Recombinant interferon‐α‐2a for treatment of chronic hepatitis C: results of a multicenter randomized controlled dose study

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Abstract
To compare the efficacy of low and relatively high dosages of recombinant interferon (IFN)‐α‐2a in Japanese patients with chronic hepatitis C, as well as to characterize the type of patients who will respond well to a low‐dosage treatment, 88 patients with histologically proven chronic hepatitis C were randomly assigned to two treatment groups; one treated with IFN‐α‐2a 6 MU daily for 2 weeks followed by 6 MU three times weekly for 22 weeks (6‐MU group), and another given the same initial treatment followed by 3 MU three times weekly for 22 weeks (3‐MU group). The rate of sustained normalization of ALT 6 months after the cessation of treatment was 33% in the 3‐MU group and 40% in the 6‐MU group (p=0.64). In addition, there was no difference in elimination of serum HCV‐RNA 6 months after the cessation of treatment between the 3‐MU group (26%) and 6‐MU group (29%). Multivariate stepwise regression analysis revealed that serum HCV‐RNA level (p=0.0035) and platelet count (p=0.0009) were independent variables useful in predicting a sustained response of ALT. The sustained response rate of ALT in patients with a serum HCV‐RNA level less than 105 copies/ml and serum platelet level above 15×104/μl was 71%, whereas that in patients with a serum HCV‐RNA level above 105 copies/ml and serum platelet level less than 15×104/μl was 12%. These results indicate that a high rate of sustained response to IFN therapy can be expected in chronic hepatitis C patients with a low serum level of HCV‐RNA and a high level of platelets, even if treated with a low dose of IFN.