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news.Idenix Pharmaceuticals has obtained encouraging preliminary phase IIa trial data for valopicitabine plus pegylated interferon in hepatitis C, with patients achieving a mean viral load reduction of more than 99.99% at 24 weeks.
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In this phase IIa clinical trial, valopicitabine (NM283) in combination with pegylated interferon was evaluated in treatment-naive genotype 1 hepatitis C patients. In the trial, nine patients receiving the combination have reached 24 weeks of treatment, and achieved a mean reduction in serum HCV RNA of 4.5 log10, or more than 99.99%.
“This is the first time that we are seeing 24-week data for an antiviral drug directly targeting a specific enzyme of the hepatitis C virus,” said Dr Nezam Afdhal, a principal investigator in the phase IIa valopicitabine trials and chief of hepatology at Beth Israel Deaconess Medical Center in Boston and associate professor at Harvard Medical School.
“These preliminary data are promising and suggest that direct antiviral drugs, such as valopicitabine, could set a new treatment standard in hepatitis C, by offering hepatitis C patients, particularly patients infected with HCV genotype 1, potentially improved clinical benefit with fewer side effects,” Afdhal continued.
In addition to the phase IIa trial in treatment-naive patients, Idenix is conducting a phase IIb clinical trial comparing the combination of valopicitabine plus Roche’s Pegasys to the current standard of care in 171 HCV genotype 1 patients who have failed prior pegylated interferon plus ribavirin therapy. Current enrollment in this trial is approximately 50% complete and Idenix expects to complete enrollment by June.