Digestive Diseases News
Winter 2008

Research News

Hepatitis C Treatment Reduces Virus, Fails to Slow Progression of Disease

Long-term peginterferon therapy did not slow or prevent the progression of advanced liver disease in people with chronic hepatitis C who failed to respond to previous standard treatment, according to results of a National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) clinical trial. However, trial participants did experience significant decreases in liver enzymes, viral levels, and liver inflammation.

“The HALT-C [Hepatitis C Antiviral Long-term Treatment against Cirrhosis] 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., a project scientist for HALT-C and a program director in the NIDDK’s Division of Digestive Diseases and Nutrition. “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 participants with chronic hepatitis C who failed prior treatment, assessed whether long-term treatment with peginterferon alfa-2a reduced the development of cirrhosis, liver failure, or liver cancer. The 517 participants randomized to the treatment arm of the study received 90 micrograms of the drug through weekly injections for 3.5 years.

The 533 participants 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 participants had advanced liver fibrosis, a gradual scarring of the liver that puts patients at risk for progressive liver disease.

Outcomes

Outcomes assessed in the trial were death, liver cancer, ascites—excess fluid in the abdomen—or encephalopathy, and for those who did not have cirrhosis initially, the development of cirrhosis.

At the end of the study, 34.1 percent of participants in the treated group and 33.8 percent in the control group had experienced at least one outcome. Participants 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 the rates of any primary outcomes between groups.

Among treated patients, 17 percent stopped taking peginterferon within a year and a half, and 30 percent stopped taking the drug 2 years later. Adverse events, such as infections and musculoskeletal or digestive problems, were the most common reasons people stopped taking the drug.

Viral hepatitis C infects more than 100 million people worldwide and as many as 4 million people within the United States. The virus is the most common cause of liver failure and liver cancer in the United States. The best current antiviral therapy consists of injections of pegylated interferon combined with oral ribavirin prescribed for up to 1 year. This therapy eliminates the virus in about half of infected patients.

For more information about liver disease, visit the National Digestive Diseases Information Clearinghouse at www.digestive.niddk.nih.gov.

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NIH Publication No. 08–4552
March 2008