Ignite Creation Date:
2025-12-24 @ 10:44 PM
Ignite Modification Date:
2026-02-21 @ 11:36 PM
Study NCT ID:
NCT02607735
Status:
COMPLETED
Last Update Posted:
2019-03-05
First Post:
2015-11-16
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Safety and Efficacy of Sofosbuvir/Velpatasvir/Voxilaprevir in Adults With Chronic HCV Infection Who Have Previously Received Treatment With Direct-Acting Antiviral Therapy
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': 'C000654129', 'term': 'sofosbuvir velpatasvir voxilaprevir drug combination'}]}}, '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': 'Primary Study: Up to 12 Weeks + 30 days; Deferred Treatment Substudy: Up to 12 Weeks + 30 days', 'description': 'Safety Analysis Set: all participants who received at least 1 dose of study drug', 'eventGroups': [{'id': 'EG000', 'title': 'SOF/VEL/VOX (Primary Study)', 'description': 'SOF/VEL/VOX (400/100/100 mg) FDC tablet orally once daily with food for 12 weeks', 'otherNumAtRisk': 263, 'deathsNumAtRisk': 263, 'otherNumAffected': 147, 'seriousNumAtRisk': 263, 'deathsNumAffected': 0, 'seriousNumAffected': 5}, {'id': 'EG001', 'title': 'Placebo (Primary Study)', 'description': 'Placebo tablet orally once daily with food for 12 weeks', 'otherNumAtRisk': 152, 'deathsNumAtRisk': 152, 'otherNumAffected': 80, 'seriousNumAtRisk': 152, 'deathsNumAffected': 0, 'seriousNumAffected': 7}, {'id': 'EG002', 'title': 'SOF/VEL/VOX (Deferred Treatment Substudy)', 'description': 'Participants who completed placebo treatment were eligible for open-label Deferred Treatment Substudy.\n\nSOF/VEL/VOX (400/100/100 mg) FDC tablet orally once daily with food for 12 weeks', 'otherNumAtRisk': 147, 'deathsNumAtRisk': 147, 'otherNumAffected': 87, 'seriousNumAtRisk': 147, 'deathsNumAffected': 0, 'seriousNumAffected': 6}], 'otherEvents': [{'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 263, 'numAffected': 48}, {'groupId': 'EG001', 'numAtRisk': 152, 'numAffected': 19}, {'groupId': 'EG002', 'numAtRisk': 147, 'numAffected': 28}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 263, 'numAffected': 37}, {'groupId': 'EG001', 'numAtRisk': 152, 'numAffected': 12}, {'groupId': 'EG002', 'numAtRisk': 147, 'numAffected': 21}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 263, 'numAffected': 20}, {'groupId': 'EG001', 'numAtRisk': 152, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 147, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 263, 'numAffected': 56}, {'groupId': 'EG001', 'numAtRisk': 152, 'numAffected': 30}, {'groupId': 'EG002', 'numAtRisk': 147, 'numAffected': 31}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 263, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 152, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 147, 'numAffected': 9}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 263, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 152, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 147, 'numAffected': 7}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 263, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 152, 'numAffected': 14}, {'groupId': 'EG002', 'numAtRisk': 147, 'numAffected': 7}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 263, 'numAffected': 66}, {'groupId': 'EG001', 'numAtRisk': 152, 'numAffected': 26}, {'groupId': 'EG002', 'numAtRisk': 147, 'numAffected': 29}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 263, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 152, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 147, 'numAffected': 5}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}], 'seriousEvents': [{'term': 'Acute myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 263, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 152, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 147, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 263, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 152, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 147, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Ventricular fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 263, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 152, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 147, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Mesenteric vein thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 263, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 152, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 147, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Hepatic failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 263, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 152, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 147, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 263, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 152, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 147, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Scrotal infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 263, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 152, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 147, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Urosepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 263, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 152, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 147, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Subdural haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 263, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 152, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 147, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Wrist fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 263, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 152, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 147, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Adrenal neoplasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 263, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 152, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 147, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Basal cell carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 263, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 152, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 147, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Hepatocellular carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 263, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 152, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 147, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Ovarian cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 263, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 152, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 147, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Cerebral haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 263, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 152, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 147, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Generalised tonic-clonic seizure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 263, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 152, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 147, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Seizure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 263, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 152, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 147, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Schizophrenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 263, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 152, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 147, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Nephrolithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 263, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 152, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 147, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Chronic obstructive pulmonary disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 263, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 152, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 147, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Arteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 263, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 152, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 147, 'numAffected': 0}], 'organSystem': 'Vascular disorders', '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) (Primary Study)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '263', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'SOF/VEL/VOX (Primary Study)', 'description': 'SOF/VEL/VOX (400/100/100 mg) FDC tablet orally once daily with food for 12 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '96.2', 'groupId': 'OG000', 'lowerLimit': '93.1', 'upperLimit': '98.8'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000'], 'statisticalMethod': '2-sided exact 1-sample binomial test', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'The SVR12 rate for the SOF/VEL/VOX group was compared to the performance goal of 85% using a 2-sided exact 1-sample binomial test at the 0.05 significance level.'}], 'paramType': 'NUMBER', 'timeFrame': 'Posttreatment Week 12', 'description': 'SVR12 was defined as HCV RNA \\< the lower limit of quantitation (LLOQ) at 12 weeks after stopping study treatment.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in the Full Analysis Set (all randomized/enrolled participants who took at least 1 dose of study drug) in the SOF/VEL/VOX group were analyzed. This outcome measure was not assessed for participants in the Placebo group because they did not have a Posttreatment Week 12 visit.'