The purpose of this study is to assess the safety, tolerability, and efficacy of sofosbuvir (GS-7977; PSI-7977) administered in combination with pegylated interferon and ribavirin (PEG/RBV) in treatment-naive patients with HCV genotypes 1,4,5,6, or indeterminate genotype.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
332
Sofosbuvir (SOF) administered as a 400 mg tablet orally once daily
Ribavirin (RBV) tablets administered orally in a divided daily dose according to package insert weight-based dosing recommendations (\< 75kg = 1000 mg and ≥ 75 kg = 1200 mg)
Pegylated interferon alfa-2a (PEG) 180 μg administered once weekly by subcutaneous injection
Percentage of Participants With Sustained Virologic Response 24 Weeks Following Completion of Treatment (SVR24)
SVR24 was defined as HCV RNA \< the limit of detection (LOD; \< 15 IU/mL) 24 weeks after the last dose of study drug.
Time frame: Post-treatment Week 24
Percentage of Participants Who Experienced Adverse Events
Adverse events (AEs) occurring from baseline (Day 1 for all groups) to 30 days following the last dose of study drug were summarized across the participant population. A participant was counted once if they had a qualifying event.
Time frame: Baseline (Day 1) to post-treatment Day 30
Percentage of Participants With Sustained Virologic Response 12 Weeks Following Completion of Treatment (SVR12)
SVR12 was defined as HCV RNA \< LOD 12 weeks after the last dose of study drug.
Time frame: Post-treatment Week 12
Change in HCV RNA at Week 2
Time frame: Baseline (Day 1) to Week 2
Change in HCV RNA at Week 4
Time frame: Baseline (Day 1) to Week 4
Change in HCV RNA at Week 8
Time frame: Baseline (Day 1) to Week 8
Change in HCV RNA at Week 12
Time frame: Baseline (Day 1) to Week 12
Percentage of Participants With HCV RNA < LOD at Week 2
Time frame: Week 2
Percentage of Participants With HCV RNA Below < LOD at Week 4
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Alabama Liver and Digestive Specialist
Montgomery, Alabama, United States
Clopton Clinic
Jonesboro, Arkansas, United States
Advanced Clinical Research Institute
Anaheim, California, United States
Providence Clinical Research
Burbank, California, United States
Southern California Liver Centers
Coronado, California, United States
Cedars Sinai Medical Center
Los Angeles, California, United States
eStudy Site
Oceanside, California, United States
Desta Digestive Disease Medical Center
San Diego, California, United States
Medical Associates Reseach Group
San Diego, California, United States
Kaiser Permanente Hepatology Research
San Diego, California, United States
...and 36 more locations
Time frame: Week 4
Percentage of Participants With HCV RNA Below < LOD at Week 8
Time frame: Week 8
Percentage of Participants With HCV RNA Below < LOD at Week 12
Time frame: Week 12
Percentage of Participants With HCV RNA Below < LOD at Week 24
Time frame: Week 24
Percentage of Participants With ALT Normalization at Week 12
ALT normalization was defined as ALT \> ULN at baseline and ALT ≤ ULN at Week 12.
Time frame: Baseline (Day 1) to Week 12
Percentage of Participants With ALT Normalization at Week 24
ALT normalization was defined as ALT \> ULN at baseline (Day 1 for all groups) and ALT ≤ ULN at Week 24.
Time frame: Baseline (Day 1) to Week 24
Percentage of Participants With ALT Normalization at Post-treatment Week 4
ALT normalization was defined as ALT \> ULN at baseline (Day 1 for all groups) and ALT ≤ ULN at Post-treatment Week 4.
Time frame: Baseline (Day 1) to Post-treatment Week 4
Percentage of Participants With Virologic Failure During Treatment
Virologic failure was defined as either * HCV RNA ≥ 15 IU/mL after having previously had HCV RNA \< 15 IU/mL while on treatment, confirmed with 2 consecutive values or last available measurement (ie, breakthrough); * \> 1 log10 IU/mL increase in HCV RNA from nadir while on treatment, confirmed with 2 consecutive values or last available measurement (ie, rebound);or * HCV RNA persistently ≥ 15 IU/mL through 8 weeks of treatment (ie, nonresponse) Baseline was Day 1 for all groups.
Time frame: Baseline (Day 1) to Week 24
Percentage of Participants With Virologic Failure Following Treatment (Viral Relapse).
Viral relapse was defined as HCV RNA \< 15 IU/mL at end of treatment, confirmed with 2 consecutive values or last available measurement.
Time frame: End of treatment to Post-treatment Week 24