Viewing Study NCT02378935

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Ignite Creation Date: 2025-12-24 @ 10:40 PM
Ignite Modification Date: 2026-03-04 @ 10:12 PM
Study NCT ID: NCT02378935
Status: COMPLETED
Last Update Posted: 2020-03-06
First Post: 2015-02-27
Is NOT Gene Therapy: True
Has Adverse Events: True
Brief Title: Safety and Efficacy of Voxilaprevir Plus Sofosbuvir/Velpatasvir Fixed Dose Combination in Adults With Chronic Genotype 1 HCV Infection
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': 'C000619503', 'term': 'voxilaprevir'}, {'id': 'C000611331', 'term': 'sofosbuvir-velpatasvir drug combination'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTrialDisclosures@gilead.com', 'title': 'Clinical Trial Disclosures', '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': 'Up to 12 weeks plus 30 days', 'description': 'Safety Analysis Set', 'eventGroups': [{'id': 'EG000', 'title': 'VOX+SOF/VEL 6 Weeks, Treatment Naive, Non Cirrhotic', 'description': 'VOX 100 mg tablet + SOF/VEL (400/100 mg) FDC tablet administered once daily for 6 weeks in treatment naive participants without cirrhosis', 'otherNumAtRisk': 34, 'deathsNumAtRisk': 34, 'otherNumAffected': 21, 'seriousNumAtRisk': 34, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'VOX+SOF/VEL 8 Weeks, Treatment Naive, Non Cirrhotic', 'description': 'VOX 100 mg tablet + SOF/VEL (400/100 mg) FDC administered once daily for 8 weeks in treatment naive participants without cirrhosis', 'otherNumAtRisk': 36, 'deathsNumAtRisk': 36, 'otherNumAffected': 20, 'seriousNumAtRisk': 36, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'VOX+SOF/VEL 8 Weeks, Treatment Naive, Cirrhotic', 'description': 'VOX 100 mg tablet + SOF/VEL (400/100 mg) FDC tablet administered once daily for 8 weeks in treatment naive participants with cirrhosis', 'otherNumAtRisk': 33, 'deathsNumAtRisk': 33, 'otherNumAffected': 18, 'seriousNumAtRisk': 33, 'deathsNumAffected': 0, 'seriousNumAffected': 2}, {'id': 'EG003', 'title': 'VOX+SOF/VEL+RBV 8 Weeks, Treatment Naive, Cirrhotic', 'description': 'VOX 100 mg tablet + SOF/VEL (400/100 mg) FDC tablet + RBV tablets (1000 or 1200 mg daily based on weight) administered once daily for 8 weeks in treatment naive participants with cirrhosis', 'otherNumAtRisk': 31, 'deathsNumAtRisk': 31, 'otherNumAffected': 24, 'seriousNumAtRisk': 31, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG004', 'title': 'VOX+SOF/VEL 12 Weeks, DAA-Experienced, Non Cirrhotic', 'description': 'VOX 100 mg tablet + SOF/VEL (400/100 mg) FDC tablet administered once daily for 12 weeks in DAA-experienced participants without cirrhosis', 'otherNumAtRisk': 31, 'deathsNumAtRisk': 31, 'otherNumAffected': 15, 'seriousNumAtRisk': 31, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG005', 'title': 'VOX+SOF/VEL 12 Weeks, DAA-Experienced, Cirrhotic', 'description': 'VOX 100 mg tablet + SOF/VEL (400/100 mg) FDC tablet administered once daily for 12 weeks in DAA-experienced participants with cirrhosis', 'otherNumAtRisk': 32, 'deathsNumAtRisk': 32, 'otherNumAffected': 16, 'seriousNumAtRisk': 32, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG006', 'title': 'VOX+SOF/VEL 12 Weeks (GS-US-338-1121)', 'description': 'VOX 100 mg tablet + SOF/VEL (400/100 mg) FDC tablet administered once daily for 12 weeks in participants who were previously enrolled in Gilead sponsored phase 1b study GS-US-338-1121', 'otherNumAtRisk': 8, 'deathsNumAtRisk': 8, 'otherNumAffected': 6, 'seriousNumAtRisk': 8, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 31, 'numAffected': 7}, {'groupId': 'EG004', 'numAtRisk': 31, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 32, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 8, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 36, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 33, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 31, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 31, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 32, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 8, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 36, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 33, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 31, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 31, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 32, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 8, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 36, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 33, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 31, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 31, 'numAffected': 3}, {'groupId': 'EG005', 'numAtRisk': 32, 'numAffected': 3}, {'groupId': 'EG006', 'numAtRisk': 8, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Dry mouth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 31, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 31, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 32, 'numAffected': 2}, {'groupId': 'EG006', 'numAtRisk': 8, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 33, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 31, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 31, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 32, 'numAffected': 2}, {'groupId': 'EG006', 'numAtRisk': 8, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 36, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 33, 'numAffected': 7}, {'groupId': 'EG003', 'numAtRisk': 31, 'numAffected': 9}, {'groupId': 'EG004', 'numAtRisk': 31, 'numAffected': 3}, {'groupId': 'EG005', 'numAtRisk': 32, 'numAffected': 3}, {'groupId': 'EG006', 'numAtRisk': 8, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 36, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 33, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 31, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 31, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 32, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 8, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 36, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 33, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 31, 'numAffected': 10}, {'groupId': 'EG004', 'numAtRisk': 31, 'numAffected': 7}, {'groupId': 'EG005', 'numAtRisk': 32, 'numAffected': 3}, {'groupId': 'EG006', 'numAtRisk': 8, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Malaise', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 31, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 31, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 32, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 8, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 33, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 31, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 31, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 32, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 8, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 36, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 31, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 31, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 32, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 8, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 36, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 33, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 31, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 31, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 32, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 8, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 31, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 31, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 32, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 8, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 36, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 31, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 31, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 32, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 8, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 33, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 31, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 31, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 32, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 8, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Arthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 31, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 31, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 32, 'numAffected': 2}, {'groupId': 'EG006', 'numAtRisk': 8, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Muscle spasms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 31, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 31, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 32, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 8, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Musculoskeletal chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 33, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 31, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 31, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 32, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 8, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 36, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 33, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 31, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 31, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 32, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 8, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Dysgeusia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 31, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 31, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 32, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 8, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 36, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 33, 'numAffected': 7}, {'groupId': 'EG003', 'numAtRisk': 31, 'numAffected': 9}, {'groupId': 'EG004', 'numAtRisk': 31, 'numAffected': 4}, {'groupId': 'EG005', 'numAtRisk': 32, 'numAffected': 5}, {'groupId': 'EG006', 'numAtRisk': 8, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Paraesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 31, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 31, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 32, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 8, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Sciatica', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 31, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 31, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 32, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 8, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Sinus headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 36, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 31, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 31, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 32, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 8, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 33, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 31, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 31, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 32, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 8, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 31, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 31, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 32, 'numAffected': 2}, {'groupId': 'EG006', 'numAtRisk': 8, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 36, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 31, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 31, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 32, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 8, 'numAffected': 2}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 36, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 31, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 31, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 32, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 8, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 31, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 31, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 32, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 8, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 31, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 31, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 32, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 8, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}], 'seriousEvents': [{'term': 'Atrial flutter', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 33, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 31, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 31, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 32, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 8, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Vertigo', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 33, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 31, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 31, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 32, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 8, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Participants With Sustained Virologic Response 12 Weeks After Discontinuation of Therapy (SVR12)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}, {'value': '33', 'groupId': 'OG002'}, {'value': '31', 'groupId': 'OG003'}, {'value': '31', 'groupId': 'OG004'}, {'value': '32', 'groupId': 'OG005'}, {'value': '8', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'VOX+SOF/VEL 6 Weeks, Treatment Naive, Non Cirrhotic', 'description': 'VOX 100 mg tablet + SOF/VEL (400/100 mg) FDC tablet administered once daily for 6 weeks in treatment naive participants without cirrhosis'}, {'id': 'OG001', 'title': 'VOX+SOF/VEL 8 Weeks, Treatment Naive, Non Cirrhotic', 'description': 'VOX 100 mg tablet + SOF/VEL (400/100 mg) FDC administered once daily for 8 weeks in treatment naive participants without cirrhosis'}, {'id': 'OG002', 'title': 'VOX+SOF/VEL 8 Weeks, Treatment Naive, Cirrhotic', 'description': 'VOX 100 mg tablet + SOF/VEL (400/100 mg) FDC tablet administered once daily for 8 weeks in treatment naive participants with cirrhosis'}, {'id': 'OG003', 'title': 'VOX+SOF/VEL+RBV 8 Weeks, Treatment Naive, Cirrhotic', 'description': 'VOX 100 mg tablet + SOF/VEL (400/100 mg) FDC tablet + RBV tablets (1000 or 1200 mg daily based on weight) administered once daily for 8 weeks in treatment naive participants with cirrhosis'}, {'id': 'OG004', 'title': 'VOX+SOF/VEL 12 Weeks, DAA-Experienced, Non Cirrhotic', 'description': 'VOX 100 mg tablet + SOF/VEL (400/100 mg) FDC tablet administered once daily for 12 weeks in DAA-experienced participants without cirrhosis'}, {'id': 'OG005', 'title': 'VOX+SOF/VEL 12 Weeks, DAA-Experienced, Cirrhotic', 'description': 'VOX 100 mg tablet + SOF/VEL (400/100 mg) FDC tablet administered once daily for 12 weeks in DAA-experienced participants with cirrhosis'}, {'id': 'OG006', 'title': 'VOX+SOF/VEL 12 Weeks (GS-US-338-1121)', 'description': 'VOX 100 mg tablet + SOF/VEL (400/100 mg) FDC tablet administered once daily for 12 weeks in participants who were previously enrolled in Gilead sponsored phase 1b study GS-US-338-1121'}], 'classes': [{'categories': [{'measurements': [{'value': '70.6', 'groupId': 'OG000', 'lowerLimit': '52.5', 'upperLimit': '84.9'}, {'value': '100.0', 'groupId': 'OG001', 'lowerLimit': '90.3', 'upperLimit': '100.0'}, {'value': '93.9', 'groupId': 'OG002', 'lowerLimit': '79.8', 'upperLimit': '99.3'}, {'value': '80.6', 'groupId': 'OG003', 'lowerLimit': '62.5', 'upperLimit': '92.5'}, {'value': '100', 'groupId': 'OG004', 'lowerLimit': '88.8', 'upperLimit': '100.0'}, {'value': '100.0', 'groupId': 'OG005', 'lowerLimit': '89.1', 'upperLimit': '100.0'}, {'value': '100.0', 'groupId': 'OG006', 'lowerLimit': '63.1', 'upperLimit': '100.0'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Posttreatment Week 12', 'description': 'SVR12 was defined as HCV RNA \\< the lower limit of quantitation (LLOQ) 12 weeks following the last dose of study treatment.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set (FAS): participants who 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': '34', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}, {'value': '33', 'groupId': 'OG002'}, {'value': '31', 'groupId': 'OG003'}, {'value': '31', 'groupId': 'OG004'}, {'value': '32', 'groupId': 'OG005'}, {'value': '8', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'VOX+SOF/VEL 6 Weeks, Treatment Naive, Non Cirrhotic', 'description': 'VOX 100 mg tablet + SOF/VEL (400/100 mg) FDC tablet administered once daily for 6 weeks in treatment naive participants without cirrhosis'}, {'id': 'OG001', 'title': 'VOX+SOF/VEL 8 Weeks, Treatment Naive, Non Cirrhotic', 'description': 'VOX 100 mg tablet + SOF/VEL (400/100 mg) FDC administered once daily for 8 weeks in treatment naive participants without cirrhosis'}, {'id': 'OG002', 'title': 'VOX+SOF/VEL 8 Weeks, Treatment Naive, Cirrhotic', 'description': 'VOX 100 mg tablet + SOF/VEL (400/100 mg) FDC tablet administered once daily for 8 weeks in treatment naive participants with cirrhosis'}, {'id': 'OG003', 'title': 'VOX+SOF/VEL+RBV 8 Weeks, Treatment Naive, Cirrhotic', 'description': 'VOX 100 mg tablet + SOF/VEL (400/100 mg) FDC tablet + RBV tablets (1000 or 1200 mg daily based on weight) administered once daily for 8 weeks in treatment naive participants with cirrhosis'}, {'id': 'OG004', 'title': 'VOX+SOF/VEL 12 Weeks, DAA-Experienced, Non Cirrhotic', 'description': 'VOX 100 mg tablet + SOF/VEL (400/100 mg) FDC tablet administered once daily for 12 weeks in DAA-experienced participants without cirrhosis'}, {'id': 'OG005', 'title': 'VOX+SOF/VEL 12 Weeks, DAA-Experienced, Cirrhotic', 'description': 'VOX 100 mg tablet + SOF/VEL (400/100 mg) FDC tablet administered once daily for 12 weeks in DAA-experienced participants with cirrhosis'}, {'id': 'OG006', 'title': 'VOX+SOF/VEL 12 Weeks (GS-US-338-1121)', 'description': 'VOX 100 mg tablet + SOF/VEL (400/100 mg) FDC tablet administered once daily for 12 weeks in participants who were previously enrolled in Gilead sponsored phase 1b study GS-US-338-1121'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '6.5', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 12 Weeks', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Analysis Set'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Sustained Virologic Response 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}, {'value': '33', 'groupId': 'OG002'}, {'value': '31', 'groupId': 'OG003'}, {'value': '31', 'groupId': 'OG004'}, {'value': '32', 'groupId': 'OG005'}, {'value': '8', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'VOX+SOF/VEL 6 Weeks, Treatment Naive, Non Cirrhotic', 'description': 'VOX 100 mg tablet + SOF/VEL (400/100 mg) FDC tablet administered once daily for 6 weeks in treatment naive participants without cirrhosis'}, {'id': 'OG001', 'title': 'VOX+SOF/VEL 8 Weeks, Treatment Naive, Non Cirrhotic', 'description': 'VOX 100 mg tablet + SOF/VEL (400/100 mg) FDC administered once daily for 8 weeks in treatment naive participants without cirrhosis'}, {'id': 'OG002', 'title': 'VOX+SOF/VEL 8 Weeks, Treatment Naive, Cirrhotic', 'description': 'VOX 100 mg tablet + SOF/VEL (400/100 mg) FDC tablet administered once daily for 8 weeks in treatment naive participants with cirrhosis'}, {'id': 'OG003', 'title': 'VOX+SOF/VEL+RBV 8 Weeks, Treatment Naive, Cirrhotic', 'description': 'VOX 100 mg tablet + SOF/VEL (400/100 mg) FDC tablet + RBV tablets (1000 or 1200 mg daily based on weight) administered once daily for 8 weeks in treatment naive participants with cirrhosis'}, {'id': 'OG004', 'title': 'VOX+SOF/VEL 12 Weeks, DAA-Experienced, Non Cirrhotic', 'description': 'VOX 100 mg tablet + SOF/VEL (400/100 mg) FDC tablet administered once daily for 12 weeks in DAA-experienced participants without cirrhosis'}, {'id': 'OG005', 'title': 'VOX+SOF/VEL 12 Weeks, DAA-Experienced, Cirrhotic', 'description': 'VOX 100 mg tablet + SOF/VEL (400/100 mg) FDC tablet administered once daily for 12 weeks in DAA-experienced participants with cirrhosis'}, {'id': 'OG006', 'title': 'VOX+SOF/VEL 12 Weeks (GS-US-338-1121)', 'description': 'VOX 100 mg tablet + SOF/VEL (400/100 mg) FDC tablet administered once daily for 12 weeks in participants who were previously enrolled in Gilead sponsored phase 1b study GS-US-338-1121'}], 'classes': [{'title': 'SVR4', 'categories': [{'measurements': [{'value': '88.2', 'groupId': 'OG000', 'lowerLimit': '72.5', 'upperLimit': '96.7'}, {'value': '100.0', 'groupId': 'OG001', 'lowerLimit': '90.3', 'upperLimit': '100.0'}, {'value': '93.9', 'groupId': 'OG002', 'lowerLimit': '79.8', 'upperLimit': '99.3'}, {'value': '87.1', 'groupId': 'OG003', 'lowerLimit': '70.2', 'upperLimit': '96.4'}, {'value': '100.0', 'groupId': 'OG004', 'lowerLimit': '88.8', 'upperLimit': '100.0'}, {'value': '100.0', 'groupId': 'OG005', 'lowerLimit': '89.1', 'upperLimit': '100.0'}, {'value': '100.0', 'groupId': 'OG006', 'lowerLimit': '63.1', 'upperLimit': '100.0'}]}]}, {'title': 'SVR24', 'categories': [{'measurements': [{'value': '70.6', 'groupId': 'OG000', 'lowerLimit': '52.5', 'upperLimit': '84.9'}, {'value': '100.0', 'groupId': 'OG001', 'lowerLimit': '90.3', 'upperLimit': '100.0'}, {'value': '93.9', 'groupId': 'OG002', 'lowerLimit': '79.8', 'upperLimit': '99.3'}, {'value': '80.6', 'groupId': 'OG003', 'lowerLimit': '62.5', 'upperLimit': '92.5'}, {'value': '100.0', 'groupId': 'OG004', 'lowerLimit': '88.0', 'upperLimit': '100.0'}, {'value': '100.0', 'groupId': 'OG005', 'lowerLimit': '89.1', 