This study was to assess the safety and efficacy of sofosbuvir (GS-7977; PSI-7977) in combination with ribavirin (RBV) administered for 12 weeks compared with pegylated interferon (PEG)/RBV administered for 24 weeks in treatment-naive patients with Hepatitis C (HCV) genotype 2 or 3. Efficacy was assessed by the rate of sustained viral response (SVR) 12 weeks after the discontinuation of therapy (SVR12). This was a non-inferiority study, and if non-inferiority was demonstrated, the study was then allowed to test for superiority.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
527
Sofosbuvir 400 mg (2 × 200 mg tablets) administered orally once daily
Pegylated interferon alfa-2a (PEG) 180 μg administered once weekly by subcutaneous injection
Ribavirin (RBV) administered as 200 mg tablets up to 1200 mg in a divided daily dose * Dose of sofosbuvir+RBV group based on baseline weight: \< 75kg = 1000 mg and ≥ 75 kg = 1200 mg * Dose of PEG+RBV group: 800 mg
Percentage of Participants With Sustained Virologic Response 12 Weeks After Stopping All Study Drugs (SVR12)
SVR12 was defined as HCV RNA \< the lower limit of quantitation (LLOQ; \< 25 IU/mL) 12 weeks after study drug cessation.
Time frame: Post-treatment Week 12
Number of Participants Who Experienced Adverse Events (AEs) and Graded Laboratory Abnormalities
Time frame: Up to 24 weeks plus 30 days following the last dose of study drug
Percentage of Participants With Sustained Virologic Response 24 Weeks After Stopping All Study Drugs (SVR24)
SVR24 was defined as HCV RNA \< LLOQ 24 weeks after study drug cessation.
Time frame: Post-treatment Week 24
Percentage of Participants With HCV RNA < LLOQ on Treatment
Time frame: Up to 12 Weeks
Change From Baseline in HCV RNA
Time frame: Baseline to Week 12
Percentage of Participants With Virologic Failure During Treatment
Virologic failure was defined as either * Viral breakthrough: HCV RNA ≥ 25 IU/mL after having previously had HCV RNA \< 25 IU/mL while on treatment, confirmed with 2 consecutive values or last available measurement * Viral rebound: \> 1 log10 IU/mL increase in HCV RNA from nadir while on treatment, confirmed with 2 consecutive values or last available measurement * Non-response: HCV RNA persistently ≥ 25 IU/ml while on treatment (through Week 12)
Time frame: Baseline up to Week 24
Percentage of Participants With Viral Relapse Following Treatment
Viral relapse was defined as HCV RNA ≥ 25 IU/mL in post-treatment after having achieved \< LLOQ at last on-treatment measurement, confirmed with 2 consecutive values or last available measurement.
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University of Alabama at Birmingham
Birmingham, Alabama, United States
Alabama Liver & Digestive Specialist
Montgomery, Alabama, United States
Franco Felizarta, MD
Bakersfield, California, United States
California Liver Institute
Beverly Hills, California, United States
Arrowhead Regional Medical Center
Colton, California, United States
SCTI Research Foundation
Coronado, California, United States
eStudy Site
La Mesa, California, United States
Peter J. Ruane, M.D. Inc.
Los Angeles, California, United States
eStudySite
Oceanside, California, United States
University of California, Davis - Health System
Sacramento, California, United States
...and 87 more locations
Time frame: Up to Post-treatment Week 24