van Leth Frank, Conway Brian, Laplumé Hector, Martin Des, Fisher Martin, Jelaska Ante, Wit Ferdinand W, Lange Joep M A
Department of Internal Medicine, Academic Medical Center, University of Amsterdam, Amsterdam, The Netherlands.
Antivir Ther. 2004 Oct;9(5):721-8.
To assess whether differences in safety profiles between nevirapine (NVP) and efavirenz (EFV), as observed in the 2NN study, translated into differences in 'health related quality of life' (HRQoL).
A sub-study of the 2NN study, with antiretroviral-naive patients randomly allocated to NVP (once or twice daily), EFV or NVP+EFV, in addition to stavudine and lamivudine.
Comparing differences in changes of HRQoL over 48 weeks as measured with the Medical Outcomes Study HIV Health Survey (MOS-HIV) questionnaire, using analysis of variance.
The 2NN study enrolled 1216 patients. No validated questionnaires were available for 244 patients, and 55 patients had no HRQoL data at all, leaving 917 patients eligible for this sub-study. A total of 471 (51%) had HRQoL measurements both at baseline and week 48. The majority (69%) of patients without HRQoL measurements did, however, complete the study. The change in the physical health score (PHS) was 3.9 for NVP, 3.4 for EFV and 2.4 for NVP+EFV (P=0.712). For the mental health score (MHS) these values were 6.1, 7.0 and 3.9, respectively (P=0.098). A baseline plasma HIV-1 RNA concentration (pVL) > or = 100,000 copies/ml and a decline in pVL (per log10) were independently associated with an increase of PHS. An increase of MHS was only associated with pVL decline. Patients experiencing an adverse event during follow-up had a comparable change in PHS but a significantly smaller change in MHS, compared with those without an adverse event.
First-line ART containing NVP and/or EFV leads to an improvement in HRQoL. The gain in HRQoL was similar for NVP and EFV, but slightly lower for the combination of these drugs.
评估在2NN研究中观察到的奈韦拉平（NVP）和依非韦伦（EFV）安全性概况的差异是否转化为“健康相关生活质量”（HRQoL）的差异。
2NN研究的一项子研究，将未接受过抗逆转录病毒治疗的患者随机分配至NVP（每日一次或两次）、EFV或NVP + EFV组，同时给予司他夫定和拉米夫定。
使用方差分析，比较通过医学结局研究HIV健康调查（MOS - HIV）问卷测量的48周内HRQoL变化的差异。
2NN研究纳入了1216名患者。244名患者没有有效的问卷，55名患者完全没有HRQoL数据，剩余917名患者符合该子研究的条件。共有471名（51%）患者在基线和第48周均进行了HRQoL测量。然而，大多数（69%）未进行HRQoL测量的患者完成了研究。NVP组的身体健康评分（PHS）变化为3.9，EFV组为3.4，NVP + EFV组为2.4（P = 0.712）。心理健康评分（MHS）的相应值分别为6.1、7.0和3.9（P = 0.098）。基线血浆HIV - 1 RNA浓度（pVL）≥100,000拷贝/毫升以及pVL下降（每log10）与PHS升高独立相关。MHS升高仅与pVL下降相关。与未发生不良事件的患者相比，随访期间发生不良事件的患者PHS变化相当，但MHS变化显著较小。
含NVP和/或EFV的一线抗逆转录病毒治疗可改善HRQoL。NVP和EFV的HRQoL改善相似，但这两种药物联合使用时略低。
