Division of Global Health Equity, Brigham and Women's Hospital, Boston, Massachusetts, United States of America.
PLoS Med. 2011 Sep;8(9):e1001095. doi: 10.1371/journal.pmed.1001095. Epub 2011 Sep 20.
In a randomized clinical trial of early versus standard antiretroviral therapy (ART) in HIV-infected adults with a CD4 cell count between 200 and 350 cells/mm³ in Haiti, early ART decreased mortality by 75%. We assessed the cost-effectiveness of early versus standard ART in this trial.
Trial data included use of ART and other medications, laboratory tests, outpatient visits, radiographic studies, procedures, and hospital services. Medication, laboratory, radiograph, labor, and overhead costs were from the study clinic, and hospital and procedure costs were from local providers. We evaluated cost per year of life saved (YLS), including patient and caregiver costs, with a median of 21 months and maximum of 36 months of follow-up, and with costs and life expectancy discounted at 3% per annum. Between 2005 and 2008, 816 participants were enrolled and followed for a median of 21 months. Mean total costs per patient during the trial were US$1,381 for early ART and US$1,033 for standard ART. After excluding research-related laboratory tests without clinical benefit, costs were US$1,158 (early ART) and US$979 (standard ART). Early ART patients had higher mean costs for ART (US$398 versus US$81) but lower costs for non-ART medications, CD4 cell counts, clinically indicated tests, and radiographs (US$275 versus US$384). The cost-effectiveness ratio after a maximum of 3 years for early versus standard ART was US$3,975/YLS (95% CI US$2,129/YLS-US$9,979/YLS) including research-related tests, and US$2,050/YLS excluding research-related tests (95% CI US$722/YLS-US$5,537/YLS).
Initiating ART in HIV-infected adults with a CD4 cell count between 200 and 350 cells/mm³ in Haiti, consistent with World Health Organization advice, was cost-effective (US$/YLS <3 times gross domestic product per capita) after a maximum of 3 years, after excluding research-related laboratory tests.
ClinicalTrials.gov NCT00120510.
在海地进行的一项针对 CD4 细胞计数在 200 至 350 个/mm³之间的 HIV 感染者的早期与标准抗逆转录病毒治疗（ART）的随机临床试验中，早期 ART 降低了 75%的死亡率。我们评估了该试验中早期与标准 ART 的成本效益。
试验数据包括 ART 和其他药物的使用、实验室检查、门诊就诊、影像学研究、操作和住院服务。药物、实验室、影像学、劳动力和管理费用来自研究诊所，而医院和操作费用来自当地提供者。我们评估了每挽救 1 年生命的成本（YLS），包括患者和护理人员的成本，随访中位数为 21 个月，最长 36 个月，成本和预期寿命每年贴现 3%。2005 年至 2008 年，816 名参与者入组并随访中位数为 21 个月。试验期间每名患者的平均总费用为早期 ART 组为 1381 美元，标准 ART 组为 1033 美元。排除无临床获益的研究相关实验室检查后，费用分别为早期 ART 组 1158 美元和标准 ART 组 979 美元。早期 ART 患者的 ART 平均费用较高（398 美元对 81 美元），但非 ART 药物、CD4 细胞计数、有临床指征的检查和影像学检查费用较低（275 美元对 384 美元）。3 年内，早期 ART 与标准 ART 的成本效益比（包括研究相关检查）为 3975 美元/YLS（95%CI 2129 美元/YLS-9979 美元/YLS），排除研究相关检查后为 2050 美元/YLS（95%CI 722 美元/YLS-5537 美元/YLS）。
在海地，根据世界卫生组织的建议，对 CD4 细胞计数在 200 至 350 个/mm³之间的 HIV 感染者进行早期 ART 治疗，在最长 3 年内是具有成本效益的（每 YLS 美元<3 倍人均国内生产总值），排除研究相关实验室检查后。
ClinicalTrials.gov NCT00120510。
