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聚乙二醇干扰素α-2b联合利巴韦林治疗基因2型或3型慢性丙型肝炎患者:16周与24周对比,临床结局及直接成本分析

Therapy of chronic hepatitis C with PEG-IFN α-2b plus ribavirin in patients with genotype 2 or 3: 16 versus 24 weeks, clinical outcome and direct cost analyses.

作者信息

Fabris Paolo, Carlotto Antonio, Del Bianco Tiziana, Malfatti Federica, Tramarin Andrea, Miotti Marco A, Baldo Vincenzo, Floreani Annarosa, Giordani Maria Teresa, Grasso Alessandro

机构信息

aDepartment of Infectious Diseases and Tropical Medicine, S. Bortolo Hospital bDepartment of Infectious Diseases, Schio, Vicenza cGastroenterology Unit, Gorizia Hospital, Gorizia dDepartment of Gastroenterology, AASL2, San Paolo Hospital, Savona eInstitute of Hygiene fDepartment of Surgery, Oncology and Gastroenterology, University of Padova, Padova, Italy.

出版信息

Eur J Gastroenterol Hepatol. 2013 Dec;25(12):1396-401. doi: 10.1097/MEG.0b013e328362dc22.

Abstract

INTRODUCTION

Short antiviral therapy has been proposed for patients with chronic hepatitis C, easy genotypes, low fibrosis score, low viral load at baseline, and rapid virological response (RVR). However, this approach is not completely accepted.

OBJECTIVES

The aims of this study were (a) to evaluate the sustained virological response (SVR) in noncirrhotic patients with genotype 2 or 3, achieving an RVR, randomized to receive pegylated-interferon (IFN) α-2b plus ribavirin for either 16 or 24 weeks and (b) to carry out direct cost analysis comparing patients treated for 16 versus 24 weeks.

RESULTS

Of the 142 initially evaluated patients, 130 were enrolled according to the selection criteria, but independent of the viral load. According to the intention-to-treat analysis, SVR was achieved in 104 patients (80%). Logistic regression analysis showed that RVR (P<0.001) and genotype 2 (P<0.03) were the most important factors independently associated with SVR. Among patients with RVR, SVR was comparable between patients treated for 16 weeks and those treated for 24 weeks (86.2 vs. 89.7%, P=NS). The mean direct costs were €4003.7 for patients treated for 16 weeks and €5676.7 for those treated for 24 weeks, with a 30% difference between the two arms.

CONCLUSION

In patients achieving an RVR, a 16-week treatment with pegylated-interferon plus ribavirin was comparable to a 24-week treatment. Short treatment in patients with RVR allows us to save 30% of the direct costs, independent of the viral load at baseline.

摘要

引言

对于慢性丙型肝炎患者,若基因型简单、纤维化评分低、基线病毒载量低且有快速病毒学应答(RVR),有人提出采用短疗程抗病毒治疗。然而,这种方法尚未被完全接受。

目的

本研究的目的是:(a)评估非肝硬化的2型或3型基因型患者中实现RVR者,随机接受聚乙二醇化干扰素(IFN)α-2b联合利巴韦林治疗16周或24周后的持续病毒学应答(SVR)情况;(b)对接受16周和24周治疗的患者进行直接成本分析比较。

结果

在最初评估的142例患者中,130例根据选择标准入组,且与病毒载量无关。根据意向性分析,104例患者(80%)实现了SVR。逻辑回归分析显示,RVR(P<0.001)和2型基因型(P<0.03)是与SVR独立相关的最重要因素。在有RVR的患者中,接受16周治疗和24周治疗的患者SVR相当(86.2%对89.7%,P=无显著差异)。接受16周治疗的患者平均直接成本为4003.7欧元,接受24周治疗的患者为5676.7欧元,两组之间相差30%。

结论

在实现RVR的患者中,聚乙二醇化干扰素联合利巴韦林治疗16周与24周相当。RVR患者的短疗程治疗可使我们节省30%的直接成本,且与基线病毒载量无关。

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