This study will examine the safety, tolerability, and antiviral efficacy of sofosbuvir (SOF)+ribavirin (RBV) in treatment-naive and treatment-experienced United States Veterans with compensated cirrhosis and genotype 2 HCV infection.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
66
Sofosbuvir 400 mg tablet administered orally once daily
Ribavirin (RBV) tablets administered orally in a divided daily dose according to package insert weight-based dosing recommendations (\< 75 kg = 1000 mg and ≥ 75 kg = 1200 mg)
Unnamed facility
Long Beach, California, United States
Unnamed facility
Los Angeles, California, United States
Unnamed facility
Palo Alto, California, United States
Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy
SVR12 was defined as HCV RNA \< the lower limit of quantitation (LLOQ; ie, 25 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 12 weeks
Percentage of Participants With Sustained Virologic Response at 4 Weeks After Discontinuation of Therapy (SVR4)
SVR4 was defined as HCV RNA \< LLOQ at 4 weeks following the last dose of study drug.
Time frame: Posttreatment Week 4
Percentage of Participants Experiencing Viral Breakthrough
Viral breakthrough was defined as either: * HCV RNA ≥ LLOQ after having previously had HCV RNA \< LLOQ while receiving treatment * HCV RNA ≥ LLOQ at the last available on-treatment measurement with no subsequent follow-up values
Time frame: Up to Posttreatment Weak 12
Percentage of Participants Experiencing Viral Relapse
Viral relapse was defined as HCV RNA ≥ LLOQ during the posttreatment period after having achieved HCV RNA \< LLOQ at end of treatment.
Time frame: Up to Posttreatment Week 12
Number of Participants With Nonstructural Protein 5B (NS5B) Nucleoside Inhibitor (NI) Resistance-Associated Variants (RAVs) and RBV RAVs at Pretreatment and Posttreatment
Deep sequencing of the HCV NS5B gene was attempted for all participants who had virologic failure at pretreatment and posttreatment time points if the level of HCV RNA in the plasma sample was ≥ 1000 IU/L.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Unnamed facility
San Diego, California, United States
Unnamed facility
San Francisco, California, United States
Unnamed facility
New Haven, Connecticut, United States
Unnamed facility
Miami, Florida, United States
Unnamed facility
Decatur, Georgia, United States
Unnamed facility
Baltimore, Maryland, United States
Unnamed facility
Kansas City, Missouri, United States
...and 7 more locations
Time frame: Pretreatment and Posttreatment Week 12