Drug & Device Development

New hepatitis C drug shows good response in early trial

Last Updated: 2010-02-24 19:48:03 -0400 (Reuters Health)

By Bill Berkrot

NEW YORK, Feb 24 (Reuters) - An experimental hepatitis C treatment produced impressive early response rates with no serious safety issues, according to preliminary data from a small phase II trial.

At 12 weeks of dosing, 73% of the 26 treatment-naïve patients who received 200 mg of the non-nucleoside inhibitor ANA598 (Anadys Pharmaceuticals Inc) twice daily in combination with standard treatment had a complete virological response.

However, among the 14 patients in the control group, who received pegylated interferon and ribavirin plus placebo, the complete virological response rate was a much higher-than-expected 71%.

There was a much larger separation of response rates between the two treatment arms at weeks 4, 6, 8 and 10, when the ANA598 viral response was already at 73%, while the control group response was 54%.

The virtually identical 12-week response rate between the two arms may be due to the small number of patients and were likely skewed by the fact that 12-week data were missing from one patient from each group.

No one treated with ANA598 experienced viral rebound.

No serious adverse events were reported with ANA598, and the side effects that were observed, such as a rash, were comparable between the treatment and control groups.

Patients will continue to be treated through 24 or 48 weeks, with sustained virologic response rates becoming available toward the end of the year.

The early response rate for ANA598 is comparable to what has been seen for other promising hepatitis C treatments in clinical trials, while the control group response was far higher than what has been seen in those other studies.