Ignite Creation Date:
2025-12-25 @ 1:43 AM
Ignite Modification Date:
2026-03-01 @ 4:13 PM
Study NCT ID:
NCT02185794
Status:
COMPLETED
Last Update Posted:
2020-09-17
First Post:
2014-07-07
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Antiviral Activity of Voxilaprevir in Adults With Chronic Hepatitis C Virus Infection
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006526', 'term': 'Hepatitis C'}, {'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D006525', 'term': 'Hepatitis, Viral, Human'}, {'id': 'D004769', 'term': 'Enterovirus Infections'}, {'id': 'D010850', 'term': 'Picornaviridae Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D018178', 'term': 'Flaviviridae Infections'}], 'ancestors': [{'id': 'D000086982', 'term': 'Blood-Borne Infections'}, {'id': 'D003141', 'term': 'Communicable Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D006505', 'term': 'Hepatitis'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000619503', 'term': 'voxilaprevir'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'GileadClinicalTrials@gilead.com', 'phone': '1-833-445-3230 (GILEAD-0)', 'title': 'Gilead Clinical Study Information Center', 'organization': 'Gilead Sciences'}, 'certainAgreement': {'otherDetails': 'After conclusion of the study and without prior written approval from Gilead, investigators in this study may communicate, orally present, or publish in scientific journals or other media only after the following conditions have been met:\n\n* The results of the study in their entirety have been publicly disclosed by or with the consent of Gilead in an abstract, manuscript, or presentation form; or\n* The study has been completed at all study sites for at least 2 years', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Adverse Events: First dose date up to Day 3 plus 30 days; All-Cause Mortality: First dose date up to Week 48', 'description': 'The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug (voxilaprevir or placebo). Data were summarized by dose.', 'eventGroups': [{'id': 'EG000', 'title': 'Placebo', 'description': 'Participants with HCV infection received placebo once daily for 3 days under fasted conditions. This arm was part of cohorts 1, 2, and 3.', 'otherNumAtRisk': 8, 'deathsNumAtRisk': 8, 'otherNumAffected': 2, 'seriousNumAtRisk': 8, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Voxilaprevir 50 mg', 'description': 'Participants with HCV infection received voxilaprevir 50 mg once daily for 3 days under fasted conditions. This arm was part of cohorts 1 and 2.', 'otherNumAtRisk': 14, 'deathsNumAtRisk': 14, 'otherNumAffected': 2, 'seriousNumAtRisk': 14, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Voxilaprevir 100 mg', 'description': 'Participants with HCV infection received voxilaprevir 100 mg once daily for 3 days under fasted conditions. This arm was part of cohorts 1, 2, 3, 4, 5 and 6.', 'otherNumAtRisk': 30, 'deathsNumAtRisk': 30, 'otherNumAffected': 2, 'seriousNumAtRisk': 30, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Voxilaprevir 300 mg', 'description': 'Participants with HCV infection received voxilaprevir 300 mg once daily for 3 days under fasted conditions. This arm was part of cohorts 1 and 2.', 'otherNumAtRisk': 15, 'deathsNumAtRisk': 15, 'otherNumAffected': 2, 'seriousNumAtRisk': 15, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG004', 'title': 'Voxilaprevir 100 mg Fed', 'description': 'Participants with HCV infection received voxilaprevir 100 mg once daily for 3 days under fed conditions. This arm was part of cohorts 1, 2, 3, 4, 5 and 6.', 'otherNumAtRisk': 6, 'deathsNumAtRisk': 6, 'otherNumAffected': 1, 'seriousNumAtRisk': 6, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG005', 'title': 'Voxilaprevir 100 mg + SOF/VEL 400/100 mg', 'description': 'Participants with HCV infection received voxilaprevir 100 mg on Day 1 and voxilaprevir 100 mg plus SOF/VEL (400/100 mg) FDC on Days 2 and 3 after moderate fat meal. This arm was part of cohort 10.', 'otherNumAtRisk': 16, 'deathsNumAtRisk': 16, 'otherNumAffected': 2, 'seriousNumAtRisk': 16, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 16, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 30, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 16, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Contusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 16, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 16, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 16, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 16, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 30, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 16, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Dermatitis contact', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 16, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}], 'seriousEvents': [{'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 16, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Participants Experiencing Treatment Emergent Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '30', 'groupId': 'OG002'}, {'value': '15', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '16', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants with HCV infection received placebo once daily for 3 days under fasted conditions. This arm was part of cohorts 1, 2, and 3.'}, {'id': 'OG001', 'title': 'Voxilaprevir 50 mg', 'description': 'Participants with HCV infection received voxilaprevir 50 mg once daily for 3 days under fasted conditions. This arm was part of cohorts 1 and 2.'}, {'id': 'OG002', 'title': 'Voxilaprevir 100 mg', 'description': 'Participants with HCV infection received voxilaprevir 100 mg once daily for 3 days under fasted conditions. This arm was part of cohorts 1, 2, 3, 4, 5 and 6.'}, {'id': 'OG003', 'title': 'Voxilaprevir 300 mg', 'description': 'Participants with HCV infection received voxilaprevir 300 mg once daily for 3 days under fasted conditions. This arm was part of cohorts 1 and 2.'}, {'id': 'OG004', 'title': 'Voxilaprevir 100 mg Fed', 'description': 'Participants with HCV infection received voxilaprevir 100 mg once daily for 3 days under fed conditions. This arm was part of cohorts 1, 2, 3, 4, 5 and 6.'}, {'id': 'OG005', 'title': 'Voxilaprevir 100 mg + SOF/VEL 400/100 mg', 'description': 'Participants with HCV infection received voxilaprevir 100 mg on Day 1 and voxilaprevir 100 mg plus SOF/VEL (400/100 mg) FDC on Days 2 and 3 after moderate fat meal. This arm was part of cohort 10.'}], 'classes': [{'categories': [{'measurements': [{'value': '25.0', 'groupId': 'OG000'}, {'value': '14.3', 'groupId': 'OG001'}, {'value': '16.7', 'groupId': 'OG002'}, {'value': '13.3', 'groupId': 'OG003'}, {'value': '33.3', 'groupId': 'OG004'}, {'value': '12.5', 'groupId': 'OG005'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'First dose date up to Day 3 plus 30 days', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug (voxilaprevir or placebo). Data were summarized by dose.'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '30', 'groupId': 'OG002'}, {'value': '15', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '16', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants with HCV infection received placebo once daily for 3 days under fasted conditions. This arm was part of cohorts 1, 2, and 3.'}, {'id': 'OG001', 'title': 'Voxilaprevir 50 mg', 'description': 'Participants with HCV infection received voxilaprevir 50 mg once daily for 3 days under fasted conditions. This arm was part of cohorts 1 and 2.'}, {'id': 'OG002', 'title': 'Voxilaprevir 100 mg', 'description': 'Participants with HCV infection received voxilaprevir 100 mg once daily for 3 days under fasted conditions. This arm was part of cohorts 1, 2, 3, 4, 5 and 6.'}, {'id': 'OG003', 'title': 'Voxilaprevir 300 mg', 'description': 'Participants with HCV infection received voxilaprevir 300 mg once daily for 3 days under fasted conditions. This arm was part of cohorts 1 and 2.'}, {'id': 'OG004', 'title': 'Voxilaprevir 100 mg Fed', 'description': 'Participants with HCV infection received voxilaprevir 100 mg once daily for 3 days under fed conditions. This arm was part of cohorts 1, 2, 3, 4, 5 and 6.'}, {'id': 'OG005', 'title': 'Voxilaprevir 100 mg + SOF/VEL 400/100 mg', 'description': 'Participants with HCV infection received voxilaprevir 100 mg on Day 1 and voxilaprevir 100 mg plus SOF/VEL (400/100 mg) FDC on Days 2 and 3 after moderate fat meal. This arm was part of cohort 10.'}], 'classes': [{'title': 'Grade 1', 'categories': [{'measurements': [{'value': '37.5', 'groupId': 'OG000'}, {'value': '28.6', 'groupId': 'OG001'}, {'value': '26.7', 'groupId': 'OG002'}, {'value': '20.0', 'groupId': 'OG003'}, {'value': '50.0', 'groupId': 'OG004'}, {'value': '62.5', 'groupId': 'OG005'}]}]}, {'title': 'Grade 2', 'categories': [{'measurements': [{'value': '25.0', 'groupId': 'OG000'}, {'value': '28.6', 'groupId': 'OG001'}, {'value': '33.3', 'groupId': 'OG002'}, {'value': '13.3', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '12.5', 'groupId': 'OG005'}]}]}, {'title': 'Grade 3', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '14.3', 'groupId': 'OG001'}, {'value': '10.0', 'groupId': 'OG002'}, {'value': '26.7', 'groupId': 'OG003'}, {'value': '33.3', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}]}, {'title': 'Grade 4', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '3.3', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'First dose date up to Day 3 plus 30 days', 'description': 'Treatment-emergent laboratory abnormalities were defined as values that increase at least one toxicity grade from baseline. The severity of laboratory abnormalities was assessed as Grade 0, 1 (mild), 2 (moderate), 3 (severe), or 4 (potentially life threatening) using the Common Terminology Criteria for Adverse Events (CTCAE), version 4.03. The most severe graded abnormality from all tests was counted for each participant.