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

Primary Purpose

Hepatitis C, Chronic

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Sofosbuvir
RBV
PEG
Sponsored by
Gilead Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hepatitis C, Chronic focused on measuring Hepatitis C, HCV, Chronic Hepatitis C

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Alabama Liver and Digestive Specialist
  • Clopton Clinic
  • Advanced Clinical Research Institute
  • Providence Clinical Research
  • Southern California Liver Centers
  • Cedars Sinai Medical Center
  • eStudy Site
  • Desta Digestive Disease Medical Center
  • Medical Associates Reseach Group
  • Kaiser Permanente Hepatology Research
  • University of Colorado Denver Transplant Center and Hepatology Clinic
  • South Denver Gastreoenterology
  • Pointe West Infectious Disease
  • Avail Clinical Research
  • University of Florida College of Medicine
  • Orlando Immunology Center
  • Internal Medicine Specialists
  • Advanced Research Institute
  • South Florida Center of Gastroenterology
  • Atlanta Gastroenterology Associates
  • Gastrointestinal Specialists of Georgia
  • University of Chicago Medical Center
  • Investigative Clinical Research
  • Clinical Associates Research
  • Beth Israel Deconess Medical Center
  • U Mass Memorial Medical Center
  • Henry Ford Health System
  • St. Louis University Gastroenterology and Hepatology Clinical Research
  • University of New Mexico Health Science Center
  • North Shore University Hospital
  • Concorde Medical Group
  • New York Presbyterian Hospital
  • Mt. Sinai Medical Center
  • Asheville Gastroenterology Associates
  • Duke University Medical Center
  • University of Cincinnati
  • Columbia Gastroenterology Associates
  • North Texas Research Institute
  • Central Texas Cinical Research
  • Baylor University
  • Baylor/ St. Luke's Advanced Liver Therapy
  • Alamo Medical Research
  • Digestive and Liver Disease Specialist
  • Virginia Mason Medical Center
  • University Of Puerto Rico
  • Fundacion de Investigacion de Diego

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

SOF+PEG+RBV 12 weeks

SOF+PEG+RBV 24 weeks

SOF+PEG+RBV 12 week/Rerandomization Group

Arm Description

Participants were randomized to receive sofosbuvir+PEG+RBV for 12 weeks.

Participants were randomized to receive sofosbuvir+PEG+RBV for 24 weeks.

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.

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

Percentage of Participants With Sustained Virologic Response 12 Weeks Following Completion of Treatment (SVR12)
SVR12 was defined as HCV RNA < LOD 12 weeks after the last dose of study drug.
Change in HCV RNA at Week 2
Change in HCV RNA at Week 4
Change in HCV RNA at Week 8
Change in HCV RNA at Week 12
Percentage of Participants With HCV RNA < LOD at Week 2
Percentage of Participants With HCV RNA Below < LOD at Week 4
Percentage of Participants With HCV RNA Below < LOD at Week 8
Percentage of Participants With HCV RNA Below < LOD at Week 12
Percentage of Participants With HCV RNA Below < LOD at Week 24
Percentage of Participants With ALT Normalization at Week 12
ALT normalization was defined as ALT > ULN at baseline and ALT ≤ ULN at Week 12.
Percentage of Participants With ALT Normalization at Week 24
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
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
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).
Viral relapse was defined as HCV RNA < 15 IU/mL at end of treatment, confirmed with 2 consecutive values or last available measurement.

Full Information

First Posted
March 30, 2011
Last Updated
April 24, 2014
Sponsor
Gilead Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT01329978
Brief Title
Sofosbuvir With Pegylated Interferon and Ribavirin Hepatitis C Virus (HCV) Genotypes 1,4,5,6
Acronym
ATOMIC
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2014
Overall Recruitment Status
Completed
Study Start Date
March 2011 (undefined)
Primary Completion Date
August 2012 (Actual)
Study Completion Date
August 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Gilead Sciences

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatitis C, Chronic
Keywords
Hepatitis C, HCV, Chronic Hepatitis C

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
332 (Actual)

