Health Economics and Epidemiology Research Office, Department of Internal Medicine, School of Clinical Medicine, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.
PLoS One. 2013 Aug 7;8(8):e71719. doi: 10.1371/journal.pone.0071719. Print 2013.
Recent WHO guidelines for resource-limited settings recommend tenofovir in first-line antiretroviral therapy (ART) yet there are suggestions that patients receiving nevirapine with tenofovir have worse outcomes than those receiving efavirenz. We sought to compare outcomes among those taking nevirapine vs. efavirenz with tenofovir and lamivudine.
We analyzed data on ART naïve, non-pregnant patients, ≥ 18 years old without tuberculosis co-infection, initiating tenofovir with lamivudine and either nevirapine or efavirenz between April 1, 2010 and July 31, 2011 (when South Africa's public-sector use of tenofovir began) at Themba Lethu Clinic in South Africa. We measured virologic suppression (viral load <400 copies/ml), virologic failure (2 consecutive viral loads >1000 copies/ml), and attrition (death/loss to follow-up) all at 12 months after ART initiation. Modified Poisson regression with robust error estimation was used to estimate risk ratios (RR) and 95% confidence intervals (CI) for predictors of each outcome.
2,254 patients were prescribed efavirenz, 131 nevirapine. Patients were followed a median (range) of 12.0 (0.1-12.0) person-months. 62.2% were female and median (IQR) age was 37.7 years (31.5-44.1). Patients prescribed efavirenz had similar initiating CD4 counts (median 132 for both regimens) but were somewhat more likely to be WHO Stage III or IV (39.6% vs. 33.6%) than those prescribed nevirapine. No difference in attrition was found (aRR: 0.83; 95% CI: 0.49-1.41). Among patients with ≥ 1 viral load within 1 year on ART, those prescribed nevirapine were as likely to reach virologic suppression (aRR: 0.97; 95% CI: 0.88-1.07) but more likely to experience virologic failure (aRR: 1.84; 95% CI: 1.02-3.31) than those prescribed efavirenz.
Our results support the notion that, among patients prescribed tenofovir and lamivudine, virologic failure is more common among those taking nevirapine than among those taking efavirenz. Longer-term follow up and larger studies will be needed to confirm this finding.
最近世界卫生组织（WHO）为资源有限地区制定的指南建议将替诺福韦用于一线抗逆转录病毒治疗（ART），但有研究提示，接受奈韦拉平联合替诺福韦治疗的患者比接受依非韦伦联合替诺福韦和拉米夫定治疗的患者结局更差。我们旨在比较接受奈韦拉平与依非韦伦联合替诺福韦和拉米夫定治疗的患者结局。
我们分析了 2010 年 4 月 1 日至 2011 年 7 月 31 日期间在南非 Themba Lethu 诊所接受 ART 治疗的非妊娠、≥18 岁、无结核合并感染的初治患者的资料，他们接受了替诺福韦和拉米夫定联合奈韦拉平或依非韦伦治疗。我们在 ART 开始后 12 个月时测量了病毒学抑制（病毒载量<400 拷贝/ml）、病毒学失败（连续 2 次病毒载量>1000 拷贝/ml）和失访/死亡（attrition）。采用稳健误差估计的修正泊松回归估计每个结局的预测因素的风险比（RR）和 95%置信区间（CI）。
2254 例患者接受了依非韦伦治疗，131 例患者接受了奈韦拉平治疗。患者中位（范围）随访 12.0（0.1-12.0）个人月。62.2%为女性，中位（IQR）年龄为 37.7 岁（31.5-44.1）。接受依非韦伦治疗的患者的初始 CD4 计数相似（两种方案的中位数均为 132），但更有可能处于 WHO 分期 III 或 IV 期（39.6% vs. 33.6%）。未发现失访差异（aRR：0.83；95%CI：0.49-1.41）。在 ART 治疗 1 年内有≥1 次病毒载量的患者中，接受奈韦拉平治疗的患者达到病毒学抑制的可能性相似（aRR：0.97；95%CI：0.88-1.07），但更可能发生病毒学失败（aRR：1.84；95%CI：1.02-3.31）。
我们的结果支持这样的观点，即在接受替诺福韦和拉米夫定治疗的患者中，与接受依非韦伦治疗的患者相比，接受奈韦拉平治疗的患者更易发生病毒学失败。需要进行更长时间的随访和更大规模的研究来证实这一发现。