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in the Safety Analysis Set were analyzed. Data were summarized by dose.'}, {'type': 'PRIMARY', 'title': 'Antiviral Activity of Voxilaprevir as Measured by Change From Baseline in Plasma HCV RNA', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}, {'value': '6', 'groupId': 'OG006'}, {'value': '7', 'groupId': 'OG007'}, {'value': '2', 'groupId': 'OG008'}, {'value': '6', 'groupId': 'OG009'}, {'value': '4', 'groupId': 'OG010'}, {'value': '6', 'groupId': 'OG011'}, {'value': '6', 'groupId': 'OG012'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo (GT 1a, Cohort 1)', 'description': 'Participants with genotype (GT) 1a HCV infection received placebo once daily for 3 days under fasted conditions.'}, {'id': 'OG001', 'title': 'Voxilaprevir 50 mg (GT 1a, Cohort 1)', 'description': 'Participants with GT 1a HCV infection received voxilaprevir 50 mg once daily for 3 days under fasted conditions.'}, {'id': 'OG002', 'title': 'Voxilaprevir 100 mg (GT 1a, Cohort 1)', 'description': 'Participants with GT 1a HCV infection received voxilaprevir 100 mg once daily for 3 days under fasted conditions.'}, {'id': 'OG003', 'title': 'Voxilaprevir 300 mg (GT 1a, Cohort 1)', 'description': 'Participants with GT 1a HCV infection received voxilaprevir 300 mg once daily for 3 days under fasted conditions.'}, {'id': 'OG004', 'title': 'Placebo (GT 3, Cohort 2)', 'description': 'Participants with GT 3 HCV infection received placebo once daily for 3 days under fasted conditions.'}, {'id': 'OG005', 'title': 'Voxilaprevir 50 mg (GT 3, Cohort 2)', 'description': 'Participants with GT 3 HCV infection received voxilaprevir 50 mg once daily for 3 days under fasted conditions.'}, {'id': 'OG006', 'title': 'Voxilaprevir 100 mg (GT 3, Cohort 2)', 'description': 'Participants with GT 3 HCV infection received voxilaprevir 100 mg once daily for 3 days under fasted conditions.'}, {'id': 'OG007', 'title': 'Voxilaprevir 300 mg (GT 3, Cohort 2)', 'description': 'Participants with GT 3 HCV infection received voxilaprevir 300 mg once daily for 3 days under fasted conditions.'}, {'id': 'OG008', 'title': 'Placebo (GT 2, Cohort 3)', 'description': 'Participants with GT 2 HCV infection received placebo once daily for 3 days under fasted conditions.'}, {'id': 'OG009', 'title': 'Voxilaprevir 100 mg (GT 2, Cohort 3)', 'description': 'Participants with GT 2 HCV infection received voxilaprevir 100 mg once daily for 3 days under fasted conditions.'}, {'id': 'OG010', 'title': 'Voxilaprevir 100 mg (GT 4, Cohort 4)', 'description': 'Participants with GT 4 HCV infection received voxilaprevir 100 mg once daily for 3 days under fasted conditions.'}, {'id': 'OG011', 'title': 'Voxilaprevir 100 mg (GT 1b, Cohort 5)', 'description': 'Participants with GT 1b HCV infection received voxilaprevir 100 mg once daily for 3 days under fasted conditions.'}, {'id': 'OG012', 'title': 'Voxilaprevir 100 mg Fed (GT 3a, Cohort 6)', 'description': 'Participants with GT 3a HCV infection received voxilaprevir 100 mg once daily for 3 days under fed conditions.'}], 'classes': [{'title': 'Change at Day 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '5', 'groupId': 'OG005'}, {'value': '5', 'groupId': 'OG006'}, {'value': '7', 'groupId': 'OG007'}, {'value': '2', 'groupId': 'OG008'}, {'value': '6', 'groupId': 'OG009'}, {'value': '4', 'groupId': 'OG010'}, {'value': '6', 'groupId': 'OG011'}, {'value': '6', 'groupId': 'OG012'}]}], 'categories': [{'measurements': [{'value': '-0.12', 'spread': '0.136', 'groupId': 'OG000'}, {'value': '-3.81', 'spread': '0.516', 'groupId': 'OG001'}, {'value': '-3.97', 'spread': '0.608', 'groupId': 'OG002'}, {'value': '-3.33', 'spread': '0.902', 'groupId': 'OG003'}, {'value': '-0.24', 'spread': '0.813', 'groupId': 'OG004'}, {'value': '-1.47', 'spread': '0.416', 'groupId': 'OG005'}, {'value': '-3.20', 'spread': '0.364', 'groupId': 'OG006'}, {'value': '-3.57', 'spread': '0.483', 'groupId': 'OG007'}, {'value': '0.00', 'spread': '0.104', 'groupId': 'OG008'}, {'value': '-3.41', 'spread': '0.444', 'groupId': 'OG009'}, {'value': '-3.50', 'spread': '0.677', 'groupId': 'OG010'}, {'value': '-3.57', 'spread': '0.227', 'groupId': 'OG011'}, {'value': '-3.06', 'spread': '0.752', 'groupId': 'OG012'}]}]}, {'title': 'Change at Day 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}, {'value': '5', 'groupId': 'OG006'}, {'value': '7', 'groupId': 'OG007'}, {'value': '2', 'groupId': 'OG008'}, {'value': '6', 'groupId': 'OG009'}, {'value': '4', 'groupId': 'OG010'}, {'value': '6', 'groupId': 'OG011'}, {'value': '6', 'groupId': 'OG012'}]}], 'categories': [{'measurements': [{'value': '-0.20', 'spread': '0.519', 'groupId': 'OG000'}, {'value': '-3.58', 'spread': '1.104', 'groupId': 'OG001'}, {'value': '-4.03', 'spread': '0.594', 'groupId': 'OG002'}, {'value': '-3.37', 'spread': '0.894', 'groupId': 'OG003'}, {'value': '-0.17', 'spread': '0.285', 'groupId': 'OG004'}, {'value': '-1.43', 'spread': '0.606', 'groupId': 'OG005'}, {'value': '-3.00', 'spread': '0.470', 'groupId': 'OG006'}, {'value': '-3.28', 'spread': '0.515', 'groupId': 'OG007'}, {'value': '-0.12', 'spread': '0.151', 'groupId': 'OG008'}, {'value': '-3.37', 'spread': '0.480', 'groupId': 'OG009'}, {'value': '-3.61', 'spread': '0.702', 'groupId': 'OG010'}, {'value': '-3.60', 'spread': '0.390', 'groupId': 'OG011'}, {'value': '-2.45', 'spread': '0.664', 'groupId': 'OG012'}]}]}, {'title': 'Change at Day 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}, {'value': '5', 'groupId': 'OG006'}, {'value': '7', 'groupId': 'OG007'}, {'value': '2', 'groupId': 'OG008'}, {'value': '6', 'groupId': 'OG009'}, {'value': '4', 'groupId': 'OG010'}, {'value': '5', 'groupId': 'OG011'}, {'value': '6', 'groupId': 'OG012'}]}], 'categories': [{'measurements': [{'value': '-0.21', 'spread': '0.479', 'groupId': 'OG000'}, {'value': '-3.45', 'spread': '0.829', 'groupId': 'OG001'}, {'value': '-3.78', 'spread': '0.710', 'groupId': 'OG002'}, {'value': '-3.47', 'spread': '0.763', 'groupId': 'OG003'}, {'value': '-0.06', 'spread': '0.051', 'groupId': 'OG004'}, {'value': '-1.06', 'spread': '0.632', 'groupId': 'OG005'}, {'value': '-2.52', 'spread': '0.739', 'groupId': 'OG006'}, {'value': '-3.13', 'spread': '0.736', 'groupId': 'OG007'}, {'value': '-0.04', 'spread': '0.139', 'groupId': 'OG008'}, {'value': '-3.22', 'spread': '0.689', 'groupId': 'OG009'}, {'value': '-3.69', 'spread': '0.879', 'groupId': 'OG010'}, {'value': '-3.61', 'spread': '0.601', 'groupId': 'OG011'}, {'value': '-2.04', 'spread': '0.706', 'groupId': 'OG012'}]}]}, {'title': 'Change at Day 7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}, {'value': '6', 'groupId': 'OG006'}, {'value': '7', 'groupId': 'OG007'}, {'value': '2', 'groupId': 'OG008'}, {'value': '6', 'groupId': 'OG009'}, {'value': '4', 'groupId': 'OG010'}, {'value': '6', 'groupId': 'OG011'}, {'value': '6', 'groupId': 'OG012'}]}], 'categories': [{'measurements': [{'value': '0.01', 'spread': '0.340', 'groupId': 'OG000'}, {'value': '-3.15', 'spread': '0.973', 'groupId': 'OG001'}, {'value': '-3.88', 'spread': '0.729', 'groupId': 'OG002'}, {'value': '-3.48', 'spread': '0.695', 'groupId': 'OG003'}, {'value': '0.02', 'spread': '0.089', 'groupId': 'OG004'}, {'value': '-0.76', 'spread': '0.352', 'groupId': 'OG005'}, {'value': '-2.00', 'spread': '0.378', 'groupId': 'OG006'}, {'value': '-2.89', 'spread': '0.763', 'groupId': 'OG007'}, {'value': '-0.05', 'spread': '0.058', 'groupId': 'OG008'}, {'value': '-2.80', 'spread': '0.494', 'groupId': 'OG009'}, {'value': '-3.70', 'spread': '0.877', 'groupId': 'OG010'}, {'value': '-3.42', 'spread': '0.710', 'groupId': 'OG011'}, {'value': '-1.74', 'spread': '0.885', 'groupId': 'OG012'}]}]}, {'title': 'Change at Day 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}, {'value': '5', 'groupId': 'OG006'}, {'value': '7', 'groupId': 'OG007'}, {'value': '2', 'groupId': 'OG008'}, {'value': '6', 'groupId': 'OG009'}, {'value': '4', 'groupId': 'OG010'}, {'value': '6', 'groupId': 'OG011'}, {'value': '6', 'groupId': 'OG012'}]}], 'categories': [{'measurements': [{'value': '0.13', 'spread': '0.260', 'groupId': 'OG000'}, {'value': '-2.92', 'spread': '1.069', 'groupId': 'OG001'}, {'value': '-3.54', 'spread': '0.663', 'groupId': 'OG002'}, {'value': '-3.23', 'spread': '0.726', 'groupId': 'OG003'}, {'value': '-0.14', 'spread': '0.158', 'groupId': 'OG004'}, {'value': '-0.53', 'spread': '0.379', 'groupId': 'OG005'}, {'value': '-1.79', 'spread': '0.627', 'groupId': 'OG006'}, {'value': '-2.74', 'spread': '0.916', 'groupId': 'OG007'}, {'value': '-0.05', 'spread': '0.090', 'groupId': 'OG008'}, {'value': '-2.48', 'spread': '0.355', 'groupId': 