Sustained HBeAg and HBsAg Loss After Long-term Follow-up of HBeAg-Positive Patients Treated With Peginterferon α-2b
Background & Aims: The aim of this study was to evaluate the long-term sustainability of response in patients with hepatitis B e antigen (HBeAg)-positive chronic hepatitis B treated with pegylated interferon (PEG-IFN) α-2b alone or in combination with lamivudine. Methods: All 266 patients enrolled in the HBV99-01 study were offered participation in a long-term follow-up (LTFU) study. Patients were treated with PEG-IFN α-2b (100 μg/wk) alone or in combination with lamivudine (100 mg/day) for 52 weeks. Initial response was defined as HBeAg negativity at 26 weeks posttreatment. For the LTFU study, patients had one additional visit after the initial study (mean interval, 3.0 ± 0.8 years). Results: Of 266 patients enrolled in the initial study, 172 (65%) participated in the LTFU study. At LTFU, HBeAg and hepatitis B surface antigen (HBsAg) negativity were observed in 37% and 11% of 172 patients, respectively. Sixty-four patients were classified as initial responders and 108 as nonresponders. Among the initial responders, sustained HBeAg negativity and HBsAg loss were observed in 81% and 30%, respectively. Significantly higher rates of HBeAg negativity were observed in genotype A–infected initial responders compared with those with genotype non-A (96% vs 76%; P = .06) as well as HBsAg loss (58% vs 11%; P < .001). Conclusions: HBeAg loss after treatment with PEG-IFN α-2b alone or in combination with lamivudine is sustained in the majority of patients and is associated with a high likelihood of HBsAg loss, particularly in genotype A–infected patients. Therefore, PEG-IFN α-2b remains an important treatment option in this era of nucleos(t)ide analogue therapy.
Abbreviations used in this paper: CI, confidence interval, HR, hazard ratio, LFTU, long-term follow-up, PEG-IFN, pegylated interferon
Organized and sponsored by the Foundation for Liver Research (SLO) (Rotterdam, The Netherlands) and supported by Schering-Plough International (Kenilworth, NJ).
E.H.C.J.B. has received speaker's honoraria from Novartis and Roche. S.V.F. has served as a consultant for Hoffman-La Roche and Schering-Plough and has received research support from Schering-Plough. H.L.A.J. has served as a consultant for Bristol-Myers Squibb, Gilead, Novartis, and Roche and has received research support from Bristol-Myers Squibb, Novartis, Roche, and Schering-Plough. The following authors have nothing to disclose: H.J.F., Y.C., K.S., J.T., F.T., T.M.K.S., T.M., U.S.A., M.S., W.T., A.J.V., and B.E.H. Potential investigator conflicts of interest have not been disclosed to study participants.
Members of the HBV99-01 LTFU study group include the following: Belgium: F. Nevens, E. de Wit (University Hospital Gasthuisberg, Leuven); P. P. Michielsen, R. Braspenning (University Hospital, Antwerp); H. van Vlierberghe, A. de Geyter (University Hospital, Gent). Canada: E. J. Heathcote, D. Kaznowski (Toronto Western Hospital University Health Network, Toronto); S. Bojarski (Liver Disease Unit, Mount Sinai Hospital, Toronto). Denmark: L. R. Mathiesen, G. Kronborg, L. Rosenørn (Copenhagen University Hospital, Hvidovre). Germany: G. Gerken, S. Bein (University Hospital, Essen). Greece: G. Kitis (George Papanikolaou General Regional Hospital, Thessaloniki). Italy: G. B. Gaeta (Ospedale Gesù e Maria, Napoli); F. D'Antona, G. Montalto (Università di Palermo, Palermo). Malaysia: S. Sharmila (Hospital Selayang, Institute for Medical Research, Kuala Lumpur). The Netherlands: E. Verhey, G. Ramdjan, L. A. van Santen, A. Heijens, M. Ouwendijk, J. Francke, S. Diepstraten-Pas (Erasmus MC University Medical Center, Rotterdam); C. M. J. van Nieuwkerk, C. van Doorn (VU University Medical Center, Amsterdam); J. Drenth (University Medical Centre Radboud, Nijmegen); J. W. den Ouden-Muller (St Franciscus Hospital, Rotterdam); R. A. de Vries, P. van Embden (Rijnstate Hospital, Arnhem). Poland: R. Flisiak (Medical University of Białystok, Białystok). Singapore: R. Guan (Mount Elizabeth Medical Center, Singapore). Spain: M. Buti (Hospital General Universitari Pall d'Hebron, Barcelona); M. Rodriguez (Hospital Central de Asturias, Oviedo). Turkey: H. Simsek (Hacettepe University Faculty of Medicine, Ankara).
PII: S0016-5085(08)00850-0
doi:10.1053/j.gastro.2008.05.031
© 2008 AGA Institute. Published by Elsevier Inc. All rights reserved.
