Safety and Efficacy of Sofosbuvir Plus GS-5816 With or Without Ribavirin in Treatment-naive Subjects With Chronic HCV Infection

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences
ClinicalTrials.gov Identifier:
NCT01858766
First received: May 10, 2013
Last updated: November 7, 2013
Last verified: November 2013
  Purpose

This study will evaluate the antiviral efficacy, safety, and tolerability of sofosbuvir (SOF)+GS-5816 with or without ribavirin (RBV) in treatment-naive participants with chronic genotype (GT) 1, 2, 3, 4, 5, or 6 hepatitis C virus (HCV) infection.


Condition Intervention Phase
Hepatitis C
Drug: SOF
Drug: GS-5816
Drug: RBV
Phase 2

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 2, Multicenter, Randomized, Open-label Study to Investigate the Safety and Efficacy of Sofosbuvir+ GS-5816 for 12 Weeks in Treatment-naive Subjects With Chronic 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 12 weeks after discontinuation of therapy (SVR12) [ Time Frame: Post-treatment Week 12 ] [ Designated as safety issue: No ]
    SVR12 is defined as HCV RNA < the lower limit of quantitation (LLOQ < 25 IU/mL) 12 weeks following the last dose of study medication.

  • Incidence of adverse events leading to permanent discontinuation of study drug [ Time Frame: Baseline to Week 12 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Proportion of participants with sustained virologic response (SVR) at 4 and 24 weeks after discontinuation of therapy (SVR4 and SVR24) [ Time Frame: Post-treatment Weeks 4 and 24 ] [ Designated as safety issue: No ]
    SVR4 and SVR24 is defined as HCV RNA < LLOQ at 4 and 24 weeks following the last dose of study medication, respectively.

  • Proportion of participants with virologic failure [ Time Frame: Baseline to post-treatment Week 24 ] [ Designated as safety issue: No ]
    Virologic failure is defined as virologic breakthrough (participant achieved undetectable HCV RNA levels during treatment but subsequently had detectable HCV RNA while continuing treatment), non-response (HCV RNA ≥ LLOQ while on treatment), or relapse (participant achieved undetectable HCV RNA levels during treatment maintained undetectable HCV RNA for the duration of treatment or achieved undetectable HCV RNA within 4 weeks of the end of treatment but did not achieve SVR at 4, 12, or 24 weeks post-treatment).


