Division of Infectious Diseases and HIV Medicine, Department of Medicine, Drexel University College of Medicine, Philadelphia, Pennsylvania, United States of America.
PLoS One. 2010 Sep 7;5(9):e12617. doi: 10.1371/journal.pone.0012617.
Predictors of adverse events (AE) associated with nevirapine use are needed to better understand reports of severe rash or liver enzyme elevation (LEE) in HIV+ women.
AE rates following ART initiation were retrospectively assessed in a multi-site cohort of 612 women. Predictors of onset of rash or LEE were determined using univariate and multivariate analyses.
Of 612 subjects, 152 (24.8%) initiated NVP-based regimens with 86 (56.6%) pregnant; 460 (75.2%) initiated non-NVP regimens with 67 (14.6%) pregnant. LEE: No significant difference was found between regimens in the development of new grade ≥2 LEE (p = 0.885). Multivariate logistic regression demonstrated an increased likelihood of LEE with HCV co-infection (OR 2.502, 95% CI: 1.04 to 6, p = 0.040); pregnancy, NVP-based regimen, and baseline CD4 >250 cells/mm(3) were not associated with this toxicity. RASH: NVP initiation was associated with rash after controlling for CD4 and pregnancy (OR 2.78; 95%CI: 1.14-6.76), as was baseline CD4 >250 cells/mm(3) when controlling for pregnancy and type of regimen (OR 2.68; 95% CI: 1.19-6.02 p = 0.017).
CD4 at initiation of therapy was a predictor of rash but not LEE with NVP use in HIV+ women. Pregnancy was not an independent risk factor for the development of AEs assessed. The findings from this study have significant implications for women of child-bearing age initiating NVP-based ART particularly in resource limited settings. This study sheds more confidence on the lack of LEE risk and the need to monitor rash with the use of this medication.
需要了解奈韦拉平（Nevirapine）使用相关不良事件（AE）的预测因素，以便更好地理解 HIV+ 女性中严重皮疹或肝酶升高（LEE）的报告。
回顾性评估了 612 名女性多地点队列中抗逆转录病毒治疗（ART）起始后 AE 的发生率。使用单变量和多变量分析确定皮疹或 LEE 发病的预测因素。
在 612 名受试者中，有 152 名（24.8%）开始使用基于 NVP 的方案，其中 86 名（56.6%）处于妊娠状态；460 名（75.2%）开始使用非 NVP 方案，其中 67 名（14.6%）处于妊娠状态。LEE：在新出现的≥2 级 LEE 发展方面，方案之间无显著差异（p=0.885）。多变量逻辑回归显示 HCV 合并感染增加了 LEE 的可能性（比值比 2.502，95%CI：1.04 至 6，p=0.040）；妊娠、NVP 方案和基线 CD4>250 个细胞/mm3 与这种毒性无关。皮疹：在控制 CD4 和妊娠的情况下，NVP 起始与皮疹相关（比值比 2.78；95%CI：1.14-6.76），在控制妊娠和方案类型的情况下，基线 CD4>250 个细胞/mm3 也与皮疹相关（比值比 2.68；95%CI：1.19-6.02，p=0.017）。
在 HIV+ 女性中，治疗起始时的 CD4 是 NVP 使用后皮疹而不是 LEE 的预测因素。妊娠不是发生 AE 的独立危险因素。本研究结果对开始接受基于 NVP 的 ART 的育龄妇女具有重要意义，特别是在资源有限的环境中。这项研究更加确信了使用这种药物不会增加 LEE 风险，并且需要监测皮疹。
