Ignite Creation Date:
2025-12-24 @ 4:39 PM
Ignite Modification Date:
2026-01-04 @ 3:37 AM
Study NCT ID:
NCT01497366
Status:
COMPLETED
Last Update Posted:
2014-04-02
First Post:
2011-12-19
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Phase 3 Study of Sofosbuvir and Ribavirin
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006526', 'term': 'Hepatitis C'}], 'ancestors': [{'id': 'D000086982', 'term': 'Blood-Borne Infections'}, {'id': 'D003141', 'term': 'Communicable Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D006525', 'term': 'Hepatitis, Viral, Human'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D018178', 'term': 'Flaviviridae Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D006505', 'term': 'Hepatitis'}, {'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069474', 'term': 'Sofosbuvir'}, {'id': 'C100416', 'term': 'peginterferon alfa-2a'}], 'ancestors': [{'id': 'D014542', 'term': 'Uridine Monophosphate'}, {'id': 'D014500', 'term': 'Uracil Nucleotides'}, {'id': 'D011742', 'term': 'Pyrimidine Nucleotides'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D009711', 'term': 'Nucleotides'}, {'id': 'D009706', 'term': 'Nucleic Acids, Nucleotides, and Nucleosides'}, {'id': 'D012265', 'term': 'Ribonucleotides'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTrialDisclosures@gilead.com', 'title': 'Clinical Trial Disclosures', 'organization': 'Gilead Sciences, Inc.'}, 'certainAgreement': {'otherDetails': '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:\n\n* The results of the study in their entirety have been publicly disclosed by or with the consent of Gilead in an abstract, manuscript, or presentation form; or\n* The study has been completed at all study sites for at least 2 years', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Up to 24 weeks plus 30 days following the last dose of study drug', 'eventGroups': [{'id': 'EG000', 'title': 'Sofosbuvir+RBV', 'description': 'Participants were randomized to receive sofosbuvir+RBV for 12 weeks.', 'otherNumAtRisk': 256, 'otherNumAffected': 219, 'seriousNumAtRisk': 256, 'seriousNumAffected': 7}, {'id': 'EG001', 'title': 'PEG+RBV', 'description': 'Participants were randomized to receive PEG+RBV for 24 weeks.', 'otherNumAtRisk': 243, 'otherNumAffected': 233, 'seriousNumAtRisk': 243, 'seriousNumAffected': 3}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 256, 'numAffected': 20}, {'groupId': 'EG001', 'numAtRisk': 243, 'numAffected': 28}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 15.0'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 256, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 243, 'numAffected': 30}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 15.0'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 256, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 243, 'numAffected': 23}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 15.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 256, 'numAffected': 46}, {'groupId': 'EG001', 'numAtRisk': 243, 'numAffected': 70}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 15.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 256, 'numAffected': 23}, {'groupId': 'EG001', 'numAtRisk': 243, 'numAffected': 42}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 15.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 256, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 243, 'numAffected': 23}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 15.0'}, {'term': 'Dry mouth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 256, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 243, 'numAffected': 15}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 15.0'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 256, 'numAffected': 92}, {'groupId': 'EG001', 'numAtRisk': 243, 'numAffected': 134}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 15.0'}, {'term': 'Irritability', 'stats': [{'groupId': 'EG000', 'numAtRisk': 256, 'numAffected': 25}, {'groupId': 'EG001', 'numAtRisk': 243, 'numAffected': 40}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 15.0'}, {'term': 'Chills', 'stats': [{'groupId': 'EG000', 'numAtRisk': 256, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 243, 'numAffected': 44}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 15.0'}, {'term': 'Influenza like illness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 256, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 243, 'numAffected': 44}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 15.0'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 256, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 243, 'numAffected': 