David Stump, HGSI's executive vice president of drug development, said the company's phase 3 trials could be launched by the end of the year.
In the phase 2 study, 30 percent of the patients in the lower-dose treatment groups did not have detectable levels of the hepatitis C virus at the end of treatment, or week 48. This percentage dropped to 18 percent at the 12-week follow-up. HGSI said they considered the data positive because nearly two-thirds of the study participants had failed on previous treatment regimens.
In a phase 2b trial in interferon alpha-naive patients, Albuferon showed a trend toward being comparable to Pegasys with less frequent dosing. Approximately 75 percent of patients receiving Albuferon every 2 weeks exhibited a level of hepatitis C viral load below the level of quantitation at 12 weeks, compared with 66 percent of patients receiving Pegasys at seven-day intervals.
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