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants Who Permanently Discontinued Study Drug Due to an Adverse Event (Primary Study)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '263', 'groupId': 'OG000'}, {'value': '152', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'SOF/VEL/VOX (Primary Study)', 'description': 'SOF/VEL/VOX (400/100/100 mg) FDC tablet orally once daily with food for 12 weeks'}, {'id': 'OG001', 'title': 'Placebo (Primary Study)', 'description': 'Placebo tablet orally once daily with food for 12 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '0.4', 'groupId': 'OG000'}, {'value': '2.0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 12 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) (Primary Study)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '263', 'groupId': 'OG000'}, {'value': '152', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'SOF/VEL/VOX (Primary Study)', 'description': 'SOF/VEL/VOX (400/100/100 mg) FDC tablet orally once daily with food for 12 weeks'}, {'id': 'OG001', 'title': 'Placebo (Primary Study)', 'description': 'Placebo tablet orally once daily with food for 12 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '97.7', 'groupId': 'OG000', 'lowerLimit': '95.1', 'upperLimit': '99.2'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '2.4'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Posttreatment Week 4', 'description': 'SVR4 was defined as HCV RNA \\< LLOQ at 4 weeks after stopping study treatment, respectively.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With HCV RNA < LLOQ On Treatment (Primary Study)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '263', 'groupId': 'OG000'}, {'value': '152', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'SOF/VEL/VOX (Primary Study)', 'description': 'SOF/VEL/VOX (400/100/100 mg) FDC tablet orally once daily with food for 12 weeks'}, {'id': 'OG001', 'title': 'Placebo (Primary Study)', 'description': 'Placebo tablet orally once daily with food for 12 weeks'}], 'classes': [{'title': 'Week 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '263', 'groupId': 'OG000'}, {'value': '152', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '15.6', 'groupId': 'OG000', 'lowerLimit': '11.4', 'upperLimit': '20.5'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '2.4'}]}]}, {'title': 'Week 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '263', 'groupId': 'OG000'}, {'value': '150', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '56.7', 'groupId': 'OG000', 'lowerLimit': '50.4', 'upperLimit': '62.7'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '2.4'}]}]}, {'title': 'Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '262', 'groupId': 'OG000'}, {'value': '150', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '92.7', 'groupId': 'OG000', 'lowerLimit': '88.9', 'upperLimit': '95.6'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '2.4'}]}]}, {'title': 'Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '262', 'groupId': 'OG000'}, {'value': '150', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000', 'lowerLimit': '98.6', 'upperLimit': '100.0'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '2.4'}]}]}, {'title': 'Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '261', 'groupId': 'OG000'}, {'value': '149', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '99.6', 'groupId': 'OG000', 'lowerLimit': '97.9', 'upperLimit': '100.0'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '2.4'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Weeks 1, 2, 4, 8 and 12', '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': 'Change From Baseline in HCV RNA (Primary Study)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '262', 'groupId': 'OG000'}, {'value': '150', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'SOF/VEL/VOX (Primary Study)', 'description': 'SOF/VEL/VOX (400/100/100 mg) FDC tablet orally once daily with food for 12 weeks'}, {'id': 'OG001', 'title': 'Placebo (Primary Study)', 'description': 'Placebo tablet orally once daily with food for 12 weeks'}], 'classes': [{'title': 'Week 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '258', 'groupId': 'OG000'}, {'value': '150', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-4.20', 'spread': '0.733', 'groupId': 'OG000'}, {'value': '0.02', 'spread': '0.300', 'groupId': 'OG001'}]}]}, {'title': 'Week 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '261', 'groupId': 'OG000'}, {'value': '148', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-4.81', 'spread': '0.704', 'groupId': 'OG000'}, {'value': '0.02', 'spread': '0.322', 'groupId': 'OG001'}]}]}, {'title': 'Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '261', 'groupId': 'OG000'}, {'value': '150', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-5.07', 'spread': '0.677', 'groupId': 'OG000'}, {'value': '-0.01', 'spread': '0.441', 'groupId': 'OG001'}]}]}, {'title': 'Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '262', 'groupId': 'OG000'}, {'value': '149', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-5.11', 'spread': '0.678', 'groupId': 'OG000'}, {'value': '0.05', 'spread': '0.434', 'groupId': 'OG001'}]}]}, {'title': 'Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '261', 'groupId': 'OG000'}, {'value': '138', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-5.10', 'spread': '0.690', 'groupId': 'OG000'}, {'value': '0.03', 'spread': '0.430', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline; Weeks 1, 2, 4, 8 and 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 SVR at 24 Weeks After Discontinuation of Therapy (SVR24) (Primary Study)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '263', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'SOF/VEL/VOX (Primary Study)', 'description': 'SOF/VEL/VOX (400/100/100 mg) FDC tablet orally once daily with food for 12 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '96.2', 'groupId': 'OG000', 'lowerLimit': '93.1', 'upperLimit': '98.2'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Posttreatment Week 24', 'description': 'SVR24 was defined as HCV RNA \\< LLOQ at 24 weeks after stopping study treatment.