Clinical trial NCT01497366: Phase 3 Study of Sofosbuvir and Ribavirin
Official title: A Phase 3, Multicenter, Randomized, Active-Controlled Study to Investigate the Safety and Efficacy of PSI-7977 and Ribavirin for 12 Weeks Compared to Pegylated Interferon and Ribavirin for 24 Weeks in Treatment-Naïve Patients With Chronic Genotype 2 or 3 HCV Infection
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hepatitis C
Keywords: HCV genotype 2 (GT-2)
HCV genotype 3 (GT-3)
Lead sponsor: Gilead Sciences
Sponsor class: INDUSTRY
First posted: 2011-12-22
Enrollment: 527
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: This study was to assess the safety and efficacy of sofosbuvir (GS-7977; PSI-7977) in combination with ribavirin (RBV) administered for 12 weeks compared with pegylated interferon (PEG)/RBV administered for 24 weeks in treatment-naive patients with Hepatitis C (HCV) genotype 2 or 3. Efficacy was assessed by the rate of sustained viral response (SVR) 12 weeks after the discontinuation of therapy (SVR12). This was a non-inferiority study, and if non-inferiority was demonstrated, the study was then allowed to test for superiority.


Eligibility criteria: Inclusion Criteria:

* Chronic Genotype 2 or 3 HCV-infection
* Naive to all HCV antiviral treatment(s)

Exclusion Criteria:

* Positive test at Screening for HBsAg, anti-hepatitis B core immunoglobulin M antibody (anti-HBc IgM Ab), or anti-HIV Ab
* History of any other clinically significant chronic liver disease
* A history consistent with decompensated liver disease
* History or current evidence of psychiatric illness, immunologic disorder, hemoglobinopathy, pulmonary or cardiac disease, seizure disorder or anticonvulsant use, poorly controlled diabetes, cancer, or a history of malignancy, that makes the subject unsuitable for the study.
* Participation in a clinical study within 3 months prior to first dose

