Early View of the Effectiveness of New Direct-Acting Antiviral (DAA) Regimens in Patients with Hepatitis C Virus (HCV).
Early View of the Effectiveness of New Direct-Acting Antiviral (DAA) Regimens in Patients with Hepatitis C Virus (HCV).
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DOI：
10.1007/s12325-015-0258-5
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发表时间：
2015-11
影响因子：
3.8
通讯作者：
Marx SE
中科院分区：
文献类型：
--
作者：
Walker DR;Pedrosa MC;Manthena SR;Patel N;Marx SE
临床试验已经证明了全口服直接作用抗病毒药物（DAA）方案在治疗丙型肝炎病毒（HCV）感染患者中的疗效。该研究评估了两种最近批准的方案的真实世界有效性：帕利匹韦/利托那韦/奥比他韦;达沙布韦（3D）和索非布韦/雷迪帕韦（SOF/LDV）在HCV基因型1患者中的应用。对2013年10月1日至2015年8月14日的行政索赔数据（IMS Health以患者为中心的数据仓库/Medivo数据库）进行了回顾性分析。选择年龄≥19岁、HCV基因型1感染、3D或SOF/LDV处方填写以及治疗后第4-30周≥1次HCV病毒载量（VL）评估的患者进行分析。确定了达到持续病毒学应答（SVR;定义为HCV RNA ≤43 IU/mL）的患者数。使用Fisher精确检验比较治疗组之间的未校正SVR率。还使用多变量回归评估SVR率，并对年龄组、性别和治疗史进行调整。对治疗后12至30周进行VL评估的患者子集重复分析。共纳入1707例（44例3D和1663例SOF/LDV）患者。大多数（60%）为男性，49%的年龄为55-64岁，97%的患者在索引前1年未接受过治疗。与3D相比，SOF/LDV治疗患者实现SVR的未校正相对风险（RR）为0.98%，95%置信区间（CI）：0.93-1.02。校正基线协变量后，RR为0.98%，95%CI：0.94-1.03。在这个早期的真实世界数据中，全口服DAA方案在HCV基因型1患者中的有效性与注册试验的结果一致。两种方案的SVR率相似。需要进一步的研究来证实这些结果。艾伯维公司本文的在线版本（doi：10.1007/s12325-015-0258-5）包含补充材料，可供授权用户使用。
Clinical trials have demonstrated the efficacy of all-oral direct-acting antiviral (DAA) regimens in the treatment of patients infected with hepatitis C virus (HCV). This study assessed real-world effectiveness of two recently approved regimens; paritaprevir/ritonavir/ombitasvir; dasabuvir (3D), and sofosbuvir/ledipasvir (SOF/LDV) in patients with HCV genotype 1. A retrospective analysis of administrative claims data (IMS Health Patient-Centric Data Warehouse/Medivo database) from October 1, 2013 to August 14, 2015 was conducted. Patients ≥19 years of age with a HCV genotype 1 infection, a prescription fill for 3D or SOF/LDV, and ≥1 HCV viral load (VL) assessment from weeks 4–30 post-treatment were selected for analysis. Percentages of patients achieving sustained virologic response (SVR; defined as HCV RNA ≤43 IU/mL) were determined. Unadjusted SVR rates were compared between treatment groups using Fisher’s exact tests. SVR rates were also assessed using multivariate regression with adjustment for age group, sex, and treatment history. Analyses were repeated for a subset of patients with VL assessment from 12 to 30 weeks post-treatment. A total of 1707 (44 3D and 1663 SOF/LDV) patients were included. The majority (60%) were male, 49% were aged 55–64 years, and 97% were treatment-naïve 1 year prior to index. The unadjusted relative risk (RR) for achieving SVR in patients treated with SOF/LDV compared with 3D was 0.98%, 95% confidence interval (CI): 0.93–1.02. After adjusting for the baseline covariates, the RR was 0.98%, 95% CI: 0.94–1.03. In this early view of real-world data, effectiveness of all-oral DAA regimens in HCV genotype 1 patients was concordant with results from registration trials. SVR rates were similar for the two regimens. Further studies are needed to confirm these results. AbbVie, Inc. The online version of this article (doi:10.1007/s12325-015-0258-5) contains supplementary material, which is available to authorized users.