Interferon-Alpha in Combination with Ribavirin for the Treatment of Chronic Hepatitis C in Patients with Persistently Normal Aminotransferase Levels

Abstract

Background and Aims: A substantial proportion of patients with chronic hepatitis C virus infection have persistently normal serum transaminase levels. The aim of this study was to assess the efficacy and safety of interferon plus ribavirin combination therapy in this population. Methods: In this prospective open trial 152 patients with biopsy-proven chronic hepatitis C were enrolled, 32 of whom had persistently normal alanine aminotransferase levels (group A). The remaining 120 patients served as a comparison (group B). Patients were treated for 12 months with 4.5 million units of interferon-α_2a thrice weekly in combination with ribavirin 1,000 or 1,200 mg daily. They were followed up for at least 6 months after therapy. Serum hepatitis C RNA was detected by polymerase chain reaction and quantified by a branched DNA assay. Results: At the end of treatment, 12 (37.5%) and 48 patients (40%) were negative for HCV-RNA in groups A and B, respectively (p = 0.33). After 24 weeks of follow-up, 9 patients (28%) from group A and 36 patients (30%) from group B were still HCV-RNA negative (p = 0.4). Treatment was well tolerated by both groups. There were no alanine transferase elevations among group A patients during therapy. Conclusion: Interferon-ribavirin combination therapy was safe and induced a sustained virologic response in a significant proportion of patients with chronic hepatitis C and repeatedly normal serum transaminase levels.

Is serum alanine transaminase level a reliable marker of histological disease in chronic hepatitis C infection?

“…Nevertheless, it is worth noting that the previous study by Hasan et al . (11) and our own, dealing with predominantly genotype 4 patients, are both of middle‐eastern origin, suggesting that these findings may be peculiar to our geographical region.…”

“…In a smaller study of predominantly genotype 4 patients, Hasan et al . (11) found that the mean inflammatory and fibrosis scores were similar in patients with normal and elevated ALT. These findings are in concordance to ours, which may further suggest that ALT levels in genotype 4 patients do not reflect the histological changes.…”

Circulating Intercellular Adhesion Molecule-1 in Chronic Hepatitis C Patients with Normal or Elevated Aminotransferase before and after Alpha-Interferon Treatment

“…Unfortunately, in patients with high aminotransferase levels, there is a high rate of relapse during the follow-up period. However, better results have been reported using combination therapy with IFN plus ribavirin, with an ETR rate of 40 and 47%, respectively [40,41], or with the ongoing studies using pegylated IFN and ribavirin.…”

Towards more individualised management of hepatitis C virus patients with initially or persistently normal alanineaminotransferase levels

“…2). ALT flares were usually not seen in these small combination therapy studies [58][59][60][61][62][63][64][65].…”