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in the Full Analysis Set in the SOF/VEL/VOX group were analyzed. This outcome measure was not assessed for participants in the Placebo group because they did not have a Posttreatment Week 24 visit.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Virologic Failure (Primary Study)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '263', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'SOF/VEL/VOX (Primary Study)', 'description': 'SOF/VEL/VOX (400/100/100 mg) FDC tablet orally once daily with food for 12 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '2.7', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to Posttreatment Week 24', 'description': 'Virologic failure is 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': 'Participants in the Full Analysis Set in the SOF/VEL/VOX group were analyzed. This outcome measure was not assessed for participants in the Placebo group because they did not have a Posttreatment Week 24 visit.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With SVR at 4, 12, and 24 Weeks After Discontinuation of Therapy (Deferred Treatment Substudy)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '147', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'SOF/VEL/VOX (Deferred Treatment Substudy)', 'description': 'SOF/VEL/VOX (400/100/100 mg) FDC tablet orally once daily with food for 12 weeks'}], 'classes': [{'title': 'SVR4', 'categories': [{'measurements': [{'value': '98.6', 'groupId': 'OG000', 'lowerLimit': '95.2', 'upperLimit': '99.8'}]}]}, {'title': 'SVR12', 'categories': [{'measurements': [{'value': '97.3', 'groupId': 'OG000', 'lowerLimit': '93.2', 'upperLimit': '99.3'}]}]}, {'title': 'SVR24', 'categories': [{'measurements': [{'value': '97.3', 'groupId': 'OG000', 'lowerLimit': '93.2', 'upperLimit': '99.3'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Posttreatment Weeks 4, 12, and 24 (Deferred Treatment Substudy)', 'description': 'SVR4, SVR12 and SVR24 was defined as HCV RNA \\< LLOQ at 4, 12 and 24 weeks after stopping study treatment, respectively.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With HCV RNA < LLOQ On Treatment (Deferred Treatment Substudy)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '147', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'SOF/VEL/VOX (Deferred Treatment Substudy)', 'description': 'SOF/VEL/VOX (400/100/100 mg) FDC tablet orally once daily with food for 12 weeks'}], 'classes': [{'title': 'Week 1', 'categories': [{'measurements': [{'value': '14.3', 'groupId': 'OG000', 'lowerLimit': '9.1', 'upperLimit': '21.0'}]}]}, {'title': 'Week 2', 'categories': [{'measurements': [{'value': '62.6', 'groupId': 'OG000', 'lowerLimit': '54.2', 'upperLimit': '70.4'}]}]}, {'title': 'Week 4', 'categories': [{'measurements': [{'value': '93.2', 'groupId': 'OG000', 'lowerLimit': '87.8', 'upperLimit': '96.7'}]}]}, {'title': 'Week 8', 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000', 'lowerLimit': '97.5', 'upperLimit': '100.0'}]}]}, {'title': 'Week 12', 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000', 'lowerLimit': '97.5', 'upperLimit': '100.0'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Weeks 1, 2, 4, 8 and 12 (Deferred Treatment Substudy)', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set from the Deferred Treatment Sub study: all enrolled participants who took at least 1 dose of study drug'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in HCV RNA (Deferred Treatment Substudy)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '147', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'SOF/VEL/VOX (Deferred Treatment Substudy)', 'description': 'SOF/VEL/VOX (400/100/100 mg) FDC tablet orally once daily with food for 12 weeks'}], 'classes': [{'title': 'Week 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '139', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-4.30', 'spread': '0.626', 'groupId': 'OG000'}]}]}, {'title': 'Week 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '145', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-4.93', 'spread': '0.602', 'groupId': 'OG000'}]}]}, {'title': 'Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '147', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-5.16', 'spread': '0.512', 'groupId': 'OG000'}]}]}, {'title': 'Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '147', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-5.20', 'spread': '0.532', 'groupId': 'OG000'}]}]}, {'title': 'Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '147', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-5.20', 'spread': '0.532', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline; Weeks 1, 2, 4, 8, and 12 (Deferred Treatment Substudy)', 'unitOfMeasure': 'log10 IU/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with available data in the Full Analysis Set of the Deferred Treatment Substudy were analyzed.