在乌干达农村和肯尼亚开展的SEARCH试验中，采用简化抗逆转录病毒治疗交付模式，使CD4+计数较高的成人和儿童实现了高病毒抑制率。

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.

作者信息

Kwarisiima Dalsone, Kamya Moses R, Owaraganise Asiphas, Mwangwa Florence, Byonanebye Dathan M, Ayieko James, Plenty Albert, Black Doug, Clark Tamara D, Nzarubara Bridget, Snyman Katherine, Brown Lillian, Bukusi Elizabeth, Cohen Craig R, Geng Elvin H, Charlebois Edwin D, Ruel Theodore D, Petersen Maya L, Havlir Diane, Jain Vivek

机构信息

Infectious Diseases Research Collaboration, Kampala, Uganda.

School of Medicine, Makerere University College of Health Sciences, Kampala, Uganda.

出版信息

J Int AIDS Soc. 2017 Jul 21;20(Suppl 4):21673. doi: 10.7448/IAS.20.5.21673.

DOI:10.7448/IAS.20.5.21673

PMID:28770596

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC5577724/

Abstract

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. 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) ( = 2 for dizziness, = 2 for gynaecomastia, = 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.

摘要

引言

2015年世界卫生组织建议对所有HIV阳性者进行抗逆转录病毒治疗（ART），这要求对数百万新符合条件且CD4+细胞计数较高的人开始治疗。这一人群迫切需要高效且有效的护理模式。我们在乌干达和肯尼亚农村地区，使用一种新型简化护理模式，评估了CD4+细胞计数较高的无症状HIV阳性成人和儿童开始接受ART治疗后的临床结局。

方法

在“HIV检测与治疗：东非社区健康可持续研究”（NCT01864603）的16个干预社区中，所有HIV阳性个体，无论其CD4情况如何，均提供ART（依非韦伦[EFV]/替诺福韦酯富马酸盐+恩曲他滨（FTC）或拉米夫定（3TC））。我们研究了CD4≥350/μL的成人（≥15岁）以及CD4>500/μL的儿童（2至14岁），按照国家指南，这些人原本不符合ART治疗条件。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并最大限度提高卫生系统效率。该模式包括：（1）由护士进行访视，复杂病例转诊给医生；（2）多病种慢性病护理（包括高血压/糖尿病）；（3）以患者为中心、态度友好的工作人员；（4）病毒载量（VL）检测与咨询；（5）三个月复诊及ART药物补充；（6）预约提醒；（7）对错过预约进行分层追踪；（8）灵活的门诊时间（常规时间表之外）；（9）患者可通过电话联系临床医生。主要结局指标为48周的治疗留存率、病毒抑制（第48周测得的VL≤500拷贝/mL的比例）及不良事件。总体而言，972名CD4+≥350/μL的HIV阳性成人开始接受简化护理的ART治疗。患者中66%为女性，中位年龄34岁（四分位间距，28 - 42岁），CD4+为608/μL（四分位间距，487 - 788/μL），VL为6775拷贝/mL（四分位间距，<500 - 37,003拷贝/mL）。在第48周时，治疗留存率为92%（897/972；2人死亡/40人转诊/8人退出/4人转至其他医疗机构/21人/964人中有2%[21人]失访）。在意向性分析中，病毒抑制率在838人中为778/838（93%），在972人中为800/972（82%）。III/IV级临床/实验室不良事件罕见：972名患者中有74人发生95起此类事件（7.6%）。仅972名成人中有8人（0.8%）从EFV换用洛匹那韦（LPV）进行ART治疗（2人因头晕，2人因男性乳房发育，4人因其他原因）。在83名儿童中，第48周治疗留存率为89%（74/83），病毒抑制率为92%（65/71），III/IV级不良事件在83名儿童中有4人发生（4.8%）。