Aug. 18, 2010 -- A new generation of antiviral drugs can help reverse liver fibrosis and even early cirrhosis in patients with chronic hepatitis B virus (HBV) infection, and they continue to work for many years, new research suggests.
In a newly published study, 88% of previously untreated patients who took the drug entecavir for an average of six years continued to show reductions in liver injury, as measured by fibrosis and cirrhosis.
Known by the trade name Baraclude, entecavir was approved in 2005 for the treatment of chronic HBV infection, and it has become a first-line treatment for patients who have not been previously treated.
The study assessed long-term outcomes among patients enrolled in two phase III studies who took the drug for at least three years and as long as seven years.
HBV Drug Reverses Liver Scarring
Fifty-seven patients who were still taking the drug underwent biopsies an average of six years after beginning the treatment.
Almost all the patients (96%) showed reductions in HBV-associated inflammation, which leads to liver scarring, or fibrosis, and eventually cirrhosis, which involves extensive scarring and poor liver function.
Roughly 90% of patients showed improvements in fibrosis scores, including all 10 patients with advanced fibrosis or cirrhosis at study entry.
The research appears in the September issue of the journal Hepatology. The study was funded by Bristol-Myers Squibb, which manufactures entecavir.
The fact that most patients continued to improve while taking the drug confirms the value of long-term HBV treatment, study researcher Ting-Tsung Chang of Taiwan's National Cheng Kung University Hospital says in a news release.
Prevalence of Hepatitis B
The virus is much less common among people born in the U.S. than it was a generation ago, thanks to widespread vaccination and screening, hepatitis specialist and researcher Eugene Schiff, MD, tells WebMD.
He directs the Schiff Liver Institute at the University of Miami Miller School of Medicine.
Chronic infection is still very common in other parts of the world, however, especially Southeast Asia.
As many as 150 million people in China are chronically infected, with the main mode of transmission being birth related.
Schiff says most newly diagnosed cases of HBV in the U.S. occur in recent immigrants who have been infected all their lives but have most likely never been treated.
The CDC estimates that about 1.3 million people in the U.S. and 350 million people worldwide are chronically infected with HBV, and as many as 15% to 25% will develop liver damage, liver failure, cirrhosis, or liver cancer as a result.