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Virologic Failure (Deferred Treatment Substudy)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '147', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'SOF/VEL/VOX (Deferred Treatment Substudy)', 'description': 'SOF/VEL/VOX (400/100/100 mg) FDC tablet orally once daily with food for 12 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '2.7', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to Posttreatment Week 24 (Deferred Treatment Substudy)', 'description': 'Virologic failure is 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 in the Deferred Treatment Substudy'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'SOF/VEL/VOX (Primary Study)', 'description': 'Sofosbuvir/velpatasvir/voxilaprevir (SOF/VEL/VOX) (400/100/100 mg) fixed-dose combination (FDC) tablet orally once daily with food for 12 weeks'}, {'id': 'FG001', 'title': 'Placebo (Primary Study)', 'description': 'Placebo tablet orally once daily with food for 12 weeks'}, {'id': 'FG002', 'title': 'SOF/VEL/VOX (Deferred Treatment Substudy)', 'description': 'Participants who completed placebo treatment were eligible to enroll in to the open-label Deferred Treatment Substudy to receive SOF/VEL/VOX (400/100/100 mg) FDC tablet orally once daily with food for 12 weeks.'}], 'periods': [{'title': 'Primary Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '264'}, {'groupId': 'FG001', 'numSubjects': '152'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '257'}, {'groupId': 'FG001', 'numSubjects': '152'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Randomized but Never Treated', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Withdrew Consent', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}, {'title': 'Deferred Treatment Substudy', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '147'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '142'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '5'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '4'}]}, {'type': 'Withdrew Consent', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'Participants were enrolled at study sites in North America, Europe, and Asia Pacific. The first participant was screened on 11 November 2015. The last study visit occurred on 21 June 2017.', 'preAssignmentDetails': '520 participants were screened.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '263', 'groupId': 'BG000'}, {'value': '152', 'groupId': 'BG001'}, {'value': '415', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'SOF/VEL/VOX (Primary Study)', 'description': 'SOF/VEL/VOX (400/100/100 mg) FDC tablet orally once daily with food for 12 weeks'}, {'id': 'BG001', 'title': 'Placebo (Primary Study)', 'description': 'Placebo tablet orally once daily with food for 12 weeks'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '58', 'spread': '8.5', 'groupId': 'BG000'}, {'value': '59', 'spread': '8.0', 'groupId': 'BG001'}, {'value': '58', 'spread': '8.5', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '63', 'groupId': 'BG000'}, {'value': '31', 'groupId': 'BG001'}, {'value': '94', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '200', 'groupId': 'BG000'}, {'value': '121', 'groupId': 'BG001'}, {'value': '321', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'categories': [{'title': 'White', 'measurements': [{'value': '211', 'groupId': 'BG000'}, {'value': '124', 'groupId': 'BG001'}, {'value': '335', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '38', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '60', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Pacific Islander', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}, {'title': 'Not Disclosed', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'American Indian or Alaska Native', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Other', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '25', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '247', 'groupId': 'BG000'}, {'value': '142', 'groupId': 'BG001'}, {'value': '389', 'groupId': 'BG002'}]}, {'title': 'Not Disclosed', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '135', 'groupId': 'BG000'}, {'value': '101', 'groupId': 'BG001'}, {'value': '236', 'groupId': 'BG002'}]}]}, {'title': 'Australia', 'categories': [{'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '26', 'groupId': 'BG002'}]}]}, {'title': 'Canada', 'categories': [{'measurements': [{'value': '28', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '42', 'groupId': 'BG002'}]}]}, {'title': 'France', 'categories': [{'measurements': [{'value': '56', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '72', 'groupId': 'BG002'}]}]}, {'title': 'Germany', 'categories': [{'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '23', 'groupId': 'BG002'}]}]}, {'title': 'New Zealand', 