Ignite Creation Date:
2025-12-25 @ 1:04 AM
Ignite Modification Date:
2026-03-05 @ 12:18 AM
Study NCT ID:
NCT02243293
Status:
COMPLETED
Last Update Posted:
2021-07-30
First Post:
2014-09-04
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Co-Administration of ABT-493 and ABT-530 With and Without RBV in Subjects With Chronic Hepatitis C Virus (HCV) Genotypes 2, 3, 4, 5 or 6 Infection
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Australia', 'Canada', 'France', 'Italy', 'New Zealand', 'South Korea', 'Taiwan', 'United Kingdom', 'United States']}, 'conditionBrowseModule': {'meshes': [{'id': 'D019698', 'term': 'Hepatitis C, Chronic'}, {'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': 'D006521', 'term': 'Hepatitis, Chronic'}, {'id': 'D006505', 'term': 'Hepatitis'}, {'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000612853', 'term': 'glecaprevir'}, {'id': 'C000622691', 'term': 'pibrentasvir'}, {'id': 'D012254', 'term': 'Ribavirin'}, {'id': 'C000654128', 'term': 'glecaprevir and pibrentasvir'}], 'ancestors': [{'id': 'D012263', 'term': 'Ribonucleosides'}, {'id': 'D009705', 'term': 'Nucleosides'}, {'id': 'D009706', 'term': 'Nucleic Acids, Nucleotides, and Nucleosides'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'abbvieclinicaltrials@abbvie.com', 'phone': '800-633-9110', 'title': 'Global Medical Services', 'organization': 'AbbVie'}, 'certainAgreement': {'otherDetails': 'AbbVie requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. AbbVie requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if AbbVie needs to secure patent or proprietary protection.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the time of study drug administration until 30 days after the last dose of study drug (up to 20 weeks).', 'description': 'TEAEs and TESAEs are defined as any adverse event (AE) or serious adverse event (SAE) with an onset date that is after the first dose of study drug until 30 days after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.', 'eventGroups': [{'id': 'EG000', 'title': 'ARM A', 'description': 'ABT-493 (300 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD for 12 weeks in HCV genotype 2 (GT2) -infected treatment naïve and treatment experienced participants without cirrhosis.', 'otherNumAtRisk': 25, 'deathsNumAtRisk': 25, 'otherNumAffected': 12, 'seriousNumAtRisk': 25, 'deathsNumAffected': 1, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'ARM B', 'description': 'ABT-493 (200 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD for 12 weeks in HCV GT2 -infected treatment naïve and treatment experienced participants without cirrhosis.', 'otherNumAtRisk': 24, 'deathsNumAtRisk': 24, 'otherNumAffected': 11, 'seriousNumAtRisk': 24, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'ARM C', 'description': 'ABT-493 (200 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD and weight-based ribavirin (RBV) divided twice daily (BID) for 12 weeks in HCV GT2 -infected treatment naïve and treatment experienced participants without cirrhosis.', 'otherNumAtRisk': 25, 'deathsNumAtRisk': 25, 'otherNumAffected': 22, 'seriousNumAtRisk': 25, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG003', 'title': 'ARM D', 'description': 'ABT-493 (300 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD for 12 weeks in HCV genotype 3 (GT3) -infected treatment naïve and treatment experienced participants without cirrhosis.', 'otherNumAtRisk': 30, 'deathsNumAtRisk': 30, 'otherNumAffected': 19, 'seriousNumAtRisk': 30, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG004', 'title': 'ARM E', 'description': 'ABT-493 (200 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD for 12 weeks in HCV GT3 -infected treatment naïve and treatment experienced participants without cirrhosis.', 'otherNumAtRisk': 30, 'deathsNumAtRisk': 30, 'otherNumAffected': 20, 'seriousNumAtRisk': 30, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG005', 'title': 'ARM F', 'description': 'ABT-493 (200 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD and weight-based ribavirin (RBV) divided BID for 12 weeks in HCV GT3 -infected treatment naïve and treatment experienced participants without cirrhosis.', 'otherNumAtRisk': 31, 'deathsNumAtRisk': 31, 'otherNumAffected': 23, 'seriousNumAtRisk': 31, 'deathsNumAffected': 0, 'seriousNumAffected': 2}, {'id': 'EG006', 'title': 'ARM G', 'description': 'ABT-493 (200 mg) once daily (QD) co-administered with ABT-530 (40 mg) QD for 12 weeks in HCV GT3 -infected treatment naïve and treatment experienced participants without cirrhosis.', 'otherNumAtRisk': 30, 'deathsNumAtRisk': 30, 'otherNumAffected': 18, 'seriousNumAtRisk': 30, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG007', 'title': 'ARM J', 'description': 'ABT-493 (300 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD for 8 weeks in HCV GT2 -infected treatment naïve and treatment experienced participants without cirrhosis.', 'otherNumAtRisk': 54, 'deathsNumAtRisk': 54, 'otherNumAffected': 26, 'seriousNumAtRisk': 54, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG008', 'title': 'ARM L', 'description': 'ABT-493 (300 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD for 8 weeks in HCV GT3 -infected treatment naïve and for 12 weeks in HCV GT3 -infected treatment experienced participants without cirrhosis.', 'otherNumAtRisk': 53, 'deathsNumAtRisk': 53, 'otherNumAffected': 40, 'seriousNumAtRisk': 53, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG009', 'title': 'ARM O', 'description': 'ABT-493 (300 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD for 12 weeks in HCV GT3 -infected treatment naïve participants with compensated cirrhosis and for 16 weeks in HCV GT3 -infected treatment-experienced participants with compensated cirrhosis.', 'otherNumAtRisk': 28, 'deathsNumAtRisk': 28, 'otherNumAffected': 20, 'seriousNumAtRisk': 28, 'deathsNumAffected': 0, 'seriousNumAffected': 2}, {'id': 'EG010', 'title': 'ARM P', 'description': 'ABT-493 (300 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD and RBV (800 mg) QD for 12 weeks in HCV GT3-infected treatment naïve and treatment-experienced participants with compensated cirrhosis.', 'otherNumAtRisk': 27, 'deathsNumAtRisk': 27, 'otherNumAffected': 21, 'seriousNumAtRisk': 27, 'deathsNumAffected': 1, 'seriousNumAffected': 2}, {'id': 'EG011', 'title': 'ARM Q1', 'description': 'ABT-493/ ABT-530 (300 mg/ 120mg ) once daily (QD) for 12 weeks in HCV GT3 -infected treatment naïve participants with cirrhosis.', 'otherNumAtRisk': 40, 'deathsNumAtRisk': 40, 'otherNumAffected': 30, 'seriousNumAtRisk': 40, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG012', 'title': 'ARM Q2', 'description': 'ABT-493/ ABT-530 (300 mg/ 120mg ) once daily (QD) for 12 weeks in HCV GT3 -infected treatment experienced participants without cirrhosis.', 'otherNumAtRisk': 22, 'deathsNumAtRisk': 22, 'otherNumAffected': 12, 'seriousNumAtRisk': 22, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG013', 'title': 'ARM R1', 'description': 'ABT-493/ ABT-530 (300 mg/ 120 mg) QD for 16 weeks in HCV GT3 -infected treatment experienced participants without cirrhosis.', 'otherNumAtRisk': 22, 'deathsNumAtRisk': 22, 'otherNumAffected': 13, 'seriousNumAtRisk': 22, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG014', 'title': 'ARM R2', 'description': 'ABT-493/ ABT-530 (300 mg/ 120 mg) QD for 16 weeks in HCV GT3 -infected treatment experienced participants with cirrhosis.', 'otherNumAtRisk': 47, 'deathsNumAtRisk': 47, 'otherNumAffected': 31, 'seriousNumAtRisk': 47, 'deathsNumAffected': 0, 'seriousNumAffected': 3}, {'id': 'EG015', 'title': 'ARM S1', 'description': 'ABT-493/ ABT-530 (300 mg/ 120 mg) QD for 8 weeks in HCV GT2 infected treatment naïve and treatment experienced participants without cirrhosis.', 'otherNumAtRisk': 145, 'deathsNumAtRisk': 145, 'otherNumAffected': 78, 'seriousNumAtRisk': 145, 'deathsNumAffected': 1, 'seriousNumAffected': 1}, {'id': 'EG016', 'title': 'ARM S2', 'description': 'ABT-493/ ABT-530 (300 mg/ 120 mg) QD for 8 weeks in HCV GT4-6 infected treatment naïve and treatment experienced participants without cirrhosis.', 'otherNumAtRisk': 58, 'deathsNumAtRisk': 58, 'otherNumAffected': 32, 'seriousNumAtRisk': 58, 'deathsNumAffected': 0, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 31, 'numAffected': 2}, {'groupId': 'EG006', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 54, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 28, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 40, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 22, 'numAffected': 1}, {'groupId': 'EG014', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG015', 'numAtRisk': 145, 'numAffected': 0}, {'groupId': 'EG016', 'numAtRisk': 58, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 19.0'}, {'term': 'Ear pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 31, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 54, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 28, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 40, 'numAffected': 2}, {'groupId': 'EG012', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG015', 'numAtRisk': 145, 'numAffected': 0}, {'groupId': 'EG016', 'numAtRisk': 58, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 19.0'}, {'term': 'Abdominal discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 31, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 54, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 53, 'numAffected': 4}, {'groupId': 'EG009', 'numAtRisk': 28, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 27, 'numAffected': 2}, {'groupId': 'EG011', 'numAtRisk': 40, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG015', 'numAtRisk': 145, 'numAffected': 0}, {'groupId': 'EG016', 'numAtRisk': 58, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 19.0'}, {'term': 'Abdominal distension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 24, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG005', 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0}, {'groupId': 'EG003', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 31, 'numAffected': 2}, {'groupId': 'EG006', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 54, 'numAffected': 2}, {'groupId': 'EG008', 'numAtRisk': 53, 'numAffected': 3}, {'groupId': 'EG009', 'numAtRisk': 28, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 27, 'numAffected': 2}, {'groupId': 'EG011', 'numAtRisk': 40, 'numAffected': 2}, {'groupId': 'EG012', 'numAtRisk': 22, 'numAffected': 2}, {'groupId': 'EG013', 'numAtRisk': 22, 'numAffected': 1}, {'groupId': 'EG014', 'numAtRisk': 47, 'numAffected': 2}, {'groupId': 'EG015', 'numAtRisk': 145, 'numAffected': 3}, {'groupId': 'EG016', 'numAtRisk': 58, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 19.0'}, {'term': 'Abdominal pain lower', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 31, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 54, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 28, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 40, 'numAffected': 2}, {'groupId': 'EG012', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG015', 'numAtRisk': 145, 'numAffected': 1}, {'groupId': 'EG016', 'numAtRisk': 58, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 19.0'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 30, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 31, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 54, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 53, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 28, 'numAffected': 1}, {'groupId': 'EG010', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 40, 'numAffected': 2}, {'groupId': 'EG012', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 22, 'numAffected': 1}, {'groupId': 'EG014', 'numAtRisk': 47, 'numAffected': 1}, {'groupId': 'EG015', 'numAtRisk': 145, 'numAffected': 0}, {'groupId': 'EG016', 'numAtRisk': 58, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 19.0'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 24, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 31, 'numAffected': 2}, {'groupId': 'EG006', 'numAtRisk': 30, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 54, 'numAffected': 3}, {'groupId': 'EG008', 'numAtRisk': 53, 'numAffected': 3}, {'groupId': 'EG009', 'numAtRisk': 28, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 40, 'numAffected': 1}, {'groupId': 'EG012', 'numAtRisk': 22, 'numAffected': 2}, {'groupId': 'EG013', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 47, 'numAffected': 1}, {'groupId': 'EG015', 'numAtRisk': 145, 'numAffected': 4}, {'groupId': 'EG016', 'numAtRisk': 58, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 19.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 24, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 25, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 30, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 30, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 31, 'numAffected': 2}, {'groupId': 'EG006', 'numAtRisk': 30, 'numAffected': 2}, {'groupId': 'EG007', 'numAtRisk': 54, 'numAffected': 4}, {'groupId': 'EG008', 'numAtRisk': 53, 'numAffected': 8}, {'groupId': 'EG009', 'numAtRisk': 28, 'numAffected': 6}, {'groupId': 'EG010', 'numAtRisk': 27, 'numAffected': 1}, {'groupId': 'EG011', 'numAtRisk': 40, 'numAffected': 4}, {'groupId': 'EG012', 'numAtRisk': 22, 'numAffected': 1}, {'groupId': 'EG013', 'numAtRisk': 22, 'numAffected': 2}, {'groupId': 'EG014', 'numAtRisk': 47, 'numAffected': 1}, {'groupId': 'EG015', 'numAtRisk': 145, 'numAffected': 4}, {'groupId': 'EG016', 'numAtRisk': 58, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 19.0'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 25, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 31, 'numAffected': 2}, {'groupId': 'EG006', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 54, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 53, 'numAffected': 2}, {'groupId': 'EG009', 'numAtRisk': 28, 'numAffected': 1}, {'groupId': 'EG010', 'numAtRisk': 27, 'numAffected': 1}, {'groupId': 'EG011', 'numAtRisk': 40, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 47, 'numAffected': 3}, {'groupId': 'EG015', 'numAtRisk': 145, 'numAffected': 4}, {'groupId': 'EG016', 'numAtRisk': 58, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 19.0'}, {'term': 'Gastrooesophageal reflux disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 25, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 30, 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'groupId': 'OG012'}, {'value': '22', 'groupId': 'OG013'}, {'value': '47', 'groupId': 'OG014'}, {'value': '145', 'groupId': 'OG015'}, {'value': '58', 'groupId': 'OG016'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm A', 'description': 'ABT-493 (300 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD for 12 weeks in HCV genotype 2 (GT2) -infected treatment naïve and treatment experienced participants without cirrhosis.'}, {'id': 'OG001', 'title': 'Arm B', 'description': 'ABT-493 (200 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD for 12 weeks in HCV GT2 -infected treatment naïve and treatment experienced participants without cirrhosis.'}, {'id': 'OG002', 'title': 'Arm C', 'description': 'ABT-493 (200 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD and weight-based ribavirin (RBV) divided twice daily (BID) for 12 weeks in HCV GT2 -infected treatment naïve and treatment experienced participants without cirrhosis.'}, {'id': 'OG003', 'title': 'Arm D', 'description': 'ABT-493 (300 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD for 12 weeks in HCV genotype 3 (GT3) -infected treatment naïve and treatment experienced participants without cirrhosis.'}, {'id': 'OG004', 'title': 'Arm E', 'description': 'ABT-493 (200 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD for 12 weeks in HCV GT3 -infected treatment naïve and treatment experienced participants without cirrhosis.'}, {'id': 'OG005', 'title': 'Arm F', 'description': 'ABT-493 (200 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD and weight-based ribavirin (RBV) divided BID for 12 weeks in HCV GT3 -infected treatment naïve and treatment experienced participants without cirrhosis.'}, {'id': 'OG006', 'title': 'Arm G', 'description': 'ABT-493 (200 mg) once daily (QD) co-administered with ABT-530 (40 mg) QD for 12 weeks in HCV GT3 -infected treatment naïve and treatment experienced participants without cirrhosis.'}, {'id': 'OG007', 'title': 'Arm J', 'description': 'ABT-493 (300 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD for 8 weeks in HCV GT2 -infected treatment naïve and treatment experienced participants without cirrhosis.'}, {'id': 'OG008', 'title': 'Arm L', 'description': 'ABT-493 (300 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD for 8 weeks in HCV GT3 -infected treatment naïve and for 12 weeks in HCV GT3 -infected treatment experienced participants without cirrhosis.'}, {'id': 'OG009', 'title': 'Arm O', 'description': 'ABT-493 (300 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD for 12 weeks in HCV GT3 -infected treatment naïve participants with compensated cirrhosis and for 16 weeks in HCV GT3 -infected treatment-experienced participants with compensated cirrhosis.'}, {'id': 'OG010', 'title': 'Arm P', 'description': 'ABT-493 (300 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD and RBV (800 mg) QD for 12 weeks in HCV GT3-infected treatment naïve and treatment-experienced participants with compensated cirrhosis.'}, {'id': 'OG011', 'title': 'Arm Q1', 'description': 'ABT-493/ ABT-530 (300 mg/ 120mg ) once daily (QD) for 12 weeks in HCV GT3 -infected treatment naïve participants with cirrhosis.'}, {'id': 'OG012', 'title': 'Arm Q2', 'description': 'ABT-493/ ABT-530 (300 mg/ 120mg ) once daily (QD) for 12 weeks in HCV GT3 -infected treatment experienced participants without cirrhosis.'}, {'id': 'OG013', 'title': 'Arm R1', 'description': 'ABT-493/ ABT-530 (300 mg/ 120 mg) QD for 16 weeks in HCV GT3 -infected treatment experienced participants without cirrhosis.'}, {'id': 'OG014', 'title': 'Arm R2', 'description': 'ABT-493/ ABT-530 (300 mg/ 120 mg) QD for 16 weeks in HCV GT3 -infected treatment experienced participants with cirrhosis.'}, {'id': 'OG015', 'title': 'Arm S1', 'description': 'ABT-493/ ABT-530 (300 mg/ 120 mg) QD for 8 weeks in HCV GT2 infected treatment naïve and treatment experienced participants without cirrhosis.'}, {'id': 'OG016', 'title': 'Arm S2', 'description': 'ABT-493/ ABT-530 (300 mg/ 120 mg) QD for 8 weeks in HCV GT4-6 infected treatment naïve and treatment experienced participants without cirrhosis.'}], 'classes': [{'categories': [{'measurements': [{'value': '96.0', 'groupId': 'OG000', 'lowerLimit': '80.5', 'upperLimit': '99.3'}, {'value': '100.0', 'groupId': 'OG001', 'lowerLimit': '86.2', 'upperLimit': '100.0'}, {'value': '100.0', 'groupId': 'OG002', 'lowerLimit': '86.7', 'upperLimit': '100.0'}, {'value': '93.3', 'groupId': 'OG003', 'lowerLimit': '78.7', 'upperLimit': '98.2'}, {'value': '93.3', 'groupId': 'OG004', 'lowerLimit': '78.7', 'upperLimit': '98.2'}, {'value': '93.5', 'groupId': 'OG005', 'lowerLimit': '79.3', 'upperLimit': '98.2'}, {'value': '83.3', 'groupId': 'OG006', 'lowerLimit': '66.4', 'upperLimit': '92.7'}, {'value': '98.1', 'groupId': 'OG007', 'lowerLimit': '90.2', 'upperLimit': '99.7'}, {'value': '94.3', 'groupId': 'OG008', 'lowerLimit': '84.6', 'upperLimit': '98.1'}, {'value': '96.4', 'groupId': 'OG009', 'lowerLimit': '82.3', 'upperLimit': '99.4'}, {'value': '100.0', 'groupId': 'OG010', 'lowerLimit': '87.5', 'upperLimit': '100.0'}, {'value': '97.5', 'groupId': 'OG011', 'lowerLimit': '87.1', 'upperLimit': '99.6'}, {'value': '90.9', 'groupId': 'OG012', 'lowerLimit': '72.2', 'upperLimit': '97.5'}, {'value': '95.5', 'groupId': 'OG013', 'lowerLimit': '78.2', 'upperLimit': '99.2'}, {'value': '95.7', 'groupId': 'OG014', 'lowerLimit': '85.8', 'upperLimit': '98.8'}, {'value': '97.9', 'groupId': 'OG015', 'lowerLimit': '94.1', 'upperLimit': '99.3'}, {'value': '93.1', 'groupId': 'OG016', 'lowerLimit': '83.6', 'upperLimit': '97.3'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '12 weeks after the last actual dose of study drug', 'description': 'SVR12 was defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) level less than the lower limit of quantification \\[\\<LLOQ\\]) 12 weeks after the last dose of study drug.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who received at least 1 dose of study drug (ITT population) with evaluable data; participants with missing data after backwards imputation were imputed as nonresponders.'}, {'type': 'PRIMARY', 'title': 'Percentage of Genotype 2 (GT2) Direct-acting Antiviral Agents (DAA)-Naive Participants (in Part 4, Arm S1) With Sustained Virologic Response 12 Weeks Post-treatment (SVR12) as Compared to Historical Control', 'denoms': [{'units': 'Participants', 'counts': [{'value': '137', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm S1', 'description': 'ABT-493/ ABT-530 (300 mg/ 120 mg) QD for 8 weeks in HCV GT2 infected treatment naïve and treatment experienced participants without cirrhosis.'}], 'classes': [{'categories': [{'measurements': [{'value': '98.5', 'groupId': 'OG000', 'lowerLimit': '96.5', 'upperLimit': '100.0'}]}]}], 'analyses': [{'groupIds': ['OG000'], 'paramType': 'Percentage of Participants', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '98.5', 'ciLowerLimit': '96.5', 'ciUpperLimit': '100.0', 'estimateComment': '95% CI was calculated using the normal approximation to the binomial distribution.', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'The non-inferiority of the rate of sustained virologic response at 12 weeks after treatment as compared to historical control (in genotype 2 (GT2) DAA-naive participants in Part 4, arm S) was analyzed; the lower confidence bound of the 2-sided 95% confidence interval (95% CI) for the percentage of participants with sustained virologic response at 12 weeks after treatment must exceed 89% to achieve noninferiority.'}], 'paramType': 'NUMBER', 'timeFrame': '12 weeks after the last actual dose of study drug', 'description': 'SVR12 was defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) level less than the lower limit of quantification \\[\\<LLOQ\\]) 12 weeks after the last dose of study drug.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who received at least 1 dose of study drug (ITT population) with evaluable data; participants with missing data after backwards imputation were imputed as nonresponders.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Sustained Virologic Response 4 Weeks Post-treatment (SVR4)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}, {'value': '25', 'groupId': 'OG002'}, {'value': '30', 'groupId': 'OG003'}, {'value': '30', 'groupId': 'OG004'}, {'value': '31', 'groupId': 'OG005'}, {'value': '30', 'groupId': 'OG006'}, {'value': '54', 'groupId': 'OG007'}, {'value': '53', 'groupId': 'OG008'}, {'value': '28', 'groupId': 'OG009'}, {'value': '27', 'groupId': 'OG010'}, {'value': '40', 'groupId': 'OG011'}, {'value': '22', 'groupId': 'OG012'}, {'value': '22', 'groupId': 'OG013'}, {'value': '47', 'groupId': 'OG014'}, {'value': '145', 'groupId': 'OG015'}, {'value': '58', 'groupId': 'OG016'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm A', 'description': 'ABT-493 (300 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD for 12 weeks in HCV genotype 2 (GT2) -infected treatment naïve and treatment experienced participants without cirrhosis.'}, {'id': 'OG001', 'title': 'Arm B', 'description': 'ABT-493 (200 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD for 12 weeks in HCV GT2 -infected treatment naïve and treatment experienced participants without cirrhosis.'}, {'id': 'OG002', 'title': 'Arm C', 'description': 'ABT-493 (200 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD and weight-based ribavirin (RBV) divided twice daily (BID) for 12 weeks in HCV GT2 -infected treatment naïve and treatment experienced participants without cirrhosis.'}, {'id': 'OG003', 'title': 'Arm D', 'description': 'ABT-493 (300 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD for 12 weeks in HCV genotype 3 (GT3) -infected treatment naïve and treatment experienced participants without cirrhosis.'}, {'id': 'OG004', 'title': 'Arm E', 'description': 'ABT-493 (200 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD for 12 weeks in HCV GT3 -infected treatment naïve and treatment experienced participants without cirrhosis.'}, {'id': 'OG005', 'title': 'Arm F', 'description': 'ABT-493 (200 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD and weight-based ribavirin (RBV) divided BID for 12 weeks in HCV GT3 -infected treatment naïve and treatment experienced participants without cirrhosis.'}, {'id': 'OG006', 'title': 'Arm G', 'description': 'ABT-493 (200 mg) once daily (QD) co-administered with ABT-530 (40 mg) QD for 12 weeks in HCV GT3 -infected treatment naïve and treatment experienced participants without cirrhosis.'}, {'id': 'OG007', 'title': 'Arm J', 'description': 'ABT-493 (300 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD for 8 weeks in HCV GT2 -infected treatment naïve and treatment experienced participants without cirrhosis.'}, {'id': 'OG008', 'title': 'Arm L', 'description': 'ABT-493 (300 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD for 8 weeks in HCV GT3 -infected treatment naïve and for 12 weeks in HCV GT3 -infected treatment experienced participants without cirrhosis.'}, {'id': 'OG009', 'title': 'Arm O', 'description': 'ABT-493 (300 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD for 12 weeks in HCV GT3 -infected treatment naïve participants with compensated cirrhosis and for 16 weeks in HCV GT3 -infected treatment-experienced participants with compensated cirrhosis.'}, {'id': 'OG010', 'title': 'Arm P', 'description': 'ABT-493 (300 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD and RBV (800 mg) QD for 12 weeks in HCV GT3-infected treatment naïve and treatment-experienced participants with compensated cirrhosis.'}, {'id': 'OG011', 'title': 'Arm Q1', 'description': 'ABT-493/ ABT-530 (300 mg/ 120mg ) once daily (QD) for 12 weeks in HCV GT3 -infected treatment naïve participants with cirrhosis.'}, {'id': 'OG012', 'title': 'Arm Q2', 'description': 'ABT-493/ ABT-530 (300 mg/ 120mg ) once daily (QD) for 12 weeks in HCV GT3 -infected treatment experienced participants without cirrhosis.'}, {'id': 'OG013', 'title': 'Arm R1', 'description': 'ABT-493/ ABT-530 (300 mg/ 120 mg) QD for 16 weeks in HCV GT3 -infected treatment experienced participants without cirrhosis.'}, {'id': 'OG014', 'title': 'Arm R2', 'description': 'ABT-493/ ABT-530 (300 mg/ 120 mg) QD for 16 weeks in HCV GT3 -infected treatment experienced participants with cirrhosis.'}, {'id': 'OG015', 'title': 'Arm S1', 'description': 'ABT-493/ ABT-530 (300 mg/ 120 mg) QD for 8 weeks in HCV GT2 infected treatment naïve and treatment experienced participants without cirrhosis.'}, {'id': 'OG016', 'title': 'Arm S2', 'description': 'ABT-493/ ABT-530 (300 mg/ 120 mg) QD for 8 weeks in HCV GT4-6 infected treatment naïve and treatment experienced participants without cirrhosis.'}], 'classes': [{'categories': [{'measurements': [{'value': '96.0', 'groupId': 'OG000', 'lowerLimit': '80.5', 'upperLimit': '99.3'}, {'value': '100.0', 'groupId': 'OG001', 'lowerLimit': '86.2', 'upperLimit': '100.0'}, {'value': '100.0', 'groupId': 'OG002', 'lowerLimit': '86.7', 'upperLimit': '100.0'}, {'value': '93.3', 'groupId': 'OG003', 'lowerLimit': '78.7', 'upperLimit': '98.2'}, {'value': '93.3', 'groupId': 'OG004', 'lowerLimit': '78.7', 'upperLimit': '98.2'}, {'value': '93.5', 'groupId': 'OG005', 'lowerLimit': '79.3', 'upperLimit': '98.2'}, {'value': '93.3', 'groupId': 'OG006', 'lowerLimit': '78.7', 'upperLimit': '98.2'}, {'value': '98.1', 'groupId': 'OG007', 'lowerLimit': '90.2', 'upperLimit': '99.7'}, {'value': '96.2', 'groupId': 'OG008', 'lowerLimit': '87.2', 'upperLimit': '99.0'}, {'value': '96.4', 'groupId': 'OG009', 'lowerLimit': '82.3', 'upperLimit': '99.4'}, {'value': '100.0', 'groupId': 'OG010', 'lowerLimit': '87.5', 'upperLimit': '100.0'}, {'value': '97.5', 'groupId': 'OG011', 'lowerLimit': '87.1', 'upperLimit': '99.6'}, {'value': '95.5', 'groupId': 'OG012', 'lowerLimit': '78.2', 'upperLimit': '99.2'}, {'value': '95.5', 'groupId': 'OG013', 'lowerLimit': '78.2', 'upperLimit': '99.2'}, {'value': '95.7', 'groupId': 'OG014', 'lowerLimit': '85.8', 'upperLimit': '98.8'}, {'value': '97.9', 'groupId': 'OG015', 'lowerLimit': '94.1', 'upperLimit': '99.3'}, {'value': '98.3', 'groupId': 'OG016', 'lowerLimit': '90.9', 'upperLimit': '99.7'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '4 weeks after the last actual dose of study drug', 'description': 'SVR4 was defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) level less than the lower limit of quantification \\[\\<LLOQ\\]) 4 weeks after the last dose of study drug.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who received at least 1 dose of study drug (ITT population) with evaluable data; participants with missing data after backwards imputation were imputed as nonresponders.