Elion Richard, Dejesus Edwin, Sension Michael, Berger Daniel, Towner William, Richmond Gary, St Clair Marty, Yau Linda, Ha Belinda
George Washington University, Washington, DC, USA.
HIV Clin Trials. 2008 May-Jun;9(3):152-63. doi: 10.1310/hct0903-152.
To assess the efficacy and safety of a once-daily (QD) regimen consisting of the co-formulation of abacavir/lamivudine (ABC/3TC) and atazanavir plus ritonavir (ATV-RTV) in antiretroviral (ART)-naïve patients with plasma HIV-1 RNA >5,000 copies/mL.
This open-label, multicenter study conducted between September 2004 and June 2006 included 112 patients who received ABC 600 mg/3TC 300 mg and ATV 300 mg-RTV 100 mg QD. Drug switches were permitted for ABC hypersensitivity and ATV-related hyperbilirubinemia. Primary endpoints were proportion of patients achieving HIV-1 RNA <50 copies/mL at Week 48 and treatment discontinuation due to study drugs.
A total of 111 patients were treated. At Week 48, the proportion of patients achieving HIV-1 RNA <50 copies/mL was 77% (85/111) by intent-to-treat (ITT) missing=failure, switch included response rate. Drug substitutions occurred in 8 (7%) patients for suspected ABC hypersensitivity reaction (HSR) and in 6 (5%) patients for ATV-related toxicities; only 1 patient discontinued study due to ABC HSR. Four patients met confirmed virologic nonresponse (HIV RNA >or= 400 copies/mL). Treatment-emergent drug resistance was rare, and no patient had virus that developed reduced susceptibility to ATV. Median change from baseline (95% confidence interval) in fasting lipids at Week 48 was 39 (26-66) mg/dL for triglycerides, 28 (22-38) mg/dL for total cholesterol (C), 14 (10.5-16) mg/dL for HDL-C, and 8 (2-16.5) mg/dL for LDL-C.
ABC/3TC and ATV-RTV QD is an effective and well-tolerated regimen in ART-naïve patients through 48 weeks, with a modest impact on fasting lipids.
评估由阿巴卡韦/拉米夫定（ABC/3TC）与阿扎那韦加利托那韦（ATV-RTV）联合制剂组成的每日一次（QD）方案，用于治疗血浆HIV-1 RNA>5000拷贝/mL且未接受过抗逆转录病毒治疗（ART）的患者的疗效和安全性。
这项开放标签、多中心研究于2004年9月至2006年6月进行，纳入了112例接受ABC 600 mg/3TC 300 mg和ATV 300 mg-RTV 100 mg QD治疗的患者。对于ABC超敏反应和与ATV相关的高胆红素血症允许更换药物。主要终点为在第48周时HIV-1 RNA<50拷贝/mL的患者比例以及因研究药物导致的治疗中断情况。
共治疗了111例患者。在第48周时，按意向性分析（ITT）缺失=失败、包括换药在内的应答率计算，HIV-1 RNA<50拷贝/mL的患者比例为77%（85/111）。8例（7%）患者因疑似ABC超敏反应（HSR）进行了药物替换，6例（5%）患者因与ATV相关的毒性进行了药物替换；仅1例患者因ABC HSR停止研究。4例患者达到确诊的病毒学无应答（HIV RNA≥400拷贝/mL）。治疗中出现的耐药罕见，且没有患者的病毒对ATV的敏感性降低。第48周时，空腹血脂相对于基线的中位数变化（95%置信区间）为：甘油三酯39（26-66）mg/dL，总胆固醇（C）28（22-38）mg/dL，高密度脂蛋白胆固醇（HDL-C）14（10.5-16）mg/dL，低密度脂蛋白胆固醇（LDL-C）8（2-16.5）mg/dL。
ABC/3TC和ATV-RTV QD方案在未接受过ART的患者中治疗48周是有效且耐受性良好的方案，对空腹血脂有适度影响。