'upperLimit': '100.0'}, {'value': '100.0', 'groupId': 'OG006', 'lowerLimit': '63.1', 'upperLimit': '100.0'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Posttreatment Weeks 4 and 24', 'description': 'SVR4 and SVR24 were defined as HCV RNA \\< LLOQ at 4 and 24 weeks following the last dose of study drug, 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', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}, {'value': '33', 'groupId': 'OG002'}, {'value': '31', 'groupId': 'OG003'}, {'value': '31', 'groupId': 'OG004'}, {'value': '32', 'groupId': 'OG005'}, {'value': '8', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'VOX+SOF/VEL 6 Weeks, Treatment Naive, Non Cirrhotic', 'description': 'VOX 100 mg tablet + SOF/VEL (400/100 mg) FDC tablet administered once daily for 6 weeks in treatment naive participants without cirrhosis'}, {'id': 'OG001', 'title': 'VOX+SOF/VEL 8 Weeks, Treatment Naive, Non Cirrhotic', 'description': 'VOX 100 mg tablet + SOF/VEL (400/100 mg) FDC administered once daily for 8 weeks in treatment naive participants without cirrhosis'}, {'id': 'OG002', 'title': 'VOX+SOF/VEL 8 Weeks, Treatment Naive, Cirrhotic', 'description': 'VOX 100 mg tablet + SOF/VEL (400/100 mg) FDC tablet administered once daily for 8 weeks in treatment naive participants with cirrhosis'}, {'id': 'OG003', 'title': 'VOX+SOF/VEL+RBV 8 Weeks, Treatment Naive, Cirrhotic', 'description': 'VOX 100 mg tablet + SOF/VEL (400/100 mg) FDC tablet + RBV tablets (1000 or 1200 mg daily based on weight) administered once daily for 8 weeks in treatment naive participants with cirrhosis'}, {'id': 'OG004', 'title': 'VOX+SOF/VEL 12 Weeks, DAA-Experienced, Non Cirrhotic', 'description': 'VOX 100 mg tablet + SOF/VEL (400/100 mg) FDC tablet administered once daily for 12 weeks in DAA-experienced participants without cirrhosis'}, {'id': 'OG005', 'title': 'VOX+SOF/VEL 12 Weeks, DAA-Experienced, Cirrhotic', 'description': 'VOX 100 mg tablet + SOF/VEL (400/100 mg) FDC tablet administered once daily for 12 weeks in DAA-experienced participants with cirrhosis'}, {'id': 'OG006', 'title': 'VOX+SOF/VEL 12 Weeks (GS-US-338-1121)', 'description': 'VOX 100 mg tablet + SOF/VEL (400/100 mg) FDC tablet administered once daily for 12 weeks in participants who were previously enrolled in Gilead sponsored phase 1b study GS-US-338-1121'}], 'classes': [{'title': 'Week 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}, {'value': '33', 'groupId': 'OG002'}, {'value': '31', 'groupId': 'OG003'}, {'value': '31', 'groupId': 'OG004'}, {'value': '32', 'groupId': 'OG005'}, {'value': '8', 'groupId': 'OG006'}]}], 'categories': [{'measurements': [{'value': '23.5', 'groupId': 'OG000', 'lowerLimit': '10.7', 'upperLimit': '41.2'}, {'value': '38.9', 'groupId': 'OG001', 'lowerLimit': '23.1', 'upperLimit': '56.5'}, {'value': '33.3', 'groupId': 'OG002', 'lowerLimit': '18.0', 'upperLimit': '51.8'}, {'value': '16.1', 'groupId': 'OG003', 'lowerLimit': '5.5', 'upperLimit': '33.7'}, {'value': '22.6', 'groupId': 'OG004', 'lowerLimit': '9.6', 'upperLimit': '41.1'}, {'value': '28.1', 'groupId': 'OG005', 'lowerLimit': '13.7', 'upperLimit': '46.7'}, {'value': '12.5', 'groupId': 'OG006', 'lowerLimit': '0.3', 'upperLimit': '52.7'}]}]}, {'title': 'Week 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}, {'value': '33', 'groupId': 'OG002'}, {'value': '31', 'groupId': 'OG003'}, {'value': '31', 'groupId': 'OG004'}, {'value': '32', 'groupId': 'OG005'}, {'value': '8', 'groupId': 'OG006'}]}], 'categories': [{'measurements': [{'value': '79.4', 'groupId': 'OG000', 'lowerLimit': '62.1', 'upperLimit': '91.3'}, {'value': '75.0', 'groupId': 'OG001', 'lowerLimit': '57.8', 'upperLimit': '87.9'}, {'value': '63.6', 'groupId': 'OG002', 'lowerLimit': '45.1', 'upperLimit': '79.6'}, {'value': '54.8', 'groupId': 'OG003', 'lowerLimit': '36.0', 'upperLimit': '72.7'}, {'value': '58.1', 'groupId': 'OG004', 'lowerLimit': '39.1', 'upperLimit': '75.5'}, {'value': '62.5', 'groupId': 'OG005', 'lowerLimit': '43.7', 'upperLimit': '78.9'}, {'value': '75.0', 'groupId': 'OG006', 'lowerLimit': '34.9', 'upperLimit': '96.8'}]}]}, {'title': 'Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}, {'value': '33', 'groupId': 'OG002'}, {'value': '31', 'groupId': 'OG003'}, {'value': '31', 'groupId': 'OG004'}, {'value': '32', 'groupId': 'OG005'}, {'value': '8', 'groupId': 'OG006'}]}], 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000', 'lowerLimit': '89.7', 'upperLimit': '100.0'}, {'value': '94.4', 'groupId': 'OG001', 'lowerLimit': '81.3', 'upperLimit': '99.3'}, {'value': '90.9', 'groupId': 'OG002', 'lowerLimit': '75.7', 'upperLimit': '98.1'}, {'value': '96.8', 'groupId': 'OG003', 'lowerLimit': '83.3', 'upperLimit': '99.9'}, {'value': '93.5', 'groupId': 'OG004', 'lowerLimit': '78.6', 'upperLimit': '99.2'}, {'value': '96.9', 'groupId': 'OG005', 'lowerLimit': '83.8', 'upperLimit': '99.9'}, {'value': '100.0', 'groupId': 'OG006', 'lowerLimit': '63.1', 'upperLimit': '100.0'}]}]}, {'title': 'Week 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}, {'value': '33', 'groupId': 'OG002'}, {'value': '30', 'groupId': 'OG003'}, {'value': '31', 'groupId': 'OG004'}, {'value': '32', 'groupId': 'OG005'}, {'value': '8', 'groupId': 'OG006'}]}], 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000', 'lowerLimit': '89.7', 'upperLimit': '100.0'}, {'value': '100.0', 'groupId': 'OG001', 'lowerLimit': '90.3', 'upperLimit': '100.0'}, {'value': '97.0', 'groupId': 'OG002', 'lowerLimit': '84.2', 'upperLimit': '99.9'}, {'value': '100.0', 'groupId': 'OG003', 'lowerLimit': '88.4', 'upperLimit': '100.0'}, {'value': '100.0', 'groupId': 'OG004', 'lowerLimit': '88.8', 'upperLimit': '100.0'}, {'value': '100.0', 'groupId': 'OG005', 'lowerLimit': '89.1', 'upperLimit': '100.0'}, {'value': '100.0', 'groupId': 'OG006', 'lowerLimit': '63.1', 'upperLimit': '100.0'}]}]}, {'title': 'Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}, {'value': '33', 'groupId': 'OG002'}, {'value': '31', 'groupId': 'OG003'}, {'value': '31', 'groupId': 'OG004'}, {'value': '32', 'groupId': 'OG005'}, {'value': '8', 'groupId': 'OG006'}]}], 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG001', 'lowerLimit': '90.3', 'upperLimit': '100.0'}, {'value': '100.0', 'groupId': 'OG002', 'lowerLimit': '89.4', 'upperLimit': '100.0'}, {'value': '100.0', 'groupId': 'OG003', 'lowerLimit': '88.4', 'upperLimit': '100.0'}, {'value': '100.0', 'groupId': 'OG004', 'lowerLimit': '88.8', 'upperLimit': '100.0'}, {'value': '100.0', 'groupId': 'OG005', 'lowerLimit': '89.1', 'upperLimit': '100.0'}, {'value': '100.0', 'groupId': 'OG006', 'lowerLimit': '63.1', 'upperLimit': '100.0'}]}]}, {'title': 'Week 10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '31', 'groupId': 'OG004'}, {'value': '32', 'groupId': 'OG005'}, {'value': '8', 'groupId': 'OG006'}]}], 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG004', 'lowerLimit': '88.8', 'upperLimit': '100.0'}, {'value': '100.0', 'groupId': 'OG005', 'lowerLimit': '89.1', 'upperLimit': '100.0'}, {'value': '100.0', 'groupId': 'OG006', 'lowerLimit': '63.1', 'upperLimit': '100.0'}]}]}, {'title': 'Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '31', 'groupId': 'OG004'}, {'value': '32', 'groupId': 'OG005'}, {'value': '8', 'groupId': 'OG006'}]}], 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG004', 