The Kentucky Viral Hepatitis Treatment Study

NCT03949764 | Completed Phase 4 FDA Drug

• 2 other identifiers: 47239R01DA047952
• Study Type: interventional
• Target: 374
• Locations: 1 country
• Sites: 1

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.

Conditions

Hepatitis C; Opioid-Related Disorders; Injection Drug Use

Outcome Measures

Primary Outcomes (4)

• 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

• 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

• 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

• 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 Outcomes (2)

• Prevalence of HCV

  Visit 8, 102 weeks post-baseline

• Incidence of HCV

  Visit 8, 102 weeks post-baseline

Study Arms (2)

HCV Positive Study Participants

EXPERIMENTAL

Study participants will be administered a standard 12-week course of sofosbuvir/velpatasvir (Epclusa®).

Drug: Sofosbuvir/velpatasvir (Epclusa®)

Control (Pike County)

NO INTERVENTION

After completion of the study, we will compare HCV incidence and prevalence rates in Perry County (intervention) and Pike County (control). This will be measured through data provided by the local health departments of each county. Confidential Hepatitis C screening will be conducted in some cases, and resources will be provided to those testing positive but they will not receive treatment as part of this study.

Interventions

Sofosbuvir/velpatasvir (Epclusa®) DRUG

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.

HCV Positive Study Participants

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Jennifer Havens: lead
• National Institute on Drug Abuse (NIDA): collaborator
• National Cancer Institute (NCI): collaborator
• Gilead Sciences: collaborator
• University of Kentucky: collaborator
• Icahn School of Medicine at Mount Sinai: collaborator
• University of Bristol: collaborator

Study Sites (1)

ARH Medical Mall

Hazard, Kentucky, 41701, United States

Location

Related Publications (1)

• Havens JR, Schaninger T, Fraser H, Lofwall M, Staton M, Young AM, Hoven A, Walsh SL, Vickerman P. Eliminating hepatitis C in a rural Appalachian county: protocol for the Kentucky Viral Hepatitis Treatment Study (KeY Treat), a phase IV, single-arm, open-label trial of sofosbuvir/velpatasvir for the treatment of hepatitis C. BMJ Open. 2021 Jul 5;11(7):e041490. doi: 10.1136/bmjopen-2020-041490.

  PMID: 34226208 DERIVED

MeSH Terms

Conditions

Hepatitis C; Opioid-Related Disorders

Interventions

Sofosbuvir; velpatasvir; sofosbuvir-velpatasvir drug combination

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis; Liver Diseases; Digestive System Diseases; Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Uridine Monophosphate; Uracil Nucleotides; Pyrimidine Nucleotides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Nucleotides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleotides

Study Officials

• Jennifer Havens, PhD

  University of Kentucky Ctr on Drug & Alcohol Rsrch

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 2, 2019
• First Posted: May 14, 2019
• Study Start: September 23, 2019
• Primary Completion: June 30, 2025
• Study Completion: June 30, 2025
• Last Updated: August 6, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share

Locations

US (1)