Viewing Study NCT02822794

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Ignite Creation Date: 2025-12-25 @ 1:41 AM
Ignite Modification Date: 2026-02-25 @ 8:31 PM
Study NCT ID: NCT02822794
Status: COMPLETED
Last Update Posted: 2018-11-14
First Post: 2016-06-30
Is NOT Gene Therapy: True
Has Adverse Events: True
Brief Title: Sofosbuvir/Velpatasvir Fixed-Dose Combination and Ribavirin for 12 or 24 Weeks in Participants With Chronic Genotype 1 or 2 Hepatitis C Virus Infection Who Have Previously Failed a Direct-Acting Antiviral-Containing Regimen
Sponsor:
Organization:
Overview Dates Organization Conditions Design Enrollment Locations Outcomes Modules Raw JSON

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': 'C000611331', 'term': 'sofosbuvir-velpatasvir drug combination'}, {'id': 'D012254', 'term': 'Ribavirin'}], 'ancestors': [{'id': 'D012263', 'term': 'Ribonucleosides'}, {'id': 'D009705', 'term': 'Nucleosides'}, {'id': 'D009706', 'term': 'Nucleic Acids, Nucleotides, and Nucleosides'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'GileadClinicalTrials@gilead.com', 'phone': '1-833-445-3230 (GILEAD-0)', 'title': 'Gilead Clinical Study Information Center', 'organization': 'Gilead Sciences'}, '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': 'Adverse Events and Serious Adverse Events: Up to 24 weeks + 30 days. All-Cause Mortality: Up to Posttreatment Week 24.', 'description': 'Safety Analysis Set: participants who received at least 1 dose of study drug', 'eventGroups': [{'id': 'EG000', 'title': 'SOF/VEL+RBV 12 Weeks', 'description': 'SOF/VEL (400/100 mg) FDC tablet orally once daily + RBV capsule (600, 800, or 1000 mg daily based on weight) for 12 weeks in participants with genotype 1 or genotype 2 HCV infection', 'otherNumAtRisk': 57, 'deathsNumAtRisk': 57, 'otherNumAffected': 43, 'seriousNumAtRisk': 57, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'SOF/VEL+RBV 24 Weeks', 'description': 'SOF/VEL (400/100 mg) FDC tablet orally once daily + RBV capsule (600, 800, or 1000 mg daily based on weight) for 24 weeks in participants with genotype 1 or genotype 2 HCV infection', 'otherNumAtRisk': 60, 'deathsNumAtRisk': 60, 'otherNumAffected': 38, 'seriousNumAtRisk': 60, 'deathsNumAffected': 0, 'seriousNumAffected': 4}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 60, 'numAffected': 13}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 60, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 60, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Stomatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 60, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Malaise', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 60, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 60, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Oral herpes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 60, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Pharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 60, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Viral upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numAffected': 20}, {'groupId': 'EG001', 'numAtRisk': 60, 'numAffected': 13}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 60, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 60, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Upper respiratory tract inflammation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 60, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Dry skin', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 60, 'numAffected': 4}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Eczema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 60, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 60, 'numAffected': 4}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 60, 'numAffected': 3}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}], 'seriousEvents': [{'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 60, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Hepatic angiosarcoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 60, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Hepatocellular carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 60, 'numAffected': 2}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '48', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'SOF/VEL+RBV 12 Weeks (GT1)', 'description': 'SOF/VEL (400/100 mg) FDC tablet orally once daily + RBV capsule (600, 800, or 1000 mg daily based on weight) for 12 weeks in participants with genotype 1 (GT1) HCV infection'}, {'id': 'OG001', 'title': 'SOF/VEL+RBV 12 Weeks (GT2)', 'description': 'SOF/VEL (400/100 mg) FDC tablet orally once daily + RBV capsule (600, 800, or 1000 mg daily based on weight) for 12 weeks in participants with genotype 2 (GT2) HCV infection'}, {'id': 'OG002', 'title': 'SOF/VEL+RBV 24 Weeks (GT1)', 'description': 'SOF/VEL (400/100 mg) FDC tablet orally once daily + RBV capsule (600, 800, or 1000 mg daily based on weight) for 24 weeks in participants with genotype 1 (GT1) HCV infection'}, {'id': 'OG003', 'title': 'SOF/VEL+RBV 24 Weeks (GT2)', 'description': 'SOF/VEL (400/100 mg) FDC tablet orally once daily + RBV capsule (600, 800, or 1000 mg daily based on weight) for 24 weeks in participants with genotype 2 (GT2) HCV infection'}], 'classes': [{'categories': [{'measurements': [{'value': '85.1', 'groupId': 'OG000', 'lowerLimit': '71.7', 'upperLimit': '93.8'}, {'value': '70.0', 'groupId': 'OG001', 'lowerLimit': '34.8', 'upperLimit': '93.3'}, {'value': '97.9', 'groupId': 'OG002', 'lowerLimit': '88.9', 'upperLimit': '99.9'}, {'value': '91.7', 'groupId': 'OG003', 'lowerLimit': '61.5', 'upperLimit': '99.8'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000'], 'statisticalMethod': 'Binomial test', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'P-value is obtained from the 2-sided exact 1-sample binomial test for the superiority of SOF/VEL+RBV 12 Weeks (GT1) over the performance goal of 50%.'