Patients with chronic hepatitis C who have not responded to an initial round of antiviral treatment are unlikely to respond to long-term “maintenance therapy” as well, an NIH funded multi-center clinical trial has found. Patients who do not respond well to initial medication are usually placed on maintenance therapy in the attempt to keep the disease in control. The study also showed a health decline in patients with liver disease over the course of four years.

“This course of treatment had been adopted by a number of doctors in the U.S. and in other countries, though it had yet to be proven to work. That practice should be stopped based on the results of this trial. There is no rationale for using maintenance therapy,” said lead author, Adrian Di Bisceglie, M.D., professor of internal medicine, chief of hepatology and co-director of the Liver Center at Saint Louis University. “The treatment is clearly ineffective.”

The study, which will be published in the Dec.4 issue of the New England Journal of Medicine, analyzed the effects of low-dose peginterferon maintenance therapy when used as a treatment for patients with advanced chronic hepatitis. The study involved a total of 1050 non-respondent patients with advanced liver disease. They were divided into two groups: the first group received low doses of peginterferon for 3.5 years to try to suppress the hepatitis C virus and slow the progression of liver disease while the rest of the patients were assigned to a control group. After four years, there was no difference in treatment outcomes for the two groups. 30 % of the patients in both the groups had developed liver failure, liver cancer, 10 to 12 percent developed severe liver disease (if they had milder cirrhosis at the start of the study).

As a conclusion, the study showed long-term therapy with peginterferon did not reduce the rate of disease progression in patients with chronic hepatitis C and advanced fibrosis, with or without cirrhosis, who had not had a response to initial treatment with peginterferon and ribavirin.

“The lesson we learned is that once chronic hepatitis C gets to the stage of advanced fibrosis, patients can decline rapidly,” the authors concluded.

The study was conducted at multiple medical centers and supported by the National Institute of Diabetes and Digestive and Kidney Disease, a component of the National Institutes of Health (NIH).

Hepatitis C is a chronic, potentially fatal virus that can cause liver ailments, including cancer and liver failure. Many patients who contract the blood-borne hepatitis C are asymptomatic for many years. Early symptoms include jaundice, nausea, and fatigue. The disease is most often transmitted by sharing unclean needles and syringes. Chronic infection can cause inflammation of the liver (chronic hepatitis). An estimated 150-200 million people worldwide are infected with hepatitis C. No vaccine against hepatitis C is available.