Sustained HBeAg and HBsAg loss after long-term follow-up of HBeAg-positive patients treated with peginterferon α-2b

Sustained HBeAg and HBsAg loss after long-term follow-up of HBeAg-positive patients treated with peginterferon α-2b
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DOI:
10.1053/j.gastro.2008.05.031
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发表时间:
2008-08-01
期刊:
影响因子:
29.4
通讯作者:
Janssen, Harry L. A.
Janssen, Harry L. A.
中科院分区:
医学1区
文献类型:
--
作者:
Buster, Erik H. C. J.;Flink, Hajo J.;Janssen, Harry L. A.

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背景和目标:本研究的目的是评价单用聚乙二醇干扰素(PEG-IFN)α-2 B b或与拉米夫定联合治疗B e抗原(HBeAg)阳性慢性B型肝炎患者应答的长期可持续性。方法:所有266例入组HBV 99 -01研究的患者均参与了长期随访(LTFU)研究。患者接受PEG-IFN α-2b(100 μ g/周)单独治疗或与拉米夫定(100 mg/天)联合治疗52周。初始应答定义为治疗后26周HBeAg阴性。对于LTFU研究,患者在初始研究后有一次额外访视(平均间隔,3.0 ± 0.8年)。结果:在入组初始研究的266例患者中,72例(65%)参与了LTFU研究。在LTFU,HBeAg和B型肝炎表面抗原(HBsAg)阴性分别观察到37%和11%的172例患者。64例患者被归类为初始应答者,108例为无应答者。在初始应答者中,分别有81%和30%观察到持续HBeAg阴性和HBsAg丢失。与非A基因型相比,A基因型感染的初始应答者HBeAg阴性率显著更高(96% vs 76%; P = 0.06),HBsAg丢失率也显著更高(58% vs 11%; P
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) alpha-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 alpha-2b (100 mu g/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, 72 (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