每日一次服用奈韦拉平的安全性和有效性：一项多队列研究。

Safety and efficacy of once-daily nevirapine dosing: a multicohort study.

作者信息

Calmy Alexandra, Vallier Nathalie, Nguyen Alain, Lange Joep Ma, Battegay Manuel, de Wolf Frank, Reiss Peter, Lima Viviane D, Hirschel Bernard, Hogg Robert S, Yip Benita, Montaner Julio S G, Wit Ferdinand W

机构信息

Division of Infectious Disease/HIV unit, University Hospital Geneva, Geneva, Switzerland.

出版信息

Antivir Ther. 2009;14(7):931-8. doi: 10.3851/IMP1418.

DOI:10.3851/IMP1418

PMID:19918097

Abstract

BACKGROUND

Nevirapine (NVP) is often prescribed once daily in clinical practice in combination with a once daily nucleoside backbone. We investigated the relationship of NVP dosing with safety and efficacy.

METHODS

Patients from the Dutch AIDS Therapy Evaluation in the Netherlands (ATHENA) cohort study, Canadian HAART Observational Medical Evaluation and Research (HOMER) cohort and Swiss HIV Cohort Study (SHCS) using NVP-based combination therapy either once daily or twice daily were included. Risk factors for discontinuing NVP because of hypersensitivity reactions (HSRs) were investigated using multivariate logistic regression. Risk factors for virological failure 96 weeks after NVP initiation were identified using logistic regression and Cox models.

RESULTS

Of 5,636 patients (774 once daily and 4,862 twice daily), 268 (4.8%) discontinued NVP because of HSR between 2 and 18 weeks. Logistic regression showed that, compared with patients with detectable HIV type-1 (HIV-1) RNA starting twice-daily NVP, there was a significantly higher risk of discontinuation of once-daily NVP because of HSR in patients with detectable HIV-1 RNA at the start of NVP (odds ratio [OR] 1.52; P=0.04), whereas the risk was actually significantly lower in patients starting once-daily NVP with undetectable HIV-1 RNA (OR 0.44; P=0.04). Cox models showed that risk of virological failure was not different for twice- versus once-daily NVP in treatment-naive patients (twice-daily versus once-daily hazard ratio [HR] 1.01; P=0.95), treatment-experienced patients experiencing treatment failure (twice-daily versus once-daily HR 1.22; P=0.30) or patients with undetectable HIV-1 RNA simplifying treatment with NVP (twice-daily versus once-daily HR 1.29; P=0.30).

CONCLUSIONS

Initiation of a once-daily NVP-based regimen in patients with suppressed viraemia carries a low risk of treatment-limiting HSR. Once- or twice-daily NVP-based regimens appear to have similar antiretroviral efficacy.

摘要

背景

在临床实践中，奈韦拉平（NVP）通常与每日一次的核苷类药物联合使用，每日给药一次。我们研究了NVP给药剂量与安全性和疗效之间的关系。

方法

纳入来自荷兰艾滋病治疗评估队列研究（ATHENA）、加拿大高效抗逆转录病毒治疗观察性医学评估与研究队列（HOMER）以及瑞士HIV队列研究（SHCS）的患者，这些患者使用基于NVP的联合治疗方案，每日一次或每日两次。使用多变量逻辑回归研究因超敏反应（HSR）而停用NVP的危险因素。使用逻辑回归和Cox模型确定NVP开始治疗96周后病毒学失败的危险因素。

结果

在5636例患者中（774例每日一次，4862例每日两次），268例（4.8%）在2至18周之间因HSR停用NVP。逻辑回归显示，与开始每日两次服用NVP时可检测到HIV-1 RNA的患者相比，开始服用NVP时可检测到HIV-1 RNA的患者因HSR停用每日一次NVP的风险显著更高（比值比[OR]1.52；P = 0.04），而开始每日一次服用NVP且HIV-1 RNA检测不到的患者风险实际上显著更低（OR 0.44；P = 0.04）。Cox模型显示，在初治患者（每日两次与每日一次风险比[HR]1.01；P = 0.95）、经历过治疗失败的经治患者（每日两次与每日一次HR 1.22；P = 0.30）或HIV-1 RNA检测不到且用NVP简化治疗的患者中，每日两次与每日一次服用NVP的病毒学失败风险没有差异（每日两次与每日一次HR 1.29；P = 0.30）。