INSERM, U, Paris, France.
AIDS. 2012 Nov 28;26(18):2345-50. doi: 10.1097/QAD.0b013e32835646e0.
We aimed to determine the effectiveness of boosted protease inhibitor monotherapy (BPIMT) initiated as a maintenance strategy in routine care and identify predictive factors of failure.
Observational study in the FHDH-ANRS CO4 cohort.
Five hundred and twenty-nine virologically suppressed individuals switched to BPIMT in the period 2006-2010, 75% had at least 12 and 49% at least 24 months of follow-up. Virological failure (two consecutive HIV-RNA > 50 copies/ml or one HIV-RNA > 50 copies/ml followed by BPIMT discontinuation) and treatment failure (virological failure, antiretroviral reintensification or death) were analysed separately.
At baseline, 11% were protease inhibitor-naive, median duration on combined antiretroviral therapy was 84 months and median duration of suppressed viremia was 38 months. Nine percent had a history of virological failure, while on a protease inhibitor-containing regimen, and rates of virological failure were higher among those individuals [adjusted hazard ratio, 1.6; 95% confidence interval (CI), 0.9-2.9]. Compared to individuals with less than 1 year of sustained virological suppression before the switch to BPIMT, those with longer duration were less likely to experience virological failure [hazard ratio, 0.7; (95% CI, 0.4-1.2) and 0.6 (95%CI, 0.4-0.9)] for a duration of 12-23 months and 24 months or more, respectively. Rates of failure were similar for BPIMT with lopinavir-ritonavir (RTV) or darunavir-RTV, but increased for BPIMT with atazanavir-RTV. Same risk factors were associated with treatment failure.
The safety and efficacy of a maintenance strategy with BPIMT in a routine care setting matched the results of randomized clinical trials. A longer duration since last virological rebound before switching to BPIMT was associated with a decreased risk of subsequent failure.
我们旨在确定在常规护理中作为维持治疗策略起始的强化蛋白酶抑制剂单药治疗（BPIMT）的疗效，并确定失败的预测因素。
FHDH-ANRS CO4 队列的观察性研究。
2006-2010 年期间，529 名病毒学抑制患者转换为 BPIMT，75%的患者至少有 12 个月和 49%的患者至少有 24 个月的随访。分别分析病毒学失败（两次连续 HIV-RNA>50 拷贝/ml 或一次 HIV-RNA>50 拷贝/ml 后 BPIMT 停药）和治疗失败（病毒学失败、抗逆转录病毒再强化或死亡）。
在基线时，11%的患者为蛋白酶抑制剂初治者，联合抗逆转录病毒治疗的中位时间为 84 个月，抑制病毒血症的中位时间为 38 个月。9%的患者有病毒学失败的病史，而在蛋白酶抑制剂治疗方案中，病毒学失败的发生率较高[调整后的危险比，1.6；95%置信区间（CI），0.9-2.9]。与转换为 BPIMT 前持续病毒学抑制时间少于 1 年的患者相比，持续病毒学抑制时间较长的患者发生病毒学失败的风险较低[危险比，0.7；（95%CI，0.4-1.2）和 0.6（95%CI，0.4-0.9）]，持续时间分别为 12-23 个月和 24 个月或更长。洛匹那韦-利托那韦（RTV）或达芦那韦-RTV 的 BPIMT 失败率相似，但阿扎那韦-RTV 的 BPIMT 失败率增加。相同的危险因素与治疗失败相关。
BPIMT 维持治疗策略在常规护理环境中的安全性和疗效与随机临床试验的结果相匹配。在转换为 BPIMT 之前，最后一次病毒学反弹后的时间越长，随后失败的风险越低。