'lowerLimit': '88.8', 'upperLimit': '100.0'}, {'value': '100.0', 'groupId': 'OG005', 'lowerLimit': '89.1', 'upperLimit': '100.0'}, {'value': '100.0', 'groupId': 'OG006', 'lowerLimit': '63.1', 'upperLimit': '100.0'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline through end of treatment (Week 6, Week 8 or Week 12, as applicable)', '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': 'HCV RNA Change From Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}, {'value': '33', 'groupId': 'OG002'}, {'value': '31', 'groupId': 'OG003'}, {'value': '31', 'groupId': 'OG004'}, {'value': '32', 'groupId': 'OG005'}, {'value': '8', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'VOX+SOF/VEL 6 Weeks, Treatment Naive, Non Cirrhotic', 'description': 'VOX 100 mg tablet + SOF/VEL (400/100 mg) FDC tablet administered once daily for 6 weeks in treatment naive participants without cirrhosis'}, {'id': 'OG001', 'title': 'VOX+SOF/VEL 8 Weeks, Treatment Naive, Non Cirrhotic', 'description': 'VOX 100 mg tablet + SOF/VEL (400/100 mg) FDC administered once daily for 8 weeks in treatment naive participants without cirrhosis'}, {'id': 'OG002', 'title': 'VOX+SOF/VEL 8 Weeks, Treatment Naive, Cirrhotic', 'description': 'VOX 100 mg tablet + SOF/VEL (400/100 mg) FDC tablet administered once daily for 8 weeks in treatment naive participants with cirrhosis'}, {'id': 'OG003', 'title': 'VOX+SOF/VEL+RBV 8 Weeks, Treatment Naive, Cirrhotic', 'description': 'VOX 100 mg tablet + SOF/VEL (400/100 mg) FDC tablet + RBV tablets (1000 or 1200 mg daily based on weight) administered once daily for 8 weeks in treatment naive participants with cirrhosis'}, {'id': 'OG004', 'title': 'VOX+SOF/VEL 12 Weeks, DAA-Experienced, Non Cirrhotic', 'description': 'VOX 100 mg tablet + SOF/VEL (400/100 mg) FDC tablet administered once daily for 12 weeks in DAA-experienced participants without cirrhosis'}, {'id': 'OG005', 'title': 'VOX+SOF/VEL 12 Weeks, DAA-Experienced, Cirrhotic', 'description': 'VOX 100 mg tablet + SOF/VEL (400/100 mg) FDC tablet administered once daily for 12 weeks in DAA-experienced participants with cirrhosis'}, {'id': 'OG006', 'title': 'VOX+SOF/VEL 12 Weeks (GS-US-338-1121)', 'description': 'VOX 100 mg tablet + SOF/VEL (400/100 mg) FDC tablet administered once daily for 12 weeks in participants who were previously enrolled in Gilead sponsored phase 1b study GS-US-338-1121'}], 'classes': [{'title': 'Change at Week 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}, {'value': '33', 'groupId': 'OG002'}, {'value': '31', 'groupId': 'OG003'}, {'value': '31', 'groupId': 'OG004'}, {'value': '32', 'groupId': 'OG005'}, {'value': '8', 'groupId': 'OG006'}]}], 'categories': [{'measurements': [{'value': '-4.64', 'spread': '0.556', 'groupId': 'OG000'}, {'value': '-4.60', 'spread': '0.595', 'groupId': 'OG001'}, {'value': '-4.15', 'spread': '0.733', 'groupId': 'OG002'}, {'value': '-4.31', 'spread': '0.658', 'groupId': 'OG003'}, {'value': '-4.40', 'spread': '0.577', 'groupId': 'OG004'}, {'value': '-4.19', 'spread': '0.504', 'groupId': 'OG005'}, {'value': '-4.71', 'spread': '0.486', 'groupId': 'OG006'}]}]}, {'title': 'Change at Week 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}, {'value': '33', 'groupId': 'OG002'}, {'value': '31', 'groupId': 'OG003'}, {'value': '31', 'groupId': 'OG004'}, {'value': '32', 'groupId': 'OG005'}, {'value': '8', 'groupId': 'OG006'}]}], 'categories': [{'measurements': [{'value': '-5.00', 'spread': '0.504', 'groupId': 'OG000'}, {'value': '-4.98', 'spread': '0.519', 'groupId': 'OG001'}, {'value': '-4.57', 'spread': '0.662', 'groupId': 'OG002'}, {'value': '-4.85', 'spread': '0.583', 'groupId': 'OG003'}, {'value': '-4.97', 'spread': '0.711', 'groupId': 'OG004'}, {'value': '-4.66', 'spread': '0.520', 'groupId': 'OG005'}, {'value': '-5.27', 'spread': '0.450', 'groupId': 'OG006'}]}]}, {'title': 'Change at Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}, {'value': '33', 'groupId': 'OG002'}, {'value': '30', 'groupId': 'OG003'}, {'value': '31', 'groupId': 'OG004'}, {'value': '32', 'groupId': 'OG005'}, {'value': '8', 'groupId': 'OG006'}]}], 'categories': [{'measurements': [{'value': '-5.07', 'spread': '0.514', 'groupId': 'OG000'}, {'value': '-5.06', 'spread': '0.534', 'groupId': 'OG001'}, {'value': '-4.81', 'spread': '0.576', 'groupId': 'OG002'}, {'value': '-5.17', 'spread': '0.481', 'groupId': 'OG003'}, {'value': '-5.22', 'spread': '0.755', 'groupId': 'OG004'}, {'value': '-4.84', 'spread': '0.601', 'groupId': 'OG005'}, {'value': '-5.35', 'spread': '0.385', 'groupId': 'OG006'}]}]}, {'title': 'Change at Week 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}, {'value': '33', 'groupId': 'OG002'}, {'value': '30', 'groupId': 'OG003'}, {'value': '31', 'groupId': 'OG004'}, {'value': '32', 'groupId': 'OG005'}, {'value': '8', 'groupId': 'OG006'}]}], 'categories': [{'measurements': [{'value': '-5.07', 'spread': '0.514', 'groupId': 'OG000'}, {'value': '-5.08', 'spread': '0.549', 'groupId': 'OG001'}, {'value': '-4.84', 'spread': '0.586', 'groupId': 'OG002'}, {'value': '-5.16', 'spread': '0.480', 'groupId': 'OG003'}, {'value': '-5.24', 'spread': '0.767', 'groupId': 'OG004'}, {'value': '-4.84', 'spread': '0.611', 'groupId': 'OG005'}, {'value': '-5.35', 'spread': '0.385', 'groupId': 'OG006'}]}]}, {'title': 'Change at Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}, {'value': '33', 'groupId': 'OG002'}, {'value': '30', 'groupId': 'OG003'}, {'value': '31', 'groupId': 'OG004'}, {'value': '32', 'groupId': 'OG005'}, {'value': '8', 'groupId': 'OG006'}]}], 'categories': [{'measurements': [{'value': '-5.08', 'spread': '0.549', 'groupId': 'OG001'}, {'value': '-4.85', 'spread': '0.591', 'groupId': 'OG002'}, {'value': '-5.16', 'spread': '0.480', 'groupId': 'OG003'}, {'value': '-5.24', 'spread': '0.767', 'groupId': 'OG004'}, {'value': '-4.84', 'spread': '0.611', 'groupId': 'OG005'}, {'value': '-5.35', 'spread': '0.385', 'groupId': 'OG006'}]}]}, {'title': 'Change at Week 10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '31', 'groupId': 'OG004'}, {'value': '32', 'groupId': 'OG005'}, {'value': '8', 'groupId': 'OG006'}]}], 'categories': [{'measurements': [{'value': '-5.24', 'spread': '0.767', 'groupId': 'OG004'}, {'value': '-4.84', 'spread': '0.611', 'groupId': 'OG005'}, {'value': '-5.35', 'spread': '0.385', 'groupId': 'OG006'}]}]}, {'title': 'Change at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '31', 'groupId': 'OG004'}, {'value': '32', 'groupId': 'OG005'}, {'value': '8', 'groupId': 'OG006'}]}], 'categories': [{'measurements': [{'value': '-5.24', 'spread': '0.767', 'groupId': 'OG004'}, {'value': '-4.84', 'spread': '0.611', 'groupId': 'OG005'}, {'value': '-5.35', 'spread': '0.385', 'groupId': 'OG006'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline through end of treatment (Week 6, Week 8 or Week 12, as applicable)', 'unitOfMeasure': 'log10 IU/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in the Full Analysis Set with available data were analyzed'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Virologic Failure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}, {'value': '33', 'groupId': 'OG002'}, {'value': '31', 'groupId': 'OG003'}, {'value': '31', 'groupId': 'OG004'}, {'value': '32', 'groupId': 'OG005'}, {'value': '8', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'VOX+SOF/VEL 