Safety and Efficacy of Sofosbuvir/Ledipasvir Fixed-Dose Combination (FDC) With and Without Ribavirin for the Treatment of HCV

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences
ClinicalTrials.gov Identifier:
NCT01701401
First received: October 2, 2012
Last updated: January 10, 2014
Last verified: January 2014
  Purpose

The purpose of this study is to evaluate the safety, tolerability and antiviral efficacy of sofosbuvir (SOF)/ledipasvir (LDV) fixed dose combination (FDC) tablets with or without ribavirin (RBV) administered for 12 and 24 weeks in treatment-naive subjects with chronic genotype 1 HCV infection.


Condition Intervention Phase
Chronic Hepatitis C Virus
Drug: SOF/LDV
Drug: RBV
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase 3, Multicenter, Randomized, Open-Label Study to Investigate the Efficacy and Safety of Sofosbuvir/GS-5885 Fixed-Dose Combination (FDC) +/- Ribavirin for 12 and 24 Weeks in Treatment-Naive Subjects With Chronic Genotype 1 HCV Infection.

Resource links provided by NLM:


Further study details as provided by Gilead Sciences:

Primary Outcome Measures:
  • Proportion of participants with sustained virologic response (SVR) 12 weeks after discontinuation of study drug [ Time Frame: Post-treatment Week 12 ] [ Designated as safety issue: No ]
    SVR12 is defined as HCV RNA level < the lower limit of quantification (LLOQ) 12 weeks after last dose of study drug.

  • Proportion of participants experiencing an adverse event leading to permanent discontinuation of study drug [ Time Frame: Up to 24 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Proportion of participants with SVR at 4 and 24 weeks after discontinuation of study drug [ Time Frame: Post-treatment Weeks 4 and 24 ] [ Designated as safety issue: No ]
    SVR4 and SVR24 are is defined as HCV RNA level < LLOQ at 4 and 24 weeks after discontinuation of study drug, respectively.

  • Proportion of participants with HCV RNA < LLOQ on treatment [ Time Frame: Up to 24 weeks ] [ Designated as safety issue: No ]
  • Change from baseline in HCV RNA [ Time Frame: Baseline to post-treatment Week 24 ] [ Designated as safety issue: No ]
  • Proportion of participants with virologic failure [ Time Frame: Up to post-treatment Week 24 ] [ Designated as safety issue: No ]
    Baseline to post-treatment Week 24


Estimated Enrollment: 800
Study Start Date: September 2012
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: SOF/LDV 24 weeks
Participants will receive SOF/LDV for 24 weeks
Drug: SOF/LDV
Sofosbuvir (SOF) 400 mg/ledipasvir (LDV) 90 mg fixed dose combination (FDC) tablet administered orally once daily
Other Names:
  • Sovaldi™
  • GS-7977
  • PSI-7977
  • GS-5885
Experimental: SOF/LDV+RBV 24 weeks
Participants will receive SOF/LDV+RBV for 24 weeks.
Drug: SOF/LDV
Sofosbuvir (SOF) 400 mg/ledipasvir (LDV) 90 mg fixed dose combination (FDC) tablet administered orally once daily
Other Names:
  • Sovaldi™
  • GS-7977
  • PSI-7977
  • GS-5885
Drug: RBV
Ribavirin (RBV) 1000 or 1200 mg administered orally in a divided daily dose
Experimental: SOF/LDV 12 weeks
Participants will receive SOF/LDV for 12 weeks
Drug: SOF/LDV
Sofosbuvir (SOF) 400 mg/ledipasvir (LDV) 90 mg fixed dose combination (FDC) tablet administered orally once daily
Other Names:
  • Sovaldi™
  • GS-7977
  • PSI-7977
  • GS-5885
Experimental: SOF/LDV+RBV 12 weeks
Participants will receive SOF/LDV+RBV for 12 weeks.
Drug: SOF/LDV
Sofosbuvir (SOF) 400 mg/ledipasvir (LDV) 90 mg fixed dose combination (FDC) tablet administered orally once daily
Other Names:
  • Sovaldi™
  • GS-7977
  • PSI-7977
  • GS-5885
Drug: RBV
Ribavirin (RBV) 1000 or 1200 mg administered orally in a divided daily dose

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age > 18, with chronic genotype 1 HCV infection
  • HCV treatment-naive
  • HCV RNA > 10,000 IU/mL at Screening
  • Cirrhosis determination; a liver biopsy may be required
  • Screening laboratory values within defined thresholds
  • Use of two effective contraception methods if female of childbearing potential or sexually active male

Exclusion Criteria:

  • Pregnant or nursing female or male with pregnant female partner
  • Co-infection with HIV or HBV
  • Current or prior history of clinical hepatic decompensation
  • Hepatocellular carcinoma (HCC) or other malignancy (with exception of certain resolved skin cancers)
  • Chronic use of systemic immunosuppressive agents
  • History of clinically significant illness or any other medical disorder that may interfere with subject treatment, assessment or compliance with the protocol
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01701401

  Show 88 Study Locations
Sponsors and Collaborators
Gilead Sciences
Investigators
Study Director: Jenny Yang, Pharm D Gilead Sciences
  More Information

No publications provided

Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT01701401     History of Changes
Other Study ID Numbers: GS-US-337-0102, 2012-003387-43
Study First Received: October 2, 2012
Last Updated: January 10, 2014
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board
Germany: Federal Institute for Drugs and Medical Devices
Spain: Agencia Española de Medicamentos y Productos Sanitarios
Italy: The Italian Medicines Agency
United Kingdom: Medicines and Healthcare Products Regulatory Agency
France: Agence Nationale de Sécurité du Médicament et des produits de santé

Keywords provided by Gilead Sciences:
HCV genotype 1 (GT-1)
HCV
Sustained Virologic Response
Direct Acting Antiviral
Combination Therapy
GS-7977
GS-5885
Ribavirin
Open Label
Sofosbuvir
Additional relevant MeSH terms:
Hepatitis
Hepatitis, Chronic
Hepatitis C
Hepatitis C, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antimetabolites
Molecular Mechanisms of Pharmacological Action

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis, Chronic
Hepatitis C
Hepatitis C, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Anti-Infective Agents
Ribavirin
Molecular Mechanisms of Pharmacological Action
Therapeutic Uses
Pharmacologic Actions
Antiviral Agents
Antimetabolites

ClinicalTrials.gov processed this record on April 17, 2014