Núñez Marina, Soriano Vincent, Martín-Carbonero Luz, Barrios Ana, Barreiro Pablo, Blanco Francisco, García-Benayas Teresa, González-Lahoz Juan
Service of Infectious Diseases, Hospital Carlos III, Instituto de Salud Carlos III, Madrid, Spain.
HIV Clin Trials. 2002 May-Jun;3(3):186-94. doi: 10.1310/0cj5-2abq-cb00-6mr6.
A randomized, open-label, pilot study was undertaken to explore the antiviral activity and tolerability of two nonnucleoside reverse transcriptase inhibitors (NNRTIs), nevirapine (NVP) and efavirenz (EFV).
HIV-infected antiretroviral-naive adults with CD4 counts >100 cells/mm(3) and detectable plasma HIV RNA below 100,000 copies/mL were randomized to receive didanosine (ddI) and stavudine (d4T) plus either NVP or EFV. Assessments were made every 12 weeks. Primary endpoints were the proportion of patients reaching plasma HIV RNA <50 copies/mL and/or developing NNRTI-related toxicities leading to drug discontinuation. Baseline characteristics were comparable for participants in the EFV (n = 31) and NVP arms (n = 36).
At 48 weeks, 23/31 (74%) patients in the EFV group and 23/36 (64%) in the NVP group had <50 HIV RNA copies/mL (intention-to-treat analysis). Adverse events led to NNRTI discontinuation in 4 and 3 patients in the EFV and NVP arms, respectively. There were no statistically significant differences between groups regarding any primary endpoint. NVP and EFV along with two NRTIs may be equally well tolerated and effective at achieving <50 HIV RNA copies/mL in naive patients with CD4 counts >100 cells/mm(3) and HIV RNA <10(5) copies/mL.
A much larger study is needed to demonstrate any significant differences between NVP and EFV, if they exist at all.
开展一项随机、开放标签的试点研究，以探索两种非核苷类逆转录酶抑制剂（NNRTIs）奈韦拉平（NVP）和依非韦伦（EFV）的抗病毒活性和耐受性。
将CD4细胞计数>100个细胞/mm³且血浆HIV RNA低于100,000拷贝/mL的初治HIV感染成人随机分组，接受去羟肌苷（ddI）和司他夫定（d4T）加NVP或EFV治疗。每12周进行一次评估。主要终点是血浆HIV RNA<50拷贝/mL的患者比例和/或发生导致停药的与NNRTI相关的毒性反应。依非韦伦组（n = 31）和奈韦拉平组（n = 36）参与者的基线特征具有可比性。
在48周时，依非韦伦组23/31（74%）的患者和奈韦拉平组23/36（64%）的患者血浆HIV RNA<50拷贝/mL（意向性分析）。依非韦伦组和奈韦拉平组分别有4例和3例患者因不良事件停用NNRTI。两组在任何主要终点方面均无统计学显著差异。对于CD4细胞计数>100个细胞/mm³且HIV RNA<10⁵拷贝/mL的初治患者，NVP和EFV与两种核苷类逆转录酶抑制剂联合使用时，耐受性可能相当，且在使血浆HIV RNA<50拷贝/mL方面同样有效。
需要开展规模大得多的研究来证明NVP和EFV之间是否存在任何显著差异（如果确实存在差异的话）。
