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 pati ents 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, t he dose and duration of this therapy for cirrhotic patients remain controve rsial. Aims: The aims of this study were to determine a useful regimen of i nterferon treatment for such patients, to identify the predictors of the re sponse to interferon and to assess the clinical outcome after interferon th erapy. Methods: Forty-seven patients were treated with 6 million units of n atural interferon alpha for either 26 weeks (19 cases) or 52 weeks (28 case s). Results: Sustained virological response with HCV eradication was not ob served 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 tre atment would be more useful for cirrhotic patients. However, no clearance o f HCV RNA was found for patients with a high viral load (serum HCV RNA leve l greater than or equal to 10(7) copies/ml serum), even when the 52-week co urse 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 eradicatio n (P = 0.01). The 4-year appearance rates of hepatocellular carcinoma in th e 26- and 52-week courses of interferon therapy were predicted to be 45.4 a nd 26.0%, respectively. Thus, the cumulative probability without hepatocell ular 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 5 2-week group. Conclusions: The use of a 12-month course of interferon treat ment for HCV-related cirrhotic patients may be beneficial for eradicating H CV, with the benefits being greater for patients with a low viral load. Suc h cirrhotic patients should be treated with a 12-month course of interferon in expectation of HCV eradication. However, its usefulness needs to be stu died further in a large number of patients. (C) 2000 Elsevier Science Irela nd Ltd. All rights reserved.