Sofosbuvir With Pegylated Interferon and Ribavirin Hepatitis C Virus (HCV) Genotypes 1,4,5,6
ATOMIC
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
1 other identifier
interventional
332
2 countries
46
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Mar 2011
Shorter than P25 for phase_2
46 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2011
CompletedFirst Submitted
Initial submission to the registry
March 30, 2011
CompletedFirst Posted
Study publicly available on registry
April 6, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2012
CompletedResults Posted
Study results publicly available
May 26, 2014
CompletedMay 26, 2014
April 1, 2014
1.4 years
March 30, 2011
January 6, 2014
April 24, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Percentage of Participants With Sustained Virologic Response 24 Weeks Following Completion of Treatment (SVR24)
SVR24 was defined as HCV RNA \< the limit of detection (LOD; \< 15 IU/mL) 24 weeks after the last dose of study drug.
Post-treatment Week 24
Percentage of Participants Who Experienced Adverse Events
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.
Baseline (Day 1) to post-treatment Day 30
Secondary Outcomes (15)
Percentage of Participants With Sustained Virologic Response 12 Weeks Following Completion of Treatment (SVR12)
Post-treatment Week 12
Change in HCV RNA at Week 2
Baseline (Day 1) to Week 2
Change in HCV RNA at Week 4
Baseline (Day 1) to Week 4
Change in HCV RNA at Week 8
Baseline (Day 1) to Week 8
Change in HCV RNA at Week 12
Baseline (Day 1) to Week 12
- +10 more secondary outcomes
Study Arms (3)
SOF+PEG+RBV 12 weeks
EXPERIMENTALParticipants were randomized to receive sofosbuvir+PEG+RBV for 12 weeks.
SOF+PEG+RBV 24 weeks
EXPERIMENTALParticipants were randomized to receive sofosbuvir+PEG+RBV for 24 weeks.
SOF+PEG+RBV 12 week/Rerandomization Group
EXPERIMENTALParticipants 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
Sofosbuvir (SOF) administered as a 400 mg tablet orally once daily
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)
Pegylated interferon alfa-2a (PEG) 180 μg administered once weekly by subcutaneous injection
Eligibility Criteria
You may qualify if:
- Males and females with Chronic Hepatitis C (HCV) Genotype 1,4,5,6, or indeterminate
- Naive to previous HCV treatment
You may not qualify if:
- Positive for HBsAg, anti-HBc IgM Ab, or anti-HIV Ab
- History of any other clinically significant chronic liver disease
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Gilead Scienceslead
Study Sites (46)
Alabama Liver and Digestive Specialist
Montgomery, Alabama, 36116, United States
Clopton Clinic
Jonesboro, Arkansas, 72401, United States
Advanced Clinical Research Institute
Anaheim, California, 92801, United States
Providence Clinical Research
Burbank, California, 91505, United States
Southern California Liver Centers
Coronado, California, 92118, United States
Cedars Sinai Medical Center
Los Angeles, California, 90048, United States
eStudy Site
Oceanside, California, 92056, United States
Desta Digestive Disease Medical Center
San Diego, California, 92114, United States
Medical Associates Reseach Group
San Diego, California, 92123, United States
Kaiser Permanente Hepatology Research
San Diego, California, 92154, United States
University of Colorado Denver Transplant Center and Hepatology Clinic
Aurora, Colorado, 80045, United States
South Denver Gastreoenterology
Englewood, Colorado, 80110, United States
Pointe West Infectious Disease
Bradenton, Florida, 34209, United States
Avail Clinical Research
DeLand, Florida, 32720, United States
University of Florida College of Medicine
Gainesville, Florida, 32610, United States
Orlando Immunology Center
Orlando, Florida, 32803, United States
Internal Medicine Specialists
Orlando, Florida, 32806, United States
Advanced Research Institute
Trinity, Florida, 34655, United States
South Florida Center of Gastroenterology
Wellington, Florida, 33414, United States
Atlanta Gastroenterology Associates
Atlanta, Georgia, 30308, United States
Gastrointestinal Specialists of Georgia
Marietta, Georgia, 30060, United States
University of Chicago Medical Center
Chicago, Illinois, 60637, United States
Investigative Clinical Research
Annapolis, Maryland, 21401, United States
Clinical Associates Research
Reisterstown, Maryland, 21136, United States
Beth Israel Deconess Medical Center
Boston, Massachusetts, 02215, United States
U Mass Memorial Medical Center
Worcester, Massachusetts, 01655, United States
Henry Ford Health System
Novi, Michigan, 48377, United States
St. Louis University Gastroenterology and Hepatology Clinical Research
St Louis, Missouri, 63104, United States
University of New Mexico Health Science Center
Albuquerque, New Mexico, 87131, United States
North Shore University Hospital
Manhasset, New York, 11303, United States
Concorde Medical Group
New York, New York, 10016, United States
New York Presbyterian Hospital
New York, New York, 10021, United States
Mt. Sinai Medical Center
New York, New York, 10029, United States
Asheville Gastroenterology Associates
Asheville, North Carolina, 28801, United States
Duke University Medical Center
Durham, North Carolina, United States
University of Cincinnati
Cincinnati, Ohio, 45267, United States
Columbia Gastroenterology Associates
Columbia, South Carolina, 29204, United States
North Texas Research Institute
Arlington, Texas, 76012, United States
Central Texas Cinical Research
Austin, Texas, 78705, United States
Baylor University
Dallas, Texas, 75246, United States
Baylor/ St. Luke's Advanced Liver Therapy
Houston, Texas, 77030, United States
Alamo Medical Research
San Antonio, Texas, 78215, United States
Digestive and Liver Disease Specialist
Norfolk, Virginia, 23502, United States
Virginia Mason Medical Center
Seattle, Washington, 98101, United States
University Of Puerto Rico
San Juan, Puerto Rico, 00935, Puerto Rico
Fundacion de Investigacion de Diego
San Juan, Puerto Rico, Puerto Rico
Related Publications (2)
Lawitz E, Poordad FF, Pang PS, Hyland RH, Ding X, Mo H, Symonds WT, McHutchison JG, Membreno FE. Sofosbuvir and ledipasvir fixed-dose combination with and without ribavirin in treatment-naive and previously treated patients with genotype 1 hepatitis C virus infection (LONESTAR): an open-label, randomised, phase 2 trial. Lancet. 2014 Feb 8;383(9916):515-23. doi: 10.1016/S0140-6736(13)62121-2. Epub 2013 Nov 5.
PMID: 24209977DERIVEDKowdley 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.
PMID: 23499440DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Clinical Trial Disclosures
- Organization
- Gilead Sciences, Inc.
Study Officials
- STUDY DIRECTOR
Robert H. Hyland, DPhil
Gilead Sciences
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 30, 2011
First Posted
April 6, 2011
Study Start
March 1, 2011
Primary Completion
August 1, 2012
Study Completion
August 1, 2012
Last Updated
May 26, 2014
Results First Posted
May 26, 2014
Record last verified: 2014-04