}, {'pValue': '<0.001', 'groupIds': ['OG002'], 'statisticalMethod': 'Binomial test', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'P-value is obtained from the 2-sided exact 1-sample binomial test for the superiority of SOF/VEL +RBV 24 Weeks (GT1) over the performance goal of 50%.'}], 'paramType': 'NUMBER', 'timeFrame': 'Posttreatment Week 12', 'description': 'SVR12 was defined as HCV RNA \\< the lower limit of quantitation (LLOQ; ie, 15 IU/mL) at 12 weeks after stopping study treatment.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set: participants who were randomized and received at least 1 dose of study drug.'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'SOF/VEL+RBV 12 Weeks', 'description': 'SOF/VEL (400/100 mg) FDC tablet orally once daily + RBV capsule (600, 800, or 1000 mg daily based on weight) for 12 weeks in participants with genotype 1 or 2 HCV infection'}, {'id': 'OG001', 'title': 'SOF/VEL+RBV 24 Weeks', 'description': 'SOF/VEL (400/100 mg) FDC tablet orally once daily + RBV capsule (600, 800, or 1000 mg daily based on weight) for 24 weeks in participants with genotype 1 or 2 HCV infection'}], 'classes': [{'categories': [{'measurements': [{'value': '1.8', 'groupId': 'OG000'}, {'value': '3.3', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 24 weeks', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Analysis Set'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With SVR at 4 Weeks After Discontinuation of Therapy (SVR4)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'SOF/VEL+RBV 12 Weeks', 'description': 'SOF/VEL (400/100 mg) FDC tablet orally once daily + RBV capsule (600, 800, or 1000 mg daily based on weight) for 12 weeks in participants with genotype 1 or genotype 2 HCV infection'}, {'id': 'OG001', 'title': 'SOF/VEL+RBV 24 Weeks', 'description': 'SOF/VEL (400/100 mg) FDC tablet orally once daily + RBV capsule (600, 800, or 1000 mg daily based on weight) for 24 weeks in participants with genotype 1 or genotype 2 HCV infection'}], 'classes': [{'categories': [{'measurements': [{'value': '86.0', 'groupId': 'OG000', 'lowerLimit': '74.2', 'upperLimit': '93.7'}, {'value': '98.3', 'groupId': 'OG001', 'lowerLimit': '91.1', 'upperLimit': '100.0'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Posttreatment Week 4', 'description': 'SVR4 was defined as HCV RNA \\< LLOQ at 4 weeks after stopping study treatment.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With SVR at 24 Weeks After Discontinuation of Therapy (SVR24)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'SOF/VEL+RBV 12 Weeks', 'description': 'SOF/VEL (400/100 mg) FDC tablet orally once daily + RBV capsule (600, 800, or 1000 mg daily based on weight) for 12 weeks in participants with genotype 1 or genotype 2 HCV infection'}, {'id': 'OG001', 'title': 'SOF/VEL+RBV 24 Weeks', 'description': 'SOF/VEL (400/100 mg) FDC tablet orally once daily + RBV capsule (600, 800, or 1000 mg daily based on weight) for 24 weeks in participants with genotype 1 or genotype 2 HCV infection'}], 'classes': [{'categories': [{'measurements': [{'value': '82.5', 'groupId': 'OG000', 'lowerLimit': '70.1', 'upperLimit': '91.3'}, {'value': '96.7', 'groupId': 'OG001', 'lowerLimit': '88.5', 'upperLimit': '99.6'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Posttreatment Week 24', 'description': 'SVR 24 was defined as HCV RNA \\< LLOQ at 24 weeks after stopping study treatment.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With HCV RNA < LLOQ at Week 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'SOF/VEL+RBV 12 Weeks', 'description': 'SOF/VEL (400/100 mg) FDC tablet orally once daily + RBV capsule (600, 800, or 1000 mg daily based on weight) for 12 weeks in participants with genotype 1 or genotype 2 HCV infection'}, {'id': 'OG001', 'title': 'SOF/VEL+RBV 24 Weeks', 'description': 'SOF/VEL (400/100 mg) FDC tablet orally once daily + RBV capsule (600, 800, or 1000 mg daily based on weight) for 24 weeks in participants with genotype 1 or genotype 2 HCV infection'}], 'classes': [{'categories': [{'measurements': [{'value': '21.1', 'groupId': 'OG000', 'lowerLimit': '11.4', 'upperLimit': '33.9'}, {'value': '25.0', 'groupId': 'OG001', 'lowerLimit': '14.7', 'upperLimit': '37.9'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 1', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With HCV RNA < LLOQ at Week 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'SOF/VEL+RBV 12 Weeks', 'description': 'SOF/VEL (400/100 mg) FDC tablet orally once daily + RBV capsule (600, 800, or 1000 mg daily based on weight) for 12 weeks in participants with genotype 1 or genotype 2 HCV infection'}, {'id': 'OG001', 'title': 'SOF/VEL+RBV 24 Weeks', 'description': 'SOF/VEL (400/100 mg) FDC tablet orally once daily + RBV capsule (600, 800, or 1000 mg daily based on weight) for 24 weeks in participants with genotype 1 or genotype 2 HCV infection'}], 'classes': [{'categories': [{'measurements': [{'value': '64.3', 'groupId': 'OG000', 'lowerLimit': '50.4', 'upperLimit': '76.6'}, {'value': '70.0', 'groupId': 'OG001', 'lowerLimit': '56.8', 'upperLimit': '81.2'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 2', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in the Full Analysis Set with available data were analyzed.