6 Weeks, Treatment Naive, Non Cirrhotic', 'description': 'VOX 100 mg tablet + SOF/VEL (400/100 mg) FDC tablet administered once daily for 6 weeks in treatment naive participants without cirrhosis'}, {'id': 'OG001', 'title': 'VOX+SOF/VEL 8 Weeks, Treatment Naive, Non Cirrhotic', 'description': 'VOX 100 mg tablet + SOF/VEL (400/100 mg) FDC administered once daily for 8 weeks in treatment naive participants without cirrhosis'}, {'id': 'OG002', 'title': 'VOX+SOF/VEL 8 Weeks, Treatment Naive, Cirrhotic', 'description': 'VOX 100 mg tablet + SOF/VEL (400/100 mg) FDC tablet administered once daily for 8 weeks in treatment naive participants with cirrhosis'}, {'id': 'OG003', 'title': 'VOX+SOF/VEL+RBV 8 Weeks, Treatment Naive, Cirrhotic', 'description': 'VOX 100 mg tablet + SOF/VEL (400/100 mg) FDC tablet + RBV tablets (1000 or 1200 mg daily based on weight) administered once daily for 8 weeks in treatment naive participants with cirrhosis'}, {'id': 'OG004', 'title': 'VOX+SOF/VEL 12 Weeks, DAA-Experienced, Non Cirrhotic', 'description': 'VOX 100 mg tablet + SOF/VEL (400/100 mg) FDC tablet administered once daily for 12 weeks in DAA-experienced participants without cirrhosis'}, {'id': 'OG005', 'title': 'VOX+SOF/VEL 12 Weeks, DAA-Experienced, Cirrhotic', 'description': 'VOX 100 mg tablet + SOF/VEL (400/100 mg) FDC tablet administered once daily for 12 weeks in DAA-experienced participants with cirrhosis'}, {'id': 'OG006', 'title': 'VOX+SOF/VEL 12 Weeks (GS-US-338-1121)', 'description': 'VOX 100 mg tablet + SOF/VEL (400/100 mg) FDC tablet administered once daily for 12 weeks in participants who were previously enrolled in Gilead sponsored phase 1b study GS-US-338-1121'}], 'classes': [{'categories': [{'measurements': [{'value': '29.4', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '6.1', 'groupId': 'OG002'}, {'value': '19.4', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to Posttreatment Week 24', 'description': '* 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': 'VOX+SOF/VEL 6 Weeks, Treatment Naive, Non Cirrhotic', 'description': 'Voxilaprevir (VOX) 100 mg tablet + sofosbuvir/veltapasvir (Epclusa® ; SOF/VEL) (400/100 mg) fixed-dose combination (FDC) tablet administered once daily for 6 weeks in treatment naive participants without cirrhosis'}, {'id': 'FG001', 'title': 'VOX+SOF/VEL 8 Weeks, Treatment Naive, Non Cirrhotic', 'description': 'VOX 100 mg tablet + SOF/VEL (400/100 mg) FDC tablet administered once daily for 8 weeks in treatment naive participants without cirrhosis'}, {'id': 'FG002', 'title': 'VOX+SOF/VEL 8 Weeks, Treatment Naive, Cirrhotic', 'description': 'VOX 100 mg tablet + SOF/VEL (400/100 mg) FDC tablet administered once daily for 8 weeks in treatment naive participants with cirrhosis'}, {'id': 'FG003', 'title': 'VOX+SOF/VEL+RBV 8 Weeks, Treatment Naive, Cirrhotic', 'description': 'VOX 100 mg tablet + SOF/VEL (400/100 mg) FDC tablet + ribavirin (RBV) tablets (1000 or 1200 mg daily based on weight) administered once daily for 8 weeks in treatment naive participants with cirrhosis'}, {'id': 'FG004', 'title': 'VOX+SOF/VEL 12 Weeks, DAA-Experienced, Non Cirrhotic', 'description': 'VOX 100 mg tablet + SOF/VEL (400/100 mg) FDC tablet administered once daily for 12 weeks in direct-acting antiviral (DAA) experienced participants without cirrhosis'}, {'id': 'FG005', 'title': 'VOX+SOF/VEL 12 Weeks, DAA-Experienced, Cirrhotic', 'description': 'VOX 100 mg tablet + SOF/VEL (400/100 mg) FDC tablet administered once daily for 12 weeks in DAA-experienced participants with cirrhosis'}, {'id': 'FG006', 'title': 'VOX+SOF/VEL 12 Weeks (GS-US-338-1121)', 'description': 'VOX 100 mg tablet + SOF/VEL (400/100 mg) FDC tablet administered once daily for 12 weeks in participants who were previously enrolled in Gilead sponsored phase 1b study GS-US-338-1121'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '34'}, {'groupId': 'FG001', 'numSubjects': '36'}, {'groupId': 'FG002', 'numSubjects': '33'}, {'groupId': 'FG003', 'numSubjects': '31'}, {'groupId': 'FG004', 'numSubjects': '31'}, {'groupId': 'FG005', 'numSubjects': '32'}, {'groupId': 'FG006', 'numSubjects': '8'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '24'}, {'groupId': 'FG001', 'numSubjects': '36'}, {'groupId': 'FG002', 'numSubjects': '30'}, {'groupId': 'FG003', 'numSubjects': '25'}, {'groupId': 'FG004', 'numSubjects': '31'}, {'groupId': 'FG005', 'numSubjects': '32'}, {'groupId': 'FG006', 'numSubjects': '8'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '6'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '6'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Participants were enrolled at study sites in United States and New Zealand. The first participant was screened on 17 February 2015. The last study visit occurred on 12 April 2016.', 'preAssignmentDetails': '255 participants were screened. Enrollment was sequential, with the longer treatment duration groups enrolled, treated, and evaluated for Sustained Virologic Response 4 Weeks After Discontinuation of Therapy (SVR4) prior to enrollment of the shorter treatment duration groups, which were not enrolled, at the discretion of the Sponsor.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'BG000'}, {'value': '36', 'groupId': 'BG001'}, {'value': '33', 'groupId': 'BG002'}, {'value': '31', 'groupId': 'BG003'}, {'value': '31', 'groupId': 'BG004'}, {'value': '32', 'groupId': 'BG005'}, {'value': '8', 'groupId': 'BG006'}, {'value': '205', 'groupId': 'BG007'}]}], 'groups': [{'id': 'BG000', 'title': 'VOX+SOF/VEL 6 Weeks, Treatment Naive, Non Cirrhotic', 'description': 'VOX 100 mg tablet + SOF/VEL (400/100 mg) FDC tablet administered once daily for 6 weeks in treatment naive participants without cirrhosis'}, {'id': 'BG001', 'title': 'VOX+SOF/VEL 8 Weeks, Treatment Naive, Non Cirrhotic', 'description': 'VOX 100 mg tablet + SOF/VEL (400/100 mg) FDC administered once daily for 8 weeks in treatment naive participants without cirrhosis'}, {'id': 'BG002', 'title': 'VOX+SOF/VEL 8 Weeks, Treatment Naive, Cirrhotic', 'description': 'VOX 100 mg tablet + SOF/VEL (400/100 mg) FDC tablet administered once daily for 8 weeks in treatment naive participants with cirrhosis'}, {'id': 'BG003', 'title': 'VOX+SOF/VEL+RBV 8 Weeks, Treatment Naive, Cirrhotic', 'description': 'VOX 100 mg tablet + SOF/VEL (400/100 mg) FDC tablet + RBV tablets (1000 or 1200 mg daily based on weight) administered once daily for 8 weeks in treatment naive participants with cirrhosis'}, {'id': 'BG004', 'title': 'VOX+SOF/VEL 12 Weeks, DAA-Experienced, Non Cirrhotic', 'description': 'VOX 100 mg tablet + SOF/VEL (400/100 mg) FDC tablet administered once daily for 12 weeks in DAA-experienced participants without cirrhosis'}, {'id': 'BG005', 'title': 'VOX+SOF/VEL 12 Weeks, DAA-Experienced, Cirrhotic', 'description': 'VOX 100 mg tablet + SOF/VEL (400/100 mg) FDC tablet administered once daily for 12 weeks in DAA-experienced participants with cirrhosis'}, {'id': 'BG006', 'title': 'VOX+SOF/VEL 12 Weeks (GS-US-338-1121)', 'description': 'VOX 100 mg tablet + SOF/VEL (400/100 mg) FDC tablet administered once daily for 12 weeks in participants who were previously enrolled in Gilead sponsored phase 1b study GS-US-338-1121'}, {'id': 'BG007', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '53', 