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: May 14, 2014
Last verified: May 2014
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: May 14, 2014
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 August 19, 2014