33}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 15.0'}, {'term': 'Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 256, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 243, 'numAffected': 30}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 15.0'}, {'term': 'Injection site reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 256, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 243, 'numAffected': 17}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 15.0'}, {'term': 'Injection site erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 256, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 243, 'numAffected': 14}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 15.0'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 256, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 243, 'numAffected': 5}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 15.0'}, {'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 256, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 243, 'numAffected': 44}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 15.0'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 256, 'numAffected': 21}, {'groupId': 'EG001', 'numAtRisk': 243, 'numAffected': 40}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 15.0'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 256, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 243, 'numAffected': 35}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 15.0'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 256, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 243, 'numAffected': 20}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 15.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 256, 'numAffected': 64}, {'groupId': 'EG001', 'numAtRisk': 243, 'numAffected': 108}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 15.0'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 256, 'numAffected': 27}, {'groupId': 'EG001', 'numAtRisk': 243, 'numAffected': 33}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 15.0'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 256, 'numAffected': 31}, {'groupId': 'EG001', 'numAtRisk': 243, 'numAffected': 71}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 15.0'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 256, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 243, 'numAffected': 35}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 15.0'}, {'term': 'Anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 256, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 243, 'numAffected': 16}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 15.0'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 256, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 243, 'numAffected': 21}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 15.0'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 256, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 243, 'numAffected': 20}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 15.0'}, {'term': 'Oropharyngeal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 256, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 243, 'numAffected': 10}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 15.0'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 256, 'numAffected': 23}, {'groupId': 'EG001', 'numAtRisk': 243, 'numAffected': 43}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 15.0'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 256, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 243, 'numAffected': 42}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 15.0'}, {'term': 'Alopecia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 256, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 243, 'numAffected': 24}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 15.0'}, {'term': 'Dry skin', 'stats': [{'groupId': 'EG000', 'numAtRisk': 256, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 243, 'numAffected': 23}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 15.0'}], 'seriousEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 256, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 243, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 15.0'}, {'term': 'Atrioventriclar shock', 'stats': [{'groupId': 'EG000', 'numAtRisk': 256, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 243, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 15.0'}, {'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 256, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 243, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 15.0'}, {'term': 'Allergy to arthropod