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This multicenter study was to evaluate subjects with chronic genotype 2 or 3 HCV infection who were interferon (IFN) ineligible, IFN intolerant or unwilling to take IFN. Participants were randomized in a 3:1 ratio to receive sofosbuvir (SOF)+ribavirin (RBV), or placebo to match SOF+placebo to match RBV. Randomization was stratified by presence/absence of cirrhosis. Approximately 20% of participants may have had evidence of cirrhosis at screening.
Participants who were randomized to the placebo arm and completed all scheduled study procedures were eligible to receive active SOF+RBV in open-label Study GS-US-334-0109.
Participants who do not achieve sustained virologic response (SVR) were eligible for enrollment in the Sequence Registry Study GS-US-248-0123. The purpose of the Sequence Registry Study is to monitor the persistence of resistant mutations for up to 3 years.
Participants who achieved SVR were eligible for enrollment in the SVR Registry Study GS-US-248-0122. The purpose of the SVR Registry Study is to evaluate durability of SVR for up to 3 years after treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SOF+RBV | Experimental | Participants were randomized to receive SOF+RBV for 12 weeks. |
|
| Placebo | Placebo Comparator | Participants were randomized to receive placebo to match SOF plus placebo to match RBV for 12 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SOF | Drug | Sofosbuvir (SOF) 400 mg tablet administered orally once daily |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Achieving SVR12 | SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ, ie, < 25 IU/mL) 12 weeks after cessation of therapy | Post-treatment Week 12 |
| Number of Participants Experiencing Adverse Events Leading to Permanent Discontinuation of Study Drug | The number of subjects experiencing adverse events leading to permanent discontinuation of study drug was summarized. Adverse events may or may not have been related to study treatment. | 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 | Post-treatment 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 2 or 3
Cirrhosis determination
Subject meets one of the following classifications:
Screening laboratory values within defined thresholds
Subject has not been treated with any investigational drug or device within 30 days of the Screening visit
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 Liver Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 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. | |
| 23607593 | Derived |
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410 participants were screened and 280 were randomized. Of those participants randomized, 278 received at least one dose of study drug, and comprise the Safety Analysis Set and the Full Analysis Set.
Participants were enrolled at 54 sites in the North America, Australia, and New Zealand. The first participant was screened on 07 March 2012. The last participant observation was on 04 February 2013.
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| ID | Title | Description |
|---|---|---|
| FG000 | SOF+RBV | Participants were randomized to receive sofosbuvir (SOF)+ribavirin (RBV) for 12 weeks. SOF was administered as a 400 mg tablet orally once daily. RBV was administered as 200 mg tablets (1000-1200 mg daily based on weight) according to package insert recommendations. |
| FG001 | Placebo |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| RBV | Drug | Ribavirin (RBV) was administered as a tablet orally according to package insert weight-based dosing recommendations (< 75kg = 1000 mg and ≥ 75 kg = 1200 mg). |
|
| Placebo to match SOF | Drug | Placebo to match SOF was administered orally once daily. |
|
| Placebo to match RBV | Drug | Placebo to match RBV was administered orally twice daily. |
|
| Post-treatment Week 24 |
| Percentage of Participants Experiencing 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 Experiencing 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 |
| Lightspeed Medical | Los Angeles | California | 90036 | United States |
| Anthony Mills MD, Inc. | Los Angeles | California | 90069 | United States |
| Medical Associates Research Group | San Diego | California | 912123 | United States |
| UCSD Antiviral Research Center | San Diego | California | 92103 | 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 | Englewood | Colorado | 80113 | United States |
| Whitman Walker Clinic | Washington D.C. | District of Columbia | 20009 | United States |
| University of Florida | Gainesville | Florida | 32610-0277 | United States |
| Borland-Groover Clinic | 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 |
| 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 | 02114-2696 | United States |
| Beth Israel Deaconess Medical Center | Boston | Massachusetts | 02115 | 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 | 55407 | 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 |
| 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 |
| Duke University | Durham | North Carolina | 27710 | United States |
| Digestive Health Specialists, PA | Winston-Salem | North Carolina | 27103 | United States |
| University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | United States |
| University Gastroenterology | Providence | Rhode Island | 02905 | 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 |
| Therapeutic Concepts, PA | Houston | Texas | 77004 | 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 |
| Liver Institute of Virginia, Bon Secours St.Mary's | Newport News | Virginia | 23602 | United States |
| Digestive and Liver Disease Specialists | Norfolk | Virginia | 23502 | United States |
| Virginia Mason Medical Center | Seattle | Washington | 98101 | United States |
| Westmead Hospital | Westmead | New South Wales | 2145 | Australia |
| Royal Brisbane & Women's Hospital | Herston | Queensland | 4029 | Australia |
| St. Vincent's Hospital | Melbourne | 3065 | Australia |
| Monash Medical Centre | Melbourne | 3168 | Australia |
| University of Calgary | Calgary | Alberta | T2N 4Z6 | Canada |
| Gordon & Leslie Diamond Health Care Centre | Vancouver | British Columbia | V5Z 1M9 | Canada |
| (G.I.R.I.) Gastrointestinal Research Institute | Vancouver | British Columbia | V6Z 2K5 | Canada |
| Toronto Liver Centre | Toronto | Ontario | M6H 3M1 | Canada |
| CHUM - The Research Centre | Montreal | Quebec | H2X 3J4 | Canada |
| Auckland Clinical Studies Limited | Auckland | 1640 | New Zealand |
| Christchurch Hospital | Christchurch | 8011 | New Zealand |
| Fundacion De Investigacion De Diego | San Juan | Puerto Rico | 00927 | Puerto Rico |
| Clinical Research Puerto Rico Inc | San Juan | 00909-1711 | Puerto Rico |
| Jacobson IM, Gordon SC, Kowdley KV, Yoshida EM, Rodriguez-Torres M, Sulkowski MS, Shiffman ML, Lawitz E, Everson G, Bennett M, Schiff E, Al-Assi MT, Subramanian GM, An D, Lin M, McNally J, Brainard D, Symonds WT, McHutchison JG, Patel K, Feld J, Pianko S, Nelson DR; POSITRON Study; FUSION Study. Sofosbuvir for hepatitis C genotype 2 or 3 in patients without treatment options. N Engl J Med. 2013 May 16;368(20):1867-77. doi: 10.1056/NEJMoa1214854. Epub 2013 Apr 23. |
Participants were randomized to receive placebo to match SOF plus placebo to match RBV for 12 weeks. Placebos were administered in the same manner as their active counterparts. |
| Randomized and Treated |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
Participants in the Safety Analysis Set (randomized and received at least 1 dose of study drug) were analyzed for baseline characteristics.
