Health utilities using SF-6D scores in Japanese patients with chronic hepatitis C treated with sofosbuvir-based regimens in clinical trials.
Health utilities using SF-6D scores in Japanese patients with chronic hepatitis C treated with sofosbuvir-based regimens in clinical trials.
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在临床试验中，用基于沙发布韦的治疗方案治疗的日本慢性丙型肝炎患者使用SF-6D评分的卫生公用事业。
DOI：
10.1186/s12955-017-0598-8
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发表时间：
2017-01-31
影响因子：
3.6
通讯作者：
Hunt S
中科院分区：
文献类型：
--
作者：
Younossi Z;Stepanova M;Omata M;Mizokami M;Walters M;Hunt S
健康效用是针对健康状况的基于偏好的衡量标准，通常用于经济分析中以估计质量调整生命年。我们的目的是报告日本丙型肝炎病毒 (HCV) 患者在不同治疗方案治疗期间的标准 SF-6D 健康效用评分。日本患者参加了索磷布韦 (SOF) 联合或不联合雷迪帕韦 (LDV) 和/或利巴韦林 (RBV) 的临床试验。 SF-6D 健康效用分数是通过 SF-36 仪器在多个时间点计算得出的。纳入了 494 名 HCV 患者（基因型 1 和 2）：19% 患有肝硬化，48% 有抗 HCV 治疗史。其中，153 人接受了 SOF + RBV，170 人接受了 LDV/SOF + RBV，171 人接受了 LDV/SOF 12 周； SVR 率分别为：97%、98% 和 100%。采用三种方案治疗的患者在治疗前具有相似的 SF-6D 评分（p= 0.87）：76.1±11.5。在接受含 RBV 方案治疗期间，患者的健康效用评分在治疗结束时下降至 74.3±±12.5 (p=±0.03)，而接受不含 RBV LDV/SOF 治疗的患者在治疗 12 周后其 SF-6D 评分改善至 79.2±±12.8 (p = 0.0004)。治疗后第 12 周，在达到 SVR-12 的患者中，治疗方案之间的 SF-6D 评分相似 (p = 0.36)，并且较基线平均改善 +1.4 分 (p = 0.01)。在多变量分析中，RBV 的使用与治疗期间较低的效用评分独立相关（β=4.7±1.6，p<0.0001）。日本 HCV 患者的健康状况较低，感染清除后往往会有所改善。
Health utilities are preference-based measures for health states which are typically used in economic analyses to estimate quality-adjusted life years. Our aim is to report the standard SF-6D health utility scores in Japanese patients with hepatitis C virus (HCV) during treatment with different regimens. Japanese patients were enrolled in clinical trials of sofosbuvir (SOF) used in combination with or without ledipasvir (LDV) and/or ribavirin (RBV). The SF-6D health utility scores were calculated at multiple time points from the SF-36 instrument. Four hundred ninety-four patients with HCV (genotype 1 and 2) were enrolled: 19% with cirrhosis, 48% with a prior history of anti-HCV treatment. Of those, 153 received SOF + RBV, 170 received LDV/SOF + RBV, 171 received LDV/SOF for 12 weeks; the SVR rates were: 97, 98 and 100%, respectively. Patients treated with the three regimens had similar SF-6D scores before treatment (p = 0.87): 76.1 ± 11.5. During treatment with RBV containing regimen, patients experienced a decrement in their health utility scores to 74.3 ± 12.5 by the end of treatment (p = 0.03), while patients treated with RBV-free LDV/SOF had their SF-6D scores improved to 79.2 ± 12.8 after 12 weeks of treatment (p = 0.0004). At post-treatment week 12, in patients who achieved SVR-12, the SF-6D scores were similar between the treatment regimens (p = 0.36), and an average improvement of +1.4 points from baseline (p = 0.01) was noted. In multivariate analysis, the use of RBV was independently associated with lower utility score during treatment (beta = 4.7 ± 1.6, p < 0.0001). Health utilities are lower in Japanese HCV patients and tend to improve after clearance of infection.