HEPATITIS C TREATMENT REDUCES THE VIRUS BUT LIVER DAMAGE CONTINUES

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> U.S. Department of Health and Human Services > NATIONAL INSTITUTES OF HEALTH

NIH News > National Institute of Diabetes and Digestive and Kidney Diseases

(NIDDK) <http://www.niddk.nih.gov/>> For Immediate Release: Thursday, December

4, 2008 > > CONTACT: Curtis, 301-496-3583, <e-mail:

niddkmedia@...>> > HEPATITIS C TREATMENT REDUCES THE VIRUS BUT LIVER

DAMAGE CONTINUES> > 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 Inc. > > " 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 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 groups. > > 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 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. > > 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. M. Di

Bisceglie (Study Chair), Saint Louis University School of Medicine, Saint Louis,

Mo.> -- Dr. S. Lok, University of Michigan Medical Center, Ann Arbor > --

Dr. Gyongyi Szabo, University of Massachusetts, Worcester.> -- Dr. R.

, University of California, Irvine and VA Long Beach Healthcare System,

Long Beach, Calif.> -- T. Everson, University of Colorado Health

Sciences Center, Denver> -- Dr. Herbert L. Bonkovsky, University of Connecticut

Health Center, Farmington.> -- Dr. L. , Keck School of Medicine,

University of Southern California, Los Angeles> -- Dr. M. Lee,

University of Texas Southwestern Medical Center, Dallas> -- Dr. L.

Shiffman, Virginia Commonwealth University Medical Center, Richmond > --

Dr. Chihiro Morishima and Dr. Gretch, University of Washington, Seattle>

-- Dr. 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

<http://www2.niddk.nih.gov/AboutNIDDK/ResearchAndPlanning/Liver_Disease/Action_P\

lan_For_Liver_Disease_Intro.htm>> > For consumer-based information about the

liver, visit NIDDK's National Digestive Diseases Information Clearinghouse

(NDDIC) online at <www.digestive.niddk.nih.gov> > > More information about the

HALT-C trial (NCT00252642) can be found at <www.clinicaltrials.gov>> > NIDDK,

part of the NIH, conducts and supports basic and clinical research and research

training on some of the most common, severe and disabling conditions affecting

Americans. The Institute's research interests include diabetes and other

endocrine and metabolic diseases; digestive diseases, nutrition, and obesity;

and kidney, urologic and hematologic diseases. For more information, visit

<www.niddk.nih.gov>.> > The National Institutes of Health (NIH) - The Nation's

Medical Research Agency - is comprised of 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 investigates the causes, treatments, and

cures for both common and rare diseases. For more information about NIH and its

programs, visit <www.nih.gov>.> > ##> > This NIH News Release is available

online at:> <http://www.nih.gov/news/health/dec2008/niddk-04.htm>.> > To

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