This is a single center study characterizing the experience of administration of 4 weeks of pan-genotypic DAA therapy in kidney transplantation to prevent the transmission of hepatitis C virus infection from an HCV-positive donor kidney to an HCV-negative recipient.
The goal of this study is to determine if the administration of glecaprevir and pibrentasvir (G/P) for 4 weeks beginning in the immediate peri-transplant period prevents establishment of HCV infection in HCV negative recipients receiving transplanted kidneys from HCV RNA positive donors.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
2
4 weeks of treatment starting within 24 hrs of kidney transplant
Massachusetts General Hospital
Boston, Massachusetts, United States
Number of Participants With Undetectable Blood HCV RNA Level
Negative HCV RNA by blood testing at 12 weeks after the last dose of G/P
Time frame: 12 weeks post last dose of treatment with G/P
Adverse Events
Serious and non-serious adverse events attributed to study drug and/or HCV-viremia
Time frame: 1 Year Study Period
HCV RNA Viral Load
Assessment of HCV RNA viral load at on-treatment visits, measured at both week 2 and week 4 on treatment. The viral loads measured at Week 2 and 4 are averaged together and reported in copies per mL
Time frame: Measured at Week 2 and Week 4 of Treatment;
Allograft Function
Post-transplant allograft function measured by mean eGFR over study period
Time frame: 1 Year Study Period
Rate of Death, Graft Failure, Acute Allograft Rejection, Delayed Graft Function, ALT Elevation
The rate of clinical safety outcomes: death, graft failure, acute allograft rejection, delayed graft functions, ALT elevations \> 5x ULN related to study treatment with glecaprevir/Pibrentasvir
Time frame: 1 Year Study Period
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