Sofosbuvir With Pegylated Interferon and Ribavirin Hepatitis C Virus (HCV) Genotypes 1,4,5,6 (ATOMIC)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences
ClinicalTrials.gov Identifier:
NCT01329978
First received: March 30, 2011
Last updated: August 27, 2013
Last verified: August 2013
  Purpose

The purpose of this study is to assess the safety, tolerability, and efficacy of sofosbuvir (GS-7977; PSI-7977) administered in combination with pegylated interferon and ribavirin (PEG/RBV) in treatment naive patients with HCV genotypes 1,4,5,6, or indeterminate genotype.


Condition Intervention Phase
Hepatitis C, Chronic
Drug: Sofosbuvir
Drug: RBV
Drug: PEG
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: The ATOMIC Study: A Multicenter, Open-label, Randomized, Duration Finding Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics Following Oral Administration of PSI-7977 in Combination With Pegylated Interferon and Ribavirin in Treatment-Naive Patients With Chronic HCV Infection Genotype 1,4, 5, or 6

Resource links provided by NLM:


Further study details as provided by Gilead Sciences:

Primary Outcome Measures:
  • Number of participants with adverse events as a measure of safety and tolerability [ Time Frame: 12 or 24 weeks ] [ Designated as safety issue: Yes ]
    To assess the safety of sofosbuvir in combination with PEG/RBV for 12 or 24 weeks of treatment

  • Efficacy of sofosbuvir in subjects treated for 12 or 24 weeks [ Time Frame: 12 or 24 weeks ] [ Designated as safety issue: No ]
    To assess the efficacy of sofosbuvir with PEG/RBV for 12 or 24 weeks of treatment as measured by HCV RNA levels of detection.


Secondary Outcome Measures:
  • Change in circulating HCV ribonucleic acid (RNA) [ Time Frame: 12 or 24 weeks ] [ Designated as safety issue: No ]
    To assess the change in circulating HCV RNA in patients over 12 or 24 weeks of dosing.

  • Number of participants with Sustained Viral Response (SVR) post-treatment [ Time Frame: Week 12 or Week 24 ] [ Designated as safety issue: No ]
    To assess the SVR at Week 12 or Week 24 after treatment.


Enrollment: 332
Study Start Date: March 2011
Study Completion Date: August 2012
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 12 Weeks sofosbuvir with PEG/RBV
12 weeks of sofosbuvir in combination with PEG/RBV
Drug: Sofosbuvir
Sofosbuvir administered as a 400 mg tablet orally once daily
Other Names:
  • GS-7977
  • PSI-7977
Drug: RBV
Ribavirin (RBV) tablets administered orally in a divided daily dose according to package insert weight-based dosing recommendations (< 75kg = 1000 mg and ≥ 75 kg = 1200 mg)
Other Name: Copegus®
Drug: PEG
Pegylated interferon alfa-2a (PEG) 180 μg administered once weekly by subcutaneous injection
Other Name: Pegasys®
Experimental: 24 Weeks sofosbuvir with PEG/RBV
24 weeks of sofosbuvir in combination with PEG/RBV
Drug: Sofosbuvir
Sofosbuvir administered as a 400 mg tablet orally once daily
Other Names:
  • GS-7977
  • PSI-7977
Drug: RBV
Ribavirin (RBV) tablets administered orally in a divided daily dose according to package insert weight-based dosing recommendations (< 75kg = 1000 mg and ≥ 75 kg = 1200 mg)
Other Name: Copegus®
Drug: PEG
Pegylated interferon alfa-2a (PEG) 180 μg administered once weekly by subcutaneous injection
Other Name: Pegasys®
Experimental: Sofosbuvir with PEG/RBV
12 Weeks of sofosbuvir in combination with PEG/RBV; subjects are re-randomized at Week 12 to either sofosbuvir monotherapy or sofosbuvir with RBV
Drug: Sofosbuvir
Sofosbuvir administered as a 400 mg tablet orally once daily
Other Names:
  • GS-7977
  • PSI-7977
Drug: RBV
Ribavirin (RBV) tablets administered orally in a divided daily dose according to package insert weight-based dosing recommendations (< 75kg = 1000 mg and ≥ 75 kg = 1200 mg)
Other Name: Copegus®
Drug: PEG
Pegylated interferon alfa-2a (PEG) 180 μg administered once weekly by subcutaneous injection
Other Name: Pegasys®

  Eligibility

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

Inclusion Criteria:

  • Males and females with Chronic Hepatitis C (HCV) Genotype 1,4,5,6, or indeterminate
  • Naive to previous HCV treatment

Exclusion Criteria:

  • Positive for HBsAg, anti-HBc IgM Ab, or anti-HIV Ab
  • History of any other clinically significant chronic liver disease
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01329978

  Show 46 Study Locations
Sponsors and Collaborators
Gilead Sciences
Investigators
Study Director: Bob Hindes Gilead Sciences
  More Information

No publications provided by Gilead Sciences

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT01329978     History of Changes
Other Study ID Numbers: P7977-0724
Study First Received: March 30, 2011
Last Updated: August 27, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Gilead Sciences:
Hepatitis C
HCV
Chronic Hepatitis C

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

ClinicalTrials.gov processed this record on April 16, 2014