{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,11,11]],"date-time":"2025-11-11T22:27:08Z","timestamp":1762900028347,"version":"3.41.2"},"reference-count":46,"publisher":"Oxford University Press (OUP)","issue":"1","license":[{"start":{"date-parts":[[2020,11,19]],"date-time":"2020-11-19T00:00:00Z","timestamp":1605744000000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"}],"funder":[{"DOI":"10.13039\/100000026","name":"National Institute on Drug Abuse","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100000026","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100000002","name":"National Institutes of Health","doi-asserted-by":"publisher","award":["R01DA040499"],"award-info":[{"award-number":["R01DA040499"]}],"id":[{"id":"10.13039\/100000002","id-type":"DOI","asserted-by":"publisher"}]},{"name":"National Center for Advancing Translational Sciences Colorado Clinical and Translational Science Awards","award":["UL1 TR002535"],"award-info":[{"award-number":["UL1 TR002535"]}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2021,1,1]]},"abstract":"<jats:title>Abstract<\/jats:title>\n               <jats:sec>\n                  <jats:title>Background<\/jats:title>\n                  <jats:p>Hepatitis C virus treatment in persons who use drugs (PWUD) is often withheld due to adherence and reinfection concerns. In this study, we report treatment outcomes, technology-based adherence data, and adherence predictors in PWUD and\/or alcohol.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Methods<\/jats:title>\n                  <jats:p>INCLUD was a prospective, open-label study of ledipasvir\/sofosbuvir for 12 weeks in PWUD aged 18\u201370 years. Participants were randomized to wireless (wirelessly observed therapy) or video-based directly observed therapy (vDOT). Drug use was assessed every 2 weeks. Sustained virologic response (SVR) was examined by intention-to-treat and as-treated. Factors associated with missing \u22651 dose(s) between visits were examined using generalized linear models.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Results<\/jats:title>\n                  <jats:p>Sixty participants received \u22651 ledipasvir\/sofosbuvir dose (47 human immunodeficiency virus [HIV]\/hepatitis C virus [HCV], 13 HCV only; 78% male; 22% black; 25% cirrhotic). Substance use occurred at 94% of person-visits: 60% marijuana, 56% alcohol, 37% methamphetamine, 22% opioids, 17% cocaine, and 20% injection drug use. The SVR by intention-to-treat was 86.7% (52 of 60) and as-treated was 94.5% (52 of 55). Confirmed failures included 1 relapse, 1 reinfection, and 1 unknown (suspected reinfection). Median total adherence was 96% (interquartile range [IQR], 85%\u2013100%; range, 30%\u2013101%), and between-visit adherence was 100% (IQR, 86%\u2013100%; range, 0%\u2013107%). The odds of missing \u22651 dose between visits increased with HIV coinfection (2.94; 95% confidence interval [CI], 1.37\u20136.32; P\u2005=\u2005.006), black race (4.09; 95% CI, 1.42\u201311.74; P\u2005=\u2005.009), methamphetamine use (2.51; 95% CI, 1.44\u20134.37; P\u2005=\u2005.0.001), and cocaine use (2.12; 95% CI, 1.08\u20134.18; P\u2005=\u2005.03) and decreased with marijuana use (0.34; 95% CI, 0.17\u20130.70; P\u2005=\u2005.003) and vDOT (0.43; 95% CI, 0.21\u20130.87; P\u2005=\u2005.02).<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Conclusions<\/jats:title>\n                  <jats:p>Persons who use drugs achieved high SVR rates with high, but variable, ledipasvir\/sofosbuvir adherence using technology-based methods. These findings support efforts to expand HCV treatment in PWUD.<\/jats:p>\n               <\/jats:sec>","DOI":"10.1093\/ofid\/ofaa564","type":"journal-article","created":{"date-parts":[[2020,11,20]],"date-time":"2020-11-20T05:21:43Z","timestamp":1605849703000},"source":"Crossref","is-referenced-by-count":13,"title":["Adherence to Direct-Acting Antiviral Therapy in People Actively Using Drugs and Alcohol: The INCLUD Study"],"prefix":"10.1093","volume":"8","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-3832-8699","authenticated-orcid":false,"given":"Kristina M","family":"Brooks","sequence":"first","affiliation":[{"name":"Department of Pharmaceutical Sciences, Skaggs School of Pharmacy and Pharmaceutical Sciences, University of Colorado Anschutz Medical Campus, Aurora, Colorado, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Jose R","family":"Castillo-Mancilla","sequence":"additional","affiliation":[{"name":"Division of Infectious Diseases, School of Medicine, University of Colorado Anschutz Medical Campus, Aurora, Colorado, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Mary","family":"Morrow","sequence":"additional","affiliation":[{"name":"Department of Biostatistics and Bioinformatics, Colorado School of Public Health, University of Colorado Anschutz Medical Campus, Aurora, Colorado, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Samantha","family":"MaWhinney","sequence":"additional","affiliation":[{"name":"Department of Biostatistics and Bioinformatics, Colorado School of Public Health, University of Colorado Anschutz Medical Campus, Aurora, Colorado, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Sarah E","family":"Rowan","sequence":"additional","affiliation":[{"name":"Division of Infectious Diseases, School of Medicine, University of Colorado Anschutz Medical Campus, Aurora, Colorado, USA"},{"name":"Denver Health and Hospital Authority, Denver, Colorado, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"David","family":"Wyles","sequence":"additional","affiliation":[{"name":"Division of Infectious Diseases, School of Medicine, University of Colorado Anschutz Medical Campus, Aurora, Colorado, USA"},{"name":"Denver Health and Hospital Authority, Denver, Colorado, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Joshua","family":"Blum","sequence":"additional","affiliation":[{"name":"Denver Health and Hospital Authority, Denver, Colorado, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Ryan","family":"Huntley","sequence":"additional","affiliation":[{"name":"Department of Pharmaceutical Sciences, Skaggs School of Pharmacy and Pharmaceutical Sciences, University of Colorado Anschutz Medical Campus, Aurora, Colorado, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Lana M","family":"Salah","sequence":"additional","affiliation":[{"name":"Department of Pharmaceutical 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