Lluita contra la SIDA Foundation, Hospital Universitari Germans Trias i Pujol, Badalona, Barcelona, Spain Universitat Autònoma de Barcelona, Barcelona, Spain
Lluita contra la SIDA Foundation, Hospital Universitari Germans Trias i Pujol, Badalona, Barcelona, Spain Universitat Autònoma de Barcelona, Barcelona, Spain.
J Antimicrob Chemother. 2015 Apr;70(4):1124-9. doi: 10.1093/jac/dku509. Epub 2014 Dec 18.
Data on the efficacy of simplifying therapy using darunavir/ritonavir and lopinavir/ritonavir monotherapy in clinical practice remain limited.
A retrospective single-centre study including patients initiating darunavir/ritonavir or lopinavir/ritonavir monotherapy with a plasma HIV-1 viral load (pVL) <50 copies/mL and at least one subsequent follow-up visit. The primary endpoint was the percentage of patients remaining free of virological failure (VF; defined as a confirmed pVL >50 copies/mL or as any change in the regimen after a single determination with a pVL >50 copies/mL) during the follow-up. We also evaluated the percentage of patients remaining free of treatment failure (TF; defined as VF or the early discontinuation of monotherapy for any reason) and compared the effectiveness of the two regimens. Effectiveness was evaluated using cumulative survival analysis (at Weeks 48 and 96). Factors associated with VF and TF were analysed using Cox regression.
A total of 522 patients were included (309 receiving lopinavir/ritonavir and 213 receiving darunavir/ritonavir). The median follow-up was 64.3 (30.5-143.0) weeks. The percentage of patients free of VF and TF was 94% (95% CI 91%-96%) and 79% (95% CI 75%-82%) at 48 weeks, respectively, and 86% (95% CI 81%-89%) and 62% (95% CI 57%-67%) at 96 weeks, respectively. The risk of VF was similar for the two regimens (HR=1.0, 95% CI 0.6-1.8; P=0.962). Lopinavir/ritonavir monotherapy was associated with a 1.5-fold greater risk of TF (95% CI 1.1-2.1; P=0.012) and a 2.3-fold greater risk of discontinuation of therapy due to adverse events (95% CI 1.3-3.9; P=0.003).
The virological efficacy of darunavir/ritonavir and lopinavir/ritonavir monotherapy is high in clinical practice. Treatment discontinuation due to safety issues is more frequent with lopinavir/ritonavir.
关于简化治疗方案，即使用达芦那韦/利托那韦和洛匹那韦/利托那韦单药治疗的疗效，在临床实践中数据仍然有限。
这是一项回顾性单中心研究，共纳入了 522 名开始接受达芦那韦/利托那韦或洛匹那韦/利托那韦单药治疗，病毒载量（pVL）<50 拷贝/ml 且至少有一次后续随访的患者。主要终点是在随访期间无病毒学失败（VF；定义为确证的 pVL>50 拷贝/ml 或在单次 pVL>50 拷贝/ml 检测后方案发生任何改变）的患者比例。我们还评估了无治疗失败（TF；定义为 VF 或因任何原因停用单药治疗）的患者比例，并比较了两种方案的疗效。采用累积生存分析（第 48 周和第 96 周）评估疗效。使用 Cox 回归分析与 VF 和 TF 相关的因素。
共纳入 522 名患者（309 名接受洛匹那韦/利托那韦治疗，213 名接受达芦那韦/利托那韦治疗）。中位随访时间为 64.3（30.5-143.0）周。第 48 周时，无 VF 和 TF 的患者比例分别为 94%（95%CI 91%-96%）和 79%（95%CI 75%-82%），第 96 周时分别为 86%（95%CI 81%-89%）和 62%（95%CI 57%-67%）。两种方案的 VF 风险相似（HR=1.0，95%CI 0.6-1.8；P=0.962）。与达芦那韦/利托那韦相比，洛匹那韦/利托那韦单药治疗的 TF 风险增加 1.5 倍（95%CI 1.1-2.1；P=0.012），因不良事件停药的风险增加 2.3 倍（95%CI 1.3-3.9；P=0.003）。
在临床实践中，达芦那韦/利托那韦和洛匹那韦/利托那韦单药治疗的病毒学疗效较高。洛匹那韦/利托那韦因安全性问题停药的发生率更高。
