This study will assess the efficacy, safety, and tolerability of 16 or 24 weeks of sofosbuvir (Sovaldi®; SOF) + ribavirin (RBV), and 12 weeks of SOF+RBV+ pegylated interferon (Peg-IFN) in treatment-naive and treatment-experienced adults with chronic genotype 3 hepatitis C virus (HCV) infection, and treatment-experienced adults with cirrhosis and chronic genotype 2 HCV infection.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
601
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 Any Study Drug Due to an Adverse Event
Time frame: Up to 24 weeks
Percentage of Participants With SVR at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)
SVR4 and SVR 24 were defined as HCV RNA \< LLOQ at 4 and 24 weeks after stopping study treatment, respectively.
Time frame: Posttreatment Weeks 4 and 24
Percentage of Participants With HCV RNA < LLOQ at Weeks 1, 2, 4, 8, 12, 16, 20, and 24
Time frame: Weeks 1, 2, 4, 8, 12, 16, 20, and 24
HCV RNA at Weeks 1, 2, 4, 8, and 12
Time frame: Weeks 1, 2, 4, 8, and 12
Change From Baseline in HCV RNA at Weeks 1, 2, 4, 8, and 12
Time frame: Baseline; Weeks 1, 2, 4, 8, and 12
Percentage of Participants Experiencing On-Treatment Virologic Failure
On-treatment virologic failure was defined as: * 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)
Time frame: Up to 24 weeks
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Unnamed facility
Riverside, California, United States
Unnamed facility
San Diego, California, United States
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San Francisco, California, United States
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Aurora, Colorado, United States
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Englewood, Colorado, United States
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Miami, Florida, United States
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Wellington, Florida, United States
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Marietta, Georgia, United States
Unnamed facility
New Orleans, Louisiana, United States
Unnamed facility
Boston, Massachusetts, United States
...and 68 more locations
Percentage of Participants Experiencing Viral Relapse
Viral relapse is defined as HCV RNA ≥ LLOQ during the post-treatment period having achieved HCV RNA \< LLOQ at end of treatment, confirmed with 2 consecutive values or last available post-treatment measurement.
Time frame: Up to Posttreatment Week 24