Polymerase Inhibitor Shows Potent Antiviral Activity In Treatment Of Chronic Hepatitis C

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Chronic Hepatitis C

R1626, one of Roche's new investigational drugs for chronic hepatitis C virus (HCV) infection, has shown promising antiviral activity when given in combination with PEGASYS (peginterferon alfa-2a) and COPEGUS (ribavirin), according to results being presented at the American Association for the Study of the Liver Disease (AASLD) meeting, being held in Boston, Nov. 2-6. After four weeks of treatment with this triple combination, the virus could no longer be detected in up to 81 percent of patients, with a mean decrease in viral load of 5.2 log10 from baseline. This is indicative of a robust virological response, and R1626 is being progressed into Phase IIb study as a result of these findings.

R1626 belongs to a class of antivirals called polymerase inhibitors, which are being investigated in combination with the current standard of care, pegylated interferon and ribavirin. The hope is that this combination will increase the number of patients who are able to be successfully treated for hepatitis C.

"The results from this Phase IIa study show that R1626 has a profound antiviral effect when used in combination with PEGASYS plus COPEGUS," said Dr. Paul Pockros, Scripps Clinic, San Diego, California, the lead investigator of the study. "This effect of R1626 in combination therapy, along with the lack of resistance observed to date, means that R1626 could be an exciting drug for patients with hepatitis C, if a safe and acceptable dosing regimen can be determined in future studies."

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Antiviral Activity and Safety Results Being Presented at AASLD

The multicenter Phase IIa study enrolled patients with genotype 1 chronic HCV who have not previously received treatment. The objectives were to evaluate the four-week activity and safety of combining R1626 with PEGASYS alone or R1626 with PEGASYS plus COPEGUS in comparison to PEGASYS/COPEGUS, the standard of care. The study found:

-- Up to 81 percent of those patients treated with R1626 1500 mg (twice- daily) + PEGASYS + COPEGUS had an undetectable HCV viral load by week four (mean reduction of 5.2 log10 IU/mL)

-- ALT, a liver enzyme, normalized in approximately 50 percent of patients in R1626 treatment groups

-- Most reported adverse events were mild to moderate.

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