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BOSTON, MA -- November 5, 2002 -- Combination therapy with pegylated interferon alpha-2b and ribavirin appears safe and effective for treatment of chronic hepatitis C virus (Hepatitis C Virus) infection in patients who have normal liver enzymes, results of a small clinical evaluation indicate, according to research reported here November 3 at the American Association for the Study of Liver Disease (AASLD).

The combination achieved an overall virologic response rate of 68 percent at 12 weeks, including a 90 percent response rate in patients who had genotype non-1, said Dr. Steven Flamm, a hepatologist at Northwestern University, in Chicago, Illinois, United States.

Reduced-dose interferon plus ribavirin demonstrated activity similar to that of standard-dose pegylated interferon alpha-2b plus ribavirin, he added.

"Hepatitis C patients who have normal liver enzymes essentially have been ignored in the past," said Dr. Flamm. "The theory has been that these patients don’t have bad disease, so there is not need to treat them." A few investigators have been more aggressive with these patients and have biopsied and treated them.

"Up to now there has been no data on the combination of pegylated interferon and ribavirin in this population. These preliminary findings indicate that the combination is equally effective in patients with normal or abnormal liver enzymes, which is what I would have suspected."

Dr. Flamm reported findings on 34 patients from a larger ongoing clinical trial designed to evaluate the safety and efficacy of pegylated interferon alpha-2b plus ribavirin in patients with chronic Hepatitis C Virus infection. The protocol stipulates 48 weeks of treatment for genotype-1 patients and 24 weeks for patients who are genotype 2/3.

The patients were randomised to 1.0 or 1.5 µg/kg/week of pegylated interferon alpha-2b plus ribavirin 800 to 1400 mg/day. The subset of patients with normal liver enzymes includes 41 patients overall, 34 of which were evaluable for 12-week response, defined as undetectable levels of Hepatitis C Virus RNA.

Overall, 23 of 34 patients (68 percent) achieved responses, including 16 of 21 (76 percent) who received the reduced dose of pegylated interferon alpha-2b and seven of 13 (54 percent) in the standard-dose group.

Among genotype-1 patients, responses occurred in 10 of 14 (71) in the reduced-dose group and four of 10 (40 percent) with the standard dose of pegylated interferon alpha-2b. Responses occurred in six of seven genotype non-1 patients in the reduced-dose group and all three such patients in the standard-dose group.

Dr. Flamm noted that the combination of pegylated interferon alpha-2b plus ribavirin has been reported to achieve a 54 percent response rate in Hepatitis C Virus patients with abnormal liver enzymes.