sting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 256, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 243, 'numAffected': 0}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 15.0'}, {'term': 'Cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 256, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 243, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 15.0'}, {'term': 'Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 256, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 243, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 15.0'}, {'term': 'Osteomyelitis chronic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 256, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 243, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 15.0'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 256, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 243, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 15.0'}, {'term': 'Clavicle fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 256, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 243, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 15.0'}, {'term': 'Rib fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 256, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 243, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 15.0'}, {'term': 'Toxicity to various agents', 'stats': [{'groupId': 'EG000', 'numAtRisk': 256, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 243, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 15.0'}, {'term': 'Breast cancer in situ', 'stats': [{'groupId': 'EG000', 'numAtRisk': 256, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 243, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 15.0'}, {'term': 'Chronic obstructive pulmonary disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 256, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 243, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 15.0'}, {'term': 'Pneumothorax', 'stats': [{'groupId': 'EG000', 'numAtRisk': 256, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 243, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 15.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Participants With Sustained Virologic Response 12 Weeks After Stopping All Study Drugs (SVR12)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '253', 'groupId': 'OG000'}, {'value': '243', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Sofosbuvir+RBV', 'description': 'Participants were randomized to receive sofosbuvir+RBV for 12 weeks.'}, {'id': 'OG001', 'title': 'PEG+RBV', 'description': 'Participants were randomized to receive PEG+RBV for 24 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '67', 'groupId': 'OG000', 'lowerLimit': '61.0', 'upperLimit': '72.9'}, {'value': '67', 'groupId': 'OG001', 'lowerLimit': '60.4', 'upperLimit': '72.6'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in percentages', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.3', 'ciLowerLimit': '-7.5', 'ciUpperLimit': '8.0', 'estimateComment': 'The difference in percentages between treatment groups and the 95% CI calculated were based on stratum adjusted Mantel-Haenszel proportions.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'Non-inferiority would be demonstrated if the lower bound of the 2-sided 95% confidence interval (CI) for the difference in SVR12 rates was greater than -15%.'}], 'paramType': 'NUMBER', 'timeFrame': 'Post-treatment Week 12', 'description': 'SVR12 was defined as HCV RNA \\< the lower limit of quantitation (LLOQ; \\< 25 IU/mL) 12 weeks after study drug cessation.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set'}, {'type': 'SECONDARY', 'title': 'Number of Participants Who Experienced Adverse Events (AEs) and Graded Laboratory Abnormalities', 'denoms': [{'units': 'Participants', 'counts': [{'value': '256', 'groupId': 'OG000'}, {'value': '243', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Sofosbuvir+RBV', 'description': 'Participants were randomized to receive sofosbuvir+RBV for 12 weeks.'}, {'id': 'OG001', 'title': 'PEG+RBV', 'description': 'Participants were randomized to receive PEG+RBV for 24 weeks.'}], 'classes': [{'title': 'AEs leading to discontinuation of any study drug', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}]}, {'title': 'Serious AEs', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 laboratory abnormalities', 'categories': [{'measurements': [{'value': '33', 'groupId': 'OG000'}, {'value': '80', 'groupId': 'OG001'}]}]}, {'title': 'Grade 4 laboratory abnormalities', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}]}, {'title': 'Deaths', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 24 weeks plus 30 days following the last dose of study drug', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Analysis Set'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Sustained Virologic Response 24 Weeks After Stopping All Study Drugs (SVR24)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '253', 'groupId': 'OG000'}, {'value': '243', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Sofosbuvir+RBV', 'description': 'Participants were randomized to receive sofosbuvir+RBV for 12 weeks.'