Objective: to identify pretreatment predictive factors of long-term biochemical and virological response to interferon-alpha in chronic hepatitis C and to determine the effects of a second course of interferon-alpha in patients who responded but relapsed after interferon withdrawal.
Design: retrospective analysis.
Setting: outpatient liver clinic of a tertiary hospital in Spain.
Patients: 112 patients with chronic hepatitis C were treated with recombinant interferon-alpha (3 MU three times a week for 6 months). Twenty-four patients who responded but relapsed after interferon withdrawal were treated with a second course of interferon (3 MU three times a week for 12 months).
Results: seventy-two patients were non-responders (64%), 11 patients had a sustained response (10%) and 29 patients responded but relapsed after interferon withdrawal (26%). Five (25%) of the 24 patients who relapsed and were treated with a second course of interferon experienced a sustained response (mean follow-up: 10 months). By multivariate analysis, four pretreatment variables were found to be predictive of a complete response: age < 40 years (p = 0.0004), history of IVDA (p = 0.001), low serum levels (p = 0.013), and genotype 3 (p = 0.01). Two variables were found to be predictive of a sustained response: short duration of HCV infection (p = 0.09) and genotype 3 (p = 0.01). Sustained responders appeared to have lower HCV-RNA levels than those with complete response who relapsed and non-responders. HCV viremia levels were not associated with the severity of liver histology, duration of disease or the source of hepatitis.
Conclusions: in the present study a low sustained response rate was observed using a standard interferon-alpha regimen (3 MU three times a week for 6 months). The sustained response rate increased slightly with a second course of interferon-alpha (3 MU three times a week for 12 months) in patients with a complete response who relapsed after interferon withdrawal. Sustained response is related to viral genotype and duration of HCV infection.