Primary outcomes:
measure: Percentage of Participants With Sustained Virologic Response 12 Weeks After Stopping All Study Drugs (SVR12)
timeFrame: Post-treatment Week 12
Secondary outcomes:
measure: Number of Participants Who Experienced Adverse Events (AEs) and Graded Laboratory Abnormalities
timeFrame: Up to 24 weeks plus 30 days following the last dose of study drug
measure: Percentage of Participants With Sustained Virologic Response 24 Weeks After Stopping All Study Drugs (SVR24)
timeFrame: Post-treatment Week 24
measure: Percentage of Participants With HCV RNA < LLOQ on Treatment
timeFrame: Up to 12 Weeks
measure: Change From Baseline in HCV RNA
timeFrame: Baseline to Week 12
measure: Percentage of Participants With Virologic Failure During Treatment
timeFrame: Baseline up to Week 24
measure: Percentage of Participants With Viral Relapse Following Treatment
timeFrame: Up to Post-treatment Week 24
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
city: Montgomery
country: United States
facility: Alabama Liver & Digestive Specialist
state: Alabama
city: Bakersfield
country: United States
facility: Franco Felizarta, MD
state: California
city: Beverly Hills
country: United States
facility: California Liver Institute
state: California
city: Colton
country: United States
facility: Arrowhead Regional Medical Center
state: California
city: Coronado
country: United States
facility: SCTI Research Foundation
state: California
city: La Mesa
country: United States
facility: eStudy Site
state: California
city: Los Angeles
country: United States
facility: Peter J. Ruane, M.D. Inc.
state: California
city: Oceanside
country: United States
facility: eStudySite
state: California
city: Sacramento
country: United States
facility: University of California, Davis - Health System
state: California
city: San Diego
country: United States
facility: University of California San Diego Medical Center
state: California
city: San Diego
country: United States
facility: Research and Education, Inc.
state: California
city: San Diego
country: United States
facility: Medical Associates Research Group, Inc.
state: California
city: San Francisco
country: United States
facility: Quest Clinical Research
state: California
city: Englewood
country: United States
facility: South Denver Gastroenterology, PC
state: Colorado
city: Bradenton
country: United States
facility: Pointe West Infectious Diseases
state: Florida
city: Fort Pierce
country: United States
facility: Midway Immunology & Research Center, LLC
state: Florida
city: Gainesville
country: United States
facility: University of Florida College of Medicine
state: Florida
city: Jacksonville
country: United States
facility: Borland-Groover Clinic Baptist
state: Florida
city: Miami
country: United States
facility: University of Miami, School 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: AIDS Research Consortium of Atlanta, Inc.
state: Georgia
city: Atlanta
country: United States
facility: Atlanta Gastroenterology Associates
state: Georgia
city: Marietta
country: United States
facility: Gastrointestinal Specialists of Georgia, PC
state: Georgia
city: Chicago
country: United States
facility: University of Chicago
state: Illinois
city: Indianapolis
country: United States
facility: Indianapolis Gastroenterology Research Foundation
state: Indiana
city: Baltimore
country: United States
facility: Digestive Disease Associates, P.A.
state: Maryland
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
city: Springfield
country: United States
facility: The Research Institute
state: Massachusetts
city: Worcester
country: United States
facility: Partners in Internal Medicine, PC
state: Massachusetts
city: Worcester
country: United States
facility: University of Massachusetts, Worcester
state: Massachusetts
city: Detroit
country: United States
facility: Henry Ford Health System
state: Michigan
city: Tupelo
country: United States
facility: Digestive Health Specialists, PA
state: Mississippi
city: East Orange
country: United States
facility: Veterans Affairs Medical Center
state: New Jersey
city: Egg Harbor Township
country: United States
facility: AGA Clinical Research Associates, LLC
state: New Jersey
city: Hillsborough
country: United States
facility: ID Care
state: New Jersey
city: Morristown
country: United States
facility: Atlantic Research Affiliates, LLC
state: New Jersey
city: Santa Fe
country: United States
facility: Southwest C.A.R.E. Center
state: New Mexico
city: Manhasset
country: United States
facility: North Shore University Hospital
state: New York
city: New York
country: United States
facility: Weill Cornell Medical College
state: New York
city: New York
country: United States
facility: Mount Sinai School of Medicine
state: New York
city: Rochester
country: United States
facility: University of Rochester
state: New York
city: Asheville
country: United States
facility: Asheville Gastroenterology Associates, P.A.
state: North Carolina
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Statesville
country: United States
facility: Carolinas Center for Liver Disease
state: North Carolina
city: Winston-Salem
country: United States
