The primary objectives of this study are to evaluate the efficacy, safety, and tolerability of treatment with ledipasvir/sofosbuvir (LDV/SOF) fixed-dose combination (FDC) in treatment-naive and treatment-experienced participants with chronic genotype 1 hepatitis C virus (HCV) infection.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
384
90/400 mg FDC tablet administered orally once daily without regard to food
Percentage of Participants With Sustained Virologic Response 12 Weeks After Discontinuation of Therapy (SVR12)
SVR12 was defined as HCV RNA \< the lower limit of quantitation (LLOQ; ie, \< 25 IU/mL in Korea and Taiwan and \< 15 IU/mL in China) 12 weeks following the last dose of study drug.
Time frame: Posttreatment Week 12
Percentage of Participants Who Permanently Discontinued Study Drug Due to an Adverse Event
Time frame: Up to 12 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
Percentage of Participants Experiencing Viral Breakthrough
Viral breakthrough were defined as having achieved undetectable HCV RNA levels (HCV RNA \< LLOQ) during treatment, but did not achieve a sustained virologic response (SVR).
Time frame: Up to 12 weeks
Percentage of Participants Experiencing Viral Relapse
Viral relapse is defined as having achieved undetectable HCV RNA levels (HCV RNA \< LLOQ) within 4 weeks of end of treatment, but did not achieve an SVR.
Time frame: Week 12 to Posttreatment Week 24
HCV RNA and Change From Baseline in HCV RNA Through Week 12 for China Only
Time frame: Baseline; Week 12
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Unnamed facility
Beijing, China
Unnamed facility
Beijing, China
Unnamed facility
Beijing, China
Unnamed facility
Beijing, China
Unnamed facility
Beijing, China
Unnamed facility
Chongqing, China
Unnamed facility
Guangdong, China
Unnamed facility
Guangxi, China
Unnamed facility
Hubei, China
Unnamed facility
Hunan, China
...and 35 more locations