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INSHU: Real World Direct-Acting Antiviral (DAA) Outcomes Among People Who Inject Drugs (PWID) in the United States: Hepatitis C Real Options (HERO)
  randomized to direct observed therapy, patient navigation:....."Participants (on and not on opioid agonist therapy) are treated at community health centers (CHC) or methadone maintenance programs (MMPs) and are randomized to modified directly observed therapy (mDOT) or patient navigation (PN, standardized intervention). Those randomized to mDOT at MMPs receive SOF/VEL with daily methadone; those at CHC settings video-record themselves taking SOF/VEL daily using an 'app' (emocha)."
from Jules: This is the only large well powered US based HCV treatment study of people who inject drugs designed to evaluate SVR rates, adherence, reinfection, resistance for the goal to demonstrate the that IDUs can be successfully treated and that US and state policy should institute & fund large scale efforts to treat and cure IDUs in an effort to eliminate HCV in the USA. IDUs remain an HCV patient group on the margins of care and treatment in the US and globally. HCV is curable with only 8 or 12 weeks treatment and thus HCV can be eliminated but state and federal officials remain not committed to HCV elimination or to a large scale project to screen and treat all in the USA nor to screen and treat the key HCV-infected group, those who inject drugs. Treatment costs have come down to $10,000 to $15,000 per treatment, raising more questions why we in the US are not undertaking national or state programs to screen and treat IDUs and to eliminate HCV. Currently, there is NO commitment for funding by any state or federal entity to eliminate HCV. The aim of this study is to demonstrate that we can successfully treat and cure IDUs and to provide evidence to public and private insurers and to state and federal government officials. This study is cutting edge and unique as its the only large study to examine direct observed therapy and patient navigation, 2 important tools that could be used to treat this patient population. Participants have been enrolled and are undergoing treatment and results will be available.
Reported by Jules Levin
7th International Symposium on Hepatitis Care in Substance Users
Cascais, Portugal
19 - 21 September 2018
Lynn E. Taylor1, Feinberg J2, Kim AY3, Lum PL4, Mehta SH5, Norton BL6, Page KA7, Tsui JI8, Litwin AH9
1University of Rhode Island, 2West Virginia University, 3Harvard University, 4University of California, San Francisco, 5Johns Hopkins Bloomberg School of Public Health, 6Montefiore Medical Center, 7University of New Mexico, 8Universtiy of Washington, 9Greenville Health System, 9Clemson University, 9University of South Carolina School of Medicine
Contact: Alain H. Litwin ALitwin@ghs.org Greenville Memorial HospitalDepartment of Medicine701 Grove RoadGreenville, SC 29605 USA864-430-0911 .





The HERO Research Group includes the PI and Co-Investigators from each of the 9 sites, PIs from the CDC and the NYC DOH, statisticians and key staff (such as project directors and patient representatives), and key stakeholders. HERO study sites include: Greenville Health System and Clemson University, Albert Einstein College of Medicine/Montefiore Medical Center, University of Rhode Island, Johns Hopkins Bloomberg School of Public Health, Massachusetts General Hospital, University of California, San Francisco, University of New Mexico, University of Washington, and West Virginia University. Research reported in this presentation was supported through a Patient-Centered Outcomes Research Institute (PCORI) Award HPC-1503-28122 with additional support by Gilead Sciences, Quest Diagnostics, Monogram Biosciences, and OraSure Technologies. The opinions presented in this work are solely the responsibility of the author and do not necessarily represent the views of PCORI, its Board of Governors or Methodology Committee. We thank the community of PWID who participated in this studyw. Publish date 8/24/2018

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