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With On-treatment Virologic Failure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}, {'value': '25', 'groupId': 'OG002'}, {'value': '30', 'groupId': 'OG003'}, {'value': '30', 'groupId': 'OG004'}, {'value': '31', 'groupId': 'OG005'}, {'value': '30', 'groupId': 'OG006'}, {'value': '54', 'groupId': 'OG007'}, {'value': '53', 'groupId': 'OG008'}, {'value': '28', 'groupId': 'OG009'}, {'value': '27', 'groupId': 'OG010'}, {'value': '40', 'groupId': 'OG011'}, {'value': '22', 'groupId': 'OG012'}, {'value': '22', 'groupId': 'OG013'}, {'value': '47', 'groupId': 'OG014'}, {'value': '145', 'groupId': 'OG015'}, {'value': '58', 'groupId': 'OG016'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm A', 'description': 'ABT-493 (300 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD for 12 weeks in HCV genotype 2 (GT2) -infected treatment naïve and treatment experienced participants without cirrhosis.'}, {'id': 'OG001', 'title': 'Arm B', 'description': 'ABT-493 (200 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD for 12 weeks in HCV GT2 -infected treatment naïve and treatment experienced participants without cirrhosis.'}, {'id': 'OG002', 'title': 'Arm C', 'description': 'ABT-493 (200 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD and weight-based ribavirin (RBV) divided twice daily (BID) for 12 weeks in HCV GT2 -infected treatment naïve and treatment experienced participants without cirrhosis.'}, {'id': 'OG003', 'title': 'Arm D', 'description': 'ABT-493 (300 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD for 12 weeks in HCV genotype 3 (GT3) -infected treatment naïve and treatment experienced participants without cirrhosis.'}, {'id': 'OG004', 'title': 'Arm E', 'description': 'ABT-493 (200 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD for 12 weeks in HCV GT3 -infected treatment naïve and treatment experienced participants without cirrhosis.'}, {'id': 'OG005', 'title': 'Arm F', 'description': 'ABT-493 (200 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD and weight-based ribavirin (RBV) divided BID for 12 weeks in HCV GT3 -infected treatment naïve and treatment experienced participants without cirrhosis.'}, {'id': 'OG006', 'title': 'Arm G', 'description': 'ABT-493 (200 mg) once daily (QD) co-administered with ABT-530 (40 mg) QD for 12 weeks in HCV GT3 -infected treatment naïve and treatment experienced participants without cirrhosis.'}, {'id': 'OG007', 'title': 'Arm J', 'description': 'ABT-493 (300 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD for 8 weeks in HCV GT2 -infected treatment naïve and treatment experienced participants without cirrhosis.'}, {'id': 'OG008', 'title': 'Arm L', 'description': 'ABT-493 (300 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD for 8 weeks in HCV GT3 -infected treatment naïve and for 12 weeks in HCV GT3 -infected treatment experienced participants without cirrhosis.'}, {'id': 'OG009', 'title': 'Arm O', 'description': 'ABT-493 (300 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD for 12 weeks in HCV GT3 -infected treatment naïve participants with compensated cirrhosis and for 16 weeks in HCV GT3 -infected treatment-experienced participants with compensated cirrhosis.'}, {'id': 'OG010', 'title': 'Arm P', 'description': 'ABT-493 (300 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD and RBV (800 mg) QD for 12 weeks in HCV GT3-infected treatment naïve and treatment-experienced participants with compensated cirrhosis.'}, {'id': 'OG011', 'title': 'Arm Q1', 'description': 'ABT-493/ ABT-530 (300 mg/ 120mg ) once daily (QD) for 12 weeks in HCV GT3 -infected treatment naïve participants with cirrhosis.'}, {'id': 'OG012', 'title': 'Arm Q2', 'description': 'ABT-493/ ABT-530 (300 mg/ 120mg ) once daily (QD) for 12 weeks in HCV GT3 -infected treatment experienced participants without cirrhosis.'}, {'id': 'OG013', 'title': 'Arm R1', 'description': 'ABT-493/ ABT-530 (300 mg/ 120 mg) QD for 16 weeks in HCV GT3 -infected treatment experienced participants without cirrhosis.'}, {'id': 'OG014', 'title': 'Arm R2', 'description': 'ABT-493/ ABT-530 (300 mg/ 120 mg) QD for 16 weeks in HCV GT3 -infected treatment experienced participants with cirrhosis.'}, {'id': 'OG015', 'title': 'Arm S1', 'description': 'ABT-493/ ABT-530 (300 mg/ 120 mg) QD for 8 weeks in HCV GT2 infected treatment naïve and treatment experienced participants without cirrhosis.'}, {'id': 'OG016', 'title': 'Arm S2', 'description': 'ABT-493/ ABT-530 (300 mg/ 120 mg) QD for 8 weeks in HCV GT4-6 infected treatment naïve and treatment experienced participants without cirrhosis.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '13.3'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '13.8'}, {'value': '0', 'groupId': 'OG002', 'lowerLimit': '0.0', 'upperLimit': '13.3'}, {'value': '0', 'groupId': 'OG003', 'lowerLimit': '0.0', 'upperLimit': '11.4'}, {'value': '0', 'groupId': 'OG004', 'lowerLimit': '0.0', 'upperLimit': '11.4'}, {'value': '3.2', 'groupId': 'OG005', 'lowerLimit': '0.6', 'upperLimit': '16.2'}, {'value': '3.3', 'groupId': 'OG006', 'lowerLimit': '0.6', 'upperLimit': '16.7'}, {'value': '0', 'groupId': 'OG007', 'lowerLimit': '0.0', 'upperLimit': '6.6'}, {'value': '1.9', 'groupId': 'OG008', 'lowerLimit': '0.3', 'upperLimit': '9.9'}, {'value': '0', 'groupId': 'OG009', 'lowerLimit': '0.0', 'upperLimit': '12.1'}, {'value': '0', 'groupId': 'OG010', 'lowerLimit': '0.0', 'upperLimit': '12.5'}, {'value': '0', 'groupId': 'OG011', 'lowerLimit': '0.0', 'upperLimit': '8.8'}, {'value': '0', 'groupId': 'OG012', 'lowerLimit': '0.0', 'upperLimit': '14.9'}, {'value': '0', 'groupId': 'OG013', 'lowerLimit': '0.0', 'upperLimit': '14.9'}, {'value': '2.1', 'groupId': 'OG014', 'lowerLimit': '0.4', 'upperLimit': '11.1'}, {'value': '0', 'groupId': 'OG015', 'lowerLimit': '0.0', 'upperLimit': '2.6'}, {'value': '0', 'groupId': 'OG016', 'lowerLimit': '0.0', 'upperLimit': '6.2'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to end of treatment (treatment week 8, 12 or 16 depending on arm) or premature discontinuation from treatment', 'description': 'On-treatment virologic failure was defined as confirmed HCV RNA ≥ LLOQ after HCV RNA \\< LLOQ during treatment; confirmed increase of \\> 1 log(subscript)10(subscript) IU/mL above the lowest value post-baseline in HCV RNA during treatment; or HCV RNA ≥ LLOQ at end of treatment with at least 6 weeks of treatment.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who received at least 1 dose of study drug (ITT population) with evaluable data.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Post-treatment Relapse', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}, {'value': '25', 'groupId': 'OG002'}, {'value': '29', 'groupId': 'OG003'}, {'value': '30', 'groupId': 'OG004'}, {'value': '28', 'groupId': 'OG005'}, {'value': '28', 'groupId': 'OG006'}, {'value': '53', 'groupId': 'OG007'}, {'value': '51', 'groupId': 'OG008'}, {'value': '28', 'groupId': 'OG009'}, {'value': '27', 'groupId': 'OG010'}, {'value': '39', 'groupId': 'OG011'}, {'value': '22', 'groupId': 'OG012'}, {'value': '22', 'groupId': 'OG013'}, {'value': '46', 'groupId': 'OG014'}, {'value': '144', 'groupId': 'OG015'}, {'value': '57', 'groupId': 'OG016'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm A', 'description': 'ABT-493 (300 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD for 12 weeks in HCV genotype 2 (GT2) -infected treatment naïve and treatment experienced participants without cirrhosis.'}, {'id': 'OG001', 'title': 'Arm B', 'description': 'ABT-493 (200 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD for 12 weeks in HCV GT2 -infected treatment naïve and treatment experienced participants without cirrhosis.'}, {'id': 'OG002', 'title': 'Arm C', 'description': 'ABT-493 (200 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD and weight-based ribavirin (RBV) divided twice daily (BID) for 12 weeks in HCV GT2 -infected treatment naïve and treatment experienced participants without cirrhosis.'}, {'id': 'OG003', 'title': 'Arm D', 'description': 'ABT-493 (300 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD for 12 weeks in HCV genotype 3 (GT3) -infected treatment naïve and treatment experienced participants without cirrhosis.'}, {'id': 'OG004', 'title': 'Arm E', 'description': 'ABT-493 (200 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD for 12 weeks in HCV GT3 -infected treatment naïve and treatment experienced participants without cirrhosis.'}, {'id': 'OG005', 'title': 'Arm F', 'description': 'ABT-493 (200 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD and weight-based ribavirin (RBV) divided BID for 12 weeks in HCV GT3 -infected treatment naïve and treatment experienced participants without cirrhosis.'}, {'id': 'OG006', 'title': 'Arm G', 'description': 'ABT-493 (200 mg) once daily (QD) co-administered with ABT-530 (40 mg) QD for 12 weeks in HCV GT3 -infected treatment naïve and treatment experienced participants without cirrhosis.'}, {'id': 'OG007', 'title': 'Arm J', 'description': 'ABT-493 (300 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD for 8 weeks in HCV GT2 -infected treatment naïve and treatment experienced participants without cirrhosis.'}, {'id': 'OG008', 'title': 'Arm L', 'description': 'ABT-493 (300 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD for 8 weeks in HCV GT3 -infected treatment naïve and for 12 weeks in HCV GT3 -infected treatment experienced participants without cirrhosis.'}, {'id': 'OG009', 'title': 'Arm O', 'description': 'ABT-493 (300 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD for 12 weeks in HCV GT3 -infected treatment naïve participants with compensated cirrhosis and for 16 weeks in HCV GT3 -infected treatment-experienced participants with compensated cirrhosis.'}, {'id': 'OG010', 'title': 'Arm P', 'description': 'ABT-493 (300 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD and RBV (800 mg) QD for 12 weeks in HCV GT3-infected treatment naïve and treatment-experienced participants with compensated cirrhosis.'