Pegylated interferon alfa-2b alone or in combination with lamivudine for HBeAg-positive chronic hepatitis B: a randomised trial

医学 拉米夫定 内科学 聚乙二醇干扰素 胃肠病学 HBeAg 联合疗法 乙型肝炎 人口 安慰剂 α-干扰素 α-干扰素 乙型肝炎病毒 免疫学 药理学 慢性肝炎 干扰素 乙型肝炎表面抗原 病毒 利巴韦林 病理 替代医学 环境卫生
作者
Harry L.A. Janssen,Monika van Zonneveld,Hakan Şentürk,Stefan Zeuzem,Ulus Salih Akarca,Yılmaz Çakaloğlu,Krzysztof Simon,Thomas M. K. So,Guido Gerken,Robert A. de Man,Hubert G.M. Niesters,Pieter E. Zondervan,Bettina E. Hansen,Solko W. Schalm
出处
期刊:The Lancet [Elsevier BV]
卷期号:365 (9454): 123-129 被引量:1149
标识
DOI:10.1016/s0140-6736(05)17701-0
摘要

Background Treatment of HBeAg-positive patients with chronic hepatitis B is not effective in most. A combination of immunomodulatory pegylated interferon alfa-2b and antiviral lamivudine might improve the rate of sustained response. Methods 307 HBeAg-positive patients with chronic hepatitis B were assigned combination therapy (100 μg/week pegylated interferon alfa-2b and 100 mg/day lamivudine) or monotherapy (100 μg/week pegylated interferon alfa-2b and placebo) for 52 weeks. During weeks 32–52 the pegylated interferon dose was 50 μg/week in both treatment groups. The analyses were based on the modified intention-to-treat population after exclusion of 24 patients from one centre withdrawn for misconduct, ten who lost HBeAg before the study start, and seven who received no study medication. All included patients were followed up for 26 weeks after treatment. Findings 49 (36%) of 136 patients assigned monotherapy and 46 (35%) of 130 assigned combination therapy had lost HBeAg at the end of follow-up (p=0·91). More of the combination-therapy than of the monotherapy group had cleared HBeAg at the end of treatment (57 [44%] vs 40 [29%]; p=0·01) but relapsed during follow-up. Patterns were similar when response was assessed by suppression of serum hepatitis B virus (HBV) DNA or change in concentrations of alanine aminotransferase. Response rates (HBeAg loss) varied by HBV genotype (p=0·01): A, 42 (47%) patients; B, ten (44%); C, 11 (28%); and D, 26 (25%). Interpretation Treatment with pegylated interferon alfa-2b is effective for HBeAg-positive chronic hepatitis B. Combination with lamivudine in the regimen used is not superior to monotherapy. HBV genotype is an important predictor of response to treatment.
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