Phase 3 Study of Sofosbuvir and Ribavirin

NCT01497366 | Completed Phase 3 Results DMC

• 1 other identifier: P7977-1231
• Study Type: interventional
• Target: 527
• Locations: 8 countries
• Sites: 97

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.

Conditions

Hepatitis C

Keywords

HCV genotype 2 (GT-2); HCV genotype 3 (GT-3)

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants With Sustained Virologic Response 12 Weeks After Stopping All Study Drugs (SVR12)

  SVR12 was defined as HCV RNA \< the lower limit of quantitation (LLOQ; \< 25 IU/mL) 12 weeks after study drug cessation.

  Post-treatment Week 12

Secondary Outcomes (6)

• Number of Participants Who Experienced Adverse Events (AEs) and Graded Laboratory Abnormalities

  Up to 24 weeks plus 30 days following the last dose of study drug

• Percentage of Participants With Sustained Virologic Response 24 Weeks After Stopping All Study Drugs (SVR24)

  Post-treatment Week 24

• Percentage of Participants With HCV RNA < LLOQ on Treatment

  Up to 12 Weeks

• Change From Baseline in HCV RNA

  Baseline to Week 12

• Percentage of Participants With Virologic Failure During Treatment

  Baseline up to Week 24

Study Arms (2)

Sofosbuvir+RBV

EXPERIMENTAL

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

Drug: Sofosbuvir; Drug: RBV

PEG+RBV

ACTIVE COMPARATOR

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

Drug: PEG; Drug: RBV

Interventions

Sofosbuvir DRUG

Sofosbuvir 400 mg (2 × 200 mg tablets) administered orally once daily

Also known as: Sovaldi™, GS-7977, PSI-7977

Sofosbuvir+RBV

PEG DRUG

Pegylated interferon alfa-2a (PEG) 180 μg administered once weekly by subcutaneous injection

Also known as: Pegasys®

PEG+RBV

RBV DRUG

Ribavirin (RBV) administered as 200 mg tablets up to 1200 mg in a divided daily dose * Dose of sofosbuvir+RBV group based on baseline weight: \< 75kg = 1000 mg and ≥ 75 kg = 1200 mg * Dose of PEG+RBV group: 800 mg

PEG+RBV; Sofosbuvir+RBV

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Gilead Sciences: lead

Study Sites (97)

University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

Location

Alabama Liver & Digestive Specialist

Montgomery, Alabama, 36116, United States

Location

Franco Felizarta, MD

Bakersfield, California, 93301, United States

Location

California Liver Institute

Beverly Hills, California, 90210, United States

Location

Arrowhead Regional Medical Center

Colton, California, 92324, United States

Location

SCTI Research Foundation

Coronado, California, 92118, United States

Location

eStudy Site

La Mesa, California, 91940, United States

Location

Peter J. Ruane, M.D. Inc.

Los Angeles, California, 90036, United States

Location

eStudySite

Oceanside, California, 92056, United States

Location

University of California, Davis - Health System

Sacramento, California, 95817, United States

Location

University of California San Diego Medical Center

San Diego, California, 92103, United States

Location

Research and Education, Inc.

San Diego, California, 92105, United States

Location

Medical Associates Research Group, Inc.

San Diego, California, 92123, United States

Location

Quest Clinical Research

San Francisco, California, 94115, United States

Location

South Denver Gastroenterology, PC

Englewood, Colorado, 80113, United States

Location

Pointe West Infectious Diseases

Bradenton, Florida, 34209, United States

Location

Midway Immunology & Research Center, LLC

Ft. Pierce, Florida, 34982, United States

Location

University of Florida College of Medicine

Gainesville, Florida, 32610, United States

Location

Borland-Groover Clinic Baptist

Jacksonville, Florida, 32256, United States

Location

University of Miami, School of Medicine

Miami, Florida, 33136, United States

Location

Orlando Immunology Center

Orlando, Florida, 32803, United States

Location

Internal Medicine Specialists

Orlando, Florida, 32806, United States

Location

Advanced Research Institute

Trinity, Florida, 34655, United States

Location

South Florida Center of Gastroenterology

Wellington, Florida, 33414, United States

Location

AIDS Research Consortium of Atlanta, Inc.

Atlanta, Georgia, 30308, United States

Location

Atlanta Gastroenterology Associates

Atlanta, Georgia, 30308, United States

Location

Gastrointestinal Specialists of Georgia, PC

Marietta, Georgia, 30060, United States

Location

University of Chicago

Chicago, Illinois, 60637, United States

Location

Indianapolis Gastroenterology Research Foundation

Indianapolis, Indiana, 46237, United States

Location

Digestive Disease Associates, P.A.

Baltimore, Maryland, 21229, United States

Location

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02115, United States

Location

The Research Institute

Springfield, Massachusetts, 01105, United States

Location

Partners in Internal Medicine, PC

Worcester, Massachusetts, 01608-1320, United States

Location

University of Massachusetts, Worcester

Worcester, Massachusetts, 01655, United States

Location

Henry Ford Health System

Detroit, Michigan, 48202, United States

Location

Digestive Health Specialists, PA

Tupelo, Mississippi, 38801, United States

Location

Veterans Affairs Medical Center

East Orange, New Jersey, 07018, United States

Location

AGA Clinical Research Associates, LLC

Egg Harbor, New Jersey, 08234, United States

Location

ID Care

Hillsborough, New Jersey, 08844, United States

Location

Atlantic Research Affiliates, LLC

Morristown, New Jersey, 07960, United States

Location

Southwest C.A.R.E. Center

Santa Fe, New Mexico, 87505, United States

Location

North Shore University Hospital

Manhasset, New York, 11030, United States

Location

Weill Cornell Medical College

New York, New York, 10021, United States

Location

Mount Sinai School of Medicine

New York, New York, 10029, United States

Location

University of Rochester

Rochester, New York, 14662, United States

Location

Asheville Gastroenterology Associates, P.A.

Asheville, North Carolina, 28801, United States

Location

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

Carolinas Center for Liver Disease

Statesville, North Carolina, 28677, United States

Location

Digestive Health Specialists, PA

Winston-Salem, North Carolina, 27103, United States

Location

University of Cincinnati

Cincinnati, Ohio, 45267, United States

Location

Gastroenterology United of Tulsa

Tulsa, Oklahoma, 74135, United States

Location

Schleinitz Research and Gastroenterology LLC

Medford, Oregon, 97504, United States

Location

Regional Gastroenterology Associates of Lancaster, Ltd.

Lancaster, Pennsylvania, 17604, United States

Location

UPMC Center For Liver Diseases

Pittsburgh, Pennsylvania, 15213, United States

Location

University Gastroenterology

Warwick, Rhode Island, 02886, United States

Location

Gastro One

Germantown, Tennessee, 38138, United States

Location

Nashville Gastrointestinal Specialists Inc.

Nashville, Tennessee, 37211, United States

Location

Texas Clinical Research Institute, LLC

Arlington, Texas, 76012, United States

Location

Baylor University Medical Center

Dallas, Texas, 75246, United States

Location

Kelsey-Seybold Clinic PA

Houston, Texas, 77005, United States

Location

Research Specialists of Texas

Houston, Texas, 77030, United States

Location

VAMC & Baylor College

Houston, Texas, 77030, United States

Location

Alamo Medical Research

San Antonio, Texas, 78215, United States

Location

Metropolitan Research

Fairfax, Virginia, 22031, United States

Location

Digestive and Liver Disease Specialist, Ltd.

Norfolk, Virginia, 23502, United States

Location

Digestive and Liver Disease Specialists

Norfolk, Virginia, 23502, United States

Location

Virginia Mason Medical Center

Seattle, Washington, 98101, United States

Location

Canberra Hospital

Garran, Australian Capital Territory, 2605, Australia

Location

Royal Prince Alfred Hospital

Camperdown, New South Wales, 2050, Australia

Location

Concord Repatriation General Hospital

Concord, New South Wales, 2137, Australia

Location

St. George Hospital

Kogarah, New South Wales, 2217, Australia

Location

Gallipoli MRF

Greenslopes, Queensland, 4120, Australia

Location

Royal Brisbane Hospital Research Foundation

Herston, Queensland, 4029, Australia

Location

Princess Alexandria

Woollongabba, Queensland, 4102, Australia

Location

Royal Adelaide Hospital

Adelaide, South Australia, 5000, Australia

Location

Monash Medical Centre

Clayton, Victoria, 3168, Australia

Location

Austin Hospital

Heidelberg, Victoria, 3084, Australia

Location

The Alfred

Melbourne, Victoria, 3004, Australia

Location

Fremantle Hospital

Fremantle, Western Australia, 6160, Australia

Location

Sir Charles Gairdner

Nedlands, Western Australia, 6009, Australia

Location

Royal Perth Hospital

Perth, Western Australia, 6000, Australia

Location

(G.I.R.I.) Gastrointestinal Research Institute

Vancouver, British Columbia, V6Z 2K5, Canada

Location

Mount Sinai Hospital

Toronto, Ontario, M5G 1X5, Canada

Location

University Health Network-Toronto Western Hospital

Toronto, Ontario, M5G 2N2, Canada

Location

Toronto Liver Centre

Toronto, Ontario, M6H 3M1, Canada

Location

Toronto Digestive Disease Associates, Inc.

Vaughan, Ontario, L4L 4Y7, Canada

Location

Casa Sollievo della Sofferenza Hospital

San Giovanni Rotondo, 71013, Italy

Location

Academish Medisch Centrum

Amsterdam, 1105 AZ, Netherlands

Location

Auckland City Hospital

Grafton, Auckland, New Zealand

Location

Tauranga Hospital

Tauranga, BOP, 3143, New Zealand

Location

Christchurch Hospital

Chrischurch, Canterbury, 8001, New Zealand

Location

Mercy Hospital

Dunedin, OTA, 9010, New Zealand

Location

Waikato Hospital (District Health Board)

Hamilton, Waikato Region, 3240, New Zealand

Location

Wellington Hospital

Newtown, WGN, 6021, New Zealand

Location

Fundacion de Investigacion de Diego

San Juan, Puerto Rico, 00927, Puerto Rico

Location

Sahlgrenska Universitetssjukhuset, Östra Sjukhus

Gothenburg, 41685, Sweden

Location

Karolinska Universitetssjukhuset, Solna

Stockholm, 171 76, Sweden

Location

Related Publications (2)

• 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.

  PMID: 25040192 DERIVED

• 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.

  PMID: 23607594 DERIVED

MeSH Terms

Conditions

Hepatitis C

Interventions

Sofosbuvir; peginterferon alfa-2a

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis; Liver Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Uridine Monophosphate; Uracil Nucleotides; Pyrimidine Nucleotides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Nucleotides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleotides

Results Point of Contact

• Title: Clinical Trial Disclosures
• Organization: Gilead Sciences, Inc.

ClinicalTrialDisclosures@gilead.com

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 19, 2011
• First Posted: December 22, 2011
• Study Start: December 1, 2011
• Primary Completion: January 1, 2013
• Study Completion: April 1, 2013
• Last Updated: April 2, 2014
• Results First Posted: April 2, 2014

Record last verified: 2014-03

Locations

PR (1); CA (5); SE (2); AU (14); IT (1); NL (1); US (67); NZ (6)