Cost-effectiveness of Early vs. Delayed Antiretroviral Therapy in Haiti

描述（由申请人提供）：抗逆转录病毒疗法（ART）可降低工业化和欠发达地区艾滋病毒/艾滋病患者的发病率和死亡率。关于使用 ART 的重要问题仍然存在：其中关键是在资源匮乏的环境中启动 ART 的最佳时间。目前世界卫生组织 (WHO) 的指南建议在疾病过程中开始治疗的时间晚于美国卫生与公众服务部和国际艾滋病协会的指南。目前对此问题尚未达成共识。有关 ART 启动时间的政策决策必须考虑临床获益、药物相关毒性风险、人力资源需求、财务成本、治疗效果、依从性和耐药性之间的复杂权衡。候选人提议通过一项研究对早期 ART 与延迟 ART 进行成本效益分析来解决这个问题，该研究与海地 GHESKIO 中心（海地卡波西肉瘤和机会性感染研究组）正在进行的 CIPRA HT 001 随机临床试验是独立的，但又是互补的。正在进行的临床试验将艾滋病前期疾病（WHO I、I​​I 或 III 期）且 CD4 细胞计数在 200 至 350 之间的患者随机分为早期（两周内）和延迟（CD4 < 200 或临床艾滋病）ART。 CIPRA 试验的主要结果是生存。候选人提出的研究将添加有关依从性的影响以及早期与延迟 ART 的成本效益的关键信息。所提出的决策模型的研究计划由两个具体目标组成： 1. 比较 CIPRA 试验中早期治疗组和延迟治疗组患者对 ART 的依从性和依从障碍。依从性将通过药房药丸计数和患者自我报告来衡量。 2. 从社会角度进行成本效益分析，比较海地存在或不存在结核病的情况下早期和延迟 ART 的情况。结果指标将包括预期寿命、一生直接医疗费用总额以及每增加生命年的成本效益（以美元计）。敏感性分析将检查依从率、住院率和 ART 费用的影响。这项研究与公共卫生相关，因为这将是第一个基于随机临床试验数据的 ART 启动时间的成本效益分析，并将影响全球艾滋病毒的治疗。

DESCRIPTION (provided by applicant): Antiretroviral therapy (ART) decreases morbidity and mortality in patients with HIV/AIDS, both in industrialized and less developed settings. Important questions about the use of ART remain: key among them is the optimal time to initiate ART in resource-poor settings. Current World Health Organization (WHO) guidelines recommend treatment initiation later in the course of the disease than the US Department of Health and Human Services and the International AIDS Society guidelines. There is currently no consensus on the issue. Policy decisions regarding the timing of ART initiation must incorporate complex trade-offs among clinical benefits, risks of medication-related toxicity, human resource requirements, financial cost, treatment efficacy, adherence, and drug resistance. The candidate proposes to address this issue by conducting a cost-effectiveness analysis of early versus delayed ART in a study that is separate but complementary to the CIPRA HT 001 randomized clinical trial that is underway at the GHESKIO Center (Haitian Study Group on Kaposi's Sarcoma and Opportunistic Infections) in Haiti. The ongoing clinical trial randomizes patients with pre-AIDS disease (WHO stage I, II, or III) and CD4 cells counts between 200 and 350 to early (within 2 weeks) versus delayed (CD4 < 200 or clinical AIDS) ART. The primary outcome for the CIPRA trial is survival. The candidate's proposed research will add critical information regarding the impact of adherence and the cost-effectiveness of early versus delayed ART. The research plan of the proposed decision model is composed of two specific aims: 1. To compare adherence to ART and adherence barriers between patients in the early and delayed treatment groups in the CIPRA trial. Adherence will be measured by pharmacy pill counts and by patient self-report. 2. To conduct a cost-effectiveness analysis comparing early versus delayed ART in Haiti in the presence or absence of tuberculosis from a societal perspective. Outcome measures will include life expectancy, lifetime total direct medical costs, and cost-effectiveness in dollars per life-year gained. Sensitivity analyses will examine the impact of adherence rates, hospitalization rates, and cost of ART. This research is relevant to public health, as this will be the first cost-effectiveness analysis of the timing of ART initiation that is based on randomized clinical trial data, and will impact the treatment of HIV globally.