Walker David R, Pedrosa Marcos C, Manthena Shivaji R, Patel Nikil, Marx Steven E
AbbVie, Inc., North Chicago, IL, USA.
Adv Ther. 2015 Nov;32(11):1117-27. doi: 10.1007/s12325-015-0258-5. Epub 2015 Nov 4.
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.
临床试验已证明全口服直接抗病毒（DAA）方案在治疗丙型肝炎病毒（HCV）感染患者中的疗效。本研究评估了两种最近获批方案；帕立普韦/利托那韦/奥比他韦；达沙布韦（3D），以及索磷布韦/来迪帕司韦（SOF/LDV）在HCV基因1型患者中的实际疗效。
对2013年10月1日至2015年8月14日的管理索赔数据（艾美仕市场研究公司以患者为中心的数据仓库/Medivo数据库）进行回顾性分析。选择年龄≥19岁、感染HCV基因1型、有3D或SOF/LDV处方配药且在治疗后4 - 30周有≥1次HCV病毒载量（VL）评估的患者进行分析。确定实现持续病毒学应答（SVR；定义为HCV RNA≤43 IU/mL）的患者百分比。使用Fisher精确检验比较治疗组之间未经调整的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评估的患者亚组重复进行分析。
共纳入1707例患者（44例使用3D，1663例使用SOF/LDV）。大多数（60%）为男性，49%年龄在55 - 64岁，97%在索引前1年未接受过治疗。与3D相比，接受SOF/LDV治疗的患者实现SVR的未调整相对风险（RR）为0.98%，95%置信区间（CI）：0.93 - 1.02。在对基线协变量进行调整后，RR为0.98%，95%CI：0.94 - 1.03。
在这一早期的真实世界数据观察中，全口服DAA方案在HCV基因1型患者中的疗效与注册试验结果一致。两种方案的SVR率相似。需要进一步研究来证实这些结果。
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