Empilweni Services and Research Unit, Rahima Moosa Mother and Child Hospital, School of Clinical Medicine, Faculty of Health Sciences, University of the Witwatersrand, South Africa.
Gertrude H. Sergievsky Center, Columbia University.
J Pediatric Infect Dis Soc. 2018 Aug 17;7(3):e70-e77. doi: 10.1093/jpids/pix110.
Abacavir has replaced stavudine in antiretroviral therapy (ART) regimens because it has largely been phased out as a result of toxicity concerns; this loss has reduced further the already-limited drug options for children. Few data regarding virologic and metabolic outcomes among children who undergo substitution of stavudine exist. We evaluated the effects of preemptive substitution of abacavir for stavudine in children initially without lipodystrophy and virally suppressed on a stavudine-containing regimen.
At Rahima Moosa Mother and Child Hospital in Johannesburg, South Africa, virally suppressed human immunodeficiency virus (HIV)-infected children ≥36 months of age without lipodystrophy were randomly assigned to continue taking stavudine as part of their ART regimen (n = 106) or to have abacavir substituted for stavudine (n = 107). The children were followed for 56 weeks after randomization in the context of a larger trial of treatment options for ART-experienced children.
The mean age of the children was 4.3 years, and the mean duration of ART before random assignment was 3.5 years. No differences in virological outcomes, CD4 response, growth, or dyslipidemia were noted between the stavudine and abacavir groups. By 56 weeks, children in the abacavir group had less clinically detected lipodystrophy (4.7% vs 16%, respectively), a higher proportion of leg fat relative to total fat (0.243 vs 0.230, respectively; P = .006), and a lower trunk/leg-skinfold ratio (0.547 vs 0.569, respectively; P = .003) than the children in the stavudine group.
Substituting abacavir for stavudine did not compromise virological response to treatment and was associated with significantly less lipodystrophy. These results support recommendations that favor abacavir in this population.
阿巴卡韦已取代司他夫定用于抗逆转录病毒治疗（ART）方案，因为由于毒性问题，它已基本淘汰；这进一步减少了儿童本来有限的药物选择。关于接受司他夫定替代治疗的儿童的病毒学和代谢结果的数据很少。我们评估了在最初无脂肪营养不良且病毒受抑制的接受司他夫定治疗的儿童中，抢先替代阿巴卡韦的效果。
在南非约翰内斯堡的 Rahima Moosa 母婴医院，对无脂肪营养不良且病毒受抑制的、年龄≥36 个月的人类免疫缺陷病毒（HIV）感染儿童进行随机分组，继续接受其 ART 方案中的司他夫定（n = 106）或用阿巴卡韦替代司他夫定（n = 107）。在一项更大的治疗方案选择的临床试验中，在随机分组后对儿童进行了 56 周的随访。
儿童的平均年龄为 4.3 岁，随机分组前接受 ART 的平均时间为 3.5 年。在病毒学结果、CD4 反应、生长或血脂异常方面，司他夫定组和阿巴卡韦组之间无差异。在 56 周时，阿巴卡韦组中临床检测到的脂肪营养不良发生率较低（分别为 4.7%和 16%），腿部脂肪相对于总脂肪的比例较高（分别为 0.243 和 0.230；P =.006），躯干/腿部皮褶厚度比值较低（分别为 0.547 和 0.569；P =.003）。
用阿巴卡韦替代司他夫定并未影响治疗的病毒学反应，并与明显较少的脂肪营养不良有关。这些结果支持了在该人群中优先使用阿巴卡韦的建议。