}, {'id': 'OG001', 'title': 'PEG+RBV', 'description': 'Participants were randomized to receive PEG+RBV for 24 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '66.8', 'groupId': 'OG000', 'lowerLimit': '60.6', 'upperLimit': '72.6'}, {'value': '65.4', 'groupId': 'OG001', 'lowerLimit': '59.1', 'upperLimit': '71.4'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Post-treatment Week 24', 'description': 'SVR24 was defined as HCV RNA \\< LLOQ 24 weeks after study drug cessation.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With HCV RNA < LLOQ on Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '253', 'groupId': 'OG000'}, {'value': '243', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Sofosbuvir+RBV', 'description': 'Participants were randomized to receive sofosbuvir (SOF)+RBV for 12 weeks.'}, {'id': 'OG001', 'title': 'PEG+RBV', 'description': 'Participants were randomized to receive PEG+RBV for 24 weeks.'}], 'classes': [{'title': 'Week 1 (SOF+RBV, n = 252; PEG+RBV, n = 243)', 'categories': [{'measurements': [{'value': '43.7', 'groupId': 'OG000'}, {'value': '6.6', 'groupId': 'OG001'}]}]}, {'title': 'Week 2 (SOF+RBV, n = 251; PEG+RBV, n = 241)', 'categories': [{'measurements': [{'value': '92.0', 'groupId': 'OG000'}, {'value': '31.5', 'groupId': 'OG001'}]}]}, {'title': 'Week 4 (SOF+RBV, n = 250; PEG+RBV, n = 236)', 'categories': [{'measurements': [{'value': '99.6', 'groupId': 'OG000'}, {'value': '66.9', 'groupId': 'OG001'}]}]}, {'title': 'Week 8 (SOF+RBV, n = 248; PEG+RBV, n = 231)', 'categories': [{'measurements': [{'value': '99.6', 'groupId': 'OG000'}, {'value': '85.7', 'groupId': 'OG001'}]}]}, {'title': 'Week 12 (SOF+RBV, n = 244; PEG+RBV, n = 224)', 'categories': [{'measurements': [{'value': '99.2', 'groupId': 'OG000'}, {'value': '92.4', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 12 Weeks', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in the Full Analysis Set with available data were analyzed.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in HCV RNA', 'denoms': [{'units': 'Participants', 'counts': [{'value': '253', 'groupId': 'OG000'}, {'value': '243', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Sofosbuvir+RBV', 'description': 'Participants were randomized to receive sofosbuvir (SOF)+RBV for 12 weeks.'}, {'id': 'OG001', 'title': 'PEG+RBV', 'description': 'Participants were randomized to receive PEG+RBV for 24 weeks.'}], 'classes': [{'title': 'Week 1 (SOF+RBV, n = 239; PEG+RBV, n = 236)', 'categories': [{'measurements': [{'value': '-4.26', 'spread': '0.689', 'groupId': 'OG000'}, {'value': '-2.19', 'spread': '1.287', 'groupId': 'OG001'}]}]}, {'title': 'Week 2 (SOF+RBV, n = 246; PEG+RBV, n = 233)', 'categories': [{'measurements': [{'value': '-4.60', 'spread': '0.820', 'groupId': 'OG000'}, {'value': '-3.19', 'spread': '1.572', 'groupId': 'OG001'}]}]}, {'title': 'Week 4 (SOF+RBV, n = 250; PEG+RBV, n = 235)', 'categories': [{'measurements': [{'value': '-4.64', 'spread': '0.816', 'groupId': 'OG000'}, {'value': '-4.04', 'spread': '1.389', 'groupId': 'OG001'}]}]}, {'title': 'Week 8 (SOF+RBV, n = 248; PEG+RBV, n = 228)', 'categories': [{'measurements': [{'value': '-4.63', 'spread': '0.850', 'groupId': 'OG000'}, {'value': '-4.42', 'spread': '1.163', 'groupId': 'OG001'}]}]}, {'title': 'Week 12 (SOF+RBV, n = 243; PEG+RBV, n = 222)', 'categories': [{'measurements': [{'value': '-4.65', 'spread': '0.820', 'groupId': 'OG000'}, {'value': '-4.45', 'spread': '1.226', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to Week 12', 'unitOfMeasure': 'log10 IU/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in the Full Analysis Set with available data were analyzed.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Virologic Failure During Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '253', 'groupId': 'OG000'}, {'value': '243', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Sofosbuvir+RBV', 'description': 'Participants were randomized to receive sofosbuvir+RBV for 12 weeks.'