The overarching goal of the Kentucky Viral Hepatitis Treatment Project (KeY Treat) is to increase access to
treatment for the hepatitis C virus (HCV) in a rural Appalachian community in the midst of the opioid/HCV
syndemic. This study seeks to examine whether removing barriers associated with accessing direct-acting
antivirals (DAAs) for the treatment of HCV (high out-of-pocket costs, insurance restrictions requiring a
specialist, abstinence, and significant liver damage) will significantly reduce the burden of HCV in Perry
County, Kentucky. The proposed study is made possible by a significant drug donation from Gilead Sciences
for sofosbuvir/velpatasvir, a 12-week, once per day, pan-genotypic DAA. KeY Treat proposes a multi-pronged
approach to treating HCV using a mid-level provider model. In addition to DAA treatment, participants will be
offered access to subsidized medication-assisted treatment, syringe services, and case management. We will
leverage existing resources in the target community (public health, jail, hospital), as well as ongoing projects
dedicated to increasing access to HCV care in affected communities (ECHO, FOCUS) to answer whether
removing the major barriers to HCV treatment affect access, and what barriers remain. All RNA-positive
residents of Perry County, Kentucky will be eligible/recruited for study participation (N≈900), and the following
specific aims will be addressed: 1) determination of HCV treatment uptake among rural residents with chronic
HCV; 2) examination of the predictors of treatment completion among those enrolled in KeY Treat; 3)
examination of the characteristics of participants achieving sustained virologic response (SVR, or cure); 4)
establishment of long-term re-infection rates among those achieving SVR; 5) examination of 5-year reductions
in incidence and prevalence of HCV in the intervention community compared with a control county in rural
Kentucky; and 6) evaluate the impact and cost-effectiveness of KeY Treat using mathematical modeling. The
proposed research has tremendous potential to impact public health in the rural United States. The majority of
counties identified in CDC’s recent HCV/HIV hotspot analysis were rural, and there is a real need to improve
access to DAAs in order to prevent further HCV transmission, reduce the burden of advanced liver disease,
and hepatocellular carcinoma in generations to come. Data from KeY Treat will inform policies around
Medicaid/insurance restrictions for DAAs, and will deliver a much needed blueprint for the provision of HCV
treatment in resource-deprived rural areas.
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