Effective Treatment and Potential Cure for Hepatitis D – Results Disclosed at International Liver Congress
Heiner Wedmeyer reports on Bulevirtide to treat and even cure Hepatitis D, with Maria Buti, EASL Public Health Chair and EASL Secretary General Thomas Berg,

The drug Bulevirtide can successfully treat and even potentially cure Hepatitis D – the most acute diseases of the hepatitis family and hardest to treat until now, according to the results of a Phase III trial of the drug announced on Thursday, the opening day of the International Liver Congress 2022 (ILC 2022)

An estimated 12 million people worldwide have experienced HDV infection, also known as Chronic Hepatitis Delta. HDV is found in up to 5% of people worldwide living with Hepatitis B (HBV). HBV also has so far eluded a cure. But promising clinical trial results of other new drugs and drug combinations to treat HBV, and related to that, acute hepatic porphyria, also being discussed at the conference, could help advance that goal. 

“With Bulevirtide, an inhibitor of HBV and HDV entry into liver cells, we can for the first time successfully treat Hepatitis D,”  said EASL in a press statement.  Results from 48 weeks of treatment with the drug also showed HDV RNA at undetectable levels in a significant proportion of those treated, leading to hopes that the treatment could also lead to a cure.  

“This is almost a historic moment for heptatology,” said principle investigator, Heiner Wedemeyer, of Germany’s Hannover Medical School, of the findings. He speaking at an ILC press briefing about the Phase 3 trial,  undertaken in Germany, The Russian Federation, Italy and Sweden of 2 and 10 mg doses of the drug daily for a period of 48 weeks. “For us in the Hepatitis D field, this is really exciting times, completely novel data, and game-changing for treatments.”

Results of randomized, Phase 3 study of 2 mg or 10 mg dose of Bulevirtide in patients with HDV virus in four European countries, as presented at the International Liver Conference 23-26 June, 2022

Convened by the European Association for the Study of the Liver (EASL) in a hybrid format, the conference in London, 23-26 June saw 5,000 scientists, doctors, public health officials, and patient groups attending in-person for the first time since the beginning of the COVID pandemic. 

Other advances being discussed at the conference will include: new treatments for reducing liver fat and positive results from the largest human trial of preemptive drugs administered before transplantation of a hepatitis C compromised organ, which can fully protect a patient from risk associated with post operative infection.

“We may well be entering into a new golden age of hepatology science,” said Thomas Berg, Secretary-General of EASL and Head of the Division of Hepatology at Leipzig University Medical Center in Germany. “There is respite coming for those people living with Hepatitis D and we are making progress towards finding a cure for Hepatitis B which affects millions people around the world. The science is inching us towards a potential public health revolution.”

Event takes place against backdrop of increased liver disease 

This year’s EASL takes place against the backdrop of an increased prevalence of liver disease across the globe.

In Europe, chronic liver disease has a substantial impact on young and middle-aged individuals in their prime working years, with the peak age of death occurring in the late 40s and early 50s. Liver disease is now the biggest killer of 35–49-year-olds in the United Kingdom. 

This contrasts with mortality from smoking-related and other obesity-related illnesses, such as lung cancer or type 2 diabetes, for which deaths typically occur in the 60s and 70s. Consequently, data from the World Health Organization shows that liver disease is now second only to ischemic heart disease as the leading cause of years of working life lost in Europe. On average, two-thirds of all potential years of life lost due to mortality from liver diseases are years of working life.

New treatments for Non-Alcoholic Fatty Liver Disease (NAFLD) 

The Congress also will see reports on the results of the human trial of a new drug Pemvidutide with the potential to reduce both weight and liver fat; as well as results of a randomized-controlled trial on a low carbohydrate/high fat diet, and its potential impact on fatty liver disease.

The search for new treatments for Non-Alcoholic Fatty Liver Disease (NAFLD) has gained momentum over the past few years as countries worldwide grapple with a rise in the disease, just one  result of the worldwide increase in obesity levels. NAFLD is now the fastest growing disease in the world, and the most common cause of liver disease in many developed countries.  

In a proportion of people, NAFLD can cause progressive liver damage, and in some cases it may even lead to the development of liver cirrhosis and liver cancer. In the U.S. it is now the most common indication for a liver transplant, according to EASL.

It is estimated that if left unchecked, the annual predicted cost of NAFLD in Europe is estimated to be greater than €35 billion in direct costs to the health system, and a further €200 billion by way of wider costs to society.

Updated 27 June 2022

Image Credits: Wedemeyer et al, EASL2022 presentation.

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