The Kentucky Viral Hepatitis Treatment Study

Phase 4

Active, not recruiting

• Conditions: Hepatitis C; Opioid-Related Disorders; Injection Drug Use
• Interventions: Drug: Sofosbuvir/velpatasvir (Epclusa®)

• Registration Number: NCT03949764
• Lead Sponsor: Jennifer Havens

Brief Summary

The overarching goal of the Kentucky Viral Hepatitis Treatment Project (KeY Treat) is to increase hepatitis C virus (HCV) treatment access and delivery in a rural Appalachian community, which is in the midst of the opioid/hepatitis C (HCV) syndemic. KeY Treat is a clinical research study seeking to determine whether removing barriers (cost, insurance, specialist, abstinence) associated with accessing direct-acting antivirals (DAAs) for the treatment of HCV will impact health in Perry County, Kentucky.

Detailed Description

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. Existing resources in the target community (public health, jail, hospital) will be leveraged, 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.

Study Timeline

• Study First Submitted: 2019-05-02
• Study First Submitted QC: 2019-05-13
• Study First Posted: 2019-05-14
• Study Start: 2019-09-23
• Status Verified: 2024-08
• Last Update Submitted: 2025-04-03
• Last Update Posted: 2025-04-06
• Primary Completion: 2025-06-30
• Study Completion: 2025-06-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 374

Inclusion Criteria

• RNA positive for HCV
• Perry County residency (verified via ID card showing local address, lease, utility bill, etc.)
• 18 years of age or older

Exclusion Criteria

• Individuals who are unable to provide consent (to be determined by local study staff in conjunction with our psychiatrist, Dr. Lofwall, a Co-I on the study)
• Individuals under 18 years of age (study drugs not FDA-approved for those <18)
• Pregnant women (unable to participate during duration of pregnancy, but encouraged to return following delivery)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
HCV Positive Study Participants	Sofosbuvir/velpatasvir (Epclusa®)	Study participants will be administered a standard 12-week course of sofosbuvir/velpatasvir (Epclusa®).

Primary Outcome Measures

Name	Time	Method
Treatment Uptake	Visits 1-5, 1 to 12 weeks post-baseline	Defined as receiving the first dose of medication, to be measured by number of pills left and viral load.
Treatment Completion	Visit 6, 24 weeks post-baseline	Defined as receiving all doses of medication, to be measured by number of pills left and viral load.
Sustained Virologic Response (SVR)	Visit 7, 50 weeks post-baseline	Defined as undetectable viral RNA at the 12-week post-completion blood draw (SVR-12).
Re-infection	Visit 8, 102 weeks post-baseline	Defined as the presence of viral RNA at either the 6- or 12-month follow-up after achieving SVR.

Secondary Outcome Measures

Name	Time	Method
Prevalence of HCV	Visit 8, 102 weeks post-baseline	Prevalence of HCV in study population, measured by viral load.
Incidence of HCV	Visit 8, 102 weeks post-baseline	Incidence of HCV in study population, measured by viral load and new cases.

Trial Locations

Locations (1)

ARH Medical Mall; 🇺🇸 Hazard, Kentucky, United States