Vermaak John-Randel, Dave Joel A, Levitt Naomi, Heckmann Jeannine M
Neurology Research Group, Division of Neurology, Department of Medicine, University of Cape Town, Cape Town, South Africa.
Division of Endocrinology and Diabetic Medicine, Department of Medicine, University of Cape Town, Cape Town, South Africa.
AIDS Res Ther. 2015 Sep 23;12:30. doi: 10.1186/s12981-015-0073-8. eCollection 2015.
Protease inhibitors (PI)s have been associated with distal sensory polyneuropathy (DSP) and metabolic complications in high-income countries. No data exist in Africans where second-line antiretroviral therapy (ART) often include PIs.
We performed a cross-sectional study to assess the DSP frequency and metabolic risk factors in community-based South Africans taking ritonavir-boosted lopinavir as PI. Examination findings categorized subjects as having DSP (≥1 neuropathic sign) or symptomatic DSP [DSP with symptom(s)]. Fasting-state glucose and lipid profiles were assessed. We compared the ritonavir/lopinavir-group to a nested group on first-line ART [dideoxy-nucleoside reverse transcriptase inhibitors (d-drugs)] selected from a dataset collected at the same time and matched for d-drug exposure.
The ritonavir/lopinavir-group (n = 86) consisted predominantly of women (84 %) with a median age of 36 years (IQR 32-41). The median current CD4+ count was 489 cells/μL (IQR 291-665). The median exposure time to ritonavir/lopinavir was 18 months (IQR 10-26) and to d-drugs, 24 months (IQR 16-38). DSP was present in 78 % and symptomatic DSP in 48 %; symptoms were most frequently of moderate intensity. Only age independently associated with DSP and symptomatic DSP (p = 0.08 and p = 0.04, respectively). None of the metabolic syndrome components showed associations with DSP or symptomatic DSP despite a trend towards hypertriglyceridemia overall. The ritonavir/lopinavir-group had less DSP compared to the d-drug only group (p = 0.002) but the frequency of symptomatic DSP was similar (p = 0.49).
Ritonavir-boosted lopinavir did not add additional risk to developing DSP in this community-based African cohort after a median of 18 months on second-line ART.
在高收入国家,蛋白酶抑制剂(PI)与远端感觉性多发性神经病变(DSP)及代谢并发症相关。在非洲,二线抗逆转录病毒治疗(ART)常包含PI,但尚无相关数据。
我们开展了一项横断面研究,以评估接受利托那韦增强型洛匹那韦作为PI治疗的社区南非人中DSP的发生率及代谢危险因素。根据检查结果,将受试者分类为患有DSP(≥1种神经病变体征)或有症状的DSP[伴有症状的DSP]。评估空腹血糖和血脂情况。我们将利托那韦/洛匹那韦组与从同时收集的数据集里选取的、接受一线ART[双脱氧核苷逆转录酶抑制剂(d类药物)]且d类药物暴露情况匹配的嵌套组进行比较。
利托那韦/洛匹那韦组(n = 86)主要为女性(84%),中位年龄36岁(四分位间距32 - 41岁)。当前CD4 +细胞计数的中位数为489个/μL(四分位间距291 - 665)。利托那韦/洛匹那韦的中位暴露时间为18个月(四分位间距10 - 26),d类药物的中位暴露时间为24个月(四分位间距16 - 38)。78%的患者存在DSP,48%的患者有症状性DSP;症状大多为中度。仅年龄与DSP及有症状的DSP独立相关(分别为p = 0.08和p = 0.04)。尽管总体上有高甘油三酯血症的趋势,但代谢综合征各组分均未显示与DSP或有症状的DSP相关。与仅使用d类药物组相比,利托那韦/洛匹那韦组的DSP较少(p = 0.002),但有症状的DSP发生率相似(p = 0.49)。
在这个以社区为基础的非洲队列中,接受二线ART治疗中位数为18个月后,利托那韦增强型洛匹那韦并未增加发生DSP的额外风险。