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一线抗逆转录病毒治疗的比较效果:实施多替拉韦后大型真实世界队列的结果。

Comparative effectiveness of first-line antiretroviral therapy: results from a large real-world cohort after the implementation of dolutegravir.

机构信息

Department of STIs, HIV/AIDS and Viral Hepatitis, Ministry of Health of Brazil.

Tropical Medicine Division, Faculty of Medicine, University of Brasilia, Brasilia, Brazil.

出版信息

AIDS. 2019 Aug 1;33(10):1663-1668. doi: 10.1097/QAD.0000000000002254.

Abstract

OBJECTIVE

We aimed to assess the effectiveness of first-line antiretroviral therapy (ART) regimens in achieving viral suppression at 12 months, from 2014 to 2017 in Brazil.

DESIGN

A retrospective cohort study utilizing programmatic data from the Brazilian HIV Program.

METHODS

Adults (aged 15-80 years) who started ART from January 2014 to July 2017 and had a viral load 365 (±90) days after treatment initiation were included. Associations with achieving viral suppression (<50 copies/ml) at 365 (±90) days were assessed using logistic regression. Our main study variable was ART regimen, and covariates included year of ART initiation, sex/exposure group, age, education, race, region, baseline CD4 and viral load counts, and adherence measured by pharmacy refill data. We performed both intent-to-treat and per-protocol analogous analyses.

RESULTS

Out of 107 647 ART-naive patients, 71.5% initiated with tenofovir/lamivudine/efavirenz (TLE) and 10.5% with tenofovir/lamivudine/dolutegravir (TLD). Median age and CD4 cell counts were 34 [interquartile range (IQR) 26-46] and 379 cells/μl (IQR 190-568), respectively; 68.0% were men. Viral suppression by 12 months was 84.0% [95% confidence interval (95% CI) 83.7-84.2] with TLE and 90.5% (95% CI 90.0-91.0) with TLD, and below 80% for protease-inhibitor-based regimens. In the multivariable intent-to-treat-analogous analysis, controlling for cofactors related to viral suppression including adherence, the adjusted odds ratio (aOR) for TLD's viral suppression relative to TLE was 1.56 (95% CI 1.40-1.75). Findings were robust to secondary per-protocol analogous and sensitivity analysis.

CONCLUSION

Our results showed the superiority of dolutegravir- over efavirenz- and protease-inhibitor-based regimens in suppressing viral replication in a real-word cohort of HIV-positive adults. This superiority was not driven by higher levels of adherence with dolutegravir-based regimens.

摘要

目的

本研究旨在评估 2014 年至 2017 年期间,巴西一线抗逆转录病毒治疗(ART)方案在 12 个月时实现病毒抑制的效果。

设计

一项利用巴西 HIV 项目的方案数据进行的回顾性队列研究。

方法

纳入 2014 年 1 月至 2017 年 7 月期间开始接受 ART 且治疗启动后 365(±90)天病毒载量<50 拷贝/ml 的 15-80 岁成年人。采用逻辑回归评估在 365(±90)天达到病毒抑制(<50 拷贝/ml)的相关因素。我们的主要研究变量是 ART 方案,协变量包括 ART 起始年份、性别/暴露组、年龄、教育程度、种族、地区、基线 CD4 和病毒载量以及通过药房补药数据测量的依从性。我们进行了意向治疗和符合方案分析。

结果

在 107647 例未曾接受过 ART 的患者中,71.5%的患者起始方案为替诺福韦/拉米夫定/依非韦伦(TLE),10.5%的患者起始方案为替诺福韦/拉米夫定/多替拉韦(TLD)。中位年龄和 CD4 细胞计数分别为 34[四分位距(IQR)26-46]和 379 个细胞/μl(IQR 190-568);68.0%为男性。TLE 组和 TLD 组在 12 个月时的病毒抑制率分别为 84.0%(95%置信区间[95%CI]83.7-84.2)和 90.5%(95%CI 90.0-91.0),而基于蛋白酶抑制剂的方案则低于 80%。在多变量意向治疗分析中,控制了与病毒抑制相关的协变量(包括依从性),TLD 方案的病毒抑制相对于 TLE 方案的调整优势比(aOR)为 1.56(95%CI 1.40-1.75)。次要的符合方案分析和敏感性分析结果稳健。

结论

我们的研究结果显示,多替拉韦方案优于依非韦伦和基于蛋白酶抑制剂的方案,可在真实世界的 HIV 阳性成年人队列中抑制病毒复制。这种优势不是由多替拉韦方案更高的依从性驱动的。

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