sequential peginterferon-alpha and telbivudine 48 weeks in HbeAG-ve

肝胆速递

Antivir Ther. 2012 Aug 6. doi: 10.3851/IMP2281. [Epub ahead of print]
A randomized controlled trial of sequential peginterferon-alpha and telbivudine or vice versa for 48 weeks in HBeAg-negative chronic hepatitis B.
Piccolo P, Lenci I, di Paolo D, Demelia L, Sorbello O, Nosotti L, Angelico M.
Source

Hepatology Unit, Tor Vergata University, Rome, Italy. [email protected].
Abstract

Background
Short-term treatment for HBeAg-negative chronic hepatitis B remains unsatisfactory. Aim of our study was to compare efficacy and safety of two sequential regimens of peginterferon α (PEG-IFN) and telbivudine (LdT).Methods Adult patients with biopsy-proven HBeAg-negative chronic hepatitis B, elevated ALT, serum HBV DNA≥2000 IU/ml were randomized 1:1 at baseline to receive PEG-IFN 180 mcg/week for 24 weeks followed by LdT 600 mg/die for 24 weeks (PEG-IFN first), or vice versa (LdT first), plus 24-week follow-up; HCV, HDV or HIV coinfections and lamivudine-resistance were excluded. Primary endpoints were serum HBV DNA <2000 IU/ml and normal ALT at week 72.
Results
Thirty patients (86% male; median age, 48 years) were enrolled: baseline serum HBV DNA, 5.56±1.4 Log IU/ml; mean ALT 2.9±2.5 times normal. At end of follow-up (week 72), HBV DNA<2000 IU/ml was achieved in 13.3% in PEG-IFN first group vs. 46.7% in LdT first group (p=0.046). Mean ALT levels were significantly lower in LdT first group (1.3±0.9 vs. 3.2±2.7 times normal, p=0.03).PEG-IFN dose was reduced in 2 patients (7%). One patient (7%) dropped out due to myalgia.
Conclusion
Sequential treatment with 24 weeks PEG-IFN followed or preceded by 24 weeks of LdT is safe. Virological response rate at week 72 was significantly higher in patients treated with LdT followed by PEG-IFN than vice versa. A sequential antiviral regimen of LdT followed by PEG-IFN, if confirmed in larger series, could improve response rates compared to standard PEG-IFN monotherapy.

肝胆速递

AntiViral疗法2012年8月6日。 DOI：10.3851/IMP2281。 [EPUB的提前打印]
HBeAg阴性慢性乙型肝炎48周的随机对照试验的连续的聚乙二醇干扰素α和替比夫定，反之亦然
短笛，二Lenci我保罗ð，Demelia SorbelloØ，Nosotti Angelico的M. P，
源

肝病单位，Tor Vergata大学，罗马，意大利。 paola.piccolo uniroma2.it。
抽象

背景
短期治疗HBeAg阴性慢性乙型肝炎仍不能令人满意。本研究的目的是比较两个连续的治疗聚乙二醇干扰素α（PEG-IFN）和替比夫定（LDT）的疗效和安全性。
方法
经活检证实的HBeAg阴性的慢性乙型肝炎成人患者，转氨酶升高，血清HBV DNA≥2000 IU/ ml的基线时的1:1随机接受PEG-IFN180微克/周，24周，随后由LDT600毫克/死24周（PEG-IFN第一的），反之亦然（LDT第一），加上24 - 周随访，HCV，HDV或HIV合并感染及拉米夫定耐药被排除在外。主要终点为血清​​HBV DNA<2000 IU / ml和ALT正常的
Results
30例患者（86％为男性，平均年龄48岁）患者的基线血清HBV DNA，5.56±1.4日志IU/毫升，平均ALT周72. 2.9±2.5倍正常。在随访结束时（72周），HBV DNA<2000 IU/ ml时，在PEG-IFN第一组的13.3％与46.7％，LDT第一组（P = 0.046）。平均ALT水平显着降低，LDT第一组（1.3±0.9比3.2±正常人的2.7倍，P= 0.03）.PEG-IFN剂量减少2例（7％）。 1例（7％）下降，由于myalgia.
Conclusion
序贯治疗24周PEG-IFN，或之前24周的LDT是安全的。在72周的病毒学应答率显着在LDT比反之亦然PEG-IFN治疗的患者高。一个LDT PEG-IFN的抗病毒序贯治疗方案，如果得到证实大系列，可以改善反应率相比，标准的PEG-IFN单药治疗。