Tashima Karen, Staszewski Schlomo, Nelson Mark, Rachlis Anita, Skiest Daniel, Stryker Richard, Bessen Laura, Overfield Sandra, Ruiz Nancy, Wirtz Victoria
Miriam Hospital, Providence, Rhode Island 02906, USA.
AIDS. 2008 Jan 11;22(2):275-9. doi: 10.1097/QAD.0b013e3282f21b9d.
To compare the long-term efficacy and tolerability of two efavirenz-containing regimens with those of an indinavir-containing regimen in the initial use of HAART.
HIV-1-infected patients (N = 1266) were randomly assigned to receive one of three regimens: efavirenz, zidovudine plus lamivudine, n = 422; efavirenz plus indinavir, n = 429; or indinavir, zidovudine plus lamivudine, n = 415. Entrance criteria included baseline viral load greater than 10 000 copies/ml HIV-1 RNA, CD4 cell count 50 cells/mul or greater, and no previous use of lamivudine, any non-nucleoside reverse-transcriptase inhibitor or protease inhibitor. The primary endpoint was the proportion of patients (response rate) in each regimen with a viral load under 400 copies/ml at 168 weeks of treatment.
Response rates at 168 weeks were 30% in the indinavir, zidovudine, lamivudine group, 48% in the efavirenz, zidovudine, lamivudine group (P < 0.0001, difference estimate; 97.5% confidence interval (CI) 18.5; 10.9, 26), and 40% in the efavirenz plus indinavir group (P = 0.0018, difference estimate; 97.5% CI 10.2; 2.9, 17.6). Median CD4 cell counts increased above respective baselines by 292 cells/mul (efavirenz, zidovudine, lamivudine and indinavir, zidovudine, lamivudine) and 300 cells/mul (efavirenz plus indinavir). Total discontinuations were 54% (efavirenz, zidovudine, lamivudine), 63% (efavirenz plus indinavir), and 69% (indinavir, zidovudine, lamivudine) of which 13, 12 and 26%, respectively, were caused by adverse events. No new or unexpected increases in the rates or severity of adverse events occurred from long-term treatment with efavirenz-containing regimens.
Long-term HIV therapy with efavirenz-containing regimens, particularly efavirenz, zidovudine, lamivudine, provides significantly greater antiviral activity and tolerability than a regimen of indinavir, zidovudine plus lamivudine.
比较两种含依非韦伦方案与一种含茚地那韦方案在初始使用高效抗逆转录病毒治疗（HAART）时的长期疗效和耐受性。
将1266例HIV-1感染患者随机分为三组，分别接受以下三种方案之一：依非韦伦、齐多夫定加拉米夫定，n = 422；依非韦伦加茚地那韦，n = 429；或茚地那韦、齐多夫定加拉米夫定，n = 415。入选标准包括基线病毒载量大于10000拷贝/ml HIV-1 RNA、CD4细胞计数50个/μl或更高，且既往未使用过拉米夫定、任何非核苷类逆转录酶抑制剂或蛋白酶抑制剂。主要终点是每种方案在治疗168周时病毒载量低于400拷贝/ml的患者比例（应答率）。
茚地那韦、齐多夫定、拉米夫定组在168周时的应答率为30%，依非韦伦、齐多夫定、拉米夫定组为48%（P < 0.0001，差异估计值；97.5%置信区间（CI）18.5；10.9，26），依非韦伦加茚地那韦组为40%（P = 0.0018，差异估计值；97.5% CI 10.2；2.9，17.6）。CD4细胞计数中位数分别比各自基线增加292个/μl（依非韦伦、齐多夫定、拉米夫定组和茚地那韦、齐多夫定、拉米夫定组）和300个/μl（依非韦伦加茚地那韦组）。总停药率分别为54%（依非韦伦、齐多夫定、拉米夫定组）、63%（依非韦伦加茚地那韦组）和69%（茚地那韦、齐多夫定、拉米夫定组），其中分别有13%、12%和26%是由不良事件导致的。含依非韦伦方案长期治疗未出现不良事件发生率或严重程度的新的或意外增加。
含依非韦伦方案，尤其是依非韦伦、齐多夫定、拉米夫定方案，长期治疗HIV比茚地那韦、齐多夫定加拉米夫定方案具有显著更高的抗病毒活性和耐受性。
