New approach to HCV treatment. Recognition of disease process as systemic viral infection rather than as liver disease.

Chronic viral hepatitis C is a problem of immense proportions. The only therapy that currently exists and is FDA approved is interferon (IFN). Much controversy exists regarding the dose and duration as well as the effectiveness of IFN therapy. This study was performed to determine whether a new endpoint of successful treatment, HCV-RNA negativity in plasma and liver, would produce a greater number of long-term responders than is achievable with the currently recommended six months of therapy. The 45 patients enrolled in this study were randomized 2 to 1 in a treatment paradigm consisting of 5 MU IFN three times a week for six months or the same dose of IFN daily until HCV-RNA was undetectable in plasma X 3 over 3 consecutive monthly determinations followed by demonstrated HCV-RNA negativity in liver biopsy tissue. No differences in age, initial WBC count, platelet count, or hepatic injury measures were evident between the two treatment groups. At the end of therapy, 43% of those in group 1 vs 100% in group 2 responded to the IFN therapy as defined by the serum ALT level. More importantly, all of those in group 1, but only half of those in group 2, relapsed and became HCV-RNA positive with discontinuation of the IFN therapy. These data suggest that: (1) IFN therapy is more effective when given for a longer rather than a shorter period; (2) virologic response definitions are now possible and are preferred; (3) using longer therapy and a virologic endpoint, the responses achieved are more durable.

RCT Entities:   Population Interventions Outcomes