Clinical trial NCT01329978: Sofosbuvir With Pegylated Interferon and Ribavirin Hepatitis C Virus (HCV) Genotypes 1,4,5,6
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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Hepatitis C, Chronic
Keywords: Hepatitis C
HCV
Chronic Hepatitis C
Lead sponsor: Gilead Sciences
Sponsor class: INDUSTRY
First posted: 2011-04-06
Enrollment: 332
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Percentage of Participants With Sustained Virologic Response 24 Weeks Following Completion of Treatment (SVR24)
timeFrame: Post-treatment Week 24
measure: Percentage of Participants Who Experienced Adverse Events
timeFrame: Baseline (Day 1) to post-treatment Day 30
Secondary outcomes:
measure: Percentage of Participants With Sustained Virologic Response 12 Weeks Following Completion of Treatment (SVR12)
timeFrame: Post-treatment Week 12
measure: Change in HCV RNA at Week 2
timeFrame: Baseline (Day 1) to Week 2
measure: Change in HCV RNA at Week 4
timeFrame: Baseline (Day 1) to Week 4
measure: Change in HCV RNA at Week 8
timeFrame: Baseline (Day 1) to Week 8
measure: Change in HCV RNA at Week 12
timeFrame: Baseline (Day 1) to Week 12
measure: Percentage of Participants With HCV RNA < LOD at Week 2
timeFrame: Week 2
measure: Percentage of Participants With HCV RNA Below < LOD at Week 4
timeFrame: Week 4
measure: Percentage of Participants With HCV RNA Below < LOD at Week 8
timeFrame: Week 8
measure: Percentage of Participants With HCV RNA Below < LOD at Week 12
timeFrame: Week 12
measure: Percentage of Participants With HCV RNA Below < LOD at Week 24
timeFrame: Week 24
measure: Percentage of Participants With ALT Normalization at Week 12
timeFrame: Baseline (Day 1) to Week 12
measure: Percentage of Participants With ALT Normalization at Week 24
timeFrame: Baseline (Day 1) to Week 24
measure: Percentage of Participants With ALT Normalization at Post-treatment Week 4
timeFrame: Baseline (Day 1) to Post-treatment Week 4
measure: Percentage of Participants With Virologic Failure During Treatment
timeFrame: Baseline (Day 1) to Week 24
measure: Percentage of Participants With Virologic Failure Following Treatment (Viral Relapse).
timeFrame: End of treatment to Post-treatment Week 24
Other outcomes:
Locations:
city: Montgomery
country: United States
facility: Alabama Liver and Digestive Specialist
state: Alabama
city: Jonesboro
country: United States
facility: Clopton Clinic
state: Arkansas
city: Anaheim
country: United States
facility: Advanced Clinical Research Institute
state: California
city: Burbank
country: United States
facility: Providence Clinical Research
state: California
city: Coronado
country: United States
facility: Southern California Liver Centers
state: California
city: Los Angeles
country: United States
facility: Cedars Sinai Medical Center
state: California
city: Oceanside
country: United States
facility: eStudy Site
state: California
city: San Diego
country: United States
facility: Desta Digestive Disease Medical Center
state: California
city: San Diego
country: United States
facility: Medical Associates Reseach Group
state: California
city: San Diego
country: United States
facility: Kaiser Permanente Hepatology Research
state: California
city: Aurora
country: United States
facility: University of Colorado Denver Transplant Center and Hepatology Clinic
state: Colorado
city: Englewood
country: United States
facility: South Denver Gastreoenterology
state: Colorado
city: Bradenton
country: United States
facility: Pointe West Infectious Disease
state: Florida
city: Deland
country: United States
facility: Avail Clinical Research
state: Florida
city: Gainesville
country: United States
facility: University of Florida College of Medicine
state: Florida
city: Orlando
country: United States
facility: Orlando Immunology Center
state: Florida
city: Orlando
country: United States
facility: Internal Medicine Specialists
state: Florida
city: Trinity
country: United States
facility: Advanced Research Institute
state: Florida
city: Wellington
country: United States
facility: South Florida Center of Gastroenterology
state: Florida
city: Atlanta
country: United States
facility: Atlanta Gastroenterology Associates
state: Georgia
city: Marietta
country: United States
facility: Gastrointestinal Specialists of Georgia
state: Georgia
city: Chicago
country: United States
facility: University of Chicago Medical Center
state: Illinois
city: Annapolis
country: United States
facility: Investigative Clinical Research
state: Maryland
city: Reisterstown
country: United States
facility: Clinical Associates Research
state: Maryland
city: Boston
country: United States
facility: Beth Israel Deconess Medical Center
state: Massachusetts
city: Worcester
country: United States
facility: U Mass Memorial Medical Center
state: Massachusetts
city: Novi
country: United States
facility: Henry Ford Health System
state: Michigan
city: St. Louis
country: United States
facility: St. Louis University Gastroenterology and Hepatology Clinical Research
state: Missouri
city: Albuquerque
country: United States
facility: University of New Mexico Health Science Center
state: New Mexico
city: Manhasset
country: United States
facility: North Shore University Hospital
state: New York
city: New York
country: United States
facility: Concorde Medical Group
state: New York
city: New York
country: United States
facility: New York Presbyterian Hospital
state: New York
city: New York
country: United States
facility: Mt. Sinai Medical Center
state: New York
city: Asheville
country: United States
facility: Asheville Gastroenterology Associates
state: North Carolina
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Cincinnati
country: United States
facility: University of Cincinnati
state: Ohio
city: Columbia
country: United States
facility: Columbia Gastroenterology Associates
state: South Carolina
city: Arlington
country: United States
facility: North Texas Research Institute
state: Texas
city: Austin
country: United States
facility: Central Texas Cinical Research
state: Texas
city: Dallas
country: United States
facility: Baylor University
state: Texas
city: Houston
country: United States
facility: Baylor/ St. Luke's Advanced Liver Therapy
state: Texas
city: San Antonio
country: United States
facility: Alamo Medical Research
state: Texas
city: Norfolk
country: United States
facility: Digestive and Liver Disease Specialist
state: Virginia
city: Seattle
country: United States
facility: Virginia Mason Medical Center
state: Washington
city: San Juan
country: Puerto Rico
facility: University Of Puerto Rico
city: San Juan
country: Puerto Rico
facility: Fundacion de Investigacion de Diego
Study officials:
affiliation: Gilead Sciences
name: Robert H. Hyland, DPhil
role: STUDY_DIRECTOR
References:
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.
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.