Efficacy and safety of atazanavir-based highly active antiretroviral therapy in patients with virologic suppression switched from a stable, boosted or unboosted protease inhibitor treatment regimen: The SWAN study (AI424-097) 48-week results
Efficacy and safety of atazanavir-based highly active antiretroviral therapy in patients with virologic suppression switched from a stable, boosted or unboosted protease inhibitor treatment regimen: The SWAN study (AI424-097) 48-week results
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DOI：
10.1086/517497
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发表时间：
2007-06-01
影响因子：
11.8
通讯作者：
Ledesma, Emilio
中科院分区：
文献类型：
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作者：
Gatell, Jose;Salmon-Ceron, Dominique;Ledesma, Emilio
背景。阿扎那韦是一种每日一次的蛋白酶抑制剂 (PI)，用于治疗人类免疫缺陷病毒 (HIV) 感染，此前已在未接受过治疗和接受过治疗的患者队列中进行了研究。对于正在经历病毒学抑制但寻求方案简化的 HIV 感染患者，从基于 PI 的方案切换到基于不同 PI（例如阿扎那韦）的方案的有效性的数据有限。方法。改用另一种蛋白酶抑制剂 (SWAN) 研究是一项为期 48 周的开放标签试验，受试者为病毒学抑制的 HIV 阳性患者，这些患者正在接受稳定的基于 PI 的治疗方案（联合或不联合利托那韦）。患者以 2:1 的比例随机转为阿扎那韦（每天 400 毫克），或者如果他们正在接受替诺福韦治疗，则转为阿扎那韦-利托那韦（每天 300/100 毫克），或者继续接受现有的 PI。在第 48 周的研究中比较了经历病毒学反弹（定义为 HIV RNA 载量 >= 50 拷贝/mL）的患者比例。结果。患者要么接受含阿扎那韦的治疗方案（278 名患者），要么继续接受含对照 PI 的治疗方案（141 名患者）。转用含阿扎那韦方案的患者（278 人中的 19 人 [7%]）中出现病毒学反弹的患者比例明显低于继续接受对照 PI 方案的患者（141 人中的 22 人 [16%]）。转用阿扎那韦治疗的患者的总胆固醇、空腹甘油三酯和非高密度脂蛋白胆固醇升高程度明显低于对照组 PI 组的患者 P
Background. Atazanavir is a once-daily protease inhibitor (PI) for the treatment of human immunodeficiency virus (HIV) infection that has previously been studied in cohorts of treatment-naive and treatment-experienced patients. Limited data are available on the usefulness of switching from a PI-based regimen to a regimen based on a different PI, such as atazanavir, in HIV-infected patients experiencing virologic suppression but seeking regimen simplification.Methods. The Switch to Another Protease Inhibitor (SWAN) study was a 48-week, open-label trial involving HIV-positive patients with virologic suppression who were receiving stable PI-based regimens (with or without ritonavir). Patients were randomized 2: 1 to switch to atazanavir (400 mg per day)-or, if they were receiving tenofovir, to atazanavir-ritonavir (300/100 mg per day) - or to continue to receive their existing PI. The proportion of patients who experienced virologic rebound (defined as an HIV RNA load >= 50 copies/mL) was compared through study week 48.Results. Patients either received an atazanavir-containing regimen (278 patients) or continued to receive a comparator PI-containing regimen (141 patients). The proportion of patients who experienced virologic rebound was significantly lower among those who switched to an atazanavir-containing regimen (19 [7%] of 278) than it was among those who continued to receive a comparator PI regimen (22 [16%] of 141;). Patients who switched to atazanavir therapy experienced significantly fewer total cholesterol, fasting triglyceride, and non-high density lipoprotein cholesterol elevations than did patients in the comparator PI group P