ArticleOpen forum infectious diseases2021
Adherence to Direct-Acting Antiviral Therapy in People Actively Using Drugs and Alcohol: The INCLUD Study.
Article in Open forum infectious diseases, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 10 papers.
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The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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Who cites it
10 citing papers in PubMed, 16 citations in OpenAlex.
- Predictors of 007 triphosphate concentrations in dried blood spots in persons with hepatitis C and active drug or alcohol use.The Journal of antimicrobial chemotherapy · 2022Trial
- Hepatitis C Virus Direct-Acting Antiviral Treatment Adherence Patterns and Sustained Viral Response Among People Who Inject Drugs Treated in Opioid Agonist Therapy Programs.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2021Trial
- Video directly observed therapy for patients receiving office-based buprenorphine - A pilot randomized controlled trial.Drug and alcohol dependence · 2021Trial
- Development and validation of an LC-MS/MS method to quantify the alcohol biomarker phosphatidylethanol 16:0/18:1 in dried blood spots for clinical research purposes.Journal of chromatography. B, Analytical technologies in the biomedical and life sciences · 2023Article
- Impact of the first-line antiretroviral therapy on soluble markers of inflammation in cohort of human immunodeficiency virus type 1 in Moroccan patients: a prospective study.Archives of microbiology · 2023Article
- More intensive hepatitis C virus care models promote adherence among people who inject drugs with active drug use: The PREVAIL study.Journal of viral hepatitis · 2023Article
- The role of wirelessly observed therapy in improving treatment adherence.Future healthcare journal · 2022Article
- Outcomes of Real-World Integrated HCV Microelimination for People Who Inject Drugs: An expansion of the Punjab Model.EClinicalMedicine · 2021Article
- Development and Validation of a Questionnaire to Measure Medication Adherence to Direct-Acting Agents in Patients with Hepatitis C.Pharmaceutics · 2021Article
- The use of technology-based adherence monitoring in the treatment of hepatitis C virus.Therapeutic advances in infectious diseaseReview
Corrections and comments
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Authors and funding
13 authors at 3 institutions in 1 country.
Funding
Abstract
backgroundHepatitis 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.
methodsINCLUD 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.
resultsSixty 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;
conclusionsPersons 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.
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