Effectiveness of Sofosbuvir, Ledipasvir/Sofosbuvir, or Paritaprevir/Ritonavir/Ombitasvir and Dasabuvir Regimens for Treatment of Patients With Hepatitis C in the Veterans Affairs National Health Care System.
Effectiveness of Sofosbuvir, Ledipasvir/Sofosbuvir, or Paritaprevir/Ritonavir/Ombitasvir and Dasabuvir Regimens for Treatment of Patients With Hepatitis C in the Veterans Affairs National Health Care System.
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DOI：
10.1053/j.gastro.2016.05.049
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发表时间：
2016-09
期刊：
影响因子：
29.4
通讯作者：
Berry K
中科院分区：
文献类型：
--
作者：
Ioannou GN;Beste LA;Chang MF;Green PK;Lowy E;Tsui JI;Su F;Berry K
我们研究了索磷布韦、雷迪帕韦/索磷布韦、帕立瑞韦/利托那韦/翁比他韦和达沙布韦 (PrOD) 在治疗感染丙型肝炎病毒 (HCV) 基因型 1、2、3 或 4 的不同亚组患者中的真实有效性。我们对 17,487 名 HCV 感染患者（13,974 名 HCV 患者）的数据进行了回顾性分析。 2014 年 1 月 1 日至 6 月开始接受索磷布韦 (n = 2986)、雷迪帕韦/索磷布韦 (n = 11,327) 或 ProOD (n = 3174) 治疗的患者2015 年 2 月 20 日在退伍军人事务部医疗保健系统中。对截至 2016 年 4 月 15 日的数据进行分析，以评估治疗完成情况和治疗后 12 周的持续病毒学应答 (SVR12)。患者平均年龄为 61 ± 7 岁，97% 为男性，52% 为非西班牙裔白人，29% 为非西班牙裔黑人，32% 诊断为肝硬化（9.9% 为失代偿性肝硬化），36% 的纤维化 4 指数评分 >3.25（肝硬化指标），29% 之前接受过抗病毒治疗。基因 1 型 HCV 感染受试者（雷迪帕韦/索磷布韦和 PrOD 方案之间无显着差异）的 SVR12 率为 92.8%（95% 置信区间 [CI]，92.3%–93.2%），基因 2 型感染受试者（用索磷布韦和 PrOD 治疗方案治疗）的 SVR12 率为 86.2%（95% CI，84.6%–87.7%）利巴韦林），74.8%（95% CI，72.2%–77.3%）的基因型 3 感染者（接受雷迪帕韦/索磷布韦加利巴韦林的患者为 77.9%，接受索磷布韦和聚乙二醇干扰素加利巴韦林的患者为 87.0%，接受索磷布韦加利巴韦林的患者为 70.6%），以及89.6% (95% CI 82.8%–93.9%) 的人患有基因型 4 感染。在肝硬化患者中，90.6%的HCV基因型1患者、77.3%的HCV基因型2患者、65.7%的HCV基因型3患者和83.9%的HCV基因型4患者实现了SVR12。在既往接受过治疗的患者中，92.6% 为基因型 1； 80.2% 为基因型 2； 69.2% 为基因型 3； 93.5% 的基因型 4 达到了 SVR12。在初治患者中，92.8% 为基因型 1； 88.0% 基因型 2； 77.5% 基因型 3； 88.3% 的基因型 4 达到了 SVR12。雷迪帕韦/索磷布韦八周治疗方案使 94.3% 的符合条件的基因 1 型 HCV 感染患者获得了 SVR12；该疗法并未得到充分利用。在退伍军人事务部国家医疗保健系统中，基因型 1-4 的 HCV 感染患者（范围为 75% 至 93%）中有很高比例的患者达到了 SVR12，接近临床试验报告的结果，尤其是基因型 1 感染的患者。雷迪帕韦/索磷布韦 8 周治疗方案对于符合条件的基因 1 型 HCV 感染患者有效，并且可以降低费用。肝硬化和基因型 2 或 3 感染者的 SVR 仍有很大改善空间。
We investigated the real-world effectiveness of sofosbuvir, ledipasvir/sofosbuvir, and paritaprevir/ ritonavir/ombitasvir and dasabuvir (PrOD) in treatment of different subgroups of patients infected with hepatitis C virus (HCV) genotypes 1, 2, 3, or 4. We performed a retrospective analysis of data from 17,487 patients with HCV infection (13,974 with HCV genotype 1; 2131 with genotype 2; 1237 with genotype 3; and 135 with genotype 4) who began treatment with sofosbuvir (n = 2986), ledipasvir/sofosbuvir (n = 11,327), or PrOD (n = 3174), with or without ribavirin, from January 1, 2014 through June 20, 2015 in the Veterans Affairs health care system. Data through April 15, 2016 were analyzed to assess completion of treatments and sustained virologic response 12 weeks after treatment (SVR12). Mean age of patients was 61 ± 7 years, 97% were male, 52% were non-Hispanic white, 29% were non-Hispanic black, 32% had a diagnosis of cirrhosis (9.9% with decompensated cirrhosis), 36% had a Fibrosis-4 index score >3.25 (indicator of cirrhosis), and 29% had received prior antiviral treatment. An SVR12 was achieved by 92.8% (95% confidence interval [CI], 92.3%–93.2%) of subjects with HCV genotype 1 infection (no significant difference between ledipasvir/sofosbuvir and PrOD regimens), 86.2% (95% CI, 84.6%–87.7%) of those with genotype 2 infection (treated with sofosbuvir and ribavirin), 74.8% (95% CI, 72.2%–77.3%) of those with genotype 3 infection (77.9% in patients given ledipasvir/sofosbuvir plus ribavirin, 87.0% in patients given sofosbuvir and pegylated-interferon plus ribavirin, and 70.6% of patients given sofosbuvir plus ribavirin), and 89.6% (95% CI 82.8%–93.9%) of those with genotype 4 infection. Among patients with cirrhosis, 90.6% of patients with HCV genotype 1, 77.3% with HCV genotype 2, 65.7% with HCV genotype 3, and 83.9% with HCV genotype 4 achieved an SVR12. Among previously treated patients, 92.6% with genotype 1; 80.2% with genotype 2; 69.2% with genotype 3; and 93.5% with genotype 4 achieved SVR12. Among treatment-naive patients, 92.8% with genotype 1; 88.0% with genotype 2; 77.5% with genotype 3; and 88.3% with genotype 4 achieved SVR12. Eight-week regimens of ledipasvir/sofosbuvir produced an SVR12 in 94.3% of eligible patients with HCV genotype 1 infection; this regimen was underused. High proportions of patients with HCV infections genotypes 1–4 (ranging from 75% to 93%) in the Veterans Affairs national health care system achieved SVR12, approaching the results reported in clinical trials, especially in patients with genotype 1 infection. An 8-week regimen of ledipasvir/sofosbuvir is effective for eligible patients with HCV genotype 1 infection and could reduce costs. There is substantial room for improvement in SVRs among persons with cirrhosis and genotype 2 or 3 infections.