Generic fixed-dose combination antiretroviral treatment in resource-poor settings: multicentric observational cohort
Generic fixed-dose combination antiretroviral treatment in resource-poor settings: multicentric observational cohort
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DOI：
10.1097/01.aids.0000226957.79847.d6
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发表时间：
2006-05-12
期刊：
影响因子：
3.8
通讯作者：
Ferradini, Laurent
中科院分区：
文献类型：
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作者：
Calmy, Alexandra;Pinoges, Lorextu;Ferradini, Laurent
背景：固定剂量复方制剂（FDC）的使用是提高HAART疗效的重要手段。联合拉米夫定，司他夫定和奈韦拉平（3 TC/d4 T/NVP）的有效性的研究是稀缺的。目的：分析6861例患者在一个大的观察队列从21无国界医生组织（MSF）的艾滋病毒/艾滋病计划采取3 TC/d4 T/NVP，在12和18个月的治疗与亚队列分析的患者。研究方法：采用Kaplan-Meier方法和与进展至死亡相关的因素与考克斯比例风险ratio.Results进行生存分析：FDC开始时的中位基线CD 4细胞计数为89个细胞/μ l [四分位距（IQR），33-158]。中位随访时间为4.1个月（IQR，1.9-7.3）。随访期间的死亡发生率为14.2/100人-年[95%置信区间（CI），13.8-14.5]。6个月（n = 2，231）和12个月（n = 472）时的生存率估计值（不包括失访者）分别为0.93（95%CI，92-94）和0.90（95%CI，8991）。使用考克斯模型，以下因素与死亡相关：男性，有症状的感染，体重指数< 18 kg/m2，CD 4细胞计数15-50个细胞/μ l或< 15个细胞/μ l。随访1年后对655例患者进行的亚队列分析（M12 FDC队列）显示，77%的患者仍在接受HAART治疗，91%的患者仍在接受FDC治疗; 5%的患者因药物不耐受而停用FDC。在18个月，77%的患者仍然HAART.Conclusions：积极的结果为d4 T/3 TC/NVP报告长达18个月的疗效和安全性。
Background: The use fixed-dose combination (FDC) is a critical tool in improving HAART. Studies on the effectiveness of combined lamivudine, stavudine and neviraz pine (3TC/d4T/NVP) are scarce.Objective: To analyse 6861 patients in a large observational cohort from 21 Medecins Sans Frontieres (MSF) HIV/AIDS programmes taking 3TC/d4T/NVP, with subcohort analyses of patients at 12 and 18 months of treatment. Methods: Survival was analysed using Kaplan-Meier method and factors associated with progression to death with Cox proportional hazard ratio.Results: Median baseline CD4 cell count at initiating of FDC was 89 cells/mu l [inter-quartile range (IQR), 33-158]. The median follow-up time was 4.1 months (IQR, 1.9-7.3). The incidence rate of death during follow-up was 14.2/100 person-years [95% confidence interval (CI), 13.8-14.5]. Estimates of survival (excluding those lost to follow-up) were 0.93 (95%CI, 92-94)at 6 months(n =2,231) and 0.90(95%CI, 8991) at 12 months (n = 472). Using a Cox model, the following factors were associated with death: male gender, symptomatic infection, body mass index < 18 kg/m(2) and CD4 cell count 15-50 cells/mu l or < 15 cells/mu l. Subcohort analysis of 655 patients after I year of follow-up (M] 2 FDC cohort) revealed that 77% remained on HAART, 91% of A these still on the FDC regimen; 5% discontinued the FDC because of drug intolerance. At 18 months, 77% of the patients remained on HAART.Conclusions: Positive outcomes for d4T/3TC/NVP are reported for up to 18 months in terms of efficacy and safety.