Browsing by Author "H. L.Y. Chan"

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    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
    (2011-11-01) 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
    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.