Long-term clearance of hepatitis C virus following interferon α-2b or peginterferon α-2b, alone or in combination with ribavirin

Journal of Viral Hepatitis

Volume 20, Issue 8, pages 524–529, August 2013

Original Article

M. P. Manns^1,*, P. J. Pockros², G. Norkrans³, C. I. Smith⁴, T. R. Morgan⁵, D. Häussinger⁶, M. L. Shiffman⁷, S. J. Hadziyannis⁸, W. N. Schmidt⁹, I. M. Jacobson¹⁰, R. Bárcena¹¹, E. R. Schiff¹², O. S. Shaikh¹³, B. Bacon¹⁴, P. Marcellin¹⁵, W. Deng¹⁶, R. Esteban-Mur¹⁷, T. Poynard¹⁸, L. D. Pedicone^16,†, C. A. Brass^16,†, J. K. Albrecht^16,†, S. C. Gordon¹⁹

Article first published online: 3 MAR 2013

DOI: 10.1111/jvh.12074

© 2013 John Wiley & Sons Ltd

Abstract

Keywords: clinical; cure; eradication; follow-up; longitudinal

Summary

Sustained virologic response (SVR) is the standard measure for evaluating response to therapy in patients with chronic hepatitis C (CHC). The aim of this study was to prospectively assess the durability of SVR in the pivotal studies of peginterferon (PEG-IFN) α-2b or IFN α-2b. We conducted two phase 3b long-term follow-up studies of patients previously treated for CHC in eight prospective randomized studies of IFN α-2b and/or PEG-IFN α-2b. Patients who achieved SVR [undetectable hepatitis C virus (HCV) RNA 24 weeks after completion of treatment] were eligible for inclusion in these follow-up studies. In total, 636 patients with SVR following treatment with IFN α-2b and 366 with SVR following treatment with PEG-IFN α-2b were enrolled. Definite relapse (quantifiable serum HCV RNA with no subsequent undetectable HCV RNA) was reported in six patients treated with IFN α-2b and three patients treated with PEG-IFN α-2b. Based on these relapses, the point estimate for the likelihood of maintaining response after 5 years was 99.2% [95% confidence interval (CI), 98.1–99.7%] for IFN α-2b and 99.4% (95% CI, 97.7–99.9%) for PEG-IFN α-2b. Successful treatment of hepatitis C with PEG-IFN α-2b or IFN α-2b leads to clinical cure of hepatitis C in the vast majority of cases.

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