Estimated Enrollment: 340
Study Start Date: May 2013
Estimated Study Completion Date: November 2014
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: SOF+GS-5816 25 mg (GT1)
Participants with genotype 1 HCV infection will receive SOF+GS-5816 25 mg for 12 weeks.
Drug: SOF
SOF 400 mg tablet administered orally once daily
Other Names:
  • GS-7977
  • PSI-7977
Drug: GS-5816
GS-5816 25 mg or 100 mg tablet administered orally once daily
Experimental: SOF+GS-5816 100 mg (GT1)
Participants with genotype 1 HCV infection will receive SOF+GS-5816 100 mg for 12 weeks.
Drug: SOF
SOF 400 mg tablet administered orally once daily
Other Names:
  • GS-7977
  • PSI-7977
Drug: GS-5816
GS-5816 25 mg or 100 mg tablet administered orally once daily
Experimental: SOF+GS-5816 25 mg (GT3)
Participants with genotype 3 HCV infection will receive SOF+GS-5816 25 mg for 12 weeks.
Drug: SOF
SOF 400 mg tablet administered orally once daily
Other Names:
  • GS-7977
  • PSI-7977
Drug: GS-5816
GS-5816 25 mg or 100 mg tablet administered orally once daily
Experimental: SOF+GS-5816 25 mg (GT2/4/5/6)
Participants with genotype 2, 4, 5, or 6 HCV infection will receive SOF+GS-5816 25 mg for 12 weeks.
Drug: SOF
SOF 400 mg tablet administered orally once daily
Other Names:
  • GS-7977
  • PSI-7977
Drug: GS-5816
GS-5816 25 mg or 100 mg tablet administered orally once daily
Experimental: SOF+GS-5816 100 mg (GT2/4/5/6)
Participants with genotype 2, 4, 5, or 6 HCV infection will receive SOF+GS-5816 100 mg for 12 weeks.
Drug: SOF
SOF 400 mg tablet administered orally once daily
Other Names:
  • GS-7977
  • PSI-7977
Drug: GS-5816
GS-5816 25 mg or 100 mg tablet administered orally once daily
Experimental: SOF+GS-5816 25 mg (GT1) 8 weeks
Participants with genotype 1 HCV infection will receive SOF+GS-5816 25 mg for 8 weeks.
Drug: SOF
SOF 400 mg tablet administered orally once daily
Other Names:
  • GS-7977
  • PSI-7977
Drug: GS-5816
GS-5816 25 mg or 100 mg tablet administered orally once daily
Experimental: SOF+GS-5816 25 mg+RBV (GT1)
Participants with genotype 1 HCV infection will receive SOF+GS-5816 25 mg plus RBV for 8 weeks.
Drug: SOF
SOF 400 mg tablet administered orally once daily
Other Names:
  • GS-7977
  • PSI-7977
Drug: GS-5816
GS-5816 25 mg or 100 mg tablet administered orally once daily
Drug: RBV
Ribavirin (RBV) 200 mg tablets administered orally in a divided daily dose according to package insert weight-based dosing recommendations (< 75 kg = 1000 mg and ≥ 75 kg = 1200 mg)
Other Name: Ribasphere®
Experimental: SOF+GS-5816 100 mg (GT1) 8 weeks
Participants with genotype 1 HCV infection will receive SOF+GS-5816 100 mg for 8 weeks.
Drug: SOF
SOF 400 mg tablet administered orally once daily
Other Names:
  • GS-7977
  • PSI-7977
Drug: GS-5816
GS-5816 25 mg or 100 mg tablet administered orally once daily
Experimental: SOF+GS-5816 100 mg+RBV (GT1)
Participants with genotype 1 HCV infection will receive SOF+GS-5816 100 mg plus RBV for 8 weeks.
Drug: SOF
SOF 400 mg tablet administered orally once daily
Other Names:
  • GS-7977
  • PSI-7977
Drug: GS-5816
GS-5816 25 mg or 100 mg tablet administered orally once daily
Drug: RBV
Ribavirin (RBV) 200 mg tablets administered orally in a divided daily dose according to package insert weight-based dosing recommendations (< 75 kg = 1000 mg and ≥ 75 kg = 1200 mg)
Other Name: Ribasphere®
Experimental: SOF+GS-5816 25 mg (GT2)
Participants with genotype 2 HCV infection will receive SOF+GS-5816 25 mg for 8 weeks.
Drug: SOF
SOF 400 mg tablet administered orally once daily
Other Names:
  • GS-7977
  • PSI-7977
Drug: GS-5816
GS-5816 25 mg or 100 mg tablet administered orally once daily
Experimental: SOF+GS-5816 25 mg+RBV (GT2)
Participants with genotype 2 HCV infection will receive SOF+GS-5816 25 mg plus RBV for 8 weeks.
Drug: SOF
SOF 400 mg tablet administered orally once daily
Other Names:
  • GS-7977
  • PSI-7977
Drug: GS-5816
GS-5816 25 mg or 100 mg tablet administered orally once daily
Drug: RBV
Ribavirin (RBV) 200 mg tablets administered orally in a divided daily dose according to package insert weight-based dosing recommendations (< 75 kg = 1000 mg and ≥ 75 kg = 1200 mg)
Other Name: Ribasphere®
Experimental: SOF+GS-5816 100 mg (GT2)
Participants with genotype 2 HCV infection will receive SOF+GS-5816 100 mg for 8 weeks.
Drug: SOF
SOF 400 mg tablet administered orally once daily
Other Names:
  • GS-7977
  • PSI-7977
Drug: GS-5816
GS-5816 25 mg or 100 mg tablet administered orally once daily
Experimental: SOF+GS-5816 100 mg+RBV (GT2)
Participants with genotype 2 HCV infection will receive SOF+GS-5816 100 mg plus RBV for 8 weeks.
Drug: SOF
SOF 400 mg tablet administered orally once daily
Other Names:
  • GS-7977
  • PSI-7977
Drug: GS-5816
GS-5816 25 mg or 100 mg tablet administered orally once daily
Drug: RBV
Ribavirin (RBV) 200 mg tablets administered orally in a divided daily dose according to package insert weight-based dosing recommendations (< 75 kg = 1000 mg and ≥ 75 kg = 1200 mg)
Other Name: Ribasphere®
Experimental: SOF+GS-5816 100 mg (GT3)
Participants with genotype 3 HCV infection will receive SOF+GS-5816 100 mg for 12 weeks.
Drug: SOF
SOF 400 mg tablet administered orally once daily
Other Names:
  • GS-7977
  • PSI-7977
Drug: GS-5816
GS-5816 25 mg or 100 mg tablet administered orally once daily

  Eligibility

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

Inclusion Criteria:

  • Chronic HCV infection
  • Male or female, age ≥ 18 years
  • Body mass index (BMI) ≥ 18 kg/m2
  • HCV RNA ≥ 10000 IU/mL at Screening
  • Use of highly effective contraception methods if female of childbearing potential or sexually active male
  • Subject must not have cirrhosis

Exclusion Criteria

  • Current or prior history of clinically significant illness other than HCV
  • Screening ECG with clinically significant abnormalities
  • Prior exposure to HCV specific direct acting antiviral agent
  • Prior treatment of HCV with interferon or ribavirin
  • Pregnant or nursing female or male with pregnant female partner
  • Chronic liver disease of non-HCV etiology
  • Hep B
  • Active drug abuse
  • Use of any prohibited concomitant medications
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01858766

  Show 51 Study Locations
Sponsors and Collaborators
Gilead Sciences
Investigators
Study Director: John McNally, PhD Gilead Sciences
  More Information

No publications provided

Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT01858766     History of Changes
Other Study ID Numbers: GS-US-342-0102
Study First Received: May 10, 2013
Last Updated: November 7, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Gilead Sciences:
Hepatitis
HCV Genotype 1
HCV Genotype 3
treatment naive
HCV Genotype 2
HCV Genotype 4
HCV Genotype 5
HCV Genotype 6

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis C
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections

ClinicalTrials.gov processed this record on April 15, 2014