-- 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. Dose dependent,
reversible grade four neutropenia was observed in the R1626 arms (36
percent in patients receiving R1626 1500 mg + PEGASYS + COPEGUS), and
was the main reason for dose reduction and discontinuation
Lack of Resistance
According to a second presentation at the conference, resistance to R1626 was not identified following intensive testing for either two weeks of treatment with R1626 as monotherapy, or in patients treated with R1626 for four weeks in combination with the standard of care. These findings suggest that there is a high barrier to the development of resistance to R1626 in vivo.
Start of Phase IIb Trial
R1626 is being progressed into Phase IIb study, called POLI 1, to further investigate the new treatment regimens of R1626, in combination with standard or lower dose of PEGASYS and standard dose of COPEGUS. This Phase IIb trial is now open and enrolling patients in eight countries, including the United States. More information about R1626 and the clinical studies can be found on http://www.roche-trials.com.
"As a clinician, I am excited by the high rates of viral negativity
that were observed after four weeks of treatment with R1626 in combination
with the standard of care. The design of the Phase IIb study should enable
us to find the doses of R1626, PEGASYS and COPEGUS that achieve the
appropriate balance between safety and efficacy," said Dr. David Nelson,
Director of Hepatology and Liver Transplantation at the
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