High rates of viral suppression in adults and children with high CD4+ counts using a streamlined ART delivery model in the SEARCH trial in rural Uganda and Kenya.
High rates of viral suppression in adults and children with high CD4+ counts using a streamlined ART delivery model in the SEARCH trial in rural Uganda and Kenya.
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在乌干达和肯尼亚农村的搜索试验中，使用简化的ART递送模型在成年人和患有高CD4+计数的儿童的病毒抑制率高。
DOI：
10.7448/ias.20.5.21673
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发表时间：
2017-07-21
影响因子：
6
通讯作者：
Jain V
中科院分区：
文献类型：
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作者：
Kwarisiima D;Kamya MR;Owaraganise A;Mwangwa F;Byonanebye DM;Ayieko J;Plenty A;Black D;Clark TD;Nzarubara B;Snyman K;Brown L;Bukusi E;Cohen CR;Geng EH;Charlebois ED;Ruel TD;Petersen ML;Havlir D;Jain V
导言：2015年世卫组织对所有艾滋病毒阳性者进行抗逆转录病毒治疗(ART)的建议要求对数百万新符合条件的CD4+细胞高计数的人开始治疗。这一人群迫切需要高效和有效的护理模式。我们在乌干达和肯尼亚农村地区使用一种新的简化护理模式评估了无症状HIV阳性成人和儿童在开始接受高CD4+计数的抗逆转录病毒治疗时的临床结果。方法：在艾滋病毒检测和治疗可持续东非社区卫生研究(NCT01864603)的16个干预社区中，所有HIV阳性个体，无论CD4如何，都接受抗逆转录病毒治疗(efavirenz[EFV]/替诺福韦富马酸二异丙酯+恩曲他滨(FTC)或拉米夫定(3TC))。我们研究了成人(≥15岁)和儿童(2至14岁)，其中成人(≥15岁)≥为350/μL，儿童(2至14岁)CD4；500/μL根据国家指南不符合抗逆转录病毒治疗的条件。诊所实施了以患者为中心的简化护理模式，旨在减少患者层面的障碍，最大限度地提高卫生系统的效率。它包括：(1)护士与医生对复杂病例进行转诊，(2)多种疾病的慢性护理(包括高血压/糖尿病)，(3)以病人为中心的友好工作人员，(4)病毒载量(VL)检测和咨询，(5)三个月的回访和ART补充，(6)预约提醒，(7)对错过的预约进行分级跟踪，(8)灵活的门诊时间(非常规时间表)和(9)电话联系临床医生。主要结果是48周的护理保留，病毒抑制(测量48周VL和≤的百分比为500亿拷贝/毫升)和不良事件。结果：总体而言，972名艾滋病毒阳性的成年≥+μ患者L以简化的护理启动了抗逆转录病毒治疗。患者中66%为女性，年龄中位数34岁(28~42岁)，CD_4~+608/μL(IQR 487~788/μL)，VL 6775亿拷贝/毫升(IQR 500~37,003拷贝/毫升)。48周时，保留率为92%(897/972例，死亡2例/移位40例/退出8例/转移4例/21/964例[2%]失访)。意向治疗分析中778/838(93%)和800/972(82%)出现病毒抑制。III/IV级临床/实验室不良事件很少见：在74/972名患者(7.6%)中发生了95次。只有8/972名成年人(0.8%)从EFV改为Lopinavir(LPV)(n=2为头晕，n=2为男性乳房发育症，n=4为其他原因)。83例患儿中，48周滞留发生率为89%(74/83)，病毒抑制发生率为92%(65/71)，发生III/IV级不良反应4例(4.8%)。结论：使用简化的护理模式，在开始治疗时，无症状的东非成人和高CD4+计数的儿童的病毒抑制、滞留和ART安全性很高。临床试验编号：NCT01864603
Introduction: The 2015 WHO recommendation of antiretroviral therapy (ART) for all HIV-positive persons calls for treatment initiation in millions of persons newly eligible with high CD4+ counts. Efficient and effective care models are urgently needed for this population. We evaluated clinical outcomes of asymptomatic HIV-positive adults and children starting ART with high CD4+ counts using a novel streamlined care model in rural Uganda and Kenya. Methods: In the 16 intervention communities of the HIV test-and-treat Sustainable East Africa Research for Community Health Study (NCT01864603), all HIV-positive individuals irrespective of CD4 were offered ART (efavirenz [EFV]/tenofovir disoproxil fumarate + emtricitabine (FTC) or lamivudine (3TC). We studied adults (≥fifteen years) with CD4 ≥ 350/μL and children (two to fourteen years) with CD4 > 500/μL otherwise ineligible for ART by country guidelines. Clinics implemented a patient-centred streamlined care model designed to reduce patient-level barriers and maximize health system efficiency. It included (1) nurse-conducted visits with physician referral of complex cases, (2) multi-disease chronic care (including for hypertension/diabetes), (3) patient-centred, friendly staff, (4) viral load (VL) testing and counselling, (5) three-month return visits and ART refills, (6) appointment reminders, (7) tiered tracking for missed appointments, (8) flexible clinic hours (outside routine schedule) and (9) telephone access to clinicians. Primary outcomes were 48-week retention in care, viral suppression (% with measured week 48 VL ≤ 500 copies/mL) and adverse events. Results: Overall, 972 HIV-positive adults with CD4+ ≥ 350/μL initiated ART with streamlined care. Patients were 66% female and had median age thirty-four years (IQR, 28–42), CD4+ 608/μL (IQR, 487–788/μL) and VL 6775 copies/mL (IQR, <500–37,003 c/mL). At week 48, retention was 92% (897/972; 2 died/40 moved/8 withdrew/4 transferred care/21/964 [2%] were lost to follow-up). Viral suppression occurred in 778/838 (93%) and 800/972 (82%) in intention-to-treat analysis. Grade III/IV clinical/laboratory adverse events were rare: 95 occurred in 74/972 patients (7.6%). Only 8/972 adults (0.8%) switched ART from EFV to lopinavir (LPV) (n = 2 for dizziness, n = 2 for gynaecomastia, n = 4 for other reasons). Among 83 children, week 48 retention was 89% (74/83), viral suppression was 92% (65/71) and grade III/IV adverse events occurred in 4/83 (4.8%). Conclusions: Using a streamlined care model, viral suppression, retention and ART safety were high among asymptomatic East African adults and children with high CD4+ counts initiating treatment. Clinical Trial Number: NCT01864603