62 EVALUATION OF ANTIVIRAL ACTIVITY AND TOLERANCE OF A NOVEL SUSTAINED RELEASE INTERFERON-ALPHA-2B (IFN-ALPHA-2BXL) COMPARED TO PEGYLATED INTERFERON-ALPHA-2B (PEG-IFN-ALPHA-2B): A PHASE IB TRIAL IN HCV PATIENTS

changes in fibrosis scores were +0.36 (95%CI 0.07−0.64) and +0.32 (95%CI −0.39−1.03) in the E1 and placebo group, respectively (p = 0.87), while changes in inflammation scores were +0.81 (0.33−1.29) and +1.28 (0.22−2.34; p = 0.36). Multiple regression indicated the following factors as significantly associated with fibrosis progression: BMI at baseline (BMI 25), previous IFN treatment (IFN-experienced patients progress more than IFN-naive patients), and Ishak fibrosis stage at baseline (low fibrosis progress +0.80 more than high fibrosis). No association was seen between histological evolution from baseline and age, gender, HCV E1 Ab status and ALT at baseline, or ribavirin history. Conclusions: The earlier open-label findings that HCV E1 immunization was able to halt histological progression in chronic HCV patients were not confirmed in this larger, placebo-controlled trial. However, this unique setting of a placebo-controlled trial with a histological primary endpoint allowed an unbiased investigation of factors influencing disease progression. The annual increase in mean Ishak fibrosis scores of 0.11 was considerably less than reported in landmark natural progression studies.