The Kentucky Viral Hepatitis Treatment Study

Hepatitis C Clinical Trial

— KeY Treat  

Official title:

Increasing Access to Hepatitis C Treatment in Opioid Endemic Rural Areas: The Kentucky Viral Hepatitis Treatment (KeY Treat) Study

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03949764
• Other study ID #: 47239
• Secondary ID: R01DA047952
• Status: Active, not recruiting
• Phase: Phase 4
• Start date: September 23, 2019
• Est. completion date: December 31, 2024

Study information

• Verified date: July 2023
• Source: University of Kentucky
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 374
• Est. completion date: December 31, 2024
• Est. primary completion date: August 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis C
• Injection Drug Use
• Opioid-Related Disorders

Intervention

Drug:
• Sofosbuvir/velpatasvir (Epclusa®)
The protocol is intended to follow best practices/standard of care for the treatment of HCV, with additional allowances for the investigators to apply rigorous scientific practices for the research aspects of the study. While the treatment of HCV is fairly straightforward, less is known about treating active drug users and RNA-positive individuals in rural areas. We propose eight visits, including intake, four treatment-related visits, and three visits to determine re-infection (6- and 12-months post-SVR). Because determination of medication adherence and long-term reinfection rates are not part of standard clinical practice, the rural protocol developed at the conclusion of KeY Treat will be streamlined based on findings, consisting of five or fewer clinical contacts. The drug used for treatment is Epclusa®, a 12-week, once per day, pan-genotypic DAA with a favorable side effect profile. Vosevi® will also be available in cases where participants are non-responsive or are re-infected.

Locations

Country	Name	City	State
United States	ARH Medical Mall	Hazard	Kentucky

Sponsors (7)

Lead Sponsor	Collaborator
Jennifer Havens	Gilead Sciences, Icahn School of Medicine at Mount Sinai, National Cancer Institute (NCI), National Institute on Drug Abuse (NIDA), University of Bristol, University of Kentucky

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Treatment Uptake	Defined as receiving the first dose of medication, to be measured by number of pills left and viral load.	Visits 1-5, 1 to 12 weeks post-baseline
Primary	Treatment Completion	Defined as receiving all doses of medication, to be measured by number of pills left and viral load.	Visit 6, 24 weeks post-baseline
Primary	Sustained Virologic Response (SVR)	Defined as undetectable viral RNA at the 12-week post-completion blood draw (SVR-12).	Visit 7, 50 weeks post-baseline
Primary	Re-infection	Defined as the presence of viral RNA at either the 6- or 12-month follow-up after achieving SVR.	Visit 8, 102 weeks post-baseline
Secondary	Prevalence of HCV	Prevalence of HCV in study population, measured by viral load.	Visit 8, 102 weeks post-baseline
Secondary	Incidence of HCV	Incidence of HCV in study population, measured by viral load and new cases.	Visit 8, 102 weeks post-baseline