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聚乙二醇干扰素联合利巴韦林治疗非肝细胞癌相关恶性肿瘤合并丙型肝炎患者的安全性和有效性:一项多中心研究。

The safety and efficacy of peginterferon plus ribavirin in hepatitis C patients concomitant with malignancy other than hepatocellular carcinoma: a multicenter study.

作者信息

Huang Chung-Feng, Huang Jee-Fu, Chen Wu-Cheng, Yeh Ming-Lun, Huang Ching-I, Yang Jeng-Fu, Chuang Wan-Long, Dai Chia-Yen, Hsieh Ming-Yen, Lin Zu-Yau, Chen Shinn-Cherng, Yu Ming-Lung

机构信息

Hepatobiliary Division, Department of Internal Medicine, Kaohsiung Medical University Hospital, Kaohsiung, Taiwan.

Department of Occupational Medicine, Kaohsiung Municipal Ta-Tung Hospital, Kaohsiung Medical University Hospital, Kaohsiung, Taiwan.

出版信息

Hepatol Int. 2013 Mar;7(1):180-7. doi: 10.1007/s12072-012-9394-z. Epub 2012 Aug 11.

DOI:10.1007/s12072-012-9394-z
PMID:26201632
Abstract

PURPOSE

Cancer patients were generally excluded from the therapeutic guidelines of antiviral therapy. We aimed to evaluate the efficacy and safety of antiviral therapy in patients with hepatitis C virus (HCV) infection concomitant with malignancy other than hepatocellular carcinoma (HCC).

METHODS

Twenty-five HCV patients with curative malignancy other than HCC (group A) and 75 sex- and age-matched controls (group B) were recruited into a prospective and case-control analysis. All patients received peginterferon-alpha-2a (PegIFN-alpha-2a) and weight-based ribavirin according to the current treatment recommendations. The primary outcome measurement was sustained virological response (SVR). The safety issue between groups was also compared.

RESULTS

There were 22 (88.0 %) patients of group A and 59 (78.7 %) patients of group B who achieved an SVR (p = 0.39). The SVR rate was comparable between groups both in genotype-1 (HCV-1) (81.8 vs. 72.7 %, p = 0.70) and in genotype-2 (HCV-2) (92.9 vs. 83.3 %, p = 0.66) patients. Multivariate logistic regression analysis demonstrated that the achievement of a RVR (viral clearance during first 4 weeks of treatment) was the strongest predictor of an SVR (odds ratio/95 % confidence intervals [OR/CI]: 6.357/1.50 - 26.99, p = 0.01), followed by lower baseline viral loads (OR/CI: 0.403/0.174 - 0.936, p = 0.034) and higher dose of ribavirin exposure (OR/CI: 1.287/1.092 - 1.517, p = 0.003), whilst previous occurrence of cancer was not associated with SVR. Treatment adherence (76.0 vs. 72.0 %, p = 0.70) and the incidences of grade 3 or more adverse events (28.0 vs. 20.0 %, p = 0.40) were comparable between two groups.

CONCLUSIONS

Chronic hepatitis C patients with non-HCC malignancies receiving peginterferon/ribavirin combination therapy carried favorable efficacy and safety outcomes.

摘要

目的

癌症患者通常被排除在抗病毒治疗的治疗指南之外。我们旨在评估丙型肝炎病毒(HCV)感染合并除肝细胞癌(HCC)以外的恶性肿瘤患者接受抗病毒治疗的疗效和安全性。

方法

招募25例患有除HCC以外的可治愈性恶性肿瘤的HCV患者(A组)和75例年龄和性别匹配的对照者(B组)进行前瞻性病例对照分析。所有患者均根据当前治疗建议接受聚乙二醇干扰素-α-2a(PegIFN-α-2a)和基于体重的利巴韦林治疗。主要结局指标是持续病毒学应答(SVR)。还比较了两组之间的安全性问题。

结果

A组有22例(88.0%)患者和B组有59例(78.7%)患者实现了SVR(p = 0.39)。在基因1型(HCV-1)患者(81.8%对72.7%,p = 0.70)和基因2型(HCV-2)患者(92.9%对83.3%,p = 0.66)中,两组的SVR率相当。多因素逻辑回归分析表明,快速病毒学应答(治疗前4周内病毒清除)的实现是SVR的最强预测因素(比值比/95%置信区间[OR/CI]:6.357/1.50 - 26.99,p = 0.01),其次是较低的基线病毒载量(OR/CI:0.403/0.174 - 0.936,p = 0.034)和较高剂量的利巴韦林暴露(OR/CI:1.287/1.092 - 1.517,p = 0.003),而既往癌症发生情况与SVR无关。两组之间的治疗依从性(76.0%对72.0%,p = 0.70)和3级或更高级别不良事件的发生率(28.0%对20.0%,p = 0.40)相当。

结论

接受聚乙二醇干扰素/利巴韦林联合治疗的非HCC恶性肿瘤慢性丙型肝炎患者具有良好的疗效和安全性结果。

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