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

• Published in: Journal of viral hepatitis 2013-08, Vol.20 (8), p.524
• Main Authors: Manns, M. P, Pockros, P. J, Norkrans, G, Smith, C. I, Morgan, T. R, Häussinger, D, Shiffman, M. L, Hadziyannis, S. J, Schmidt, W. N, Jacobson, I. M, Bárcena, R, Schiff, E. R, Shaikh, O. S, Bacon, B, Marcellin, P, Deng, W, Esteban-Mur, R, Poynard, T, Pedicone, L. D, Brass, C. A, Albrecht, J. K, Gordon, S. C
• Format: Article
• Language: English
• ISSN: 1352-0504; 1365-2893
• DOI: 10.1111/jvh.12074

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) [alpha]-2b or IFN [alpha]-2b. We conducted two phase 3b long-term follow-up studies of patients previously treated for CHC in eight prospective randomized studies of IFN [alpha]-2b and/or PEG-IFN [alpha]-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 [alpha]-2b and 366 with SVR following treatment with PEG-IFN [alpha]-2b were enrolled. Definite relapse (quantifiable serum HCV RNA with no subsequent undetectable HCV RNA) was reported in six patients treated with IFN [alpha]-2b and three patients treated with PEG-IFN [alpha]-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 [alpha]-2b and 99.4% (95% CI, 97.7-99.9%) for PEG-IFN [alpha]-2b. Successful treatment of hepatitis C with PEG-IFN [alpha]-2b or IFN [alpha]-2b leads to clinical cure of hepatitis C in the vast majority of cases. [PUBLICATION ABSTRACT]