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聚乙二醇化干扰素α治疗经治慢性乙型肝炎患者。

Pegylated-interferon alpha therapy for treatment-experienced chronic hepatitis B patients.

作者信息

Yeh Ming-Lun, Peng Cheng-Yuan, Dai Chia-Yen, Lai Hsueh-Chou, Huang Chung-Feng, Hsieh Ming-Yen, Huang Jee-Fu, Chen Shinn-Cherng, Lin Zu-Yau, Yu Ming-Lung, Chuang Wan-Long

机构信息

Division of Hepatobiliary, Department of Internal Medicine, Kaohsiung Medical University Hospital, Kaohsiung, Taiwan; Graduate Institute of Medicine, College of Medicine, Kaohsiung Medical University, Kaohsiung, Taiwan.

Division of Hepatogastroenterology, Department of Internal Medicine, China Medical University Hospital, Taichung, Taiwan.

出版信息

PLoS One. 2015 Apr 2;10(4):e0122259. doi: 10.1371/journal.pone.0122259. eCollection 2015.

Abstract

BACKGROUND

Studies are limited on pegylated interferon (Peg-IFN) therapy for chronic hepatitis B (CHB) patients who failed or relapsed on previous antiviral therapy.

OBJECTIVES

We aimed to investigate the effect of Peg-IFN therapy in treatment-experienced CHB patients.

STUDY DESIGN

A total of 57 treatment-experienced CHB patients at two medical centers were enrolled. All of the patients were treated with Peg-IFN α-2a at 180 μg weekly for 24 or 48 weeks. The hepatitis B serological markers and viral loads were tested every 3 months until 1 year after stopping Peg-IFN therapy. The endpoints were HBV DNA <2000IU/mL, hepatitis B e antigen (HBeAg) seroconversion, and a hepatitis B surface antigen (HBsAg) loss at 12 months post-treatment.

RESULTS

In HBeAg-positive patients, 25.0%, 29.2%, and 12.5% of the patients achieved HBeAg seroconversion, HBV DNA <2000 IU/mL and a combined response, respectively, at 12 months post-treatment. Prior IFN therapy, a high baseline ALT level, a low creatinine level, undetectable HBV DNA at 12 weeks and a decline in HBV DNA >2 log10 IU/mL at 12 weeks of therapy were factors associated with treatment response. In HBeAg-negative patients, 9.1%, 15.2%, and 6.1% of the patients achieved undetectable HBV DNA, HBV DNA <2000 IU/mL, and an HBsAg loss, respectively, at 12 months post-treatment. No factor was significantly associated with the treatment response in the HBeAg-negative patients. The median HBsAg level declined from 3.4 to 2.6 log10 IU/mL in all the patients, and the 5-year cumulative rate of the HBsAg loss was 9.8% in the HBeAg-negative patients. Overall, none of the patients prematurely discontinued the Peg-IFN therapy.

CONCLUSIONS

Peg-IFN re-treatment is effective for a proportion of HBeAg-positive treatment-experienced patients; it has limited efficacy for HBeAg-negative treatment-experienced patients. Peg-IFN might facilitate HBsAg loss in HBeAg-negative treatment-experienced patients.

摘要

背景

关于聚乙二醇干扰素(Peg-IFN)治疗既往抗病毒治疗失败或复发的慢性乙型肝炎(CHB)患者的研究有限。

目的

我们旨在研究Peg-IFN治疗经治CHB患者的疗效。

研究设计

两个医疗中心共纳入57例经治CHB患者。所有患者接受Peg-IFN α-2a治疗,每周180μg,疗程24或48周。每3个月检测乙肝血清学标志物和病毒载量,直至停止Peg-IFN治疗后1年。终点指标为治疗后12个月时HBV DNA<2000IU/mL、乙肝e抗原(HBeAg)血清学转换和乙肝表面抗原(HBsAg)消失。

结果

在HBeAg阳性患者中,治疗后12个月时分别有25.0%、29.2%和12.5%的患者实现了HBeAg血清学转换、HBV DNA<2000IU/mL和联合应答。既往IFN治疗、基线ALT水平高、肌酐水平低、治疗12周时HBV DNA检测不到以及治疗12周时HBV DNA下降>2 log10 IU/mL是与治疗应答相关的因素。在HBeAg阴性患者中,治疗后12个月时分别有9.1%、15.2%和6.1%的患者实现了HBV DNA检测不到、HBV DNA<2000IU/mL和HBsAg消失。在HBeAg阴性患者中,没有因素与治疗应答显著相关。所有患者的HBsAg水平中位数从3.4降至2.6 log10 IU/mL,HBeAg阴性患者的HBsAg消失5年累积率为9.8%。总体而言,没有患者提前停用Peg-IFN治疗。

结论

Peg-IFN再治疗对一部分HBeAg阳性经治患者有效;对HBeAg阴性经治患者疗效有限。Peg-IFN可能有助于HBeAg阴性经治患者的HBsAg消失。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/5b42/4383481/3457c37c9157/pone.0122259.g001.jpg

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