The primary objectives of this study are to evaluate the efficacy, safety, and tolerability of the treatment with sofosbuvir velpatasvir (SOF/VEL) fixed-dose combination (FDC) with ribavirin (RBV) for 12 weeks in participants with chronic hepatitis C virus (HCV) infection and Child-Pugh-Turcotte (CPT) Class C cirrhosis.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
32
Tampa General Medical Group
Tampa, Florida, United States
Northwestern Memorial Hospital; Clinical Research Unit
Chicago, Illinois, United States
Digestive Disease Associates, PA
Catonsville, Maryland, 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 Permanently Discontinued Study Drug (SOF/VEL or RBV) Due to an Adverse Event
Time frame: First dose date up to Week 12
Percentage of Participants With Sustained Virologic Response 4 Weeks After Discontinuation of Therapy (SVR4)
SVR4 was defined as HCV RNA \< LLOQ 4 weeks after stopping study treatment.
Time frame: Posttreatment Week 4
Percentage of Participants With Sustained Virologic Response 24 Weeks After Discontinuation of Therapy (SVR24)
SVR24 was defined as HCV RNA \< LLOQ at 24 weeks after stopping study treatment.
Time frame: Posttreatment Week 24
Percentage of Participants With HCV RNA < LLOQ While on Study Treatment
Time frame: Weeks 2, 4, 8, and 12
Percentage of Participants With No Change, Improved, and Worsened Child-Pugh-Turcotte (CPT) Class
CPT is a chronic liver disease classification system. Classes include CPT Class A, CPT Class B, and CPT Class C, in order of greater disease severity. Participants with improved CPT class was defined as having Class C at Baseline and Class B or A at Posttreatment Week 24 or Class B at Baseline and Class A at Posttreatment Week 24. Participants with worsened CPT class was defined as having Class A at Baseline and Class B or C at Posttreatment Week 24 or Class B at Baseline and Class C at Posttreatment Week 24. Participants with no change CPT class was defined as having CPT Class same between Baseline and Posttreatment Week 24.
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Southern Therapy and Advanced Research LLC
Jackson, Mississippi, United States
Icahn School of Medicine at Mount Sinai
New York, New York, United States
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States
American Research Corporation at Texas Liver Institute
San Antonio, Texas, United States
Intermountain Liver Disease and Transplant Center
Murray, Utah, United States
Bon Secours St. Mary's Hospital of Richmond, Inc. d/b/a Bon Secours Liver Institute of Virginia
Richmond, Virginia, United States
University of Washington/ Harborview Medical Center
Seattle, Washington, United States
...and 2 more locations
Time frame: Baseline to Posttreatment Week 24
Percentage of Participants With a Decrease, No Change, or Increase in Model for End Stage Liver Disease (MELD) Score
MELD score is a chronic liver disease severity scoring system. Scores can range from 6 to 40, with higher scores indicating greater disease severity. "No change" was assigned for differences (posttreatment visits minus baseline score) of -1, 0 or 1; "Decrease" was assigned for differences that were less than or equal to -2; and "Increase" was assigned for values that were greater than or equal to 2.
Time frame: Baseline to Posttreatment Week 24
Absolute HCV RNA Level Through Week 12
Time frame: Baseline; Weeks 2, 4, 8, and 12
Change From Baseline in HCV RNA
Time frame: Baseline; Weeks 2, 4, 8, and 12
Number of Participants With Virologic Failure
Virologic failure was defined as: * On-treatment virologic failure: * Breakthrough (confirmed HCV RNA ≥ LLOQ after having previously had HCV RNA \< LLOQ while on treatment), or * Rebound (confirmed \> 1 log10 IU/mL increase in HCV RNA from nadir while on treatment), or * Non-response (HCV RNA persistently ≥ LLOQ through 8 weeks of treatment) * Virologic relapse: * Confirmed HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA \< LLOQ at last on-treatment visit
Time frame: Baseline up to Posttreatment Week 24