'OG009'}, {'value': '-3.53', 'spread': '0.637', 'groupId': 'OG010'}, {'value': '-3.27', 'spread': '0.627', 'groupId': 'OG011'}, {'value': '-1.43', 'spread': '0.987', 'groupId': 'OG012'}]}]}, {'title': 'Change at Day 10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '5', 'groupId': 'OG005'}, {'value': '5', 'groupId': 'OG006'}, {'value': '7', 'groupId': 'OG007'}, {'value': '2', 'groupId': 'OG008'}, {'value': '6', 'groupId': 'OG009'}, {'value': '4', 'groupId': 'OG010'}, {'value': '6', 'groupId': 'OG011'}, {'value': '6', 'groupId': 'OG012'}]}], 'categories': [{'measurements': [{'value': '-0.06', 'spread': '0.091', 'groupId': 'OG000'}, {'value': '-2.69', 'spread': '1.116', 'groupId': 'OG001'}, {'value': '-3.33', 'spread': '0.756', 'groupId': 'OG002'}, {'value': '-2.97', 'spread': '0.918', 'groupId': 'OG003'}, {'value': '-0.23', 'spread': '0.180', 'groupId': 'OG004'}, {'value': '-0.28', 'spread': '0.330', 'groupId': 'OG005'}, {'value': '-1.18', 'spread': '1.055', 'groupId': 'OG006'}, {'value': '-2.17', 'spread': '1.394', 'groupId': 'OG007'}, {'value': '-0.13', 'spread': '0.022', 'groupId': 'OG008'}, {'value': '-2.28', 'spread': '0.469', 'groupId': 'OG009'}, {'value': '-3.61', 'spread': '0.674', 'groupId': 'OG010'}, {'value': '-3.08', 'spread': '0.740', 'groupId': 'OG011'}, {'value': '-0.62', 'spread': '1.085', 'groupId': 'OG012'}]}]}, {'title': 'Change at Week 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}, {'value': '2', 'groupId': 'OG007'}, {'value': '1', 'groupId': 'OG008'}, {'value': '1', 'groupId': 'OG009'}, {'value': '4', 'groupId': 'OG010'}, {'value': '5', 'groupId': 'OG011'}, {'value': '4', 'groupId': 'OG012'}]}], 'categories': [{'measurements': [{'value': '0.41', 'spread': '0.873', 'groupId': 'OG000'}, {'value': '0.08', 'spread': '0.337', 'groupId': 'OG001'}, {'value': '-0.80', 'spread': '2.094', 'groupId': 'OG002'}, {'value': '-0.73', 'spread': '2.352', 'groupId': 'OG003'}, {'value': '0.41', 'groupId': 'OG004'}, {'value': '-0.03', 'spread': '0.221', 'groupId': 'OG005'}, {'value': '0.54', 'groupId': 'OG006'}, {'value': '0.06', 'spread': '0.370', 'groupId': 'OG007'}, {'value': '-0.02', 'groupId': 'OG008'}, {'value': '-0.02', 'groupId': 'OG009'}, {'value': '0.18', 'spread': '0.247', 'groupId': 'OG010'}, {'value': '-0.57', 'spread': '2.389', 'groupId': 'OG011'}, {'value': '0.16', 'spread': '0.044', 'groupId': 'OG012'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline; Days 4, 5, 6, 7, 8, 10, and Week 48', 'description': 'The outcome measure was assessed to evaluate antiviral activity of voxilaprevir only (cohorts 1 through 6). Data are summarized by treatment/cohort and placebo.', 'unitOfMeasure': 'log10 IU/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The Efficacy Analysis Set included all enrolled participants with appropriate genotype who received at least one dose of the study drug (voxilaprevir or placebo) and with at least one on-treatment HCV RNA assessment. Participants in the Efficacy Analysis Set with available data were analyzed.'}, {'type': 'SECONDARY', 'title': 'Antiviral Activity of Voxilaprevir as Measured by Absolute HCV RNA Level Through Week 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}, {'value': '6', 'groupId': 'OG006'}, {'value': '7', 'groupId': 'OG007'}, {'value': '2', 'groupId': 'OG008'}, {'value': '6', 'groupId': 'OG009'}, {'value': '4', 'groupId': 'OG010'}, {'value': '6', 'groupId': 'OG011'}, {'value': '6', 'groupId': 'OG012'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo (GT 1a, Cohort 1)', 'description': 'Participants with GT 1a HCV infection received placebo once daily for 3 days under fasted conditions.'}, {'id': 'OG001', 'title': 'Voxilaprevir 50 mg (GT 1a, Cohort 1)', 'description': 'Participants with GT 1a HCV infection received voxilaprevir 50 mg once daily for 3 days under fasted conditions.'}, {'id': 'OG002', 'title': 'Voxilaprevir 100 mg (GT 1a, Cohort 1)', 'description': 'Participants with GT 1a HCV infection received voxilaprevir 100 mg once daily for 3 days under fasted conditions.'}, {'id': 'OG003', 'title': 'Voxilaprevir 300 mg (GT 1a, Cohort 1)', 'description': 'Participants with GT 1a HCV infection received voxilaprevir 300 mg once daily for 3 days under fasted conditions.'}, {'id': 'OG004', 'title': 'Placebo (GT 3, Cohort 2)', 'description': 'Participants with GT 3 HCV infection received placebo once daily for 3 days under fasted conditions.'}, {'id': 'OG005', 'title': 'Voxilaprevir 50 mg (GT 3, Cohort 2)', 'description': 'Participants with GT 3 HCV infection received voxilaprevir 50 mg once daily for 3 days under fasted conditions.'}, {'id': 'OG006', 'title': 'Voxilaprevir 100 mg (GT 3, Cohort 2)', 'description': 'Participants with GT 3 HCV infection received voxilaprevir 100 mg once daily for 3 days under fasted conditions.'}, {'id': 'OG007', 'title': 'Voxilaprevir 300 mg (GT 3, Cohort 2)', 'description': 'Participants with GT 3 HCV infection received voxilaprevir 300 mg once daily for 3 days under fasted conditions.'}, {'id': 'OG008', 'title': 'Placebo (GT 2, Cohort 3)', 'description': 'Participants with GT 2 HCV infection received placebo once daily for 3 days under fasted conditions.'}, {'id': 'OG009', 'title': 'Voxilaprevir 100 mg (GT 2, Cohort 3)', 'description': 'Participants with GT 2 HCV infection received voxilaprevir 100 mg once daily for 3 days under fasted conditions.'}, {'id': 'OG010', 'title': 'Voxilaprevir 100 mg (GT 4, Cohort 4)', 'description': 'Participants with GT 4 HCV infection received voxilaprevir 100 mg once daily for 3 days under fasted conditions.'}, {'id': 'OG011', 'title': 'Voxilaprevir 100 mg (GT 1b, Cohort 5)', 'description': 'Participants with GT 1b HCV infection received voxilaprevir 100 mg once daily for 3 days under fasted conditions.'}, {'id': 'OG012', 'title': 'Voxilaprevir 100 mg Fed (GT 3a, Cohort 6)', 'description': 'Participants with GT 3a HCV infection received voxilaprevir 100 mg once daily for 3 days under fed conditions.'}], 'classes': [{'title': 'Pre Day 1 Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}, {'value': '6', 'groupId': 'OG006'}, {'value': '7', 'groupId': 'OG007'}, {'value': '2', 'groupId': 'OG008'}, {'value': '6', 'groupId': 'OG009'}, {'value': '4', 'groupId': 'OG010'}, {'value': '6', 'groupId': 'OG011'}, {'value': '6', 'groupId': 'OG012'}]}], 'categories': [{'measurements': [{'value': '6.73', 'spread': '0.307', 'groupId': 'OG000'}, {'value': '6.30', 'spread': '0.497', 'groupId': 'OG001'}, {'value': '6.35', 'spread': '0.526', 'groupId': 'OG002'}, {'value': '6.05', 'spread': '0.558', 'groupId': 'OG003'}, {'value': '6.11', 'spread': '0.480', 'groupId': 'OG004'}, {'value': '5.61', 'spread': '0.612', 'groupId': 'OG005'}, {'value': '6.75', 'spread': '0.346', 'groupId': 'OG006'}, {'value': '6.01', 'spread': '0.773', 'groupId': 'OG007'}, {'value': '6.71', 'spread': '0.059', 'groupId': 'OG008'}, {'value': '6.24', 'spread': '0.394', 'groupId': 'OG009'}, {'value': '6.16', 'spread': '0.730', 'groupId': 'OG010'}, {'value': '6.23', 'spread': '0.608', 'groupId': 'OG011'}, {'value': '6.01', 'spread': '0.866', 'groupId': 'OG012'}]}]}, {'title': 'Day 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '5', 'groupId': 'OG005'}, {'value': '5', 'groupId': 'OG006'}, {'value': '7', 'groupId': 'OG007'}, {'value': '2', 'groupId': 'OG008'}, {'value': '6', 'groupId': 'OG009'}, {'value': '4', 'groupId': 'OG010'}, {'value': '6', 'groupId': 'OG011'}, {'value': '6', 'groupId': 'OG012'}]}], 'categories': [{'measurements': [{'value': '6.62', 'spread': '0.378', 'groupId': 'OG000'}, {'value': '2.56', 'spread': '0.705', 'groupId': 'OG001'}, {'value': '2.38', 'spread': '0.759', 'groupId': 'OG002'}, {'value': '2.72', 'spread': '0.943', 'groupId': 'OG003'}, {'value': '5.87', 'spread': '0.332', 'groupId': 'OG004'}, {'value': '4.22', 'spread': '0.878', 'groupId': 'OG005'}, {'value': '3.54', 'spread': '0.455', 'groupId': 'OG006'}, {'value': '2.44', 'spread': '0.693', 'groupId': 'OG007'}, {'value': '6.71', 'spread': '0.164', 'groupId': 'OG008'}, {'value': '2.83', 'spread': '0.611', 'groupId': 'OG009'}, {'value': '2.65', 'spread': '0.533', 'groupId': 'OG010'}, {'value': '2.67', 'spread': '0.500', 'groupId': 'OG011'}, {'value': '2.95', 'spread': '0.505', 'groupId': 'OG012'}]}]}, {'title': 'Day 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}, {'value': '5', 'groupId': 'OG006'}, {'value': '7', 'groupId': 'OG007'}, {'value': '2', 'groupId': 'OG008'}, {'value': '6', 'groupId': 'OG009'}, {'value': '4', 'groupId': 'OG010'}, {'value': '6', 'groupId': 'OG011'}, {'value': '6', 'groupId': 'OG012'}]}], 'categories': [{'measurements': [{'value': '6.53', 'spread': '0.426', 'groupId': 'OG000'}, {'value': '2.73', 'spread': '1.203', 'groupId': 'OG001'}, {'value': '2.33', 'spread': '0.643', 'groupId': 'OG002'}, {'value': '2.67', 'spread': '0.947', 'groupId': 'OG003'}, {'value': '5.94', 'spread': '0.195', 'groupId': 'OG004'}, {'value': '4.19', 'spread': '1.104', 'groupId': 'OG005'}, {'value': '3.75', 'spread': '0.455', 'groupId': 'OG006'}, {'value': '2.73', 'spread': '0.780', 'groupId': 'OG007'}, {'value': '6.59', 'spread': '0.210', 'groupId': 'OG008'}, {'value': '2.87', 'spread': '0.603', 'groupId': 'OG009'}, {'value': '2.55', 'spread': '0.549', 'groupId': 'OG010'}, {'value': '2.63', 'spread': '0.764', 'groupId': 