Peginterferon α-2a and ribavirin versus peginterferon α-2a monotherapy in early virological responders and peginterferon α-2a and ribavirin versus peginterferon α-2a, ribavirin and amantadine triple therapy in early virological nonresponders:: the SMIEC II trial in naive patients with chronic hepatitis C
Peginterferon α-2a and ribavirin versus peginterferon α-2a monotherapy in early virological responders and peginterferon α-2a and ribavirin versus peginterferon α-2a, ribavirin and amantadine triple therapy in early virological nonresponders:: the SMIEC II trial in naive patients with chronic hepatitis C
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DOI：
10.1097/meg.0b013e3282f5196c
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发表时间：
2008-07-01
影响因子：
2.1
通讯作者：
Bandiera, Franco
中科院分区：
文献类型：
--
作者：
Angelico, Mario;Koehler-Horst, Beate;Bandiera, Franco
本研究的目的是在早期病毒学反应（EVR）的基础上比较抗丙型肝炎病毒（抗hcv）治疗方案的疗效，EVR定义为在12周的聚乙二醇干扰素α -2a （PEG-IFN）诱导治疗180微克/周后血清HCV-RNA （< 50 IU/ ml）检测不到。方法共有210例经组织学证实的慢性丙型肝炎感染（基因型1:62%）患者（69%为男性，中位年龄42岁）首次使用干扰素，接受PEG-IFN 180微克/周治疗，持续12周。EVR患者（58%）被随机分配到继续PEG-IFN单药治疗（n=64）或添加利巴韦林（RBV）， 800 mg/天（n= 57），再持续36周。无EVR的患者（42%）随机加入RBV (n=42)，或RBV加金刚烷胺200mg/天（n=47），再持续36周。持续病毒学反应（SVR，治疗完成后24周未检测到HCV-RNA）在治疗组之间进行比较。结果：PEG-IFN组EVR发生率为60.3%，PEG-IFN + RBV组（NS）为672%。2/3基因型SVR分别为66.7 vs 73.1% (NS)；在1/4基因型中，SVR分别为51.6 vs 61.3% （NS）。无EVR患者：PEG-IFN + RBV组SVR为16.7%，三联治疗组为31.9% （P=0.07）。在基因型为1/4的患者中，SVR率为9.4比29.7% （P=0.041）。结论在1/4基因型无EVR的患者中，三联治疗的SVR率高于标准双联治疗。这项研究证实，金刚烷胺的添加对早期发现的“难以治疗”的患者是有益的。
Objective The objective of this study was to compare the efficacy of anti-hepatitis C virus (anti-HCV) treatment schedules on the basis of an early virological response (EVR), defined as undetectable serum HCV-RNA (< 50 IU/ ml) after a 12-week induction course of peginterferon alpha-2a (PEG-IFN) 180 mcg/week.Methods A total of 210 interferon-naive patients (69% male; median age, 42 years) with histologically proven chronic hepatitis C infection (genotype 1: 62%) received PEG-IFN 180 mcg/week for 12 weeks. Patients with EVR (58%) were randomized to continue PEG-IFN monotherapy (n=64) or to add ribavirin (RBV), 800 mg/day (n = 57), for 36 additional weeks. Patients without EVR (42%) were randomized to add RBV (n=42), or RBV plus amantadine, 200mg/day (n=47), for 36 additional weeks. Sustained virological response (SVR, undetectable HCV-RNA 24 weeks after treatment completion) was compared among treatment groups.Results Patients with EVR: SVR rate was 60.3% in the PEG-IFN group versus 672% in the PEG-IFN + RBV group (NS). In genotypes 2/3, SVR rates were 66.7 versus 73.1% (NS); in genotypes 1/4, SVR rates were 51.6 versus 61.3%, respectively (NS). Patients without EVR: SVR was 16.7% in the PEG-IFN + RBV group versus 31.9% in the triple therapy group (P=0.07). In patients with genotypes 1/4, SVR rates were 9.4 versus 29.7% (P=0.041).Conclusion In genotypes 1/4 patients without EVR, triple therapy results in higher SVR rates than standard dual therapy. This study confirms that addition of amantadine is beneficial in early-recognized 'difficult-to-treat' patients.