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Main Search Make This Study a Gene Therapy Make This Study a Not Gene Therapy Report Bug

Ignite Creation Date: 2025-12-24 @ 5:10 PM

Ignite Modification Date: 2025-12-27 @ 10:42 PM

Study NCT ID: NCT01260350

Status: COMPLETED

Last Update Posted: 2014-11-17

First Post: 2010-12-13

Is NOT Gene Therapy: True

Has Adverse Events: True

Brief Title: Open-Labeled Study of PSI-7977 and RBV With and Without PEG-IFN in Treatment-Naïve Patients With HCV GT2 or GT3

Sponsor:

Organization:

Overview Dates Organization Conditions Design Enrollment Locations Outcomes Modules Raw JSON

Raw JSON

{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006505', 'term': 'Hepatitis'}, {'id': 'D006467', 'term': 'Hemophilia A'}], 'ancestors': [{'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D025861', 'term': 'Blood Coagulation Disorders, Inherited'}, {'id': 'D001778', 'term': 'Blood Coagulation Disorders'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D020147', 'term': 'Coagulation Protein Disorders'}, {'id': 'D006474', 'term': 'Hemorrhagic Disorders'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069474', 'term': 'Sofosbuvir'}, {'id': 'D012254', 'term': 'Ribavirin'}, {'id': 'C100416', 'term': 'peginterferon alfa-2a'}, {'id': 'C586541', 'term': 'ledipasvir'}, {'id': 'C582393', 'term': 'GS-9669'}, {'id': 'C000595958', 'term': 'ledipasvir, sofosbuvir drug combination'}], 'ancestors': [{'id': 'D014542', 'term': 'Uridine Monophosphate'}, {'id': 'D014500', 'term': 'Uracil Nucleotides'}, {'id': 'D011742', 'term': 'Pyrimidine Nucleotides'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D009711', 'term': 'Nucleotides'}, {'id': 'D009706', 'term': 'Nucleic Acids, Nucleotides, and Nucleosides'}, {'id': 'D012265', 'term': 'Ribonucleotides'}, {'id': 'D012263', 'term': 'Ribonucleosides'}, {'id': 'D009705', 'term': 'Nucleosides'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTrialDisclosures@gilead.com', 'title': 'Clinical Trial Disclosures', 'organization': 'Gilead Sciences, Inc.'}, 'certainAgreement': {'otherDetails': 'After conclusion of the study and without prior written approval from Gilead, investigators in this study may communicate, orally present, or publish in scientific journals or other media only after the following conditions have been met:\n\n* The results of the study in their entirety have been publicly disclosed by or with the consent of Gilead in an abstract, manuscript, or presentation form; or\n* The study has been completed at all study sites for at least 2 years', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Up to 12 weeks plus 30 days.', 'description': 'Adverse events are included up to the last dose date of any study drug + 30 days.', 'eventGroups': [{'id': 'EG000', 'title': 'Group 1: SOF+RBV 12 wk: GT 2 or 3, TN', 'description': 'SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-naive (TN) participants with genotype (GT) 2 or 3 HCV infection', 'otherNumAtRisk': 10, 'otherNumAffected': 10, 'seriousNumAtRisk': 10, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'Group 2: SOF+RBV 12 wk +PEG 4 wk: GT 2 or 3, TN', 'description': 'SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks plus PEG 180 µg once weekly for 4 weeks in treatment-naive participants with genotype 2 or 3 HCV infection', 'otherNumAtRisk': 9, 'otherNumAffected': 9, 'seriousNumAtRisk': 9, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Group 3: SOF+RBV 12 wk+PEG 8 wk: GT 2 or 3, TN', 'description': 'SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks plus PEG 180 µg once weekly for 8 weeks in treatment-naive participants with genotype 2 or 3 HCV infection', 'otherNumAtRisk': 10, 'otherNumAffected': 10, 'seriousNumAtRisk': 10, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Group 4: SOF+RBV+PEG 12 wk: GT 2 or 3, TN', 'description': 'SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus PEG 180 µg once weekly for 12 weeks in treatment-naive participants with genotype 2 or 3 HCV infection', 'otherNumAtRisk': 11, 'otherNumAffected': 11, 'seriousNumAtRisk': 11, 'seriousNumAffected': 0}, {'id': 'EG004', 'title': 'Group 5: SOF 12 wk: GT 2 or 3, TN', 'description': 'SOF 400 mg once daily for 12 weeks in treatment-naive participants with genotype 2 or 3 HCV infection', 'otherNumAtRisk': 10, 'otherNumAffected': 10, 'seriousNumAtRisk': 10, 'seriousNumAffected': 0}, {'id': 'EG005', 'title': 'Group 6: SOF+RBV+PEG 8 wk: GT 2 or 3, TN', 'description': 'SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus PEG 180 µg once weekly for 8 weeks in treatment-naive participants with genotype 2 or 3 HCV infection', 'otherNumAtRisk': 10, 'otherNumAffected': 10, 'seriousNumAtRisk': 10, 'seriousNumAffected': 1}, {'id': 'EG006', 'title': 'Group 7: SOF+RBV 12 wk: GT 1, TE', 'description': 'SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-experienced (TE) participants with genotype 1 HCV infection who did not respond to prior treatment', 'otherNumAtRisk': 10, 'otherNumAffected': 10, 'seriousNumAtRisk': 10, 'seriousNumAffected': 0}, {'id': 'EG007', 'title': 'Group 8: SOF+RBV 12 wk: GT 1, TN', 'description': 'SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-naive participants with genotype 1 HCV infection', 'otherNumAtRisk': 25, 'otherNumAffected': 25, 'seriousNumAtRisk': 25, 'seriousNumAffected': 1}, {'id': 'EG008', 'title': 'Group 9: SOF+RBV 12 wk: GT 2 or 3, TE', 'description': 'SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-experienced participants with genotype 2 or 3 HCV infection', 'otherNumAtRisk': 25, 'otherNumAffected': 24, 'seriousNumAtRisk': 25, 'seriousNumAffected': 0}, {'id': 'EG009', 'title': 'Group 10: SOF+RBV 8 wk: GT 2 or 3, TN', 'description': 'SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 8 weeks in treatment-naive participants with genotype 2 or 3 HCV infection', 'otherNumAtRisk': 25, 'otherNumAffected': 25, 'seriousNumAtRisk': 25, 'seriousNumAffected': 2}, {'id': 'EG010', 'title': 'Group 11: SOF+RBV 12 wk: GT 2 or 3, TN', 'description': 'SOF 400 mg once daily plus split-dose RBV (800 mg in a divided daily dose) for 12 weeks in treatment-naive participants with genotype 2 or 3 HCV infection', 'otherNumAtRisk': 10, 'otherNumAffected': 10, 'seriousNumAtRisk': 10, 'seriousNumAffected': 0}, {'id': 'EG011', 'title': 'Group 12: SOF+RBV+LDV 12 wk: GT 1, TE', 'description': 'SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus LDV 90 mg once daily for 12 weeks in treatment-experienced participants with genotype 1 HCV infection who did not respond to prior treatment', 'otherNumAtRisk': 9, 'otherNumAffected': 9, 'seriousNumAtRisk': 9, 'seriousNumAffected': 0}, {'id': 'EG012', 'title': 'Group 13: SOF+RBV+LDV 12 wk: GT 1, TN', 'description': 'SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus LDV 90 mg once daily for 12 weeks in treatment-naive participants with genotype 1 HCV infection', 'otherNumAtRisk': 25, 'otherNumAffected': 24, 'seriousNumAtRisk': 25, 'seriousNumAffected': 2}, {'id': 'EG013', 'title': 'Group 14: SOF+RBV+GS-9669 12 wk: GT 1, TE', 'description': 'SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus GS-9669 500 mg once daily for 12 weeks in treatment-experienced participants with genotype 1 HCV infection who did not respond to prior treatment', 'otherNumAtRisk': 10, 'otherNumAffected': 10, 'seriousNumAtRisk': 10, 'seriousNumAffected': 0}, {'id': 'EG014', 'title': 'Group 15: SOF+RBV+GS-9669 12 wk: GT 1, TN', 'description': 'SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus GS-9669 500 mg once daily for 12 weeks in treatment-naive participants with genotype 1 HCV infection', 'otherNumAtRisk': 25, 'otherNumAffected': 25, 'seriousNumAtRisk': 25, 'seriousNumAffected': 0}, {'id': 'EG015', 'title': 'Group 16: LDV/SOF FDC 12 wk: GT 1, Fibrosis', 'description': 'LDV 90 mg/SOF 400 mg FDC once daily for 12 weeks in treatment-experienced participants with genotype 1 HCV infection with Stage F4 fibrosis who did not respond to prior treatment', 'otherNumAtRisk': 10, 'otherNumAffected': 7, 'seriousNumAtRisk': 10, 'seriousNumAffected': 0}, {'id': 'EG016', 'title': 'Group 17: LDV/SOF FDC+RBV 12 wk: GT 1, Fibrosis', 'description': 'LDV 90 mg/SOF 400 mg FDC once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-experienced participants with genotype 1 HCV infection with Stage F4 fibrosis who did not respond to prior treatment', 'otherNumAtRisk': 9, 'otherNumAffected': 8, 'seriousNumAtRisk': 9, 'seriousNumAffected': 0}, {'id': 'EG017', 'title': 'Group 18: LDV/SOF FDC 12 wk: GT 2 or 3, TN', 'description': 'LDV 90 mg/SOF 400 mg FDC once daily for 12 weeks in treatment-naive participants with genotype 2 or 3 HCV infection', 'otherNumAtRisk': 10, 'otherNumAffected': 7, 'seriousNumAtRisk': 10, 'seriousNumAffected': 0}, {'id': 'EG018', 'title': 'Group 20: LDV/SOF FDC+RBV 12 wk: GT 1, Hemophiliac', 'description': 'LDV 90 mg/SOF 400 mg FDC once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in hemophiliac participants with genotype 1 HCV infection', 'otherNumAtRisk': 14, 'otherNumAffected': 13, 'seriousNumAtRisk': 14, 'seriousNumAffected': 2}, {'id': 'EG019', 'title': 'Group 21: LDV/SOF FDC+RBV 6 wk: GT 1, TN', 'description': 'LDV 90 mg/SOF 400 mg FDC once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 6 weeks in treatment-naive participants with genotype 1 HCV infection', 'otherNumAtRisk': 25, 'otherNumAffected': 22, 'seriousNumAtRisk': 25, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 11, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 10, 'numAffected': 3}, {'groupId': 'EG006', 'numAtRisk': 10, 'numAffected': 2}, {'groupId': 'EG007', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG010', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 