'OG011'}, {'value': '3.56', 'spread': '0.273', 'groupId': 'OG012'}]}]}, {'title': 'Day 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}, {'value': '5', 'groupId': 'OG006'}, {'value': '7', 'groupId': 'OG007'}, {'value': '2', 'groupId': 'OG008'}, {'value': '6', 'groupId': 'OG009'}, {'value': '4', 'groupId': 'OG010'}, {'value': '5', 'groupId': 'OG011'}, {'value': '6', 'groupId': 'OG012'}]}], 'categories': [{'measurements': [{'value': '6.52', 'spread': '0.320', 'groupId': 'OG000'}, {'value': '2.85', 'spread': '1.000', 'groupId': 'OG001'}, {'value': '2.57', 'spread': '1.028', 'groupId': 'OG002'}, {'value': '2.57', 'spread': '0.818', 'groupId': 'OG003'}, {'value': '6.05', 'spread': '0.532', 'groupId': 'OG004'}, {'value': '4.55', 'spread': '1.203', 'groupId': 'OG005'}, {'value': '4.23', 'spread': '0.604', 'groupId': 'OG006'}, {'value': '2.88', 'spread': '0.882', 'groupId': 'OG007'}, {'value': '6.68', 'spread': '0.199', 'groupId': 'OG008'}, {'value': '3.02', 'spread': '0.754', 'groupId': 'OG009'}, {'value': '2.46', 'spread': '0.300', 'groupId': 'OG010'}, {'value': '2.85', 'spread': '0.685', 'groupId': 'OG011'}, {'value': '3.98', 'spread': '0.413', 'groupId': 'OG012'}]}]}, {'title': 'Day 7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}, {'value': '5', 'groupId': 'OG006'}, {'value': '7', 'groupId': 'OG007'}, {'value': '2', 'groupId': 'OG008'}, {'value': '6', 'groupId': 'OG009'}, {'value': '4', 'groupId': 'OG010'}, {'value': '6', 'groupId': 'OG011'}, {'value': '6', 'groupId': 'OG012'}]}], 'categories': [{'measurements': [{'value': '6.74', 'spread': '0.059', 'groupId': 'OG000'}, {'value': '3.15', 'spread': '1.268', 'groupId': 'OG001'}, {'value': '2.47', 'spread': '0.821', 'groupId': 'OG002'}, {'value': '2.56', 'spread': '0.714', 'groupId': 'OG003'}, {'value': '6.13', 'spread': '0.569', 'groupId': 'OG004'}, {'value': '4.85', 'spread': '0.886', 'groupId': 'OG005'}, {'value': '4.75', 'spread': '0.268', 'groupId': 'OG006'}, {'value': '3.12', 'spread': '0.991', 'groupId': 'OG007'}, {'value': '6.67', 'spread': '0.001', 'groupId': 'OG008'}, {'value': '3.44', 'spread': '0.613', 'groupId': 'OG009'}, {'value': '2.45', 'spread': '0.359', 'groupId': 'OG010'}, {'value': '2.82', 'spread': '1.111', 'groupId': 'OG011'}, {'value': '4.27', 'spread': '0.485', 'groupId': 'OG012'}]}]}, {'title': 'Day 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}, {'value': '5', 'groupId': 'OG006'}, {'value': '7', 'groupId': 'OG007'}, {'value': '2', 'groupId': 'OG008'}, {'value': '6', 'groupId': 'OG009'}, {'value': '4', 'groupId': 'OG010'}, {'value': '6', 'groupId': 'OG011'}, {'value': '6', 'groupId': 'OG012'}]}], 'categories': [{'measurements': [{'value': '6.86', 'spread': '0.144', 'groupId': 'OG000'}, {'value': '3.38', 'spread': '1.019', 'groupId': 'OG001'}, {'value': '2.81', 'spread': '0.901', 'groupId': 'OG002'}, {'value': '2.81', 'spread': '0.671', 'groupId': 'OG003'}, {'value': '5.97', 'spread': '0.323', 'groupId': 'OG004'}, {'value': '5.08', 'spread': '0.655', 'groupId': 'OG005'}, {'value': '4.96', 'spread': '0.531', 'groupId': 'OG006'}, {'value': '3.27', 'spread': '1.100', 'groupId': 'OG007'}, {'value': '6.66', 'spread': '0.031', 'groupId': 'OG008'}, {'value': '3.76', 'spread': '0.497', 'groupId': 'OG009'}, {'value': '2.62', 'spread': '0.278', 'groupId': 'OG010'}, {'value': '2.96', 'spread': '1.111', 'groupId': 'OG011'}, {'value': '4.59', 'spread': '0.528', 'groupId': 'OG012'}]}]}, {'title': 'Day 10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '5', 'groupId': 'OG005'}, {'value': '5', 'groupId': 'OG006'}, {'value': '7', 'groupId': 'OG007'}, {'value': '2', 'groupId': 'OG008'}, {'value': '6', 'groupId': 'OG009'}, {'value': '4', 'groupId': 'OG010'}, {'value': '6', 'groupId': 'OG011'}, {'value': '6', 'groupId': 'OG012'}]}], 'categories': [{'measurements': [{'value': '6.68', 'spread': '0.263', 'groupId': 'OG000'}, {'value': '3.61', 'spread': '1.041', 'groupId': 'OG001'}, {'value': '3.03', 'spread': '0.857', 'groupId': 'OG002'}, {'value': '3.07', 'spread': '0.887', 'groupId': 'OG003'}, {'value': '5.88', 'spread': '0.300', 'groupId': 'OG004'}, {'value': '5.43', 'spread': '0.803', 'groupId': 'OG005'}, {'value': '5.56', 'spread': '0.987', 'groupId': 'OG006'}, {'value': '3.83', 'spread': '1.417', 'groupId': 'OG007'}, {'value': '6.58', 'spread': '0.081', 'groupId': 'OG008'}, {'value': '3.96', 'spread': '0.555', 'groupId': 'OG009'}, {'value': '2.54', 'spread': '0.553', 'groupId': 'OG010'}, {'value': '3.15', 'spread': '1.210', 'groupId': 'OG011'}, {'value': '5.40', 'spread': '0.697', 'groupId': 'OG012'}]}]}, {'title': 'Week 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}, {'value': '2', 'groupId': 'OG007'}, {'value': '1', 'groupId': 'OG008'}, {'value': '1', 'groupId': 'OG009'}, {'value': '4', 'groupId': 'OG010'}, {'value': '5', 'groupId': 'OG011'}, {'value': '4', 'groupId': 'OG012'}]}], 'categories': [{'measurements': [{'value': '6.97', 'spread': '0.488', 'groupId': 'OG000'}, {'value': '6.29', 'spread': '0.825', 'groupId': 'OG001'}, {'value': '5.55', 'spread': '2.007', 'groupId': 'OG002'}, {'value': '5.20', 'spread': '2.085', 'groupId': 'OG003'}, {'value': '6.18', 'groupId': 'OG004'}, {'value': '5.13', 'spread': '0.207', 'groupId': 'OG005'}, {'value': '7.29', 'groupId': 'OG006'}, {'value': '6.38', 'spread': '1.479', 'groupId': 'OG007'}, {'value': '6.65', 'groupId': 'OG008'}, {'value': '6.13', 'groupId': 'OG009'}, {'value': '6.34', 'spread': '0.696', 'groupId': 'OG010'}, {'value': '5.65', 'spread': '2.473', 'groupId': 'OG011'}, {'value': '5.98', 'spread': '0.891', 'groupId': 'OG012'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Pre Day 1 Dose); Days 4, 5, 6, 7, 8, 10, and Week 48', 'description': 'The outcome measure was assessed to evaluate antiviral activity of voxilaprevir only (cohorts 1 through 6).', 'unitOfMeasure': 'log10 IU/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in the Efficacy Analysis Set with available data were analyzed. Data are summarized by treatment/cohort and placebo.'}, {'type': 'SECONDARY', 'title': 'Antiviral Activity of Voxilaprevir as Measured by Number of Participants Achieving Reductions From Baseline in HCV RNA', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}, {'value': '6', 'groupId': 'OG006'}, {'value': '7', 'groupId': 'OG007'}, {'value': '2', 'groupId': 'OG008'}, {'value': '6', 'groupId': 'OG009'}, {'value': '4', 'groupId': 'OG010'}, {'value': '6', 'groupId': 'OG011'}, {'value': '6', 'groupId': 'OG012'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo (GT 1a, Cohort 1)', 'description': 'Participants with GT 1a HCV infection received placebo once daily for 3 days under fasted conditions.'}, {'id': 'OG001', 'title': 'Voxilaprevir 50 mg (GT 1a, Cohort 1)', 'description': 'Participants with GT 1a HCV infection received voxilaprevir 50 mg once daily for 3 days under fasted conditions.'}, {'id': 'OG002', 'title': 'Voxilaprevir 100 mg (GT 1a, Cohort 1)', 'description': 'Participants with GT 1a HCV infection received voxilaprevir 100 mg once daily for 3 days under fasted conditions.'}, {'id': 'OG003', 'title': 'Voxilaprevir 300 mg (GT 1a, Cohort 1)', 'description': 'Participants with GT 1a HCV infection received voxilaprevir 300 mg once daily for 3 days under fasted conditions.'}, {'id': 'OG004', 'title': 'Placebo (GT 3, Cohort 2)', 'description': 'Participants with GT 3 HCV infection received placebo once daily for 3 days under fasted conditions.'}, {'id': 'OG005', 'title': 'Voxilaprevir 50 mg (GT 3, Cohort 2)', 'description': 'Participants with GT 3 HCV infection received voxilaprevir 50 mg once daily for 3 days under fasted conditions.'}, {'id': 'OG006', 'title': 'Voxilaprevir 100 mg (GT 3, Cohort 2)', 'description': 'Participants with GT 3 HCV infection received voxilaprevir 100 mg once daily for 3 days under fasted conditions.'}, {'id': 'OG007', 'title': 'Voxilaprevir 300 mg (GT 3, Cohort 2)', 'description': 'Participants with GT 3 HCV infection received voxilaprevir 300 mg once daily for 3 days under fasted conditions.'}, {'id': 'OG008', 'title': 'Placebo (GT 2, Cohort 3)', 'description': 'Participants with GT 2 HCV infection received placebo once daily for 3 days under fasted conditions.'}, {'id': 'OG009', 'title': 'Voxilaprevir 100 mg (GT 2, Cohort 3)', 'description': 'Participants with GT 2 HCV infection received voxilaprevir 100 mg once daily for 3 days under fasted conditions.'}, {'id': 'OG010', 'title': 'Voxilaprevir 100 mg (GT 4, Cohort 4)', 'description': 'Participants with GT 4 HCV infection received voxilaprevir 100 mg once daily for 3 days under fasted conditions.'}, {'id': 'OG011', 'title': 'Voxilaprevir 100 mg (GT 1b, Cohort 5)', 'description': 'Participants with GT 1b HCV infection received voxilaprevir 100 mg once daily for 3 days under fasted conditions.'}, {'id': 'OG012', 'title': 'Voxilaprevir 100 mg Fed (GT 3a, Cohort 6)', 'description': 'Participants with GT 3a HCV infection received voxilaprevir 100 mg once daily for 3 days under fed conditions.'