Lymphoblastoid interferon alfa-n1 improves the long-term response to a 6-month course of treatment in chronic hepatitis C compared with recombinant interferon alfa-2b: Results of an international randomized controlled trial

✍ Scribed by Geoffrey C. Farrell; Bruce R. Bacon; Robert D. Goldin

• Publisher: John Wiley and Sons
• Year: 1998
• Tongue: English
• Weight: 122 KB
• Volume: 27
• Category: Article
• ISSN: 0270-9139
• DOI: 10.1002/hep.510270429

✦ Synopsis

The aim of this study was to compare the short-term and long-term efficacy and safety of lymphoblastoid interferon with a recombinant interferon alfa (IFN-␣) in a 24-week treatment course for chronic hepatitis C. One thousand seventy-one patients with chronic hepatitis C were randomized to receive lymphoblastoid IFN-␣n1 or recombinant IFN-␣2b at the same dosing regimen, 3 million units administered subcutaneously three times a week for 24 weeks. Hepatitis C viral (HCV) genotype (by line probe assay) was determined at baseline, and serum HCV RNA level (by quantitative reverse-transcriptase polymerase chain reaction) was measured at baseline and weeks 24, 48, and 72. Primary end points were normalization of serum alanine aminotransferase (ALT) levels at end of therapy (week 24) and sustained ALT normalization at weeks 48 and 72. Secondary end points were nondetectability of serum HCV RNA at 24, 48, and 72 weeks, and histological improvement at weeks 24 and 72. The two treatment groups were similar with respect to demographic, clinical, and histological variables (10% had cirrhosis at entry), baseline serum HCV RNA levels, and distribution of HCV genotypes. Intent-totreat analysis showed that ALT response at end of treatment was 35.3% for IFN-␣n1 and 37.9% for IFN-␣2b (P ‫؍‬ .38). Histological improvement and nondetectability of HCV RNA were also similar between the two treatment groups at the end of treatment, as were the type and frequency of reported adverse experiences. Among treatment responders, post-treatment relapse was significantly less frequent Abbreviations: HCV, hepatitis C virus; ALT, alanine aminotransferase; IFN, interferon; SR, sustained response; HAI, Knodell' s Histological Activity Index; ETR, end-of-treatment response in ALT levels.