}, {'id': 'OG001', 'title': 'PEG+RBV', 'description': 'Participants were randomized to receive PEG+RBV for 24 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.4', 'groupId': 'OG000'}, {'value': '7.4', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline up to Week 24', 'description': 'Virologic failure was defined as either\n\n* Viral breakthrough: HCV RNA ≥ 25 IU/mL after having previously had HCV RNA \\< 25 IU/mL while on treatment, confirmed with 2 consecutive values or last available measurement\n* Viral rebound: \\> 1 log10 IU/mL increase in HCV RNA from nadir while on treatment, confirmed with 2 consecutive values or last available measurement\n* Non-response: HCV RNA persistently ≥ 25 IU/ml while on treatment (through Week 12)', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Viral Relapse Following Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '249', 'groupId': 'OG000'}, {'value': '217', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Sofosbuvir+RBV', 'description': 'Participants were randomized to receive sofosbuvir+RBV for 12 weeks.'}, {'id': 'OG001', 'title': 'PEG+RBV', 'description': 'Participants were randomized to receive PEG+RBV for 24 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '30.5', 'groupId': 'OG000'}, {'value': '22.6', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to Post-treatment Week 24', 'description': 'Viral relapse was defined as HCV RNA ≥ 25 IU/mL in post-treatment after having achieved \\< LLOQ at last on-treatment measurement, confirmed with 2 consecutive values or last available measurement.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in the Full Analysis Set with available data were analyzed.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Sofosbuvir+RBV', 'description': 'Participants were randomized to receive sofosbuvir+ribavirin (RBV) for 12 weeks.'}, {'id': 'FG001', 'title': 'PEG+RBV', 'description': 'Participants were randomized to receive PEG+RBV for 24 weeks.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '263'}, {'groupId': 'FG001', 'numSubjects': '264'}]}, {'type': 'Randomized But Not Treated', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '21'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '224'}, {'groupId': 'FG001', 'numSubjects': '176'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '39'}, {'groupId': 'FG001', 'numSubjects': '88'}]}], 'dropWithdraws': [{'type': 'Virologic failure', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '50'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '10'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '6'}]}, {'type': 'Initiated Non-protocol HCV Treatment', 'reasons': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Randomized but not treated', 'reasons': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '21'}]}]}], 'recruitmentDetails': 'Subjects were enrolled in a total of 90 study sites in the United States, Australia, New Zealand, Canada, Sweden, Italy, and the Netherlands. The first participant was screened on 19 December 2011. The last participant observation was on 08 April 2013.', 'preAssignmentDetails': '666 participants were screened and 527 were randomized; 499 participants received at least 1 dose of study drug, and comprise the Safety Analysis Set. The 496 participants with genotype 2 or 3 HCV infection who were randomized and received at least 1 dose of study drug comprise the Full Analysis Set.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '256', 'groupId': 'BG000'}, {'value': '243', 'groupId': 'BG001'}, {'value': '499', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Sofosbuvir+RBV', 'description': 'Participants were randomized to receive sofosbuvir+RBV for 12 weeks.'}, {'id': 'BG001', 'title': 'PEG+RBV', 'description': 'Participants were randomized to receive PEG+RBV for 24 weeks.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '48', 'spread': '10.8', 'groupId': 'BG000'}, {'value': '48', 'spread': '11.4', 'groupId': 'BG001'}, {'value': '48', 'spread': '11.0', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '85', 'groupId': 'BG000'}, {'value': '87', 'groupId': 'BG001'}, {'value': '172', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '171', 'groupId': 'BG000'}, {'value': '156', 'groupId': 'BG001'}, {'value': '327', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '41', 'groupId': 'BG000'}, {'value': '31', 'groupId': 'BG001'}, {'value': '72', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '215', 'groupId': 'BG000'}, {'value': '212', 'groupId': 'BG001'}, {'value': '427', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Black or African American', 'categories': [{'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}]}]}, {'title': 'White', 'categories': [{'measurements': [{'value': '223', 'groupId': 'BG000'}, {'value': '212', 'groupId': 'BG001'}, {'value': '435', 'groupId': 'BG002'}]}]}, {'title': 