In chronic hepatitis B, it is difficult to predict an early therapeutic response. We investigated the viral decline during therapy with pegylated interferon alpha-2b (PEG-IFN) with or without lamivudine in 266 HBeAg-positive chronic hepatitis B patients. In patients treated with PEG-IFN and lamivudi
Prediction of the response to peg-interferon-alfa in patients with HBeAg positive chronic hepatitis B using decline of HBV DNA during treatment
✍ Scribed by Bettina E. Hansen; Erik H.C.J. Buster; Ewout W. Steyerberg; Emmanuel Lesaffre; Harry L.A. Janssen
- Publisher
- John Wiley and Sons
- Year
- 2010
- Tongue
- English
- Weight
- 193 KB
- Volume
- 82
- Category
- Article
- ISSN
- 0146-6615
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✦ Synopsis
Abstract
Peginterferon (PEG‐IFN) results in HBeAg loss combined with virologic response in only a minority of patients with HBeAg positive chronic hepatitis B. Baseline predictors of response to PEG‐IFN include HBV‐genotype, pre‐treatment HBV DNA levels, and ALT. The aims of this study were to develop a model, which improves the baseline prediction of response to PEG‐IFN for individual patients by including early HBV DNA measurements during treatment and to establish an early indication for cessation of treatment. One hundred thirty‐six patients treated with PEG‐IFN were included in the study. Response was defined as loss of HBeAg and HBV DNA <10,000 copies/ml at 26 weeks post‐treatment. Logistic regression analysis techniques were used to develop a dynamic prediction model with HBV DNA during the first 32 weeks of therapy. An early clinically useful rule for dis(continuation) of treatment was identified with a grid of cut‐off values of HBV DNA decline during treatment. Adding HBV DNA decline to baseline prediction increased c‐statistics from 0.846 to 0.857, 0.855 to 0.866 at weeks 4, 12, and 24. A HBV DNA decline of at least 2 log~10~ within 24 weeks was strongly associated with response when added to the baseline prediction model: OR 5.7 (95% CI: 1.70–20.0; P = 0.004). A dynamic model including HBV DNA decline during treatment provides more accurate predictions of response to PEG‐IFN. The model strongly supports individual decision making on treatment (dis)continuation in patients with HBeAg positive chronic hepatitis B. It is recommended that PEG‐IFN treatment is stopped by 24 weeks if HBV DNA declined <2 log~10~. J. Med. Virol. 82: 1135–1142, 2010. © 2010 Wiley‐Liss, Inc.
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Ferenci is a consultant for, advises, is on the speakers' bureau of, and received grants from Roche. Dr. Janssen is a consultant for and received grants from Roche, Bristol-Myers Squibb, Schering-Plough, Novartis, and Gilead. Dr. Flisiak received grants from Roche.
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