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Valopicitabine Combined with Standard of Care Cleared Hepatitis C,Virus in 72% of Patients Who Completed 12 Weeks of Treatment in a,Phase II Trial

f ribavirin, and pegylated interferon alpha 2a; and patients in arm C (n=39) received placebo, weight- based dosing of ribavirin and pegylated interferon alpha 2a. For all patients in this study there was a seven day lead-in period, where patients received either valopicitabine or placebo alone; the additional components of each arm's therapeutic regimen were administered beginning on day eight.

The primary endpoint of the study was to assess pharmacokinetic and pharmacodynamic drug-drug interaction between valopicitabine and ribavirin after 36 days of treatment. Drug levels for both NM107 (the active form of valopicitabine) and ribavirin when administered alone or together were within the range of 80 to 125 percent, indicating the lack of an interaction. At day 36, 23 percent of patients treated with triple combination therapy (arm B) were HCV PCR-negative per protocol, compared to 11 percent of patients treated with the standard of care (arm C) and 14 percent of patients treated with valopicitabine and pegylated interferon (arm A). These findings demonstrated no pharmacokinetic or pharmacodynamic drug-drug interaction between valopicitabine and ribavirin.

The key secondary endpoints for the study were antiviral activity, safety and tolerability at 12 weeks. Of patients that completed 12 weeks of therapy, 72.2 percent of patients treated with triple combination therapy (arm B) achieved HCV PCR-negativity, compared to 61.5 percent of patients treated with the standard of care (arm C). There were three discontinuations from the study, all due to adverse events (AEs), one of which was attributed by the clinical investigator to valopicitabine-related gastrointestinal toxicity. The two other AEs, including a serious adverse event (SAE), were attributed by the clinical investigators to pegylated interferon or pegylated interferon/ribavirin. All of the discontinuations occurred in the triple combination arm (arm B).

At the end of 12 weeks, patients we
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