Calza Leonardo, Manfredi Roberto, Colangeli Vincenzo, Pocaterra Daria, Rosseti Nirmala, Pavoni Michele, Chiodo Francesco
Department of Internal Medicine, Geriatrics and Nephrologic Diseases, Section of Infectious Diseases, Alma Mater Studiorum University of Bologna, S. Orsola-Malpighi Hospital, via G. Massarenti 11, Bologna, Italy.
AIDS Patient Care STDS. 2009 Sep;23(9):691-7. doi: 10.1089/apc.2009.0039.
Randomized, open-label, prospective clinical trial assessing efficacy and safety on hyperlipidemia of a switching from a regimen including one protease inhibitor and one thymidine analogue to atazanavir/ritonavir plus abacavir/lamivudine or tenofovir/emtricitabine. Adult HIV-infected patients on their first antiretroviral therapy (of at least 48-week duration), including one protease inhibitor and zidovudine or stavudine, with stable immunovirologic features, and having diagnosis of persisting hyperlipidemia, were randomized to replace current treatment with atazanavir/ritonavir plus abacavir/lamivudine (arm A) or tenofovir/emtricitabine (arm B), and were followed for 48 weeks. Eighty-nine patients were enrolled: 42 patients were randomized to arm A, and 47 to arm B. At the end of the 48-week follow-up, incidence of virologic failure was comparable in both arms, and associated with a poor drug compliance. Increase in CD4 lymphocyte count was significantly higher in arm A after a 24-week study period (62.5 versus 39.2 x 10(6) cells/L; p < 0.05), while immunologic responses were comparable at the end of 48-week follow-up (91.5 versus 83.6; p > 0.05). A statistically significant reduction (-15.4%) in mean triglyceridaemia versus respective baseline values was reported in both groups (p < 0.05), without statistically significant difference between arm A and B. Similar results were reported for total cholesterol and low-density lipoprotein (LDL) cholesterol levels. Safety and tolerability profiles were comparable in both groups. Switching from a protease inhibitor- and thymidine analogue-based antiretroviral regimen to atazanavir/ritonavir plus abacavir/lamivudine or tenofovir/emtricitabine proved effective in the management of hyperlipidemia, without significant differences in lipid-lowering effect, virologic efficacy, and safety profile between these regimens.
一项随机、开放标签、前瞻性临床试验，评估从包含一种蛋白酶抑制剂和一种胸苷类似物的治疗方案转换为阿扎那韦/利托那韦加阿巴卡韦/拉米夫定或替诺福韦/恩曲他滨对高脂血症的疗效和安全性。接受首次抗逆转录病毒治疗（至少持续48周）的成年HIV感染患者，治疗方案包括一种蛋白酶抑制剂和齐多夫定或司他夫定，免疫病毒学特征稳定，且诊断为持续性高脂血症，被随机分为两组，一组用阿扎那韦/利托那韦加阿巴卡韦/拉米夫定替代当前治疗（A组），另一组用替诺福韦/恩曲他滨替代当前治疗（B组），并随访48周。共纳入89例患者：42例患者被随机分入A组，47例分入B组。在48周随访结束时，两组的病毒学失败发生率相当，且与药物依从性差有关。在24周研究期后，A组的CD4淋巴细胞计数增加显著更高（62.5对39.2×10⁶个细胞/L；p<0.05），而在48周随访结束时免疫反应相当（91.5对83.6；p>0.05）。两组均报告平均甘油三酯血症较各自基线值有统计学显著降低（-15.4%）（p<0.05），A组和B组之间无统计学显著差异。总胆固醇和低密度脂蛋白（LDL）胆固醇水平也有类似结果。两组的安全性和耐受性概况相当。从基于蛋白酶抑制剂和胸苷类似物的抗逆转录病毒治疗方案转换为阿扎那韦/利托那韦加阿巴卡韦/拉米夫定或替诺福韦/恩曲他滨，在高脂血症管理中被证明是有效的，这些方案在降脂效果、病毒学疗效和安全性方面无显著差异。
