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Title: Shorter durations and lower doses of peginterferon alfa-2a are associated with inferior hepatitis B e antigen seroconversion rates in hepatitis B virus genotypes B or C
Authors: Y. F. Liaw
J. D. Jia
H. L.Y. Chan
K. H. Han
T. Tanwandee
W. L. Chuang
D. M. Tan
X. Y. Chen
E. Gane
T. Piratvisuth
L. Chen
Q. Xie
J. J.Y. Sung
C. Wat
C. Bernaards
Y. Cui
P. Marcellin
Chang Gung University College of Medicine
Capital Medical University China
Chinese University of Hong Kong
Yonsei University College of Medicine
Mahidol University
Kaohsiung Medical University Chung-Ho Memorial Hospital
Xiangya Hospital of Central-south University
Auckland City Hospital
Prince of Songkla University
Fudan University
Ruijin Hospital
Roche Products Limited UK
Genentech Incorporated
Shanghai Roche Pharmaceuticals Ltd
Hopital Beaujon
Keywords: Medicine
Issue Date: 1-Nov-2011
Citation: Hepatology. Vol.54, No.5 (2011), 1591-1599
Abstract: As there is currently a lack of consensus on the most appropriate dose and duration of peginterferon alfa-2a (PEG-IFNα-2a) therapy in hepatitis B e antigen (HBeAg)-positive patients, the efficacy and safety of either 24 or 48 weeks' duration and 90 μg/week or 180 μg/week doses were compared. HBeAg-positive patients (n = 544; 34% genotype B, 51% genotype C) were randomized to receive PEG-IFNα-2a (2 × 2 factorial design) for 24 or 48 weeks and at 90 μg/week or 180 μg/week and included in the per-protocol population. The primary efficacy endpoint of the noninferiority study was HBeAg seroconversion 6 months posttreatment. The prespecified odds ratio (OR) noninferiority margin was 1.88 with a one-sided significance level of 0.025. The highest rates of HBeAg seroconversion 6 months posttreatment were in the 180/48 arm (36.2% versus 14.1%-25.8% in the other arms). When the dose and duration arms were pooled, the OR for noninferiority of 24 weeks versus 48 weeks was 2.17 (95% confidence interval [CI] 1.43, 3.31; P = 0.749) and for 90 μg versus 180 μg was 1.79 (95% CI 1.18, 2.72; P = 0.410). As the upper limit of the 95% CI of the ORs were > 1.88, 24 weeks were inferior to 48 weeks and 90 μg/week was inferior to 180 μg/week. The highest rates of response in the 180/48 arm were achieved by patients with HBsAg < 1,500 IU/mL at Week 12 (58%) or Week 24 (57%), whereas patients with HBsAg > 20,000 IU/mL did not respond. Adverse events were typical of those associated with PEG-IFNα-2a. Conclusion: Compared with lower doses and shorter durations, the licensed PEG-IFNα-2a treatment regimen (180μg/48 weeks) was the most efficacious and beneficial for HBeAg-positive patients predominantly infected with hepatitis B virus genotypes B or C. © 2011 American Association for the Study of Liver Diseases.
ISSN: 15273350
Appears in Collections:Scopus 2011-2015

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