Jayaweera Dushyantha, Dejesus Edwin, Nguyen Kim L, Grimm Kristy, Butcher David, Seekins Daniel W
Miller School of Medicine, University of Miami, Miami, FL 33136, USA.
HIV Clin Trials. 2009 Nov-Dec;10(6):375-84. doi: 10.1310/hct1006-375.
This study evaluated the long-term efficacy, safety, adherence, and quality of life (QoL) of a once-daily efavirenz-based antiretroviral regimen in two 96-week prospective open-label single-arm studies of treatment-naïve HIV-1-infected patients.
Patients received once-daily efavirenz 600 mg and lamivudine 300 mg with either enteric-coated didanosine 400 mg (Daily Antiretroviral Therapy trial [DART] I) or extended-release stavudine 100 mg (DART II). The primary efficacy outcome measure was HIV RNA <400 copies/mL at Week 48.
In an intent-to-treat (ITT) analysis, HIV RNA level <400 (<50) copies/mL was reached by 82%(80%) and 74% (72%) of patients at Week 48 in DART I and II. At Week 96, the corresponding values were 74% (68%) and 55% (54%), respectively. Both regimens were well tolerated. There were no discontinuations for virologic failure. Medication adherence assessed by pill counts was above 80% in 90% of the patients in DART I and more than 80% of patients in DART II. Treatment produced a significant improvement in overall QoL.
Once-daily efavirenz-based antiretroviral therapy was effective, durable, and well tolerated. In this study, a high level of adherence was achieved with improvement in overall QoL.
在两项针对初治HIV-1感染患者的为期96周的前瞻性开放标签单臂研究中，评估一种基于每日一次依非韦伦的抗逆转录病毒疗法的长期疗效、安全性、依从性和生活质量（QoL）。
患者每日一次接受600毫克依非韦伦和300毫克拉米夫定，同时服用400毫克肠溶去羟肌苷（每日抗逆转录病毒治疗试验[DART]I）或100毫克缓释司他夫定（DART II）。主要疗效指标是第48周时HIV RNA<400拷贝/毫升。
在意向性治疗（ITT）分析中，DART I和II中分别有82%（80%）和74%（72%）的患者在第48周时HIV RNA水平达到<400（<50）拷贝/毫升。在第96周时，相应的值分别为74%（68%）和55%（54%）。两种治疗方案耐受性均良好。没有因病毒学失败而停药的情况。通过药丸计数评估的药物依从性在DART I中90%的患者中高于80%，在DART II中超过80%的患者中高于80%。治疗使总体生活质量有显著改善。
基于每日一次依非韦伦的抗逆转录病毒疗法有效、持久且耐受性良好。在本研究中，实现了高水平的依从性，总体生活质量得到改善。
