ArticlesPeginterferon alfa-2b plus ribavirin compared with interferon alfa-2b plus ribavirin for initial treatment of chronic hepatitis C: a randomised trial
Introduction
Chronic hepatitis C infection affects nearly 300 million people worldwide and is one of the main causes of chronic liver disease and commonest indication for liver transplantation.1, 2, 3, 4, 5, 6 The most effective initial therapy for patients with this disorder is the combination of interferon alfa-2b plus ribavirin given for 24 or 48 weeks. With this two-drug regimen, about 40% of patients achieve a sustained virological response (SVR) and the associated potential long-term benefits.7, 8
The addition of a polyethyleneglycol molecule to interferon produces a biologically active molecule with a longer half-life than the natural molecule and more favourable pharmacokinetics; these characteristics allow for more convenient once-weekly dosing.9 When pegylated a interferons are given alone to patients with chronic hepatitis C for 48 weeks, the SVR rate is approximately twice that with standard interferon.10, 11 However, relapse rates after cessation of monotherapy with pegylated interferon remain high, and most patients infected with hepatitis C virus (HCV) genotype 1 do not achieve SVR.10, 11 Addition of ribavirin to interferon alfa-2b decreases the risk of relapse.7, 8 The addition of ribavirin to peginterferon alfa-2b might therefore be expected to decrease the risk of relapse after therapy.12 This study aimed to assess the safety and efficacy of two different regimens of peginterferon alfa-2b in combination with ribavirin compared with interferon alfa-2b plus ribavirin, and to identify predictors of response for peginterferon alfa-2b plus ribavirin.
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Selection of patients
Eligible patients were previously untreated adults who had HCV RNA detectable in serum by PCR, who had undergone a liver biopsy within 1 year before entry that was consistent with chronic hepatitis, and who had high serum values of alanine aminotransferase (above the upper limit of normal >43 IU/L for men, >34 IU/L for women) with minimum haematological and biochemical values of: haemoglobin 120 g/L for women and 130 g/L for men; white-blood-cell count 3×109/L; neutrophil count 1·5·109/L;
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