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}]}, {'title': 'United Kingdom', 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'IL28b Status', 'classes': [{'categories': [{'title': 'CC', 'measurements': [{'value': '47', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '74', 'groupId': 'BG002'}]}, {'title': 'CT', 'measurements': [{'value': '165', 'groupId': 'BG000'}, {'value': '93', 'groupId': 'BG001'}, {'value': '258', 'groupId': 'BG002'}]}, {'title': 'TT', 'measurements': [{'value': '51', 'groupId': 'BG000'}, {'value': '32', 'groupId': 'BG001'}, {'value': '83', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'The CC, CT, and TT alleles are different forms of the IL28b gene', 'unitOfMeasure': 'Participants'}, {'title': 'HCV RNA', 'classes': [{'categories': [{'measurements': [{'value': '6.3', 'spread': '0.68', 'groupId': 'BG000'}, {'value': '6.3', 'spread': '0.63', 'groupId': 'BG001'}, {'value': '6.3', 'spread': '0.66', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'log10 IU/mL', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'HCV RNA Category', 'classes': [{'categories': [{'title': '< 800,000 IU/mL', 'measurements': [{'value': '73', 'groupId': 'BG000'}, {'value': '36', 'groupId': 'BG001'}, {'value': '109', 'groupId': 'BG002'}]}, {'title': '≥ 800,000 IU/mL', 'measurements': [{'value': '190', 'groupId': 'BG000'}, {'value': '116', 'groupId': 'BG001'}, {'value': '306', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Safety Analysis Set: all participants who received at least 1 dose of study drug'}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 416}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-11-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-07', 'completionDateStruct': {'date': '2017-06-21', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-02-08', 'studyFirstSubmitDate': '2015-11-16', 'resultsFirstSubmitDate': '2017-10-04', 'studyFirstSubmitQcDate': '2015-11-16', 'lastUpdatePostDateStruct': {'date': '2019-03-05', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-11-14', 'studyFirstPostDateStruct': {'date': '2015-11-18', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-12-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-10-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12) (Primary Study)', 'timeFrame': 'Posttreatment Week 12', 'description': 'SVR12 was defined as HCV RNA \\< the lower limit of quantitation (LLOQ) at 12 weeks after stopping study treatment.'}, {'measure': 'Percentage of Participants Who Permanently Discontinued Study Drug Due to an Adverse Event (Primary Study)', 'timeFrame': 'Up to 12 weeks'}], 'secondaryOutcomes': [{'measure': 'Percentage of Participants With SVR at 4 Weeks After Discontinuation of Therapy (SVR4) (Primary Study)', 'timeFrame': 'Posttreatment Week 4', 'description': 'SVR4 was defined as HCV RNA \\< LLOQ at 4 weeks after stopping study treatment, respectively.'}, {'measure': 'Percentage of Participants With HCV RNA < LLOQ On Treatment (Primary Study)', 'timeFrame': 'Weeks 1, 2, 4, 8 and 12'}, {'measure': 'Change From Baseline in HCV RNA (Primary Study)', 'timeFrame': 'Baseline; Weeks 1, 2, 4, 8 and 12'}, {'measure': 'Percentage of Participants With SVR at 24 Weeks After Discontinuation of Therapy (SVR24) (Primary Study)', 'timeFrame': 'Posttreatment Week 24', 'description': 'SVR24 was defined as HCV RNA \\< LLOQ at 24 weeks after stopping study treatment.'}, {'measure': 'Percentage of Participants With Virologic Failure (Primary Study)', 'timeFrame': 'Up to Posttreatment Week 24', 'description': 'Virologic failure is 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.'}, {'measure': 'Percentage of Participants With SVR at 4, 12, and 24 Weeks After Discontinuation of Therapy (Deferred Treatment Substudy)', 'timeFrame': 'Posttreatment Weeks 4, 12, and 24 (Deferred Treatment Substudy)', 'description': 'SVR4, SVR12 and SVR24 was defined as HCV RNA \\< LLOQ at 4, 12 and 24 weeks after stopping study treatment, respectively.'}, {'measure': 'Percentage of Participants With HCV RNA < LLOQ On Treatment (Deferred Treatment Substudy)', 'timeFrame': 'Weeks 1, 2, 4, 8 and 12 (Deferred Treatment Substudy)'}, {'measure': 'Change From Baseline in HCV RNA (Deferred Treatment Substudy)', 'timeFrame': 'Baseline; Weeks 1, 2, 4, 8, and 12 (Deferred Treatment Substudy)'}, {'measure': 'Percentage of Participants With Virologic Failure (Deferred Treatment Substudy)', 'timeFrame': 'Up to Posttreatment Week 24 (Deferred Treatment Substudy)', 'description': 'Virologic failure is 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': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Chronic Hepatitis C Infection'], 'conditions': ['Hepatitis C']}, 'referencesModule': {'references': [{'type': 'BACKGROUND', 'citation': 'Bourlière M, Gordon SC, Ramji A, Ravendhran N, Tran TT, Hyland RH, et al. Sofosbuvir/Velpatasvir/Voxilaprevir for 12 Weeks as a Salvage Regimen in NS5A Inhibitor-Experienced Patients with Genotype 1-6 Infection: The Phase 3 POLARIS-1 Study [Abstract 194]. J Hepatology 2016;63 (1S):102A.'