AbstractA lack of adherence to long-term antiretroviral therapy may impact viral suppression. The current study examined the relationship between medication adherence and clinical outcomes in people with human immunodeficiency virus infection (PWH) receiving bictegravir, emtricitabine, and tenofovir alafenamide fumarate (B/F/TAF).

摘要缺乏长期抗逆转录病毒治疗的依从性可能会影响病毒抑制。目前的研究检查了接受比曲格韦，恩曲他滨和富马酸替诺福韦阿拉芬胺（B/F/TAF）治疗的人类免疫缺陷病毒感染（PWH）患者的药物依从性与临床结果之间的关系。

A retrospective cohort study using two Japanese claims databases was conducted. Adherence was measured by the proportion of days covered (PDC). Patients were grouped into 3 PDC category and persistence was estimated by Kaplan-Meier method. Cox regression analysis was performed to investigate whether the PDC was associated with treatment discontinuation.

使用两个日本索赔数据库进行了回顾性队列研究。依从性通过覆盖天数（PDC）的比例来衡量。将患者分为3个PDC类别，并通过Kaplan-Meier方法估计持续性。进行Cox回归分析以调查PDC是否与治疗中断有关。

Among 952 patients, 820 (86.1%), 95 (10.0%), and 37 (3.9%) patients were grouped into the PDC ≥ 90%, 80– < 90%, and < 80% groups, respectively. Across all PDC groups, more than 90% of patients who received B/F/TAF were receiving treatment at 1 year. There was no significant difference in the risk of discontinuation between the lower PDC groups (80– < 90% and < 80%) and the PDC ≥ 90% group (0.400 [0.096, 1.661]; 2.244 [0.663, 7.594], hazard ratio [95% confidence interval], respectively).

在952例患者中，820例（86.1%），95例（10.0%）和37例（3.9%）患者分别分为PDC≥90%，80-90%和80%组。在所有PDC组中，超过90%接受B/F/TAF治疗的患者在1年时接受治疗。低PDC组（80%-90%和80%）和PDC≥90%组（0.400[0.096,1.661]；2.244[0.663,7.594]，风险比[95%置信区间]）之间的停药风险没有显着差异。

A drug resistance test was implemented for 15 patients, none of whom discontinued B/F/TAF after the test. The results suggest that events that could cause discontinuation, such as virologic failure, were not associated with PDC..

对15名患者进行了耐药性测试，测试后均未停止B/F/TAF。结果表明，可能导致停药的事件，如病毒学失败，与PDC无关。。

IntroductionThe development of combination antiretroviral therapy (ART) has significantly increased the life expectancy of people with human immunodeficiency virus (HIV) infection (PWH). Until an HIV eradication strategy is discovered, PWH require lifelong ART to maintain viral suppression. Long-term medication use is associated with a number of issues, such as worsening quality of life, financial burden, and drug resistance1.

引言联合抗逆转录病毒疗法（ART）的发展显着提高了人类免疫缺陷病毒（HIV）感染者（PWH）的预期寿命。在发现根除艾滋病毒的策略之前，PWH需要终身抗逆转录病毒治疗来维持病毒抑制。长期用药与许多问题有关，例如生活质量恶化，经济负担和耐药性1。

Hence, treatment adherence is important for maintaining viral suppression to achieve long-term treatment success2,3,4.While some studies have indicated that 95% adherence is necessary to maintain viral suppression2, others have suggested that this level of adherence is not necessary with more recent regimens and that the level of adherence required may vary between treatments3,4.

因此，治疗依从性对于维持病毒抑制以实现长期治疗成功非常重要2,3,4。虽然一些研究表明95%的依从性对于维持病毒抑制是必要的2，但其他研究表明，对于最近的方案，这种依从性水平不是必需的，并且所需的依从性水平可能因治疗而异3,4。

Factors such as the ease of administration, including the number of pills and frequency of doses, and the motivation of patients are reported to be important factors in maintaining treatment adherence5. Regarding ART regimens, several real-world studies have reported that single-tablet regimens (STRs) have better adherence and long-term persistence than multiple-tablet regimens (MTRs)5,6,7.One STR—a combination tablet containing bictegravir, emtricitabine, and tenofovir alafenamide fumarate (B/F/TAF)—was launched in 2019 and recommended as a first-line treatment in Japanese clinical guidelines.