}], 'classes': [{'title': 'Day 4', 'categories': [{'title': 'Missing HCV RNA', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}, {'value': '0', 'groupId': 'OG010'}, {'value': '0', 'groupId': 'OG011'}, {'value': '0', 'groupId': 'OG012'}]}, {'title': '< 1 log10 IU/mL decrease in HCV RNA', 'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '2', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}, {'value': '0', 'groupId': 'OG010'}, {'value': '0', 'groupId': 'OG011'}, {'value': '0', 'groupId': 'OG012'}]}, {'title': '≥1 and <2 log10 IU/mL decrease in HCV RNA', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '4', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}, {'value': '0', 'groupId': 'OG010'}, {'value': '0', 'groupId': 'OG011'}, {'value': '0', 'groupId': 'OG012'}]}, {'title': '≥2 and <3 log10 IU/mL decrease in HCV RNA', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '1', 'groupId': 'OG009'}, {'value': '1', 'groupId': 'OG010'}, {'value': '0', 'groupId': 'OG011'}, {'value': '3', 'groupId': 'OG012'}]}, {'title': '≥3 log10 IU/mL decrease in HCV RNA', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '4', 'groupId': 'OG006'}, {'value': '6', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '5', 'groupId': 'OG009'}, {'value': '3', 'groupId': 'OG010'}, {'value': '6', 'groupId': 'OG011'}, {'value': '3', 'groupId': 'OG012'}]}]}, {'title': 'Day 5', 'categories': [{'title': 'Missing HCV RNA', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}, {'value': '0', 'groupId': 'OG010'}, {'value': '0', 'groupId': 'OG011'}, {'value': '0', 'groupId': 'OG012'}]}, {'title': '< 1 log10 IU/mL decrease in HCV RNA', 'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '2', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}, {'value': '0', 'groupId': 'OG010'}, {'value': '0', 'groupId': 'OG011'}, {'value': '0', 'groupId': 'OG012'}]}, {'title': '≥1 and <2 log10 IU/mL decrease in HCV RNA', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '4', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}, {'value': '0', 'groupId': 'OG010'}, {'value': '0', 'groupId': 'OG011'}, {'value': '1', 'groupId': 'OG012'}]}, {'title': '≥2 and <3 log10 IU/mL decrease in HCV RNA', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}, {'value': '2', 'groupId': 'OG006'}, {'value': '2', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '2', 'groupId': 'OG009'}, {'value': '1', 'groupId': 'OG010'}, {'value': '0', 'groupId': 'OG011'}, {'value': '3', 'groupId': 'OG012'}]}, {'title': '≥3 log10 IU/mL decrease in HCV RNA', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '3', 'groupId': 'OG006'}, {'value': '5', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '4', 'groupId': 'OG009'}, {'value': '3', 'groupId': 'OG010'}, {'value': '6', 'groupId': 'OG011'}, {'value': '2', 'groupId': 'OG012'}]}]}, {'title': 'Day 6', 'categories': [{'title': 'Missing HCV RNA', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}, {'value': '0', 'groupId': 'OG010'}, {'value': '1', 'groupId': 'OG011'}, {'value': '0', 'groupId': 'OG012'}]}, {'title': '< 1 log10 IU/mL decrease in HCV RNA', 'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '2', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '2', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}, {'value': '0', 'groupId': 'OG010'}, {'value': '0', 'groupId': 'OG011'}, {'value': '0', 'groupId': 'OG012'}]}, {'title': '≥1 and <2 log10 IU/mL decrease in HCV RNA', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '4', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}, {'value': '0', 'groupId': 'OG010'}, {'value': '0', 'groupId': 'OG011'}, {'value': '3', 'groupId': 'OG012'}]}, {'title': '≥2 and <3 log10 IU/mL decrease in HCV RNA', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '3', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '2', 'groupId': 'OG009'}, {'value': '1', 'groupId': 'OG010'}, {'value': '1', 'groupId': 'OG011'}, {'value': '2', 'groupId': 'OG012'}]}, {'title': '≥3 log10 IU/mL decrease in HCV RNA', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}, {'value': '5', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '4', 'groupId': 'OG009'}, {'value': '3', 'groupId': 'OG010'}, {'value': '4', 'groupId': 'OG011'}, {'value': '1', 'groupId': 'OG012'}]}]}, {'title': 'Day 7', 'categories': [{'title': 'Missing HCV RNA', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}, {'value': '0', 'groupId': 'OG010'}, {'value': '0', 'groupId': 'OG011'}, {'value': '0', 'groupId': 'OG012'}]}, {'title': '< 1 log10 IU/mL decrease in HCV RNA', 'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '4', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '2', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}, {'value': '0', 'groupId': 'OG010'}, {'value': '0', 'groupId': 'OG011'}, {'value': '1', 'groupId': 'OG012'}]}, {'title': '≥1 and <2 log10 IU/mL decrease in HCV RNA', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '2', 'groupId': 'OG005'}, {'value': '3', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}, {'value': '0', 'groupId': 'OG010'}, {'value': '0', 'groupId': 'OG011'}, {'value': '2', 'groupId': 'OG012'}]}, {'title': '≥2 and <3 log10 IU/mL decrease in HCV RNA', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '2', 'groupId': 'OG006'}, {'value': '2', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '3', 'groupId': 'OG009'}, {'value': '1', 'groupId': 'OG010'}, {'value': '2', 'groupId': 'OG011'}, {'value': '3', 'groupId': 'OG012'}]}, {'title': '≥3 log10 IU/mL decrease in HCV RNA', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '4', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '3', 'groupId': 'OG009'}, {'value': '3', 'groupId': 'OG010'}, {'value': '4', 'groupId': 'OG011'}, {'value': '0', 'groupId': 'OG012'}]}]}, {'title': 'Day 8', 'categories': [{'title': 'Missing HCV RNA', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}, {'value': '0', 'groupId': 'OG010'}, {'value': '0', 'groupId': 'OG011'}, {'value': '0', 'groupId': 'OG012'}]}, {'title': '< 1 log10 IU/mL decrease in HCV RNA', 'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}, {'value': '2', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}, {'value': '0', 'groupId': 'OG010'}, {'value': '0', 'groupId': 'OG011'}, {'value': '3', 'groupId': 'OG012'}]}, {'title': '≥1 and <2 log10 IU/mL decrease in HCV RNA', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '4', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}, {'value': '0', 'groupId': 'OG010'}, {'value': '0', 'groupId': 'OG011'}, {'value': '2', 'groupId': 'OG012'}]}, {'title': '≥2 and <3 log10 IU/mL decrease in HCV RNA', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}, {'value': '2', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '6', 'groupId': 'OG009'}, {'value': '1', 'groupId': 'OG010'}, {'value': '2', 'groupId': 'OG011'}, {'value': '1', 'groupId': 'OG012'}]}, {'title': '≥3 log10 IU/mL decrease in HCV RNA', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '4', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}, {'value': '3', 'groupId': 'OG010'}, {'value': '4', 'groupId': 'OG011'}, {'value': '0', 'groupId': 'OG012'}]}]}, {'title': 'Day 10', 'categories': [{'title': 'Missing HCV RNA', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}, {'value': '0', 'groupId': 'OG010'}, {'value': '0', 'groupId': 'OG011'}, {'value': '0', 'groupId': 'OG012'}]}, {'title': '< 1 log10 IU/mL decrease in HCV RNA', 'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '5', 'groupId': 'OG005'}, {'value': '2', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}, {'value': '2', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}, {'value': '0', 'groupId': 'OG010'}, {'value': '0', 'groupId': 'OG011'}, {'value': '4', 'groupId': 'OG012'}]}, {'title': '≥1 and <2 log10 IU/mL decrease in HCV RNA', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '2', 'groupId': 'OG006'}, {'value': '2', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '2', 'groupId': 'OG009'}, {'value': '0', 'groupId': 'OG010'}, {'value': '1', 'groupId': 'OG011'}, {'value': '1', 'groupId': 'OG012'}]}, {'title': '≥2 and <3 log10 IU/mL decrease in HCV RNA', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '4', 'groupId': 'OG009'}, {'value': '0', 'groupId': 'OG010'}, {'value': '1', 'groupId': 'OG011'}, {'value': '1', 'groupId': 'OG012'}]}, {'title': '≥3 log10 IU/mL decrease in HCV RNA', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '3', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}, {'value': '4', 'groupId': 'OG010'}, {'value': '4', 'groupId': 'OG011'}, {'value': '0', 'groupId': 'OG012'}]}]}, {'title': 'Week 48', 'categories': [{'title': 'Missing HCV RNA', 'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '5', 'groupId': 'OG006'}, {'value': '5', 'groupId': 'OG007'}, {'value': '1', 'groupId': 'OG008'}, {'value': '5', 'groupId': 'OG009'}, {'value': '0', 'groupId': 'OG010'}, {'value': '1', 'groupId': 'OG011'}, {'value': '2', 'groupId': 'OG012'}]}, {'title': '< 1 log10 IU/mL decrease in HCV RNA', 'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}, {'value': '2', 'groupId': 'OG007'}, {'value': '1', 'groupId': 'OG008'}, {'value': '1', 'groupId': 'OG009'}, {'value': '4', 'groupId': 'OG010'}, {'value': '4', 'groupId': 'OG011'}, {'value': '4', 'groupId': 'OG012'}]}, {'title': '≥1 and <2 log10 IU/mL decrease in HCV RNA', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}, {'value': '0', 'groupId': 'OG010'}, {'value': '0', 'groupId': 'OG011'}, {'value': '0', 'groupId': 'OG012'}]}, {'title': '≥2 and <3 log10 IU/mL decrease in HCV RNA', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}, {'value': '0', 'groupId': 'OG010'}, {'value': '0', 'groupId': 'OG011'}, {'value': '0', 'groupId': 'OG012'}]}, {'title': '≥3 log10 IU/mL decrease in HCV RNA', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}, {'value': '0', 'groupId': 'OG010'}, {'value': '1', 'groupId': 'OG011'}, {'value': '0', 'groupId': 'OG012'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline; Days 4, 5, 6, 7, 8, 10, and Week 48', 'description': 'Categorical declines from baseline were summarized by the number of participants with a \\< 1, ≥ 1 to \\<2, ≥ 2 to \\<3, or ≥ 3 log10 IU/mL decrease in HCV RNA from baseline to each postdose assessment up to Week 48 by treatment/cohort and placebo. The outcome measure was assessed to evaluate antiviral activity of voxilaprevir only (cohorts 1 through 6).