Although Hepatitis C Treatment Reduces The Virus, Liver Damage Continues
10 Dec 2008
Treating patients who have chronic hepatitis C and advanced liver disease
with long-term pegylated interferon significantly decreased their liver
enzymes, viral levels and liver inflammation, but the treatment did not slow
or prevent the progression of serious liver disease, a study finds.
These findings come from the clinical trial, Hepatitis C Antiviral Long-Term
Treatment Against Cirrhosis (HALT-C) and are reported in the Dec. 4 issue of
the New England Journal of Medicine. HALT-C was funded by the National
Institutes of Health (NIH) with additional support from Hoffmann-La Roche
"The results from HALT- C show without question that maintenance therapy
with peginterferon does not prevent progression of liver disease among
patients who have failed prior treatments," said James Everhart, M.D.,
project scientist for HALT-C in the Division of Digestive Diseases and
Nutrition, National Institute of Diabetes and Digestive and Kidney Diseases
(NIDDK), the principal sponsor of HALT-C at NIH. "These findings heighten
the incentive to develop more effective drugs for patients with severe liver
disease due to hepatitis C."
Peginterferon therapy for up to 48 weeks is standard for chronic hepatitis
C. But patients who do not have a sustained response to initial therapy have
been given the drug over a longer time based on studies showing that this
approach suppresses viral and enzyme levels, even if the virus is not
completely eliminated. However, it was not known if long-term therapy would
improve important clinical outcomes such as liver damage and death.
HALT-C, a randomized multicenter trial of 1,050 patients with chronic
hepatitis C who had failed prior treatment to eradicate the infection,
tested whether long-term treatment with peginterferon alfa-2a would reduce
the development of cirrhosis, liver cancer, or liver failure. The 517
patients randomized to the treatment arm received 90 micrograms of
peginterferon in weekly injections for 3.5 years. The 533 patients in the
control arm underwent the same follow-up and care as the treated patients
including liver biopsies, quarterly clinic visits and blood tests. All
patients had advanced liver fibrosis, a gradual scarring of the liver that
puts patients at risk for progressive liver disease and liver failure.
The outcomes studied in HALT-C were death, liver cancer, or liver failure,
and for those who did not have cirrhosis initially, the development of
cirrhosis. At the end of the study, 34.1 percent of the treated group and
33.8 percent of the control group had experienced at least one outcome.
Patients in the treated group had significantly lower blood levels of the
hepatitis C virus and improvement in liver inflammation. However, there was
no major difference in rates of any of the primary outcomes between the
Among treated patients, 17 percent stopped peginterferon after 18 months and
30 percent stopped the drug after two years. Infections, musculoskeletal or
digestive problems were the most common reasons for stopping the drug.
According to HALT-C study chair and principal investigator Adrian M. Di
Bisceglie, M.D., professor of internal medicine at Saint Louis University
School of Medicine in Missouri, looking into how maintenance therapy works
in non-responders is an important step. "Patients should not receive
interferon as maintenance therapy for chronic hepatitis C. However, we can
build on what was learned in HALT-C to identify better treatments that may
delay or prevent liver damage in patients with advanced disease," he said.
Article adapted by Medical News Today from original press release.
The hepatitis C virus infects more than 100 million persons worldwide and as
many as 4 million in the United States. Hepatitis C ranks with alcohol abuse
as the most common cause of chronic liver disease and leads to about 1,000
liver transplants in the United States each year. The best current antiviral
therapy of pegylated interferon given by injection in combination with oral
ribavirin for about 6 months to a year eliminates the virus in about 50
percent of infected patients.
The following researchers and clinical centers conducted the HALT-C study:
Dr. Jules L. Dienstag, Massachusetts General Hospital and Harvard Medical
School, Boston, Mass.
Dr. Adrian M. Di Bisceglie (Study Chair), Saint Louis University School of
Medicine, Saint Louis, Mo.
Dr. Anna S. Lok, University of Michigan Medical Center, Ann Arbor
Dr. Gyongyi Szabo, University of Massachusetts, Worcester
Dr. Timothy R. Morgan, University of California, Irvine and VA Long Beach
Healthcare System, Long Beach, Calif.
Gregory T. Everson, University of Colorado Health Sciences Center, Denver
Dr. Herbert L. Bonkovsky, University of Connecticut Health Center,
Dr. Karen L. Lindsay, Keck School of Medicine, University of Southern
California, Los Angeles
Dr. William M. Lee, University of Texas Southwestern Medical Center, Dallas
Dr. Mitchell L. Shiffman, Virginia Commonwealth University Medical Center,
Dr. Chihiro Morishima and Dr. David Gretch, University of Washington,
Dr. Kristin K. Snow, New England Research Institutes, Watertown, Mass.