The primary objective of this study is to evaluate the efficacy, safety, and tolerability of ledipasvir/sofosbuvir (LDV/SOF) fixed dose combination (FDC) for 12 weeks with or without ribavirin (RBV) in participants without cirrhosis, and LDV/SOF FDC for 12 weeks with RBV or LDV/SOF FDC for 24 weeks without RBV in participants with cirrhosis.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
87
Percentage of Participants With Sustained Virologic Response 12 Weeks After Cessation 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 Discontinued From Study Treatment for an Adverse Event
Time frame: Up to 24 weeks
Percentage of Participants With HCV RNA < the Lower Limit of Quantitation (LLOQ) at 4 and 24 Weeks Posttreatment
SVR4 and SVR24 were defined as HCV RNA \< LLOQ at 4 and 24 weeks following the last dose of study drug, respectively.
Time frame: Posttreatment Weeks 4 and 24
Percentage of Participants With Viral Breakthrough
Viral breakthrough was defined as HCV RNA ≥ LLOQ after having previously had HCV RNA \< LLOQ while receiving treatment.
Time frame: Up to 24 weeks
Percentage of Participants With Viral Relapse
Viral relapse was defined as confirmed HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA \<LLOQ at last on-treatment visit.
Time frame: Up to Posttreatment Week 24
Number of Participants With Emerging Resistance
The full-length NS3, NS5A, and NS5B coding regions were deep sequenced at pretreatment (baseline) for all participants included in the Full Analysis Set, and at posttreatment for all participants who relapsed.
Time frame: Up to Posttreatment Week 24
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Little Rock, Arkansas, United States
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Los Angeles, California, United States
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Pasadena, California, United States
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Rialto, California, United States
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Sacramento, California, United States
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Ventura, California, United States
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New Haven, Connecticut, United States
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Largo, Florida, United States
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Weston, Florida, United States
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Chicago, Illinois, United States
...and 32 more locations