25, 'numAffected': 3}, {'groupId': 'EG013', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG015', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG016', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG017', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG018', 'numAtRisk': 14, 'numAffected': 2}, {'groupId': 'EG019', 'numAtRisk': 25, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Haemolytic anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 11, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 25, 'numAffected': 5}, {'groupId': 'EG008', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 25, 'numAffected': 2}, {'groupId': 'EG010', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 25, 'numAffected': 3}, {'groupId': 'EG013', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 25, 'numAffected': 3}, {'groupId': 'EG015', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG016', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG017', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG018', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG019', 'numAtRisk': 25, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Iron deficiency anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG015', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG016', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG017', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG018', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG019', 'numAtRisk': 25, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Lymphadenopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 25, 'numAffected': 2}, {'groupId': 'EG015', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG016', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG017', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG018', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG019', 'numAtRisk': 25, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 11, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG015', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG016', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG017', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG018', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG019', 'numAtRisk': 25, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Palpitations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 25, 'numAffected': 2}, {'groupId': 'EG013', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG015', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG016', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG017', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG018', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG019', 'numAtRisk': 25, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Ear discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG015', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG016', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG017', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG018', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG019', 'numAtRisk': 25, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Eustachian tube obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG015', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG016', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG017', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG018', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG019', 'numAtRisk': 25, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Tinnitus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG008', 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'EG017', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG018', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG019', 'numAtRisk': 25, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Pulmonary embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG010', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG015', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG016', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG017', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG018', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG019', 'numAtRisk': 25, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Participants Who Experienced Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '11', 'groupId': 'OG003'}, {'value': '10', 'groupId': 'OG004'}, {'value': '10', 'groupId': 'OG005'}, {'value': '10', 'groupId': 'OG006'}, {'value': '25', 'groupId': 'OG007'}, {'value': '25', 'groupId': 'OG008'}, {'value': '25', 'groupId': 'OG009'}, {'value': '10', 'groupId': 'OG010'}, {'value': '9', 'groupId': 'OG011'}, {'value': '25', 'groupId': 'OG012'}, {'value': '10', 'groupId': 'OG013'}, {'value': '25', 'groupId': 'OG014'}, {'value': '10', 'groupId': 