比替格拉韦联合恩曲他滨/替诺福韦阿拉胺的短期神经精神耐受性临床研究

IF 1.3 4区 医学 Q4 INFECTIOUS DISEASES Antiviral Therapy Pub Date : 2020-01-01 DOI:10.3851/IMP3351
Christian Hoffmann, Knud Schewe, Stefan Fenske, Thomas Buhk, Michael Sabranski, Axel Adam, Stefan Hansen, Hans-Jürgen Stellbrink
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引用次数: 11

摘要

背景:神经精神不良事件(NPAEs)导致多替重力韦(DTG)停药在实际使用中比在随机临床试验(rct)中更常见。最近批准的比替格拉韦+恩曲他滨和替诺福韦alafenamide (BIC/F/TAF)的固定剂量组合在rct中显示出与DTG相当的NPAE发生率,但一些有利的患者报告结果。我们对临床实践中的神经精神耐受性很感兴趣。方法:对2018年6月起在单一中心(两个亚中心)开始BIC/F/TAF治疗的所有患者进行回顾性随访。我们比较了任何ae和NPAEs引起的停药率与开始使用dtg方案的患者的停药率。结果:截至2019年5月,共有943例患者(852例男性,76例女性,15例跨性别和性别多样化)在随机对照试验外启动了BIC/F/TAF。中位随访6.2个月后,分别有50例(5.3%)和31例(3.3%)患者因ae或NPAEs而停止BIC/F/TAF治疗。在多变量分析中,既往抑郁和亚中心仍然是NPAEs的预测因素,但对年龄、性别、种族或既往dtg相关ae无效。与1043名接受dtg方案治疗的患者相比,BIC/F/TAF在前6个月内估计的npae相关停药率相当(P=0.36)。交叉不耐受较低,只有5/55既往DTG不耐受的患者因NPAEs而不得不停止BIC/F/TAF。结论:BIC/F/TAF的短期耐受性与含dtg的方案相当。如DTG所见,停药率高于随机对照试验。先前存在的抑郁症以及医生的意识可能对BIC/F/TAF的耐受性和持续产生影响。相比之下,先前的DTG不耐受性的预测价值有限。
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Short-term neuropsychiatric tolerability of bictegravir combined with emtricitabine/tenofovir alafenamide in clinical practice.

Background: Neuropsychiatric AEs (NPAEs) leading to dolutegravir (DTG) discontinuation were seen more frequently in real-world use than in randomized clinical trials (RCTs). The recently approved fixed-dose combination bictegravir plus emtricitabine and tenofovir alafenamide (BIC/F/TAF) has shown comparable NPAE rates but some favourable patient-reported outcomes in RCTs compared with DTG. We were interested in its neuropsychiatric tolerability in clinical practice.

Methods: All patients starting BIC/F/TAF from June 2018 in a single centre (two subcentres) were followed retrospectively. Discontinuation rates due to any AEs and NPAEs were compared with those of patients initiating DTG-based regimens.

Results: As of May 2019, a total of 943 patients (852 males, 76 females, 15 transgender and gender diverse) initiated BIC/F/TAF outside RCTs. After a median follow-up of 6.2 months, 50 (5.3%) and 31 (3.3%) patients had discontinued BIC/F/TAF due to any AEs or to NPAEs, respectively. In multivariate analysis, a pre-existing depression and subcentre remained predictive for NPAEs, but not age, gender, ethnicity or prior DTG-related AEs. Compared with 1,043 patients treated with DTG-based regimens, the estimated NPAE-related discontinuation rate with BIC/F/TAF was comparable during the first 6 months (P=0.36). Cross-intolerance was low, and only 5/55 patients with prior DTG intolerability had to discontinue BIC/F/TAF due to NPAEs.

Conclusions: Short-term tolerability of BIC/F/TAF was comparable to DTG-containing regimens. As seen with DTG, discontinuation rates were higher than in RCTs. A pre-existing depression but also physician's awareness may have an impact on tolerability and continuation of BIC/F/TAF. In contrast, prior intolerability of DTG was of limited predictive value.

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来源期刊
Antiviral Therapy
Antiviral Therapy 医学-病毒学
CiteScore
2.60
自引率
8.30%
发文量
35
审稿时长
4-8 weeks
期刊介绍: Antiviral Therapy (an official publication of the International Society of Antiviral Research) is an international, peer-reviewed journal devoted to publishing articles on the clinical development and use of antiviral agents and vaccines, and the treatment of all viral diseases. Antiviral Therapy is one of the leading journals in virology and infectious diseases. The journal is comprehensive, and publishes articles concerning all clinical aspects of antiviral therapy. It features editorials, original research papers, specially commissioned review articles, letters and book reviews. The journal is aimed at physicians and specialists interested in clinical and basic research.
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