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This study was to assess whether sofosbuvir in combination with ribavirin (RBV) and pegylated interferon alfa 2a (PEG) administered for 12 weeks is safe and effective in patients with hepatitis C virus (HCV) genotypes 1, 4, 5 , or 6 as assessed by the rate of sustained viral response (SVR) 12 weeks after discontinuation of therapy (SVR12).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sofosbuvir+PEG+RBV | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sofosbuvir | Drug | Sofosbuvir 400 mg tablet administered orally once daily |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Achieving Sustained Virologic Response (SVR)12 | SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ; ie, 25 IU/mL) 12 weeks after cessation of therapy. | Posttreatment Week 12 |
| Number of Participants Experiencing Adverse Events Leading to Permanent Discontinuation of Study Drug | The number of participants experiencing adverse events leading to permanent discontinuation of study drug was summarized. Adverse events may or may not have been related to study treatment. Participants discontinuing study drug were permitted to remain on the study for further assessments. | Baseline to Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Achieving SVR4 | SVR4 was defined as HCV RNA < LLOQ 4 weeks after cessation of therapy | Posttreatment Week 4 |
| Percentage of Participants Achieving SVR24 | SVR24 was defined as HCV RNA < LLOQ 24 weeks after cessation of therapy |
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Inclusion Criteria:
Infection with HCV genotype 1, 4, 5, or 6
Cirrhosis determination
Subject met the following classifications:
Use of highly effective contraception methods if female of childbearing potential or sexually active male
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama Birmingham | Birmingham | Alabama | 35294-2170 | United States | ||
| SCTI Research Foundation |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23607594 | Result | 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. | |
| 24316172 |
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456 participants were screened and 328 were enrolled; 327 participants were treated, and comprise the Safety Analysis Set and the Full Analysis Set.
Subjects were enrolled in a total of 55 study sites in the United States. The first participant was screened on 18 June 2012. The last participant observation was on 16 April 2013.
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| ID | Title | Description |
|---|---|---|
| FG000 | Sofosbuvir+PEG+RBV | Participants received Sofosbuvir+pegylated interferon alfa 2a (PEG)+ribavirin (RBV) for 12 weeks and were followed for 24 weeks following treatment. Sofosbuvir (400 mg) was administered as an oral tablet, PEG (180 µg) as a subcutaneous injection, and RBV (1000-1200 mg) as 200 mg oral tablets. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| RBV | Drug | 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 | Drug | Pegylated interferon alfa-2a (PEG) 180 μg administered once weekly by subcutaneous injection |
|
|
| Posttreatment Week 24 |
| Percentage of Participants With Viral Breakthrough | Viral breakthrough was defined as HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ while receiving treatment, confirmed with 2 consecutive values (second confirmation value could be posttreatment), or last available on-treatment measurement with no subsequent follow-up values. | Baseline to Week 12 |
| Percentage of Participants With Viral Relapse | Viral relapse was defined as HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA < LLOQ at end of treatment, confirmed with 2 consecutive values or last available posttreatment measurement. | End of treatment to post-treatment Week 24 |
| Coronado |
| California |
| 92118 |
| United States |
| Kaiser Permanente | Los Angeles | California | 90027 | United States |
| Peter J. Ruane, MD, Inc. | Los Angeles | California | 90036 | United States |
| Anthony Mills MD, Inc. | Los Angeles | California | 90069 | United States |
| University of California San Diego | San Diego | California | 92103 | United States |
| Medical Associates Research Group, Inc. | San Diego | California | 92123 | United States |
| Kaiser Permanente | San Diego | California | 92154 | United States |
| Quest Clinical Research | San Francisco | California | 94115 | United States |
| University of Colorado | Aurora | Colorado | 80045 | United States |
| South Denver Gastroenterology, PC | Englewood | Colorado | 80113 | United States |
| Whitman Walker Clinic | Washington D.C. | District of Columbia | 20009 | United States |
| Capital Medical Associates | Washington D.C. | District of Columbia | 20036 | United States |
| University of Florida | Gainesville | Florida | 32610-0277 | United States |
| Borland-Groover Clinic Baptist | Jacksonville | Florida | 32256 | United States |
| University of Miami Center for Liver Diseases | Miami | Florida | 33136 | United States |
| Advanced Research Institute | New Port Richey | Florida | 34653 | United States |
| Orlando Immunology Center (ACH) | Orlando | Florida | 32803-1851 | United States |
| Internal Medicine Specialists | Orlando | Florida | 32806 | United States |
| South Florida Center of Gastroenterology, P.A. | Wellington | Florida | 33414 | United States |
| Digestive Healthcare of Georgia | Atlanta | Georgia | 30309 | United States |
| Infectious Disease Specialist of Atlanta | Decatur | Georgia | 30033 | United States |
| Gastrointestinal Specialists of Georgia, PC | Marietta | Georgia | 30060 | United States |
| Indianapolis Gastroenterology Research Foundation | Indianapolis | Indiana | 46237 | United States |
