Gerstoft Jan, Kirk Ole, Obel Niels, Pedersen Court, Mathiesen Lars, Nielsen Henrik, Katzenstein Terese L, Lundgren Jens D
Department of Infectious Diseases at Rigshospitalet, Copenhagen, Denmark.
AIDS. 2003 Sep 26;17(14):2045-52. doi: 10.1097/00002030-200309260-00005.
Highly active antiretroviral therapy containing three nucleoside reverse transcriptase inhibitors has been somewhat successful, but the clinical efficacy is unclear.
Randomized, controlled, open-label trial of 180 antiretroviral drug-naive HIV-infected patients allocated to a regimen of abacavir, stavudine and didanosine (A/S/D, n = 60), ritonavir and saquinavir (R/S 400/400 mg twice daily; n = 60) or nelfinavir and nevirapine (N/N 1250/200 mg twice daily; n = 60); the latter two in combination with lamivudine and zidovudine. The primary endpoint was HIV plasma RNA < or = 20 copies/ml after 48 weeks.
At baseline, the median CD4 cell count was 161 x 106 cells/l (range, 0-920) and the HIV RNA was 5.0 log10 copies/ml (range, 2.7-6.7). At 48 weeks, 43% in the A/S/D arm had a HIV RNA < or = 20 copies/ml, compared with 69% in the N/N arm (P < 0.01) and 62% in the R/S arm (P < 0.05). In a multivariate analysis, the A/S/D arm had an odds ratio of obtaining a viral load of < or = 20 copies/ml at week 48 of 0.25 [95% confidence interval (CI) 0.10-0.59] versus N/N and 0.53 (95% CI, 0.33-0.83) versus R/S. The A/S/D arm had a particularly poor outcome in patients with higher viral load and AIDS at baseline: 63% had to discontinue A/S/D (any drug). Side effects were more frequent in the A/S/D arm and included neuropathy 27%, suspicion of hypersensitivity 12%, and increase in lactate accompanied by systemic symptoms 8%.
The A/S/D regimen had a low efficacy and a high frequency of adverse events and cannot be recommended.
包含三种核苷类逆转录酶抑制剂的高效抗逆转录病毒疗法已取得一定成效，但临床疗效尚不清楚。
对180例未接受过抗逆转录病毒药物治疗的HIV感染患者进行随机、对照、开放标签试验，患者被分配接受阿巴卡韦、司他夫定和去羟肌苷方案（A/S/D，n = 60）、利托那韦和沙奎那韦方案（R/S，400/400毫克，每日两次；n = 60）或奈非那韦和奈韦拉平方案（N/N，1250/200毫克，每日两次；n = 60）；后两种方案与拉米夫定和齐多夫定联合使用。主要终点是48周后HIV血浆RNA≤20拷贝/毫升。
基线时，CD4细胞计数中位数为161×10⁶个/升（范围为0 - 920），HIV RNA为5.0 log₁₀拷贝/毫升（范围为2.7 - 6.7）。48周时，A/S/D组中43%的患者HIV RNA≤20拷贝/毫升，而N/N组为69%（P < 0.01），R/S组为62%（P < 0.05）。在多变量分析中，A/S/D组在48周时获得病毒载量≤20拷贝/毫升的优势比，与N/N组相比为0.25 [95%置信区间（CI）0.10 - 0.59]，与R/S组相比为0.53（95% CI，0.33 - 0.83）。在基线时病毒载量较高和患有艾滋病的患者中，A/S/D组的结局特别差：63%的患者不得不停用A/S/D（任何药物）。A/S/D组的副作用更频繁，包括神经病变27%、疑似过敏12%以及伴有全身症状的乳酸升高8%。
A/S/D方案疗效低且不良事件发生率高，不推荐使用。