'Asian', 'categories': [{'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '29', 'groupId': 'BG002'}]}]}, {'title': 'American Indian/Alaska Native/First Nations', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}]}, {'title': 'Hawaiian or Pacific Islander', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}]}, {'title': 'Black and White', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}, {'title': 'South American', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '165', 'groupId': 'BG000'}, {'value': '151', 'groupId': 'BG001'}, {'value': '316', 'groupId': 'BG002'}]}]}, {'title': 'Canada', 'categories': [{'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '39', 'groupId': 'BG002'}]}]}, {'title': 'Australia', 'categories': [{'measurements': [{'value': '32', 'groupId': 'BG000'}, {'value': '29', 'groupId': 'BG001'}, {'value': '61', 'groupId': 'BG002'}]}]}, {'title': 'Netherlands', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}]}, {'title': 'Italy', 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}]}, {'title': 'New Zealand', 'categories': [{'measurements': [{'value': '29', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '59', 'groupId': 'BG002'}]}]}, {'title': 'Sweden', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Hepatitis C Virus (HCV) genotype', 'classes': [{'title': 'Genotype 1', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}, {'title': 'Genotype 2', 'categories': [{'measurements': [{'value': '70', 'groupId': 'BG000'}, {'value': '67', 'groupId': 'BG001'}, {'value': '137', 'groupId': 'BG002'}]}]}, {'title': 'Genotype 3', 'categories': [{'measurements': [{'value': '183', 'groupId': 'BG000'}, {'value': '176', 'groupId': 'BG001'}, {'value': '359', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Baseline HCV RNA', 'classes': [{'categories': [{'measurements': [{'value': '6.0', 'spread': '0.82', 'groupId': 'BG000'}, {'value': '6.0', 'spread': '0.78', 'groupId': 'BG001'}, {'value': '6.0', 'spread': '0.80', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'log10 IU/mL', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Baseline HCV RNA Category', 'classes': [{'title': '< 6 log10 IU/mL', 'categories': [{'measurements': [{'value': '108', 'groupId': 'BG000'}, {'value': '106', 'groupId': 'BG001'}, {'value': '214', 'groupId': 'BG002'}]}]}, {'title': '≥ 6 log10 IU/mL', 'categories': [{'measurements': [{'value': '148', 'groupId': 'BG000'}, {'value': '137', 'groupId': 'BG001'}, {'value': '285', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'IL28b genotype', 'classes': [{'title': 'CC', 'categories': [{'measurements': [{'value': '108', 'groupId': 'BG000'}, {'value': '106', 'groupId': 'BG001'}, {'value': '214', 'groupId': 'BG002'}]}]}, {'title': 'CT', 'categories': [{'measurements': [{'value': '121', 'groupId': 'BG000'}, {'value': '98', 'groupId': 'BG001'}, {'value': '219', 'groupId': 'BG002'}]}]}, {'title': 'TT', 'categories': [{'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '38', 'groupId': 'BG001'}, {'value': '63', 'groupId': 'BG002'}]}]}, {'title': 'Missing', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Cirrhosis', 'classes': [{'title': 'No', 'categories': [{'measurements': [{'value': '205', 'groupId': 'BG000'}, {'value': '189', 'groupId': 'BG001'}, {'value': '394', 'groupId': 'BG002'}]}]}, {'title': 'Yes', 'categories': [{'measurements': [{'value': '50', 'groupId': 'BG000'}, {'value': '50', 'groupId': 'BG001'}, {'value': '100', 'groupId': 'BG002'}]}]}, {'title': 'Missing', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'Safety Analysis Set'}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 527}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-03', 'dispFirstSubmitDate': '2013-11-20', 'completionDateStruct': {'date': '2013-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-03-04', 'studyFirstSubmitDate': '2011-12-19', 'dispFirstSubmitQcDate': '2013-11-20', 'resultsFirstSubmitDate': '2014-01-15', 'studyFirstSubmitQcDate': '2011-12-21', 'dispFirstPostDateStruct': {'date': '2013-12-06', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2014-04-02', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2014-03-04', 'studyFirstPostDateStruct': {'date': '2011-12-22', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-04-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Participants With Sustained Virologic Response 12 Weeks After Stopping All Study Drugs (SVR12)', 'timeFrame': 'Post-treatment Week 12', 'description': 'SVR12 was defined as HCV RNA \\< the lower limit of quantitation (LLOQ; \\< 25 IU/mL) 12 weeks after study drug cessation.'}], 'secondaryOutcomes': [{'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', 'description': 'SVR24 was defined as HCV RNA \\< LLOQ 24 weeks after study drug cessation.'