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| ID | Title | Description |
|---|---|---|
| BG000 | SOF+RBV | Participants were randomized to receive SOF+RBV for 12 weeks. SOF was administered as a 400 mg tablet orally once daily. RBV was administered as 200 mg tablets (1000-1200 mg daily based on weight) according to package insert recommendations. |
| BG001 | Placebo | Participants were randomized to receive placebo to match SOF plus placebo to match RBV for 12 weeks. Placebos were administered in the same manner as their active counterparts. |
| BG002 | Total | Total of all reporting groups |
| 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 (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
| ||||||||||||||||
| Cirrhosis | Number | participants |
| ||||||||||||||||
| HCV Genotype | Number | participants |
| ||||||||||||||||
| IL28 Genotype | Number | participants |
| ||||||||||||||||
| HCV RNA | Mean | Standard Deviation | log10 IU/mL |
| |||||||||||||||
| HCV RNA Category | Number | participants |
| ||||||||||||||||
| Interferon Classification | 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 SVR12 | 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: participants with genotype 2 or 3 HCV infection who were randomized into the study and received at least 1 dose of study drug | Posted | Number | percentage of participants | Post-treatment Week 12 |
|
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| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Number of Participants Experiencing Adverse Events Leading to Permanent Discontinuation of Study Drug | The number of subjects experiencing adverse events leading to permanent discontinuation of study drug was summarized. Adverse events may or may not have been related to study treatment. | Safety Analysis Set: participants were randomized and received at least 1 dose of study drug | Posted | Number | participants | Baseline to Week 12 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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 | Post-treatment Week 4 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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 | Post-treatment Week 24 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants Experiencing 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 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants Experiencing 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 who had an end-of-treatment response (HCV RNA < LLOQ as the last observed on-treatment value) were analyzed. | Posted | Number | percentage of participants | End of treatment to post-treatment Week 24 |
|
|
Baseline to last dose date of study regimen + 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 | SOF+RBV | Participants were randomized to receive SOF+RBV for 12 weeks. SOF was administered as a 400 mg tablet orally once daily. RBV was administered as 200 mg tablets (1000-1200 mg daily based on weight) according to package insert recommendations. | 11 | 207 | 184 | 207 | ||
| EG001 | Placebo | Participants were randomized to receive placebo to match SOF plus placebo to match RBV for 12 weeks. Placebos were administered in the same manner as their active counterparts. | 2 | 71 | 55 | 71 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pancreatitis | Gastrointestinal disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Drug withdrawal syndrome | General disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Bile duct stone | Hepatobiliary disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Hypersensitivity | Immune system disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Abdominal abscess | Infections and infestations | MedDRA (15.0) | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA (15.0) | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA (15.0) | Systematic Assessment |
| |
| Overdose | Injury, poisoning and procedural complications | MedDRA (15.0) | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA (15.0) | Systematic Assessment |
| |
| Injury | Injury, poisoning and procedural complications | MedDRA (15.0) | Systematic Assessment |
| |
| Road traffic accident | Injury, poisoning and procedural complications | MedDRA (15.0) | Systematic Assessment |
| |
| Spinal compression fracture | Injury, poisoning and procedural complications | MedDRA (15.0) | Systematic Assessment |
| |
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Hepatic neoplasm malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (15.0) | Systematic Assessment |
| |
| Abnormal behaviour | Psychiatric disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Eczema | Skin and subcutaneous tissue disorders | 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 |
| |
| Nausea | Gastrointestinal disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Irritability | General disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Oedema peripheral | 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 |
| |
| 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 |
| |
| Anxiety | Psychiatric disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Rash | 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 |
Not provided
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| ID | Term |
|---|---|
| D000069474 | Sofosbuvir |
| 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 |
Not provided
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| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Canada |
|
| Australia |
|
| New Zealand |
|
| Yes |
|
| Genotype 3 |
|
| CT |
|
| TT |
|
| ≥ 6 log10 IU/mL |
|
| Intolerant |
|
| Unwilling |
|
| Superiority or Other |
|
|
|
|
|
|
|