}, {'id': 'OG011', 'title': 'Arm Q1', 'description': 'ABT-493/ ABT-530 (300 mg/ 120mg ) once daily (QD) for 12 weeks in HCV GT3 -infected treatment naïve participants with cirrhosis.'}, {'id': 'OG012', 'title': 'Arm Q2', 'description': 'ABT-493/ ABT-530 (300 mg/ 120mg ) once daily (QD) for 12 weeks in HCV GT3 -infected treatment experienced participants without cirrhosis.'}, {'id': 'OG013', 'title': 'Arm R1', 'description': 'ABT-493/ ABT-530 (300 mg/ 120 mg) QD for 16 weeks in HCV GT3 -infected treatment experienced participants without cirrhosis.'}, {'id': 'OG014', 'title': 'Arm R2', 'description': 'ABT-493/ ABT-530 (300 mg/ 120 mg) QD for 16 weeks in HCV GT3 -infected treatment experienced participants with cirrhosis.'}, {'id': 'OG015', 'title': 'Arm S1', 'description': 'ABT-493/ ABT-530 (300 mg/ 120 mg) QD for 8 weeks in HCV GT2 infected treatment naïve and treatment experienced participants without cirrhosis.'}, {'id': 'OG016', 'title': 'Arm S2', 'description': 'ABT-493/ ABT-530 (300 mg/ 120 mg) QD for 8 weeks in HCV GT4-6 infected treatment naïve and treatment experienced participants without cirrhosis.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '13.8'}, {'value': '0.0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '13.8'}, {'value': '0.0', 'groupId': 'OG002', 'lowerLimit': '0.0', 'upperLimit': '13.3'}, {'value': '3.4', 'groupId': 'OG003', 'lowerLimit': '0.6', 'upperLimit': '17.2'}, {'value': '6.7', 'groupId': 'OG004', 'lowerLimit': '1.8', 'upperLimit': '21.3'}, {'value': '0.0', 'groupId': 'OG005', 'lowerLimit': '0.0', 'upperLimit': '12.1'}, {'value': '7.1', 'groupId': 'OG006', 'lowerLimit': '2.0', 'upperLimit': '22.6'}, {'value': '0.0', 'groupId': 'OG007', 'lowerLimit': '0.0', 'upperLimit': '6.8'}, {'value': '2.0', 'groupId': 'OG008', 'lowerLimit': '0.3', 'upperLimit': '10.3'}, {'value': '3.6', 'groupId': 'OG009', 'lowerLimit': '0.6', 'upperLimit': '17.7'}, {'value': '0.0', 'groupId': 'OG010', 'lowerLimit': '0.0', 'upperLimit': '12.5'}, {'value': '0', 'groupId': 'OG011', 'lowerLimit': '0.0', 'upperLimit': '9.0'}, {'value': '9.1', 'groupId': 'OG012', 'lowerLimit': '2.5', 'upperLimit': '27.8'}, {'value': '4.5', 'groupId': 'OG013', 'lowerLimit': '0.8', 'upperLimit': '21.8'}, {'value': '2.2', 'groupId': 'OG014', 'lowerLimit': '0.4', 'upperLimit': '11.3'}, {'value': '1.4', 'groupId': 'OG015', 'lowerLimit': '0.4', 'upperLimit': '4.9'}, {'value': '0', 'groupId': 'OG016', 'lowerLimit': '0.0', 'upperLimit': '6.3'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From the end of treatment through 12 weeks after the last dose of study drug', 'description': 'Post-treatment relapse was defined as confirmed HCV RNA ≥ LLOQ between the end of treatment and 12 weeks after the last dose of study drug among participants who completed treatment with HCV RNA levels \\< LLOQ at the end of treatment, excluding reinfection.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who received at least 1 dose of study drug (ITT population) with evaluable data, completed treatment, and had HCV RNA \\<LLOQ at the final treatment visit.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Arm A', 'description': 'ABT-493 (300 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD for 12 weeks in HCV genotype 2 (GT2) -infected treatment naïve and treatment experienced participants without cirrhosis.'}, {'id': 'FG001', 'title': 'Arm B', 'description': 'ABT-493 (200 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD for 12 weeks in HCV GT2 -infected treatment naïve and treatment experienced participants without cirrhosis.'}, {'id': 'FG002', 'title': 'Arm C', 'description': 'ABT-493 (200 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD and weight-based ribavirin (RBV) divided twice daily (BID) for 12 weeks in HCV GT2 -infected treatment naïve and treatment experienced participants without cirrhosis.'}, {'id': 'FG003', 'title': 'Arm D', 'description': 'ABT-493 (300 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD for 12 weeks in HCV genotype 3 (GT3) -infected treatment naïve and treatment experienced participants without cirrhosis.'}, {'id': 'FG004', 'title': 'Arm E', 'description': 'ABT-493 (200 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD for 12 weeks in HCV GT3 -infected treatment naïve and treatment experienced participants without cirrhosis.'}, {'id': 'FG005', 'title': 'Arm F', 'description': 'ABT-493 (200 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD and weight-based ribavirin (RBV) divided BID for 12 weeks in HCV GT3 -infected treatment naïve and treatment experienced participants without cirrhosis.'}, {'id': 'FG006', 'title': 'Arm G', 'description': 'ABT-493 (200 mg) once daily (QD) co-administered with ABT-530 (40 mg) QD for 12 weeks in HCV GT3 -infected treatment naïve and treatment experienced participants without cirrhosis.'}, {'id': 'FG007', 'title': 'Arm H', 'description': 'ABT-493 (200 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD for 8 weeks in HCV GT2 -infected treatment naïve and treatment experienced participants without cirrhosis.'}, {'id': 'FG008', 'title': 'Arm I', 'description': 'ABT-493 (200 mg) once daily (QD) co-administered with ABT-530 (40 mg) QD for 8 weeks in HCV GT2 -infected treatment naïve and treatment experienced participants without cirrhosis.'}, {'id': 'FG009', 'title': 'Arm J', 'description': 'ABT-493 (300 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD for 8 weeks in HCV GT2 -infected treatment naïve and treatment experienced participants without cirrhosis.'}, {'id': 'FG010', 'title': 'Arm K', 'description': 'ABT-493 (200 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD for 8 weeks in HCV GT3 -infected treatment naïve and treatment experienced participants without cirrhosis.'}, {'id': 'FG011', 'title': 'Arm L', 'description': 'ABT-493 (300 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD for 8 weeks in HCV GT3 -infected treatment naïve and for 12 weeks in HCV GT3 -infected treatment experienced participants without cirrhosis.'}, {'id': 'FG012', 'title': 'Arm M', 'description': 'ABT-493 (200 mg) once daily (QD) co-administered with ABT-530 (80 mg) QD for 12 weeks in HCV GT3 -infected treatment naïve participants with compensated cirrhosis.'}, {'id': 'FG013', 'title': 'Arm N', 'description': 'ABT-493 (200 mg) once daily (QD) co-administered with ABT-530 (80 mg) QD and ribavirin (RBV) (800 mg) QD for 12 weeks in HCV GT3 -infected treatment naïve participants with compensated cirrhosis.'}, {'id': 'FG014', 'title': 'Arm O', 'description': 'ABT-493 (300 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD for 12 weeks in HCV GT3 -infected treatment naïve participants with compensated cirrhosis and for 16 weeks in HCV GT3 -infected treatment-experienced participants with compensated cirrhosis.'}, {'id': 'FG015', 'title': 'Arm P', 'description': 'ABT-493 (300 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD and RBV (800 mg) QD for 12 weeks in HCV GT3-infected treatment naïve and treatment-experienced participants with compensated cirrhosis.'}, {'id': 'FG016', 'title': 'Arm Q1', 'description': 'ABT-493/ ABT-530 (300 mg/ 120mg ) once daily (QD) for 12 weeks in HCV GT3 -infected treatment naïve participants with cirrhosis.'}, {'id': 'FG017', 'title': 'Arm Q2', 'description': 'ABT-493/ ABT-530 (300 mg/ 120mg ) once daily (QD) for 12 weeks in HCV GT3 -infected treatment experienced participants without cirrhosis.'}, {'id': 'FG018', 'title': 'Arm R1', 'description': 'ABT-493/ ABT-530 (300 mg/ 120 mg) QD for 16 weeks in HCV GT3 -infected treatment experienced participants without cirrhosis.'}, {'id': 'FG019', 'title': 'Arm R2', 'description': 'ABT-493/ ABT-530 (300 mg/ 120 mg) QD for 16 weeks in HCV GT3 -infected treatment experienced participants with cirrhosis.'}, {'id': 'FG020', 'title': 'Arm S1', 'description': 'ABT-493/ ABT-530 (300 mg/ 120 mg) QD for 8 weeks in HCV GT2 infected treatment naïve and treatment experienced participants without cirrhosis.'}, {'id': 'FG021', 'title': 'Arm S2', 'description': 'ABT-493/ ABT-530 (300 mg/ 120 mg) QD for 8 weeks in HCV GT4-6 infected treatment naïve and treatment experienced participants without cirrhosis.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '25'}, {'groupId': 'FG001', 'numSubjects': '24'}, {'groupId': 'FG002', 'numSubjects': '25'}, {'groupId': 'FG003', 'numSubjects': '30'}, {'groupId': 'FG004', 'numSubjects': '31'}, {'groupId': 'FG005', 'numSubjects': '31'}, {'groupId': 'FG006', 'numSubjects': '30'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '55'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '53'}, {'groupId': 'FG012', 'numSubjects': '0'}, {'groupId': 'FG013', 'numSubjects': '0'}, {'groupId': 'FG014', 'numSubjects': '28'}, {'groupId': 'FG015', 'numSubjects': '27'}, {'groupId': 'FG016', 'numSubjects': '40'}, {'groupId': 'FG017', 'numSubjects': '22'}, {'groupId': 'FG018', 'numSubjects': '22'}, {'groupId': 'FG019', 'numSubjects': '48'}, {'groupId': 'FG020', 'numSubjects': '145'}, {'groupId': 'FG021', 'numSubjects': '58'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '23'}, {'groupId': 'FG001', 'numSubjects': '23'}, {'groupId': 'FG002', 'numSubjects': '24'}, {'groupId': 'FG003', 'numSubjects': '29'}, {'groupId': 'FG004', 'numSubjects': '30'}, {'groupId': 'FG005', 'numSubjects': '31'}, {'groupId': 'FG006', 'numSubjects': '27'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '53'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '50'}, {'groupId': 'FG012', 'numSubjects': '0'}, {'groupId': 'FG013', 'numSubjects': '0'}, {'groupId': 'FG014', 'numSubjects': '27'}, {'groupId': 'FG015', 'numSubjects': '26'}, {'groupId': 'FG016', 'numSubjects': '37'}, {'groupId': 'FG017', 