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

March 30, 2011
August 27, 2013
March 2011
August 2012   (final data collection date for primary outcome measure)
  • 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.
  • 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 PSI-7977 in combination with PEG/RBV for 12 or 24 weeks of treatment
  • Efficacy of PSI-7977 in subjects treated for 12 or 24 weeks [ Time Frame: 12 or 24 weeks ] [ Designated as safety issue: No ]
    To assess the efficacy of PSI-7977 with PEG/RBV for 12 or 24 weeks of treatment as measured by HCV RNA levels of detection.
Complete list of historical versions of study NCT01329978 on ClinicalTrials.gov Archive Site
  • 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.
Same as current
Not Provided
Not Provided
 
Sofosbuvir With Pegylated Interferon and Ribavirin Hepatitis C Virus (HCV) Genotypes 1,4,5,6
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

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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Hepatitis C, Chronic
  • 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: 12 Weeks sofosbuvir with PEG/RBV
    12 weeks of sofosbuvir in combination with PEG/RBV
    Interventions:
    • Drug: Sofosbuvir
    • Drug: RBV
    • Drug: PEG
  • Experimental: 24 Weeks sofosbuvir with PEG/RBV
    24 weeks of sofosbuvir in combination with PEG/RBV
    Interventions:
    • Drug: Sofosbuvir
    • Drug: RBV
    • Drug: PEG
  • 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
    Interventions:
    • Drug: Sofosbuvir
    • Drug: RBV
    • Drug: PEG
Kowdley KV, Lawitz E, Crespo I, Hassanein T, Davis MN, DeMicco M, Bernstein DE, Afdhal N, Vierling JM, Gordon SC, Anderson JK, Hyland RH, Dvory-Sobol H, An D, Hindes RG, Albanis E, Symonds WT, Berrey MM, Nelson DR, Jacobson IM. Sofosbuvir with pegylated interferon alfa-2a and ribavirin for treatment-naive patients with hepatitis C genotype-1 infection (ATOMIC): an open-label, randomised, multicentre phase 2 trial. Lancet. 2013 Jun 15;381(9883):2100-7. doi: 10.1016/S0140-6736(13)60247-0. Epub 2013 Mar 15.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
332
August 2012
August 2012   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Puerto Rico
 
NCT01329978
P7977-0724
No
Gilead Sciences
Gilead Sciences
Not Provided
Study Director: Bob Hindes Gilead Sciences
Gilead Sciences
August 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP