DeJesus Edwin, Ruane Peter, McDonald Cheryl, Garcia Fernando, Sharma Shetal, Corales Roberto, Ravishankar Jayashree, Khanlou Homayoun, Shamblaw David, Ecker Janet, Ebrahimi Ramin, Flaherty John
Orlando Immunology Center, Orlando, Florida 32803, USA.
HIV Clin Trials. 2008 Mar-Apr;9(2):103-14. doi: 10.1310/hct0902-103.
Evaluate the impact of switching from twice-daily zidovudine/lamivudine (AZT/3TC) to once-daily tenofovir DF plus emtricitabine (TDF/FTC) with efavirenz (EFV).
Prospective, multicenter, single-arm 24-week trial.
Patients on EFV + AZT/3TC for > or =8 weeks with HIV-1 RNA <400 copies/mL were switched to EFV + TDF/FTC and assessed for safety/tolerability, virologic and immunologic responses, adherence, and quality of life at 4, 12, and 24 weeks.
Of 402 patients, 2% discontinued for an adverse event (AE) and 1 patient for virologic failure. At 24 weeks, 87% had HIV RNA <400 copies/mL, and 74% versus 71% at baseline had undetectable (HIV RNA <50 copies/mL) viral load (ITT; M=F). Treatment-emergent AEs were infrequent (< or = 5%) with gastrointestinal complaints being the most common. At 24 weeks compared to baseline, hemoglobin (Hb) increased by a median of 0.6 g/dL (p < .001), and a decrease in creatinine clearance of 7.6 mL/min (p < .001) was observed. Fasting lipids decreased slightly (p < .02) in a subset of patients studied (n = 160). A higher percentage of patients reported being "very satisfied" with treatment and the absence of regimen side effects at 24 weeks versus baseline (p < .001). At 24 weeks, 86% of patients took > or = 95% of doses versus 78% at baseline (p = .002).
Patients switched to EFV + TDF/FTC maintained virologic suppression and the regimen was well tolerated. Patients reported increased satisfaction with treatment and fewer were bothered by side effects.
评估从每日两次的齐多夫定/拉米夫定（AZT/3TC）转换为每日一次的替诺福韦酯加恩曲他滨（TDF/FTC）联合依非韦伦（EFV）的影响。
前瞻性、多中心、单臂24周试验。
接受EFV + AZT/3TC治疗≥8周且HIV-1 RNA＜400拷贝/mL的患者转换为EFV + TDF/FTC，并在4周、12周和24周时评估安全性/耐受性、病毒学和免疫学反应、依从性及生活质量。
402例患者中，2%因不良事件（AE）停药，1例因病毒学失败停药。在24周时，87%的患者HIV RNA＜400拷贝/mL，意向性分析（ITT）中，74%的患者病毒载量不可检测（HIV RNA＜50拷贝/mL），而基线时为71%（男性=女性）。治疗中出现的AE不常见（≤5%），胃肠道不适最为常见。与基线相比，24周时血红蛋白（Hb）中位数增加0.6 g/dL（p＜0.001），肌酐清除率下降7.6 mL/min（p＜0.001）。在部分研究患者（n = 160）中，空腹血脂略有下降（p＜0.02）。与基线相比，24周时更高比例的患者报告对治疗“非常满意”且无治疗方案副作用（p＜0.001）。24周时，86%的患者服药剂量≥95%，而基线时为78%（p = 0.002）。
转换为EFV + TDF/FTC的患者维持了病毒学抑制，且该治疗方案耐受性良好。患者报告对治疗的满意度增加，受副作用困扰的患者减少。
