This study will evaluate the efficacy, safety, and tolerability of sofosbuvir (SOF; GS-7977) plus ribavirin (RBV) in adults with chronic genotypes 1, 2, and 3 HCV infection who are coinfected with HIV-1.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
224
Unnamed facility
Birmingham, Alabama, United States
Unnamed facility
Coronado, California, United States
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) at 12 weeks after stopping study treatment.
Time frame: Posttreatment Week 12
Incidence of Adverse Events Leading to Permanent Discontinuation of Study Drug(s)
The percentage of participants 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 \< LLOQ at 4 and 24 weeks following the last dose of study drug, respectively.
Time frame: Posttreatment Weeks 4 and 24
Change From Baseline in HCV RNA at Week 1
Time frame: Baseline; Week 1
Change From Baseline in HCV RNA at Week 2
Time frame: Baseline; Week 2
Change From Baseline in HCV RNA at Week 4
Time frame: Baseline; Week 4
Change From Baseline in HCV RNA at Week 6
Time frame: Baseline; Week 6
Change From Baseline in HCV RNA at Week 8
Time frame: Baseline; Week 8
Percentage of Participants Experiencing On-treatment Virologic Failure
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Unnamed facility
Los Angeles, California, United States
Unnamed facility
Lutherville, California, United States
Unnamed facility
Oakland, California, United States
Unnamed facility
Sacramento, California, United States
Unnamed facility
San Francisco, California, United States
Unnamed facility
Torrance, California, United States
Unnamed facility
Washington D.C., District of Columbia, United States
Unnamed facility
Miami, Florida, United States
...and 17 more locations
On-treatment virologic failure was defined as: 1. Viral breakthrough: HCV RNA ≥ LLOQ after having previously had HCV RNA \< LLOQ while on treatment, confirmed with 2 consecutive values (second confirmation value may have been posttreatment) or with a last available on-treatment measurement and no subsequent follow-up values, or 2. Viral rebound: \> 1 log10 IU/mL increase in HCV RNA from nadir while on treatment, confirmed with 2 consecutive values (second confirmation value may have been posttreatment) or with a last available on-treatment measurement and no subsequent follow-up values, or 3. Nonresponse: HCV RNA persistently ≥ LLOQ through 8 weeks of treatment
Time frame: Up to 24 weeks
Percentage of Participants Experiencing Viral Relapse
Viral relapse was defined as having achieved undetectable HCV RNA levels (HCV RNA \< LLOQ) at end of treatment, but did not achieve an SVR.
Time frame: Up to Posttreatment Week 24