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聚乙二醇干扰素 alfa-2a 联合利巴韦林比聚乙二醇干扰素 alfa-2b 联合利巴韦林更有效治疗慢性丙型肝炎病毒感染。

Peginterferon alfa-2a plus ribavirin is more effective than peginterferon alfa-2b plus ribavirin for treating chronic hepatitis C virus infection.

机构信息

Department of Gastroenterology, Liver Unit, Cardarelli Hospital, Napoli, Italy.

出版信息

Gastroenterology. 2010 Jan;138(1):116-22. doi: 10.1053/j.gastro.2009.10.005. Epub 2009 Oct 20.

Abstract

BACKGROUND & AIMS: Patients with chronic hepatitis C virus (HCV) infection are frequently treated with a combination of pegylated interferon (peginterferon) and ribavirin. This study compared the efficacy and safety of peginterferon alfa-2a and peginterferon alfa-2b, each in combination with ribavirin.

METHODS

A total of 320 consecutive, treatment-naive, HCV RNA-positive patients with chronic hepatitis were randomly assigned to once-weekly peginterferon alfa-2a (180 microg, group A) or peginterferon alfa-2b (1.5 microg/kg, group B) plus ribavirin 1000 mg/day (body weight <75 kg) or 1200 mg/day (body weight >or=75 kg) for 48 weeks (genotype 1 or 4) or 24 weeks (genotype 2 or 3). The primary end point was sustained virological response (SVR) by intention-to-treat.

RESULTS

More patients in group A than group B achieved an SVR (110/160 [68.8%] vs 87/160 [54.4%]; P = .008). Higher SVR rates were obtained in group A than group B among patients with genotype 1/4 (51/93 [54.8%] vs 37/93 [39.8%]; P = .04), with genotype 2/3 (59/67 [88.1%] vs 50/67 [74.6%]; P = .046), without cirrhosis (96/127 [75.6%] vs 75/134 [55.9%]; P = .005), and with baseline levels HCV RNA >500,000 IU/mL (58/84 [69%] vs 43/93 [46.2%]; P = .002). SVR rates in groups A and B were not statistically different among patients with baseline HCV RNA <or=500,000 IU/mL (52/76 [68.4%] vs 44/67 [65.7%]; P = .727) or in patients with cirrhosis (14/33 [42.4%] vs 12/26 [46.1%]; P = .774).

CONCLUSIONS

In patients with chronic HCV infection, peginterferon alfa-2a plus ribavirin produced a significantly higher SVR rate than peginterferon alfa-2b plus ribavirin.

摘要

背景与目的

慢性丙型肝炎病毒(HCV)感染患者常接受聚乙二醇干扰素(peginterferon)和利巴韦林联合治疗。本研究比较了聚乙二醇干扰素 alfa-2a 和聚乙二醇干扰素 alfa-2b 分别联合利巴韦林治疗的疗效和安全性。

方法

320 例连续、初治、HCV RNA 阳性的慢性肝炎患者被随机分配至每周一次的聚乙二醇干扰素 alfa-2a(180 μg,A 组)或聚乙二醇干扰素 alfa-2b(1.5 μg/kg,B 组)联合利巴韦林 1000 mg/天(体重<75 kg)或 1200 mg/天(体重≥75 kg),治疗 48 周(基因型 1 或 4)或 24 周(基因型 2 或 3)。主要终点为意向治疗的持续病毒学应答(SVR)。

结果

A 组的 SVR 率(110/160 [68.8%])高于 B 组(87/160 [54.4%])(P =.008)。A 组的 SVR 率高于 B 组的基因型 1/4(51/93 [54.8%] vs 37/93 [39.8%];P =.04),基因型 2/3(59/67 [88.1%] vs 50/67 [74.6%];P =.046),无肝硬化(96/127 [75.6%] vs 75/134 [55.9%];P =.005)和基线 HCV RNA>500,000 IU/mL(58/84 [69%] vs 43/93 [46.2%];P =.002)患者。A 组和 B 组在基线 HCV RNA<500,000 IU/mL(52/76 [68.4%] vs 44/67 [65.7%];P =.727)或肝硬化患者(14/33 [42.4%] vs 12/26 [46.1%];P =.774)中的 SVR 率无统计学差异。

结论

在慢性 HCV 感染患者中,聚乙二醇干扰素 alfa-2a 联合利巴韦林的 SVR 率显著高于聚乙二醇干扰素 alfa-2b 联合利巴韦林。

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