Antiretroviral Therapy for the Prevention of HIV-1 Transmission.
Antiretroviral Therapy for the Prevention of HIV-1 Transmission.
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DOI：
10.1056/nejmoa1600693
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发表时间：
2016-09-01
期刊：
影响因子：
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通讯作者：
HPTN 052 Study Team
中科院分区：
文献类型：
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作者：
Cohen MS;Chen YQ;McCauley M;Gamble T;Hosseinipour MC;Kumarasamy N;Hakim JG;Kumwenda J;Grinsztejn B;Pilotto JH;Godbole SV;Chariyalertsak S;Santos BR;Mayer KH;Hoffman IF;Eshleman SH;Piwowar-Manning E;Cottle L;Zhang XC;Makhema J;Mills LA;Panchia R;Faesen S;Eron J;Gallant J;Havlir D;Swindells S;Elharrar V;Burns D;Taha TE;Nielsen-Saines K;Celentano DD;Essex M;Hudelson SE;Redd AD;Fleming TR;HPTN 052 Study Team
对艾滋病毒预防试验网络(HPTN)052试验数据的中期分析表明，在血清不一致的夫妇中，抗逆转录病毒疗法(ART)预防了超过96%的人类免疫缺陷病毒1型(HIV-1)引起的基因相关感染。然后向所有HIV-1感染患者(指数参与者)提供抗逆转录病毒治疗。这项研究包括5年多的随访，以评估这种预防艾滋病毒-1传播的疗法的持久性。我们随机分配了1763名指数参与者，让他们接受早期或延迟的ART。在早期抗逆转录病毒治疗组中，886名参与者在登记时开始接受治疗(CD4+计数，每立方毫米350至550个细胞)。在延迟抗逆转录病毒治疗组中，877名参与者在连续两次CD4+计数降至每立方毫米250个细胞以下或如果出现表明获得性免疫缺陷综合征(即艾滋病定义的疾病)的疾病后开始治疗。主要的研究终点是在意向治疗分析中诊断先前HIV-1阴性的伴侣中存在与基因相关的HIV-1感染。指数参与者被跟踪了10031人年；伴侣被跟踪了8509人年。在伴侣中，在试验期间观察到78例HIV-1感染(年发病率0.9%；95%可信区间[CI]，0.7至1.1)。72例(92%)的伴侣感染被确定为病毒连锁状态。在这些感染中，46例相关(早期ART组3例，延迟ART组43例；发病率0.5%；95%可信区间0.4~0.7)；26例无关联(14例早期ART组和12例延迟ART组；发病率0.3%；95%可信区间0.2~0.4)。早期抗逆转录病毒治疗与延迟抗逆转录病毒治疗相比，关联伴侣感染的风险降低93%(风险比，0.07；95%可信区间，0.02至0.22)。当指标参与者中的HIV-1感染被ART稳定抑制时，没有观察到关联感染。早期启动抗逆转录病毒疗法导致性伴侣中与基因有关的艾滋病毒-1感染持续减少。(由国家过敏和传染病研究所资助；HPTN 052 ClinicalTrials.gov编号，NCT00074581。)
An interim analysis of data from the HIV Prevention Trials Network (HPTN) 052 trial showed that antiretroviral therapy (ART) prevented more than 96% of genetically linked infections caused by human immunodeficiency virus type 1 (HIV-1) in serodiscordant couples. ART was then offered to all patients with HIV-1 infection (index participants). The study included more than 5 years of follow-up to assess the durability of such therapy for the prevention of HIV-1 transmission. We randomly assigned 1763 index participants to receive either early or delayed ART. In the early-ART group, 886 participants started therapy at enrollment (CD4+ count, 350 to 550 cells per cubic millimeter). In the delayed-ART group, 877 participants started therapy after two consecutive CD4+ counts fell below 250 cells per cubic millimeter or if an illness indicative of the acquired immunodeficiency syndrome (i.e., an AIDS-defining illness) developed. The primary study end point was the diagnosis of genetically linked HIV-1 infection in the previously HIV-1– negative partner in an intention-to-treat analysis. Index participants were followed for 10,031 person-years; partners were followed for 8509 person-years. Among partners, 78 HIV-1 infections were observed during the trial (annual incidence, 0.9%; 95% confidence interval [CI], 0.7 to 1.1). Viral-linkage status was determined for 72 (92%) of the partner infections. Of these infections, 46 were linked (3 in the early-ART group and 43 in the delayed-ART group; incidence, 0.5%; 95% CI, 0.4 to 0.7) and 26 were unlinked (14 in the early-ART group and 12 in the delayed-ART group; incidence, 0.3%; 95% CI, 0.2 to 0.4). Early ART was associated with a 93% lower risk of linked partner infection than was delayed ART (hazard ratio, 0.07; 95% CI, 0.02 to 0.22). No linked infections were observed when HIV-1 infection was stably suppressed by ART in the index participant. The early initiation of ART led to a sustained decrease in genetically linked HIV-1 infections in sexual partners. (Funded by the National Institute of Allergy and Infectious Diseases; HPTN 052 ClinicalTrials.gov number, NCT00074581.)