本文由小咖机器人翻译整理

期刊来源：JAMA

原文链接：https://doi.org/10.1001/jama.2024.2452

摘要内容如下：

重要性

便利的远程医疗可以通过减轻地理和时间障碍来促进丙型肝炎病毒的消除。

目的

比较通过整合到阿片类药物治疗计划中的便利远程医疗治疗的阿片类药物使用障碍患者与非现场肝炎专家转诊患者对丙型肝炎病毒的持续病毒学应答。

设计、设置和参与者

使用阶梯式楔形设计的前瞻性、整群随机临床试验。纽约州的12个项目包括2017年3月1日至2020年2月29日期间登记的丙型肝炎感染参与者（n=602）。对2022年12月1日至2023年9月1日的数据进行了分析。

干预

通过与肝炎专家共同管理，使用直接作用抗病毒药物进行丙型肝炎治疗，或者通过整合到阿片类药物治疗计划中的便利远程医疗（n=290）或标准护理场外转诊（n=312）。

主要成果和措施

主要结果是丙型肝炎病毒治愈。12个项目从异地转诊开始，每9个月，4个随机选择的站点在没有参与者交叉的3个步骤中过渡到便利的远程医疗。参与者完成了2年的随访，以进行再感染评估。纳入标准要求6个月的阿片类药物治疗和丙型肝炎药物的保险覆盖。广义线性混合效应模型用于检验干预效果，并在基于个体的意向治疗分析中对时间、聚类和效应修正进行调整。

结果

在602名参与者中，369名为男性（61.3%）；296人（49.2%）为美洲印第安人或阿拉斯加土著人、亚洲人、黑人或非洲裔美国人、多种族或其他（即未选择种族类别，根据美国国立卫生研究院的5个标准类别收集种族数据）；白种人306例，占50.8%。远程医疗组参与者的平均（SD）年龄为47.1（13.1）岁；转诊组为48.9（12.8）岁。在远程医疗方面，290名参与者中有268人（92.4%）开始接受治疗，而312名参与者中有126人（40.4%）开始接受转诊。意向性治疗的治愈百分比在远程医疗组中为90.3%（262/290），在复诊组中为39.4%（123 312），研究组效应的估计对数比值比为2.9（95%CI，2.0-3.5；P<.001），无有效修饰。观察到的治愈率为远程医疗290名参与者中的246人（84.8%）和转诊312名参与者中的106人（34.0%）。亚组效应不显著，包括纤维化分期、城市或农村参与者居住地或精神健康（焦虑或抑郁）共病情况。非法药物使用显著减少（转诊:95%CI，1.2-4.8；P=.001；远程医疗:95%CI，0.3-1.0；P<.001）在治愈的参与者中。极少发生再感染（n=13），丙型肝炎病毒再感染发生率为2.5/100人-年。两组参与者都将医疗服务满意度评为高或非常高。

结论和相关性

与异地转诊相比，阿片类药物治疗计划整合的便利远程医疗显著提高了丙型肝炎病毒的治愈率，参与者满意度也很高。在治愈的参与者中，非法药物的使用显著减少，再次感染的情况也很少。

试用注册

ClinicalTrials.gov标识符：NCT02933970。

英文原文如下：

Abstracts

Importance  Facilitated telemedicine may promote hepatitis C virus elimination by mitigating geographic and temporal barriers.

Objective  To compare sustained virologic responses for hepatitis C virus among persons with opioid use disorder treated through facilitated telemedicine integrated into opioid treatment programs compared with off-site hepatitis specialist referral.

Design, Setting, and Participants  Prospective, cluster randomized clinical trial using a stepped wedge design. Twelve programs throughout New York State included hepatitis C-infected participants (n = 602) enrolled between March 1, 2017, and February 29, 2020. Data were analyzed from December 1, 2022, through September 1, 2023.

Intervention  Hepatitis C treatment with direct-acting antivirals through comanagement with a hepatitis specialist either through facilitated telemedicine integrated into opioid treatment programs (n = 290) or standard-of-care off-site referral (n = 312).

Main Outcomes and Measures  The primary outcome was hepatitis C virus cure. Twelve programs began with off-site referral, and every 9 months, 4 randomly selected sites transitioned to facilitated telemedicine during 3 steps without participant crossover. Participants completed 2-year follow-up for reinfection assessment. Inclusion criteria required 6-month enrollment in opioid treatment and insurance coverage of hepatitis C medications. Generalized linear mixed-effects models were used to test for the intervention effect, adjusted for time, clustering, and effect modification in individual-based intention-to-treat analysis.

Results  Among 602 participants, 369 were male (61.3%); 296 (49.2%) were American Indian or Alaska Native, Asian, Black or African American, multiracial, or other (ie, no race category was selected, with race data collected according to the 5 standard National Institutes of Health categories); and 306 (50.8%) were White. The mean (SD) age of the enrolled participants in the telemedicine group was 47.1 (13.1) years; that of the referral group was 48.9 (12.8) years. In telemedicine, 268 of 290 participants (92.4%) initiated treatment compared with 126 of 312 participants (40.4%) in referral. Intention-to-treat cure percentages were 90.3% (262 of 290) in telemedicine and 39.4% (123 of 312) in referral, with an estimated logarithmic odds ratio of the study group effect of 2.9 (95% CI, 2.0-3.5; P < .001) with no effect modification. Observed cure percentages were 246 of 290 participants (84.8%) in telemedicine vs 106 of 312 participants (34.0%) in referral. Subgroup effects were not significant, including fibrosis stage, urban or rural participant residence location, or mental health (anxiety or depression) comorbid conditions. Illicit drug use decreased significantly (referral: 95% CI, 1.2-4.8; P = .001; telemedicine: 95% CI, 0.3-1.0; P < .001) among cured participants. Minimal reinfections (n = 13) occurred, with hepatitis C virus reinfection incidence of 2.5 per 100 person-years. Participants in both groups rated health care delivery satisfaction as high or very high.

Conclusions and Relevance  Opioid treatment program-integrated facilitated telemedicine resulted in significantly higher hepatitis C virus cure rates compared with off-site referral, with high participant satisfaction. Illicit drug use declined significantly among cured participants with minimal reinfections.

Trial Registration  ClinicalTrials.gov Identifier: NCT02933970.

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