{"doi":"10.1093/ofid/ofaa564","title":"Adherence to Direct-Acting Antiviral Therapy in People Actively Using Drugs and Alcohol: The INCLUD Study","abstract":"Abstract Background 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. Methods INCLUD was a prospective, open-label study of ledipasvir/sofosbuvir for 12 weeks in PWUD aged 18–70 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 ≥1 dose(s) between visits were examined using generalized linear models. Results Sixty participants received ≥1 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%–100%; range, 30%–101%), and between-visit adherence was 100% (IQR, 86%–100%; range, 0%–107%). The odds of missing ≥1 dose between visits increased with HIV coinfection (2.94; 95% confidence interval [CI], 1.37–6.32; P = .006), black race (4.09; 95% CI, 1.42–11.74; P = .009), methamphetamine use (2.51; 95% CI, 1.44–4.37; P = .0.001), and cocaine use (2.12; 95% CI, 1.08–4.18; P = .03) and decreased with marijuana use (0.34; 95% CI, 0.17–0.70; P = .003) and vDOT (0.43; 95% CI, 0.21–0.87; P = .02). Conclusions 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.","journal":"Open Forum Infectious Diseases","year":2020,"id":79894,"datarank":0.0,"base_score":0.0,"endowment":0.0,"self_citation_contribution":0.0,"citation_network_contribution":0.0,"self_endowment_contribution":0.0,"citer_contribution":0.0,"corpus_percentile":null,"corpus_rank":null,"citation_count":16,"citer_count":0,"citers_with_citation_signal":0,"citers_with_endowment":0,"datacite_reuse_total":0,"is_dataset":false,"is_dataset_confidence":0.9154,"is_data_producer":false,"deposit_databanks":null,"is_oa":true,"file_count":0,"downloads":0,"has_version_chain":false,"published_date":"2020-01-01","fair_score":null,"fair_percentile":null,"algorithm_id":"datarank_citation_only_1hop_v6","ranking_scope":"data_only","authors":[{"id":395985,"name":"José Castillo‐Mancilla","orcid":"0000-0003-1242-1745","position":1,"is_corresponding":false},{"id":395981,"name":"Mary Morrow","orcid":"0000-0002-2115-4864","position":2,"is_corresponding":false},{"id":395984,"name":"Samantha MaWhinney","orcid":"0000-0002-9818-0059","position":3,"is_corresponding":false},{"id":348514,"name":"Sarah E. Rowan","orcid":"0000-0003-2144-7410","position":4,"is_corresponding":false},{"id":414478,"name":"David Wyles","orcid":"0009-0000-3750-5924","position":5,"is_corresponding":false},{"id":414479,"name":"Joshua Blum","orcid":"0009-0001-5910-3034","position":6,"is_corresponding":false},{"id":415144,"name":"Ryan Huntley","orcid":null,"position":7,"is_corresponding":false},{"id":415145,"name":"Lana M. Salah","orcid":null,"position":8,"is_corresponding":false},{"id":415146,"name":"Arya Tehrani","orcid":null,"position":9,"is_corresponding":false},{"id":280276,"name":"Lane R. Bushman","orcid":null,"position":10,"is_corresponding":false},{"id":279022,"name":"Peter L. Anderson","orcid":"0000-0002-1200-8494","position":11,"is_corresponding":false},{"id":355013,"name":"Jennifer J. Kiser","orcid":null,"position":12,"is_corresponding":false},{"id":414477,"name":"Kristina M. Brooks","orcid":"0000-0002-3832-8699","position":0,"is_corresponding":true}],"reference_count":34,"raw_metadata":null,"created_at":"2026-07-18T21:50:57.971597Z","pmid":"33447634","pmcid":null,"fwci":null,"citation_percentile":null,"influential_citations":0,"oa_status":null,"license":null,"views":0,"total_file_size_bytes":0,"version_count":0,"fair_f":null,"fair_a":null,"fair_i":null,"fair_r":null,"fair_zscore":null,"fair_rationale":null,"fair_model":null,"fair_agent_version":null,"fair_fulltext_source":null,"fair_has_llm":null,"fair_computed_at":null,"clinical_trials":[],"software_tools":[],"db_accessions":[],"linked_datasets":[],"topics":[]}