This is a single center study for the donation of Hepatitis C Virus (HCV)-positive livers to HCV negative recipient patients, with preemptive, interventional treatment to prevent HCV transmission upon transplantation.
Patients will be selected based on diminished likelihood of receiving a liver from the waitlist within a period during which they would be likely to succumb to severe comorbidities. This will be determined in part through use of a patient's Model of End Stage Liver Disease (MELD) score, listing status, and clinical judgment. To ensure maximal benefit for the recipient, only high quality donor livers will be accepted.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
PREVENTION
Masking
NONE
Enrollment
33
HCV Treatment for 12 Weeks
Masschusetts General Hospital
Boston, Massachusetts, United States
Number of Participants With Undetectable Hepatitis C Virus (HCV) Viral RNA
Number of dosed subjects with negative HCV viral RNA at 12 weeks after the last dose of treatment.
Time frame: 12 weeks post treatment
Number of Participants With Treatment Emergent Adverse Events and Out of Range Lab Values
Safety and tolerability of direct acting antiviral therapy in the liver transplant patient will be monitored by quantifying the number of treatment related adverse events per patient and evaluating clinically significant out of range laboratory results as compared to baseline/pretreatment values per patient.
Time frame: 12 weeks
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