8. Arms, Groups, and Interventions

Arm Title
SOF+PEG+RBV 12 weeks
Arm Type
Experimental
Arm Description
Participants were randomized to receive sofosbuvir+PEG+RBV for 12 weeks.
Arm Title
SOF+PEG+RBV 24 weeks
Arm Type
Experimental
Arm Description
Participants were randomized to receive sofosbuvir+PEG+RBV for 24 weeks.
Arm Title
SOF+PEG+RBV 12 week/Rerandomization Group
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Sofosbuvir
Other Intervention Name(s)
Sovaldi®, GS-7977, PSI-7977
Intervention Description
Sofosbuvir (SOF) administered as a 400 mg tablet orally once daily
Intervention Type
Drug
Intervention Name(s)
RBV
Other Intervention Name(s)
Copegus®
Intervention Description
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)
Intervention Type
Drug
Intervention Name(s)
PEG
Other Intervention Name(s)
Pegasys®
Intervention Description
Pegylated interferon alfa-2a (PEG) 180 μg administered once weekly by subcutaneous injection
Primary Outcome Measure Information:
Title
Percentage of Participants With Sustained Virologic Response 24 Weeks Following Completion of Treatment (SVR24)
Description
SVR24 was defined as HCV RNA < the limit of detection (LOD; < 15 IU/mL) 24 weeks after the last dose of study drug.
Time Frame
Post-treatment Week 24
Title
Percentage of Participants Who Experienced Adverse Events
Description
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.
Time Frame
Baseline (Day 1) to post-treatment Day 30
Secondary Outcome Measure Information:
Title
Percentage of Participants With Sustained Virologic Response 12 Weeks Following Completion of Treatment (SVR12)
Description
SVR12 was defined as HCV RNA < LOD 12 weeks after the last dose of study drug.
Time Frame
Post-treatment Week 12
Title
Change in HCV RNA at Week 2
Time Frame
Baseline (Day 1) to Week 2
Title
Change in HCV RNA at Week 4
Time Frame
Baseline (Day 1) to Week 4
Title
Change in HCV RNA at Week 8
Time Frame
Baseline (Day 1) to Week 8
Title
Change in HCV RNA at Week 12
Time Frame
Baseline (Day 1) to Week 12
Title
Percentage of Participants With HCV RNA < LOD at Week 2
Time Frame
Week 2
Title
Percentage of Participants With HCV RNA Below < LOD at Week 4
Time Frame
Week 4
Title
Percentage of Participants With HCV RNA Below < LOD at Week 8
Time Frame
Week 8
Title
Percentage of Participants With HCV RNA Below < LOD at Week 12
Time Frame
Week 12
Title
Percentage of Participants With HCV RNA Below < LOD at Week 24
Time Frame
Week 24
Title
Percentage of Participants With ALT Normalization at Week 12
Description
ALT normalization was defined as ALT > ULN at baseline and ALT ≤ ULN at Week 12.
Time Frame
Baseline (Day 1) to Week 12
Title
Percentage of Participants With ALT Normalization at Week 24
Description
ALT normalization was defined as ALT > ULN at baseline (Day 1 for all groups) and ALT ≤ ULN at Week 24.
Time Frame
Baseline (Day 1) to Week 24
Title
Percentage of Participants With ALT Normalization at Post-treatment Week 4
Description
ALT normalization was defined as ALT > ULN at baseline (Day 1 for all groups) and ALT ≤ ULN at Post-treatment Week 4.
Time Frame
Baseline (Day 1) to Post-treatment Week 4
Title
Percentage of Participants With Virologic Failure During Treatment
Description
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.
Time Frame
Baseline (Day 1) to Week 24
Title
Percentage of Participants With Virologic Failure Following Treatment (Viral Relapse).
Description
Viral relapse was defined as HCV RNA < 15 IU/mL at end of treatment, confirmed with 2 consecutive values or last available measurement.
Time Frame
End of treatment to Post-treatment Week 24

