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Safety and Efficacy of Sofosbuvir/GS-5885 Fixed-Dose Combination (FDC) +/-Ribavirin for the Treatment of HCV

This study is currently recruiting participants.
Verified May 2013 by Gilead Sciences
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences
ClinicalTrials.gov Identifier:
NCT01701401
First received: October 2, 2012
Last updated: May 21, 2013
Last verified: May 2013
History of Changes
  Purpose

The purpose of this study is to evaluate the safety, tolerability and antiviral efficacy of sofosbuvir/GS-5885 (FDC) with or without 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: Sofosbuvir/GS-5885 400/90 mg
Drug: Ribavirin
 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:

Drug Information available for: Ribavirin
U.S. FDA Resources

Further study details as provided by Gilead Sciences:

Primary Outcome Measures:
  • Sustained virologic response after discontinuation of therapy. [ Time Frame: 12 weeks after discontinuation of therapy. ] [ Designated as safety issue: No ]
    Sustained virologic response (SVR) 12 weeks after the end of treatment (SVR12 defined as HCV RNA < lower limit of quantification [LLOQ] 12 weeks after last dose of study drug).

  • Safety and tolerability of combination treatment with sofosbuvir (SOF)/GS-5885 fixed-dose combination (FDC) +/- RBV as measured by review of the accumulated safety data. [ Time Frame: Safety and tolerability on treatment and 30 days post last dose. ] [ Designated as safety issue: Yes ]
    Frequency and severity of adverse events.


Secondary Outcome Measures:
  • Sustained virologic response after discontinuation of therapy. [ Time Frame: 4 and 24 weeks after discontinuation of therapy. ] [ Designated as safety issue: No ]
    Sustained virologic response (SVR) at 4 and 24 weeks after discontinuation of therapy (SVR4 and SVR24 defined as HCV RNA < lower limit of quantification [LLOQ] 12 weeks after last dose of study drug).

  • Kinetics of circulating HCV RNA during and after treatment discontinuation. [ Time Frame: 12 and 24 weeks ] [ Designated as safety issue: No ]
    To evaluate the kinetics of circulating HCV RNA during treatment and after treatment discontinuation.

  • Viral resistance to sofosbuvir and GS-5885 combination therapy during and after treatment. [ Time Frame: 12 and 24 weeks ] [ Designated as safety issue: No ]
    To evaluate the emergence of viral resistance to sofosbuvir and GS-5885 during treatment and after treatment discontinuation.

  • Characterization of steady state pharmacokinetics of sofosbuvir and GS-5885 during treatment and after treatment discontinuation. [ Time Frame: 12 and 24 weeks. ] [ Designated as safety issue: No ]
    To characterize steady state pharmacokinetics of sofosbuvir and GS-5885 during treatment and after treatment discontinuation.


Estimated Enrollment: 800
Study Start Date: October 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: Sofosbuvir/GS-5885 (FDC Tablet) for 24 weeks Drug: Sofosbuvir/GS-5885 400/90 mg
FDC tablet (SOF 400 mg/GS-5885 90 mg) once daily
Other Name: Sofosbuvir is also known as GS-7977 or PSI-7977.
Experimental: Sofosbuvir/GS-5885 (FDC Tablet) + Ribavirin for 24 weeks Drug: Sofosbuvir/GS-5885 400/90 mg
FDC tablet (SOF 400 mg/GS-5885 90 mg) once daily
Other Name: Sofosbuvir is also known as GS-7977 or PSI-7977.
Drug: Ribavirin
RBV (1000 or 1200 mg/day divided BID)
Experimental: Sofosbuvir/GS-5885 (FDC Tablet) for 12 weeks Drug: Sofosbuvir/GS-5885 400/90 mg
FDC tablet (SOF 400 mg/GS-5885 90 mg) once daily
Other Name: Sofosbuvir is also known as GS-7977 or PSI-7977.
Experimental: Sofosbuvir/GS-5885 (FDC Tablet) + Ribavirin for 12 weeks Drug: Sofosbuvir/GS-5885 400/90 mg
FDC tablet (SOF 400 mg/GS-5885 90 mg) once daily
Other Name: Sofosbuvir is also known as GS-7977 or PSI-7977.
Drug: Ribavirin
RBV (1000 or 1200 mg/day divided BID)

  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

Contacts
Contact: Paul Chang, MPH 337-0102alerts@gilead.com

  Show 88 Study Locations
Sponsors and Collaborators
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: May 21, 2013
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: L’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 May 23, 2013