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

海地早期抗逆转录病毒治疗与延迟抗逆转录病毒治疗的成本效益

• 批准号: 8018138
• 负责人: SERENA Patricia KOENIG
• 金额: $ 12.54万
• 依托单位: BRIGHAM AND WOMEN'S HOSPITAL
• 依托单位国家: 美国
• 财政年份: 2004
• 资助国家: 美国
• 起止时间: 2004-09-01 至 2012-04-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8018138
• 关键词: AIDS/HIV problem; Acquired Immunodeficiency Syndrome; Address; Adherence; Adult; Affect; Benefits and Risks; CD4 Lymphocyte Count; Cells; Clinical; Clinical Trials; Complex; Computer Simulation; Consensus; Cost Effectiveness Analysis; Cost Measures; Data; Data Analyses; Data Set; Decision Modeling; Disease; Drug resistance; Early treatment; Financial cost; Grant; Guidelines; HIV; Haiti; Hospitalization; Human Resources; Infection; International; International AIDS; Journals; Kaposi Sarcoma; Laboratories; Life; Life Expectancy; Manuscripts; Measures; Medical; Mentored Research Scientist Development Award; Methodology; Modeling; Monitor; Morbidity - disease rate; Opportunistic Infections; Outcome; Outcome Measure; Patient Self-Report; Patients; Peer Review; Pharmaceutical Preparations; Pharmacy facility; Policies; Preparation; Principal Investigator; Public Health; Publications; Pulmonary Tuberculosis; Questionnaires; Randomized; Randomized Clinical Trials; Research; Resources; Societies; Staging; Time; Toxic effect; Treatment Cost; Treatment Efficacy; Treatment outcome; Tuberculosis; United States Dept. of Health and Human Services; United States National Institutes of Health; World Health Organization; antiretroviral therapy; arm; base; cohort; cost; cost effectiveness; data modeling; disease natural history; life time cost; medication compliance; mortality; pill; primary outcome; programs; skills; therapy adherence; therapy outcome

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.

描述（由申请人提供）：抗逆转录病毒疗法（ART）降低了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。关于使用抗逆转录病毒疗法的重要问题仍然存在：其中的关键是在资源匮乏的环境中启动抗逆转录病毒疗法的最佳时间。目前世界卫生组织（WHO）的指南建议在疾病过程中晚于美国卫生与公众服务部和国际艾滋病协会的指南开始治疗。目前在这个问题上没有达成共识。关于ART启动时间的政策决定必须在临床获益、药物相关毒性风险、人力资源需求、财务成本、治疗疗效、依从性和耐药性之间进行复杂的权衡。候选人建议通过在一项研究中进行早期与延迟ART的成本效益分析来解决这个问题，该研究是独立的，但与正在海地GHESKIO中心（海地卡波西肉瘤和寄生虫感染研究组）进行的CIPRA HT 001随机临床试验互补。正在进行的临床试验将艾滋病前期疾病（WHO I、II或III期）和CD 4细胞计数在200至350之间的患者随机分为早期（2周内）和延迟（CD 4 < 200或临床艾滋病）ART。CIPRA试验的主要结果是生存率。候选人提出的研究将增加关于早期与延迟ART的依从性和成本效益的影响的关键信息。建议的决策模型的研究计划由两个具体目标组成：1。比较CIPRA试验中早期和延迟治疗组患者对ART的依从性和依从性障碍。依从性将通过药房药丸计数和患者自我报告来衡量。2.进行成本效益分析，从社会角度比较海地在存在或不存在结核病的情况下早期与延迟抗逆转录病毒疗法。结果指标将包括预期寿命、终生总直接医疗费用和每生命年获得的成本效益。敏感性分析将检查依从率，住院率和ART成本的影响。这项研究与公共卫生有关，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。