Chelsea and Westminster Hospital, London, UK.
AIDS. 2011 Nov 28;25(18):2249-58. doi: 10.1097/QAD.0b013e32834c4c06.
The Study of Etravirine Neuropsychiatric Symptoms versus Efavirenz (SENSE) trial compared etravirine with efavirenz in treatment-naive patients. The primary endpoint was neuropsychiatric adverse events up to week 12; HIV RNA suppression at week 48 was a secondary endpoint.
Patients with HIV RNA more than 5000 copies/ml were randomized to etravirine 400 mg once daily (n = 79) or efavirenz (n = 78), plus two nucleoside analogues. HIV RNA less than 50 copies/ml at week 48 was analysed using the time to loss of virological response (TLOVR) algorithm. Drug resistance at treatment failure and safety endpoints were also evaluated.
At baseline, the median CD4 cell count was 302 cells/μl and HIV RNA was 4.8 log10 copies/ml. In the intent to treat TLOVR analysis at week 48, 60 of 79 (76%) patients on etravirine versus 58 of 78 (74%) on efavirenz had HIV RNA less than 50 copies/ml. In the on-treatment analysis, 60 of 65 (92%) taking etravirine had HIV RNA les than 50 copies/ml versus 58 of 65 (89%) for efavirenz: etravirine showed noninferior efficacy versus efavirenz in both analyses (P < 0.05). Four patients had virological failure in the etravirine arm: none developed resistance to nucleoside analogues or nonnucleosides. Seven patients had virological failure in the efavirenz arm: three developed treatment-emergent resistance to nucleoside analogues and/or nonnucleosides. At the week 48 visit, the percentage with ongoing neuropsychiatric adverse events was 6.3% for etravirine and 21.5% for efavirenz (P = 0.011).
First-line treatment with etravirine 400 mg once daily and two nucleoside reverse transcriptase inhibitors (NRTIs) led to similar rates of HIV RNA suppression, compared with efavirenz and two NRTIs. None of the patients with virological failure in the etravirine arm developed resistance to nonnucleosides.
依曲韦林神经精神症状研究（SENSE）试验比较了依曲韦林与依非韦伦在初治患者中的疗效。主要终点为治疗 12 周内的神经精神不良事件；次要终点为治疗 48 周时 HIV RNA 抑制情况。
将 HIV RNA 大于 5000 拷贝/ml 的患者随机分为依曲韦林 400mg 每日一次（n=79）或依非韦伦（n=78）组，两组均加用两种核苷逆转录酶抑制剂。第 48 周时采用病毒学应答丢失时间（TLOVR）算法分析 HIV RNA 小于 50 拷贝/ml 的患者。还评估了治疗失败时的耐药情况和安全性终点。
基线时，中位 CD4 细胞计数为 302 个/μl，HIV RNA 为 4.8log10 拷贝/ml。在第 48 周时的意向治疗 TLOVR 分析中，依曲韦林组 79 例中有 60 例（76%），依非韦伦组 78 例中有 58 例（74%）HIV RNA 小于 50 拷贝/ml。在治疗组分析中，65 例接受依曲韦林治疗的患者中有 60 例（92%）HIV RNA 小于 50 拷贝/ml，而 65 例接受依非韦伦治疗的患者中有 58 例（89%）：依曲韦林在两种分析中均显示出非劣效于依非韦伦的疗效（P<0.05）。依曲韦林组有 4 例发生病毒学失败：均未对核苷类似物或非核苷类药物产生耐药性。依非韦伦组有 7 例发生病毒学失败：其中 3 例对核苷类似物和/或非核苷类药物出现治疗后耐药。第 48 周时，依曲韦林组持续出现神经精神不良事件的比例为 6.3%，依非韦伦组为 21.5%（P=0.011）。
与依非韦伦和两种核苷逆转录酶抑制剂相比，依曲韦林 400mg 每日一次联合两种核苷逆转录酶抑制剂治疗初治患者，HIV RNA 抑制率相似。依曲韦林组病毒学失败的患者均未对非核苷类药物产生耐药性。
