An important subset of patients with chronic hepatitis C have normal ALT levels despite having detectable HCV RNA in serum. These patients are typically identified after donating blood and being found positive for antibody to HCV (anti-HCV). A strict definition of this patient population is needed, which should include the presence of anti-HCV, detectable HCV RNA by PCR and persistently normal ALT levels. These patients are usually asymptomatic, but on liver biopsy almost all have histologic evidence of chronic hepatitis. The histologic findings generally are mild, and cirrhosis is rare. The long-term outcome of this group of patients with chronic HCV infection is not known, but the prognosis is probably good. In small, uncontrolled trials of IFN-alpha in patients with normal ALT levels, end-of-treatment virologic responses occurred in 42% of patients, and sustained responses 6 to 12 months afterwards in 13% of patients. These rates of response are not very different from those reported in patients with elevated ALT levels. Importantly, in most studies, serum ALT levels became elevated during IFN therapy in approximately one half of patients, and levels remained elevated in some of these patients after therapy. These findings suggest that IFN-alpha therapy is not usually beneficial and may be harmful in chronic hepatitis C patients with normal ALT levels. Combination therapy with IFN and ribavirin has not been evaluated in this group of patients.
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