Short-course antiretroviral therapy in primary HIV infection.
Short-course antiretroviral therapy in primary HIV infection.
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原发性HIV感染中的短期抗逆转录病毒疗法。
DOI：
10.1056/nejmoa1110039
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发表时间：
2013-01-17
期刊：
影响因子：
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通讯作者：
Babiker A
中科院分区：
文献类型：
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作者：
SPARTAC Trial Investigators;Fidler S;Porter K;Ewings F;Frater J;Ramjee G;Cooper D;Rees H;Fisher M;Schechter M;Kaleebu P;Tambussi G;Kinloch S;Miro JM;Kelleher A;McClure M;Kaye S;Gabriel M;Phillips R;Weber J;Babiker A
短期抗逆转录病毒治疗（ART）在原发性人类免疫缺陷病毒（HIV）感染可能会延迟疾病进展，但尚未得到充分的评价。我们随机将患有原发性HIV感染的成年人分配到ART 48周，ART 12周，或没有ART（标准护理），在血清转换后6个月内开始治疗。主要终点是CD 4+细胞计数小于350个/mm 3或长期ART启动。共有366名参与者（60%为男性）随机接受48周ART（123名参与者），12周ART（120名参与者）或标准治疗（123名），平均随访4.2年。48周ART组中有50%达到了主要终点，而12周ART组和标准治疗组分别为61%。与标准治疗相比，48周ART的平均风险比为0.63（95%置信区间[CI]，0.45至0.90; P = 0.01），与标准治疗相比，12周ART的平均风险比为0.93（95% CI，0.67至1.29; P = 0.67）。在48周ART组中，CD 4+细胞计数低于350个细胞/立方毫米的参与者比例为28%，12周组为40%，标准治疗组为40%。长期ART启动的相应值分别为22%、21%和22%。48周ART治疗组达到主要终点的中位时间比标准治疗组长65周（95%CI，17 - 114）。事后分析发现，ART开始与主要终点之间的间隔时间越长，ART开始与估计的血清转换越接近（P = 0.09），48周的ART在完成短期治疗后36周使HIV RNA水平降低0.44 log 10拷贝/毫升（95%CI，0.25至0.64）。在获得性免疫缺陷综合征、死亡或严重不良事件的发生率方面，两组间无显著差异。在原发性HIV感染患者中，48周的ART疗程延迟了疾病进展，尽管没有显著长于治疗持续时间。没有证据表明ART中断对临床结局有不良影响。（由Wellcome Trust资助; SPARTAC Controlled-Trials.com编号，ISRCTN 76742797和EudraCT编号，2004-000446-20。）
Short-course antiretroviral therapy (ART) in primary human immunodeficiency virus (HIV) infection may delay disease progression but has not been adequately evaluated. We randomly assigned adults with primary HIV infection to ART for 48 weeks, ART for 12 weeks, or no ART (standard of care), with treatment initiated within 6 months after seroconversion. The primary end point was a CD4+ count of less than 350 cells per cubic millimeter or long-term ART initiation. A total of 366 participants (60% men) underwent randomization to 48-week ART (123 participants), 12-week ART (120), or standard care (123), with an average follow-up of 4.2 years. The primary end point was reached in 50% of the 48-week ART group, as compared with 61% in each of the 12-week ART and standard-care groups. The average hazard ratio was 0.63 (95% confidence interval [CI], 0.45 to 0.90; P = 0.01) for 48-week ART as compared with standard care and was 0.93 (95% CI, 0.67 to 1.29; P = 0.67) for 12-week ART as compared with standard care. The proportion of participants who had a CD4+ count of less than 350 cells per cubic millimeter was 28% in the 48-week ART group, 40% in the 12-week group, and 40% in the standard-care group. Corresponding values for long-term ART initiation were 22%, 21%, and 22%. The median time to the primary end point was 65 weeks (95% CI, 17 to 114) longer with 48-week ART than with standard care. Post hoc analysis identified a trend toward a greater interval between ART initiation and the primary end point the closer that ART was initiated to estimated seroconversion (P = 0.09), and 48-week ART conferred a reduction in the HIV RNA level of 0.44 log10 copies per milliliter (95% CI, 0.25 to 0.64) 36 weeks after the completion of short-course therapy. There were no significant between-group differences in the incidence of the acquired immunodeficiency syndrome, death, or serious adverse events. A 48-week course of ART in patients with primary HIV infection delayed disease progression, although not significantly longer than the duration of the treatment. There was no evidence of adverse effects of ART interruption on the clinical outcome. (Funded by the Wellcome Trust; SPARTAC Controlled-Trials.com number, ISRCTN76742797, and EudraCT number, 2004-000446-20.)