'OG015'}, {'value': '9', 'groupId': 'OG016'}, {'value': '10', 'groupId': 'OG017'}, {'value': '14', 'groupId': 'OG018'}, {'value': '25', 'groupId': 'OG019'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1: SOF+RBV 12 wk: GT 2 or 3, TN', 'description': 'SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-naive (TN) participants with genotype (GT) 2 or 3 HCV infection'}, {'id': 'OG001', 'title': 'Group 2: SOF+RBV 12 wk +PEG 4 wk: GT 2 or 3, TN', 'description': 'SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks plus PEG 180 µg once weekly for 4 weeks in treatment-naive participants with genotype 2 or 3 HCV infection'}, {'id': 'OG002', 'title': 'Group 3: SOF+RBV 12 wk+PEG 8 wk: GT 2 or 3, TN', 'description': 'SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks plus PEG 180 µg once weekly for 8 weeks in treatment-naive participants with genotype 2 or 3 HCV infection'}, {'id': 'OG003', 'title': 'Group 4: SOF+RBV+PEG 12 wk: GT 2 or 3, TN', 'description': 'SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus PEG 180 µg once weekly for 12 weeks in treatment-naive participants with genotype 2 or 3 HCV infection'}, {'id': 'OG004', 'title': 'Group 5: SOF 12 wk: GT 2 or 3, TN', 'description': 'SOF 400 mg once daily for 12 weeks in treatment-naive participants with genotype 2 or 3 HCV infection'}, {'id': 'OG005', 'title': 'Group 6: SOF+RBV+PEG 8 wk: GT 2 or 3, TN', 'description': 'SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus PEG 180 µg once weekly for 8 weeks in treatment-naive participants with genotype 2 or 3 HCV infection'}, {'id': 'OG006', 'title': 'Group 7: SOF+RBV 12 wk: GT 1, TE', 'description': 'SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-experienced (TE) participants with genotype 1 HCV infection who did not respond to prior treatment'}, {'id': 'OG007', 'title': 'Group 8: SOF+RBV 12 wk: GT 1, TN', 'description': 'SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-naive participants with genotype 1 HCV infection'}, {'id': 'OG008', 'title': 'Group 9: SOF+RBV 12 wk: GT 2 or 3, TE', 'description': 'SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-experienced participants with genotype 2 or 3 HCV infection'}, {'id': 'OG009', 'title': 'Group 10: SOF+RBV 8 wk: GT 2 or 3, TN', 'description': 'SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 8 weeks in treatment-naive participants with genotype 2 or 3 HCV infection'}, {'id': 'OG010', 'title': 'Group 11: SOF+RBV 12 wk: GT 2 or 3, TN', 'description': 'SOF 400 mg once daily plus split-dose RBV (800 mg in a divided daily dose) for 12 weeks in treatment-naive participants with genotype 2 or 3 HCV infection'}, {'id': 'OG011', 'title': 'Group 12: SOF+RBV+LDV 12 wk: GT 1, TE', 'description': 'SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus LDV 90 mg once daily for 12 weeks in treatment-experienced participants with genotype 1 HCV infection who did not respond to prior treatment'}, {'id': 'OG012', 'title': 'Group 13: SOF+RBV+LDV 12 wk: GT 1, TN', 'description': 'SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus LDV 90 mg once daily for 12 weeks in treatment-naive participants with genotype 1 HCV infection'}, {'id': 'OG013', 'title': 'Group 14: SOF+RBV+GS-9669 12 wk: GT 1, TE', 'description': 'SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus GS-9669 500 mg once daily for 12 weeks in treatment-experienced participants with genotype 1 HCV infection who did not respond to prior treatment'}, {'id': 'OG014', 'title': 'Group 15: SOF+RBV+GS-9669 12 wk: GT 1, TN', 'description': 'SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus GS-9669 500 mg once daily for 12 weeks in treatment-naive participants with genotype 1 HCV infection'}, {'id': 'OG015', 'title': 'Group 16: LDV/SOF FDC 12 wk: GT 1, Fibrosis', 'description': 'LDV 90 mg/SOF 400 mg FDC once daily for 12 weeks in treatment-experienced participants with genotype 1 HCV infection with Stage F4 fibrosis who did not respond to prior treatment'}, {'id': 'OG016', 'title': 'Group 17: LDV/SOF FDC+RBV 12 wk: GT 1, Fibrosis', 'description': 'LDV 90 mg/SOF 400 mg FDC once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-experienced participants with genotype 1 HCV infection with Stage F4 fibrosis who did not respond to prior treatment'}, {'id': 'OG017', 'title': 'Group 18: LDV/SOF FDC 12 wk: GT 2 or 3, TN', 'description': 'LDV 90 mg/SOF 400 mg FDC once daily for 12 weeks in treatment-naive participants with genotype 2 or 3 HCV infection'}, {'id': 'OG018', 'title': 'Group 20: LDV/SOF FDC+RBV 12 wk: GT 1, Hemophiliac', 'description': 'LDV 90 mg/SOF 400 mg FDC once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in hemophiliac participants with genotype 1 HCV infection'}, {'id': 'OG019', 'title': 'Group 21: LDV/SOF FDC+RBV 6 wk: GT 1, TN', 'description': 'LDV 90 mg/SOF 400 mg FDC once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 