Kirk Ole, Lundgren Jens D, Pedersen Court, Mathiesen Lars R, Nielsen Henrik, Katzenstein Terese L, Obel Niels, Gerstoft Jan
Department of Infectious Diseases, Hvidovre University Hospital, Hvidovre, Denmark.
Antivir Ther. 2003 Dec;8(6):595-602.
A triple-class HAART regimen may be associated with a better virological effect than conventional regimens, but may also lead to toxicity and more profound resistance.
Randomized, controlled, open-label trial of 233 protease inhibitor- and non-nucleoside reverse transcriptase inhibitor-naive HIV-infected patients allocated to a regimen of nelfinavir and nevirapine (1250/200 mg twice daily; n = 118) or ritonavir and saquinavir (400/400 mg twice daily; n = 115), both in combination with two nucleoside reverse transcriptase inhibitors. The primary end-point was HIV RNA < or = 20 copies/ml after 48 weeks (missing value = failure). Patients remained under follow-up also in case of switch from the randomized therapy.
At baseline, the median CD4 cell counts were 126 (range: 0-942) (nelfinavir/nevirapine) and 150 (0-642) (ritonavir/saquinavir) cells/mm3, and HIV RNA measurements 5.0 copies/ml (1.3-6.4) in both groups. A total of 102 (86%) and 101 (88%) were antiretroviral-naive. 44% discontinued randomized therapy; P = 0.13. Of these, 80 and 73% switched therapy due to adverse events; P = 0.99. At week 48, 69 and 56%, respectively, had a HIV RNA < or = 20 copies/ml; P = 0.037.
A regimen of nelfinavir/nevirapine had a favourable virological effect and tolerability over a 48-week period compared with ritonavir/saquinavir, when administered in combination with two nucleoside reverse transcriptase inhibitors. However, more extensive follow-up is required to determine the long-term consequences of triple class HAART regimens, including the development of broad drug resistance.
与传统治疗方案相比，三联高效抗逆转录病毒治疗（HAART）方案可能具有更好的病毒学效果，但也可能导致毒性反应和更严重的耐药性。
对233例未接受过蛋白酶抑制剂和非核苷类逆转录酶抑制剂治疗的HIV感染患者进行随机、对照、开放标签试验，将其分为两组，一组接受奈非那韦和奈韦拉平治疗方案（每日两次，每次1250/200毫克；n = 118），另一组接受利托那韦和沙奎那韦治疗方案（每日两次，每次400/400毫克；n = 115），两组均联合两种核苷类逆转录酶抑制剂。主要终点为48周后HIV RNA≤20拷贝/毫升（缺失值视为治疗失败）。即使患者从随机治疗方案转换治疗，仍继续进行随访。
基线时，奈非那韦/奈韦拉平组的CD4细胞计数中位数为126（范围：0 - 942）个/立方毫米，利托那韦/沙奎那韦组为150（0 - 642）个/立方毫米，两组的HIV RNA测量值均为5.0拷贝/毫升（1.3 - 6.4）。共有102例（86%）和101例（88%）患者此前未接受过抗逆转录病毒治疗。44%的患者中断了随机治疗；P = 0.13。其中，分别有80%和73%的患者因不良事件而转换治疗方案；P = 0.99。在第48周时，两组分别有69%和56%的患者HIV RNA≤20拷贝/毫升；P = 0.037。
与利托那韦/沙奎那韦相比，奈非那韦/奈韦拉平治疗方案在联合两种核苷类逆转录酶抑制剂给药时，在48周期间具有良好的病毒学效果和耐受性。然而，需要更广泛的随访来确定三联HAART方案的长期后果，包括广泛耐药性的发展。
