Division of Gastroenterology, Department of Internal Medicine, Nippon Medical School Chiba Hokusoh Hospital, Inzai, Chiba, Japan.
J Viral Hepat. 2012 Sep;19(9):615-22. doi: 10.1111/j.1365-2893.2011.01584.x. Epub 2012 Feb 9.
Pegylated interferon (PEG-IFN)/ribavirin combination therapy is the standard-of-care (SOC) treatment for chronic hepatitis C patients infected with hepatitis C virus (HCV) genotype 1b and high viral load. The addition of fluvastatin to SOC treatment has been suggested to be effective for better outcome in retrospective pilot analyses. We investigated whether the combination of fluvastatin with PEG-IFN/ribavirin could actually improve sustained viral response (SVR) in patients with HCV genotype 1b and high viral load. A randomized, open-labeled, controlled study was conducted between July 2008 and December 2009 in 101 chronic hepatitis C patients allocated to PEG-IFN/ribavirin combination therapy with or without fluvastatin. SVR rates were calculated in groups, stratifying host and viral factors. We also analyzed predictive factors for SVR among patients on fluvastatin with multivariate regression analysis. Rapid and early virological, and end of treatment response rates in the fluvastatin group were not significantly different from those in the non-fluvastatin group. Notwithstanding, SVR rate was significantly higher in the fluvastatin group than in the non-fluvastatin group (63.0%vs 41.7%, P = 0.0422). Comparison of the two groups stratifying demographic data and HCV characteristics showed significantly higher SVR rates to more than 80% in males, more than two mutations in the interferon sensitivity determining region (ISDR), and a history of relapse among the fluvastatin group than the non-fluvastatin group. Being male and major genotype IL28B single nucleotide polymorphisms (SNPs) were independent predictive factors for SVR among patients on fluvastatin with multivariate analysis. Fluvastatin-combined with PEG-IFN/ribavirin therapy significantly improves SVR rates in patients with HCV genotype 1b and high viral load. Male and major genotype IL28B SNPs were independent predictors for SVR among patients on fluvastatin combination therapy.
聚乙二醇干扰素（PEG-IFN）/利巴韦林联合疗法是慢性丙型肝炎病毒（HCV）基因型 1b 且病毒载量高的患者的标准治疗（SOC）。在回顾性试点分析中，添加氟伐他汀到 SOC 治疗被认为可提高疗效。我们研究了氟伐他汀联合 PEG-IFN/利巴韦林治疗是否可实际提高 HCV 基因型 1b 且病毒载量高的患者的持续病毒学应答（SVR）率。2008 年 7 月至 2009 年 12 月，我们进行了一项随机、开放标签、对照研究，纳入了 101 例慢性丙型肝炎患者，分配到 PEG-IFN/利巴韦林联合治疗加或不加氟伐他汀。根据宿主和病毒因素分层，计算各组的 SVR 率。我们还通过多元回归分析分析了氟伐他汀治疗患者的 SVR 预测因素。氟伐他汀组的快速和早期病毒学及治疗结束时的应答率与非氟伐他汀组无显著差异。然而，氟伐他汀组的 SVR 率显著高于非氟伐他汀组（63.0%vs41.7%，P=0.0422）。比较两组的人口统计学数据和 HCV 特征显示，氟伐他汀组的 SVR 率显著高于 80%的男性、干扰素敏感性决定区（ISDR）中多于两个突变和复发史患者，而非氟伐他汀组。多元分析显示，氟伐他汀治疗患者中，男性和主要基因型 IL28B 单核苷酸多态性（SNP）是 SVR 的独立预测因素。氟伐他汀联合 PEG-IFN/利巴韦林治疗可显著提高 HCV 基因型 1b 且病毒载量高的患者的 SVR 率。男性和主要基因型 IL28B SNP 是氟伐他汀联合治疗患者 SVR 的独立预测因素。
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