'numSubjects': '21'}, {'groupId': 'FG018', 'numSubjects': '22'}, {'groupId': 'FG019', 'numSubjects': '47'}, {'groupId': 'FG020', 'numSubjects': '143'}, {'groupId': 'FG021', 'numSubjects': '55'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '3'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '2'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '3'}, {'groupId': 'FG012', 'numSubjects': '0'}, {'groupId': 'FG013', 'numSubjects': '0'}, {'groupId': 'FG014', 'numSubjects': '1'}, {'groupId': 'FG015', 'numSubjects': '1'}, {'groupId': 'FG016', 'numSubjects': '3'}, {'groupId': 'FG017', 'numSubjects': '1'}, {'groupId': 'FG018', 'numSubjects': '0'}, {'groupId': 'FG019', 'numSubjects': '1'}, {'groupId': 'FG020', 'numSubjects': '2'}, {'groupId': 'FG021', 'numSubjects': '3'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '0'}, {'groupId': 'FG012', 'numSubjects': '0'}, {'groupId': 'FG013', 'numSubjects': '0'}, {'groupId': 'FG014', 'numSubjects': '0'}, {'groupId': 'FG015', 'numSubjects': '1'}, {'groupId': 'FG016', 'numSubjects': '0'}, {'groupId': 'FG017', 'numSubjects': '0'}, {'groupId': 'FG018', 'numSubjects': '0'}, {'groupId': 'FG019', 'numSubjects': '0'}, {'groupId': 'FG020', 'numSubjects': '1'}, {'groupId': 'FG021', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '1'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '1'}, {'groupId': 'FG012', 'numSubjects': '0'}, {'groupId': 'FG013', 'numSubjects': '0'}, {'groupId': 'FG014', 'numSubjects': '0'}, {'groupId': 'FG015', 'numSubjects': '0'}, {'groupId': 'FG016', 'numSubjects': '0'}, {'groupId': 'FG017', 'numSubjects': '0'}, {'groupId': 'FG018', 'numSubjects': '0'}, {'groupId': 'FG019', 'numSubjects': '0'}, {'groupId': 'FG020', 'numSubjects': '0'}, {'groupId': 'FG021', 'numSubjects': '1'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '3'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '2'}, {'groupId': 'FG012', 'numSubjects': '0'}, {'groupId': 'FG013', 'numSubjects': '0'}, {'groupId': 'FG014', 'numSubjects': '0'}, {'groupId': 'FG015', 'numSubjects': '0'}, {'groupId': 'FG016', 'numSubjects': '3'}, {'groupId': 'FG017', 'numSubjects': '1'}, {'groupId': 'FG018', 'numSubjects': '0'}, {'groupId': 'FG019', 'numSubjects': '0'}, {'groupId': 'FG020', 'numSubjects': '1'}, {'groupId': 'FG021', 'numSubjects': '2'}]}, {'type': 'Enrolled into a Re-treatment Study', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '0'}, {'groupId': 'FG012', 'numSubjects': '0'}, {'groupId': 'FG013', 'numSubjects': '0'}, {'groupId': 'FG014', 'numSubjects': '1'}, {'groupId': 'FG015', 'numSubjects': '0'}, {'groupId': 'FG016', 'numSubjects': '0'}, {'groupId': 'FG017', 'numSubjects': '0'}, {'groupId': 'FG018', 'numSubjects': '0'}, {'groupId': 'FG019', 'numSubjects': '0'}, {'groupId': 'FG020', 'numSubjects': '0'}, {'groupId': 'FG021', 'numSubjects': '0'}]}, {'type': "Randomized but did'nt receive study drug", 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '1'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '0'}, {'groupId': 'FG012', 'numSubjects': '0'}, {'groupId': 'FG013', 'numSubjects': '0'}, {'groupId': 'FG014', 'numSubjects': '0'}, {'groupId': 'FG015', 'numSubjects': '0'}, {'groupId': 'FG016', 'numSubjects': '0'}, {'groupId': 'FG017', 'numSubjects': '0'}, {'groupId': 'FG018', 'numSubjects': '0'}, {'groupId': 'FG019', 'numSubjects': '1'}, {'groupId': 'FG020', 'numSubjects': '0'}, {'groupId': 'FG021', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Enrollment into arms H, I, K, M and N was not opened by AbbVie.', 'preAssignmentDetails': 'Intent-to-treat population: all participants who received at least 1 dose of study drug'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '25', 'groupId': 'BG002'}, {'value': '30', 'groupId': 'BG003'}, {'value': '30', 'groupId': 'BG004'}, {'value': '31', 'groupId': 'BG005'}, {'value': '30', 'groupId': 'BG006'}, {'value': '54', 'groupId': 'BG007'}, {'value': '53', 'groupId': 'BG008'}, {'value': '28', 'groupId': 'BG009'}, {'value': '27', 'groupId': 'BG010'}, {'value': '40', 'groupId': 'BG011'}, {'value': '22', 'groupId': 'BG012'}, {'value': '22', 'groupId': 'BG013'}, {'value': '47', 'groupId': 'BG014'}, {'value': '145', 'groupId': 'BG015'}, {'value': '58', 'groupId': 'BG016'}, {'value': '691', 'groupId': 'BG017'}]}], 'groups': [{'id': 'BG000', 'title': 'Arm A', 'description': 'ABT-493 (300 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD for 12 weeks in HCV genotype 2 (GT2) -infected treatment naïve and treatment experienced participants without cirrhosis.'}, {'id': 'BG001', 'title': 'Arm B', 'description': 'ABT-493 (200 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD for 12 weeks in HCV GT2 -infected treatment naïve and treatment experienced participants without cirrhosis.'}, {'id': 'BG002', 'title': 'Arm C', 'description': 'ABT-493 (200 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD and weight-based ribavirin (RBV) divided twice daily (BID) for 12 weeks in HCV GT2 -infected treatment naïve and treatment experienced participants without cirrhosis.'}, {'id': 'BG003', 'title': 'Arm D', 'description': 'ABT-493 (300 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD for 12 weeks in HCV genotype 3 (GT3) -infected treatment naïve and treatment experienced participants without cirrhosis.'}, {'id': 'BG004', 'title': 'Arm E', 'description': 'ABT-493 (200 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD for 12 weeks in HCV GT3 -infected treatment naïve and treatment experienced participants without cirrhosis.'}, {'id': 'BG005', 'title': 'Arm F', 'description': 'ABT-493 (200 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD and weight-based ribavirin (RBV) divided BID for 12 weeks in HCV GT3 -infected treatment naïve and treatment experienced participants without cirrhosis.'}, {'id': 'BG006', 'title': 'Arm G', 'description': 'ABT-493 (200 mg) once daily (QD) co-administered with ABT-530 (40 mg) QD for 12 weeks in HCV GT3 -infected treatment naïve and treatment experienced participants without cirrhosis.'}, {'id': 'BG007', 'title': 'Arm J', 'description': 'ABT-493 (300 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD for 8 weeks in HCV GT2 -infected treatment naïve and treatment experienced participants without cirrhosis.'}, {'id': 'BG008', 'title': 'Arm L', 'description': 'ABT-493 (300 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD for 8 weeks in HCV GT3 -infected treatment naïve and for 12 weeks in HCV GT3 -infected treatment experienced participants without cirrhosis.'}, {'id': 'BG009', 'title': 'Arm O', 'description': 'ABT-493 (300 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD for 12 weeks in HCV GT3 -infected treatment naïve participants with compensated cirrhosis and for 16 weeks in HCV GT3 -infected treatment-experienced participants with compensated cirrhosis.'}, {'id': 'BG010', 'title': 'Arm P', 'description': 'ABT-493 (300 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD and RBV (800 mg) QD for 12 weeks in HCV GT3-infected treatment naïve and treatment-experienced participants with compensated cirrhosis.'}, {'id': 'BG011', 'title': 'Arm Q1', 'description': 'ABT-493/ ABT-530 (300 mg/ 120mg ) once daily (QD) for 12 weeks in HCV GT3 -infected treatment naïve participants with cirrhosis.'}, {'id': 'BG012', 'title': 'Arm Q2', 'description': 'ABT-493/ ABT-530 (300 mg/ 120mg ) once daily (QD) for 12 weeks in HCV GT3 -infected treatment experienced participants without cirrhosis.'}, {'id': 'BG013', 'title': 'Arm R1', 'description': 'ABT-493/ ABT-530 (300 mg/ 120 mg) QD for 16 weeks in HCV GT3 -infected treatment experienced participants without cirrhosis.'}, {'id': 'BG014', 'title': 'Arm R2', 'description': 'ABT-493/ ABT-530 (300 mg/ 120 mg) QD for 16 weeks in HCV GT3 -infected treatment experienced participants with cirrhosis.'}, {'id': 'BG015', 'title': 'Arm S1', 'description': 'ABT-493/ ABT-530 (300 mg/ 120 mg) QD for 8 weeks in HCV GT2 infected treatment naïve and treatment experienced participants without cirrhosis.'}, {'id': 'BG016', 'title': 'Arm S2', 'description': 'ABT-493/ ABT-530 (300 mg/ 120 mg) QD for 8 weeks in HCV GT4-6 infected treatment naïve and treatment experienced participants without cirrhosis.'}, {'id': 'BG017', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'title': '< 65 years', 'categories': [{'measurements': [{'value': '21', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}, {'value': '28', 'groupId': 'BG003'}, {'value': '29', 'groupId': 'BG004'}, {'value': '30', 'groupId': 'BG005'}, {'value': '28', 'groupId': 'BG006'}, {'value': '44', 'groupId': 'BG007'}, {'value': '52', 'groupId': 'BG008'}, {'value': '26', 'groupId': 'BG009'}, {'value': '24', 'groupId': 'BG010'}, {'value': '38', 'groupId': 'BG011'}, {'value': '18', 'groupId': 'BG012'}, {'value': '19', 'groupId': 'BG013'}, {'value': '39', 'groupId': 'BG014'}, {'value': '128', 'groupId': 'BG015'}, {'value': '49', 'groupId': 'BG016'}, {'value': '616', 'groupId': 'BG017'}]}]}, {'title': '>= 65 years', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '1', 'groupId': 'BG005'}, {'value': '2', 'groupId': 'BG006'}, {'value': '10', 'groupId': 'BG007'}, {'value': '1', 'groupId': 'BG008'}, {'value': '2', 'groupId': 'BG009'}, {'value': '3', 'groupId': 'BG010'}, {'value': '2', 'groupId': 'BG011'}, {'value': '4', 'groupId': 'BG012'}, {'value': '3', 'groupId': 'BG013'}, {'value': '8', 'groupId': 'BG014'}, {'value': '17', 'groupId': 'BG015'}, {'value': '9', 'groupId': 'BG016'}, {'value': '75', 'groupId': 'BG017'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}, {'value': '11', 'groupId': 'BG003'}, {'value': '16', 'groupId': 'BG004'}, {'value': '12', 'groupId': 'BG005'}, {'value': '15', 'groupId': 'BG006'}, {'value': '21', 'groupId': 'BG007'}, {'value': '21', 'groupId': 'BG008'}, {'value': '13', 'groupId': 'BG009'}, {'value': '9', 