Schackman Bruce R, Scott Callie A, Walensky Rochelle P, Losina Elena, Freedberg Kenneth A, Sax Paul E
Department of Public Health, Weill Cornell Medical College, New York, New York 10021, USA.
AIDS. 2008 Oct 1;22(15):2025-33. doi: 10.1097/QAD.0b013e3283103ce6.
To evaluate the clinical impact and cost-effectiveness of HLA-B*5701 testing to guide selection of first-line HIV regimens in the United States.
Cost-effectiveness analysis using a simulation model of HIV disease. The prevalence of HLA-B5701 and the probabilities of confirmed and unconfirmed severe systemic hypersensitivity reaction among patients taking abacavir testing HLA-B5701 positive and negative were from the Prospective Randomized Evaluation of DNA Screening in a Clinical Trial study. The monthly costs of abacavir-based and tenofovir-based regimens were $1135 and $1139, respectively; similar virologic efficacy was assumed and this assumption was varied in sensitivity analysis.
Simulated cohort of patients initiating HIV therapy.
The interventions are first-line abacavir, lamivudine, and efavirenz without pretreatment HLA-B5701 testing; the same regimen with HLA-B5701 testing; and first-line tenofovir, emtricitabine, and efavirenz.
Quality-adjusted life years and lifetime medical costs discounted at 3% per annum, cost-effectiveness ratios ($/QALY).
Abacavir-based treatment without HLA-B5701 testing resulted in a projected 30.93 years life expectancy, 16.23 discounted quality-adjusted life years, and $472,200 discounted lifetime cost per person. HLA-B5701 testing added 0.04 quality-adjusted months at an incremental cost of $110, resulting in a cost-effectiveness ratio of $36,700/QALY compared with no testing. Initiating treatment with a tenofovir-based regimen increased costs without improving quality-adjusted life expectancy. HLA-B5701 testing remained the preferred strategy only if abacavir-based treatment had equal efficacy and cost less per month than tenofovir-based treatment. Results were also sensitive to the cost of HLA-B5701 testing and the prevalence of HLA-B*5701.
Pharmacogenetic testing for HLA-B*5701 is cost-effective only if abacavir-based treatment is as effective and costs less than tenofovir-based treatment.
评估HLA - B*5701检测在美国指导一线抗HIV治疗方案选择中的临床影响和成本效益。
使用HIV疾病模拟模型进行成本效益分析。HLA - B5701的患病率以及接受阿巴卡韦检测的HLA - B5701阳性和阴性患者中确诊和未确诊的严重全身性超敏反应概率来自一项临床试验中DNA筛查的前瞻性随机评估研究。基于阿巴卡韦和基于替诺福韦的治疗方案的月成本分别为1135美元和1139美元；假设两者具有相似的病毒学疗效，并在敏感性分析中对这一假设进行了调整。
模拟开始接受HIV治疗的患者队列。
干预措施包括不进行HLA - B5701预处理检测的一线阿巴卡韦、拉米夫定和依非韦伦治疗方案；进行HLA - B5701检测的相同治疗方案；以及一线替诺福韦、恩曲他滨和依非韦伦治疗方案。
质量调整生命年和按每年3%贴现的终身医疗成本、成本效益比（美元/质量调整生命年）。
不进行HLA - B5701检测的基于阿巴卡韦的治疗方案预计人均预期寿命为30.93年，贴现质量调整生命年为16.23年，贴现终身成本为472,200美元。HLA - B5701检测增加了0.04个质量调整月，增量成本为110美元，与不检测相比，成本效益比为36,700美元/质量调整生命年。开始使用基于替诺福韦的治疗方案会增加成本，且未改善质量调整预期寿命。仅当基于阿巴卡韦的治疗与基于替诺福韦的治疗疗效相同且每月成本更低时；HLA - B5701检测仍是首选策略。结果对HLA - B5701检测成本和HLA - B*5701患病率也很敏感。
仅当基于阿巴卡韦的治疗与基于替诺福韦的治疗疗效相同且成本更低时，HLA - B*5701的药物遗传学检测才具有成本效益。