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With HCV RNA < LLOQ at Week 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'SOF/VEL+RBV 12 Weeks', 'description': 'SOF/VEL (400/100 mg) FDC tablet orally once daily + RBV capsule (600, 800, or 1000 mg daily based on weight) for 12 weeks in participants with genotype 1 or genotype 2 HCV infection'}, {'id': 'OG001', 'title': 'SOF/VEL+RBV 24 Weeks', 'description': 'SOF/VEL (400/100 mg) FDC tablet orally once daily + RBV capsule (600, 800, or 1000 mg daily based on weight) for 24 weeks in participants with genotype 1 or genotype 2 HCV infection'}], 'classes': [{'categories': [{'measurements': [{'value': '91.1', 'groupId': 'OG000', 'lowerLimit': '80.4', 'upperLimit': '97.0'}, {'value': '90.0', 'groupId': 'OG001', 'lowerLimit': '79.5', 'upperLimit': '96.2'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 3', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in the Full Analysis Set with available data were analyzed.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With HCV RNA < LLOQ at Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'SOF/VEL+RBV 12 Weeks', 'description': 'SOF/VEL (400/100 mg) FDC tablet orally once daily + RBV capsule (600, 800, or 1000 mg daily based on weight) for 12 weeks in participants with genotype 1 or genotype 2 HCV infection'}, {'id': 'OG001', 'title': 'SOF/VEL+RBV 24 Weeks', 'description': 'SOF/VEL (400/100 mg) FDC tablet orally once daily + RBV capsule (600, 800, or 1000 mg daily based on weight) for 24 weeks in participants with genotype 1 or genotype 2 HCV infection'}], 'classes': [{'categories': [{'measurements': [{'value': '98.2', 'groupId': 'OG000', 'lowerLimit': '90.4', 'upperLimit': '100.0'}, {'value': '98.3', 'groupId': 'OG001', 'lowerLimit': '91.1', 'upperLimit': '100.0'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 4', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in the Full Analysis Set with available data were analyzed.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With HCV RNA < LLOQ at Week 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'SOF/VEL+RBV 12 Weeks', 'description': 'SOF/VEL (400/100 mg) FDC tablet orally once daily + RBV capsule (600, 800, or 1000 mg daily based on weight) for 12 weeks in participants with genotype 1 or genotype 2 HCV infection'}, {'id': 'OG001', 'title': 'SOF/VEL+RBV 24 Weeks', 'description': 'SOF/VEL (400/100 mg) FDC tablet orally once daily + RBV capsule (600, 800, or 1000 mg daily based on weight) for 24 weeks in participants with genotype 1 or genotype 2 HCV infection'}], 'classes': [{'categories': [{'measurements': [{'value': '98.2', 'groupId': 'OG000', 'lowerLimit': '90.4', 'upperLimit': '100.0'}, {'value': '98.3', 'groupId': 'OG001', 'lowerLimit': '91.1', 'upperLimit': '100.0'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 5', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in the Full Analysis Set with available data were analyzed.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With HCV RNA < LLOQ at Week 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'SOF/VEL+RBV 12 Weeks', 'description': 'SOF/VEL (400/100 mg) FDC tablet orally once daily + RBV capsule (600, 800, or 1000 mg daily based on weight) for 12 weeks in participants with genotype 1 or genotype 2 HCV infection'}, {'id': 'OG001', 'title': 'SOF/VEL+RBV 24 Weeks', 'description': 'SOF/VEL (400/100 mg) FDC tablet orally once daily + RBV capsule (600, 800, or 1000 mg daily based on weight) for 24 weeks in participants with genotype 1 or genotype 2 HCV infection'}], 'classes': [{'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000', 'lowerLimit': '93.6', 'upperLimit': '100.0'}, {'value': '98.3', 'groupId': 'OG001', 'lowerLimit': '91.1', 'upperLimit': '100.0'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 6', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in the Full Analysis Set with available data were analyzed.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With HCV RNA < LLOQ at Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'SOF/VEL+RBV 12 Weeks', 'description': 'SOF/VEL (400/100 mg) FDC tablet orally once daily + RBV capsule (600, 800, or 1000 mg daily based on weight) for 12 weeks in participants with genotype 1 or genotype 2 HCV infection'}, {'id': 'OG001', 'title': 'SOF/VEL+RBV 24 Weeks', 'description': 'SOF/VEL (400/100 mg) FDC tablet orally once daily + RBV capsule (600, 800, or 1000 mg daily based on weight) for 24 weeks in participants with genotype 1 or genotype 2 HCV infection'}], 'classes': [{'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000', 'lowerLimit': '93.6', 'upperLimit': '100.0'}, {'value': '100.0', 'groupId': 'OG001', 'lowerLimit': '94.0', 'upperLimit': '100.0'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 8', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in the Full Analysis Set with available data were analyzed.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With HCV RNA < LLOQ at Week 10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'SOF/VEL+RBV 12 Weeks', 'description': 'SOF/VEL (400/100 mg) FDC tablet orally once daily + RBV capsule (600, 800, or 1000 mg daily based on weight) for 12 weeks in participants with genotype 1 or genotype 2 HCV infection'}, {'id': 'OG001', 'title': 'SOF/VEL+RBV 24 Weeks', 'description': 'SOF/VEL (400/100 mg) FDC tablet orally once daily + RBV capsule (600, 800, or 1000 mg daily based on weight) for 24 weeks in participants with genotype 1 or genotype 2 HCV infection'}], 'classes': [{'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000', 'lowerLimit': '93.6', 'upperLimit': '100.0'}, {'value': '100.0', 'groupId': 'OG001', 'lowerLimit': '93.9', 'upperLimit': '100.0'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 10', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in the Full Analysis Set with available data were analyzed.