'groupId': 'BG010'}, {'value': '16', 'groupId': 'BG011'}, {'value': '8', 'groupId': 'BG012'}, {'value': '8', 'groupId': 'BG013'}, {'value': '11', 'groupId': 'BG014'}, {'value': '84', 'groupId': 'BG015'}, {'value': '21', 'groupId': 'BG016'}, {'value': '293', 'groupId': 'BG017'}]}, {'title': 'Male', 'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}, {'value': '19', 'groupId': 'BG003'}, {'value': '14', 'groupId': 'BG004'}, {'value': '19', 'groupId': 'BG005'}, {'value': '15', 'groupId': 'BG006'}, {'value': '33', 'groupId': 'BG007'}, {'value': '32', 'groupId': 'BG008'}, {'value': '15', 'groupId': 'BG009'}, {'value': '18', 'groupId': 'BG010'}, {'value': '24', 'groupId': 'BG011'}, {'value': '14', 'groupId': 'BG012'}, {'value': '14', 'groupId': 'BG013'}, {'value': '36', 'groupId': 'BG014'}, {'value': '61', 'groupId': 'BG015'}, {'value': '37', 'groupId': 'BG016'}, {'value': '398', 'groupId': 'BG017'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}, {'value': '5', 'groupId': 'BG005'}, {'value': '5', 'groupId': 'BG006'}, {'value': '6', 'groupId': 'BG007'}, {'value': '2', 'groupId': 'BG008'}, {'value': '4', 'groupId': 'BG009'}, {'value': '2', 'groupId': 'BG010'}, {'value': '9', 'groupId': 'BG011'}, {'value': '1', 'groupId': 'BG012'}, {'value': '0', 'groupId': 'BG013'}, {'value': '4', 'groupId': 'BG014'}, {'value': '11', 'groupId': 'BG015'}, {'value': '2', 'groupId': 'BG016'}, {'value': '65', 'groupId': 'BG017'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '24', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '21', 'groupId': 'BG002'}, {'value': '26', 'groupId': 'BG003'}, {'value': '27', 'groupId': 'BG004'}, {'value': '26', 'groupId': 'BG005'}, {'value': '25', 'groupId': 'BG006'}, {'value': '48', 'groupId': 'BG007'}, {'value': '51', 'groupId': 'BG008'}, {'value': '24', 'groupId': 'BG009'}, {'value': '25', 'groupId': 'BG010'}, {'value': '31', 'groupId': 'BG011'}, {'value': '21', 'groupId': 'BG012'}, {'value': '22', 'groupId': 'BG013'}, {'value': '43', 'groupId': 'BG014'}, {'value': '134', 'groupId': 'BG015'}, {'value': '56', 'groupId': 'BG016'}, {'value': '626', 'groupId': 'BG017'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '0', 'groupId': 'BG009'}, {'value': '0', 'groupId': 'BG010'}, {'value': '0', 'groupId': 'BG011'}, {'value': '0', 'groupId': 'BG012'}, {'value': '0', 'groupId': 'BG013'}, {'value': '0', 'groupId': 'BG014'}, {'value': '0', 'groupId': 'BG015'}, {'value': '0', 'groupId': 'BG016'}, {'value': '0', 'groupId': 'BG017'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}], 'populationDescription': 'All participants who received atleast 1 dose of study drug (ITT population)'}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 694}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-09-19'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-07', 'dispFirstSubmitDate': '2017-02-08', 'completionDateStruct': {'date': '2017-02-23', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-07-09', 'studyFirstSubmitDate': '2014-09-04', 'dispFirstSubmitQcDate': '2017-02-08', 'resultsFirstSubmitDate': '2017-08-31', 'studyFirstSubmitQcDate': '2014-09-15', 'dispFirstPostDateStruct': {'date': '2017-02-10', 'type': 'ACTUAL'}, 'lastUpdatePostDateStruct': {'date': '2021-07-30', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-08-31', 'studyFirstPostDateStruct': {'date': '2014-09-17', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-10-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-10-25', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12)', 'timeFrame': '12 weeks after the last actual dose of study drug', 'description': 'SVR12 was defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) level less than the lower limit of quantification \\[\\<LLOQ\\]) 12 weeks after the last dose of study drug.'}, {'measure': 'Percentage of Genotype 2 (GT2) Direct-acting Antiviral Agents (DAA)-Naive Participants (in Part 4, Arm S1) With Sustained Virologic Response 12 Weeks Post-treatment (SVR12) as Compared to Historical Control', 'timeFrame': '12 weeks after the last actual dose of study drug', 'description': 'SVR12 was defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) level less than the lower limit of quantification \\[\\<LLOQ\\]) 12 weeks after the last dose of study drug.'}], 'secondaryOutcomes': [{'measure': 'Percentage of Participants With Sustained Virologic Response 4 Weeks Post-treatment (SVR4)', 'timeFrame': '4 weeks after the last actual dose of study drug', 'description': 'SVR4 was defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) level less than the lower limit of quantification \\[\\<LLOQ\\]) 4 weeks after the last dose of study drug.'}, {'measure': 'Percentage of Participants With On-treatment Virologic Failure', 'timeFrame': 'Up to end of treatment (treatment week 8, 12 or 16 depending on arm) or premature discontinuation from treatment', 'description': 'On-treatment virologic failure was defined as confirmed HCV RNA ≥ LLOQ after HCV RNA \\< LLOQ during treatment; confirmed increase of \\> 1 log(subscript)10(subscript) IU/mL above the lowest value post-baseline in HCV RNA during treatment; or HCV RNA ≥ LLOQ at end of treatment with at least 6 weeks of treatment.'}, {'measure': 'Percentage of Participants With Post-treatment Relapse', 'timeFrame': 'From the end of treatment through 12 weeks after the last dose of study drug', 'description': 'Post-treatment relapse was defined as confirmed HCV RNA ≥ LLOQ between the end of treatment and 12 weeks after the last dose of study drug among participants who completed treatment with HCV RNA levels \\< LLOQ at the end of treatment, excluding reinfection.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Hepatitis C Virus (HCV)', 'Hepatitis C', 'Chronic Hepatitis C', 'interferon free', 'Hepatitis C Genotype 2', 'Hepatitis C Genotype 3', 'Hepatitis C Genotype 4', 'Hepatitis C Genotype 5', 'Hepatitis C Genotype 6'], 'conditions': ['Chronic Hepatitis C', 'Hepatitis C Virus']}, 'referencesModule': {'references': [{'pmid': '28412293', 'type': 'BACKGROUND', 'citation': 'Kwo PY, Poordad F, Asatryan A, Wang S, Wyles DL, Hassanein T, Felizarta F, Sulkowski MS, Gane E, Maliakkal B, Overcash JS, Gordon SC, Muir AJ, Aguilar H, Agarwal K, Dore GJ, Lin CW, Liu R, Lovell SS, Ng TI, Kort J, Mensa FJ. Glecaprevir and pibrentasvir yield high response rates in patients with HCV genotype 1-6 without cirrhosis. J Hepatol. 2017 Aug;67(2):263-271. doi: 10.1016/j.jhep.2017.03.039. Epub 2017 Apr 13.'}, {'pmid': '31568620', 'type': 'DERIVED', 'citation': 'Brown A, Welzel TM, Conway B, Negro F, Brau N, Grebely J, Puoti M, Aghemo A, Kleine H, Pugatch D, Mensa FJ, Chen YJ, Lei Y, Lawitz E, Asselah T. Adherence to pan-genotypic glecaprevir/pibrentasvir and efficacy in HCV-infected patients: A pooled analysis of clinical trials. Liver Int. 2020 Apr;40(4):778-786. doi: 10.1111/liv.14266. Epub 2019 Oct 18.'}, {'pmid': '30977945', 'type': 'DERIVED', 'citation': 'Back D, Belperio P, Bondin M, Negro F, Talal AH, Park C, Zhang Z, Pinsky B, Crown E, Mensa FJ, Marra F. Efficacy and safety of glecaprevir/pibrentasvir in patients with chronic HCV infection and psychiatric disorders: An integrated analysis. J Viral Hepat. 2019 Aug;26(8):951-960. doi: 10.1111/jvh.13110. Epub 2019 May 20.'}, {'pmid': '30923816', 'type': 'DERIVED', 'citation': 'Gane E, Poordad F, Zadeikis N, Valdes J, Lin CW, Liu W, Asatryan A, Wang S, Stedman C, Greenbloom S, Nguyen T, Elkhashab M, Worns MA, Tran A, Mulkay JP, Setze C, Yu Y, Pilot-Matias T, Porcalla A, Mensa FJ. Safety and Pharmacokinetics of Glecaprevir/Pibrentasvir in Adults With Chronic Genotype 1-6 Hepatitis C Virus Infections and Compensated Liver Disease. Clin Infect Dis. 2019 Oct 30;69(10):1657-1664. doi: 10.1093/cid/ciz022.'}, {'pmid': '30012435', 'type': 'DERIVED', 'citation': 'Flamm S, Reddy KR, Zadeikis N, Hassanein T, Bacon BR, Maieron A, Zeuzem S, Bourliere M, Calleja JL, Kosloski MP, Oberoi RK, Lin CW, Yu Y, Lovell S, Semizarov D, Mensa FJ. Efficacy and Pharmacokinetics of Glecaprevir and Pibrentasvir With Concurrent Use of Acid-Reducing Agents in Patients With Chronic HCV Infection. Clin Gastroenterol Hepatol. 2019 Feb;17(3):527-535.e6. doi: 10.1016/j.cgh.2018.07.003. Epub 2018 Sep 10.'}, {'pmid': '28951228', 'type': 'DERIVED', 'citation': 'Asselah T, Kowdley KV, Zadeikis N, Wang S, Hassanein T, Horsmans Y, Colombo M, Calinas F, Aguilar H, de Ledinghen V, Mantry PS, Hezode C, Marinho RT, Agarwal K, Nevens F, Elkhashab M, Kort J, Liu R, Ng TI, Krishnan P, Lin CW, Mensa FJ. Efficacy of Glecaprevir/Pibrentasvir for 8 or 12 Weeks in Patients With Hepatitis C Virus Genotype 2, 4, 5, or 6 Infection Without Cirrhosis. Clin Gastroenterol Hepatol. 2018 Mar;16(3):417-426. doi: 10.1016/j.cgh.2017.09.027. Epub 2017 Sep 22.'}, {'pmid': '27456384', 'type': 'DERIVED', 'citation': 'Gane E, Poordad F, Wang S, Asatryan A, Kwo PY, Lalezari J, Wyles DL, Hassanein T, Aguilar H, Maliakkal B, Liu R, Lin CW, Ng TI, Kort J, Mensa FJ. High Efficacy of ABT-493 and ABT-530 Treatment in Patients With HCV Genotype 1 or 3 Infection and Compensated Cirrhosis. Gastroenterology. 2016 Oct;151(4):651-659.e1. doi: 10.1053/j.gastro.2016.07.020. Epub 2016 Jul 25.'}], 'seeAlsoLinks': [{'url': 'http://rxabbvie.com', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this phase 2/3, open-label, multipart, multicenter study was to evaluate the efficacy, and safety of co-administration of ABT-493 and ABT-530 with and without ribavirin (RBV) in chronic HCV genotype 2 (GT2-), genotype 3 (GT3-), genotype 4 (GT4), genotype 5 (GT5-), or genotype 6 (GT6-) infected participants with or without cirrhosis.', 'detailedDescription': 'The study consisted of four independent parts with treatment and post-treatment periods of enrollment. Parts 1 and 2 were the supportive/ exploratory parts (phase 2) of the study and part 3 and 4 were the confirmatory/ registrational parts (phase 3) of the study. In parts 1 and 2 of the study, ABT-493 and ABT-530 were co-administered as separate tablets. However, in parts 3 and 4 of the study, the ABT-493/ABT-530 co-formulated tablets were administered.