Interferon Inappropriate for Long-Term Hepatitis C Treatment

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Hepatitis Central

December 08, 2008

Interferon Inappropriate for Long-Term Hepatitis C Treatment

The results are in from a 3-1/2 year study of long-term interferon treatment

against the Hepatitis C virus. By examining clinical outcomes, researchers

evaluated whether or not long-term use of interferon would be helpful or even

appropriate for HCV patients.

Interferon As Long-term Treatment For Hepatitis C Not Effective

ScienceDaily (Dec. 8, 2008) - Use of the drug interferon as a long-term

maintenance strategy to slow the progression of liver disease associated with

the hepatitis C virus is ineffective, UT Southwestern Medical Center researchers

and their colleagues from nine other institutions have found in a multicenter

study.

Results of the 3½-year study, called the HALT-C (Hepatitis C Antiviral Long-Term

Treatment Against Cirrhosis) Trial, appear in today's issue of The New England

Journal of Medicine. The researchers found no difference in the rate of

progression of liver disease among patients who received interferon and those

who did not.

" It wasn't that there was an insignificant difference; there was absolutely no

difference whatsoever in the progression to cirrhosis and other disease

complications, " said Dr. M. Lee, professor of internal medicine at UT

Southwestern and a principal investigator for the study. " It is a negative study

but an important one. "

Dr. Lee said physicians should not expect any benefit from the long-term use of

interferon by itself in slowing disease progression. By contrast, use of

interferon with other drugs such as ribavirin can lead to viral eradication, or

complete clearance of hepatitis C virus, a result that will " stop the disease in

its tracks, " Dr. Lee said.

Hepatitis C is a viral infection that causes liver inflammation and can progress

over many years to cirrhosis, liver cancer, liver failure and death. The disease

affects more than 3 million people in the United States and 170 million people

worldwide. It is the most common reason for liver transplantation in the U.S.

There is no vaccine to prevent hepatitis C virus infection. The combination of

interferon and ribavirin works for about 40 percent to 50 percent of people with

the virus, while the other 50 percent to 60 percent of patients will continue to

progress to later states of liver disease, Dr. Lee said.

In addition to interferon and ribavirin, new drug agents such as protease and

polymerase inhibitors are being used in clinical studies at UT Southwestern to

improve rates of virus eradication. Food and Drug Administration approval of

these agents is likely to be three years away, Dr. Lee said.

In the HALT-C Trial, conducted between August 2000 and June 2007, 1,050 people

with hepatitis C who did not respond to initial antiviral treatment were

assigned randomly to either a group that received treatment with a type of

interferon called peginterferon or to a group that did not. About 120 patients

were enrolled at UT Southwestern.

Participants were monitored every three months and underwent liver scans and

biopsies at specified intervals through the study period. Researchers found that

although the level of hepatitis C virus in blood and certain enzymes in the

liver decreased significantly with treatment, there was not a significant

difference in ultimate clinical outcome.

" Currently, we use interferon only to clear the virus, " said Dr. Lee. " If you

cannot clear the virus with treatment, the idea that struggling long term

through the side effects of interferon is somehow going to help you rid yourself

of cirrhosis is just not plausible any longer. "

Some patients cannot tolerate the side effects of the different types of

interferon medication, which can cause extreme flu-like symptoms, such as fever,

chills, fatigue, depression, muscle aches, chest pain, difficulty breathing,

nausea, vomiting, and weight and hair loss.

Other researchers from UT Southwestern involved in the study were Dr.

, professor of pathology, and Dr. Malet, professor of internal

medicine.

Also involved in the study were researchers from Saint Louis University School

of Medicine; Virginia Commonwealth University Medical Center; University of

Colorado School of Medicine; University of Southern California; National

Institute of Diabetes and Digestive and Kidney Diseases; University of Michigan

Medical Center; University of Connecticut Health Center; University of

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

Washington.

The study was funded by the National Institutes of Health. Pharmaceutical

manufacturer Hoffman-LaRoche, through an agreement with the NIH, also provided

funding.

Dr. Lee has received consulting fees from Eli Lilly, Fibrogen and Astra Zeneca,

and grant support from Hoffmann-LaRoche, Schering-Plough, Vertex

Pharmaceuticals, GlaxoKline, Siemens, Globelmmune and Bristol-Myers Squibb.

Adapted from materials provided by UT Southwestern Medical Center.

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URL for Article Source:

http://www.sciencedaily.com/releases/2008/12/081204133645.htm