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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: April 24, 2014
Last verified: April 2014

March 30, 2011
April 24, 2014
March 2011
August 2012   (final data collection date for primary outcome measure)
  • Percentage of Participants With Sustained Virologic Response 24 Weeks Following Completion of Treatment (SVR24) [ Time Frame: Post-treatment Week 24 ] [ Designated as safety issue: No ]
    SVR24 was defined as HCV RNA < the limit of detection (LOD; < 15 IU/mL) 24 weeks after the last dose of study drug.
  • Percentage of Participants Who Experienced Adverse Events [ Time Frame: Baseline (Day 1) to post-treatment Day 30 ] [ Designated as safety issue: Yes ]
    Adverse events (AEs) occurring from baseline (Day 1 for all groups) to 30 days following the last dose of study drug were summarized across the participant population. A participant was counted once if they had a qualifying event.
  • 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
  • Percentage of Participants With Sustained Virologic Response 12 Weeks Following Completion of Treatment (SVR12) [ Time Frame: Post-treatment Week 12 ] [ Designated as safety issue: No ]
    SVR12 was defined as HCV RNA < LOD 12 weeks after the last dose of study drug.
  • Change in HCV RNA at Week 2 [ Time Frame: Baseline (Day 1) to Week 2 ] [ Designated as safety issue: No ]
  • Change in HCV RNA at Week 4 [ Time Frame: Baseline (Day 1) to Week 4 ] [ Designated as safety issue: No ]
  • Change in HCV RNA at Week 8 [ Time Frame: Baseline (Day 1) to Week 8 ] [ Designated as safety issue: No ]
  • Change in HCV RNA at Week 12 [ Time Frame: Baseline (Day 1) to Week 12 ] [ Designated as safety issue: No ]
  • Percentage of Participants With HCV RNA < LOD at Week 2 [ Time Frame: Week 2 ] [ Designated as safety issue: No ]
  • Percentage of Participants With HCV RNA Below < LOD at Week 4 [ Time Frame: Week 4 ] [ Designated as safety issue: No ]
  • Percentage of Participants With HCV RNA Below < LOD at Week 8 [ Time Frame: Week 8 ] [ Designated as safety issue: No ]
  • Percentage of Participants With HCV RNA Below < LOD at Week 12 [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
  • Percentage of Participants With HCV RNA Below < LOD at Week 24 [ Time Frame: Week 24 ] [ Designated as safety issue: No ]
  • Percentage of Participants With ALT Normalization at Week 12 [ Time Frame: Baseline (Day 1) to Week 12 ] [ Designated as safety issue: No ]
    ALT normalization was defined as ALT > ULN at baseline and ALT ≤ ULN at Week 12.
  • Percentage of Participants With ALT Normalization at Week 24 [ Time Frame: Baseline (Day 1) to Week 24 ] [ Designated as safety issue: No ]
    ALT normalization was defined as ALT > ULN at baseline (Day 1 for all groups) and ALT ≤ ULN at Week 24.
  • Percentage of Participants With ALT Normalization at Post-treatment Week 4 [ Time Frame: Baseline (Day 1) to Post-treatment Week 4 ] [ Designated as safety issue: No ]
    ALT normalization was defined as ALT > ULN at baseline (Day 1 for all groups) and ALT ≤ ULN at Post-treatment Week 4.
  • Percentage of Participants With Virologic Failure During Treatment [ Time Frame: Baseline (Day 1) to Week 24 ] [ Designated as safety issue: No ]

    Virologic failure was defined as either

    • HCV RNA ≥ 15 IU/mL after having previously had HCV RNA < 15 IU/mL while on treatment, confirmed with 2 consecutive values or last available measurement (ie, breakthrough);
    • > 1 log10 IU/mL increase in HCV RNA from nadir while on treatment, confirmed with 2 consecutive values or last available measurement (ie, rebound);or
    • HCV RNA persistently ≥ 15 IU/mL through 8 weeks of treatment (ie, nonresponse)

    Baseline was Day 1 for all groups.

  • Percentage of Participants With Virologic Failure Following Treatment (Viral Relapse). [ Time Frame: End of treatment to Post-treatment Week 24 ] [ Designated as safety issue: No ]
    Viral relapse was defined as HCV RNA < 15 IU/mL at end of treatment, confirmed with 2 consecutive values or last available measurement.
  • 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.
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 (SOF) administered as a 400 mg tablet orally once daily
    Other Names:
    • Sovaldi®
    • 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: SOF+PEG+RBV 12 weeks
    Participants were randomized to receive sofosbuvir+PEG+RBV for 12 weeks.
    Interventions:
    • Drug: Sofosbuvir
    • Drug: RBV
    • Drug: PEG
  • Experimental: SOF+PEG+RBV 24 weeks
    Participants were randomized to receive sofosbuvir+PEG+RBV for 24 weeks.
    Interventions:
    • Drug: Sofosbuvir
    • Drug: RBV
    • Drug: PEG
  • Experimental: SOF+PEG+RBV 12 week/Rerandomization Group
    Participants were randomized to receive sofosbuvir+PEG+RBV for 12 weeks, then were rerandomized to receive sofosbuvir only or sofosbuvir+RBV for 12 additional weeks.
    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: Robert H. Hyland, DPhil Gilead Sciences
Gilead Sciences
April 2014

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