Infectious Diseases Unit, DIBIC "Luigi Sacco", University of Milan, Milan, Italy.
Infectious Diseases Unit, DIBIC "Luigi Sacco", University of Milan, Milan, Italy.
Antiviral Res. 2016 May;129:52-57. doi: 10.1016/j.antiviral.2016.02.010. Epub 2016 Feb 20.
We evaluated predictive factors involved in durability and therapeutic failure of atazanavir (ATV)-based antiretroviral regimens with or without ritonavir (r) in real life setting. This retrospective study of HIV-1-positive patients evaluated the factors related to ATV continuance and the time-dependent probability of therapeutic failure (HIV-RNA >200 copies/mL and concomitant discontinuation of ATV). We also investigated the rate of therapeutic failure and the variations in total bilirubin levels from starting unboosted ATV-based regimens. The study involved 1030 patients: 183 treatment-naïve patients (17.8%) started ATV/r (17 subsequently switched to unboosted ATV); 653 (63.4%) switched to ATV/r from previous antiretroviral regimens (121 subsequently switched to unboosted ATV); and 194 (18.8%) switched to unboosted ATV from previous ATV-free regimens. The median ATV follow-up was 28 months (interquartile range 7-56). The risk of ATV discontinuation was significantly lower in patients switched to unboosted ATV from ATV/r (HR 0.45; p < 0.0001). The discontinuation of ATV correlated with female gender (HR 1.26; p = 0.035), use of a zidovudine/didanosine/stavudine containing backbone (HR 1.8; p = 0.004), and a baseline CD4+ cell counts of <200/μL (HR 1.54; p = 0.003), the last of which was also associated with a higher risk of therapeutic failure (HR 2.42; p = 0.001). Total bilirubin levels were significantly lower in the patients switching from ATV/r to unboosted ATV. Unboosted ATV-based therapies are safe and effective options in patients whose immuno-virological conditions are stable, and allow the long-term survival of ATV-containing regimens.
我们评估了在真实环境中基于阿扎那韦（ATV）的抗病毒方案（联合或不联合利托那韦[r]）的耐用性和治疗失败的预测因素。这项回顾性 HIV-1 阳性患者研究评估了与 ATV 持续使用相关的因素，以及治疗失败的时间依赖性概率（HIV-RNA >200 拷贝/mL 且同时停用 ATV）。我们还研究了从开始使用未强化 ATV 为基础的方案起治疗失败的发生率和总胆红素水平的变化。该研究纳入了 1030 名患者：183 名初治患者（17.8%）开始使用 ATV/r（17 名随后转换为未强化 ATV）；653 名（63.4%）从先前的抗病毒方案转换为 ATV/r（121 名随后转换为未强化 ATV）；194 名（18.8%）从先前的无 ATV 方案转换为未强化 ATV。ATV 的中位随访时间为 28 个月（四分位距 7-56）。与从 ATV/r 转换为未强化 ATV 的患者相比，ATV 停药的风险显著降低（HR 0.45；p<0.0001）。ATV 停药与女性（HR 1.26；p=0.035）、使用含齐多夫定/去羟肌苷/司他夫定的骨架（HR 1.8；p=0.004）和基线 CD4+细胞计数<200/μL（HR 1.54；p=0.003）相关，后者与治疗失败的风险增加相关（HR 2.42；p=0.001）。从 ATV/r 转换为未强化 ATV 的患者的总胆红素水平显著降低。对于免疫病毒学状况稳定的患者，基于未强化 ATV 的治疗是安全有效的选择，可维持包含 ATV 的方案的长期生存。
