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2011 年英国初治和经治的抗逆转录病毒治疗(ART)患者中洛匹那韦/利托那韦(LPV/r)和阿扎那韦/利托那韦(ATV+RTV)方案的经济学和与健康相关的生活质量(HRQoL)比较。

Economic and health-related quality-of-life (HRQoL) comparison of lopinavir/ritonavir (LPV/r) and atazanavir plus ritonavir (ATV+RTV) based regimens for antiretroviral therapy (ART)-naïve and -experienced United Kingdom patients in 2011.

机构信息

Department of Health Science and Research, College of Health Professions, Medical University of South Carolina, SC 29425, USA.

出版信息

J Med Econ. 2012;15(4):796-806. doi: 10.3111/13696998.2012.691927. Epub 2012 Jun 7.

Abstract

BACKGROUND

Using a United Kingdom (UK)-based National Health Services perspective for 2011 this study first estimated the cost-effectiveness and budget impact implications for lopinavir/ritonavir (LPV/r) vs atazanavir plus ritonavir (ATV+RTV) treatment of antiretroviral therapy (ART)-naïve patients and secondly examined the long-term health-related quality-of-life (HRQoL) and economic implications for LPV/r vs ATV+RTV treatment of ART-experienced patients.

METHODS

A previously published Markov model that integrates epidemiological data of human immunodeficiency virus (HIV) with predictors of coronary heart disease (CHD) was modified under a clearly specified set of assumptions to reflect viral load (VL) suppression profiles and other differences for these two regimens, applying results from the CASTLE study in ART-naïve patients and using data from BMS-045 in ART-experienced patients. ART costs were referenced to current (2011) pricing guidelines in the UK. Medical care costs reflected UK treatment patterns and relevant drug pricing. Costs and outcomes were discounted at 3.5% per year. Costs are expressed in British pounds (£) and life expectancy in quality-adjusted life years (QALYs).

RESULTS

In the ART-naïve subjects, the model predicted a marginal improved life expectancy of 0.031 QALYs (11 days) for the ATV+RTV regimen as a result of predicted CHD outcomes based on lower increases in cholesterol levels compared with the LPV/r regimen. The model demonstrated cost savings with the LPV/r regimen. The total lifetime cost savings was £4070 per patient for the LPV/r regimen. LPV/r saved £2133 and £3409 per patient at 5 and 10 years, respectively. Referenced to LPV/r, the incremental cost-effectiveness ratio (ICER) for ATV+RTV was £149,270/QALY. For ART-experienced patients VL suppression differences favored LPV/r, while CHD risk associated with elevated total cholesterol marginally favored ATV+RTV, resulting in a net improvement in life expectancy of 0.31 QALYs (106 days) for LPV/r. Five-year costs were £5538 per patient greater for ATV+RTV, with a discounted lifetime saving of £1445 per LPV/r patient. LPV/r was modestly dominant economically, producing better outcomes and cost savings.

LIMITATIONS

The limitations of this study include uncertainty related to how well the model's assumptions capture current practice, as well as the validity of the model parameters used. This study was limited to using aggregated data in the public domain from the two clinical trials. Thus, some of the model parameters may reflect limitations due to trial design and data aggregation bias. This study has attempted to illuminate the effect of these limitations by presenting the results of the comprehensive sensitivity analysis.

CONCLUSIONS

Based on 2011 costs of HIV in the UK and the published efficacy data from the CASTLE and BMS-045 studies, ATV+RTV-based regimens are not expected to be a cost-effective use of resources for ART-naïve patients similar to patients in the CASTLE study, nor for ART-experienced patients based on the only published comparison of ATV+RTV and LPV/r.

摘要

背景

本研究采用英国国家卫生服务体系(NHS)的视角,对 2011 年洛匹那韦/利托那韦(LPV/r)与阿扎那韦/利托那韦(ATV+RTV)治疗初治抗逆转录病毒治疗(ART)患者的成本效果和预算影响进行了首次估计,其次还考察了 LPV/r 与 ATV+RTV 治疗 ART 经验患者的长期健康相关生活质量(HRQoL)和经济影响。

方法

先前发表的一种马尔可夫模型,该模型整合了人类免疫缺陷病毒(HIV)的流行病学数据与冠心病(CHD)的预测因素,根据这两种方案的病毒载量(VL)抑制情况和其他差异进行了修改,并明确规定了一系列假设,该模型适用于初治患者的 CASTLE 研究结果,并使用 BMS-045 的数据。ART 成本参照了英国当前(2011 年)的定价指南。医疗费用反映了英国的治疗模式和相关药物定价。成本和结果按每年 3.5%贴现。成本以英镑(£)表示,预期寿命以质量调整生命年(QALY)表示。

结果

在初治患者中,该模型预测由于 LPV/r 方案的胆固醇水平升高幅度较低,与 ATV+RTV 方案相比,冠心病结局导致的预期寿命延长了 0.031 QALY(11 天)。LPV/r 方案显示出成本节约。LPV/r 方案每位患者的终身成本节约为 4070 英镑。LPV/r 在 5 年和 10 年时分别为每位患者节省 2133 英镑和 3409 英镑。相对于 LPV/r,ATV+RTV 的增量成本效果比(ICER)为 149270 英镑/QALY。对于 ART 经验患者,VL 抑制差异有利于 LPV/r,而与总胆固醇升高相关的冠心病风险则略微有利于 ATV+RTV,导致 LPV/r 患者的预期寿命净增加 0.31 QALY(106 天)。ATV+RTV 患者五年的成本增加了 5538 英镑,每例 LPV/r 患者的终生节省成本为 1445 英镑。LPV/r 在经济上略有优势,产生了更好的结果和成本节约。

局限性

本研究的局限性包括模型的假设如何很好地捕捉当前实践的不确定性,以及使用的模型参数的有效性。本研究仅限于使用公共领域中来自两项临床试验的汇总数据。因此,一些模型参数可能反映了由于试验设计和数据汇总偏倚而产生的限制。本研究试图通过展示全面敏感性分析的结果来阐明这些局限性的影响。

结论

基于英国 2011 年 HIV 的成本和 CASTLE 和 BMS-045 研究发表的疗效数据,对于类似 CASTLE 研究中的患者的初治患者,基于 ATV+RTV 的方案预计不会是资源的成本有效使用,对于基于 ATV+RTV 和 LPV/r 的唯一已发表比较的 ART 经验患者也不是成本有效使用。

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