Youle Mike, Staszweski Schlomo, Clotet Bonaventura, Arribas José Ramon, Blaxhult Anders, Carosi Giampiero, Dejesus Edwin, Di Perri Gianni, Estrada Vicente, Fisher Martin, Kovacs Colin, Kulasegaram Ranjababu, Lazzarin Adriano, Marriott Debbie, Muñoz Leopoldo, Reynes Jacques, Shalit Peter, Slim Jihad, Tsoukas Chris, Vaccaro Anthony, Vera José
Royal Free Hospital Centre for HIV Medicine, Royal Free Hospital, London, UK.
HIV Clin Trials. 2006 Mar-Apr;7(2):86-96. doi: 10.1310/2xvk-pbgl-735n-wh72.
Recent data from clinical trials investigating the efficacy of enfuvirtide, a fusion inhibitor, in treatment-experienced patients have revealed that the addition of enfuvirtide (ENF) to an active boosted protease inhibitor regimen doubles the rate of virological response. At week 48 of the TORO studies, 55% of patients previously naive to and receiving lopinavir/ritonavir (LPV/r) with ENF achieved a viral load of <400 copies/mL compared with 24% of patients treated with LPV/r alone. At week 24 of the RESIST studies, 70% of previously ENF-naive patients who took both ENF and tipranavir/ritonavir (TPV/r) achieved a >or=1 log10 reduction in viral load compared with 37% of such patients treated with TPV/r alone. Similarly, concomitant use of TMC114/ritonavir (TMC114/r) with ENF, compared with TMC114/r alone, increased the number of patients with <50 copies/mL from 46% to 64% in a combined 24-week analysis from the POWER trials. Data from these trials suggest that combining one agent from a new class with a new agent from a previously exposed class offers a greater chance of achieving full virological control than either type of agent alone. Undetectable viraemia should be the primary objective for treatment-experienced patients requiring a switch in therapy, and the present data support the combination of an active boosted protease inhibitor with an agent from a new class (e.g., ENF) for triple-class-experienced patients.
近期关于融合抑制剂恩夫韦肽在经治患者中疗效的临床试验数据显示,在高效强化蛋白酶抑制剂治疗方案中加用恩夫韦肽(ENF)可使病毒学应答率翻倍。在TORO研究的第48周,既往未接受过治疗且接受洛匹那韦/利托那韦(LPV/r)联合ENF治疗的患者中,55%的患者病毒载量降至<400拷贝/毫升,而单独接受LPV/r治疗的患者这一比例为24%。在RESIST研究的第24周,既往未接受过ENF治疗且同时服用ENF和替拉那韦/利托那韦(TPV/r)的患者中,70%的患者病毒载量降低≥1 log10,而单独接受TPV/r治疗的患者这一比例为37%。同样,在POWER试验合并的24周分析中,与单独使用TMC114/利托那韦(TMC114/r)相比,TMC114/r与ENF联合使用使病毒载量<50拷贝/毫升的患者比例从46%增至64%。这些试验数据表明,将一类新药物中的一种与既往使用过的一类新药物联合使用,比单独使用任何一种药物更有可能实现完全病毒学控制。对于需要更换治疗方案的经治患者,不可检测的病毒血症应是主要治疗目标,目前的数据支持将高效强化蛋白酶抑制剂与一类新药物(如ENF)联合用于接受过三类药物治疗的患者。