ROCHE PRESENTS DATA ON ORAL POLYMERASE INHIBITOR IN HEPATITIS C

New clinical data on the hepatitis C virus (HCV) polymerase inhibitor R1626 -- currently being developed by Roche -- show viral reductions greater than those described for other polymerase inhibitors, according to data presented at the 57th Annual Meeting of the American Association for the Study of Liver Diseases. These results were achieved in chronic hepatitis C patients infected with the difficult-to-treat genotype 1 virus.

In a Phase I study, 47 patients with genotype 1 hepatitis C were randomized to receive either oral treatment with R1626 twice daily or placebo for 14 days. The final results presented at the meeting included patients who received the higher doses of R1626 at 3,000 or 4,500 mg twice a day.

Clinically significant mean reductions in serum HCV RNA (a measure of how much virus is in the blood) were seen with R1626 at the doses of 3,000 and 4,500 mg. R1626 showed good tolerability following dosing for 14 days up to 3,000 mg twice daily. No patient was prematurely withdrawn from the study. Increasing numbers of adverse events were noted at higher dose levels, and reversible mild to moderate hematological changes were observed with increasing doses.

In light of these results, Roche has already begun a Phase II trial to evaluate how well R1626 works in combination with Pegasus (peginterferon alfa-2a) and Copegus (ribavirin USP).