Takuva Simbarashe, Evans Denise, Zuma Khangelani, Okello Velephi, Louwagie Goedele
Clinical HIV Research Unit, Department of Internal Medicine, School of Clinical Medicine, Faculty of Health Sciences, University of the Witwatersrand, South Africa.
Pan Afr Med J. 2013 May 3;15:5. doi: 10.11604/pamj.2013.15.5.1889. Print 2013.
Nevirapine (NVP) and Efavirenz (EFV) have generally comparable clinical and virologic efficacy. However, data comparing NVP durability to EFV are imprecise. We analyzed cohort data to compare durability of NVP to EFV among patients initiating ART in Mbabane, Swaziland. The primary outcome was poor regimen durability defined as any modification of NVP or EFV to the ART regimen. Multivariate Cox proportional hazards models were employed to estimate the risk of poor regimen durability (all-cause) for the two regimens and also separately to estimate risk of drug-related toxicity. We analyzed records for 769 patients initiating ART in Mbabane, Swaziland from March 2006 to December 2007. 30 patients (3.9%) changed their NVP or EFV-based regimen during follow up. Cumulative incidence for poor regimen durability was 5.3% and 2.7% for NVP and EFV, respectively. Cumulative incidence for drug-related toxicity was 1.9% and 2.7% for NVP and EFV, respectively. Burden of TB was high and 14 (46.7%) modifications were due to patients substituting NVP due to beginning TB treatment. Though the estimates were imprecise, use of NVP - based regimens seemed to be associated with higher risk of modifications compared to use of EFV - based regimens (HR 2.03 95%CI 0.58 - 7.05) and NVP - based regimens had a small advantage over EFV - based regimens with regard to toxicity - related modifications (HR 0.87 95%CI 0.26 - 2.90). Due to the high burden of TB and a significant proportion of patients changing their ART regimen after starting TB treatment, use of EFV as the preferred NNRTI over NVP in high TB endemic settings may result in improved first-line regimen tolerance. Further studies comparing the cost-effectiveness of delivering these two NNRTIs in light of their different limitations are required.
奈韦拉平（NVP）和依非韦伦（EFV）在临床和病毒学疗效方面总体相当。然而，比较NVP与EFV耐久性的数据并不精确。我们分析了队列数据，以比较在斯威士兰姆巴巴内开始接受抗逆转录病毒治疗（ART）的患者中NVP与EFV的耐久性。主要结局是治疗方案耐久性差，定义为对ART方案中的NVP或EFV进行任何调整。采用多变量Cox比例风险模型来估计两种方案治疗方案耐久性差（全因）的风险，并分别估计药物相关毒性的风险。我们分析了2006年3月至2007年12月在斯威士兰姆巴巴内开始接受ART治疗的769例患者的记录。30例患者（3.9%）在随访期间改变了基于NVP或EFV的治疗方案。NVP和EFV治疗方案耐久性差的累积发生率分别为5.3%和2.7%。NVP和EFV药物相关毒性的累积发生率分别为1.9%和2.7%。结核病负担较高，14例（46.7%）调整是由于患者因开始结核病治疗而更换NVP。尽管估计不精确，但与基于EFV方案相比，基于NVP方案的使用似乎与更高的调整风险相关（风险比2.03，95%置信区间0.58 - 7.05），并且基于NVP方案在与毒性相关的调整方面比基于EFV方案有小优势（风险比0.87，95%置信区间0.26 - 2.90）。由于结核病负担高以及相当比例的患者在开始结核病治疗后改变其ART方案，在结核病高流行地区使用EFV作为首选非核苷类逆转录酶抑制剂（NNRTI）而非NVP可能会提高一线治疗方案的耐受性。需要进一步研究根据这两种NNRTI的不同局限性比较其成本效益。
