Outcomes after reinitiating antiretroviral therapy in children randomized to planned treatment interruptions-猫眼课题宝

DOI：

10.1097/qad.0b013e32835c1181

发表时间：

2013-02-20

期刊：

AIDS

影响因子：

3.8

通讯作者：

中科院分区：

医学2区

文献类型：

作者：

Bunupuradah, Torsak;Duong, Trinh;Gibb, Diana

背景：在抗逆转录病毒治疗(SMART)管理策略(SMART)试验中，被随机分为CD4驱动的计划治疗中断(PTI)的成年人的死亡/机会性疾病的额外风险在抗逆转录病毒治疗(ART)重新启动后仍然存在。方法：将HIV-RNA<50拷贝/毫升，CD4至少30%(2-6岁)或至少500个/亩L(7-15岁)的儿童随机分为持续抗逆转录病毒治疗(CART)和经皮冠状动脉介入治疗(ISRCTN 36694210)。试验结束后，所有患者都被建议恢复抗逆转录病毒治疗。结果：101名儿童(51名CART，50名PTI；中位基线年龄9.2岁)总体随访时间中位数为4.6年(3.7-5.0年)。在试验后的两年期间，没有死亡或新的疾病控制和预防中心(CDC)B/C期事件。PTI组和CART组至少两个事件的临床分级率相似[相对危险度(RR)1.03；95%可信区间(CI)0.43，2.50；P0.94]。治疗2年后，PTI组和CART组的CD4%绝对值分别为-1.6%(-4.5%；1.3%；P=0.27)，HIV RNA低于50拷贝/ml的比例分别为82%和86%(P=0.57)，生长和空腹血脂均无差异。重新启动抗逆转录病毒治疗后较高的CD4%恢复率的关键预测因素是基线时较高的CD4%(P&lt；0.001)和重新启动ART后较长的时间(P&lt；0.001)。在整个随访期间，4名(8%)PTI与5名(10%)CT儿童将ART替换为失败(P=0.75%)，9名(18%)与1名(2%)(P=0.008)将ART替换为简化。结论：在PENTA 11试验结束2年后，未观察到PTI的不良临床、免疫学或病毒学后果。虽然ART中断一般不被推荐，但对于儿童来说，这可能是一个可以接受的选择，特别是当有计划外治疗中断的高风险时。(C)2013沃尔特斯·克鲁沃健康垂直酒吧Lippincott Williams&Wilkins AIDS 2013，27：579-589

Background: Excess risks for death/opportunistic disease in adults randomized to CD4-driven planned treatment interruption (PTI) in the Strategies for Management of Antiretroviral Therapy (SMART) trial remained after antiretroviral therapy (ART) re-initiation. Risks for children following PTI were evaluated in long-term follow-up of children in the PENTA 11 trial.Methods: Children with HIV RNA below 50 copies/ml and CD4 at least 30% (2-6 years) or at least 500 cells/mu l (7-15 years) were randomized to continuous ART (cART) or PTI in PENTA 11 (ISRCTN 36694210). After the end of the trial, all were recommended to resume ART. Data were collected annually and analysed up to the second year of visit.Results: One hundred and one (51 cART, 50 PTI; median baseline age 9.2 years) children had median overall follow-up 4.6 (range 3.7-5.0) years. During 2-year post-trial period, there were no deaths or new Centers for Disease Control and Prevention (CDC) stage B/C events. Rate of clinical grade of at least two events was similar between PTI and cART [relative risk (RR) 1.03; 95% confidence interval (CI) 0.43, 2.50; P 0.94]. At 2 years, difference in absolute CD4% between PTI and cART was -1.6% (-4.5%; 1.3%; P = 0.27), and proportions with HIV RNA below 50 copies/ml were 82 versus 86% (P = 0.57), respectively; no differences in growth or fasting lipids were observed. Key predictors of greater CD4% recovery after re-initiating ART were higher CD4% at baseline (P < 0.001) and longer time since ART re-initiation (P < 0.001). During overall follow-up, 4 (8%) PTI versus 5 (10%) CT children switched ART for failure (P = 0.75) and 9 (18%) versus 1 (2%) (P = 0.008) substituted ART for simplification.Conclusions: No adverse clinical, immunological or virological consequences of PTI were observed 2 years after the end of PENTA 11 trial. Although ART interruption is not generally recommended, it may be an acceptable option for children, particularly when there is high risk of unplanned treatment interruptions. (C) 2013 Wolters Kluwer Health vertical bar Lippincott Williams & Wilkins AIDS 2013, 27: 579-589

Outcomes after reinitiating antiretroviral therapy in children randomized to planned treatment interruptions

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