在欧洲进行利匹韦林（RPV）利用的观察性队列研究。
Observational cohort study of rilpivirine (RPV) utilization in Europe.
机构信息
Centre for Clinical Research, Epidemiology, Modelling and Evaluation (CREME), Institute for Global Health, University College London, Rowland Hill St, London, NW3 2PF, UK.
CHIP, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.
出版信息
AIDS Res Ther. 2022 Aug 6;19(1):38. doi: 10.1186/s12981-022-00457-0.
INTRODUCTION
Data on safety and effectiveness of RPV from the real-world setting as well as comparisons with other NNRTIs such as efavirenz (EFV) remain scarce.
METHODS
Participants of EuroSIDA were included if they had started a RPV- or an EFV-containing regimen over November 2011-December 2017. Statistical testing was conducted using non-parametric Mann-Whitney U test and Chi-square test. A logistic regression model was used to compare participants' characteristics by treatment group. Kaplan-Meier analysis was used to estimate the cumulative risk of virological failure (VF, two consecutive values > 50 copies/mL).
RESULTS
1,355 PLWH who started a RPV-based regimen (11% ART-naïve), as well as 333 initiating an EFV-containing regimen were included. Participants who started RPV differed from those starting EFV for demographics (age, geographical region) and immune-virological profiles (CD4 count, HIV RNA). The cumulative risk of VF for the RPV-based group was 4.5% (95% CI 3.3-5.7%) by 2 years from starting treatment (71 total VF events). Five out of 15 (33%) with resistance data available in the RPV group showed resistance-associated mutations vs. 3/13 (23%) among those in the EFV group. Discontinuations due to intolerance/toxicity were reported for 73 (15%) of RPV- vs. 45 (30%) of EFV-treated participants (p = 0.0001). The main difference was for toxicity of central nervous system (CNS, 3% vs. 22%, p < 0.001).
CONCLUSION
Our estimates of VF > 50 copies/mL and resistance in participants treated with RPV were similar to those reported by other studies. RPV safety profile was favourable with less frequent discontinuation due to toxicity than EFV (especially for CNS).
简介
有关 RPV 在真实环境中的安全性和有效性的数据，以及与其他 NNRTIs（如依非韦伦[EFV]）的比较数据仍然很少。
方法
如果参与者在 2011 年 11 月至 2017 年 12 月期间开始使用 RPV 或 EFV 治疗方案，则将其纳入 EuroSIDA 研究。使用非参数曼-惠特尼 U 检验和卡方检验进行统计检验。使用逻辑回归模型比较治疗组参与者的特征。使用 Kaplan-Meier 分析估计病毒学失败（VF，两次连续值＞50 拷贝/mL）的累积风险。
结果
共纳入 1355 名开始使用 RPV 治疗方案的 HIV 感染者（11%为初治）和 333 名开始使用 EFV 治疗方案的感染者。与开始 EFV 治疗的参与者相比，开始 RPV 治疗的参与者在人口统计学特征（年龄、地理区域）和免疫病毒学特征（CD4 计数、HIV RNA）方面存在差异。开始治疗后 2 年内，基于 RPV 的治疗组 VF 的累积风险为 4.5%（95%CI 3.3-5.7%）（共发生 71 例 VF 事件）。在 RPV 组中，有 5 例（33%）有耐药数据，其中有耐药相关突变，而在 EFV 组中，有 3 例（23%）有耐药相关突变。因不耐受/毒性而停药的 RPV 组参与者为 73 例（15%），EFV 组为 45 例（30%）（p=0.0001）。主要差异在于中枢神经系统毒性（CNS，3% vs. 22%，p＜0.001）。
结论
我们对 RPV 治疗参与者中 VF＞50 拷贝/mL 和耐药的估计与其他研究报告的相似。与 EFV 相比，RPV 的安全性较好，因毒性导致停药的频率较低（尤其是 CNS）。
Zotero 插件