Freedberg K A, Losina E, Weinstein M C, Paltiel A D, Cohen C J, Seage G R, Craven D E, Zhang H, Kimmel A D, Goldie S J
Division of General Internal Medicine and the Partners AIDS Research Center, Massachusetts General Hospital and Harvard Medical School, Boston 02114, USA.
N Engl J Med. 2001 Mar 15;344(11):824-31. doi: 10.1056/NEJM200103153441108.
Combination antiretroviral therapy with a combination of three or more drugs has become the standard of care for patients with human immunodeficiency virus (HIV) infection in the United States. We estimated the clinical benefits and cost effectiveness of three-drug antiretroviral regimens.
We developed a mathematical simulation model of HIV disease, using the CD4 cell count and HIV RNA level as predictors of the progression of disease. Outcome measures included life expectancy, life expectancy adjusted for the quality of life, lifetime direct medical costs, and cost effectiveness in dollars per quality-adjusted year of life gained. Clinical data were derived from major clinical trials, including the AIDS Clinical Trials Group 320 Study. Data on costs were based on the national AIDS Cost and Services Utilization Survey, with drug costs obtained from the Red Book.
For patients similar to those in the AIDS Clinical Trials Group 320 Study (mean CD4 cell count, 87 per cubic millimeter), life expectancy adjusted for the quality of life increased from 1.53 to 2.91 years, and per-person lifetime costs increased from $45,460 to $77,300 with three-drug therapy as compared with no therapy. The incremental cost per quality-adjusted year of life gained, as compared with no therapy, was $23,000. On the basis of additional data from other major studies, the cost-effectiveness ratio for three-drug therapy ranged from $13,000 to $23,000 per quality-adjusted year of life gained. The initial CD4 cell count and drug costs were the most important determinants of costs, clinical benefits, and cost effectiveness.
Treatment of HIV infection with a combination of three antiretroviral drugs is a cost-effective use of resources.
在美国，使用三种或更多药物联合的抗逆转录病毒疗法已成为人类免疫缺陷病毒（HIV）感染患者的标准治疗方案。我们评估了三联抗逆转录病毒治疗方案的临床益处和成本效益。
我们建立了一个HIV疾病的数学模拟模型，将CD4细胞计数和HIV RNA水平作为疾病进展的预测指标。结果指标包括预期寿命、根据生活质量调整的预期寿命、终身直接医疗费用以及每获得一个质量调整生命年的成本效益（以美元计）。临床数据来自主要临床试验，包括艾滋病临床试验组320研究。成本数据基于全国艾滋病成本与服务利用调查，药物成本从《红皮书》获取。
对于与艾滋病临床试验组320研究中的患者相似的患者（平均CD4细胞计数为每立方毫米87个），与不治疗相比，三联疗法使根据生活质量调整的预期寿命从1.53年增加到2.91年，人均终身成本从45,460美元增加到77,300美元。与不治疗相比，每获得一个质量调整生命年的增量成本为23,000美元。根据其他主要研究的额外数据，三联疗法的成本效益比为每获得一个质量调整生命年13,000美元至23,000美元。初始CD4细胞计数和药物成本是成本、临床益处和成本效益的最重要决定因素。
使用三种抗逆转录病毒药物联合治疗HIV感染是一种具有成本效益的资源利用方式。
