Data on two-drug regimens (2DRs) have shown high efficacy and tolerability in treatment-naive and treatment-experienced HIV-1 patients. Current guidelines recommend 2DRs as alternative to three-drug regimens (3DRs) to reduce long-term drug exposure and costs. Nevertheless, real-world experience with 2DR is limited. This study assessed the use of 2DR in routine clinical practice in a tertiary hospital. A retrospective, observational, descriptive study was performed on the use of dual therapy in adult HIV-1 patients. Individuals on antiretroviral treatment (ART) with dolutegravir plus lamivudine or dolutegravir plus rilpivirine who started 2DR between November 1, 2018, and April 30, 2019, were eligible for our study. Follow-up period was 48 weeks. Overall, 112 patients started 2DR; median age was 51 years and 88.4% were men. Most patients (97.3%) were treatment experienced before dual therapy, with 9.6 ± 8.0 years of prior ART on average. Around 96.4% of patients were virologically suppressed before 2DR. Most common reasons to start dual therapy were treatment simplification (49.5%), avoidance of long-term toxicities (21.1%), and intolerance to previous ART (18.3%). The main regimen used in dual therapy was dolutegravir plus lamivudine (98.2%). Only eight patients discontinued dual therapy; the main reason for discontinuation was toxicity. All patients who did not discontinue 2DR were virologically suppressed at week 48. ART simplification saved €130,117.58 during the study period. In our cohort, dual therapy was mainly used for virologically suppressed patients, before availability of the single-tablet 2DR. Switching to a 2DR may be a key option for treatment simplification and avoidance of long-term toxicities. Furthermore, 2DR could provide a more cost-effective alternative to 3DR.

中文翻译：

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超出临床试验指征的 HIV-1 感染患者的两种药物方案的真实世界经验：48 周的结果

两种药物方案 (2DR) 的数据表明，在未接受过治疗和接受过治疗的 HIV-1 患者中具有很高的疗效和耐受性。当前指南推荐 2DR 作为三药方案 (3DR) 的替代方案，以减少长期药物暴露和成本。然而，2DR 的实际经验是有限的。本研究评估了 2DR 在三级医院的常规临床实践中的使用。对成人 HIV-1 患者使用双重治疗进行了一项回顾性、观察性、描述性研究。2018 年 11 月 1 日至 2019 年 4 月 30 日期间开始接受 2DR 的多替拉韦加拉米夫定或多替拉韦加利匹韦林进行抗逆转录病毒治疗 (ART) 的个体有资格参加我们的研究。随访期为 48 周。总体而言，112 名患者开始了 2DR；中位年龄为 51 岁，88.4% 为男性。大多数患者（97. 3%) 是在双重治疗之前经历过的治疗，平均 9.6 ± 8.0 年的既往 ART。大约 96.4% 的患者在 2DR 之前被病毒学抑制。开始双重治疗的最常见原因是治疗简化 (49.5%)、避免长期毒性 (21.1%) 和对既往 ART 不耐受 (18.3%)。双重治疗中使用的主要方案是多替拉韦加拉米夫定 (98.2%)。只有 8 名患者停止了双重治疗；停药的主要原因是毒性。所有没有停止 2DR 的患者在第 48 周都被病毒学抑制。在研究期间，ART 简化节省了 130,117.58 欧元。在我们的队列中，在单片 2DR 可用之前，双重治疗主要用于病毒学抑制的患者。改用 2DR 可能是简化治疗和避免长期毒性的关键选择。此外，2DR 可以提供比 3DR 更具成本效益的替代方案。