Objectives: To define the biochemical and virological course and IgM response to HCV-core protein in long-term responders (LTRs) during a long surveillance (5 years).
Design: From 1989 to 1991, 98 patients (pts) with biopsy-proven chronic hepatitis C were enrolled into this study. These pts underwent human leukocyte interferon-alpha (LE-IFN alpha) therapy at the prolonged schedule (3 MU thrice weekly for 1 year).
Methods: Serum alanine-aminotransferases (ALTs) were assessed monthly during and until 1 year after treatment, then every 3 months during the observation period. Qualitative and quantitative HCV RNA and HCV IgM were measured in all pts on baseline samples and in LTRs also after treatment and every following year.
Results: Based on serum ALT course, the pts were defined as: LTRs (14 pts), if their serum ALT levels returned to the normal range during therapy and remained so for at least 1 year afterwards; responders with relapse (RRs, 20 pts), if their serum ALT levels returned to the normal range during therapy but increased after ending treatment; and non-responders (NRs, 64 pts), if their serum ALT levels remained abnormal throughout therapy. No significant differences were seen regarding IgM anti-HCV positivity and serum ALT levels among the three groups. LTRs (12 HCV-RNA negative and two HCV-RNA positive at the end of treatment) maintained their virological status and not one of them experienced an elevation of serum ALT levels throughout the surveillance.
Conclusion: Patients affected by chronic hepatitis C and treated with interferon, but who did not experience a biochemical or virological relapse within the first year of follow-up would not relapse later on; thus, we are able to conclude that these subjects made a complete recovery.