Santos José Ramón, Moltó José, Llibre Josep Maria, Pérez Nuria, Miranda Cristina, Clotet Bonaventura
Lluita contra la SIDA Foundation, Germans Trias i Pujol University Hospital, Barcelona, Spain Universitat Autónoma de Barcelona, Barcelona, Spain.
HIV Clin Trials. 2009 May-Jun;10(3):129-34. doi: 10.1310/hct1003-129.
To assess the effectiveness and safety of antiretroviral therapy with unboosted atazanavir (400 mg once daily) plus co-formulated abacavir/lamivudine as a treatment simplification strategy in HIV-infected patients with sustained viral suppression in routine clinical practice.
We performed a retrospective study including patients who were switched to unboosted atazanavir plus abacavir/lamivudine and whose HIV-1 RNA was <50 copies/mL. The primary endpoint was the percentage of subjects who maintained viral suppression after 48 weeks of follow-up. Secondary endpoints included the percentage of subjects who maintained viral suppression after 96 weeks of follow-up, the incidence of adverse events, changes in CD4+ T-cell count and in lipid profile, and the percentage of patients with subtherapeutic atazanavir trough concentrations during follow-up.
Forty-six patients were included. None had a prior history of resistance to protease inhibitors or to lamivudine or abacavir. The percentage of patients with viral suppression at Week 48 was 73.9% when all the included patients were considered (full dataset analysis) and 85.0% when only subjects on treatment were considered. There was a continuous immune recovery and an improvement in lipid profile during follow-up. Two thirds of the patients had subtherapeutic atazanavir trough concentrations in plasma in at least one determination during follow-up.
Antiretroviral therapy with unboosted atazanavir plus abacavir/lamivudine is safe and effective in the long term as a treatment simplification strategy in HIV-infected patients with sustained virological suppression in routine clinical practice.
评估在常规临床实践中，使用未增效的阿扎那韦（每日一次，400毫克）联合复方阿巴卡韦/拉米夫定进行抗逆转录病毒治疗作为一种治疗简化策略，对病毒得到持续抑制的HIV感染患者的有效性和安全性。
我们进行了一项回顾性研究，纳入了换用未增效阿扎那韦联合阿巴卡韦/拉米夫定且HIV-1 RNA低于50拷贝/毫升的患者。主要终点是随访48周后维持病毒抑制的受试者百分比。次要终点包括随访96周后维持病毒抑制的受试者百分比、不良事件发生率、CD4+ T细胞计数和血脂谱的变化，以及随访期间阿扎那韦谷浓度低于治疗水平的患者百分比。
共纳入46例患者。无一例有对蛋白酶抑制剂、拉米夫定或阿巴卡韦的耐药史。在考虑所有纳入患者时（完整数据集分析），第48周时病毒抑制患者的百分比为73.9%，仅考虑接受治疗的受试者时为85.0%。随访期间有持续的免疫恢复和血脂谱改善。三分之二的患者在随访期间至少有一次血浆阿扎那韦谷浓度低于治疗水平。
在常规临床实践中，对于病毒得到持续抑制的HIV感染患者，使用未增效的阿扎那韦联合阿巴卡韦/拉米夫定作为一种治疗简化策略，长期来看是安全有效的。
