CD4 细胞计数高的艾滋病病毒感染哺乳期妇女的母体健康状况:治疗策略试验结果。

Q2 Medicine
Risa M Hoffman, Konstantia Nadia Angelidou, Sean S Brummel, Friday Saidi, Avy Violari, Dingase Dula, Vidya Mave, Lee Fairlie, Gerhard Theron, Moreen Kamateeka, Tsungai Chipato, Benjamin H Chi, Lynda Stranix-Chibanda, Teacler Nematadzira, Dhayendre Moodley, Debika Bhattacharya, Amita Gupta, Anne Coletti, James A McIntyre, Karin L Klingman, Nahida Chakhtoura, David E Shapiro, Mary Glenn Fowler, Judith S Currier
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引用次数: 0

摘要

研究背景IMPAACT PROMISE 1077BF/FF是一项针对CD4+ T细胞计数高的孕妇和产后妇女的抗逆转录病毒疗法(ART)策略的随机研究。我们描述了该研究中被随机分配在分娩后继续或停止抗逆转录病毒疗法的妇女的产后结果:方法:在妊娠期间开始接受抗逆转录病毒疗法的妇女,在接受抗逆转录病毒疗法前的 CD4+ 细胞计数≥350 cells/mm3 ,在产后被随机分配继续或停止治疗。这些妇女来自印度、马拉维、南非、坦桑尼亚、乌干达、赞比亚和津巴布韦。主要研究结果是发展为艾滋病定义性疾病或死亡的综合结果。对数秩检验和 Cox 回归模型评估了治疗效果。发病率按每百人年计算。一项事后分析评估了 WHO 2/3 阶段事件。所有分析均为意向治疗分析:共有 1611 名妇女入组(2011 年 6 月至 2014 年 10 月),其中 95% 为母乳喂养。入组年龄中位数为27岁,CD4+细胞计数为728 cells/mm3,大多数女性为非洲黑人(97%)。中位随访 1.6 年后,很少出现艾滋病定义性疾病或死亡,不同治疗方案之间没有显著差异(HR:0-55;95%CI 0-14,2-08,p = 0.37)。持续抗逆转录病毒疗法减少了世卫组织 2/3 期事件(HR:0-60;95%CI 0-39,0-90,p = 0.01)。在 2 级、3 级或 4 级安全事件发生率方面,两组没有差异(P = 0.61):产后 18 个月内,以母乳喂养为主且 CD4+ 细胞计数较高的妇女很少发生严重临床事件。抗逆转录病毒疗法在减少该人群中的 WHO 2/3 事件方面具有明显优势。
本文章由计算机程序翻译,如有差异,请以英文原文为准。

Maternal health outcomes among HIV-infected breastfeeding women with high CD4 counts: results of a treatment strategy trial.

Maternal health outcomes among HIV-infected breastfeeding women with high CD4 counts: results of a treatment strategy trial.

Maternal health outcomes among HIV-infected breastfeeding women with high CD4 counts: results of a treatment strategy trial.

Maternal health outcomes among HIV-infected breastfeeding women with high CD4 counts: results of a treatment strategy trial.

Background: IMPAACT PROMISE 1077BF/FF was a randomized study of antiretroviral therapy (ART) strategies for pregnant and postpartum women with high CD4+ T-cell counts. We describe postpartum outcomes for women in the study who were randomized to continue or discontinue ART after delivery.

Methods: Women with pre-ART CD4+ cell counts ≥350 cells/mm3 who started ART during pregnancy were randomized postpartum to continue or discontinue treatment. Women were enrolled from India, Malawi, South Africa, Tanzania, Uganda, Zambia, and Zimbabwe. The primary outcome was a composite of progression to AIDS-defining illness or death. Log-rank tests and Cox regression models assessed treatment effects. Incidence rates were calculated per 100 person-years. A post hoc analysis evaluated WHO Stage 2/3 events. All analyses were intent-to-treat.

Findings: 1611 women were enrolled (June 2011-October 2014) and 95% were breastfeeding. Median age at entry was 27 years, CD4+ count 728 cells/mm3 and the majority of women were Black African (97%). After a median follow-up of 1.6 years, progression to AIDS-defining illness or death was rare and there was no significant difference between arms (HR: 0·55; 95%CI 0·14, 2·08, p = 0.37). WHO Stage 2/3 events were reduced with continued ART (HR: 0·60; 95%CI 0·39, 0·90, p = 0.01). The arms did not differ with respect to the rate of grade 2, 3, or 4 safety events (p = 0.61).

Interpretation: Serious clinical events were rare among predominately breastfeeding women with high CD4+ cell counts over 18 months after delivery. ART had significant benefit in reducing WHO 2/3 events in this population.

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来源期刊
HIV Clinical Trials
HIV Clinical Trials 医学-传染病学
CiteScore
1.76
自引率
0.00%
发文量
0
审稿时长
>12 weeks
期刊介绍: HIV Clinical Trials is devoted exclusively to presenting information on the latest developments in HIV/AIDS clinical research. This journal enables readers to obtain the most up-to-date, innovative research from around the world.
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