Hepatitis CPhase 4KeY TreatNCT03949764
The Kentucky Viral Hepatitis Treatment Study
A Phase 4 study testing Sofosbuvir/velpatasvir (Epclusa®) in people with Hepatitis C and Opioid-Related Disorders, run by Jennifer Havens at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatitis C, Opioid-Related Disorders, Injection Drug Use
- What is being tested?
- Sofosbuvir/velpatasvir (Epclusa®)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 380 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Sep 2019to 30 Jun 2025
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- RNA positive for HCV
- Perry County residency (verified via ID card showing local address, lease, utility bill, etc.)
- 18 years of age or older
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Increasing Access to Hepatitis C Treatment in Opioid Endemic Rural Areas: The Kentucky Viral Hepatitis Treatment (KeY Treat) Study
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.
Read the 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.
- Conditions
- Hepatitis C, Opioid-Related Disorders, Injection Drug Use
- Being tested
- Sofosbuvir/velpatasvir (Epclusa®)
- Medical subject headings
- Hepatitis C, Opioid-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| HCV Positive Study Participants | Experimental | Study participants will be administered a standard 12-week course of sofosbuvir/velpatasvir (Epclusa®). Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Participants Who Started HCV Treatment
Participants who received at least one dose of study medication. This is measured by number of pills left and viral load.
Measured: Baseline through Week 12
Participants Who Completed Treatment
Treatment completion was defined as receiving all prescribed doses of medication. This is measured by pill count and viral load.
Measured: Visit 6, 24 weeks post-baseline
Number of Participants With Sustained Virologic Response (SVR)
Defined as undetectable viral RNA at the 12-week post-completion blood draw (SVR-12).
Measured: Visit 7, 50 weeks post-baseline
Number of Participants for Follow-Up Re-Infection Assessment
Defined as the presence of viral RNA at either the 6- or 12-month follow-up after achieving SVR.
Measured: Visit 8, 102 weeks post-baseline
Secondary outcomes (2)
Prevalence of HCV
Prevalence of HCV in study population, measured by viral load.
Measured: Visit 8, 102 weeks post-baseline
Incidence of HCV
State surveillance data required to calculate HCV incidence were unavailable during the study period; therefore this outcome could not be evaluated.
Measured: Visit 8, 102 weeks post-baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2019
- Study start23 Sep 2019
- Primary completion30 Jun 2025
- Study completion30 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hepatitis CStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 380 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jennifer Havens
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA), National Cancer Institute (NCI), Gilead Sciences, University of Kentucky, Icahn School of Medicine at Mount Sinai, University of Bristol
- Responsible party
- Sponsor-investigator, Jennifer Havens, University of Kentucky
- Investigators
- Jennifer Havens, PhD, Principal investigator, University of Kentucky Ctr on Drug & Alcohol Rsrch
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03949764
- Sponsor's protocol ID
- 47239
- Other IDs
- R01DA047952
- Acronym
- KeY Treat
- Status last verified
- Jul 2026
- First submitted
- 2 May 2019
- Last updated
- 20 Oct 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
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.
PubMed 34226208
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Increasing Access to Hepatitis C Treatment in Opioid Endemic Rural Areas: The Kentucky Viral Hepatitis Treatment (KeY Treat) Study
- ClinicalTrials.gov ID
- NCT03949764
- Acronym / sponsor ID
- KeY Treat / 47239
- Conditions
- Hepatitis C, Opioid-Related Disorders, Injection Drug Use
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 380 participants (actual)
- Lead sponsor
- Jennifer HavensUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA), National Cancer Institute (NCI), Gilead Sciences, University of Kentucky, Icahn School of Medicine at Mount Sinai, University of Bristol
- Study start
- 23 Sep 2019 (actual)
- Primary completion
- 30 Jun 2025 (actual)
- Study completion
- 30 Jun 2025 (actual)
- First posted
- 14 May 2019 (actual)
- Results
- Posted 20 Oct 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HCV Positive Study Participants | Experimental | Drug: Sofosbuvir/velpatasvir (Epclusa®)Study participants will be administered a standard 12-week course of 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- RNA positive for HCV
- Perry County residency (verified via ID card showing local address, lease, utility bill, etc.)
- 18 years of age or older
Key exclusion criteria (3 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Drug | HCV Positive Study Participants |
Primary outcome
Participants Who Started HCV Treatment
Time frame: Baseline through Week 12
Participants who received at least one dose of study medication. This is measured by number of pills left and viral load.
Participants Who Completed Treatment
Time frame: Visit 6, 24 weeks post-baseline
Treatment completion was defined as receiving all prescribed doses of medication. This is measured by pill count and viral load.
Number of Participants With Sustained Virologic Response (SVR)
Time frame: Visit 7, 50 weeks post-baseline
Defined as undetectable viral RNA at the 12-week post-completion blood draw (SVR-12).
Number of Participants for Follow-Up Re-Infection Assessment
Time frame: 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.
2 secondary outcomes
Prevalence of HCV
Time frame: Visit 8, 102 weeks post-baseline
Incidence of HCV
Time frame: Visit 8, 102 weeks post-baseline
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 34226208Havens 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.
- Individual participant dataSharing planned: Yes
Related trials for Hepatitis C
RecruitingObservational study
Evaluation of Patients With Liver Disease
Hepatitis D, Hepatitis C
Active, not recruitingPhase 4
People With CHC Who Achieved a Sustained Virological Response Following Therapy With Direct Acting Antiviral Agents
Diabetes Mellitus, Hepatitis C, Chronic
RecruitingObservational study
"Constitution of a Biological Collection to Establish Preclinical Translational Models for the Study of Tumors and Chronic Liver Diseases".
Chronic Liver Disease and Cirrhosis, Liver Cancer
Active, not recruitingPhase 4
Sofosbuvir/Velpatasvir Treatment of Chronic Hepatitis C During Pregnancy
Hepatitis C, Chronic, Pregnancy; Infection
Not yet recruitingPhase 4
Combating Related Epidemics in HCV
HIV - Human Immunodeficiency Virus, Hepatitis B Virus (HBV)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jennifer Havens, PhD principal investigator
University of Kentucky Ctr on Drug & Alcohol Rsrch
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Sofosbuvir/velpatasvir (Epclusa®) in people with Hepatitis C and Opioid-Related Disorders, run by Jennifer Havens at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 20 Oct 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Participants Who Started HCV Treatment (time frame: Baseline through Week 12). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03949764, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2026.