| Graves-Gilbert Clinic | Bowling Green | Kentucky | 42101 | United States |
| Gastroenterology Associates, LLC | Baton Rouge | Louisiana | 70809 | United States |
| Johns Hopkins University | Lutherville | Maryland | 21093 | United States |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
| Beth Israel Deaconess Medical Center | Boston | Massachusetts | 02215 | United States |
| The Research Institute | Springfield | Massachusetts | 01105 | United States |
| Henry Ford Health System | Novi | Michigan | 48377 | United States |
| Minnesota Gastroenterology, P.A. | Saint Paul | Minnesota | 55114 | United States |
| Kansas City Gastroenterology and Hepatology | Kansas City | Missouri | 64131 | United States |
| Comprehensive Clinical Research | Berlin | New Jersey | 08009 | United States |
| ID Care | Hillsborough | New Jersey | 08844 | United States |
| Southwest C.A.R.E. Center | Santa Fe | New Mexico | 87505 | United States |
| Binghamton Gastroenterology Associates | Binghamton | New York | 13903 | United States |
| Weill Cornell Medical College | New York | New York | 10021 | United States |
| Mount Sinai School of Medicine | New York | New York | 10029 | United States |
| Asheville Gastroenterology Associates, P.A. | Asheville | North Carolina | 28801 | United States |
| Duke University Medical Center | Durham | North Carolina | 27710 | United States |
| Digestive Health Specialists, PA | Winston-Salem | North Carolina | 27103 | United States |
| Hospital of the University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | United States |
| University Gastroenterology | Providence | Rhode Island | 02905 | United States |
| The Miriam Hospital | Providence | Rhode Island | 02906 | United States |
| Gastro One | Germantown | Tennessee | 38138 | United States |
| Nashville Gastrointestinal Specialists, Inc | Nashville | Tennessee | 37211 | United States |
| Southwest Infectious Disease Clinical Research, Inc. | Dallas | Texas | 75219 | United States |
| Research Specialists of Texas | Houston | Texas | 77030 | United States |
| Alamo Medical Research | San Antonio | Texas | 78215 | United States |
| Metropolitan Research | Fairfax | Virginia | 22031 | United States |
| Inova Fairfax Hospital Center for Liver Diseases | Falls Church | Virginia | 22042 | United States |
| Digestive and Liver Disease Specialists | Norfolk | Virginia | 23502 | United States |
| Bon Secours St. Mary's Hospital of Richmond, Inc. | Richmond | Virginia | 23226 | United States |
| Virginia Mason Medical Center | Seattle | Washington | 98101 | United States |
| Fundacion De Investigacion De Diego | San Juan | PR | 00927 | Puerto Rico |
| Result |
| Younossi ZM, Stepanova M, Henry L, Gane E, Jacobson IM, Lawitz E, Nelson D, Gerber L, Nader F, Hunt S. Effects of sofosbuvir-based treatment, with and without interferon, on outcome and productivity of patients with chronic hepatitis C. Clin Gastroenterol Hepatol. 2014 Aug;12(8):1349-59.e13. doi: 10.1016/j.cgh.2013.11.032. Epub 2013 Dec 6. |
| 25040192 | Derived | 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. |
| Enrolled and Treated |
|
| COMPLETED |
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| NOT COMPLETED |
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Safety Analysis Set
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| ID | Title | Description |
|---|---|---|
| BG000 | Sofosbuvir+PEG+RBV | Participants received Sofosbuvir+PEG+RBV for 12 weeks and were followed for 24 weeks following treatment. Sofosbuvir (400 mg) was administered as an oral tablet, PEG (180 µg) as a subcutaneous injection, and RBV (1000-1200 mg) as 200 mg oral tablets. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| ||||||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| |||||||||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| |||||||||||||||||||||||
| Race/Ethnicity, Customized | Number | participants |
| |||||||||||||||||||||||
| Hepatitis C Virus (HCV) genotype | Number | participants |
| |||||||||||||||||||||||
| HCV RNA | Mean | Standard Deviation | log10 IU/mL |
| ||||||||||||||||||||||
| HCV RNA Category | Number | participants |
| |||||||||||||||||||||||
| IL28 Genotype | CC, CT, and TT alleles are different forms of the IL28b gene. | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Participants Achieving Sustained Virologic Response (SVR)12 | SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ; ie, 25 IU/mL) 12 weeks after cessation of therapy. | Full Analysis Set | Posted | Number | percentage of participants | Posttreatment Week 12 |
|
|
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| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Number of Participants Experiencing Adverse Events Leading to Permanent Discontinuation of Study Drug | The number of participants experiencing adverse events leading to permanent discontinuation of study drug was summarized. Adverse events may or may not have been related to study treatment. Participants discontinuing study drug were permitted to remain on the study for further assessments. | Safety Analysis Set | Posted | Number | participants | Baseline to Week 12 |
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| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants Achieving SVR4 | SVR4 was defined as HCV RNA < LLOQ 4 weeks after cessation of therapy | Full Analysis Set | Posted | Number | percentage of participants | Posttreatment Week 4 |
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| Secondary | Percentage of Participants Achieving SVR24 | SVR24 was defined as HCV RNA < LLOQ 24 weeks after cessation of therapy | Full Analysis Set | Posted | Number | percentage of participants | Posttreatment Week 24 |
