Abacavir safety and effectiveness in young infants with HIV in South African observational cohorts.

IF 1.3 4区医学 Q4 INFECTIOUS DISEASES Antiviral Therapy Pub Date : 2023-02-01 DOI:10.1177/13596535231168480

Reneé de Waal, Helena Rabie, Karl-Günter Technau, Brian Eley, Nosisa Sipambo, Mark Cotton, Andrew Boulle, Robin Wood, Frank Tanser, Geoffrey Fatti, Matthias Egger, Mary-Ann Davies

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Abstract

Background: WHO guidelines recommend abacavir in first-line antiretroviral treatment for children and neonates. However, there is no approved dose <3 months of age, and data in neonates are limited.

Methods: We included infants who initiated ART aged <3 months, between 2006 and 2019, in nine South African cohorts. In those who received abacavir or zidovudine, we described antiretroviral discontinuation rates; and 6- and 12-month viral suppression (<400 copies/mL). We compared infants aged <28 and ≥28 days, those weighing <3 and ≥3 kg.

Results: Overall 837/1643 infants (51%) received abacavir and 443 (27%) received zidovudine. Median (interquartile range, IQR) age was 52 days (23-71), CD4 percentage was 27.9 (19.2-38.0), and weight was 4.0 kg (3.0-4.7) at ART initiation. In those with ≥1 month's follow-up, 100/718 (14%) infants discontinued abacavir, at a median of 17.5 months (IQR 6.5-39.5). Abacavir discontinuations did not differ by age or weight category (p = 0.4 and 0.2, respectively); and were less frequent than zidovudine discontinuations (adjusted hazard ratio 0.14, 95% confidence interval 0.10-0.20). Viral suppression at 12 months occurred in 43/79 (54%) and 130/250 (52%) of those who started abacavir aged <28 and ≥28 days, respectively (p = 0.8); 11/19 (58%) and 31/60 (52%) in those who weighed <3 and ≥3 kg, respectively (p = 0.6); and 174/329 (53%) in those on abacavir versus 77/138 (56%) in those on zidovudine (adjusted odds ratio 1.8, 95% confidence interval 1.0-3.2).

Conclusion: Our data suggest that abacavir may be used safely in infants <28 days old or who weigh <3 kg.

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南非观察性队列中阿巴卡韦对感染艾滋病毒的幼婴的安全性和有效性。

背景：世界卫生组织指南建议将阿巴卡韦作为儿童和新生儿的一线抗逆转录病毒治疗药物。然而，目前还没有批准的剂量：我们纳入了开始接受抗逆转录病毒疗法的大龄婴儿：共有 837/1643 名婴儿（51%）接受了阿巴卡韦治疗，443 名婴儿（27%）接受了齐多夫定治疗。开始接受抗逆转录病毒疗法时的年龄中位数（四分位数间距，IQR）为 52 天（23-71），CD4 百分比为 27.9（19.2-38.0），体重为 4.0 公斤（3.0-4.7）。在随访时间≥1个月的婴儿中，有100/718（14%）名婴儿在中位数17.5个月（IQR 6.5-39.5）时停用了阿巴卡韦。阿巴卡韦停药与年龄或体重类别无差异（p = 0.4 和 0.2）；停药频率低于齐多夫定（调整后危险比为 0.14，95% 置信区间为 0.10-0.20）。开始服用阿巴卡韦的患者中，分别有43/79（54%）和130/250（52%）人在12个月后出现病毒抑制（年龄p=0.8）；开始服用阿巴卡韦的患者中，分别有11/19（58%）和31/60（52%）人在12个月后出现病毒抑制（年龄p=0.6）；服用阿巴卡韦的患者中，分别有174/329（53%）人和77/138（56%）人服用齐多夫定（调整后的几率比1.8，95%置信区间1.0-3.2）：我们的数据表明，阿巴卡韦可以安全地用于婴儿

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来源期刊

Antiviral Therapy 医学-病毒学

CiteScore

2.60

自引率

8.30%

发文量

审稿时长

4-8 weeks

期刊介绍： Antiviral Therapy (an official publication of the International Society of Antiviral Research) is an international, peer-reviewed journal devoted to publishing articles on the clinical development and use of antiviral agents and vaccines, and the treatment of all viral diseases. Antiviral Therapy is one of the leading journals in virology and infectious diseases. The journal is comprehensive, and publishes articles concerning all clinical aspects of antiviral therapy. It features editorials, original research papers, specially commissioned review articles, letters and book reviews. The journal is aimed at physicians and specialists interested in clinical and basic research.