Published: Apr 8, 2014
By Michael Smith, North American Correspondent, MedPage Today
LONDON -- New treatments for hepatitis C virus (HCV) will have most of the limelight this week at the annual meeting of the European Association for the Study of the Liver.
A tidal wave of novel direct-acting agents has been building for several years and is set to break here, according to the association's secretary-general, Markus Peck, MD, of the Medical University of Vienna in Austria.
"What strikes you most," Peck told MedPage Today, "is first of all the number of phase III trials that are being presented ... the most phase III data you will ever see in a liver meeting."
That's because several companies are rushing to get novel regimens approved and into the clinic, he said.
Indeed, of the 18 abstracts in the first three general sessions of the meeting, nine have to do with new treatments for HCV, as do half of the late-breaking oral presentations. There are also several parallel sessions devoted to HCV therapy.
But equally important, he said, are the "consistently positive results ... more or less independent of what kind of patients you are looking at: treatment-naive patients, previously treated patients, patients with advanced liver disease -- it's always working."
"It's fascinating and fantastic at the same time," he said. Even a year ago, Peck added, experts would not have expected to "treat patients for 3 months -- maybe even 2 months -- and cure 95% or 98% of them."
The direct-acting agents are so-called because they work on aspects of the virus itself, unlike the two drugs that until very recently were the mainstays of HCV therapy -- pegylated interferon-alfa and ribavirin.
Peginterferon is a general immune system booster with a range of unpleasant side effects, while ribavirin is a general antiviral drug with its own drawbacks. Cure rates with the combination -- the so-called sustained virologic response or SVR -- vary depending on the HCV genotype of the patient but are generally regarded as low.
A major goal of recent research, including much to be presented here, has been to combine different direct-acting agents in order to avoid using peginterferon. In addition, some of the trials to be reported here have also examined ribavirin-free regimens.
Studies of other forms of viral hepatitis are also being reported here, Peck said, "but nothing can match the success of HCV treatment at the moment."
For instance, there will be data on hepatitis B therapy that is "interesting ... but nothing game-changing" but Peck said future meetings are likely to see more work on HBV once the furor over HCV dies down.
Researchers also will detail some early investigations into hepatitis D and E, he said.
Other aspects of liver disease are also under examination here, including what is touted as the first phase III trial in 20 years for a new drug -- obeticholic acid -- to treat primary biliary cirrhosis.
"This is something that is very new," Peck said. While the condition is not common, it accounts for between 4% and 5% of liver transplant patients, he added, and "everyone who's treating people for liver disease has several patients."
And Spanish researchers are to present data form a phase III trial on the use of statins in patients with portal hypertension that is likely to draw some attention, Peck said, if only because it's something other than viral hepatitis.
In all, more than 1,000 abstracts are to be presented, Peck said.