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| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Viral Breakthrough | Viral breakthrough was defined as HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ while receiving treatment, confirmed with 2 consecutive values (second confirmation value could be posttreatment), or last available on-treatment measurement with no subsequent follow-up values. | Full Analysis Set | Posted | Number | percentage of participants | Baseline to Week 12 |
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| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Viral Relapse | Viral relapse was defined as HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA < LLOQ at end of treatment, confirmed with 2 consecutive values or last available posttreatment measurement. | Participants in the Full Analysis Set with available data were analyzed. | Posted | Number | percentage of participants | End of treatment to post-treatment Week 24 |
|
|
Baseline to Week 12 plus 30 days
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Sofosbuvir+PEG+RBV | Participants received Sofosbuvir+PEG+RBV for 12 weeks and were followed for 24 weeks following treatment. Sofosbuvir (400 mg) was administered as an oral tablet, PEG (180 µg) as a subcutaneous injection, and RBV (1000-1200 mg) as 200 mg oral tablets. | 4 | 327 | 310 | 327 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | MedDRA (15.0) | Systematic Assessment |
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| Pyrexia | General disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Cryoglobulonaemia | Immune system disorders | MedDRA (15.0) | Systematic Assessment |
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| Spinal compression fracture | Injury, poisoning and procedural complications | MedDRA (15.0) | Systematic Assessment |
| |
| Laryngeal cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (15.0) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (15.0) | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA (15.0) | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA (15.0) | Systematic Assessment |
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| Constipation | Gastrointestinal disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA (15.0) | Systematic Assessment |
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| Pyrexia | General disorders | MedDRA (15.0) | Systematic Assessment |
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| Chills | General disorders | MedDRA (15.0) | Systematic Assessment |
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| Influenza like illness | General disorders | MedDRA (15.0) | Systematic Assessment |
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| Irritability | General disorders | MedDRA (15.0) | Systematic Assessment |
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| Pain | General disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Injection site reaction | General disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Injection site erythema | General disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA (15.0) | Systematic Assessment |
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| Depression | Psychiatric disorders | MedDRA (15.0) | Systematic Assessment |
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| Anxiety | Psychiatric disorders | MedDRA (15.0) | Systematic Assessment |
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| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (15.0) | Systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (15.0) | Systematic Assessment |
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| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA (15.0) | Systematic Assessment |
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| Pruritus | Skin and subcutaneous tissue disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA (15.0) | Systematic Assessment |
|
After conclusion of the study and without prior written approval from Gilead, investigators in this study may communicate, orally present, or publish in scientific journals or other media only after the following conditions have been met:
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Trial Disclosures | Gilead Sciences, Inc. | ClinicalTrialDisclosures@gilead.com |
| ID | Term |
|---|---|
| D019698 | Hepatitis C, Chronic |
| ID | Term |
|---|---|
| D006526 | Hepatitis C |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D006525 | Hepatitis, Viral, Human |
| D014777 | Virus Diseases |
| D018178 | Flaviviridae Infections |
| D012327 | RNA Virus Infections |
| D006521 | Hepatitis, Chronic |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000069474 | Sofosbuvir |
| D012254 | Ribavirin |
| C100416 | peginterferon alfa-2a |
| ID | Term |
|---|---|
| D014542 | Uridine Monophosphate |
| D014500 | Uracil Nucleotides |
| D011742 | Pyrimidine Nucleotides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D009711 | Nucleotides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D012265 | Ribonucleotides |
| D012263 | Ribonucleosides |
| D009705 | Nucleosides |
Not provided
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| Unknown or Not Reported |
|
| Asian |
|
| American Indian/ Alaska Native/ First Nations |
|
| Hawaiian or Pacific Islander |
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| Other |
|
| Genotype 1b |
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| Genotype 4 |
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| Genotype 5 |
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| Genotype 6 |
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| TT |
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