Pretreatment viral load and response to interferon therapy for liver cirrhosis caused by hepatitis C virus: a multicenter controlled study

Background: The selection of hepatitis C virus (HCV)-related cirrhotic patients for interferon treatment is necessary to improve the efficacy of this treatment. Currently, it is impossible to predict which cirrhotic patients will ultimately respond to this treatment with viral clearance. Moreover, the dose and duration of this therapy for cirrhotic patients remain controversial. Aims: The aims of this study were to determine a useful regimen of interferon treatment for such patients, to identify the predictors of the response to interferon and to assess the clinical outcome after interferon therapy. Methods: Forty-seven patients were treated with 6 million units of natural interferon alpha for either 26 weeks (19 cases) or 52 weeks (28 cases). Results: Sustained virological response with HCV eradication was not observed in patients treated for 26 weeks but it was found in five cases (18%) treated for 52 weeks (P = 0.14), suggesting that prolonged interferon treatment would be more useful for cirrhotic patients. However, no clearance of HCV RNA was found for patients with a high viral load (serum HCV RNA level greater than or equal to 10(7) copies/ml serum), even when the 52-week course of interferon treatment was carried out. HCV eradication was achieved in patients with HCV RNA level of less than 10(6) copies/ml, when prolonged interferon therapy was performed. In multivariate regression analysis, the pretreatment level of HCV RNA correlated independently with HCV eradication (P = 0.01). The 4-year appearance rates of hepatocellular carcinoma in the 26- and 52-week courses of interferon therapy were predicted to be 45.4 and 26.0%, respectively. Thus, the cumulative probability without hepatocellular carcinoma appeared to be higher for the 52-week group than the 26-week group, partly because the frequency of HCV eradication was higher in the 52-week group. Conclusions: The use of a 12-month course of interferon treatment for HCV-related cirrhotic patients may be beneficial for eradicating HCV, with the benefits being greater for patients with a low viral load. Such cirrhotic patients should be treated with a 12-month course of interferon in expectation of HCV eradication. However, its usefulness needs to be studied further in a large number of patients. (C) 2000 Elsevier Science Ireland Ltd. All rights reserved.