Phase 3
Completed N=341
Efficacy and Safety of Sofosbuvir/Ledipasvir ± Ribavirin in Japanese Participants With Chronic Genotype 1 HCV Infection
Chronic HCV Infection
Source: ClinicalTrials.gov NCT01975675 ↗
Enrolled (actual)
341
Serious AEs
1.5%
Results posted
Jun 2015
Primary outcomePrimary: Percentage of Participants With Sustained Virologic Response (SVR) at 12 Weeks After Discontinuation of Therapy (SVR12), Treatment-naive, Noncirrhotic Participants — 100.0; 97.2 percentage of participants — p=< 0.001
Summary
This study will evaluate the antiviral efficacy of sofosbuvir (SOF)/ledipasvir (LDV) fixed-dose combination (FDC) tablet with or without ribavirin (RBV) in treatment-naive or treatment-experienced Japanese participants with chronic genotype 1 HCV infection. Participants receive 12 weeks of treatment and continue assessments during a 24-week posttreatment follow-up period.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Sustained Virologic Response (SVR) at 12 Weeks After Discontinuation of Therapy (SVR12), Treatment-naive, Noncirrhotic Participants |
100.0; 97.2 | < 0.001 sig |
| PRIMARY Percentage of Participants With Sustained Virologic Response at 12 Weeks After Discontinuation of Therapy (SVR12) |
100.0; 96.4; 100.0; 100.0 | — |
| PRIMARY Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event |
0; 1.8 | — |
| SECONDARY Percentage of Participants With Sustained Virologic Response at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24) |
100.0; 96.4; 100.0; 100.0; 100.0; 96.4 | — |
| SECONDARY Percentage of Participants Experiencing Virologic Failure |
0; 0; 0; 0; 0; 1.2 | — |
Eligibility Criteria
Inclusion Criteria
- Body weight ≥ 40 kg
- HCV RNA ≥ 10^5 IU/mL at screening
Exclusion Criteria
- Current or prior history of any clinically-significant illness (other than HCV)
- Pregnant or nursing female or male with pregnant female partner
- Chronic liver disease of a non-HCV etiology
- Infection with hepatitis B virus (HBV) or human immunodeficiency virus (HIV)
Data sourced from ClinicalTrials.gov (NCT01975675). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.