Integrated Hepatitis C–Opioid Use Disorder Care Through Facilitated Telemedicine

Author:

Talal Andrew H.1,Markatou Marianthi2,Liu Anran2,Perumalswami Ponni V.34,Dinani Amreen M.3,Tobin Jonathan N.56,Brown Lawrence S.78

Affiliation:

1. Division of Gastroenterology, Hepatology, and Nutrition, Jacobs School of Medicine and Biomedical Sciences, University at Buffalo, Buffalo, New York

2. Department of Biostatistics, University at Buffalo, Buffalo, New York

3. Division of Liver Diseases, Department of Medicine, Icahn School of Medicine at Mount Sinai, New York, New York

4. Division of Gastroenterology and Hepatology, University of Michigan, Ann Arbor

5. Clinical Directors Network, Inc (CDN), New York, New York

6. The Rockefeller University Center for Clinical and Translational Science, New York, New York

7. START Treatment & Recovery Centers, Brooklyn, New York

8. Weill Cornell Medicine, New York, New York

Abstract

ImportanceFacilitated telemedicine may promote hepatitis C virus elimination by mitigating geographic and temporal barriers.ObjectiveTo 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 ParticipantsProspective, 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.InterventionHepatitis 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 MeasuresThe 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.ResultsAmong 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 RelevanceOpioid 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 RegistrationClinicalTrials.gov Identifier: NCT02933970

Publisher

American Medical Association (AMA)

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