Fischl Margaret A, Ribaudo Heather J, Collier Ann C, Erice Alejo, Giuliano Marina, Dehlinger Marjorie, Eron Joseph J, Saag Michael S, Hammer Scott M, Vella Stefano, Morse Gene D, Feinberg Judith E, Demeter Lisa M, Eshleman Susan H
Department of Medicine, University of Miami School of Medicine, Miami, Florida 33101, USA.
J Infect Dis. 2003 Sep 1;188(5):625-34. doi: 10.1086/377311. Epub 2003 Aug 15.
To compare long-term virologic benefits of antiretroviral regimens in persons with advanced human immunodeficiency virus (HIV) disease, a randomized, open-label study was conducted of 517 subjects with no or limited previous experience with antiretroviral therapy. Subjects received lamivudine plus zidovudine and indinavir (indinavir group), efavirenz plus indinavir (efavirenz + indinavir group), or nelfinavir plus indinavir (nelfinavir + indinavir group) and were monitored for 2.1 years. Virologic failure was lower in the efavirenz + indinavir group (P=.04) and higher in the nelfinavir + indinavir group (P=.006), compared with that in the indinavir group. No difference in grade 3 or 4 adverse event rates in the efavirenz + indinavir group (P=.97) and a trend toward an increased rate in the nelfinavir + indinavir group (P=.07), compared with the indinavir group, were noted. A 4-drug regimen containing efavirenz plus indinavir resulted in a superior virologic response, whereas one containing nelfinavir plus indinavir resulted in an inferior response and a greater likelihood of toxicity.
为比较抗逆转录病毒疗法对晚期人类免疫缺陷病毒（HIV）疾病患者的长期病毒学疗效，对517名既往未接受过抗逆转录病毒治疗或接受过有限治疗的受试者进行了一项随机、开放标签研究。受试者接受拉米夫定加齐多夫定和茚地那韦（茚地那韦组）、依非韦伦加茚地那韦（依非韦伦+茚地那韦组）或奈非那韦加茚地那韦（奈非那韦+茚地那韦组）治疗，并接受了2.1年的监测。与茚地那韦组相比，依非韦伦+茚地那韦组的病毒学失败率较低（P = 0.04），而奈非那韦+茚地那韦组的病毒学失败率较高（P = 0.006）。与茚地那韦组相比，依非韦伦+茚地那韦组3级或4级不良事件发生率无差异（P = 0.97），奈非那韦+茚地那韦组有不良事件发生率增加的趋势（P = 0.07）。含依非韦伦加茚地那韦的四联疗法产生了更好的病毒学反应，而含奈非那韦加茚地那韦的疗法产生的反应较差且毒性更大。
