Clinical trial: interferon alpha-2b continuous long-term therapy vs. repeated 24-week cycles for re-treating chronic hepatitis C

Authors


Prof. J. G. McHutchison, Duke Clinical Research Institute, Duke University Medical Center, PO Box 17969, Durham, NC 27715, USA.
E-mail: mchut001@mc.duke.edu

Summary

Background  Treatment options are limited for patients with hepatitis C virus who do not experience sustained viral eradication with pegylated interferon and ribavirin therapy.

Aim  To compare, in an open-label, randomized study, long-term continuous interferon alpha-2b treatment with repeated 24-week courses in patients with chronic hepatitis C virus that relapsed after prior interferon monotherapy.

Methods  A total of 499 patients received 24 weeks of interferon alpha-2b, 3 MIU administered 3 TIW. Responders (normal alanine aminotransferase and negative hepatitis C virus -RNA, = 244) were then randomized to continuous interferon therapy (1, 2 or 3 MIU TIW depending on response) or cyclical therapy (3 MIU TIW for 24 weeks per relapse). Mean Knodell inflammation (I + II + III) and necrosis (IV) scores at baseline vs. year 2 were compared.

Results  Patients receiving continuous low-dose therapy vs. cycled therapy had larger reductions in inflammation (−3.9 vs. −3.1) and fibrosis (−0.49 vs. −0.24). Among both groups, the mean change was −3.4 for inflammation and −0.36 for fibrosis. Overall, 73% (95% CI: 67–79) of patients experienced reduced inflammation and 28% (95% CI: 22–34) had reduced fibrosis.

Conclusions  Our results suggest hepatitis C virus patients experiencing viral suppression during long-term maintenance therapy with interferon demonstrate histological improvement. Further prospective trials testing this hypothesis are in progress.

Ancillary