Prevention of Transmission of Hepatitis C Virus (HCV) From HCV-Viremic Organ Donor

Study Overview
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Brief Summary
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This trial will be done in participants who undergo transplantation of heart, kidney or lung at University of California, San Diego (UCSD) and receive a hepatitis C infected donor organ. In this trial, the plan is to start hepatitis C treatment just before transplant surgery and treat for a short one-week course to see if hepatitis C infection can be prevented in the transplant recipient. The plan is to perform this trial in 10 participants and if successful, the next step is to try to make it standard of care as prevention of infection is better than treating hepatitis C after discharge from transplant surgery (which is usually a 12 week standard treatment).

Official Title
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Prevention of Transmission of Hepatitis C Virus (HCV) From HCV-Viremic Organ Donor to HCVNegative Organ Transplant Recipient - Pilot Trial

Conditions
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Hepatitis C, Hepatitis C Virus Infection, Response to Therapy of

Intervention / Treatment
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* Drug: glecaprevir/pibrentasvir (GLE/PIB)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: adults aged 18 years or greater participants actively listed for heart, lung and/or kidney transplant participants have already consented to receive HCV-viremic organs as part of the institution's clinical practice protocol (involves education and informed consent), and are able to sign informed consent for this research study. Exclusion Criteria: participants who have a prior history of HCV infection regardless of treatment status, pre-existing human immunodeficiency virus (HIV) or hepatitis B virus (HBV) infection participants who are not able to sign informed consent for this research study participants who have not agreed to accept HCV+ organs as part of the UCSD clinical practice protocol participants who are listed for a liver transplant (either as a single organ or combined organ transplant).

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment Arm<br> | Drug: glecaprevir/pibrentasvir (GLE/PIB)<br>* The study intervention consists of a single daily dose of GLE/PIB 100/40 mg (one dose consists of 3 tablets) administered orally; or crushed and administered via a feeding tube if participant is unable to swallow by mouth, for example in the immediate post-operative period. First dose will be administered in the pre-operative period within 4 hours of surgery followed by once daily doses for 7 days total.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of participants with Sustained Virological Response | The primary outcome is the percentage of patients sustained virological response (SVR) at day 91 after completion of a 7-day course of GLE/PIB. | 91 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of participants with treatment-related Serious Adverse Events | Safety and tolerability of the 7-day GLR/PIB course. Safety and tolerability will be assessed by documenting Serious Adverse Events (based on NIH criteria) for the duration of the study. Safety assessments will occur through review of the medical record of the patient, review of laboratory parameters and open-ended questions at the in-person assessments. | 91 days |