The Kentucky Viral Hepatitis Treatment Study

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.

Conditions

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

Interventions

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.

Sponsors & Collaborators

• National Institute on Drug Abuse (NIDA)

  collaborator NIH

• National Cancer Institute (NCI)

  collaborator NIH

• Gilead Sciences

  collaborator INDUSTRY

• University of Kentucky

  collaborator OTHER

• Icahn School of Medicine at Mount Sinai

  collaborator OTHER

• University of Bristol

  collaborator OTHER

• Jennifer Havens

  lead OTHER

Principal Investigators

• Jennifer Havens, PhD · University of Kentucky Ctr on Drug & Alcohol Rsrch

Study Design

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2019-09-23

Primary Completion

2025-06-30

Completion

2025-06-30

FDA Drug

Yes

Countries

• United States

Study Locations