Matthew J. Akiyama, MD, MSc; Brianna L. Norton, DO, MPH; Julia H. Arnsten, MD, MPH; Linda Agyemang, MPH; Moonseong Heo, PhD; Alain H. Litwin, MD, MS, MPH
Note: All authors had full access to all the data in the study and take responsibility for the integrity of the data and the accuracy of the data analysis.
Disclaimer: The contents of this publication are solely the responsibility of the authors and do not necessarily represent the views of the funding agencies or the U.S. government.
Financial Support: By grants R01DA034086 and K99DA043011 from the National Institute on Drug Abuse. Gilead Sciences also provided support (grant IN-337-1779) for the research and supplied study medication, SOF/LDV.
Disclosures: Dr. Akiyama has served on an advisory board for Gilead Sciences outside the submitted work. Dr. Norton reports grants from Merck and Co. outside the submitted work. Dr. Litwin reports grants from Gilead Sciences during the conduct of the study, and grants and personal fees from Gilead Sciences and Merck Pharmaceuticals outside the submitted work. Authors not named here have disclosed no conflicts of interest. Disclosures can also be viewed at www.acponline.org/authors/icmje/ConflictOfInterestForms.do?msNum=M18-1715.
Editors' Disclosures: Christine Laine, MD, MPH, Editor in Chief, reports that her spouse has stock options/holdings with Targeted Diagnostics and Therapeutics. Darren B. Taichman, MD, PhD, Executive Editor, reports that he has no financial relationships or interests to disclose. Cynthia D. Mulrow, MD, MSc, Senior Deputy Editor, reports that she has no relationships or interests to disclose. Jaya K. Rao, MD, MHS, Deputy Editor, reports that she has stock holdings/options in Eli Lilly and Pfizer. Catharine B. Stack, PhD, MS, Deputy Editor, Statistics, reports that she has stock holdings in Pfizer, Johnson & Johnson, and Colgate-Palmolive. Christina C. Wee, MD, MPH, Deputy Editor, reports employment with Beth Israel Deaconess Medical Center. Sankey V. Williams, MD, Deputy Editor, reports that he has no financial relationships or interests to disclose. Yu-Xiao Yang, MD, MSCE, Deputy Editor, reports that he has no financial relationships or interest to disclose.
Reproducible Research Statement:Study protocol: See the Supplement. Statistical code: Not available. Data set: Available from Dr. Litwin (e-mail, firstname.lastname@example.org).
Corresponding Author: Alain Litwin, MD, MS, MPH, Department of Medicine, 701 Grove Road, 5th Floor Support Tower, Greenville, SC 29605; e-mail, email@example.com or firstname.lastname@example.org.
Current Author Addresses: Drs. Akiyama, Norton, and Arnsten and Ms. Agyemang: 3300 Kossuth Avenue, Bronx, NY 10467.
Dr. Heo: 605 Grove Road, Suite 205, Greenville, SC 29605.
Dr. Litwin: Department of Medicine, 701 Grove Road, 5th Floor Support Tower, Greenville, SC 29605.
Author Contributions: Conception and design: J.H. Arnsten, A.H. Litwin.
Analysis and interpretation of the data: M.J. Akiyama, J.H. Arnsten, M. Heo, A.H. Litwin.
Drafting of the article: M.J. Akiyama, B.L. Norton, J.H. Arnsten, L. Agyemang, A.H. Litwin.
Critical revision for important intellectual content: M.J. Akiyama, B.L. Norton, J.H. Arnsten, M. Heo, A.H. Litwin.
Final approval of the article: M.J. Akiyama, B.L. Norton, J.H. Arnsten, L. Agyemang, M. Heo, A.H. Litwin.
Provision of study materials or patients: A.H. Litwin.
Statistical expertise: M. Heo.
Obtaining of funding: M. Heo, A.H. Litwin.
Administrative, technical, or logistic support: J.H. Arnsten, L. Agyemang, A.H. Litwin.
Collection and assembly of data: M.J. Akiyama, L. Agyemang, M. Heo, A.H. Litwin.
Many people who inject drugs (PWID) are denied treatment for hepatitis C virus (HCV) infection, even if they are receiving opioid agonist therapy (OAT). Research suggests that HCV in PWID may be treated effectively, but optimal models of care for promoting adherence and sustained virologic response (SVR) have not been evaluated in the direct-acting antiviral (DAA) era.
To determine whether directly observed therapy (DOT) and group treatment (GT) are more effective than self-administered individual treatment (SIT) in promoting adherence and achieving SVR among PWID receiving OAT.
Three-group, randomized controlled trial conducted from October 2013 to April 2017. (ClinicalTrials.gov: NCT01857245)
Three OAT programs in Bronx, New York.
Persons aged 18 years and older with genotype 1 HCV infection who were willing to receive HCV therapy on site in the OAT program. Of 190 persons screened, 158 were randomly assigned to a study group and 150 initiated treatment: DOT (n = 51), GT (n = 48), and SIT (n = 51).
2 intensive interventions (DOT and GT) and 1 control condition (SIT).
Primary: adherence, measured by using electronic blister packs. Secondary: HCV treatment completion and SVR 12 weeks after treatment completion.
Mean age was 51 years; 65% of participants had positive results on urine drug testing during the 6 months before treatment, and 75% reported ever injecting drugs. Overall adherence, estimated from mixed-effects models using the daily timeframe, was 78% (95% CI, 75% to 81%) and was greater among participants randomly assigned to DOT (86% [CI, 80% to 92%]) than those assigned to SIT (75% [CI, 70% to 81%]; difference, 11% [CI, 5% to 18%]; Bonferroni-corrected P = 0.001). No significant difference in adherence was observed between participants randomly assigned to GT (80% [CI, 74% to 86%]) and those assigned to SIT (difference, 4.7% [CI, −2% to 11%]; Bonferroni-corrected P = 0.29). The HCV treatment completion rate was 97%, with no differences among groups (P = 0.53). Overall SVR was 94% (CI, 89% to 97%); the SVR rate was 98% in the DOT group, 94% in the GT group, and 90% in the SIT group (P = 0.152).
These findings may not be generalizable to PWID not enrolled in OAT programs.
All models of onsite HCV care delivered to PWID in OAT programs resulted in high SVR, despite ongoing drug use. Directly observed therapy was associated with greater adherence than SIT.
National Institute on Drug Abuse and Gilead Sciences.
Akiyama MJ, Norton BL, Arnsten JH, et al. Intensive Models of Hepatitis C Care for People Who Inject Drugs Receiving Opioid Agonist Therapy: A Randomized Controlled Trial. Ann Intern Med. 2019;170:594–603. [Epub ahead of print 9 April 2019]. doi: 10.7326/M18-1715
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Published: Ann Intern Med. 2019;170(9):594-603.
Published at www.annals.org on 9 April 2019
Gastroenterology/Hepatology, Infectious Disease, Liver Disease, Viral Hepatitis.
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Print ISSN: 0003-4819 | Online ISSN: 1539-3704
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