This is an Open-label Phase 3 study in adults with chronic genotypes 1, 2, 3, and 4 HCV infection who are co-infected with HIV-1.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
275
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 (\< 75kg = 1000 mg and ≥ 75 kg = 1200 mg)
Unnamed facility
Darlinghurst, New South Wales, Australia
Unnamed facility
Sydney, New South Wales, Australia
Unnamed facility
Melbourne, Victoria, Australia
Percentage of Participants With Sustained Virologic Response (SVR) at 12 Weeks After Discontinuation of Therapy (SVR12)
SVR12 was defined as HCV RNA \< the lower limit of quantitation (LLOQ, ie, \< 25 IU/mL) 12 weeks following the last dose of study drug.
Time frame: Posttreatment Week 12
Incidence of Adverse Events Leading to Permanent Discontinuation of Study Drug(s)
The percentage of participants permanently discontinuing any study drug due to an adverse event was summarized.
Time frame: Up to 24 weeks
Percentage of Participants With Sustained Virologic Response at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)
SVR4 and SVR24 were defined as HCV RNA \< the lower limit of quantitation (LLOQ) 4 weeks and 24 weeks following the last dose of study drug, respectively.
Time frame: Posttreatment Weeks 4 and 24
HCV RNA Change From Baseline at Week 1
Time frame: Baseline; Week 1
HCV RNA Change From Baseline at Week 2
Time frame: Baseline; Week 2
HCV RNA Change From Baseline at Week 4
Time frame: Baseline; Week 4
HCV RNA Change From Baseline at Week 6
Time frame: Baseline; Week 6
HCV RNA Change From Baseline at Week 8
Time frame: Baseline; Week 8
Percentage of Participants Experiencing Virologic Failure
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Unnamed facility
Parkville, Victoria, Australia
Unnamed facility
Lyon, France
Unnamed facility
Nice, France
Unnamed facility
Paris, France
Unnamed facility
Berlin, Germany
Unnamed facility
Bonn, Germany
Unnamed facility
Düsseldorf, Germany
...and 14 more locations
On-treatment virologic failure was defined as either: * Virologic 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 * Nonresponse (HCV RNA persistently ≥ LLOQ through 8 weeks of treatment). Virologic relapse was defined as confirmed HCV RNA ≥ LLOQ during the posttreatment period, having achieved HCV RNA \< LLOQ at last on-treatment visit."
Time frame: Baseline up to Posttreatment Week 24