六周延长剂量奈韦拉平的疗效因婴儿出生体重而异，在低出生体重婴儿中相对疗效最佳。
Efficacy of Six-Week Extended-Dose Nevirapine Varies by Infant Birth Weight with Greatest Relative Efficacy in Low Birth Weight Infants.
作者信息
Gupte Nikhil, Kinikar Aarti, McIntire Katherine N, Bhosale Ramesh, Patil Sandesh, Suryavanshi Nishi, Mave Vidya, Kulkarni Vandana, Bollinger Robert C, Gupta Amita
机构信息
Department of Medicine, Johns Hopkins University School of Medicine, Baltimore, Maryland, United States of America.
Byramji Jeejeebhoy Government Medical College-Johns Hopkins University HIV Clinical Trials Unit, Biramji Jeejeebhoy Government Medical College, Pune, Maharashtra, India.
出版信息
PLoS One. 2016 Sep 30;11(9):e0162979. doi: 10.1371/journal.pone.0162979. eCollection 2016.
Latest World Health Organization guidelines recommend weight-based nevirapine prophylaxis for all HIV-exposed infants in resource-limited settings, yet low birth weight (LBW) infants (< 2500 g) have been understudied. Using data from the NIH-funded India six-week extended-dose nevirapine (SWEN) study, a randomized clinical trial of SWEN versus single-dose nevirapine (SD) for prevention of breast-milk HIV-1 transmission, we examined the relative impact of SWEN among 737 mother-infant pairs stratified by infant birth weight. Birth weight groups were defined as very LBW (VLBW) ≤ 2000 g, moderate LBW (MLBW) >2000 g and ≤ 2500 g, and normal birth weight (NBW) > 2500 g. Outcomes were HIV-1 infection, HIV-1 infection or death by 12 months, and severe adverse events (SAEs). The Kaplan-Meier method was used to estimate probability of efficacy outcomes in birth weight groups, and differential effects of SWEN by birth weight group were examined using Cox proportional hazards models adjusting for independent risk factors for HIV maternal-to-child transmission and significant covariates. Among 50 VLBW, 249 MLBW, and 433 NBW infants, 50% were randomized to SWEN; median gestational age was 36, 38 and 38 weeks, respectively; and there was no difference in breastfeeding duration (p = 0.99). Compared to SD: SWEN-treated VLBW had lower estimates of HIV-1 infection (13% vs. 38%, p = 0.004) and HIV-1 infection or death (13% vs. 41%, p = 0.002); SWEN-treated MLBW had lower estimated HIV-1 infection (13% vs. 17%, p = 0.042); and efficacy endpoints were similar by treatment arm in NBW. In multivariate analysis, SWEN was associated with reduced risk of HIV-1 infection or death by 83% (p = 0.03) in VLBW versus 45% (p = 0.05) in MLBW. SAE frequency was similar by treatment arm in VLBW (68% vs. 76%, p = 0.53) and MLBW (37% vs. 36%, p = 0.93). SWEN may safely increase HIV-free survival among HIV-exposed LBW infants with greatest protective advantage among infants ≤ 2000 g.
世界卫生组织最新指南建议，在资源有限的环境中，对所有暴露于艾滋病病毒的婴儿进行基于体重的奈韦拉平预防治疗，但低出生体重（LBW）婴儿（<2500克）的相关研究较少。利用美国国立卫生研究院资助的印度六周延长剂量奈韦拉平（SWEN）研究的数据，该研究是一项关于SWEN与单剂量奈韦拉平（SD）预防母乳中HIV-1传播的随机临床试验，我们在737对母婴中按婴儿出生体重分层，研究了SWEN的相对影响。出生体重组定义为极低出生体重（VLBW）≤2000克、中度低出生体重（MLBW）>2000克且≤2500克以及正常出生体重（NBW）>2500克。观察指标为HIV-1感染、12个月时的HIV-1感染或死亡以及严重不良事件（SAE）。采用Kaplan-Meier方法估计出生体重组中疗效指标的概率，并使用Cox比例风险模型，对HIV母婴传播的独立危险因素和显著协变量进行调整，研究SWEN在不同出生体重组中的差异效应。在50例VLBW、249例MLBW和433例NBW婴儿中，50%被随机分配至SWEN组；中位孕周分别为36周、38周和38周；母乳喂养持续时间无差异（p = 0.99）。与SD相比：接受SWEN治疗的VLBW婴儿HIV-1感染估计值较低（13%对38%，p = 0.004），HIV-1感染或死亡估计值较低（13%对41%，p = 0.002）；接受SWEN治疗的MLBW婴儿HIV-1感染估计值较低（13%对17%，p = 0.042）；NBW婴儿中各治疗组的疗效终点相似。在多变量分析中，与SD相比，SWEN使VLBW婴儿HIV-1感染或死亡风险降低83%（p = 0.03），使MLBW婴儿降低45%（p = 0.05）。VLBW（68%对76%，p = 0.53）和MLBW（37%对36%，p = 0.93）中各治疗组的SAE频率相似。SWEN可能安全地提高暴露于艾滋病病毒的低出生体重婴儿的无艾滋病病毒生存率，在≤2000克的婴儿中具有最大的保护优势。
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