Novel therapy combinations gain ground in treating...( nd have no other effective treatment op...),Health

nd have no other effective treatment options. Combination treatment using a new antiviral therapy is showing promise in suppressing the virus, according to a phase II US multi-center study. The therapy, valopicitabine, has shown anti-HCV activity alone and in combination with pegIFN (pegylated interferon) in early trials, without viral breakthrough for study periods up to six months.

The current study compared the outcomes of five different treatments in patients who have not experienced remission with standard therapies: valopicitabine alone (800 mg/d), one of three combination arms with the drug at 400 mg/d, 800 mg/d or dose-ramping 400 to 800 mg/d plus pegIFN, or pegIFN with ribavirin as a control group.

For the 162 patients who have completed the trial period at 24 weeks, results show that the two higher-dose combination arms had much better response rates than the control group, experiencing on average a 2.5 to 3.0 log decrease in hepatitis RNA reductions by week 24, a significantly better response than the comparator. No viral breakthrough has been seen to date. However, vomiting and dehydration requiring hospitalization occurred in three patients taking the highest dose (800 mg), forcing the research team to halt the use of that dose and continue using only the lower doses of 200 to 400 mg of the drug.

"For patients whose disease has not responded to current therapies, this new combination treatment may produce excellent results, at the maximally acceptable dosage," according to Paul Pockros, M.D., of Scripps Clinic in California, and lead study author. "Continued treatment will determine if these encouraging early responses will result in a sustained response, hopefully improving patient quality of life and long-term survival."

Comparison of Daily Consensus Interferon versus Peginterferon alfa 2a Extended Therapy of 72 Weeks for Peginterferon / Ribavirin Relapse Patients with Chronic Hepatitis C [Abstract S1060]'"/>

Contact: Aimee Frank
newsroom@gastro.org
213-743-6219
American Gastroenterological Association
21-May-2006

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