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Boosted protease inhibitor monotherapy as a maintenance strategy: An observational study

机译:强化蛋白酶抑制剂单一疗法作为维持策略:一项观察性研究

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Objectives: 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. Design: Observational study in the FHDH-ANRS CO4 cohort. Methods: 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. Results: 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. Conclusion: 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.
机译:目的:我们旨在确定强化蛋白酶抑制剂单一疗法(BPIMT)作为常规治疗中的维持策略的有效性,并确定失败的预测因素。设计:在FHDH-ANRS CO4队列中进行的观察性研究。方法:2006年至2010年间,有529名受病毒抑制的个体改用BPIMT,其中75%的患者至少接受了12个月的随访,49%的患者接受了至少24个月的随访。分别分析了病毒学衰竭(两个连续的HIV-RNA> 50拷贝/ ml或一个HIV-RNA> 50拷贝/ ml,然后中断BPIMT)和治疗失败(病毒学失败,抗逆转录病毒强化或死亡)。结果:在基线时,未使用蛋白酶抑制剂的患者为11%,联合抗逆转录病毒疗法的中位时间为84个月,抑制病毒血症的中位时间为38个月。 9%的人有病毒学失败史,而在使用含蛋白酶抑制剂的治疗方案中,这些人的病毒学失败率更高[调整后的危险比为1.6; 95%置信区间(CI),0.9-2.9]。与改用BPIMT之前持续病毒抑制时间少于1年的个体相比,持续时间较长的个体发生病毒学衰竭的可能性较小[危险比,0.7; (95%CI,0.4-1.2)和0.6(95%CI,0.4-0.9)]分别持续12-23个月和24个月或更长时间。洛匹那韦-利托那韦(RTV)或darunavir-RTV的BPIMT的失败率相似,但阿扎那韦-RTV的BPIMT的失败率增加。相同的危险因素与治疗失败相关。结论:BPIMT维持策略在常规护理环境中的安全性和有效性与随机临床试验的结果相符。自从上次病毒学反弹到转用BPIMT以来持续时间更长,与随后失败的风险降低有关。

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