基于多替拉韦的双重疗法在 HIV 经治患者中的应用：马德里的真实研究。

Dolutegravir-Based Dual Therapies in HIV Pretreated Patients: A Real-Life Study in Madrid.

机构信息

Instituto de Investigación Sanitaria Gregorio Marañón, Madrid, Spain.

出版信息

Ann Pharmacother. 2022 Apr;56(4):401-411. doi: 10.1177/10600280211038504. Epub 2021 Aug 12.

DOI:10.1177/10600280211038504

PMID:34382435

Abstract

BACKGROUND

Few studies describe the use of dolutegravir (DTG)-based dual therapies under routine clinical practice.

OBJECTIVES

To report real-life data on the use of DTG-based dual therapies in treatment-experienced patients.

METHODS

This was an observational, retrospective study. It included all treatment-experienced HIV patients starting a DTG-based dual therapy from 2014 to 2018. The primary end point was to identify the incidence and reasons for the switch. The secondary end points were to assess the effectiveness, safety, adherence, and costs after 48 weeks of treatment (W48).

RESULTS

The incidence of the switch to a DTG-based dual therapy increased from 1.6 patients per 1000 patient-years in 2014 to 38.6 in 2018. A total of 241 patients initiated this therapy: 113 (46.9%) patients started DTG plus rilpivirine (RPV), 72 (29.9%), DTG plus lamivudine (3TC), and 68 (28.2%), DTG plus boosted-darunavir (b-DRV). A total of 170 patients completed W48 of follow-up. By intention-to-treat analysis, 89.3% of virologically suppressed (VS) patients (94.3% with DTG plus b-DRV, 91.3% with DTG plus 3TC, and 87.2% with DTG plus RPV) and 56.7% of non-VS patients (71.4% with DTG plus RPV and 52.2% with DTG plus b-DRV) achieved a viral load <50 copies/mL at W48. The protocol-defined virological failure was 6.5%. Overall, 8.8% of patients had early discontinuation. The annual cost increased by €800 per patient ($916).

CONCLUSIONS AND RELEVANCE

The use of DTG-based dual therapies has increased in real life, showing a favorable effectiveness and safety profile. Treatment costs increased, except for the switch to DTG plus 3TC.

摘要

背景

很少有研究描述在常规临床实践中使用多替拉韦（DTG）为基础的双重疗法。

目的

报告在治疗经验丰富的患者中使用 DTG 为基础的双重疗法的真实数据。

方法

这是一项观察性、回顾性研究。它纳入了所有从 2014 年到 2018 年开始 DTG 为基础的双重疗法的治疗经验丰富的 HIV 患者。主要终点是确定转换的发生率和原因。次要终点是评估治疗 48 周后（W48）的疗效、安全性、依从性和成本。

结果

转换为 DTG 为基础的双重疗法的发生率从 2014 年的每 1000 名患者中有 1.6 名患者增加到 2018 年的 38.6 名。共有 241 名患者开始接受这种治疗：113 名（46.9%）患者开始 DTG 加利匹韦林（RPV），72 名（29.9%）患者开始 DTG 加拉米夫定（3TC），68 名（28.2%）患者开始 DTG 加达芦那韦（b-DRV）。共有 170 名患者完成了 W48 的随访。根据意向治疗分析，89.3%的病毒学抑制（VS）患者（94.3%的 DTG 加 b-DRV，91.3%的 DTG 加 3TC，87.2%的 DTG 加 RPV）和 56.7%的非 VS 患者（71.4%的 DTG 加 RPV 和 52.2%的 DTG 加 b-DRV）在 W48 时达到了病毒载量<50 拷贝/ml。方案定义的病毒学失败率为 6.5%。总体而言，有 8.8%的患者早期停药。每位患者的年治疗费用增加了 800 欧元（916 美元）。