撒哈拉以南非洲成人治疗队列中一线抗逆转录病毒治疗的监测和转换：协作分析。
Monitoring and switching of first-line antiretroviral therapy in adult treatment cohorts in sub-Saharan Africa: collaborative analysis.
机构信息
Institute of Social and Preventive Medicine, University of Bern, Bern, Switzerland.
Centre de Recherche INSERM U897, Epidemiologie-Biostatistique, Institut de Santé Publique, Epidémiologie et Développement, Université de Bordeaux, Bordeaux, France.
出版信息
Lancet HIV. 2015 Jul;2(7):e271-8. doi: 10.1016/S2352-3018(15)00087-9. Epub 2015 Jun 16.
BACKGROUND
HIV-1 viral load testing is recommended to monitor antiretroviral therapy (ART) but is not universally available. The aim of our study was to assess monitoring of first-line ART and switching to second-line ART in sub-Saharan Africa.
METHODS
We did a collaborative analysis of cohort studies from 16 countries in east Africa, southern Africa, and west Africa that participate in the international epidemiological database to evaluate AIDS (IeDEA). We included adults infected with HIV-1 who started combination ART between January, 2004, and January, 2013. We defined switching of ART as a change from a non-nucleoside reverse-transcriptase inhibitor (NNRTI)-based regimen to one including a protease inhibitor, with adjustment of one or more nucleoside reverse-transcriptase inhibitors (NRTIs). Virological and immunological failures were defined according to WHO criteria. We calculated cumulative probabilities of switching and hazard ratios with 95% CIs comparing routine viral load monitoring, targeted viral load monitoring, CD4 monitoring, and clinical monitoring, adjusting for programme and individual characteristics.
FINDINGS
Of 297,825 eligible patients, 10,352 (3%) switched to second-line ART during 782 ,412 person-years of follow-up. Compared with CD4 monitoring, hazard ratios for switching were 3·15 (95% CI 2·92-3·40) for routine viral load monitoring, 1·21 (1·13-1·30) for targeted viral load monitoring, and 0·49 (0·43-0·56) for clinical monitoring. Of 6450 patients with confirmed virological failure, 58·0% (95% CI 56·5-59·6) switched by 2 years, and of 15,892 patients with confirmed immunological failure, 19·3% (18·5-20·0) switched by 2 years. Of 10,352 patients who switched, evidence of treatment failure based on one CD4 count or viral load measurement ranged from 86 (32%) of 268 patients with clinical monitoring to 3754 (84%) of 4452 with targeted viral load monitoring. Median CD4 counts at switching were 215 cells per μL (IQR 117-335) with routine viral load monitoring, but were lower with other types of monitoring (range 114-133 cells per μL).
INTERPRETATION
Overall, few patients switched to second-line ART and switching happened late in the absence of routine viral load monitoring. Switching was more common and happened earlier after initiation of ART with targeted or routine viral load testing.
FUNDING
National Institute of Allergy and Infectious Diseases, Swiss National Science Foundation.
背景
HIV-1 病毒载量检测被推荐用于监测抗逆转录病毒治疗（ART），但并非普遍可用。我们研究的目的是评估撒哈拉以南非洲国家一线 ART 监测和二线 ART 转换情况。
方法
我们对来自东非、南部非洲和西非 16 个国家的参与国际艾滋病流行病学数据库评估（IeDEA）的队列研究进行了合作分析。我们纳入了于 2004 年 1 月至 2013 年 1 月期间开始接受联合 ART 的感染 HIV-1 的成年人。我们将 ART 转换定义为从非核苷类逆转录酶抑制剂（NNRTI）为基础的方案转换为包含蛋白酶抑制剂的方案，同时调整一种或多种核苷类逆转录酶抑制剂（NRTIs）。根据世界卫生组织（WHO）标准定义病毒学和免疫学失败。我们计算了累积的转换概率和危险比（HR），并对常规病毒载量监测、靶向病毒载量监测、CD4 监测和临床监测进行了比较，同时调整了方案和个体特征。
结果
在 297825 名合格患者中，在 782412 人年的随访期间，有 10352 名（3%）患者转为二线 ART。与 CD4 监测相比，常规病毒载量监测的转换 HR 为 3.15（95%CI 2.92-3.40），靶向病毒载量监测为 1.21（1.13-1.30），临床监测为 0.49（0.43-0.56）。在 6450 名经确认发生病毒学失败的患者中，有 58.0%（95%CI 56.5-59.6）在 2 年内进行了转换，在 15892 名经确认发生免疫学失败的患者中，有 19.3%（18.5-20.0）在 2 年内进行了转换。在 10352 名转换患者中，基于一次 CD4 计数或病毒载量测量的治疗失败证据范围为临床监测的 268 例患者中的 86 例（32%）至靶向病毒载量监测的 4452 例患者中的 3754 例（84%）。常规病毒载量监测时转换时的 CD4 中位数为 215 个细胞/μL（IQR 117-335），但其他类型监测时则较低（范围为 114-133 个细胞/μL）。
结论
总体而言，很少有患者转为二线 ART，并且在缺乏常规病毒载量监测的情况下，转换发生较晚。在开始 ART 时采用靶向或常规病毒载量检测时，转换更为常见且发生更早。
资助
美国国立过敏和传染病研究所，瑞士国家科学基金会。
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