据报道，服用方便性（包括药丸数量和剂量频率）以及患者的动机等因素是维持治疗依从性的重要因素5。关于ART方案，一些现实世界的研究报道，单片剂方案（STR）比多片剂方案（MTRs）具有更好的依从性和长期持久性[5,6,7]。一种STR-a联合片剂含有比格拉韦，恩曲他滨和富马酸替诺福韦阿拉芬胺（B/F/TAF）-于2019年推出，并被推荐为日本临床指南中的一线治疗药物。

B/F/TAF is a fixed-dose triple combination therapy that is taken as a single tablet once daily with or without food, low drug-drug-interaction and has a high resistance barrier. These features are also highlighted in the Japanese guidelines as a principal factor for treatment optimization in the setting of viral suppression, including improvement of patient quality of life (QOL)8.

B/F/TAF是一种固定剂量的三联疗法，每天一次作为单一片剂服用，有或没有食物，药物相互作用低，耐药性高。这些特征在日本指南中也被强调为病毒抑制治疗优化的主要因素，包括改善患者生活质量（QOL）8。

.

.

(i)

（一）

Time to discontinuation: Treatment discontinuation was defined as an interval between the end of supply and the next prescription date of 90 days or more. Patients without discontinuation were defined as “persistent”.

停药时间：停药被定义为从供应结束到下一个处方日期90天或更长时间之间的间隔。。

(ii)

（二）

Time to a drug resistance test: A drug resistance test is considered for the case of viremia of 500–1000 copies/mL and is recommended for the case of more than 1000 copies/mL in the Japanese clinical guideline for HIV drug resistance testing20. The records were considered surrogate markers of viremia.

进行耐药性测试的时间：在日本HIV耐药性测试临床指南中，对于500-1000拷贝/mL的病毒血症，考虑进行耐药性测试，对于1000拷贝/mL以上的病毒血症，建议进行耐药性测试20。这些记录被认为是病毒血症的替代标志物。

The implementation of a drug resistance test was defined by the receipt of a genotypic test for drug resistance. Patients who discontinued treatment were classified as censored..

耐药性测试的实施是通过接受耐药性基因型测试来定义的。停止治疗的患者被归类为审查。。

(iii)

（三）

Time to the combined endpoint: The combined endpoint was defined as the discontinuation of treatment (definition (i)) after the implementation of a drug resistance test (definition (ii)). This endpoint implies drug discontinuation after viremia, a possible surrogate marker of virologic failure, as Japanese guidelines highly recommend resistance testing before changing the ART for virologic failure8.

。这一终点意味着病毒血症后停药，这是病毒学失败的一个可能的替代标志，因为日本指南强烈建议在改变ART治疗病毒学失败之前进行耐药性检测8。

Hence, in this study, this combined endpoint was considered a surrogate endpoint for virological failure..

因此，在这项研究中，这个联合终点被认为是病毒学失败的替代终点。。

Patients who dropped out or died were censored. The follow-up started from the index date to the event, censored, or 1 year, whichever came first.Patient characteristicsAge at the index date, comorbidities (renal disease, mental disease, metabolic disease, cardiovascular disease, and hepatitis B virus infection) within the lookback period or in the index month, pill number burden (the number of unique co-medications (any formulation) prescribed on the index date other than ART), ART experience (ART prescription within the previous 105 days), and an AIDS-defining condition within the lookback period or in the index month were collected as patient characteristics.

辍学或死亡的患者被审查。后续行动从索引日期开始，到事件发生、审查或1年（以先到者为准）。患者特征在索引日期，回顾期或索引月内的合并症（肾脏疾病，精神疾病，代谢疾病，心血管疾病和乙型肝炎病毒感染），药丸数量负担（除ART外的索引日期规定的独特联合用药（任何制剂）的数量），ART经验（前105天内的ART处方）以及回顾期或索引月内的艾滋病定义条件被收集为患者特征。

Operational definitions, such as the ICD-10 codes in the claims databases, are shown in Supplementary Tables S1, S2.Statistical analysisIn the primary analysis, a Kaplan‒Meier curve for each outcome was generated. The persistence rate at 1 year (discontinuation-free survival estimated by the Kaplan‒Meier method) was also estimated.

