Interferon Alfa-2b and Ribavirin for Patients with Chronic Hepatitis C and Normal ALT: Final Results
Ira M. Jacobson, M. W. Russo, E. Lebovics, S. Esposito, H. Tobias, F. Klion, Robert S. Brown Jr, D. Dieterich, C. Brass, NY Normal ALT Study Group, New York, NY; Westchester, NY; Flushing, NY; Kenilworth, NJ
Most studies establishing the role of antiviral therapy in patients with chronic hepatitis C (CHC) have excluded patients with normal ALT levels. It is estimated that anywhere from <5% to 20% of hepatitis C patients with normal ALTs have significant hepatic fibrosis. Small trials with interferon monotherapy suggested limited efficacy and/or de novo ALT elevations (treatment induced rising of ALTS) in response to treatment . There is little published data on combination therapy in these patients.
The aim of this study was to evaluate the efficacy of two doses of interferon alfa-2b (IFN) combined with ribavirin (RBV) in patients with CHC and normal ALT levels. Patients with biopsy-proven CHC who were PCR-positive for HCV RNA and at least 2 normal ALT levels 3 or more months apart were randomized to: Group 1: IFN 3 MU tiw plus RBV 1000-1200 mg depending on weight < or > 75 kg, or Group 2: IFN 5 MU tiw plus RBV 1000-1200 mg Patients were treated for 24 weeks and a PCR obtained. Therapy was stopped if the PCR was positive and continued for an additional 24 weeks if the PCR was negative. A final PCR (NGI) was obtained 24 weeks after cessation of therapy.
56 patients were randomized and received at least one dose of medications; 43 (77%) received at least 24 weeks of treatment. The majority of the patients were female (60%). 15% of patients were F3/F4. The rates of sustained response (SR) in the overall study population, by treatment group, and by genotype are shown in the Table. Of 10 African-American patients, 1/10 (10%) had SR. In the overall study group, 3 patients had end of treatment response, followed by relapse, and another 3 had breakthrough relapse. There were 3 serious adverse events (MI, confusion, suicidal ideation). 4 patients developed thyroid dysfunction. 5 patients had mild, transient ALT elevations. No sustained ALT elevations were noted.
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