Background: Few studies have evaluated interferon and ribavirin therapy in hepatitis C virus-infected patients with persistently normal alanine aminotransferase (ALT) levels.
Aim: To determine the efficacy and safety of combination therapy in this population, and to evaluate the impact of treatment on health-related quality of life.
Methods: Forty-six hepatitis C virus-infected patients with persistently normal ALT levels and 92 matched subjects with elevated ALT levels were treated with interferon-alpha2b plus ribavirin for up to 48 weeks. Health-related quality of life was measured prior to therapy and 24 weeks after completion of treatment using the Hepatitis Quality of Life Questionnaire.
Results: Overall, 32.6% of patients with normal ALT levels and 28.3% of those with elevated ALT levels had undetectable hepatitis C virus RNA at 24 weeks after completion of treatment (P = 0.60). Three patients in the normal ALT group had mild transient ALT elevations during therapy. Compared with baseline, treatment was associated with significant improvements in nearly all domains of health-related quality of life in both groups of patients.
Conclusions: In hepatitis C virus-infected patients with persistently normal ALT levels, interferon-alpha and ribavirin therapy is efficacious, safe, and associated with significant improvements in health-related quality of life.