Phase 3
Completed N=384
Efficacy and Safety of Ledipasvir/Sofosbuvir Fixed-Dose Combination in Participants With Chronic Genotype 1 HCV Infection
Chronic HCV Infection
Source: ClinicalTrials.gov NCT02021656 ↗
Enrolled (actual)
384
Serious AEs
1.8%
Results posted
Dec 2018
Primary outcomePrimary: Percentage of Participants With Sustained Virologic Response 12 Weeks After Discontinuation of Therapy (SVR12) — 100.0; 99.2 Percentage of participants — p=<0.001
◆ Published Evidence
Established
27citations · ~3 / year
Ledipasvir/sofosbuvir fixed-dose combination tablet in Taiwanese patients with chronic genotype 1 hepatitis C virus.
Summary
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.
Linked Publications (2)
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Ledipasvir/sofosbuvir fixed-dose combination tablet in Taiwanese patients with chronic genotype 1 hepatitis C virus.
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A phase IIIb study of ledipasvir/sofosbuvir fixed-dose combination tablet in treatment-naïve and treatment-experienced Korean patients chronically infected with genotype 1 hepatitis C virus.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Sustained Virologic Response 12 Weeks After Discontinuation of Therapy (SVR12) |
100.0; 99.2 | <0.001 sig |
| PRIMARY Percentage of Participants Who Permanently Discontinued Study Drug Due to an Adverse Event |
0; 0.5 | — |
| SECONDARY Percentage of Participants With Sustained Virologic Response at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24) |
100.0; 99.2; 100.0; 99.0 | — |
| SECONDARY Percentage of Participants Experiencing Viral Breakthrough |
0; 0 | — |
| SECONDARY Percentage of Participants Experiencing Viral Relapse |
0; 0.5 | — |
| SECONDARY HCV RNA and Change From Baseline in HCV RNA Through Week 12 for China Only |
6.31; -5.16 | — |
Eligibility Criteria
Key Inclusion Criteria
- Willing and able to provide written informed consent
- HCV RNA ≥ 10^4 IU/mL at screening
- HCV treatment-naive, as defined as no prior exposure to any interferon (IFN) or other approved or experimental HCV-specific direct-acting antiviral agent; OR HCV treatment-experienced with medical records that include sufficient detail of prior IFN-based treatment to allow for categorization of prior response as either intolerant, non-responder, or experienced viral breakthrough or relapse.
- Genotype 1 HCV at screening
- HCV infection documented by anti-HCV antibody test, genotyping test, or liver biopsy
Key Exclusion Criteria
- Pregnant or nursing female
- Chronic liver disease of a non-HCV etiology
- Current or prior history of any clinically-significant illness (other than HCV)
- Infection with hepatitis B virus (HBV) or human immunodeficiency virus (HIV)
NOTE: Other protocol defined Inclusion/ Exclusion criteria may apply.
Data sourced from ClinicalTrials.gov (NCT02021656) and the linked publication. 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.