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in the Efficacy Analysis Set were analyzed.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Who Have HCV RNA < Lower Limit of Quantitation (LLOQ) Detected, and < LLOQ Target Not Detected (TND)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}, {'value': '6', 'groupId': 'OG006'}, {'value': '7', 'groupId': 'OG007'}, {'value': '2', 'groupId': 'OG008'}, {'value': '6', 'groupId': 'OG009'}, {'value': '4', 'groupId': 'OG010'}, {'value': '6', 'groupId': 'OG011'}, {'value': '6', 'groupId': 'OG012'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo (GT 1a, Cohort 1)', 'description': 'Participants with GT 1a HCV infection received placebo once daily for 3 days under fasted conditions.'}, {'id': 'OG001', 'title': 'Voxilaprevir 50 mg (GT 1a, Cohort 1)', 'description': 'Participants with GT 1a HCV infection received voxilaprevir 50 mg once daily for 3 days under fasted conditions.'}, {'id': 'OG002', 'title': 'Voxilaprevir 100 mg (GT 1a, Cohort 1)', 'description': 'Participants with GT 1a HCV infection received voxilaprevir 100 mg once daily for 3 days under fasted conditions.'}, {'id': 'OG003', 'title': 'Voxilaprevir 300 mg (GT 1a, Cohort 1)', 'description': 'Participants with GT 1a HCV infection received voxilaprevir 300 mg once daily for 3 days under fasted conditions.'}, {'id': 'OG004', 'title': 'Placebo (GT 3, Cohort 2)', 'description': 'Participants with GT 3 HCV infection received placebo once daily for 3 days under fasted conditions.'}, {'id': 'OG005', 'title': 'Voxilaprevir 50 mg (GT 3, Cohort 2)', 'description': 'Participants with GT 3 HCV infection received voxilaprevir 50 mg once daily for 3 days under fasted conditions.'}, {'id': 'OG006', 'title': 'Voxilaprevir 100 mg (GT 3, Cohort 2)', 'description': 'Participants with GT 3 HCV infection received voxilaprevir 100 mg once daily for 3 days under fasted conditions.'}, {'id': 'OG007', 'title': 'Voxilaprevir 300 mg (GT 3, Cohort 2)', 'description': 'Participants with GT 3 HCV infection received voxilaprevir 300 mg once daily for 3 days under fasted conditions.'}, {'id': 'OG008', 'title': 'Placebo (GT 2, Cohort 3)', 'description': 'Participants with GT 2 HCV infection received placebo once daily for 3 days under fasted conditions.'}, {'id': 'OG009', 'title': 'Voxilaprevir 100 mg (GT 2, Cohort 3)', 'description': 'Participants with GT 2 HCV infection received voxilaprevir 100 mg once daily for 3 days under fasted conditions.'}, {'id': 'OG010', 'title': 'Voxilaprevir 100 mg (GT 4, Cohort 4)', 'description': 'Participants with GT 4 HCV infection received voxilaprevir 100 mg once daily for 3 days under fasted conditions.'}, {'id': 'OG011', 'title': 'Voxilaprevir 100 mg (GT 1b, Cohort 5)', 'description': 'Participants with GT 1b HCV infection received voxilaprevir 100 mg once daily for 3 days under fasted conditions.'}, {'id': 'OG012', 'title': 'Voxilaprevir 100 mg Fed (GT 3a, Cohort 6)', 'description': 'Participants with GT 3a HCV infection received voxilaprevir 100 mg once daily for 3 days under fed conditions.'}], 'classes': [{'title': 'Day 4 < LLOQ detected', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}, {'value': '0', 'groupId': 'OG010'}, {'value': '0', 'groupId': 'OG011'}, {'value': '0', 'groupId': 'OG012'}]}]}, {'title': 'Day 5 < LLOQ detected', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}, {'value': '0', 'groupId': 'OG010'}, {'value': '0', 'groupId': 'OG011'}, {'value': '0', 'groupId': 'OG012'}]}]}, {'title': 'Day 6 < LLOQ TND', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}, {'value': '0', 'groupId': 'OG010'}, {'value': '0', 'groupId': 'OG011'}, {'value': '0', 'groupId': 'OG012'}]}]}, {'title': 'Day 7 < LLOQ detected', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}, {'value': '0', 'groupId': 'OG010'}, {'value': '1', 'groupId': 'OG011'}, {'value': '0', 'groupId': 'OG012'}]}]}, {'title': 'Day 8 < LLOQ detected', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}, {'value': '0', 'groupId': 'OG010'}, {'value': '1', 'groupId': 'OG011'}, {'value': '0', 'groupId': 'OG012'}]}]}, {'title': 'Day 10 < LLOQ TND', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}, {'value': '0', 'groupId': 'OG010'}, {'value': '1', 'groupId': 'OG011'}, {'value': '0', 'groupId': 'OG012'}]}]}, {'title': 'Week 48 < LLOQ TND', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}, {'value': '0', 'groupId': 'OG010'}, {'value': '0', 'groupId': 'OG011'}, {'value': '0', 'groupId': 'OG012'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Days 4, 5, 6, 7, 8, 10, and Week 48', 'description': 'The lower limit of quantitation (LLOQ) detection for HCV RNA levels was 15 IU/mL. HCV detected means calculated HCV RNA level is below LLOQ of the assay. The outcome measure was assessed to evaluate antiviral activity of voxilaprevir only (cohorts 1 through 6).', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in the Efficacy Analysis Set were analyzed. Data are summarized by treatment/cohort and placebo.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Placebo', 'description': 'Participants with HCV infection received placebo once daily for 3 days under fasted conditions. This arm was part of cohorts 1, 2 and 3.'}, {'id': 'FG001', 'title': 'Voxilaprevir 50 mg', 'description': 'Participants with HCV infection received voxilaprevir 50 mg once daily for 3 days under fasted conditions. This arm was part of cohorts 1 and 2.'}, {'id': 'FG002', 'title': 'Voxilaprevir 100 mg', 'description': 'Participants with HCV infection received voxilaprevir 100 mg once daily for 3 days under fasted conditions. This arm was part of cohorts 1, 2, 3, 4, 5 and 6.'}, {'id': 'FG003', 'title': 'Voxilaprevir 300 mg', 'description': 'Participants with HCV infection received voxilaprevir 300 mg once daily for 3 days under fasted conditions. This arm was part of cohorts 1 and 2.'}, {'id': 'FG004', 'title': 'Voxilaprevir 100 mg Fed', 'description': 'Participants with HCV infection received voxilaprevir 100 mg once daily for 3 days under fed conditions. This arm was part of cohorts 1, 2, 3, 4, 5 and 6.'}, {'id': 'FG005', 'title': 'Voxilaprevir 100 mg + SOF/VEL 400/100 mg', 'description': 'Participants with HCV infection received voxilaprevir 100 mg on Day 1 and voxilaprevir 100 mg plus sofosbuvir (SOF)/velpatasvir (VEL) (400/100 mg) fixed-dose combination (FDC) on Days 2 and 3 after moderate fat or light meal. This arm was part of cohort 10.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '20'}, {'groupId': 'FG002', 'numSubjects': '33'}, {'groupId': 'FG003', 'numSubjects': '16'}, {'groupId': 'FG004', 'numSubjects': '7'}, {'groupId': 'FG005', 'numSubjects': '16'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '7'}, {'groupId': 'FG002', 'numSubjects': '17'}, {'groupId': 'FG003', 'numSubjects': '8'}, {'groupId': 'FG004', 'numSubjects': '4'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '13'}, {'groupId': 'FG002', 'numSubjects': '16'}, {'groupId': 'FG003', 'numSubjects': '8'}, {'groupId': 'FG004', 'numSubjects': '3'}, {'groupId': 'FG005', 'numSubjects': '16'}]}], 'dropWithdraws': [{'type': 'Enrolled but Never Dosed', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': "Investigator's Discretion", 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '2'}, {'groupId': 'FG004', 'numSubjects': '2'}, {'groupId': 'FG005', 'numSubjects': '15'}]}, {'type': 'Withdrew Consent', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '10'}, {'groupId': 'FG003', 'numSubjects': '2'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '3'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'Participants were enrolled at study sites in United States and Puerto Rico. The first participant was screened on 13 June 2014. The last study visit occurred on 28 September 2015.', 'preAssignmentDetails': 'Participants were enrolled in Cohorts 1, 2, 3, 4, 5, 6 and 10. Cohorts 7, 8, and 9 were not conducted.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}, {'value': '15', 'groupId': 'BG003'}, {'value': '6', 'groupId': 'BG004'}, {'value': '16', 'groupId': 'BG005'}, {'value': '89', 'groupId': 'BG006'}]}], 'groups': [{'id': 'BG000', 'title': 'Placebo', 'description': 'Participants with HCV infection received placebo once daily for 3 days under fasted conditions. This arm was part of cohorts 1, 2 and 3.'}, {'id': 'BG001', 'title': 'Voxilaprevir 50 mg', 'description': 'Participants with HCV infection received voxilaprevir 50 mg once daily for 3 days under fasted conditions. This arm was part of cohorts 1 and 2.'