6 weeks in treatment-naive participants with genotype 1 HCV infection'}], 'classes': [{'title': 'Any AE', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '11', 'groupId': 'OG003'}, {'value': '10', 'groupId': 'OG004'}, {'value': '10', 'groupId': 'OG005'}, {'value': '10', 'groupId': 'OG006'}, {'value': '25', 'groupId': 'OG007'}, {'value': '24', 'groupId': 'OG008'}, {'value': '25', 'groupId': 'OG009'}, {'value': '10', 'groupId': 'OG010'}, {'value': '9', 'groupId': 'OG011'}, {'value': '24', 'groupId': 'OG012'}, {'value': '10', 'groupId': 'OG013'}, {'value': '25', 'groupId': 'OG014'}, {'value': '7', 'groupId': 'OG015'}, {'value': '8', 'groupId': 'OG016'}, {'value': '7', 'groupId': 'OG017'}, {'value': '13', 'groupId': 'OG018'}, {'value': '22', 'groupId': 'OG019'}]}]}, {'title': 'Drug-related AE', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '11', 'groupId': 'OG003'}, {'value': '7', 'groupId': 'OG004'}, {'value': '10', 'groupId': 'OG005'}, {'value': '10', 'groupId': 'OG006'}, {'value': '25', 'groupId': 'OG007'}, {'value': '20', 'groupId': 'OG008'}, {'value': '21', 'groupId': 'OG009'}, {'value': '7', 'groupId': 'OG010'}, {'value': '9', 'groupId': 'OG011'}, {'value': '24', 'groupId': 'OG012'}, {'value': '10', 'groupId': 'OG013'}, {'value': '21', 'groupId': 'OG014'}, {'value': '5', 'groupId': 'OG015'}, {'value': '8', 'groupId': 'OG016'}, {'value': '6', 'groupId': 'OG017'}, {'value': '12', 'groupId': 'OG018'}, {'value': '19', 'groupId': 'OG019'}]}]}, {'title': 'Grade 3 or higher AE', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '1', 'groupId': 'OG009'}, {'value': '0', 'groupId': 'OG010'}, {'value': '0', 'groupId': 'OG011'}, {'value': '3', 'groupId': 'OG012'}, {'value': '0', 'groupId': 'OG013'}, {'value': '2', 'groupId': 'OG014'}, {'value': '0', 'groupId': 'OG015'}, {'value': '1', 'groupId': 'OG016'}, {'value': '0', 'groupId': 'OG017'}, {'value': '1', 'groupId': 'OG018'}, {'value': '0', 'groupId': 'OG019'}]}]}, {'title': 'AE leading to drug discontinuation', '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': '1', 'groupId': 'OG012'}, {'value': '0', 'groupId': 'OG013'}, {'value': '0', 'groupId': 'OG014'}, {'value': '0', 'groupId': 'OG015'}, {'value': '0', 'groupId': 'OG016'}, {'value': '0', 'groupId': 'OG017'}, {'value': '3', 'groupId': 'OG018'}, {'value': '2', 'groupId': 'OG019'}]}]}, {'title': 'Serious AE', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '2', 'groupId': 'OG009'}, {'value': '0', 'groupId': 'OG010'}, {'value': '0', 'groupId': 'OG011'}, {'value': '2', 'groupId': 'OG012'}, {'value': '0', 'groupId': 'OG013'}, {'value': '0', 'groupId': 'OG014'}, {'value': '0', 'groupId': 'OG015'}, {'value': '0', 'groupId': 'OG016'}, {'value': '0', 'groupId': 'OG017'}, {'value': '2', 'groupId': 'OG018'}, {'value': '0', 'groupId': 'OG019'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 12 weeks plus 30 days', 'description': 'Adverse events (AEs) occurring from baseline (Day 1 for all groups) to 30 days following the last dose of study drug were summarized across the participant population. A participant was counted once if they had a qualifying event.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Analysis Set: participants were randomized and received at least one dose of study medication.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Sustained Virologic Response 12 Weeks Following Completion of Treatment (SVR12)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '11', 'groupId': 'OG003'}, {'value': '10', 'groupId': 'OG004'}, {'value': '10', 'groupId': 'OG005'}, {'value': '10', 'groupId': 'OG006'}, {'value': '25', 'groupId': 'OG007'}, {'value': '25', 'groupId': 'OG008'}, {'value': '25', 'groupId': 'OG009'}, {'value': '10', 'groupId': 'OG010'}, {'value': '9', 'groupId': 'OG011'}, {'value': '25', 'groupId': 'OG012'}, {'value': '10', 'groupId': 'OG013'}, {'value': '25', 'groupId': 'OG014'}, {'value': '10', 'groupId': 'OG015'}, {'value': '9', 'groupId': 'OG016'}, {'value': '10', 'groupId': 'OG017'}, {'value': '14', 'groupId': 'OG018'}, {'value': '25', 'groupId': 'OG019'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1: SOF+RBV 12 wk: GT 2 or 3, TN', 'description': 'SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-naive (TN) participants with genotype (GT) 2 or 3 HCV infection'}, {'id': 'OG001', 'title': 'Group 2: SOF+RBV 12 wk +PEG 4 wk: GT 2 or 3, TN', 'description': 'SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks plus PEG 180 µg once weekly for 4 weeks in treatment-naive participants with genotype 2 or 3 HCV infection'}, {'id': 'OG002', 'title': 'Group 3: SOF+RBV 12 wk+PEG 8 wk: GT 2 or 3, TN', 'description': 'SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks plus PEG 180 µg once weekly for 8 weeks in treatment-naive participants with genotype 2 or 3 HCV infection'}, {'id': 'OG003', 'title': 'Group 4: SOF+RBV+PEG 