The primary objective of this registry study is to assess the durability of sustained virologic response (SVR) and clinical progression or regression of liver disease including the incidence of hepatocellular carcinoma following SVR in participants with cirrhosis after treatment with a sofosbuvir-based regimen for HCV infection.
Study Type
OBSERVATIONAL
Enrollment
1,609
Exposure of interest for participants who received sofosbuvir in a previous Gilead study for chronic HCV infection.
Exposure of interest for participants who received LDV/SOF in a previous Gilead study for chronic HCV infection.
Percentage of Participants Maintaining Sustained Virologic Response (SVR) at Week 240
SVR at Week 240 was defined as HCV RNA\< lower limit of quantification (LLOQ i.e., 15 or 25 international units per milliliter \[IU/mL\]) or last available HCV RNA\< LLOQ with no subsequent follow-up values at Week 240 after enrollment in this registry study. Percentage of participants who maintained SVR status by Week 240 was estimated using a Kaplan-Meier model.
Time frame: Week 240
Percentage of Participants With Any Liver-Associated Events
The percentage of participants with any liver-associated events since registry start (enrollment) through Week 240 was estimated using a Kaplan-Meier model.
Time frame: Enrollment up to 240 weeks
Percentage of Participants Who Developed Hepatocellular Carcinoma (HCC) Through Week 240
Participants with de novo HCC since registry start were defined as participants who had not been identified with HCC prior to registry start and only had HCC since registry start. The percentage of participants who developed de novo HCC through Week 240 was estimated using a Kaplan-Meier model.
Time frame: Enrollment up to 240 weeks
Number of Participants With Detectable HCV RNA Due to Re-emergence of Pre-existing Virus Through Week 240
Time frame: Enrollment up to 240 weeks
Number of Participants With Detectable HCV Resistance Mutations Through Week 240
Time frame: Enrollment up to 240 weeks
Number of Participants With Detectable HCV RNA Due to Re-infection Through Week 240
Reinfection was defined as HCV RNA \> LLOQ on 2 samples collected at least 1 week apart with a different virus than that present prior to treatment baseline in the parent study.
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Exposure of interest for participants who received SOF/VEL in a previous Gilead study for chronic HCV infection.
Exposure of interest for participants who received SOF/VEL/VOX in a previous Gilead study for chronic HCV infection.
The other SOF-based regimens may have included the following: * BMS-790052 (Daclatasvir) + GS-7977 (SOF) with or without RBV * LDV/SOF + GS-9669, GS-7977 (SOF) + with or without RBV + TMC-435 (Simeprevir) * LDV/SOF + Vedroprevir (VDV), LDV/SOF + GS-9669 (250 mg and 500 mg) * LDV/SOF + VDV + RBV * Simeprevir + SOF * TMC-435 (Simeprevir) + VEL/SOF
Participants were enrolled from ineligible parent treatment group.
University of Alabama at Birmingham
Birmingham, Alabama, United States
Scripps Clinic Medical Group
La Jolla, California, United States
V.A. Long Beach Medical Center
Long Beach, California, United States
Cedars Sinai Medical Center
Los Angeles, California, United States
Kaiser Permanente Medical Center
Los Angeles, California, United States
Tarrant County ID Associates
Los Angeles, California, United States
The Liver Center
Pasadena, California, United States
Inland Empire Liver Foundation
Rialto, California, United States
University of California, Davis Medical Center
Sacramento, California, United States
Kaiser Permanente
San Diego, California, United States
...and 128 more locations
Time frame: Enrollment up to 240 weeks