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With HCV RNA < LLOQ at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'SOF/VEL+RBV 12 Weeks', 'description': 'SOF/VEL 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Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'SOF/VEL+RBV 24 Weeks', 'description': 'SOF/VEL (400/100 mg) FDC tablet orally once daily + RBV capsule (600, 800, or 1000 mg daily based on weight) for 24 weeks in participants with genotype 1 or genotype 2 HCV infection'}], 'classes': [{'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000', 'lowerLimit': '93.8', 'upperLimit': '100.0'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 16', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in the Full Analysis Set from the SOF/VEL+RBV 24 Weeks Group with available data were analyzed.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With HCV RNA < LLOQ at Week 20', 'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'SOF/VEL+RBV 24 Weeks', 'description': 'SOF/VEL (400/100 mg) FDC tablet orally once daily + RBV capsule (600, 800, or 1000 mg daily based on weight) for 24 weeks in participants with genotype 1 or genotype 2 HCV infection'}], 'classes': [{'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000', 'lowerLimit': '93.8', 'upperLimit': '100.0'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 20', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in the Full Analysis Set from the SOF/VEL+RBV 24 Weeks Group with available data were analyzed.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With HCV RNA < LLOQ at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'SOF/VEL+RBV 24 Weeks', 'description': 'SOF/VEL (400/100 mg) FDC tablet orally once daily + RBV capsule (600, 800, or 1000 mg daily based on weight) for 24 weeks in participants with genotype 1 or genotype 2 HCV infection'}], 'classes': [{'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000', 'lowerLimit': '93.8', 'upperLimit': '100.0'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 24', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in the Full Analysis Set from the SOF/VEL+RBV 24 Weeks Group with available data were analyzed.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in HCV RNA at Week 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'SOF/VEL+RBV 12 Weeks', 'description': 'SOF/VEL (400/100 mg) FDC tablet orally once daily + RBV capsule (600, 800, or 1000 mg daily based on weight) for 12 weeks in participants with genotype 1 or genotype 2 HCV infection'}, {'id': 'OG001', 'title': 'SOF/VEL+RBV 24 Weeks', 'description': 'SOF/VEL (400/100 mg) FDC tablet orally once daily + RBV capsule (600, 800, or 1000 mg daily based on weight) for 24 weeks in participants with genotype 1 or genotype 2 HCV infection'}], 'classes': [{'categories': [{'measurements': [{'value': '-4.40', 'spread': '0.640', 'groupId': 'OG000'}, {'value': '-4.36', 'spread': '0.698', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline; Week 1', 'unitOfMeasure': 'log10 IU/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in the Full Analysis Set with available data were analyzed.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in HCV RNA at Week 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'SOF/VEL+RBV 12 Weeks', 'description': 'SOF/VEL (400/100 mg) FDC tablet orally once daily + RBV capsule (600, 800, or 1000 mg daily based on weight) for 12 weeks in participants with genotype 1 or genotype 2 HCV infection'}, {'id': 'OG001', 'title': 'SOF/VEL+RBV 24 Weeks', 'description': 'SOF/VEL (400/100 mg) FDC tablet orally once daily + RBV capsule (600, 800, or 1000 mg daily based on weight) for 24 weeks in participants with genotype 1 or genotype 2 HCV infection'}], 'classes': [{'categories': [{'measurements': [{'value': '-4.91', 'spread': '0.510', 'groupId': 'OG000'}, {'value': '-4.89', 'spread': '0.603', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline; Week 2', 'unitOfMeasure': 'log10 IU/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in the Full Analysis Set with available data were analyzed.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in HCV RNA at Week 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'SOF/VEL+RBV 12 Weeks', 'description': 'SOF/VEL (400/100 mg) FDC tablet orally once daily + RBV capsule (600, 800, or 1000 mg daily based on weight) for 12 weeks in participants with genotype 1 or genotype 2 HCV infection'}, {'id': 'OG001', 'title': 'SOF/VEL+RBV 24 Weeks', 'description': 'SOF/VEL (400/100 mg) FDC tablet orally once daily + RBV capsule (600, 800, or 1000 mg daily based on weight) for 24 weeks in participants with genotype 1 or genotype 2 HCV infection'}], 'classes': [{'categories': [{'measurements': [{'value': '-5.07', 'spread': '0.506', 'groupId': 'OG000'}, {'value': '-5.02', 'spread': '0.575', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline; Week 3', 'unitOfMeasure': 'log10 IU/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in the Full Analysis Set with available data were analyzed.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in HCV RNA at Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'SOF/VEL+RBV 12 Weeks', 'description': 'SOF/VEL (400/100 mg) FDC tablet orally once daily + RBV capsule (600, 800, or 1000 mg daily based on weight) for 12 weeks in participants with genotype 1 or genotype 2 HCV infection'}, {'id': 'OG001', 'title': 'SOF/VEL+RBV 24 Weeks', 'description': 'SOF/VEL (400/100 mg) FDC tablet orally once daily + RBV capsule (600, 800, or 1000 mg daily based on weight) for 24 weeks in participants with genotype 1 or genotype 2 HCV infection'}], 'classes': [{'categories': [{'measurements': [{'value': '-5.12', 'spread': '0.486', 'groupId': 'OG000'}, {'value': '-5.04', 'spread': '0.580', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline; Week 4', 'unitOfMeasure': 'log10 IU/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in the Full Analysis Set with available data were analyzed.