12 wk: GT 2 or 3, TN', 'description': 'SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus PEG 180 µg once weekly for 12 weeks in treatment-naive participants with genotype 2 or 3 HCV infection'}, {'id': 'OG004', 'title': 'Group 5: SOF 12 wk: GT 2 or 3, TN', 'description': 'SOF 400 mg once daily for 12 weeks in treatment-naive participants with genotype 2 or 3 HCV infection'}, {'id': 'OG005', 'title': 'Group 6: SOF+RBV+PEG 8 wk: GT 2 or 3, TN', 'description': 'SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus PEG 180 µg once weekly for 8 weeks in treatment-naive participants with genotype 2 or 3 HCV infection'}, {'id': 'OG006', 'title': 'Group 7: SOF+RBV 12 wk: GT 1, TE', 'description': 'SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-experienced (TE) participants with genotype 1 HCV infection who did not respond to prior treatment'}, {'id': 'OG007', 'title': 'Group 8: SOF+RBV 12 wk: GT 1, TN', 'description': 'SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-naive participants with genotype 1 HCV infection'}, {'id': 'OG008', 'title': 'Group 9: SOF+RBV 12 wk: GT 2 or 3, TE', 'description': 'SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-experienced participants with genotype 2 or 3 HCV infection'}, {'id': 'OG009', 'title': 'Group 10: SOF+RBV 8 wk: GT 2 or 3, TN', 'description': 'SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 8 weeks in treatment-naive participants with genotype 2 or 3 HCV infection'}, {'id': 'OG010', 'title': 'Group 11: SOF+RBV 12 wk: GT 2 or 3, TN', 'description': 'SOF 400 mg once daily plus split-dose RBV (800 mg in a divided daily dose) for 12 weeks in treatment-naive participants with genotype 2 or 3 HCV infection'}, {'id': 'OG011', 'title': 'Group 12: SOF+RBV+LDV 12 wk: GT 1, TE', 'description': 'SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus LDV 90 mg once daily for 12 weeks in treatment-experienced participants with genotype 1 HCV infection who did not respond to prior treatment'}, {'id': 'OG012', 'title': 'Group 13: SOF+RBV+LDV 12 wk: GT 1, TN', 'description': 'SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus LDV 90 mg once daily for 12 weeks in treatment-naive participants with genotype 1 HCV infection'}, {'id': 'OG013', 'title': 'Group 14: SOF+RBV+GS-9669 12 wk: GT 1, TE', 'description': 'SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus GS-9669 500 mg once daily for 12 weeks in treatment-experienced participants with genotype 1 HCV infection who did not respond to prior treatment'}, {'id': 'OG014', 'title': 'Group 15: SOF+RBV+GS-9669 12 wk: GT 1, TN', 'description': 'SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus GS-9669 500 mg once daily for 12 weeks in treatment-naive participants with genotype 1 HCV infection'}, {'id': 'OG015', 'title': 'Group 16: LDV/SOF FDC 12 wk: GT 1, Fibrosis', 'description': 'LDV 90 mg/SOF 400 mg FDC once daily for 12 weeks in treatment-experienced participants with genotype 1 HCV infection with Stage F4 fibrosis who did not respond to prior treatment'}, {'id': 'OG016', 'title': 'Group 17: LDV/SOF FDC+RBV 12 wk: GT 1, Fibrosis', 'description': 'LDV 90 mg/SOF 400 mg FDC once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-experienced participants with genotype 1 HCV infection with Stage F4 fibrosis who did not respond to prior treatment'}, {'id': 'OG017', 'title': 'Group 18: LDV/SOF FDC 12 wk: GT 2 or 3, TN', 'description': 'LDV 90 mg/SOF 400 mg FDC once daily for 12 weeks in treatment-naive participants with genotype 2 or 3 HCV infection'}, {'id': 'OG018', 'title': 'Group 20: LDV/SOF FDC+RBV 12 wk: GT 1, Hemophiliac', 'description': 'LDV 90 mg/SOF 400 mg FDC once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in hemophiliac participants with genotype 1 HCV infection'}, {'id': 'OG019', 'title': 'Group 21: LDV/SOF FDC+RBV 6 wk: GT 1, TN', 'description': 'LDV 90 mg/SOF 400 mg FDC once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 6 weeks in treatment-naive participants with genotype 1 HCV infection'}], 'classes': [{'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000', 'lowerLimit': '69.2', 'upperLimit': '100.0'}, {'value': '100.0', 'groupId': 'OG001', 'lowerLimit': '66.4', 'upperLimit': '100.0'}, {'value': '100.0', 'groupId': 'OG002', 'lowerLimit': '69.2', 'upperLimit': '100.0'}, {'value': '100.0', 'groupId': 'OG003', 'lowerLimit': '71.5', 'upperLimit': '100.0'}, {'value': '60.0', 'groupId': 'OG004', 'lowerLimit': '26.2', 'upperLimit': '87.8'}, {'value': '100.0', 'groupId': 'OG005', 'lowerLimit': '69.2', 'upperLimit': '100.0'}, {'value': '10.0', 'groupId': 'OG006', 'lowerLimit': '0.3', 'upperLimit': '44.5'}, {'value': '84.0', 'groupId': 'OG007', 'lowerLimit': '63.9', 'upperLimit': '9'}, {'value': '68.0', 'groupId': 'OG008'}, {'value': '64.0', 'groupId': 'OG009', 'lowerLimit': '42.5', 'upperLimit': '82.0'}, {'value': '60.0', 