Walensky Rochelle P, Wolf Lindsey L, Wood Robin, Fofana Mariam O, Freedberg Kenneth A, Martinson Neil A, Paltiel A David, Anglaret Xavier, Weinstein Milton C, Losina Elena
Massachusetts General Hospital, Brigham and Women's Hospital, Harvard University Medical School, Harvard School of Public Health, and Boston University School of Public Health, Boston, Massachusetts 02114, USA.
Ann Intern Med. 2009 Aug 4;151(3):157-66. doi: 10.7326/0003-4819-151-3-200908040-00138. Epub 2009 Jul 20.
The results of international clinical trials that are assessing when to initiate antiretroviral therapy (ART) will not be available for several years.
To inform HIV treatment decisions about the optimal CD4 threshold at which to initiate ART in South Africa while awaiting the results of these trials.
Cost-effectiveness analysis by using a computer simulation model of HIV disease.
Published data from randomized trials and observational cohorts in South Africa.
HIV-infected patients in South Africa.
5-year and lifetime.
Modified societal.
No treatment, ART initiated at a CD4 count less than 0.250 x 10(9) cells/L, and ART initiated at a CD4 count less than 0.350 x 10(9) cells/L.
Morbidity, mortality, life expectancy, medical costs, and cost-effectiveness.
RESULTS OF BASE-CASE ANALYSIS: If 10% to 100% of HIV-infected patients are identified and linked to care, a CD4 count threshold for ART initiation of 0.350 x 10(9) cells/L would reduce severe opportunistic diseases by 22,000 to 221,000 and deaths by 25,000 to 253,000 during the next 5 years compared with ART initiation at 0.250 x 10(9) cells/L; cost increases would range from $142 million (10%) to $1.4 billion (100%). Either ART initiation strategy would increase long-term survival by at least 7.9 years, with a mean per-person life expectancy of 3.8 years with no ART and 12.5 years with an initiation threshold of 0.350 x 10(9) cells/L. Compared with an initiation threshold of 0.250 x 10(9) cells/L, a threshold of 0.350 x 10(9) cells/L has an incremental cost-effectiveness ratio of $1200 per year of life saved.
Initiating ART at a CD4 count less than 0.350 x 10(9) cells/L would remain cost-effective over the next 5 years even if the probability that the trial would demonstrate the superiority of earlier therapy is as low as 17%.
This model does not consider the possible benefits of initiating ART at a CD4 count greater than 0.350 x 10(9) cells/L or of reduced HIV transmission.
Earlier initiation of ART in South Africa will probably reduce morbidity and mortality, improve long-term survival, and be cost-effective. While awaiting trial results, treatment guidelines should be liberalized to allow initiation at CD4 counts less than 0.350 x 10(9) cells/L, earlier than is currently recommended.
National Institute of Allergy and Infectious Diseases and the Doris Duke Charitable Foundation.
评估何时开始抗逆转录病毒治疗（ART）的国际临床试验结果在数年内都无法获得。
在等待这些试验结果期间，为南非关于开始ART的最佳CD4阈值的HIV治疗决策提供信息。
使用HIV疾病计算机模拟模型进行成本效益分析。
南非随机试验和观察队列的已发表数据。
南非的HIV感染患者。
5年和终身。
修正的社会视角。
不治疗、CD4细胞计数低于0.250×10⁹个细胞/L时开始ART、CD4细胞计数低于0.350×10⁹个细胞/L时开始ART。
发病率、死亡率、预期寿命、医疗费用和成本效益。
如果10%至100%的HIV感染患者被识别并与治疗相联系，与CD4细胞计数为0.250×10⁹个细胞/L时开始ART相比，CD4细胞计数为0.350×10⁹个细胞/L时开始ART在未来5年内将减少22,000至221,000例严重机会性疾病和25,000至253,000例死亡；成本增加范围为1.42亿美元（10%）至14亿美元（100%）。两种ART启动策略都将使长期生存率至少提高7.9年，不进行ART时人均预期寿命为3.8年，启动阈值为0.350×10⁹个细胞/L时人均预期寿命为12.5年。与CD4细胞计数为0.250×10⁹个细胞/L时的启动阈值相比，CD4细胞计数为0.350×10⁹个细胞/L时的启动阈值每挽救一年生命的增量成本效益比为1200美元。
即使试验证明早期治疗优越性的概率低至17%，在CD4细胞计数低于0.350×10⁹个细胞/L时开始ART在未来5年内仍具有成本效益。
该模型未考虑CD4细胞计数高于0.350×10⁹个细胞/L时开始ART的可能益处或HIV传播减少的情况。
在南非更早开始ART可能会降低发病率和死亡率，提高长期生存率，并具有成本效益。在等待试验结果期间，治疗指南应放宽，允许在CD4细胞计数低于0.350×10⁹个细胞/L时开始治疗，比目前推荐的时间更早。
美国国立过敏与传染病研究所和多丽丝·杜克慈善基金会。
