Hepatitis C Treatment Reduces the Virus but
Serious Liver Problems May Progress
Patients with chronic hepatitis C and advanced liver disease who
did not respond to previous standard therapy experienced significant
decreases in their liver enzymes, viral levels, and liver inflammation
following treatment with long-term pegylated interferon. However,
the treatment did not slow or prevent the progression of serious
liver disease. These findings come from the clinical trial, Hepatitis
C Antiviral Long-Term Treatment Against Cirrhosis (HALT-C) and
were reported at the annual meeting of the American Association
for the Study of Liver Disease in Boston on November 5, 2007. HALT-C
is funded by the National Institutes of Health (NIH) with additional
support from Hoffmann-La Roche Inc.
"The HALT-C trial unequivocally demonstrated 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 and a program
director for 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 results
add to the incentive to develop more effective drugs that will
benefit patients with severe liver disease due to hepatitis C."
HALT-C, a randomized multicenter trial of 1,050 patients with
chronic hepatitis C who had failed prior treatment to eradicate
the infection, assessed whether long-term treatment with peginterferon
alfa-2a reduced the development of cirrhosis, liver failure, or
liver cancer. 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.
The outcomes assessed in HALT-C were death, liver cancer, ascites
(excess fluid in the abdomen), or encephalopathy (brain and nervous
system damage), and for those who did not have cirrhosis initially,
the development of cirrhosis. At the end of the study, 34.1 percent
of the patients in the treated group and 33.8 percent of the patients
in 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 less liver inflammation. However, there was
no major difference in rates of any of the primary outcomes between
groups.
Among treated patients, 17 percent stopped peginterferon by one
year and six months and 30 percent stopped the drug two years later.
Adverse events such as infections, musculoskeletal or digestive
problems were the most common reasons patients stopped taking the
drug.
Viral hepatitis C infects more than 100 million persons worldwide
and as many as 4 million persons 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 consists
of pegylated interferon given by injection in combination with
oral ribavirin prescribed for about 6 months to a year. This therapy
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
Dr. Adrian M. Di Bisceglie (Study Chair), Saint Louis University
School of Medicine, Saint Louis
Dr. Anna S. Lok, University of Michigan Medical Center, Ann Arbor,
Mich.
Dr. Gyongyi Szabo, University of Massachusetts, Worcester, Mass.
Dr. Timothy R. Morgan, University of California- Irvine, Irvine,
California and VA Long Beach Healthcare System, Long Beach, Calif.
Dr. Gregory T. Everson, University of Colorado Health Sciences
Center, Denver
Dr. Herbert L. Bonkovsky, University of Connecticut Health Center,
Farmington, Conn.
Dr. Karen L. Lindsay, Keck School of Medicine, University of Southern
California, Los Angeles, Calif.
Dr. William M. Lee, University of Texas Southwestern Medical Center,
Dallas
Dr. Mitchell L. Shiffman, Virginia Commonwealth University Medical
Center, Richmond, Va.
Dr. Chihiro Morishima and Dr. David Gretch, University of Washington,
Seattle
Dr. Kristin K. Snow, New England Research Institutes, Watertown,
Mass.
Dr. Marc G. Ghany, Liver Diseases Branch, NIDDK, NIH, Bethesda,
Md.
For information about liver disease research, see: www2.niddk.nih.gov/AboutNIDDK/ResearchAndPlanning/Liver_Disease/Action_Plan_For_Liver_Disease_Intro.htm
For consumer-based information about the liver, visit NIDDK’s
National Digestive Diseases Information Clearinghouse (NDDIC) online
at: digestive.niddk.nih.gov
NIDDK, a component of the NIH, conducts and supports research
in diabetes and other endocrine and metabolic diseases; digestive
diseases, nutrition, and obesity; and kidney, urologic, and hematologic
diseases. Spanning the full spectrum of medicine and afflicting
people of all ages and ethnic groups, these diseases encompass
some of the most common, severe, and disabling conditions affecting
Americans. For more information about NIDDK and its programs, see
www.niddk.nih.gov.
The National Institutes of Health (NIH) — The Nation's
Medical Research Agency — includes 27 Institutes and
Centers and is a component of the U.S. Department of Health and
Human Services. It is the primary federal agency for conducting
and supporting basic, clinical and translational medical research,
and it investigates the causes, treatments, and cures for both
common and rare diseases. For more information about NIH and
its programs, visit www.nih.gov.
|