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Anti-viral

Epclusa for Hepatitis C (KeY Treat Trial)

Phase 4

Waitlist Available

Led By Jennifer Havens, PhD

Research Sponsored by Jennifer Havens

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

RNA positive for HCV

18 years of age or older

Must not have

Individuals under 18 years of age (study drugs not FDA-approved for those <18)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up visits 1-5, 1 to 12 weeks post-baseline

Awards & highlights

Approved for 10 Other Conditions

Pivotal Trial

No Placebo-Only Group

All Individual Drugs Already Approved

Drug Has Already Been Approved

Summary

This trial is testing whether making it easier for people with hepatitis C to get treatment will improve their health in Perry County, Kentucky.

Who is the study for?

This trial is for adults over 18 living in Perry County, Kentucky who have tested RNA positive for Hepatitis C. It's not open to those under 18, pregnant women during pregnancy, or anyone unable to give informed consent.

What is being tested?

The study tests the impact of providing easy access to a hepatitis C treatment called Sofosbuvir/velpatasvir (Epclusa®) without barriers like cost and insurance issues in a rural community affected by opioid use.

What are the potential side effects?

Sofosbuvir/velpatasvir may cause headaches, fatigue, nausea, insomnia and sometimes more serious side effects such as slow heart rate or liver problems. Each person's experience with side effects can vary.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have tested positive for hepatitis C.

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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am 18 years old or older.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ visits 1-5, 1 to 12 weeks post-baseline

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~visits 1-5, 1 to 12 weeks post-baseline

This trial's timeline: 3 weeks for screening, Varies for treatment, and visits 1-5, 1 to 12 weeks post-baseline for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Re-infection

Sustained Virologic Response (SVR)

Treatment Completion

+1 more

Secondary study objectives

Incidence of HCV

Prevalence of HCV

Awards & Highlights

Approved for 10 Other Conditions

This treatment demonstrated efficacy for 10 other conditions.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: HCV Positive Study ParticipantsExperimental Treatment1 Intervention

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

Group II: Control (Pike County)Active Control1 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.

0 / 3Eligibility criteria met