Early treatment with interferon alpha-2b can prevent chronic liver disease in those with hepatitis C

Treatment with interferon alpha-2b during the early stages of hepatitis C infection can prevent chronic liver disease, according to a German study released yesterday by the New England Journal of Medicine. The study, which will be published in the Nov. 15 issue of NEJM, was released early by the editors because of the “potential clinical implications” of its findings.

Researchers affiliated with the German Acute Hepatitis C Therapy Group identified 44 patients with acute hepatitis C infection between 1998 and 2001. The patients were injected with five million U of interferon alpha-2b daily for four weeks, followed by injections three times a week for 20 weeks. Researchers measured patients’ serum HCV RNA levels before and during therapy and 24 weeks after the last injection. Only one patient could not tolerate the therapy and dropped out of the study after 12 weeks. Ninety-eight percent of the patients (42/43) who completed follow-up had undetectable levels of HCV RNA and normal serum alanine aminotransferase levels.

Hitting hard, hitting early

Although the findings suggest that getting patients into therapy early could save thousands from developing chronic liver disease, doctors said it will be difficult to put the clinical findings into practice because most people are unaware that they have the disease until chronic signs begin to develop, as early signs such as muscle ache and poor appetite are sometimes mistaken for the flu. According to Dr. Michael Manns, one of the study’s authors, “Now that we know that we can cure the disease when we treat it in its acute phase, we have to work for an alertness of physicians and patients.” Early treatment is most feasible with health care workers who may have been exposed through contaminated blood from needle sticks. Intravenous drug users and those who get the virus through unprotected sex, who may not realize they have hepatitis C, will be more difficult to treat. The six-month therapy costs about $6, 000, Manns said. In addition, the drug can cause side effects such as muscle and joint pain, headache, fever, a reduction in white blood cells or platelets and depression.

Other treatments

Nearly four million Americans and 170 million people worldwide are infected with hepatitis C, with 70% developing “long-lasting” infections, which account for about half of all cases of chronic liver disease in the United States. About 50% of those with chronic hepatitis C can be suppressed with a two-drug combination therapy consisting of peginterferon and ribavirin, according to Jay Hoofnagle of the National Institute of Diabetes, Digestive and Kidney Diseases. Researchers at the University of Massachusetts are currently conducting clinical trials, underwritten by the NIH, to test the effects of long-term treatment using interferon alfa-2b in combination with ribavirin on hepatitis C patients. Dr. Herbert Bonkovsky, the principal investigator of the Hepatitis C Anti-Viral Long-Term Therapy to Prevent Cirrhosis study, said that the group is recording a success rate near 50%.

Patients must have previously been treated with interferon alpha-2b, either alone or in combination with ribavirin, for 12 weeks and must have “at least moderately advanced” scar tissue on their livers to be eligible for the year-long study. Sixty people are currently enrolled in the study, but researchers hope to eventually enrol 180 volunteers. “This [treatment] is designed for the 50% we can’t cure even with the best modern therapy. If we give them long-term treatment for three-and-a-half years, it prevents cirrhosis, ” Bonkovsky said. A small percentage of people can clear the infection on their own, Dr. Karen Lindsay, an associate professor of clinical medicine at the University of Southern California’s Keck School of Medicine, said, adding that one fault of the new study is that it did not contain a control group, leaving “no way to compare the study’s findings with what would have happened had nature been left to take its course.” However, she did concede that a 98% suppression rate would be unlikely in nature.