facility: Digestive Health Specialists, PA
state: North Carolina
city: Cincinnati
country: United States
facility: University of Cincinnati
state: Ohio
city: Tulsa
country: United States
facility: Gastroenterology United of Tulsa
state: Oklahoma
city: Medford
country: United States
facility: Schleinitz Research and Gastroenterology LLC
state: Oregon
city: Lancaster
country: United States
facility: Regional Gastroenterology Associates of Lancaster, Ltd.
state: Pennsylvania
city: Pittsburgh
country: United States
facility: UPMC Center For Liver Diseases
state: Pennsylvania
city: Warwick
country: United States
facility: University Gastroenterology
state: Rhode Island
city: Germantown
country: United States
facility: Gastro One
state: Tennessee
city: Nashville
country: United States
facility: Nashville Gastrointestinal Specialists Inc.
state: Tennessee
city: Arlington
country: United States
facility: Texas Clinical Research Institute, LLC
state: Texas
city: Dallas
country: United States
facility: Baylor University Medical Center
state: Texas
city: Houston
country: United States
facility: Kelsey-Seybold Clinic PA
state: Texas
city: Houston
country: United States
facility: Research Specialists of Texas
state: Texas
city: Houston
country: United States
facility: VAMC & Baylor College
state: Texas
city: San Antonio
country: United States
facility: Alamo Medical Research
state: Texas
city: Fairfax
country: United States
facility: Metropolitan Research
state: Virginia
city: Norfolk
country: United States
facility: Digestive and Liver Disease Specialist, Ltd.
state: Virginia
city: Norfolk
country: United States
facility: Digestive and Liver Disease Specialists
state: Virginia
city: Seattle
country: United States
facility: Virginia Mason Medical Center
state: Washington
city: Garran
country: Australia
facility: Canberra Hospital
state: Australian Capital Territory
city: Camperdown
country: Australia
facility: Royal Prince Alfred Hospital
state: New South Wales
city: Concord
country: Australia
facility: Concord Repatriation General Hospital
state: New South Wales
city: Kogarah
country: Australia
facility: St. George Hospital
state: New South Wales
city: Greenslopes
country: Australia
facility: Gallipoli MRF
state: Queensland
city: Herston
country: Australia
facility: Royal Brisbane Hospital Research Foundation
state: Queensland
city: Woollongabba
country: Australia
facility: Princess Alexandria
state: Queensland
city: Adelaide
country: Australia
facility: Royal Adelaide Hospital
state: South Australia
city: Clayton
country: Australia
facility: Monash Medical Centre
state: Victoria
city: Heidelberg
country: Australia
facility: Austin Hospital
state: Victoria
city: Melbourne
country: Australia
facility: The Alfred
state: Victoria
city: Fremantle
country: Australia
facility: Fremantle Hospital
state: Western Australia
city: Nedlands
country: Australia
facility: Sir Charles Gairdner
state: Western Australia
city: Perth
country: Australia
facility: Royal Perth Hospital
state: Western Australia
city: Vancouver
country: Canada
facility: (G.I.R.I.) Gastrointestinal Research Institute
state: British Columbia
city: Toronto
country: Canada
facility: Mount Sinai Hospital
state: Ontario
city: Toronto
country: Canada
facility: University Health Network-Toronto Western Hospital
state: Ontario
city: Toronto
country: Canada
facility: Toronto Liver Centre
state: Ontario
city: Vaughan
country: Canada
facility: Toronto Digestive Disease Associates, Inc.
state: Ontario
city: San Giovanni Rotondo
country: Italy
facility: Casa Sollievo della Sofferenza Hospital
city: Amsterdam
country: Netherlands
facility: Academish Medisch Centrum
city: Grafton
country: New Zealand
facility: Auckland City Hospital
state: Auckland
city: Tauranga
country: New Zealand
facility: Tauranga Hospital
state: BOP
city: Chrischurch
country: New Zealand
facility: Christchurch Hospital
state: Canterbury
city: Dunedin
country: New Zealand
facility: Mercy Hospital
state: OTA
city: Hamilton
country: New Zealand
facility: Waikato Hospital (District Health Board)
state: Waikato
city: Newtown
country: New Zealand
facility: Wellington Hospital
state: WGN
city: San Juan
country: Puerto Rico
facility: Fundacion de Investigacion de Diego
city: Göteborg
country: Sweden
facility: Sahlgrenska Universitetssjukhuset, Östra Sjukhus
city: Stockholm
country: Sweden
facility: Karolinska Universitetssjukhuset, Solna
Study officials:
References:
citation: Stepanova M, Nader F, Cure S, Bourhis F, Hunt S, Younossi ZM. Patients' preferences and health utility assessment with SF-6D and EQ-5D in patients with chronic hepatitis C treated with sofosbuvir regimens. Aliment Pharmacol Ther. 2014 Sep;40(6):676-85. doi: 10.1111/apt.12880. Epub 2014 Jul 15.
citation: Lawitz E, Mangia A, Wyles D, Rodriguez-Torres M, Hassanein T, Gordon SC, Schultz M, Davis MN, Kayali Z, Reddy KR, Jacobson IM, Kowdley KV, Nyberg L, Subramanian GM, Hyland RH, Arterburn S, Jiang D, McNally J, Brainard D, Symonds WT, McHutchison JG, Sheikh AM, Younossi Z, Gane EJ. Sofosbuvir for previously untreated chronic hepatitis C infection. N Engl J Med. 2013 May 16;368(20):1878-87. doi: 10.1056/NEJMoa1214853. Epub 2013 Apr 23.