Patients in the trial who were treated with interferon did experience a significant decrease in viral levels and liver inflammation, but the trial unequivocally demonstrated that treatment with long-term pegylated interferon – also called peginterferon – does not prevent the worsening of liver disease in patients who’ve failed prior treatments.

“The results are this study are very clear – long-term therapy with peginterferon for those with chronic hepatitis C is not effective in preventing progression of liver disease for patients who did not respond to an initial course of treatment,” said Adrian Di Bisceglie, M.D., professor of internal medicine at Saint Louis University School of Medicine and chairman of the trial’s steering committee.

“Furthermore, the relatively high rate of liver disease progression – about 30 percent over nearly four years – indicates the potential severity of chronic hepatitis C and emphasizes the importance of the ongoing search for new and more effective treatments,” Di Bisceglie added.

Results of the study were reported by Di Bisceglie at the annual meeting of the American Association for the Study of Liver Disease in Boston this week.

Hepatitis C infects more than 100 million people worldwide and as many as 4 million people in the U.S. It ranks with alcohol abuse as the most common cause of chronic liver disease and leads to some 1,000 liver transplants in the U.S. each year.

The randomized, multi-site study involved 1,050 patients with chronic hepatitis C who’d failed prior treatments to eradicate the infection. All had advanced liver fibrosis – a gradual scarring of the liver that puts patients at risk for progressive liver disease.

The trial assessed whether long-treatment with peginterferon prevented the patients from developing cirrhosis, liver failure or liver cancer. Roughly half of the patients in the study received 90 micrograms of peginterferon in weekly injections for 3.5 years. The other half, the control group, underwent the same follow-up and care as the treated patients, including liver biopsies, quarterly clinic visits and blood tests.

At the end of the study, while patients treated with interferon did have significantly lower blood levels of the hepatitis C virus and less liver inflammation, 34.1 percent of them had experienced one or more of the following outcomes: excess fluid in the abdomen; brain and nervous system damage; cirrhosis (for those who did not have it initially); liver cancer; or death. Of patients in the control group, 33.8 percent experienced one or more of the outcomes.

Among treated patients, adverse side effects had caused 17 percent to stop peginterferon after 18 months and 30 percent to stop treatment by the end of the trial.

Source: Saint Louis University