Schackman Bruce R, Freedberg Kenneth A, Weinstein Milton C, Sax Paul E, Losina Elena, Zhang Hong, Goldie Sue J
Department of Health Policy and Management, Harvard School of Public Health, Boston, MA, USA.
Arch Intern Med. 2002 Nov 25;162(21):2478-86. doi: 10.1001/archinte.162.21.2478.
The appropriate time to initiate antiretroviral therapy is controversial for human immunodeficiency virus (HIV)-infected patients with CD4 cell counts between 200/microL and 350/microL and low levels of HIV RNA, potentially leading to barriers to treatment access.
To examine the effect of cholesterol changes and fat redistribution symptoms on the clinical benefits and cost-effectiveness of early antiretroviral therapy in these patients.
We used a state-transition model to compare initiating antiretroviral therapy at CD4 cell counts of 350/microL (early therapy) with initiating therapy at CD4 cell counts of 200/microL (deferred therapy) in patients with HIV RNA levels of 10,000 to 30,000 copies/mL. Data were from randomized clinical trials, cohort studies, and other published literature.
If cholesterol changes associated with antiretroviral therapy resulted in a permanent increase in coronary heart disease risk, life expectancy with early therapy was 16.54 years (vs 16.66 years without this risk) and with deferred therapy was 13.73 years (vs 13.80 years without this risk). Early therapy was a more efficient use of resources (ie, dominated) compared with deferred therapy. Early therapy cost $13,000 per quality-adjusted life-year compared with no therapy with or without increased coronary heart disease risk, and $17,000 to $24,000 per quality-adjusted life-year taking into account the quality-of-life reduction in patients with fat distribution symptoms. Early therapy had a higher quality-adjusted life expectancy than deferred therapy as long as this quality-of-life reduction was 70% or less.
Changes in cholesterol or quality of life associated with antiretroviral therapy do not justify limiting access to early HIV treatment. The effect of fat redistribution symptoms on quality of life will determine the optimal choice of early vs deferred therapy for an individual patient.
对于CD4细胞计数在200/微升至350/微升之间且HIV RNA水平较低的人类免疫缺陷病毒（HIV）感染患者，启动抗逆转录病毒治疗的合适时机存在争议，这可能导致治疗获取障碍。
研究胆固醇变化和脂肪重新分布症状对这些患者早期抗逆转录病毒治疗的临床益处和成本效益的影响。
我们使用状态转换模型，比较HIV RNA水平为10,000至30,000拷贝/毫升的患者在CD4细胞计数为350/微升时启动抗逆转录病毒治疗（早期治疗）与在CD4细胞计数为200/微升时启动治疗（延迟治疗）的情况。数据来自随机临床试验、队列研究和其他已发表的文献。
如果与抗逆转录病毒治疗相关的胆固醇变化导致冠心病风险永久增加，早期治疗的预期寿命为16.54年（无此风险时为16.66年），延迟治疗的预期寿命为13.73年（无此风险时为13.80年）。与延迟治疗相比，早期治疗是对资源的更有效利用（即占优）。与无论有无冠心病风险增加的不治疗相比，早期治疗每质量调整生命年成本为13,000美元，考虑到有脂肪分布症状患者的生活质量下降，每质量调整生命年成本为17,000至24,000美元。只要这种生活质量下降为70%或更低，早期治疗的质量调整预期寿命就高于延迟治疗。
与抗逆转录病毒治疗相关的胆固醇变化或生活质量变化并不能成为限制早期HIV治疗获取的理由。脂肪重新分布症状对生活质量的影响将决定个体患者早期治疗与延迟治疗的最佳选择。
