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

Hepatitis C, Chronic Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01329978
• Other study ID #: P7977-0724
• Status: Completed
• Phase: Phase 2
• First received: March 30, 2011
• Last updated: April 24, 2014
• Start date: March 2011
• Est. completion date: August 2012

Study information

• Verified date: April 2014
• Source: Gilead Sciences
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 332
• Est. completion date: August 2012
• Est. primary completion date: August 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis C
• Hepatitis C, Chronic

Intervention

Drug:
• Sofosbuvir
Sofosbuvir (SOF) administered as a 400 mg tablet orally once daily
• 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)
• PEG
Pegylated interferon alfa-2a (PEG) 180 µg administered once weekly by subcutaneous injection

Locations

Country	Name	City	State
Puerto Rico	Fundacion de Investigacion de Diego	San Juan
Puerto Rico	University Of Puerto Rico	San Juan
United States	University of New Mexico Health Science Center	Albuquerque	New Mexico
United States	Advanced Clinical Research Institute	Anaheim	California
United States	Investigative Clinical Research	Annapolis	Maryland
United States	North Texas Research Institute	Arlington	Texas
United States	Asheville Gastroenterology Associates	Asheville	North Carolina
United States	Atlanta Gastroenterology Associates	Atlanta	Georgia
United States	University of Colorado Denver Transplant Center and Hepatology Clinic	Aurora	Colorado
United States	Central Texas Cinical Research	Austin	Texas
United States	Beth Israel Deconess Medical Center	Boston	Massachusetts
United States	Pointe West Infectious Disease	Bradenton	Florida
United States	Providence Clinical Research	Burbank	California
United States	University of Chicago Medical Center	Chicago	Illinois
United States	University of Cincinnati	Cincinnati	Ohio
United States	Columbia Gastroenterology Associates	Columbia	South Carolina
United States	Southern California Liver Centers	Coronado	California
United States	Baylor University	Dallas	Texas
United States	Avail Clinical Research	Deland	Florida
United States	Duke University Medical Center	Durham	North Carolina
United States	South Denver Gastreoenterology	Englewood	Colorado
United States	University of Florida College of Medicine	Gainesville	Florida
United States	Baylor/ St. Luke's Advanced Liver Therapy	Houston	Texas
United States	Clopton Clinic	Jonesboro	Arkansas
United States	Cedars Sinai Medical Center	Los Angeles	California
United States	North Shore University Hospital	Manhasset	New York
United States	Gastrointestinal Specialists of Georgia	Marietta	Georgia
United States	Alabama Liver and Digestive Specialist	Montgomery	Alabama
United States	Concorde Medical Group	New York	New York
United States	Mt. Sinai Medical Center	New York	New York
United States	New York Presbyterian Hospital	New York	New York
United States	Digestive and Liver Disease Specialist	Norfolk	Virginia
United States	Henry Ford Health System	Novi	Michigan
United States	eStudy Site	Oceanside	California
United States	Internal Medicine Specialists	Orlando	Florida
United States	Orlando Immunology Center	Orlando	Florida
United States	Clinical Associates Research	Reisterstown	Maryland
United States	Alamo Medical Research	San Antonio	Texas
United States	Desta Digestive Disease Medical Center	San Diego	California
United States	Kaiser Permanente Hepatology Research	San Diego	California
United States	Medical Associates Reseach Group	San Diego	California
United States	Virginia Mason Medical Center	Seattle	Washington
United States	St. Louis University Gastroenterology and Hepatology Clinical Research	St. Louis	Missouri
United States	Advanced Research Institute	Trinity	Florida
United States	South Florida Center of Gastroenterology	Wellington	Florida
United States	U Mass Memorial Medical Center	Worcester	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Gilead Sciences

Countries where clinical trial is conducted

United States,  Puerto Rico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	Yes
Secondary	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.	Post-treatment Week 12	No
Secondary	Change in HCV RNA at Week 2		Baseline (Day 1) to Week 2	No
Secondary	Change in HCV RNA at Week 4		Baseline (Day 1) to Week 4	No
Secondary	Change in HCV RNA at Week 8		Baseline (Day 1) to Week 8	No
Secondary	Change in HCV RNA at Week 12		Baseline (Day 1) to Week 12	No
Secondary	Percentage of Participants With HCV RNA < LOD at Week 2		Week 2	No
Secondary	Percentage of Participants With HCV RNA Below < LOD at Week 4		Week 4	No
Secondary	Percentage of Participants With HCV RNA Below < LOD at Week 8		Week 8	No
Secondary	Percentage of Participants With HCV RNA Below < LOD at Week 12		Week 12	No
Secondary	Percentage of Participants With HCV RNA Below < LOD at Week 24		Week 24	No
Secondary	Percentage of Participants With ALT Normalization at Week 12	ALT normalization was defined as ALT > ULN at baseline and ALT = ULN at Week 12.	Baseline (Day 1) to Week 12	No
Secondary	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.	Baseline (Day 1) to Week 24	No
Secondary	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.	Baseline (Day 1) to Post-treatment Week 4	No
Secondary	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.	Baseline (Day 1) to Week 24	No
Secondary	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.	End of treatment to Post-treatment Week 24	No