}, {'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', 'description': 'Virologic failure was defined as either\n\n* Viral breakthrough: HCV RNA ≥ 25 IU/mL after having previously had HCV RNA \\< 25 IU/mL while on treatment, confirmed with 2 consecutive values or last available measurement\n* Viral rebound: \\> 1 log10 IU/mL increase in HCV RNA from nadir while on treatment, confirmed with 2 consecutive values or last available measurement\n* Non-response: HCV RNA persistently ≥ 25 IU/ml while on treatment (through Week 12)'}, {'measure': 'Percentage of Participants With Viral Relapse Following Treatment', 'timeFrame': 'Up to Post-treatment Week 24', 'description': 'Viral relapse was defined as HCV RNA ≥ 25 IU/mL in post-treatment after having achieved \\< LLOQ at last on-treatment measurement, confirmed with 2 consecutive values or last available measurement.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['HCV genotype 2 (GT-2)', 'HCV genotype 3 (GT-3)'], 'conditions': ['Hepatitis C']}, 'referencesModule': {'references': [{'pmid': '25040192', 'type': 'DERIVED', '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."}, {'pmid': '23607594', 'type': 'DERIVED', '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.'}]}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Chronic Genotype 2 or 3 HCV-infection\n* Naive to all HCV antiviral treatment(s)\n\nExclusion Criteria:\n\n* Positive test at Screening for HBsAg, anti-hepatitis B core immunoglobulin M antibody (anti-HBc IgM Ab), or anti-HIV Ab\n* History of any other clinically significant chronic liver disease\n* A history consistent with decompensated liver disease\n* 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.\n* Participation in a clinical study within 3 months prior to first dose'}, 'identificationModule': {'nctId': 'NCT01497366', 'acronym': 'FISSION', 'briefTitle': 'Phase 3 Study of Sofosbuvir and Ribavirin', 'organization': {'class': 'INDUSTRY', 'fullName': 'Gilead Sciences'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'P7977-1231'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Sofosbuvir+RBV', 'description': 'Participants were randomized to receive sofosbuvir+RBV for 12 weeks.', 'interventionNames': ['Drug: Sofosbuvir', 'Drug: RBV']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'PEG+RBV', 'description': 'Participants were randomized to receive PEG+RBV for 24 weeks.', 'interventionNames': ['Drug: PEG', 'Drug: RBV']}], 'interventions': [{'name': 'Sofosbuvir', 'type': 'DRUG', 'otherNames': ['Sovaldi™', 'GS-7977', 'PSI-7977'], 'description': 'Sofosbuvir 400 mg (2 × 200 mg tablets) administered orally once daily', 'armGroupLabels': ['Sofosbuvir+RBV']}, {'name': 'PEG', 'type': 'DRUG', 'otherNames': ['Pegasys®'], 'description': 'Pegylated interferon alfa-2a (PEG) 180 μg administered once weekly by subcutaneous injection', 'armGroupLabels': ['PEG+RBV']}, {'name': 'RBV', 'type': 'DRUG', 'description': 'Ribavirin (RBV) administered as 200 mg tablets up to 1200 mg in a divided daily dose\n\n* Dose of sofosbuvir+RBV group based on baseline weight: \\< 75kg = 1000 mg and ≥ 75 kg = 1200 mg\n* Dose of PEG+RBV group: 800 mg', 'armGroupLabels': ['PEG+RBV', 'Sofosbuvir+RBV']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35294', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'University of Alabama at Birmingham', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '36116', 'city': 'Montgomery', 'state': 'Alabama', 'country': 'United States', 'facility': 'Alabama Liver & Digestive Specialist', 'geoPoint': {'lat': 32.36681, 'lon': -86.29997}}, {'zip': '93301', 'city': 'Bakersfield', 'state': 'California', 'country': 'United States', 'facility': 'Franco Felizarta, MD', 'geoPoint': {'lat': 35.37329, 'lon': -119.01871}}, {'zip': '90210', 'city': 'Beverly Hills', 'state': 'California', 'country': 'United States', 'facility': 'California Liver Institute', 'geoPoint': {'lat': 34.07362, 'lon': -118.40036}}, {'zip': '92324', 'city': 'Colton', 'state': 'California', 'country': 'United States', 'facility': 'Arrowhead Regional Medical Center', 'geoPoint': {'lat': 34.0739, 'lon': -117.31365}}, {'zip': '92118', 'city': 'Coronado', 'state': 'California', 'country': 'United States', 'facility': 'SCTI Research Foundation', 'geoPoint': {'lat': 32.68589, 'lon': -117.18309}}, {'zip': '91940', 'city': 'La Mesa', 'state': 'California', 'country': 'United States', 'facility': 'eStudy Site', 'geoPoint': {'lat': 32.76783, 'lon': -117.02308}}, {'zip': '90036', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Peter J. 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