BACKGROUND There have been concerns about reduced adherence and human immunodeficiency virus (HIV) virological suppression (VS) among clinically well people initiating antiretroviral therapy (ART) with high pre-ART CD4 cell counts. We compared virological outcomes by pre-ART CD4 count, where universal ART initiation was provided in the HIV Prevention Trials Network 071 (PopART) trial in South Africa prior to routine national and international implementation. METHODS This prospective cohort study included adults initiating ART at facilities providing universal ART since January 2014. VS (<400 copies/mL), confirmed virological failure (VF) (2 consecutive viral loads >1000 copies/mL), and viral rebound were compared between participants in strata of baseline CD4 cell count. RESULTS The sample included 1901 participants. VS was ≥94% among participants with baseline CD4 count ≥500 cells/µL at all 6-month intervals to 30 months. The risk of an elevated viral load (≥400 copies/mL) was independently lower among participants with baseline CD4 count ≥500 cells/µL (3.3%) compared to those with CD4 count 200-499 cells/µL (9.2%) between months 18 and 30 (adjusted relative risk, 0.30 [95% confidence interval, .12-.74]; P = .010). The incidence rate of VF was 7.0, 2.0, and 0.5 per 100 person-years among participants with baseline CD4 count <200, 200-499, and ≥500 cells/µL, respectively (P < .0001). VF was independently lower among participants with baseline CD4 count ≥500 cells/µL (adjusted hazard ratio [aHR], 0.23; P = .045) and 3-fold higher among those with baseline CD4 count <200 cells/µL (aHR, 3.49; P < .0001). CONCLUSIONS Despite previous concerns, participants initiating ART with CD4 counts ≥500 cells/µL had very good virological outcomes, being better than those with CD4 counts 200-499 cells/µL. CLINICAL TRIALS REGISTRATION NCT01900977.

中文翻译：

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在南非的 HIV 预防试验网络 071 (PopART) 试验中，人类免疫缺陷病毒 (HIV) 感染者开始早期抗逆转录病毒治疗（CD4 计数≥500 个细胞/μL）取得更好的病毒学结果。


背景 人们一直担心临床健康人群在开始抗逆转录病毒治疗（ART）时，ART 前 CD4 细胞计数较高，依从性降低和人类免疫缺陷病毒（HIV）病毒学抑制（VS）。我们通过 ART 前 CD4 计数比较了病毒学结果，其中在常规国家和国际实施之前，在南非的 HIV 预防试验网络 071 (PopART) 试验中提供了普遍的 ART 启动。方法 这项前瞻性队列研究包括自 2014 年 1 月起在提供通用 ART 的设施中开始 ART 的成年人。比较基线 CD4 细胞计数各层参与者之间的 VS（<400 id=18>1000 拷贝/mL）和病毒反弹。结果 样本包括 1901 名参与者。在基线 CD4 计数≥500 个细胞/μL 的参与者中，在所有 6 个月至 30 个月的间隔内，VS ≥94%。与 CD4 计数 200-499 个细胞/μL (9.2%) 的参与者相比，基线 CD4 计数≥500 个细胞/μL (3.3%) 的参与者在几个月内病毒载量升高 (≥400 拷贝/mL) 的风险独立较低18 和 30（调整后相对风险，0.30 [95% 置信区间，0.12-.74]；P = 0.010）。在基线 CD4 计数<200、200-499 和≥500 个细胞/μL 的参与者中，VF 的发生率分别为每 100 人年 7.0、2.0 和 0.5（P < .0001）。基线 CD4 计数≥500 个细胞/μL 的参与者中，VF 独立较低（调整后的风险比 [aHR]，0.23；P = 0.045），而基线 CD4 计数 <200 个细胞/μL 的参与者中，VF 较高 3 倍（aHR，3.49） ; P <.0001)。结论 尽管存在先前的担忧，但 CD4 计数≥500 个细胞/μL 开始 ART 的参与者具有非常好的病毒学结果，优于 CD4 计数 200-499 个细胞/μL 的参与者。临床试验注册 NCT01900977。