking point for the envelopes of the viruses on the liver cell so that the viruses can no longer enter the cell. Patients who are already infected also benefit: the drug protects newly formed liver cells from HDV infection, while at the same time cells that are already infected are destroyed by the immune system. The virus is thus deprived of its basis of existence, because in order to continue to exist in the body it must always infect new liver cells. “Bulevirtide is a real game changer. We now expect that full approval will also be granted by the European Medicines Agency in the near future,” says Prof. Wedemeyer.”
The text is based on a press release of the Hannover Medical School written by Kirsten Pötzke.