}, {'pmid': '29155352', 'type': 'BACKGROUND', 'citation': 'Younossi ZM, Stepanova M, Gordon S, Zeuzem S, Mann MP, Jacobson I, Bourliere M, Cooper C, Flamm S, Reddy KR, Kowdley K, Younossi I, Hunt S. Patient-Reported Outcomes Following Treatment of Chronic Hepatitis C Virus Infection With Sofosbuvir and Velpatasvir, With or Without Voxilaprevir. Clin Gastroenterol Hepatol. 2018 Apr;16(4):567-574.e6. doi: 10.1016/j.cgh.2017.11.023. Epub 2017 Nov 16.'}, {'pmid': '29859740', 'type': 'BACKGROUND', 'citation': 'Bourliere M, Gordon SC, Schiff ER, Tran TT, Ravendhran N, Landis CS, Hyland RH, Stamm LM, Zhang J, Dvory-Sobol H, Subramanian GM, Brainard DM, McHutchison JG, Serfaty L, Thompson AJ, Sepe TE, Curry MP, Reddy KR, Manns MP. Deferred treatment with sofosbuvir-velpatasvir-voxilaprevir for patients with chronic hepatitis C virus who were previously treated with an NS5A inhibitor: an open-label substudy of POLARIS-1. Lancet Gastroenterol Hepatol. 2018 Aug;3(8):559-565. doi: 10.1016/S2468-1253(18)30118-3. Epub 2018 May 31.'}, {'pmid': '28564569', 'type': 'RESULT', 'citation': 'Bourliere M, Gordon SC, Flamm SL, Cooper CL, Ramji A, Tong M, Ravendhran N, Vierling JM, Tran TT, Pianko S, Bansal MB, de Ledinghen V, Hyland RH, Stamm LM, Dvory-Sobol H, Svarovskaia E, Zhang J, Huang KC, Subramanian GM, Brainard DM, McHutchison JG, Verna EC, Buggisch P, Landis CS, Younes ZH, Curry MP, Strasser SI, Schiff ER, Reddy KR, Manns MP, Kowdley KV, Zeuzem S; POLARIS-1 and POLARIS-4 Investigators. Sofosbuvir, Velpatasvir, and Voxilaprevir for Previously Treated HCV Infection. N Engl J Med. 2017 Jun 1;376(22):2134-2146. doi: 10.1056/NEJMoa1613512.'}]}, 'descriptionModule': {'briefSummary': 'The primary objectives of this study are to evaluate the safety and efficacy of treatment with sofosbuvir/velpatasvir/voxilaprevir (SOF/VEL/VOX) in adults with chronic hepatitis C virus (HCV) infection who have previously received treatment with direct-acting antiviral therapy.\n\nParticipants randomized to placebo may be eligible for deferred treatment with active SOF/VEL/VOX.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Key Inclusion Criteria:\n\n* Willing and able to provide written informed consent\n* HCV RNA ≥ 10\\^4 IU/mL at screening\n* Chronic HCV infection (≥ 6 months)\n* Treatment experienced with a direct acting antiviral medication for HCV\n* Use of protocol specified methods of contraception\n\nKey Exclusion Criteria:\n\n* Current or prior history of clinically significant illness that may interfere with participation in the study\n* Screening ECG with clinically significant abnormalities\n* Laboratory results outside of acceptable ranges at screening\n* Pregnant or nursing female\n* Chronic liver disease not caused by HCV\n* Infection with hepatitis B virus (HBV) or human immunodeficiency virus (HIV)\n\nNote: Other protocol defined Inclusion/Exclusion criteria may apply.'}, 'identificationModule': {'nctId': 'NCT02607735', 'acronym': 'POLARIS-1', 'briefTitle': 'Safety and Efficacy of Sofosbuvir/Velpatasvir/Voxilaprevir in Adults With Chronic HCV Infection Who Have Previously Received Treatment With Direct-Acting Antiviral Therapy', 'organization': {'class': 'INDUSTRY', 'fullName': 'Gilead Sciences'}, 'officialTitle': 'A Phase 3, Global, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Investigate the Safety and Efficacy of Sofosbuvir/Velpatasvir/GS-9857 Fixed-Dose Combination for 12 Weeks in Direct-Acting Antiviral-Experienced Subjects With Chronic HCV Infection', 'orgStudyIdInfo': {'id': 'GS-US-367-1171'}, 'secondaryIdInfos': [{'id': '2015-003455-21', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'SOF/VEL/VOX (Primary Study)', 'description': 'SOF/VEL/VOX for 12 weeks', 'interventionNames': ['Drug: SOF/VEL/VOX']}, {'type': 'EXPERIMENTAL', 'label': 'Placebo (Primary Study)', 'description': 'Placebo to match SOF/VEL/VOX for 12 weeks', 'interventionNames': ['Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'SOF/VEL/VOX (Deferred Treatment Substudy)', 'description': 'SOF/VEL/VOX for 12 weeks for eligible participants initially randomized to receive placebo', 'interventionNames': ['Drug: SOF/VEL/VOX']}], 'interventions': [{'name': 'SOF/VEL/VOX', 'type': 'DRUG', 'otherNames': ['Vosevi®', 'GS-7977/GS-5816/GS-9857'], 'description': '400/100/100 mg fixed dose-combination (FDC) tablet administered orally once daily with food', 'armGroupLabels': ['SOF/VEL/VOX (Deferred Treatment Substudy)', 'SOF/VEL/VOX (Primary Study)']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Tablet administered orally once daily with food', 'armGroupLabels': ['Placebo (Primary Study)']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Long Beach', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 33.76696, 'lon': -118.18923}}, {'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'city': 'Palo Alto', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 37.44188, 'lon': -122.14302}}, {'city': 'Pasadena', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 34.14778, 'lon': -118.14452}}, {'city': 'Rialto', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 34.1064, 'lon': -117.37032}}, {'city': 'San Diego', 'state': 'California', 'country': 'United States', 'geoPoint': 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