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in HCV RNA at Week 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'SOF/VEL+RBV 12 Weeks', 'description': 'SOF/VEL (400/100 mg) FDC tablet orally once daily + RBV capsule (600, 800, or 1000 mg daily based on weight) for 12 weeks in participants with genotype 1 or genotype 2 HCV infection'}, {'id': 'OG001', 'title': 'SOF/VEL+RBV 24 Weeks', 'description': 'SOF/VEL (400/100 mg) FDC tablet orally once daily + RBV capsule (600, 800, or 1000 mg daily based on weight) for 24 weeks in participants with genotype 1 or genotype 2 HCV infection'}], 'classes': [{'categories': [{'measurements': [{'value': '-5.13', 'spread': '0.487', 'groupId': 'OG000'}, {'value': '-5.05', 'spread': '0.579', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline; Week 5', 'unitOfMeasure': 'log10 IU/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in the Full Analysis Set with available data were analyzed.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in HCV RNA at Week 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'SOF/VEL+RBV 12 Weeks', 'description': 'SOF/VEL (400/100 mg) FDC tablet orally once daily + RBV capsule (600, 800, or 1000 mg daily based on weight) for 12 weeks in participants with genotype 1 or genotype 2 HCV infection'}, {'id': 'OG001', 'title': 'SOF/VEL+RBV 24 Weeks', 'description': 'SOF/VEL (400/100 mg) FDC tablet orally once daily + RBV capsule (600, 800, or 1000 mg daily based on weight) for 24 weeks in participants with genotype 1 or genotype 2 HCV infection'}], 'classes': [{'categories': [{'measurements': [{'value': '-5.13', 'spread': '0.492', 'groupId': 'OG000'}, {'value': '-5.05', 'spread': '0.579', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline; Week 6', 'unitOfMeasure': 'log10 IU/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in the Full Analysis Set with available data were analyzed.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in HCV RNA at Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'SOF/VEL+RBV 12 Weeks', 'description': 'SOF/VEL (400/100 mg) FDC tablet orally once daily + RBV capsule (600, 800, or 1000 mg daily based on weight) for 12 weeks in participants with genotype 1 or genotype 2 HCV infection'}, {'id': 'OG001', 'title': 'SOF/VEL+RBV 24 Weeks', 'description': 'SOF/VEL (400/100 mg) FDC tablet orally once daily + RBV capsule (600, 800, or 1000 mg daily based on weight) for 24 weeks in participants with genotype 1 or genotype 2 HCV infection'}], 'classes': [{'categories': [{'measurements': [{'value': '-5.13', 'spread': '0.492', 'groupId': 'OG000'}, {'value': '-5.06', 'spread': '0.584', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline; Week 8', 'unitOfMeasure': 'log10 IU/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in the Full Analysis Set with available data were analyzed.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in HCV RNA at Week 10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'SOF/VEL+RBV 12 Weeks', 'description': 'SOF/VEL (400/100 mg) FDC tablet orally once daily + RBV capsule (600, 800, or 1000 mg daily based on weight) for 12 weeks in participants with genotype 1 or genotype 2 HCV infection'}, {'id': 'OG001', 'title': 'SOF/VEL+RBV 24 Weeks', 'description': 'SOF/VEL (400/100 mg) FDC tablet orally once daily + RBV capsule (600, 800, or 1000 mg daily based on weight) for 24 weeks in participants with genotype 1 or genotype 2 HCV infection'}], 'classes': [{'categories': [{'measurements': [{'value': '-5.13', 'spread': '0.492', 'groupId': 'OG000'}, {'value': '-5.06', 'spread': '0.589', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline; Week 10', 'unitOfMeasure': 'log10 IU/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in the Full Analysis Set with available data were analyzed.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in HCV RNA at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'SOF/VEL+RBV 12 Weeks', 'description': 'SOF/VEL (400/100 mg) FDC tablet orally once daily + RBV capsule (600, 800, or 1000 mg daily based on weight) for 12 weeks in participants with genotype 1 or genotype 2 HCV infection'}, {'id': 'OG001', 'title': 'SOF/VEL+RBV 24 Weeks', 'description': 'SOF/VEL (400/100 mg) FDC tablet orally once daily + RBV capsule (600, 800, or 1000 mg daily based on weight) for 24 weeks in participants with genotype 1 or genotype 2 HCV infection'}], 'classes': [{'categories': [{'measurements': [{'value': '-5.13', 'spread': '0.492', 'groupId': 'OG000'}, {'value': '-5.06', 'spread': '0.589', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline; 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': 'Change From Baseline in HCV RNA at Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'SOF/VEL+RBV 24 Weeks', 'description': 'SOF/VEL (400/100 mg) FDC tablet orally once daily + RBV capsule (600, 800, or 1000 mg daily based on weight) for 24 weeks in participants with genotype 1 or genotype 2 HCV infection'}], 'classes': [{'categories': [{'measurements': [{'value': '-5.06', 'spread': '0.594', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline; Week 16', 'unitOfMeasure': 'log10 IU/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in the Full Analysis Set from the SOF/VEL+RBV 24 Weeks Group with available data were analyzed.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in HCV RNA at Week 20', 'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'SOF/VEL+RBV 24 Weeks', 'description': 'SOF/VEL (400/100 mg) FDC tablet orally once daily + RBV capsule (600, 800, or 1000 mg daily based on weight) for 24 weeks in participants with genotype 1 or genotype 2 HCV infection'}], 'classes': [{'categories': [{'measurements': [{'value': '-5.06', 'spread': '0.594', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline; Week 20', 'unitOfMeasure': 'log10 IU/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in the Full Analysis Set from the SOF/VEL+RBV 24 Weeks Group with available data were analyzed.