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基于一项全国性的退伍军人研究,比较博赛泼维与特拉泼维治疗丙型肝炎病毒感染的疗效。

Similar effectiveness of boceprevir and telaprevir treatment regimens for hepatitis C virus infection on the basis of a nationwide study of veterans.

机构信息

Division of Gastroenterology, Veterans Affairs Puget Sound Health Care System, Seattle, Washington; Health Services Research and Development, Veterans Affairs Puget Sound Health Care System, Seattle, Washington; Division of Gastroenterology, University of Washington, Seattle, Washington.

Division of Internal Medicine, Veterans Affairs Puget Sound Health Care System, Seattle, Washington; Division of Internal Medicine, University of Washington, Seattle, Washington.

出版信息

Clin Gastroenterol Hepatol. 2014 Aug;12(8):1371-80. doi: 10.1016/j.cgh.2013.12.011. Epub 2013 Dec 17.

Abstract

BACKGROUND & AIMS: We investigated the real-world effectiveness of triple therapy regimens against hepatitis C virus (HCV) and compared rates of sustained virologic response (SVR) between telaprevir-based and boceprevir-based regimens in a population-based study.

METHODS

We analyzed data on all patients in the Veterans Administration healthcare system who were infected with HCV genotype 1 and began treatment with pegylated interferon, ribavirin, and either boceprevir (n = 3696, 83%) or telaprevir (n = 759, 17%) from June 2011 to February 2013.

RESULTS

Patients treated with telaprevir were more likely to have baseline characteristics associated with not achieving SVR than patients treated with boceprevir. Fewer than half of patients eligible for short-duration regimens (28 weeks for boceprevir, 24 weeks for telaprevir) successfully completed treatment (37% for boceprevir, 27.5% for telaprevir); ∼25% discontinued early, and the remaining patients were treated for longer durations. Of the patients who were supposed to complete 48-week regimens, only 35% of boceprevir-treated and 34% of telaprevir-treated patients completed >44 weeks. The rate of SVR was 51.5% overall, 42.7% among patients with cirrhosis, 56.8% among treatment-naive patients, 64.2% among prior relapsers, 31.7% among prior partial responders, and 29.8% among prior null responders. There were no significant differences in rate of SVR between patients given boceprevir or telaprevir in the entire population or among subgroups. The most important predictors of failure to achieve SVR were IL28B genotype, high viral load, black race, diabetes, high aspartate aminotransferase to platelet ratio index or FIB-4 scores, low platelet counts, or low levels of low-density lipoprotein cholesterol. Erythropoietin use was not associated with SVR.

CONCLUSIONS

In a nationwide analysis of veterans with HCV genotype 1 infection, rates of SVR were similar for those treated with boceprevir vs telaprevir. However, rates of treatment completion and SVR in real clinical practice were substantially lower than those in clinical trials.

摘要

背景与目的

我们研究了针对丙型肝炎病毒(HCV)的三联疗法方案的真实世界疗效,并在一项基于人群的研究中比较了基于替拉瑞韦和博赛匹韦方案的持续病毒学应答(SVR)率。

方法

我们分析了 2011 年 6 月至 2013 年 2 月期间在退伍军人事务部医疗保健系统中感染 HCV 基因型 1 并接受聚乙二醇干扰素、利巴韦林和博赛匹韦(n=3696,83%)或替拉瑞韦(n=759,17%)治疗的所有患者的数据。

结果

与接受博赛匹韦治疗的患者相比,接受替拉瑞韦治疗的患者具有更多与未达到 SVR 相关的基线特征。符合短疗程方案(博赛匹韦 28 周,替拉瑞韦 24 周)的患者中,不到一半成功完成治疗(博赛匹韦为 37%,替拉瑞韦为 27.5%);约 25%的患者提前停药,其余患者接受了更长时间的治疗。本应完成 48 周疗程的患者中,仅 35%的博赛匹韦治疗患者和 34%的替拉瑞韦治疗患者完成了>44 周治疗。总体 SVR 率为 51.5%,肝硬化患者为 42.7%,初治患者为 56.8%,既往复发患者为 64.2%,既往部分应答患者为 31.7%,既往无应答患者为 29.8%。在整个人群或亚组中,接受博赛匹韦或替拉瑞韦治疗的患者 SVR 率无显著差异。未达到 SVR 的最重要预测因素是 IL28B 基因型、高病毒载量、黑种人、糖尿病、天门冬氨酸氨基转移酶与血小板比值指数或 FIB-4 评分高、血小板计数低或低密度脂蛋白胆固醇水平低。使用促红细胞生成素与 SVR 无关。

结论

在一项针对 HCV 基因型 1 感染退伍军人的全国性分析中,接受博赛匹韦和替拉瑞韦治疗的患者 SVR 率相似。然而,在真实临床实践中,治疗完成率和 SVR 率明显低于临床试验。

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