。还估计了1年的持续率（通过Kaplan-Meier方法估计的无停药生存率）。

The relationships between PDC and clinical outcomes were examined using multivariable Cox regression analysis. Hazard ratios (HRs) and 95% confidence intervals (CIs) for the PDC < 80% and PDC 80–< 90% groups relative to the PDC ≥ 90% group (reference case) were estimated. Patient characteristics were included in a Cox regression analysis as covariables to adjust for confounding factors.

使用多变量Cox回归分析检查PDC与临床结果之间的关系。估计相对于PDC≥90%组（参考病例），PDC<80%和PDC 80–<90%组的危险比（HR）和95%置信区间（CI）。Cox回归分析将患者特征作为协变量包括在内，以调整混杂因素。

Among patient characteristics, renal disease was rare in all PDC groups; therefore, it was excluded as a covariable from the analysis.In the secondary analysis, the relationships between patient characteristics and clinical outcomes (discontinuation and a drug resistance test) were evaluated by univariate Cox regression analysis, which included each characteristic as an exploratory variable.Furthermore.

；因此，它被排除在分析的协变量之外。在二次分析中，通过单变量Cox回归分析评估患者特征与临床结果（停药和耐药性测试）之间的关系，其中包括每个特征作为探索性变量。此外。

Data availability

数据可用性

The datasets generated and/or analyzed during the present study are not publicly available because they were purchased from commercial providers (Medical Data Vision Co., Ltd. and JMDC Inc.) but are available from the corresponding author upon reasonable request.

本研究期间生成和/或分析的数据集不公开，因为它们是从商业提供商（Medical Data Vision Co.，Ltd.和JMDC Inc.）购买的，但可根据合理要求从通讯作者处获得。

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Download referencesAcknowledgementsThis study was sponsored by Gilead Sciences, K.K. The authors acknowledge the contributions of Masahisa Jinushi, James Jarrett, and Megan Dunbar to this study. Medical writing and editorial assistance were provided by Sachie Inoue and Yuriko Masuda of CRECON Medical Assessment, Inc., and were funded by Gilead Sciences, K.K.Author informationAuthors and AffiliationsGilead Sciences, K.K., Tokyo, JapanNao Taguchi, Yi Piao, Keisuke Harada & Tetsuya TanikawaGilead Sciences Europe Ltd, Uxbridge, UKAnnalisa RubinoGilead Sciences, Taipei, TaiwanKuanYeh LeeGilead Sciences, Foster City, USAMegan ChenDepartment of General Medicine, Faculty of Medicine, Juntendo University, Tokyo, JapanToshio NaitoAuthorsNao TaguchiView author publicationsYou can also search for this author in.

下载参考文献致谢本研究由英国吉利德科学公司赞助。作者感谢Masahisa Jinushi，James Jarrett和Megan Dunbar对本研究的贡献。。

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PubMed Google ScholarContributionsAll the authors contributed to the study design and interpretation of the results. All authors critically revised the draft manuscript and approved the final manuscript.Corresponding authorCorrespondence to

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NT, YP, AR, KL, MC, KH and TT are Gilead employees and stockholders. TN has received research grants from Gilead Sciences, consulting fees from Nobelpharma Co., Ltd., and TSUMURA & CO., and he has received lecture fees from MSD K.K., ViiV Healthcare and Gilead Sciences.

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Reprints and permissionsAbout this articleCite this articleTaguchi, N., Piao, Y., Rubino, A. et al. Relationship between adherence to bictegravir/emtricitabine/tenofovir alafenamide fumarate and clinical outcomes in people with HIV in Japan: a claims database analysis.

转载和许可本文引用本文Taguchi，N.，Piao，Y.，Rubino，A。等人。坚持服用比格拉韦/恩曲他滨/替诺福韦-富马酸阿拉芬胺与日本HIV感染者临床结局之间的关系：索赔数据库分析。

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