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in HCV RNA at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'SOF/VEL+RBV 24 Weeks', 'description': 'SOF/VEL (400/100 mg) FDC tablet orally once daily + RBV capsule (600, 800, or 1000 mg daily based on weight) for 24 weeks in participants with genotype 1 or genotype 2 HCV infection'}], 'classes': [{'categories': [{'measurements': [{'value': '-5.06', 'spread': '0.594', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline; Week 24', 'unitOfMeasure': 'log10 IU/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in the Full Analysis Set from the SOF/VEL+RBV 24 Weeks Group with available data were analyzed.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Overall Virologic Failure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'SOF/VEL+RBV 12 Weeks', 'description': 'SOF/VEL (400/100 mg) FDC tablet orally once daily + RBV capsule (600, 800, or 1000 mg daily based on weight) for 12 weeks in participants with genotype 1 or genotype 2 HCV infection'}, {'id': 'OG001', 'title': 'SOF/VEL+RBV 24 Weeks', 'description': 'SOF/VEL (400/100 mg) FDC tablet orally once daily + RBV capsule (600, 800, or 1000 mg daily based on weight) for 24 weeks in participants with genotype 1 or genotype 2 HCV infection'}], 'classes': [{'categories': [{'measurements': [{'value': '15.8', 'groupId': 'OG000'}, {'value': '3.3', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to Posttreatment Week 24', 'description': 'Virologic failure was defined as:\n\n* On-treatment virologic failure:\n\n * Breakthrough (confirmed HCV RNA ≥ LLOQ after having previously had HCV RNA \\< LLOQ while on treatment), or\n * Rebound (confirmed \\> 1 log10 IU/mL increase in HCV RNA from nadir while on treatment), or\n * Non-response (HCV RNA persistently ≥ LLOQ through 8 weeks of treatment)\n* Virologic relapse:\n\n * Confirmed HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA \\< LLOQ at last on-treatment visit.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'SOF/VEL FDC + RBV 12 Weeks', 'description': 'Sofosbuvir/velpatasvir (SOF/VEL) (400/100 mg) fixed-dose combination (FDC) tablet orally once daily + ribavirin (RBV) capsule (600, 800, or 1000 mg daily based on weight) for 12 weeks'}, {'id': 'FG001', 'title': 'SOF/VEL FDC + RBV 24 Weeks', 'description': 'SOF/VEL (400/100 mg) FDC tablet orally once daily + RBV capsule (600, 800, or 1000 mg daily based on weight) for 24 weeks'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '57'}, {'groupId': 'FG001', 'numSubjects': '60'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '56'}, {'groupId': 'FG001', 'numSubjects': '60'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Withdrew Consent', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Participants were enrolled at study sites in Japan. The first participant was screened on 25 July 2016. The last study visit occurred on 25 August 2017.', 'preAssignmentDetails': '132 participants were screened.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '48', 'groupId': 'BG002'}, {'value': '12', 'groupId': 'BG003'}, {'value': '117', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'SOF/VEL+RBV 12 Weeks (GT1)', 'description': 'SOF/VEL (400/100 mg) FDC tablet orally once daily + RBV capsule (600, 800, or 1000 mg daily based on weight) for 12 weeks in participants with genotype 1 (GT1) HCV infection'}, {'id': 'BG001', 'title': 'SOF/VEL+RBV 12 Weeks (GT2)', 'description': 'SOF/VEL (400/100 mg) FDC tablet orally once daily + RBV capsule (600, 800, or 1000 mg daily based on weight) for 12 weeks in participants with genotype 2 (GT2) HCV infection'}, {'id': 'BG002', 'title': 'SOF/VEL+RBV 24 Weeks (GT1)', 'description': 'SOF/VEL (400/100 mg) FDC tablet orally once daily + RBV capsule (600, 800, or 1000 mg daily based on weight) for 24 weeks in participants with genotype 1 (GT1) HCV infection'}, {'id': 'BG003', 'title': 'SOF/VEL+RBV 24 Weeks (GT2)', 'description': 'SOF/VEL (400/100 mg) FDC tablet orally once daily + RBV capsule (600, 800, or 1000 mg daily based on weight) for 24 weeks in participants with genotype 2 (GT2) HCV infection'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '63', 'spread': '9.7', 'groupId': 'BG000'}, {'value': '59', 'spread': '15.7', 'groupId': 'BG001'}, {'value': '64', 'spread': '10.1', 'groupId': 'BG002'}, {'value': '61', 'spread': '7.2', 'groupId': 'BG003'}, {'value': '63', 'spread': '10.3', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '29', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '28', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}, {'value': '67', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}, {'value': '7', 'groupId': 'BG003'}, {'value': '50', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Asian', 'categories': [{'measurements': [{'value': '47', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '48', 'groupId': 'BG002'}, {'value': '12', 'groupId': 'BG003'}, {'value': '117', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Not Hispanic or Latino', 'categories': [{'measurements': [{'value': '47', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '48', 'groupId': 'BG002'}, {'value': '12', 'groupId': 'BG003'}, {'value': '117', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'HCV genotype', 'classes': [{'categories': [{'title': 'Genotype 1a', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}]}, {'title': 'Genotype 1b', 'measurements': [{'value': '45', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '47', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '92', 