Baraclude (entecavir), a new oral drug recently approved in Europe to treat chronic hepatitis B viral infections, will provide a much needed therapy, according to liver specialists. It will help to check progress of disease in the rising tide of infections, many of which develop rapid resistance to currently available therapies.

Speaking during the 12th International Symposium on Viral Hepatitis and Liver Disease in Paris, Professor Patrick Marcellin of the Viral Hepatitis Research Unit, Hopital Beaujon, Clichy, France, said: "Europe is likely to see a significant increase in prevalence and incidence of hepatitis B in the near future as high numbers of immigrants from countries where chronic hepatitis B is endemic, settle across Europe." Two billion people are infected with hepatitis B worldwide of whom around 400 million are carriers of chronic disease. An estimated one million people in Europe are infected with hepatitis B each year of whom 90,000 become chronic carriers and up to a quarter die of complications such as liver failure or cancer .

Hepatitis B can be passed from mother to child, and can spread by sexual transmission or by other means where infection is able to enter the blood circulation such as intravenous drug injection or tattooing with an infected needle or transfusion with contaminated blood products.

In the UK the increase in prevalence is already evident, according to Professor Geoffrey Dusheiko, a hepatology specialist from London's Royal Free Hospital, who says the UK is seeing around 2000 new cases of hepatitis B per year, the vast majority occurring among recent immigrants. "A great many are from Eastern Europe; they are almost all young and very sexually active," he commented. An estimated quarter of a million people in the UK now carry the infection with about half of these living in London.

The most commonly-used treatments available currently show high rates of resistance. "Close to 100 per cent of patients treated for five years with the most-widely used drug on its own are resistant" he explained. The new drug Baraclude, which is expected to be available in a few months, has so far shown almost zero resistance in clinical trials lasting two years. Baraclude's molecular action presents a high barrier to gene mutation, he noted.

Alfredo Alberti, Associate Professor of Internal Medicine at University of Padova, Italy, discussing Baraclude said. "The drug has a high response rate and is a highly selective and very potent inhibitor of hepatitis B with the ability to rapidly reduce viral load to undetectable levels in 89 to 90 per cent of people treated for 1 to 2 years. These features will help prevent the emergence of resistance."

Baraclude, which is 300 to 400 times more potent than other antivirals, is an option for first-line therapy and is the best candidate to be included in combination with other therapies, he added.

Call for action and an end to stigma

Concerted uniform action across Europe is needed to ensure all people at risk of hepatitis B infection have equal access to anonymous free testing, vaccination and care to prevent the risk of subsequent liver failure or cancer, said Charles Gore, president of the European Liver Patients' Association.

"This is a supranational disease and we can't prevent it crossing borders" he said. Ignorance is preventing adequate surveillance from occurring and means that people go on to develop serious complications that might have been avoided. "We need a pan-European awareness campaign to help identify undiagnosed patients all over the EU and give everyone, including vulnerable groups, equal access to care." At present access to services in the EU is patchy, he commented.

Mr Gore also called for action against stigma. "People with hepatitis B feel stigmatised because the common perception is that this is a disease exclusive to intravenous drug abusers, the sexually promiscuous and illegal immigrants. This is a myth born of ignorance," he said. "It not only prevents people coming forward for testing and treatment, it also deters them from speaking to the media so awareness of the condition is not being raised; people don't want to be associated with a stigmatising disease."

The European Liver Patients' Association is trying to make sure campaigns to educate the public and encourage screening are focused on the disease itself rather than how it is acquired. "We should concentrate on the disease rather than apportion blame," he stressed.

Professor Dusheiko agrees. "Screening of different ethnic groups should be done but sensitivity is required" he said. If you can do it in a sensitive way pointing out there are good treatment options coming up, such as Baraclude, that would be helpful, he suggested. "Political will is needed along with good organisation and co-operation in these sensitive times."

The UK is regrettably one of only a handful of countries without an infant vaccination programme, he added. Cost is the main reason why mass vaccination against hepatitis B is not offered, he believes. The UK is unlikely to change in the near future. "It will take a patient, born in the UK, who acquires severe hepatitis from a sexual partner infected with hepatitis B, to sue the NHS for failing them in its duty of care to protect them against viral infection by offering vaccination," he believes. Legal action would be a wake up call. "It will happen sooner or later," he predicted.

Olwen Glynn Owen
glynnowen macline

View drug information on Baraclude.