The primary objective of this study is to evaluate the antiviral efficacy of treatment with ledipasvir/sofosbuvir (LDV/SOF) fixed-dose combination (FDC) therapy at the time of liver transplantation and through 4 weeks posttransplant in adults with genotype 1 or 4 hepatitis C virus (HCV) infection who are undergoing primary liver transplantation.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
17
90/400 mg FDC tablet administered orally
Unnamed facility
San Francisco, California, United States
Unnamed facility
Chicago, Illinois, United States
Unnamed facility
New Orleans, Louisiana, United States
Unnamed facility
Detroit, Michigan, United States
Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12)
SVR12 was defined as HCV RNA \< the lower limit of quantitation (LLOQ; ie, 15 IU/mL) at 12 weeks after stopping study treatment.
Time frame: Posttreatment Week 12
Percentage of Participants Who Prematurely Discontinued Study Drug Due to an Adverse Event
Time frame: Up to 4 weeks
Percentage of Participants With SVR 4 Weeks After Discontinuation of Therapy (SVR4)
SVR4 was defined as HCV RNA \< LLOQ at 4 weeks after stopping study treatment.
Time frame: Posttreatment Week 4
Percentage of Participants With Virologic Failure
Virologic failure was defined as: * End of treatment virologic failure: * Completed 28 days LDV/SOF treatment and had HCV RNA ≥ LLOQ at last measurement on treatment * Virologic relapse: * Confirmed HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA \< LLOQ at last on-treatment HCV RNA measurement.
Time frame: Up to Posttreatment Week 12
Percentage of Participants With HCV RNA < LLOQ While on Treatment at Days 1, 3, 5, 7, 14, 21, and 28
Time frame: Days 1, 3, 5, 7, 14, 21, and 28
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Unnamed facility
New York, New York, United States
Unnamed facility
Dallas, Texas, United States