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Screening laboratory result indicating HCV Genotype 2, 3, 4, 5, or 6 infection.\n* Chronic HCV infection.\n* Participant had to be either HCV treatment-naïve or treatment-experienced.\n* Participant had to be documented as non-cirrhotic or as having compensated cirrhosis (GT3 only).\n\nExclusion Criteria:\n\n* History of severe, life-threatening or other significant sensitivity to any drug.\n* Female who was pregnant, planning to become pregnant during the study, or breastfeeding; or male whose partner was pregnant or planning to become pregnant during the study.\n* Recent (within 6 months prior to study drug administration) history of drug or alcohol abuse that could preclude adherence to the protocol in the opinion of the investigator.\n* Positive test result at Screening for hepatitis B surface antigen (HBsAg) or anti-human immunodeficiency virus antibody (HIV Ab).\n* HCV genotype performed during screening indicating co-infection with more than one HCV genotype.'}, 'identificationModule': {'nctId': 'NCT02243293', 'briefTitle': 'A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Co-Administration of ABT-493 and ABT-530 With and Without RBV in Subjects With Chronic Hepatitis C Virus (HCV) Genotypes 2, 3, 4, 5 or 6 Infection', 'organization': {'class': 'INDUSTRY', 'fullName': 'AbbVie'}, 'officialTitle': 'A Randomized, Open-Label, Multicenter Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Co-Administration of ABT-493 and ABT-530 With and Without RBV in Subjects With Chronic Hepatitis C Virus (HCV) Genotypes 2, 3, 4, 5 or 6 Infection (SURVEYOR-II)', 'orgStudyIdInfo': {'id': 'M14-868'}, 'secondaryIdInfos': [{'id': '2014-002927-90', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Arm A', 'description': 'ABT-493 (300 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD for 12 weeks in HCV genotype 2 (GT2) -infected treatment naïve and treatment experienced participants without cirrhosis.', 'interventionNames': ['Drug: ABT-493', 'Drug: ABT-530']}, {'type': 'EXPERIMENTAL', 'label': 'Arm B', 'description': 'ABT-493 (200 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD for 12 weeks in HCV GT2 -infected treatment naïve and treatment experienced participants without cirrhosis.', 'interventionNames': ['Drug: ABT-493', 'Drug: ABT-530']}, {'type': 'EXPERIMENTAL', 'label': 'Arm C', 'description': 'ABT-493 (200 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD and weight-based ribavirin (RBV) divided twice daily (BID) for 12 weeks in HCV GT2 -infected treatment naïve and treatment experienced participants without cirrhosis.', 'interventionNames': ['Drug: ABT-493', 'Drug: ABT-530', 'Drug: ribavirin (RBV)']}, {'type': 'EXPERIMENTAL', 'label': 'Arm D', 'description': 'ABT-493 (300 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD for 12 weeks in HCV genotype 3 (GT3) -infected treatment naïve and treatment experienced participants without cirrhosis.', 'interventionNames': ['Drug: ABT-493', 'Drug: ABT-530']}, {'type': 'EXPERIMENTAL', 'label': 'Arm E', 'description': 'ABT-493 (200 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD for 12 weeks in HCV GT3 -infected treatment naïve and treatment experienced participants without cirrhosis.', 'interventionNames': ['Drug: ABT-493', 'Drug: ABT-530']}, {'type': 'EXPERIMENTAL', 'label': 'Arm F', 'description': 'ABT-493 (200 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD and weight-based ribavirin (RBV) divided BID for 12 weeks in HCV GT3 -infected treatment naïve and treatment experienced participants without cirrhosis.', 'interventionNames': ['Drug: ABT-493', 'Drug: ABT-530', 'Drug: ribavirin (RBV)']}, {'type': 'EXPERIMENTAL', 'label': 'Arm G', 'description': 'ABT-493 (200 mg) once daily (QD) co-administered with ABT-530 (40 mg) QD for 12 weeks in HCV GT3 -infected treatment naïve and treatment experienced participants without cirrhosis.', 'interventionNames': ['Drug: ABT-493', 'Drug: ABT-530']}, {'type': 'EXPERIMENTAL', 'label': 'Arm H', 'description': 'ABT-493 (200 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD for 8 weeks in HCV GT2 -infected treatment naïve and treatment experienced participants without cirrhosis.', 'interventionNames': ['Drug: ABT-493', 'Drug: ABT-530']}, {'type': 'EXPERIMENTAL', 'label': 'Arm I', 'description': 'ABT-493 (200 mg) once daily (QD) co-administered with ABT-530 (40 mg) QD for 8 weeks in HCV GT2 -infected treatment naïve and treatment experienced participants without cirrhosis.', 'interventionNames': ['Drug: ABT-493', 'Drug: ABT-530']}, {'type': 'EXPERIMENTAL', 'label': 'Arm J', 'description': 'ABT-493 (300 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD for 8 weeks in HCV GT2 -infected treatment naïve and treatment experienced participants without cirrhosis.', 'interventionNames': ['Drug: ABT-493', 'Drug: ABT-530']}, {'type': 'EXPERIMENTAL', 'label': 'Arm K', 'description': 'ABT-493 (200 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD for 8 weeks in HCV GT3 -infected treatment naïve and treatment experienced participants without cirrhosis.', 'interventionNames': ['Drug: ABT-493', 'Drug: ABT-530']}, {'type': 'EXPERIMENTAL', 'label': 'Arm L', 'description': 'ABT-493 (300 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD for 8 weeks in HCV GT3 -infected treatment naïve and for 12 weeks in HCV GT3 -infected treatment experienced participants without cirrhosis.', 'interventionNames': ['Drug: ABT-493', 'Drug: ABT-530']}, {'type': 'EXPERIMENTAL', 'label': 'Arm M', 'description': 'ABT-493 (200 mg) once daily (QD) co-administered with ABT-530 (80 mg) QD for 12 weeks in HCV GT3 -infected treatment naïve participants with compensated cirrhosis.', 'interventionNames': ['Drug: ABT-493', 'Drug: ABT-530']}, {'type': 'EXPERIMENTAL', 'label': 'Arm N', 'description': 'ABT-493 (200 mg) once daily (QD) co-administered with ABT-530 (80 mg) QD and ribavirin (RBV) (800 mg) QD for 12 weeks in HCV GT3 -infected treatment naïve participants with compensated cirrhosis.', 'interventionNames': ['Drug: ABT-493', 'Drug: ABT-530', 'Drug: ribavirin (RBV)']}, {'type': 'EXPERIMENTAL', 'label': 'Arm O', 'description': 'ABT-493 (300 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD for 12 weeks in HCV GT3 -infected treatment naïve participants with compensated cirrhosis and for 16 weeks in HCV GT3 -infected treatment-experienced participants with compensated cirrhosis.', 'interventionNames': ['Drug: ABT-493', 'Drug: ABT-530']}, {'type': 'EXPERIMENTAL', 'label': 'Arm P', 'description': 'ABT-493 (300 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD and RBV (800 mg) QD for 12 weeks in HCV GT3-infected treatment naïve and treatment-experienced participants with compensated cirrhosis.', 'interventionNames': ['Drug: ABT-493', 'Drug: ABT-530', 'Drug: ribavirin (RBV)']}, {'type': 'EXPERIMENTAL', 'label': 'Arm Q1', 'description': 'ABT-493/ ABT-530 (300 mg/ 120mg ) once daily (QD) for 12 weeks in HCV GT3 -infected treatment naïve participants with cirrhosis.', 'interventionNames': ['Drug: ABT-493/ABT-530']}, {'type': 'EXPERIMENTAL', 'label': 'Arm Q2', 'description': 'ABT-493/ ABT-530 (300 mg/ 120mg ) once daily (QD) for 12 weeks in HCV GT3 -infected treatment experienced participants without cirrhosis.', 'interventionNames': ['Drug: ABT-493/ABT-530']}, {'type': 'EXPERIMENTAL', 'label': 'Arm R1', 'description': 'ABT-493/ ABT-530 (300 mg/ 120 mg) QD for 16 weeks in HCV GT3 -infected treatment experienced participants without cirrhosis.', 'interventionNames': ['Drug: ABT-493/ABT-530']}, {'type': 'EXPERIMENTAL', 'label': 'Arm R2', 'description': 'ABT-493/ ABT-530 (300 mg/ 120 mg) QD for 16 weeks in HCV GT3 -infected treatment experienced participants with cirrhosis.', 'interventionNames': ['Drug: ABT-493/ABT-530']}, {'type': 'EXPERIMENTAL', 'label': 'Arm S1', 'description': 'ABT-493/ ABT-530 (300 mg/ 120 mg) QD for 8 weeks in HCV GT2 infected treatment naïve and treatment experienced participants without cirrhosis.', 'interventionNames': ['Drug: ABT-493/ABT-530']}, {'type': 'EXPERIMENTAL', 'label': 'Arm S2', 'description': 'ABT-493/ ABT-530 (300 mg/ 120 mg) QD for 8 weeks in HCV GT4-6 infected treatment naïve and treatment experienced participants without cirrhosis.', 'interventionNames': ['Drug: ABT-493/ABT-530']}], 'interventions': [{'name': 'ABT-493', 'type': 'DRUG', 'otherNames': ['glecaprevir'], 'description': 'Tablet', 'armGroupLabels': ['Arm A', 'Arm B', 'Arm C', 'Arm D', 'Arm E', 'Arm F', 'Arm G', 'Arm H', 'Arm I', 'Arm J', 'Arm K', 'Arm L', 'Arm M', 'Arm N', 'Arm O', 'Arm P']}, {'name': 'ABT-530', 'type': 'DRUG', 'otherNames': ['pibrentasvir'], 'description': 'Tablet', 'armGroupLabels': ['Arm A', 'Arm B', 'Arm C', 'Arm D', 'Arm E', 'Arm F', 'Arm G', 'Arm H', 'Arm I', 'Arm J', 'Arm K', 'Arm L', 'Arm M', 'Arm N', 'Arm O', 'Arm P']}, {'name': 'ribavirin (RBV)', 'type': 'DRUG', 'description': 'Tablet', 'armGroupLabels': ['Arm C', 'Arm F', 'Arm N', 'Arm P']}, {'name': 'ABT-493/ABT-530', 'type': 'DRUG', 'otherNames': ['ABT-493 also known as glecaprevir', 'ABT-530 also known as pibrentasvir', 'MAVYRET'], 'description': 'Tablet; ABT-493 co-formulated ABT-530', 'armGroupLabels': ['Arm Q1', 'Arm Q2', 'Arm R1', 'Arm R2', 'Arm S1', 'Arm S2']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'AbbVie Inc.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'AbbVie'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AbbVie', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}