'groupId': 'BG004'}]}, {'title': 'Genotype 2a/2c', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}, {'value': '7', 'groupId': 'BG004'}]}, {'title': 'Genotype 2b', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}, {'value': '6', 'groupId': 'BG004'}]}, {'title': 'Genotype 2 (No Confirmed Subtype)', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}, {'value': '9', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'IL28b Status', 'classes': [{'categories': [{'title': 'CC', 'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '21', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}, {'value': '50', 'groupId': 'BG004'}]}, {'title': 'CT', 'measurements': [{'value': '28', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}, {'value': '55', 'groupId': 'BG004'}]}, {'title': 'TT', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '12', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'The CC, CT, and TT alleles are different forms of the IL28b gene.', 'unitOfMeasure': 'Participants'}, {'title': 'HCV RNA (log10 IU/mL)', 'classes': [{'categories': [{'measurements': [{'value': '6.2', 'spread': '.47', 'groupId': 'BG000'}, {'value': '6.6', 'spread': '.46', 'groupId': 'BG001'}, {'value': '6.2', 'spread': '.51', 'groupId': 'BG002'}, {'value': '6.2', 'spread': '.86', 'groupId': 'BG003'}, {'value': '6.2', 'spread': '.54', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'log10 IU/mL', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'HCV RNA Category', 'classes': [{'categories': [{'title': '< 800,000 IU/mL', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}, {'value': '25', 'groupId': 'BG004'}]}, {'title': '≥ 800,000 IU/mL', 'measurements': [{'value': '37', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '38', 'groupId': 'BG002'}, {'value': '8', 'groupId': 'BG003'}, {'value': '92', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Safety Analysis Set: participants who received at least 1 dose of study drug'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2017-06-13', 'size': 725088, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_000.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2018-05-24T09:52', 'hasProtocol': False}, {'date': '2016-06-13', 'size': 3094776, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_001.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2018-06-22T13:54', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 117}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-07-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-07', 'completionDateStruct': {'date': '2017-08-25', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-10-19', 'studyFirstSubmitDate': '2016-06-30', 'resultsFirstSubmitDate': '2018-05-24', 'studyFirstSubmitQcDate': '2016-06-30', 'lastUpdatePostDateStruct': {'date': '2018-11-14', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-07-02', 'studyFirstPostDateStruct': {'date': '2016-07-04', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2018-07-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-06-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12)', 'timeFrame': 'Posttreatment Week 12', 'description': 'SVR12 was defined as HCV RNA \\< the lower limit of quantitation (LLOQ; ie, 15 IU/mL) at 12 weeks after stopping study treatment.'}, {'measure': 'Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event', 'timeFrame': 'Up to 24 weeks'}], 'secondaryOutcomes': [{'measure': 'Percentage of Participants With SVR at 4 Weeks After Discontinuation of Therapy (SVR4)', 'timeFrame': 'Posttreatment Week 4', 'description': 'SVR4 was defined as HCV RNA \\< LLOQ at 4 weeks after stopping study treatment.'}, {'measure': 'Percentage of Participants With SVR at 24 Weeks After Discontinuation of Therapy (SVR24)', 'timeFrame': 'Posttreatment Week 24', 'description': 'SVR 24 was defined as HCV RNA \\< LLOQ at 24 weeks after stopping study treatment.'}, {'measure': 'Percentage of Participants With HCV RNA < LLOQ at Week 1', 'timeFrame': 'Week 1'}, {'measure': 'Percentage of Participants With HCV RNA < LLOQ at Week 2', 'timeFrame': 'Week 2'}, {'measure': 'Percentage of Participants With HCV RNA < LLOQ at Week 3', 'timeFrame': 'Week 3'}, {'measure': 'Percentage of Participants With HCV RNA < LLOQ at Week 4', 'timeFrame': 'Week 4'}, {'measure': 'Percentage of Participants With HCV RNA < LLOQ at Week 5', 'timeFrame': 'Week 5'}, {'measure': 'Percentage of Participants With HCV RNA < LLOQ at Week 6', 'timeFrame': 'Week 6'}, {'measure': 'Percentage of Participants With HCV RNA < LLOQ at Week 8', 'timeFrame': 'Week 8'}, {'measure': 'Percentage of Participants With HCV RNA < LLOQ at Week 10', 'timeFrame': 'Week 10'}, {'measure': 'Percentage of Participants With HCV RNA < LLOQ at Week 12', 'timeFrame': 'Week 12'}, {'measure': 'Percentage of Participants With HCV RNA < LLOQ at Week 16', 'timeFrame': 'Week 16'}, {'measure': 'Percentage of Participants With HCV RNA < LLOQ at Week 20', 'timeFrame': 'Week 20'}, {'measure': 'Percentage of Participants With HCV RNA < LLOQ at Week 24', 'timeFrame': 'Week 24'}, {'measure': 'Change From Baseline in HCV RNA at Week 1', 'timeFrame': 'Baseline; Week 1'}, {'measure': 'Change From Baseline in HCV RNA at Week 2', 'timeFrame': 'Baseline; Week 2'}, {'measure': 'Change From Baseline in HCV RNA at Week 3', 'timeFrame': 'Baseline; Week 3'}, {'measure': 'Change From Baseline in HCV RNA at Week 4', 'timeFrame': 'Baseline; Week 4'}, {'measure': 'Change From Baseline in HCV RNA at Week 5', 'timeFrame': 'Baseline; Week 5'}, {'measure': 'Change From Baseline in HCV RNA at Week 6', 'timeFrame': 'Baseline; Week 6'}, {'measure': 'Change From Baseline in HCV RNA at Week 8', 'timeFrame': 'Baseline; Week 8'}, {'measure': 'Change From Baseline in HCV RNA at Week 10', 'timeFrame': 'Baseline; Week 