Efficacy of interferon treatment for patients with chronic hepatitis C: Comparison of response in cirrhotics, fibrotics, or nonfibrotics

Chronic hepatitis C patients (472 patients) were treated with consensus int erferon (CIFN) or interferon (IFN) alfa-2b for 6 months in a large multicen ter trial. Efficacy was assessed by clearance of hepatitis C virus (HCV) RN A using reverse transcription polymerase chain reaction (RT-PCR) (<100 copi es/ml), normalization of serum alanine aminotransferase (ALT), and histolog ical improvement. The purpose of these analyses was to compare these effica cy parameters in nonfibrotics, fibrotics, and cirrhotics, Patients with chr onic HCV and cirrhosis showed the same benefit from IFN treatment as noncir rhotic patients when efficacy was assessed by clearance of serum HCV RNA or by histological benefit. Sustained HCV RNA response rates were similar whe n measured among nonfibrotic (11%), fibrotic (13%), and cirrhotic (11%) pat ients. Improvement in histologic activity index (HAI) scores was noted amon g all 3 groups. Cirrhotic patients had a lower sustained ALT response rate (12%) than did nonfibrotic patients (23%). Ninety percent of nonfibrotics, but only 71% of fibrotics and 67% of cirrhotics, who sustained a virologica l response normalized their ALT. This suggests that cirrhotic patients may clear the hepatitis C virus without normalization of ALT levels. The patter n of both HCV RNA clearance over time and ALT decrease was similar among no nfibrotics, fibrotics, and cirrhotics. Tolerability to IFN therapy was simi lar among the 3 groups except that more cirrhotics required dose reduction because of thrombocytopenia, In patients with cirrhosis, ALT levels may be a less appropriate endpoint in the measurement of response to therapy We co nclude that liver cirrhosis should not be a reason for excluding patients f rom therapy because both cirrhotic and fibrotic HCV patients benefit from I FN therapy not only by clearance of virus but by improvements in liver hist ology.