}, {'id': 'BG002', 'title': 'Voxilaprevir 100 mg', 'description': 'Participants with HCV infection received voxilaprevir 100 mg once daily for 3 days under fasted conditions. This arm was part of cohorts 1, 2, 3, 4, 5 and 6.'}, {'id': 'BG003', 'title': 'Voxilaprevir 300 mg', 'description': 'Participants with HCV infection received voxilaprevir 300 mg once daily for 3 days under fasted conditions. This arm was part of cohorts 1 and 2.'}, {'id': 'BG004', 'title': 'Voxilaprevir 100 mg Fed', 'description': 'Participants with HCV infection received voxilaprevir 100 mg once daily for 3 days under fed conditions. This arm was part of cohorts 1, 2, 3, 4, 5 and 6.'}, {'id': 'BG005', 'title': 'Voxilaprevir 100 mg + SOF/VEL 400/100 mg', 'description': 'Participants with HCV infection received voxilaprevir 100 mg on Day 1 and voxilaprevir 100 mg plus SOF/VEL (400/100 mg) FDC on Days 2 and 3 after moderate fat meal. This arm was part of cohort 10.'}, {'id': 'BG006', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '52', 'spread': '6.1', 'groupId': 'BG000'}, {'value': '49', 'spread': '7.7', 'groupId': 'BG001'}, {'value': '52', 'spread': '8.0', 'groupId': 'BG002'}, {'value': '43', 'spread': '9.4', 'groupId': 'BG003'}, {'value': '51', 'spread': '6.2', 'groupId': 'BG004'}, {'value': '56', 'spread': '5.2', 'groupId': 'BG005'}, {'value': '51', 'spread': '8.4', 'groupId': 'BG006'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}, {'value': '7', 'groupId': 'BG005'}, {'value': '29', 'groupId': 'BG006'}]}, {'title': 'Male', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '21', 'groupId': 'BG002'}, {'value': '10', 'groupId': 'BG003'}, {'value': '4', 'groupId': 'BG004'}, {'value': '9', 'groupId': 'BG005'}, {'value': '60', 'groupId': 'BG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'categories': [{'title': 'Black or African American', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '22', 'groupId': 'BG006'}]}, {'title': 'White', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}, {'value': '12', 'groupId': 'BG003'}, {'value': '5', 'groupId': 'BG004'}, {'value': '16', 'groupId': 'BG005'}, {'value': '67', 'groupId': 'BG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}, {'value': '8', 'groupId': 'BG003'}, {'value': '6', 'groupId': 'BG004'}, {'value': '9', 'groupId': 'BG005'}, {'value': '44', 'groupId': 'BG006'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}, {'value': '7', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '7', 'groupId': 'BG005'}, {'value': '45', 'groupId': 'BG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'HCV Genotype', 'classes': [{'categories': [{'title': '1a', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '8', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '9', 'groupId': 'BG005'}, {'value': '37', 'groupId': 'BG006'}]}, {'title': '1b', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '3', 'groupId': 'BG005'}, {'value': '9', 'groupId': 'BG006'}]}, {'title': '2', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '1', 'groupId': 'BG005'}, {'value': '1', 'groupId': 'BG006'}]}, {'title': '2a/2c', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '2', 'groupId': 'BG006'}]}, {'title': '2b', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '2', 'groupId': 'BG005'}, {'value': '8', 'groupId': 'BG006'}]}, {'title': '3a', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '7', 'groupId': 'BG003'}, {'value': '6', 'groupId': 'BG004'}, {'value': '1', 'groupId': 'BG005'}, {'value': '28', 'groupId': 'BG006'}]}, {'title': '4', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '2', 'groupId': 'BG006'}]}, {'title': '4a/4c/4d', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '2', 'groupId': 'BG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'HCV RNA', 'classes': [{'categories': [{'measurements': [{'value': '6.6', 'spread': '0.39', 'groupId': 'BG000'}, {'value': '6.0', 'spread': '0.64', 'groupId': 'BG001'}, {'value': '6.4', 'spread': '0.53', 'groupId': 'BG002'}, {'value': '6.0', 'spread': '0.64', 'groupId': 'BG003'}, {'value': '6.0', 'spread': '0.87', 'groupId': 'BG004'}, {'value': '6.2', 'spread': '0.83', 'groupId': 'BG005'}, {'value': '6.2', 'spread': '0.65', 'groupId': 'BG006'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'log10 IU/mL', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'HCV RNA Category', 'classes': [{'categories': [{'title': '< 800,000 IU/mL', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}, {'value': '4', 'groupId': 'BG004'}, {'value': '4', 'groupId': 'BG005'}, {'value': '28', 'groupId': 'BG006'}]}, {'title': '≥ 800,000 IU/mL', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}, {'value': '9', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}, {'value': '12', 'groupId': 'BG005'}, {'value': '61', 'groupId': 'BG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}], 'populationDescription': 'The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug (voxilaprevir or placebo).'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 101}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-06-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-08', 'completionDateStruct': {'date': '2015-09-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-08-28', 'studyFirstSubmitDate': '2014-07-07', 'resultsFirstSubmitDate': '2020-08-06', 'studyFirstSubmitQcDate': '2014-07-07', 'lastUpdatePostDateStruct': {'date': '2020-09-17', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-08-06', 'studyFirstPostDateStruct': {'date': '2014-07-10', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2020-08-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2014-12-22', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Participants Experiencing Treatment Emergent Adverse Events', 'timeFrame': 'First dose date up to Day 3 plus 30 days'}, {'measure': 'Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities', 'timeFrame': 'First dose date up to Day 3 plus 30 days', 'description': 'Treatment-emergent laboratory abnormalities were defined as values that increase at least one toxicity grade from baseline. The severity of laboratory abnormalities was assessed as Grade 0, 1 (mild), 2 (moderate), 3 (severe), or 4 (potentially life threatening) using the Common Terminology Criteria for Adverse Events (CTCAE), version 4.03. The most severe graded abnormality from all tests was counted for each participant.'}, {'measure': 'Antiviral Activity of Voxilaprevir as Measured by Change From Baseline in Plasma HCV RNA', 'timeFrame': 'Baseline; Days 4, 5, 6, 7, 8, 10, and Week 48', 'description': 'The outcome measure was assessed to evaluate antiviral activity of voxilaprevir only (cohorts 1 through 6). Data are summarized by treatment/cohort and placebo.'}], 'secondaryOutcomes': [{'measure': 'Antiviral Activity of Voxilaprevir as Measured by Absolute HCV RNA Level Through Week 48', 'timeFrame': 'Baseline (Pre Day 1 Dose); Days 4, 5, 6, 7, 8, 10, and Week 48', 'description': 'The outcome measure was assessed to evaluate antiviral activity of voxilaprevir only (cohorts 1 through 6).'}, {'measure': 'Antiviral Activity of Voxilaprevir as Measured by Number of Participants Achieving Reductions From Baseline in HCV RNA', 'timeFrame': 'Baseline; Days 4, 5, 6, 7, 8, 10, and Week 48', 'description': 'Categorical declines from baseline were summarized by the number of participants with a \\< 1, ≥ 1 to \\<2, ≥ 2 to \\<3, or ≥ 3 log10 IU/mL decrease in HCV RNA from baseline to each postdose assessment up to Week 48 by treatment/cohort and placebo. The outcome measure was assessed to evaluate antiviral activity of voxilaprevir only (cohorts 1 through 6).'}, {'measure': 'Percentage of Participants Who Have HCV RNA < Lower Limit of Quantitation (LLOQ) Detected, and < LLOQ Target Not Detected (TND)', 'timeFrame': 'Days 4, 5, 6, 7, 8, 10, and Week 48', 'description': 'The lower limit of quantitation (LLOQ) detection for HCV RNA levels was 15 IU/mL. HCV detected means calculated HCV RNA level is below LLOQ of the assay. The outcome measure was assessed to evaluate antiviral activity of voxilaprevir only (cohorts 1 through 6).'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Sustained Virologic Response', 'Direct Acting Antiviral', 'Combination Therapy', 'Liver Diseases', 'Digestive System Diseases', 'Hepatitis, Viral, Human', 'Enterovirus Infections', 'Picornaviridae Infections', 'RNA Virus Infections', 'Flaviviridae Infections', 'Antiviral Agents', 'Anti-Infective Agents', 'Therapeutic Uses', 'Pharmacologic Actions', 'Antimetabolites', 'Molecular Mechanisms of Pharmacological Action'], 'conditions': ['Hepatitis C Virus Infection']}, 'referencesModule': {'references': [{'type': 'RESULT', 'citation': 'Rodriguez-Torres M, Glass S, Hill J, Freilich B, Hassman D, Di Bisceglie A, Taylor J, Kirby B, Yang J, An D, Stamm L, Brainard D, Kim S, Krefetz D, Smith W, Marbury T, Lawitz E. The Pangenotypic NS3/4A Protease Inhibitor GS-9857 Demonstrates Potent Antiviral Activity in Patients Infected With HCV Genotype 1, 2, 3, or 4 in a 3-Day Monotherapy Study [Poster P0901]. Presented at the European Association for the Study of the Liver (EASL) 50th International Liver Congress 2015, April 22-26, 2015, Vienna, Austria.'