Dataset for Hepmarc: a 96 week randomised controlled feasibility trial of add-on maraviroc in people with HIV and non-alcoholic fatty liver disease

Data for paper published in PLOS ONE 14.07.2023 These files were used for the statistical analysis of the hemparc feasibility trial using Stata software verson 17, and are as follows, both Stata format and .csv format as appropriate. The .do file is a simple text file. hepmarc_data minimum dataset: .csv, .dta: See doi:10.1136/bmjopen-2019-035596 for study protocol describing all data collected hepmarc Data dictionary .xls, .dta; description of each data fields in minimum dataset hepmarc AE listing: Adverse events listing .csv, .dta hepmarc SAP v1.0 240322_.xls .dta; description of each data fields in minimum dataset hepmarc data.do Stata .do file used to perform the analysis Notes: Each particpant's age has been altered by a random amount to preserve anonymity. There are two rows for two of the participants who each reported two adverse reactions. Abstract Objectives Maraviroc may reduce hepatic inflammation in people with HIV and non-alcoholic fatty liver disease (HIV-NAFLD) through CCR5-receptor antagonism, which warrants further exploration. Methods We performed an open-label 96-week randomised-controlled feasibility trial of maraviroc plus optimised background therapy (OBT) versus OBT alone, in a 1:1 ratio, for people with virologically-suppressed HIV-1 and NAFLD without cirrhosis. Dosing followed recommendations for HIV therapy in the Summary of Product Characteristics for maraviroc. The primary outcomes were safety, recruitment and retention rates, adherence and data completeness. Secondary outcomes included the change in Fibroscan-assessed liver stiffness measurements (LSM), controlled attenuation parameter (CAP) and Enhanced Liver Fibrosis (ELF) scores. Results Fifty-three participants (53/60, 88% of target) were recruited; 23 received maraviroc plus OBT; 89% were male; 19% had type 2 diabetes mellitus. The median baseline LSM, CAP & ELF scores were 6.2 (IQR 4.6-7.8) kPa, 325 (IQR 279-351) dB/m and 9.1 (IQR 8.6-9.6) respectively. Primary outcomes: all individuals eligible after screening were randomised; there was 92% (SD 6.6%) adherence to maraviroc [target >90%]; 83% (95%CI 70%-92%) participant retention [target >65%]; 5.5% of data were missing [target Secondary outcomes: no important differences were seen by treatment group for the change from baseline in LSM, CAP or ELF scores Conclusions This feasibility study provides preliminary evidence of maraviroc safety amongst people with HIV-NAFLD, and acceptable recruitment, retention, and adherence rates. These data support a definitive randomised-controlled trial assessing maraviroc impact on hepatic steatosis and fibrosis. Clinical trial registry: ISCRTN, registration number 31461655.本数据集对应2023年7月14日发表于《PLOS ONE》的论文。所用文件均用于借助Stata 17软件开展的hepmarc可行性试验统计分析，涵盖Stata格式与.csv格式两类（按需提供），其中.do文件为纯文本格式。具体文件列表如下：1. hepmarc核心数据集（minimum dataset）：包含.csv与.dta格式文件；研究方案及所有采集数据的说明可参见DOI：10.1136/bmjopen-2019-035596；2. hepmarc数据字典（Data dictionary）：包含.xls与.dta格式文件，用于说明核心数据集内各数据字段的含义；3. hepmarc不良事件清单（Adverse Events listing，简称AE listing）：包含.csv与.dta格式文件，收录不良事件相关记录；4. hepmarc统计分析计划（Statistical Analysis Plan，SAP）v1.0 240322：包含.xls与.dta格式文件，用于说明核心数据集各数据字段的含义；5. hepmarc data.do：用于执行本次统计分析的Stata do文件。备注：为保护受试者匿名性，所有受试者的年龄均经随机数值扰动处理；有2名受试者分别报告了2起不良事件，因此对应数据包含2行记录。摘要研究背景：马拉韦罗（Maraviroc）可通过CCR5受体（CCR5-receptor）拮抗作用，改善人类免疫缺陷病毒（Human Immunodeficiency Virus，简称HIV）合并非酒精性脂肪性肝病（Non-Alcoholic Fatty Liver Disease，简称NAFLD，即HIV-NAFLD）患者的肝脏炎症，该治疗方向有待进一步探索。研究方法：本研究针对病毒学抑制的HIV-1感染合并无肝硬化NAFLD患者，开展一项开放标签、96周、1:1随机对照可行性试验，对比马拉韦罗联合优化背景治疗（Optimised Background Therapy，简称OBT）与单纯优化背景治疗的疗效。给药方案遵循马拉韦罗产品说明书中的HIV治疗推荐。主要结局指标包括安全性、招募率、留存率、治疗依从性及数据完整性；次要结局指标包括瞬时弹性成像（Fibroscan）评估的肝脏硬度测量值（Liver Stiffness Measurements，简称LSM）、受控衰减参数（Controlled Attenuation Parameter，简称CAP）及增强肝纤维化评分（Enhanced Liver Fibrosis，简称ELF）的变化幅度。研究结果：共招募53名受试者（完成目标人数的88%，即53/60），其中23名接受马拉韦罗联合OBT治疗；受试者中男性占比89%，2型糖尿病患病率为19%。受试者基线时的LSM中位数为6.2（四分位距IQR 4.6~7.8）kPa，CAP中位数为325（四分位距IQR 279~351）dB/m，ELF评分中位数为9.1（四分位距IQR 8.6~9.6）。主要结局指标：所有经筛选符合入组条件的受试者均完成随机分组；马拉韦罗治疗依从率为92%（标准差SD 6.6%），预设目标为>90%；受试者留存率为83%（95%置信区间95%CI 70%~92%），预设目标为>65%；数据缺失率为5.5%[原文预设目标未完整显示]。次要结局指标：不同治疗组间LSM、CAP及ELF评分较基线的变化幅度无显著差异。研究结论：本可行性试验为HIV-NAFLD患者使用马拉韦罗的安全性提供了初步证据，同时招募、留存及依从性表现均符合预期。本研究数据支持开展大型随机对照试验，以评估马拉韦罗对肝脏脂肪变性及纤维化的影响。临床试验注册信息：ISCRTN，注册编号31461655。