10'}, {'measure': 'Change From Baseline in HCV RNA at Week 12', 'timeFrame': 'Baseline; Week 12'}, {'measure': 'Change From Baseline in HCV RNA at Week 16', 'timeFrame': 'Baseline; Week 16'}, {'measure': 'Change From Baseline in HCV RNA at Week 20', 'timeFrame': 'Baseline; Week 20'}, {'measure': 'Change From Baseline in HCV RNA at Week 24', 'timeFrame': 'Baseline; Week 24'}, {'measure': 'Percentage of Participants With Overall Virologic Failure', 'timeFrame': 'Up to Posttreatment Week 24', 'description': 'Virologic failure was defined as:\n\n* On-treatment virologic failure:\n\n * Breakthrough (confirmed HCV RNA ≥ LLOQ after having previously had HCV RNA \\< LLOQ while on treatment), or\n * Rebound (confirmed \\> 1 log10 IU/mL increase in HCV RNA from nadir while on treatment), or\n * Non-response (HCV RNA persistently ≥ LLOQ through 8 weeks of treatment)\n* Virologic relapse:\n\n * Confirmed HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA \\< LLOQ at last on-treatment visit.'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hepatitis C Virus Infection']}, 'descriptionModule': {'briefSummary': 'The primary objective of this study is to evaluate the antiviral efficacy, safety, and tolerability of therapy with sofosbuvir/velpatasvir (SOF/VEL) fixed-dose combination (FDC) and ribavirin (RBV) in participants with chronic genotype 1 or 2 hepatitis C virus (HCV) infection who have previously failed a direct-acting antiviral (DAA)-containing regimen.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Key Inclusion Criteria:\n\n* Genotype 1 or 2 HCV infection\n* Chronic HCV infection (≥ 6 months prior to screening) documented by prior medical history or liver biopsy\n* Previously treated with a DAA-containing regimen of at least 4 week duration\n\nNote: Other protocol defined Inclusion/Exclusion criteria may apply.'}, 'identificationModule': {'nctId': 'NCT02822794', 'briefTitle': 'Sofosbuvir/Velpatasvir Fixed-Dose Combination and Ribavirin for 12 or 24 Weeks in Participants With Chronic Genotype 1 or 2 Hepatitis C Virus Infection Who Have Previously Failed a Direct-Acting Antiviral-Containing Regimen', 'organization': {'class': 'INDUSTRY', 'fullName': 'Gilead Sciences'}, 'officialTitle': 'A Phase 3, Multicenter, Randomized, Open-Label Study to Investigate the Efficacy and Safety of Sofosbuvir/Velpatasvir Fixed-Dose Combination and Ribavirin for 12 or 24 Weeks in Subjects With Chronic Genotype 1 or 2 HCV Infection Who Have Previously Failed a Direct-Acting Antiviral-Containing Regimen', 'orgStudyIdInfo': {'id': 'GS-US-342-3921'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'SOF/VEL FDC + RBV 12 weeks', 'description': 'SOF/VEL FDC + RBV for 12 weeks in participants with genotype 1 or 2 HCV infection', 'interventionNames': ['Drug: SOF/VEL', 'Drug: RBV']}, {'type': 'EXPERIMENTAL', 'label': 'SOF/VEL FDC + RBV 24 weeks', 'description': 'SOF/VEL FDC + RBV for 24 weeks in participants with genotype 1 or 2 HCV infection', 'interventionNames': ['Drug: SOF/VEL', 'Drug: RBV']}], 'interventions': [{'name': 'SOF/VEL', 'type': 'DRUG', 'otherNames': ['GS-7977/GS-5816', 'Epclusa®'], 'description': '400/100 mg tablet administered orally once daily', 'armGroupLabels': ['SOF/VEL FDC + RBV 12 weeks', 'SOF/VEL FDC + RBV 24 weeks']}, {'name': 'RBV', 'type': 'DRUG', 'otherNames': ['REBETOL®'], 'description': 'Capsules administered orally in a divided daily dose according to package insert weight-based dosing recommendations (≤ 60 kg = 600 mg, \\> 60 kg to ≤ 80 kg = 800 mg, and ≥ 80 kg = 1000 mg)', 'armGroupLabels': ['SOF/VEL FDC + RBV 12 weeks', 'SOF/VEL FDC + RBV 24 weeks']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Ehime', 'country': 'Japan'}, {'city': 'Hiroshima', 'country': 'Japan', 'geoPoint': {'lat': 34.4, 'lon': 132.45}}, {'city': 'Ichikawa-shi', 'country': 'Japan'}, {'city': 'Iruma-gun', 'country': 'Japan'}, {'city': 'Kashihara', 'country': 'Japan', 'geoPoint': {'lat': 34.58333, 'lon': 135.61667}}, {'city': 'Kurume-shi', 'country': 'Japan'}, {'city': 'Kyoto', 'country': 'Japan', 'geoPoint': {'lat': 35.02107, 'lon': 135.75385}}, {'city': 'Maebashi', 'country': 'Japan', 'geoPoint': {'lat': 36.4, 'lon': 139.08333}}, {'city': 'Musashino-shi', 'country': 'Japan'}, {'city': 'Nagoya', 'country': 'Japan', 'geoPoint': {'lat': 35.18147, 'lon': 136.90641}}, {'city': 'Nishinomiya', 'country': 'Japan', 'geoPoint': {'lat': 34.71562, 'lon': 135.33199}}, {'city': 'Okayama', 'country': 'Japan', 'geoPoint': {'lat': 34.65, 'lon': 133.93333}}, {'city': 'Ōgaki', 'country': 'Japan', 'geoPoint': {'lat': 35.35, 'lon': 136.61667}}, {'city': 'Ōmura', 'country': 'Japan', 'geoPoint': {'lat': 32.92139, 'lon': 129.95389}}, {'city': 'Sapporo', 'country': 'Japan', 'geoPoint': {'lat': 43.06667, 'lon': 141.35}}, {'city': 'Suita', 'country': 'Japan', 'geoPoint': {'lat': 34.76143, 'lon': 135.51567}}, {'city': 'Takamatsu', 'country': 'Japan', 'geoPoint': {'lat': 34.33333, 'lon': 134.05}}, {'city': 'Yamagata', 'country': 'Japan', 'geoPoint': {'lat': 38.23333, 'lon': 140.36667}}], 'overallOfficials': [{'name': 'Gilead Study Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Gilead Sciences'}]}, 'ipdSharingStatementModule': {'url': 'http://www.gilead.com/research/disclosure-and-transparency', 'infoTypes': ['STUDY_PROTOCOL', 'SAP'], 'timeFrame': '18 months after study completion', 'ipdSharing': 'YES', 'description': 'Qualified external researchers may request IPD for this study after study completion. For more information, please visit our website at http://www.gilead.com/research/disclosure-and-transparency.', 'accessCriteria': 'A secured external environment with username, password, and RSA code.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Gilead Sciences', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}