'groupId': 'OG010', 'lowerLimit': '26.2', 'upperLimit': '87.8'}, {'value': '100.0', 'groupId': 'OG011', 'lowerLimit': '66.4', 'upperLimit': '100.0'}, {'value': '100.0', 'groupId': 'OG012', 'lowerLimit': '86.3', 'upperLimit': '100.0'}, {'value': '100.0', 'groupId': 'OG013', 'lowerLimit': '69.2', 'upperLimit': '100.0'}, {'value': '92.0', 'groupId': 'OG014', 'lowerLimit': '74.0', 'upperLimit': '99.0'}, {'value': '70.0', 'groupId': 'OG015'}, {'value': '100.0', 'groupId': 'OG016'}, {'value': '80.0', 'groupId': 'OG017'}, {'value': '100.0', 'groupId': 'OG018'}, {'value': '68.0', 'groupId': 'OG019'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Posttreatment Week 12', 'description': 'SVR12 was defined as HCV RNA \\< the limit of detection (LOD; \\< 15 IU/mL) 12 weeks after the last dose of study drug.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Analysis Set'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With HCV RNA < LOD at Week 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '11', 'groupId': 'OG003'}, {'value': '10', 'groupId': 'OG004'}, {'value': '10', 'groupId': 'OG005'}, {'value': '10', 'groupId': 'OG006'}, {'value': '25', 'groupId': 'OG007'}, {'value': '25', 'groupId': 'OG008'}, {'value': '25', 'groupId': 'OG009'}, {'value': '10', 'groupId': 'OG010'}, {'value': '9', 'groupId': 'OG011'}, {'value': '25', 'groupId': 'OG012'}, {'value': '10', 'groupId': 'OG013'}, {'value': '25', 'groupId': 'OG014'}, {'value': '10', 'groupId': 'OG015'}, {'value': '9', 'groupId': 'OG016'}, {'value': '10', 'groupId': 'OG017'}, {'value': '14', 'groupId': 'OG018'}, {'value': '25', 'groupId': 'OG019'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1: SOF+RBV 12 wk: GT 2 or 3, TN', 'description': 'SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-naive (TN) participants with genotype (GT) 2 or 3 HCV infection'}, {'id': 'OG001', 'title': 'Group 2: SOF+RBV 12 wk +PEG 4 wk: GT 2 or 3, TN', 'description': 'SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks plus PEG 180 µg once weekly for 4 weeks in treatment-naive participants with genotype 2 or 3 HCV infection'}, {'id': 'OG002', 'title': 'Group 3: SOF+RBV 12 wk+PEG 8 wk: GT 2 or 3, TN', 'description': 'SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks plus PEG 180 µg once weekly for 8 weeks in treatment-naive participants with genotype 2 or 3 HCV infection'}, {'id': 'OG003', 'title': 'Group 4: SOF+RBV+PEG 12 wk: GT 2 or 3, TN', 'description': 'SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus PEG 180 µg once weekly for 12 weeks in treatment-naive participants with genotype 2 or 3 HCV infection'}, {'id': 'OG004', 'title': 'Group 5: SOF 12 wk: GT 2 or 3, TN', 'description': 'SOF 400 mg once daily for 12 weeks in treatment-naive participants with genotype 2 or 3 HCV infection'}, {'id': 'OG005', 'title': 'Group 6: SOF+RBV+PEG 8 wk: GT 2 or 3, TN', 'description': 'SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus PEG 180 µg once weekly for 8 weeks in treatment-naive participants with genotype 2 or 3 HCV infection'}, {'id': 'OG006', 'title': 'Group 7: SOF+RBV 12 wk: GT 1, TE', 'description': 'SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-experienced (TE) participants with genotype 1 HCV infection who did not respond to prior treatment'}, {'id': 'OG007', 'title': 'Group 8: SOF+RBV 12 wk: GT 1, TN', 'description': 'SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-naive participants with genotype 1 HCV infection'}, {'id': 'OG008', 'title': 'Group 9: SOF+RBV 12 wk: GT 2 or 3, TE', 'description': 'SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-experienced participants with genotype 2 or 3 HCV infection'}, {'id': 'OG009', 'title': 'Group 10: SOF+RBV 8 wk: GT 2 or 3, TN', 'description': 'SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 8 weeks in treatment-naive participants with genotype 2 or 3 HCV infection'}, {'id': 'OG010', 'title': 'Group 11: SOF+RBV 12 wk: GT 2 or 3, TN', 'description': 'SOF 400 mg once daily plus split-dose RBV (800 mg in a divided daily dose) for 12 weeks in treatment-naive participants with genotype 2 or 3 HCV infection'}, {'id': 'OG011', 'title': 'Group 12: SOF+RBV+LDV 12 wk: GT 1, TE', 'description': 'SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus LDV 90 mg once daily for 12 weeks in treatment-experienced participants with genotype 1 HCV infection who did not respond to prior treatment'}, {'id': 'OG012', 'title': 'Group 13: SOF+RBV+LDV 12 wk: GT 1, TN', 'description': 'SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus LDV 90 mg once daily for 12 weeks in treatment-naive participants with genotype 1 HCV infection'}, {'id': 'OG013', 'title': 'Group 14: SOF+RBV+GS-9669 12 wk: GT 1, TE', 'description': 'SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus GS-9669 500 mg once daily for 12 weeks in treatment-experienced participants with genotype 1 