'spread': '11.5', 'groupId': 'BG000'}, {'value': '51', 'spread': '14.3', 'groupId': 'BG001'}, {'value': '58', 'spread': '7.2', 'groupId': 'BG002'}, {'value': '59', 'spread': '6.7', 'groupId': 'BG003'}, {'value': '57', 'spread': '7.8', 'groupId': 'BG004'}, {'value': '59', 'spread': '6.5', 'groupId': 'BG005'}, {'value': '5.7', 'spread': '5.9', 'groupId': 'BG006'}, {'value': '56', 'spread': '9.8', 'groupId': 'BG007'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}, {'value': '12', 'groupId': 'BG003'}, {'value': '8', 'groupId': 'BG004'}, {'value': '6', 'groupId': 'BG005'}, {'value': '5', 'groupId': 'BG006'}, {'value': '71', 'groupId': 'BG007'}]}, {'title': 'Male', 'measurements': [{'value': '23', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}, {'value': '19', 'groupId': 'BG003'}, {'value': '23', 'groupId': 'BG004'}, {'value': '26', 'groupId': 'BG005'}, {'value': '3', 'groupId': 'BG006'}, {'value': '134', 'groupId': 'BG007'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Black or African American', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}, {'value': '4', 'groupId': 'BG004'}, {'value': '6', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '29', 'groupId': 'BG007'}]}]}, {'title': 'White', 'categories': [{'measurements': [{'value': '31', 'groupId': 'BG000'}, {'value': '32', 'groupId': 'BG001'}, {'value': '25', 'groupId': 'BG002'}, {'value': '26', 'groupId': 'BG003'}, {'value': '27', 'groupId': 'BG004'}, {'value': '26', 'groupId': 'BG005'}, {'value': '8', 'groupId': 'BG006'}, {'value': '175', 'groupId': 'BG007'}]}]}, {'title': 'Native Hawaiian or Pacific Islander', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '1', 'groupId': 'BG007'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Hispanic or Latino', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '7', 'groupId': 'BG003'}, {'value': '4', 'groupId': 'BG004'}, {'value': '10', 'groupId': 'BG005'}, {'value': '5', 'groupId': 'BG006'}, {'value': '42', 'groupId': 'BG007'}]}]}, {'title': 'Not Hispanic or Latino', 'categories': [{'measurements': [{'value': '31', 'groupId': 'BG000'}, {'value': '31', 'groupId': 'BG001'}, {'value': '25', 'groupId': 'BG002'}, {'value': '24', 'groupId': 'BG003'}, {'value': '27', 'groupId': 'BG004'}, {'value': '22', 'groupId': 'BG005'}, {'value': '3', 'groupId': 'BG006'}, {'value': '163', 'groupId': 'BG007'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '32', 'groupId': 'BG000'}, {'value': '36', 'groupId': 'BG001'}, {'value': '28', 'groupId': 'BG002'}, {'value': '31', 'groupId': 'BG003'}, {'value': '31', 'groupId': 'BG004'}, {'value': '32', 'groupId': 'BG005'}, {'value': '8', 'groupId': 'BG006'}, {'value': '198', 'groupId': 'BG007'}]}]}, {'title': 'New Zealand', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '7', 'groupId': 'BG007'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'IL28b Status', 'classes': [{'title': 'CC', 'categories': [{'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}, {'value': '12', 'groupId': 'BG003'}, {'value': '4', 'groupId': 'BG004'}, {'value': '4', 'groupId': 'BG005'}, {'value': '3', 'groupId': 'BG006'}, {'value': '51', 'groupId': 'BG007'}]}]}, {'title': 'CT', 'categories': [{'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}, {'value': '12', 'groupId': 'BG003'}, {'value': '19', 'groupId': 'BG004'}, {'value': '21', 'groupId': 'BG005'}, {'value': '3', 'groupId': 'BG006'}, {'value': '110', 'groupId': 'BG007'}]}]}, {'title': 'TT', 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}, {'value': '7', 'groupId': 'BG004'}, {'value': '7', 'groupId': 'BG005'}, {'value': '2', 'groupId': 'BG006'}, {'value': '40', 'groupId': 'BG007'}]}]}, {'title': 'Missing', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '4', 'groupId': 'BG007'}]}]}], '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': '6.2', 'spread': '0.51', 'groupId': 'BG000'}, {'value': '6.2', 'spread': '0.55', 'groupId': 'BG001'}, {'value': '6.0', 'spread': '0.59', 'groupId': 'BG002'}, {'value': '6.3', 'spread': '0.47', 'groupId': 'BG003'}, {'value': '6.4', 'spread': '0.77', 'groupId': 'BG004'}, {'value': '6.0', 'spread': '0.61', 'groupId': 'BG005'}, {'value': '6.5', 'spread': '0.38', 'groupId': 'BG006'}, {'value': '6.2', 'spread': '0.60', 'groupId': 'BG007'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'log10 IU/mL', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'HCV RNA Category', 'classes': [{'title': '< 800,000 IU/mL', 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}, {'value': '6', 'groupId': 'BG004'}, {'value': '16', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '58', 'groupId': 'BG007'}]}]}, {'title': '≥ 800,000 IU/mL', 'categories': [{'measurements': [{'value': '28', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}, {'value': '25', 'groupId': 'BG003'}, {'value': '25', 'groupId': 'BG004'}, {'value': '16', 'groupId': 'BG005'}, {'value': '8', 'groupId': 'BG006'}, {'value': '147', 'groupId': 'BG007'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Safety Analysis Set: participants who received at least 1 dose of study drug'}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 205}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-02-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-11', 'dispFirstSubmitDate': '2016-05-23', 'completionDateStruct': {'date': '2016-04-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-02-18', 'studyFirstSubmitDate': '2015-02-27', 'dispFirstSubmitQcDate': '2016-05-23', 'resultsFirstSubmitDate': '2017-08-16', 'studyFirstSubmitQcDate': '2015-02-27', 'dispFirstPostDateStruct': {'date': '2016-06-06', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2020-03-06', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-11-06', 'studyFirstPostDateStruct': {'date': '2015-03-04', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-12-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-02-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Participants With Sustained Virologic Response 12 Weeks After Discontinuation of Therapy (SVR12)', 'timeFrame': 'Posttreatment Week 12', 'description': 'SVR12 was defined as HCV RNA \\< the lower limit of quantitation (LLOQ) 12 weeks following the last dose of study treatment.'}, {'measure': 'Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event', 'timeFrame': 'Up to 12 Weeks'}], 'secondaryOutcomes': [{'measure': 'Percentage of Participants With Sustained Virologic Response 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)', 'timeFrame': 'Posttreatment Weeks 4 and 24', 'description': 'SVR4 and SVR24 were defined as HCV RNA \\< LLOQ at 4 and 24 weeks following the last dose of study drug, respectively.'}, {'measure': 'Percentage of Participants With HCV RNA < LLOQ on Treatment', 'timeFrame': 'Baseline through end of treatment (Week 6, Week 8 or Week 12, as applicable)'}, {'measure': 'HCV RNA Change From Baseline', 'timeFrame': 'Baseline through end of treatment (Week 6, Week 8 or Week 12, as applicable)'}, {'measure': 'Percentage of Participants With Virologic Failure', 'timeFrame': 'Up to Posttreatment Week 24', 'description': '* 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': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hepatitis C Virus Infection']}, 'referencesModule': {'references': [{'pmid': '27486034', 'type': 'RESULT', 'citation': 'Lawitz E, Reau N, Hinestrosa F, Rabinovitz M, Schiff E, Sheikh A, Younes Z, Herring R Jr, Reddy KR, Tran T, Bennett M, Nahass R, Yang JC, Lu S, Dvory-Sobol H, Stamm LM, Brainard DM, McHutchison JG, Pearlman B, Shiffman M, Hawkins T, Curry M, Jacobson I. Efficacy of Sofosbuvir, Velpatasvir, and GS-9857 in Patients With Genotype 1 Hepatitis C Virus Infection in an Open-Label, Phase 2 Trial. Gastroenterology. 