}, {'pmid': '29063860', 'type': 'RESULT', 'citation': 'Lawitz E, Yang JC, Stamm LM, Taylor JG, Cheng G, Brainard DM, Miller MD, Mo H, Dvory-Sobol H. Characterization of HCV resistance from a 3-day monotherapy study of voxilaprevir, a novel pangenotypic NS3/4A protease inhibitor. Antivir Ther. 2018;23(4):325-334. doi: 10.3851/IMP3202.'}]}, 'descriptionModule': {'briefSummary': 'The primary objective of the study is to evaluate the safety and tolerability of voxilaprevir (formerly GS-9857) alone or with sofosbuvir (SOF)/velpatasvir (VEL) fixed dose combination (FDC) and antiviral activity of voxilaprevir in adults with genotype 1, 2, 3, 4 hepatitis C virus (HCV) infection. All participants will be monitored for up to 48 weeks after the last dose.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Key Inclusion Criteria:\n\n* Chronic genotype 1-4 HCV infection\n* For Cohorts 1-9, HCV RNA ≥ 100,000 IU/mL at screening (no HCV RNA restriction for Cohort 10)\n* Screening laboratory values within defined thresholds\n* Use of two effective contraception methods if female of childbearing potential or sexually active male\n\nKey Exclusion Criteria:\n\n* Pregnant or nursing female or male with pregnant female partner\n* Presence of cirrhosis\n* Prior exposure to approved or experimental HCV Protease Inhibitors\n* Co-infection with HIV or hepatitis B virus (HBV)\n* Current or prior history of clinical hepatic decompensation\n* Chronic use of systemic immunosuppressive agents\n* History of clinically significant illness or any other medical disorder that may interfere with participant's treatment, assessment or compliance with the protocol\n\nNote: Other protocol defined Inclusion/Exclusion criteria may apply."}, 'identificationModule': {'nctId': 'NCT02185794', 'briefTitle': 'Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Antiviral Activity of Voxilaprevir in Adults With Chronic Hepatitis C Virus Infection', 'organization': {'class': 'INDUSTRY', 'fullName': 'Gilead Sciences'}, 'officialTitle': 'Phase 1b, Randomized, Double-Blind, Multiple-Dose Ranging Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Antiviral Activity of GS-9857 in Subjects With Chronic Hepatitis C Virus Infection', 'orgStudyIdInfo': {'id': 'GS-US-338-1121'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo (GT 1a, Cohort 1)', 'description': 'Participants with genotype (GT) 1a HCV infection will receive placebo once daily for 3 days under fasted conditions.', 'interventionNames': ['Drug: Placebo to match voxilaprevir']}, {'type': 'EXPERIMENTAL', 'label': 'Voxilaprevir 50 mg (GT 1a, Cohort 1)', 'description': 'Participants with GT 1a HCV infection will receive voxilaprevir 50 mg once daily for 3 days under fasted conditions.', 'interventionNames': ['Drug: Voxilaprevir']}, {'type': 'EXPERIMENTAL', 'label': 'Voxilaprevir 100 mg (GT 1a, Cohort 1)', 'description': 'Participants with GT 1a HCV infection will receive voxilaprevir 100 mg once daily for 3 days under fasted conditions.', 'interventionNames': ['Drug: Voxilaprevir']}, {'type': 'EXPERIMENTAL', 'label': 'Voxilaprevir 300 mg (GT 1a, Cohort 1)', 'description': 'Participants with GT 1a HCV infection will receive voxilaprevir 300 mg once daily for 3 days under fasted conditions.', 'interventionNames': ['Drug: Voxilaprevir']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo (GT 3, Cohort 2)', 'description': 'Participants with GT 3 HCV infection will receive placebo once daily for 3 days under fasted conditions.', 'interventionNames': ['Drug: Placebo to match voxilaprevir']}, {'type': 'EXPERIMENTAL', 'label': 'Voxilaprevir 50 mg (GT 3, Cohort 2)', 'description': 'Participants with GT 3 HCV infection will receive voxilaprevir 50 mg once daily for 3 days under fasted conditions.', 'interventionNames': ['Drug: Voxilaprevir']}, {'type': 'EXPERIMENTAL', 'label': 'Voxilaprevir 100 mg (GT 3, Cohort 2)', 'description': 'Participants with GT 3 HCV infection will receive voxilaprevir 100 mg once daily for 3 days under fasted conditions.', 'interventionNames': ['Drug: Voxilaprevir']}, {'type': 'EXPERIMENTAL', 'label': 'Voxilaprevir 300 mg (GT 3, Cohort 2)', 'description': 'Participants with GT 3 HCV infection will receive voxilaprevir 300 mg once daily for 3 days under fasted conditions.', 'interventionNames': ['Drug: Voxilaprevir']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo (GT 2, Cohort 3)', 'description': 'Participants with GT 2 HCV infection will receive placebo once daily for 3 days under fasted conditions.', 'interventionNames': ['Drug: Placebo to match voxilaprevir']}, {'type': 'EXPERIMENTAL', 'label': 'Voxilaprevir 100 mg (GT 2, Cohort 3)', 'description': 'Participants with GT 2 HCV infection will receive voxilaprevir 100 mg once daily for 3 days under fasted conditions.', 'interventionNames': ['Drug: Voxilaprevir']}, {'type': 'EXPERIMENTAL', 'label': 'Voxilaprevir 100 mg (GT 4, Cohort 4)', 'description': 'Participants with GT 4 HCV infection will receive voxilaprevir 100 mg once daily for 3 days under fasted conditions.', 'interventionNames': ['Drug: Voxilaprevir']}, {'type': 'EXPERIMENTAL', 'label': 'Voxilaprevir 100 mg (GT 1b, Cohort 5)', 'description': 'Participants with GT 1b HCV infection will receive voxilaprevir 100 mg once daily for 3 days under fasted conditions.', 'interventionNames': ['Drug: Voxilaprevir']}, {'type': 'EXPERIMENTAL', 'label': 'Voxilaprevir 100 mg Fed (GT 3a, Cohort 6)', 'description': 'Participants with GT 3a HCV infection will receive voxilaprevir 100 mg once daily for 3 days under fed conditions.', 'interventionNames': ['Drug: Voxilaprevir']}, {'type': 'EXPERIMENTAL', 'label': 'Voxilaprevir 600 mg (Cohorts 7-9)', 'description': 'Participants with genotypes 1a, 1b, 2, 3, or 4 HCV infection will receive voxilaprevir up to 600 mg under fasted or fed conditions for 3 days.', 'interventionNames': ['Drug: Voxilaprevir']}, {'type': 'EXPERIMENTAL', 'label': 'Voxilaprevir 100 mg + SOF/VEL 400/100 mg (Group 1, Cohort 10)', 'description': 'Participants with any GT HCV infection received voxilaprevir 100 mg on Day 1 after moderate fat meal and voxilaprevir 100 mg plus sofosbuvir (SOF)/velpatasvir (VEL) (400/100 mg) fixed-dose combination (FDC)on Days 2 and 3 after either a light or moderate-fat meal.', 'interventionNames': ['Drug: Voxilaprevir', 'Drug: SOF/VEL']}, {'type': 'EXPERIMENTAL', 'label': 'Voxilaprevir 100 mg + SOF/VEL 400/100 mg (Group 2, Cohort 10)', 'description': 'Participants with any GT HCV infection received voxilaprevir 100 mg on Day 1 and voxilaprevir 100 mg plus SOF/VEL (400/100 mg) FDC on Days 2 and 3 after moderate fat meal.', 'interventionNames': ['Drug: Voxilaprevir', 'Drug: SOF/VEL']}], 'interventions': [{'name': 'Voxilaprevir', 'type': 'DRUG', 'otherNames': ['GS-9857'], 'description': 'Voxilaprevir tablets administered orally once daily', 'armGroupLabels': ['Voxilaprevir 100 mg (GT 1a, Cohort 1)', 'Voxilaprevir 100 mg (GT 1b, Cohort 5)', 'Voxilaprevir 100 mg (GT 2, Cohort 3)', 'Voxilaprevir 100 mg (GT 3, Cohort 2)', 'Voxilaprevir 100 mg (GT 4, Cohort 4)', 'Voxilaprevir 100 mg + SOF/VEL 400/100 mg (Group 1, Cohort 10)', 'Voxilaprevir 100 mg + SOF/VEL 400/100 mg (Group 2, Cohort 10)', 'Voxilaprevir 100 mg Fed (GT 3a, Cohort 6)', 'Voxilaprevir 300 mg (GT 1a, Cohort 1)', 'Voxilaprevir 300 mg (GT 3, Cohort 2)', 'Voxilaprevir 50 mg (GT 1a, Cohort 1)', 'Voxilaprevir 50 mg (GT 3, Cohort 2)', 'Voxilaprevir 600 mg (Cohorts 7-9)']}, {'name': 'Placebo to match voxilaprevir', 'type': 'DRUG', 'description': 'Placebo to match voxilaprevir tablets administered orally once daily', 'armGroupLabels': ['Placebo (GT 1a, Cohort 1)', 'Placebo (GT 2, Cohort 3)', 'Placebo (GT 3, Cohort 2)']}, {'name': 'SOF/VEL', 'type': 'DRUG', 'description': '400 mg/100 mg FDC tablet administered orally once daily', 'armGroupLabels': ['Voxilaprevir 100 mg + SOF/VEL 400/100 mg (Group 1, Cohort 10)', 'Voxilaprevir 100 mg + SOF/VEL 400/100 mg (Group 2, Cohort 10)']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Costa Mesa', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 33.64113, 'lon': -117.91867}}, {'city': 'DeLand', 'state': 'Florida', 'country': 'United States', 'geoPoint': {'lat': 29.02832, 'lon': -81.30312}}, {'city': 'Orlando', 'state': 'Florida', 'country': 'United States', 'geoPoint': {'lat': 28.53834, 'lon': -81.37924}}, {'city': 'Kansas City', 'state': 'Missouri', 'country': 'United States', 'geoPoint': {'lat': 39.09973, 'lon': -94.57857}}, {'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'city': 'Berlin', 'state': 'New Jersey', 'country': 'United States', 'geoPoint': {'lat': 39.79123, 'lon': -74.92905}}, {'city': 'Marlton', 'state': 'New Jersey', 'country': 'United States', 'geoPoint': {'lat': 39.89122, 'lon': -74.92183}}, {'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'city': 'Knoxville', 'state': 'Tennessee', 'country': 'United States', 'geoPoint': {'lat': 35.96064, 'lon': -83.92074}}, {'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'city': 'San Juan', 'country': 'Puerto Rico', 'geoPoint': {'lat': 18.46633, 'lon': -66.10572}}], 'overallOfficials': [{'name': 'Gilead Study Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Gilead Sciences'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Gilead Sciences', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}