2023-06-27 09:17:44
People suffering from hepatitis D often only have a liver transplant as a way out. That could change soon: In a clinical study, the active ingredient bulevirtide lowered the viral load in the blood and liver of those affected.
Hepatitis D is a previously incurable, particularly aggressive form of liver inflammation caused by viruses. Scientists report that the disease could soon be treatable with a drug: The results of a phase 3 clinical study show that therapy with the active ingredient bulevirtide significantly reduced the amount of viral genetic material in the blood and liver. “We were also able to determine that the liver values have also improved significantly in most cases,” said Prof. Dr. Markus Cornberg from the Hannover Medical School (MHH). The study results were published in the New England Journal of Medicine.
In the study, 150 patients were treated with the drug for 48 weeks. The study is ongoing to follow the progress. Clinic Director Prof. Dr. Heiner Wedemeyer is confident: “The drug has hardly any side effects and is generally very well tolerated. Bulevirtid is a real game changer. We now expect that full approval will be granted by the European Medicines Agency in the near future. We can finally give all treating physicians a sharp sword against hepatitis D.” Previously, the drug had been provisionally approved by the European Medicines Agency (EMA) due to positive results in an earlier study.
Hepatitis D viruses depend on hepatitis B viruses to reproduce and therefore always appear together with them. This has serious consequences, because hepatitis D accelerates the course of the disease, which in many of those affected quickly leads to cirrhosis of the liver with scarring of the liver or liver cancer, making a transplant necessary.
Bulevirtide prevents hepatitis D virus from entering the liver cells. The drug is also effective in the case of an existing infection: it protects newly formed liver cells from infection, while cells that are already infected are attacked and eliminated by the immune system. In this way, the virus cannot continue to multiply.
Which: DOI 10.1056/NEJMoa2213429
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