2016 Nov;151(5):893-901.e1. doi: 10.1053/j.gastro.2016.07.039. Epub 2016 Jul 30.'}]}, 'descriptionModule': {'briefSummary': 'This primary objectives of the study are to evaluate the safety, tolerability, and efficacy of voxilaprevir (VOX) plus sofosbuvir/velpatasvir (SOF/VEL) fixed dose combination (FDC) ± ribavirin (RBV) in adults with chronic genotype 1 hepatitis C virus (HCV) infection.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Key Inclusion Criteria:\n\n* Individuals with chronic HCV infection\n* HCV RNA ≥10\\^4 IU/mL at screening\n* HCV genotype 1\n* Cirrhosis determination; a liver biopsy may be required\n* Screening laboratory values within defined thresholds\n* Use of two contraception methods if female of childbearing potential or sexually active male\n\nKey Exclusion Criteria:\n\n* Pregnant or nursing female\n* Current or prior history of hepatic decompensation\n* Hepatocellular carcinoma (HCC) or other clinically significant malignancy\n* Infection with hepatitis B virus (HBV) or human immunodeficiency virus (HIV)\n* History of clinically significant illness or any other medical disorder that may interfere with the individual's treatment, assessment or compliance with the protocol\n\nNOTE: Other protocol defined Inclusion/Exclusion criteria may apply."}, 'identificationModule': {'nctId': 'NCT02378935', 'briefTitle': 'Safety and Efficacy of Voxilaprevir Plus Sofosbuvir/Velpatasvir Fixed Dose Combination in Adults With Chronic Genotype 1 HCV Infection', 'organization': {'class': 'INDUSTRY', 'fullName': 'Gilead Sciences'}, 'officialTitle': 'A Phase 2, Global, Multicenter, Open-Label Study to Investigate the Safety and Efficacy of GS-9857 Plus Sofosbuvir/GS-5816 Fixed Dose Combination in Subjects With Chronic Genotype 1 HCV Infection', 'orgStudyIdInfo': {'id': 'GS-US-367-1168'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'VOX+SOF/VEL 6 wk, TN, without cirrhosis', 'description': 'VOX + SOF/VEL for 6 weeks (treatment naive (TN), without cirrhosis)', 'interventionNames': ['Drug: VOX', 'Drug: SOF/VEL']}, {'type': 'EXPERIMENTAL', 'label': 'VOX+SOF/VEL 8 wk, TN, without cirrhosis', 'description': 'VOX + SOF/VEL for 8 weeks (treatment naive, without cirrhosis)', 'interventionNames': ['Drug: VOX', 'Drug: SOF/VEL']}, {'type': 'EXPERIMENTAL', 'label': 'VOX+SOF/VEL 6 wk, TN, with cirrhosis', 'description': 'VOX + SOF/VEL for 6 weeks (treatment naive, with cirrhosis)', 'interventionNames': ['Drug: VOX', 'Drug: SOF/VEL']}, {'type': 'EXPERIMENTAL', 'label': 'VOX+SOF/VEL 8 wk, TN, with cirrhosis', 'description': 'VOX + SOF/VEL for 8 weeks (treatment naive, with cirrhosis)', 'interventionNames': ['Drug: VOX', 'Drug: SOF/VEL']}, {'type': 'EXPERIMENTAL', 'label': 'VOX+SOF/VEL+RBV 8 wk, TN, with cirrhosis', 'description': 'VOX + SOF/VEL+RBV for 8 weeks (treatment naive, with cirrhosis)', 'interventionNames': ['Drug: VOX', 'Drug: SOF/VEL', 'Drug: RBV']}, {'type': 'EXPERIMENTAL', 'label': 'VOX+SOF/VEL 8 wk, DAA-E, without cirrhosis', 'description': 'VOX + SOF/VEL for 8 weeks (direct-acting antiviral experienced (DAA-E), without cirrhosis)', 'interventionNames': ['Drug: VOX', 'Drug: SOF/VEL']}, {'type': 'EXPERIMENTAL', 'label': 'VOX+SOF/VEL 12 wk, DAA-E, without cirrhosis', 'description': 'VOX + SOF/VEL for 12 weeks (direct-acting antiviral experienced, without cirrhosis)', 'interventionNames': ['Drug: VOX', 'Drug: SOF/VEL']}, {'type': 'EXPERIMENTAL', 'label': 'VOX+SOF/VEL 8 wk, DAA-E, with cirrhosis', 'description': 'GS-9857 + SOF/VEL for 8 weeks (direct-acting antiviral experienced, with cirrhosis)', 'interventionNames': ['Drug: VOX', 'Drug: SOF/VEL']}, {'type': 'EXPERIMENTAL', 'label': 'VOX+SOF/VEL 12 wk, DAA-E, with cirrhosis', 'description': 'GS-9857 + SOF/VEL for 12 weeks (direct-acting antiviral experienced, with cirrhosis)', 'interventionNames': ['Drug: VOX', 'Drug: SOF/VEL']}, {'type': 'EXPERIMENTAL', 'label': 'VOX+SOF/VEL 12 wk (GS-US-338-1121)', 'description': 'VOX + SOF/VEL for 12 weeks (participants who were previously enrolled in GS-US-338-1121 phase 1b study)', 'interventionNames': ['Drug: VOX', 'Drug: SOF/VEL']}], 'interventions': [{'name': 'VOX', 'type': 'DRUG', 'otherNames': ['GS-9857'], 'description': '100 mg tablet(s) administered orally once daily with food', 'armGroupLabels': ['VOX+SOF/VEL 12 wk (GS-US-338-1121)', 'VOX+SOF/VEL 12 wk, DAA-E, with cirrhosis', 'VOX+SOF/VEL 12 wk, DAA-E, without cirrhosis', 'VOX+SOF/VEL 6 wk, TN, with cirrhosis', 'VOX+SOF/VEL 6 wk, TN, without cirrhosis', 'VOX+SOF/VEL 8 wk, DAA-E, with cirrhosis', 'VOX+SOF/VEL 8 wk, DAA-E, without cirrhosis', 'VOX+SOF/VEL 8 wk, TN, with cirrhosis', 'VOX+SOF/VEL 8 wk, TN, without cirrhosis', 'VOX+SOF/VEL+RBV 8 wk, TN, with cirrhosis']}, {'name': 'SOF/VEL', 'type': 'DRUG', 'otherNames': ['GS-7977/GS-5816', 'Epclusa®'], 'description': '400/100 mg FDC tablet administered orally once daily with food', 'armGroupLabels': ['VOX+SOF/VEL 12 wk (GS-US-338-1121)', 'VOX+SOF/VEL 12 wk, DAA-E, with cirrhosis', 'VOX+SOF/VEL 12 wk, DAA-E, without cirrhosis', 'VOX+SOF/VEL 6 wk, TN, with cirrhosis', 'VOX+SOF/VEL 6 wk, TN, without cirrhosis', 'VOX+SOF/VEL 8 wk, DAA-E, with cirrhosis', 'VOX+SOF/VEL 8 wk, DAA-E, without cirrhosis', 'VOX+SOF/VEL 8 wk, TN, with cirrhosis', 'VOX+SOF/VEL 8 wk, TN, without cirrhosis', 'VOX+SOF/VEL+RBV 8 wk, TN, with cirrhosis']}, {'name': 'RBV', 'type': 'DRUG', 'description': 'Tablets administered orally in a divided daily dose according to package insert weight-based dosing recommendations (\\< 75 kg = 1000 mg and ≥ 75 kg = 1200 mg)', 'armGroupLabels': ['VOX+SOF/VEL+RBV 8 wk, TN, with cirrhosis']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Cedars Sinai Medical Center', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'city': 'Palo Alto', 'state': 'California', 'country': 'United States', 'facility': 'Stanford 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'facility': 'Auckland Clinical Studies', 'geoPoint': {'lat': -36.84853, 'lon': 174.76349}}, {'city': 'Christchurch', 'country': 'New Zealand', 'facility': 'Christchurch Clinical Studies Trust', 'geoPoint': {'lat': -43.53333, 'lon': 172.63333}}, {'city': 'San Juan', 'country': 'Puerto Rico', 'facility': 'Fundacion de Investigacion de Diego', 'geoPoint': {'lat': 18.46633, 'lon': -66.10572}}], 'overallOfficials': [{'name': 'Gilead Study Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Gilead Sciences'}]}, 'ipdSharingStatementModule': {'url': 'https://www.gilead.com/science-and-medicine/research/clinical-trials-transparency-and-data-sharing-policy', '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 https://www.gilead.com/science-and-medicine/research/clinical-trials-transparency-and-data-sharing-policy.', 'accessCriteria': 'A secured external environment with username, password, and RSA code.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Gilead Sciences', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}