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert H. Hyland, DPhil
Organizational Affiliation
Gilead Sciences
Official's Role
Study Director
Facility Information:
Facility Name
Alabama Liver and Digestive Specialist
City
Montgomery
State/Province
Alabama
ZIP/Postal Code
36116
Country
United States
Facility Name
Clopton Clinic
City
Jonesboro
State/Province
Arkansas
ZIP/Postal Code
72401
Country
United States
Facility Name
Advanced Clinical Research Institute
City
Anaheim
State/Province
California
ZIP/Postal Code
92801
Country
United States
Facility Name
Providence Clinical Research
City
Burbank
State/Province
California
ZIP/Postal Code
91505
Country
United States
Facility Name
Southern California Liver Centers
City
Coronado
State/Province
California
ZIP/Postal Code
92118
Country
United States
Facility Name
Cedars Sinai Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
Facility Name
eStudy Site
City
Oceanside
State/Province
California
ZIP/Postal Code
92056
Country
United States
Facility Name
Desta Digestive Disease Medical Center
City
San Diego
State/Province
California
ZIP/Postal Code
92114
Country
United States
Facility Name
Medical Associates Reseach Group
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Facility Name
Kaiser Permanente Hepatology Research
City
San Diego
State/Province
California
ZIP/Postal Code
92154
Country
United States
Facility Name
University of Colorado Denver Transplant Center and Hepatology Clinic
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
South Denver Gastreoenterology
City
Englewood
State/Province
Colorado
ZIP/Postal Code
80110
Country
United States
Facility Name
Pointe West Infectious Disease
City
Bradenton
State/Province
Florida
ZIP/Postal Code
34209
Country
United States
Facility Name
Avail Clinical Research
City
Deland
State/Province
Florida
ZIP/Postal Code
32720
Country
United States
Facility Name
University of Florida College of Medicine
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32610
Country
United States
Facility Name
Orlando Immunology Center
City
Orlando
State/Province
Florida
ZIP/Postal Code
32803
Country
United States
Facility Name
Internal Medicine Specialists
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Facility Name
Advanced Research Institute
City
Trinity
State/Province
Florida
ZIP/Postal Code
34655
Country
United States
Facility Name
South Florida Center of Gastroenterology
City
Wellington
State/Province
Florida
ZIP/Postal Code
33414
Country
United States
Facility Name
Atlanta Gastroenterology Associates
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30308
Country
United States
Facility Name
Gastrointestinal Specialists of Georgia
City
Marietta
State/Province
Georgia
ZIP/Postal Code
30060
Country
United States
Facility Name
University of Chicago Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Facility Name
Investigative Clinical Research
City
Annapolis
State/Province
Maryland
ZIP/Postal Code
21401
Country
United States
Facility Name
Clinical Associates Research
City
Reisterstown
State/Province
Maryland
ZIP/Postal Code
21136
Country
United States
Facility Name
Beth Israel Deconess Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
U Mass Memorial Medical Center
City
Worcester
State/Province
Massachusetts
ZIP/Postal Code
01655
Country
United States
Facility Name
Henry Ford Health System
City
Novi
State/Province
Michigan
ZIP/Postal Code
48377
Country
United States
Facility Name
St. Louis University Gastroenterology and Hepatology Clinical Research
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63104
Country
United States
Facility Name
University of New Mexico Health Science Center
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87131
Country
United States
Facility Name
North Shore University Hospital
City
Manhasset
State/Province
New York
ZIP/Postal Code
11303
Country
United States
Facility Name
Concorde Medical Group
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
New York Presbyterian Hospital
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
Mt. Sinai Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
Asheville Gastroenterology Associates
City
Asheville
State/Province
North Carolina
ZIP/Postal Code
28801
Country
United States
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
Country
United States
Facility Name
University of Cincinnati
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45267
Country
United States
Facility Name
Columbia Gastroenterology Associates
City
Columbia
State/Province
South Carolina
ZIP/Postal Code
29204
Country
United States
Facility Name
North Texas Research Institute
City
Arlington
State/Province
Texas
ZIP/Postal Code
76012
Country
United States
Facility Name
Central Texas Cinical Research
City
Austin
State/Province
Texas
ZIP/Postal Code
78705
Country
United States
Facility Name
Baylor University
City
Dallas
State/Province
Texas
ZIP/Postal Code
75246
Country
United States
Facility Name
Baylor/ St. Luke's Advanced Liver Therapy
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Alamo Medical Research
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78215
Country
United States
Facility Name
Digestive and Liver Disease Specialist
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23502
Country
United States
Facility Name
Virginia Mason Medical Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98101
Country
United States
Facility Name
University Of Puerto Rico
City
San Juan
ZIP/Postal Code
00935
Country
Puerto Rico
Facility Name
Fundacion de Investigacion de Diego
City
San Juan
Country
Puerto Rico

12. IPD Sharing Statement

Citations:
PubMed Identifier
24209977
Citation
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. Erratum In: Lancet. 2014 Mar 8;383(9920):870.
Results Reference
derived
PubMed Identifier
23499440
Citation
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.
Results Reference
derived

Learn more about this trial

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

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