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Participants in treatment studies of hepatitis C virus (HCV) infection are generally categorized as treatment naive or treatment experienced, based on previous receipt of an interferon-based regimen such as pegylated interferon-α plus ribavirin (P/R). Treatment-experienced individuals with P/R treatment failure can be further subdivided into relapsers, partial responders, and null responders, based on plasma HCV RNA concentrations during and after therapy.
To date, no data have emerged to indicate resistance to interferon-α–based therapy, suggesting that the response rate to P/R should not be lower with retreatment than with initial therapy. To examine this issue, investigators at the FDA examined data for participants in eight earlier trial…