CD4 cell-guided scheduled treatment interruptions in HIV-infected patients with sustained immunologic response to HAART
CD4 cell-guided scheduled treatment interruptions in HIV-infected patients with sustained immunologic response to HAART
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DOI：
10.1097/qad.0b013e328321b75e
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发表时间：
2009-04-27
期刊：
影响因子：
3.8
通讯作者：
Suter, Fredy
中科院分区：
文献类型：
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作者：
Maggiolo, Franco;Airoldi, Monica;Suter, Fredy
目的：比较持续HAART和CD4细胞驱动的程序治疗中断(STI)策略。方法：长期治疗中断研究是一项随机、对照、前瞻性试验。CD_4细胞数>700个/亩的L患者符合条件，恢复抗逆转录病毒治疗的免疫学阈值为350个/亩L。主要终点是发生机会性疾病、因任何原因死亡或发生需要住院的非机会性疾病。次要终点为主要不良反应、病毒学失败和治疗费用。结果：329例患者按1：1随机化，总随访1388人年，平均4.2年。STI组患者共停止治疗241个STI周期，平均停药时间为随访期的65.3%。主要终点出现在接受STI治疗的患者中为12.1%，在对照组中为11.6%[优势比1.05；95%可信区间0.54-2.05]。性传播感染组患者被诊断为肺炎的比例较高(P=0.037)，而影响患者心血管风险的临床事件在对照组中明显更常见(P<；0.0001)。STI组8名患者(4.8%)和对照组11名(6.7%)出现病毒耐药性[优势比0.79，95%可信区间0.27-1.81]。对照组的日均治疗费用为20.29英镑，而注射组的日均治疗费用降至9.07英镑(P<；0.0001)。结论：两种治疗策略在临床上可以被认为是相同的。对于对HAART有反应的慢性感染者来说，CD4细胞引导的性传播感染似乎是一种可能的替代方案，前提是CD4细胞的减少将稳定地维持在安全阈值以上。(C)2009年Wolters Kluwer Health垂直酒吧Lippincott Williams&Wilkins
Objective: To compare continuous HAART with a CD4 cell-driven scheduled treatment interruption (STI) strategy.Methods: LOng Term Treatment Interruption Study is a randomized, controlled, prospective trial. Patients with CD4 cell counts more than 700cells/mu l were eligible, and the immunologic threshold to resume HAART was 350 cells/mu l. The primary end point was the development of an opportunistic disease, death from any cause or the Occurrence of diseases, other than opportunistic, requiring hospital admission. Secondary end points were major adverse effects, virologic failures and therapeutic costs.Results: Three hundred and twenty-nine patients were randomized 1 : 1. Total follow-up was 1388 person-years (mean 4.2 years). Patients in the STI group stopped therapy for a total of 241 STI cycles, their mean off-therapy period was 65.3% of the follow-up. The primary end point occurred in 12.1% of patients on STI and in 11.6% of controls [odds ratio 1.05; 95% confidence interval 0.54-2.05]. A higher proportion of patients in the STI arm were diagnosed with pneumonia (P=0.037), whereas clinical events influencing the cardiovascular risk of patients were significantly (P < 0.0001) more frequent among controls. Eight patients (4.8%) in the STI group and 11 (6.7%) controls developed viral resistance [odds ratio 0.79, 95% confidence interval 0.27-1.81]. The mean daily therapeutic cost was (sic)20.29 for controls and dropped to (sic)9.07 in the STI arm (P < 0.0001).Conclusion: The two strategies may be considered clinically equivalent. CD4 cell-guided STIs seem a possible alternative for chronically infected individuals responding to HAART provided that CD4 cell decrements would be steadily maintained above a safe threshold. (c) 2009 Wolters Kluwer Health vertical bar Lippincott Williams & Wilkins