Institute of Human Virology, Clinical Division, Baltimore, MD 21201, USA.
J Acquir Immune Defic Syndr. 2012 Jul 1;60(3):314-20. doi: 10.1097/QAI.0b013e31824e5256.
Although used globally, little data exist on the efficacy of nevirapine (NVP) used in combination with tenofovir (TDF)/emtricitabine or lamivudine (XTC), and no large randomized prospective control trials exists comparing this combination with efavirenz (EFV)/TDF/(XTC).
As part of the AIDSRelief program, a retrospective review of patient medical chart information along with a cross-sectional viral load, and adherence measurement was conducted between 2004 and 2009. An on-treatment analysis excluded patients who died, transferred out of care, or were lost to follow-up. A switch of antiretrovirals for any reason was considered a failure in the intent-to-treat analysis. Patients with only clinically relevant reasons for switching such as toxicity, adverse effects, viral failure or clinical/immunological failure, lost to follow-up, and death were considered failures as part of the modified-intent-to-treat analysis. Step-wise multiple regression analysis was used to identify variables that were associated with viral suppression.
A random sample of 3862 patients met criteria and were included in this analysis. In the on-treatment analysis, older age (P < 0.004) and baseline CD4 <100 cells per cubic millimeter (P < 0.021) were the most significant variables impacting viral load. Patients on TDF/XTC/EFV achieved higher rates of viral suppression compared with patients on TDF/XTC/NVP or azidothymidine (AZT)/lamivudine (3TC)/NVP.
Our data show that patients on TDF/XTC/EFV had better outcomes than patients on TDF/XTC/NVP, AZT/3TC/EFV, or AZT/3TC/NVP. High rates of virologic suppression seen in patients on this regimen are consistent with previous studies and indicate the need to increase use of this regimen in HIV programs to promote sustainable viral suppression over time.
虽然在全球范围内使用，但关于奈韦拉平（NVP）与替诺福韦（TDF）/恩曲他滨或拉米夫定（XTC）联合使用的疗效数据很少，也没有大型随机前瞻性对照试验比较这种联合用药与依非韦伦（EFV）/TDF/（XTC）。
作为 AIDSRelief 计划的一部分，我们对 2004 年至 2009 年间患者的病历信息进行了回顾性审查，同时进行了病毒载量和依从性的横断面测量。在治疗期间分析中，排除了死亡、转出治疗或失访的患者。因任何原因更换抗逆转录病毒药物均被视为意向治疗分析中的失败。因毒性、不良反应、病毒失败或临床/免疫失败、失访和死亡等仅具有临床相关性的原因而更换药物的患者，在修改意向治疗分析中被视为失败。采用逐步多元回归分析确定与病毒抑制相关的变量。
随机抽取的 3862 名患者符合标准并纳入本分析。在治疗期间分析中，年龄较大（P < 0.004）和基线 CD4 细胞<100 个/立方毫米（P < 0.021）是影响病毒载量的最重要变量。接受 TDF/XTC/EFV 治疗的患者与接受 TDF/XTC/NVP、AZT/3TC/NVP 或 AZT/3TC/EFV 治疗的患者相比，病毒抑制率更高。
我们的数据表明，接受 TDF/XTC/EFV 治疗的患者比接受 TDF/XTC/NVP、AZT/3TC/EFV 或 AZT/3TC/NVP 治疗的患者具有更好的结局。该方案治疗的患者具有较高的病毒学抑制率，这与以往的研究一致，表明需要增加在 HIV 项目中使用该方案，以促进随着时间的推移可持续的病毒抑制。