HCV infection who did not respond to prior treatment'}, {'id': 'OG014', 'title': 'Group 15: SOF+RBV+GS-9669 12 wk: GT 1, TN', 'description': 'SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus GS-9669 500 mg once daily for 12 weeks in treatment-naive participants with genotype 1 HCV infection'}, {'id': 'OG015', 'title': 'Group 16: LDV/SOF FDC 12 wk: GT 1, Fibrosis', 'description': 'LDV 90 mg/SOF 400 mg FDC once daily for 12 weeks in treatment-experienced participants with genotype 1 HCV infection with Stage F4 fibrosis who did not respond to prior treatment'}, {'id': 'OG016', 'title': 'Group 17: LDV/SOF FDC+RBV 12 wk: GT 1, Fibrosis', 'description': 'LDV 90 mg/SOF 400 mg FDC once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-experienced participants with genotype 1 HCV infection with Stage F4 fibrosis who did not respond to prior treatment'}, {'id': 'OG017', 'title': 'Group 18: LDV/SOF FDC 12 wk: GT 2 or 3, TN', 'description': 'LDV 90 mg/SOF 400 mg FDC once daily for 12 weeks in treatment-naive participants with genotype 2 or 3 HCV infection'}, {'id': 'OG018', 'title': 'Group 20: LDV/SOF FDC+RBV 12 wk: GT 1, Hemophiliac', 'description': 'LDV 90 mg/SOF 400 mg FDC once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in hemophiliac participants with genotype 1 HCV infection'}, {'id': 'OG019', 'title': 'Group 21: LDV/SOF FDC+RBV 6 wk: GT 1, TN', 'description': 'LDV 90 mg/SOF 400 mg FDC once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 6 weeks in treatment-naive participants with genotype 1 HCV infection'}], 'classes': [{'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000'}, {'value': '100.0', 'groupId': 'OG001'}, {'value': '100.0', 'groupId': 'OG002'}, {'value': '100.0', 'groupId': 'OG003'}, {'value': '100.0', 'groupId': 'OG004'}, {'value': '100.0', 'groupId': 'OG005'}, {'value': '100.0', 'groupId': 'OG006'}, {'value': '100.0', 'groupId': 'OG007'}, {'value': '100.0', 'groupId': 'OG008'}, {'value': '100.0', 'groupId': 'OG009'}, {'value': '100.0', 'groupId': 'OG010'}, {'value': '100.0', 'groupId': 'OG011'}, {'value': '100.0', 'groupId': 'OG012'}, {'value': '100.0', 'groupId': 'OG013'}, {'value': '100.0', 'groupId': 'OG014'}, {'value': '100.0', 'groupId': 'OG015'}, {'value': '100.0', 'groupId': 'OG016'}, {'value': '100.0', 'groupId': 'OG017'}, {'value': '100.0', 'groupId': 'OG018'}, {'value': '100.0', 'groupId': 'OG019'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 6', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Analysis Set'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With HCV RNA < LOD at Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '11', 'groupId': 'OG003'}, {'value': '10', 'groupId': 'OG004'}, {'value': '10', 'groupId': 'OG005'}, {'value': '10', 'groupId': 'OG006'}, {'value': '25', 'groupId': 'OG007'}, {'value': '25', 'groupId': 'OG008'}, {'value': '25', 'groupId': 'OG009'}, {'value': '10', 'groupId': 'OG010'}, {'value': '9', 'groupId': 'OG011'}, {'value': '25', 'groupId': 'OG012'}, {'value': '10', 'groupId': 'OG013'}, {'value': '25', 'groupId': 'OG014'}, {'value': '10', 'groupId': 'OG015'}, {'value': '9', 'groupId': 'OG016'}, {'value': '10', 'groupId': 'OG017'}, {'value': '14', 'groupId': 'OG018'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1: SOF+RBV 12 wk: GT 2 or 3, TN', 'description': 'SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-naive (TN) participants with genotype (GT) 2 or 3 HCV infection'}, {'id': 'OG001', 'title': 'Group 2: SOF+RBV 12 wk +PEG 4 wk: GT 2 or 3, TN', 'description': 'SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks plus PEG 180 µg once weekly for 4 weeks in treatment-naive participants with genotype 2 or 3 HCV infection'}, {'id': 'OG002', 'title': 'Group 3: SOF+RBV 12 wk+PEG 8 wk: GT 2 or 3, TN', 'description': 'SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks plus PEG 180 µg once weekly for 8 weeks in treatment-naive participants with genotype 2 or 3 HCV infection'}, {'id': 'OG003', 'title': 'Group 4: SOF+RBV+PEG 12 wk: GT 2 or 3, TN', 'description': 'SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus PEG 180 µg once weekly for 12 weeks in treatment-naive participants with genotype 2 or 3 HCV infection'}, {'id': 'OG004', 'title': 'Group 5: SOF 12 wk: GT 2 or 3, TN', 'description': 'SOF 400 mg once daily for 12 weeks in treatment-naive participants with genotype 2 or 3 HCV infection'}, {'id': 'OG005', 'title': 'Group 6: SOF+RBV+PEG 8 wk: GT 2 or 3, TN', 'description': 'SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus PEG 180 µg once weekly for 8 weeks in treatment-naive participants with genotype 2 or 3 HCV infection'}, {'id': 'OG006', 'title': 'Group 7: SOF+RBV 12 wk: GT 1, TE', 'description': 'SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-experienced (TE) participants with genotype 1 HCV infection who did not respond to prior treatment'}, {'id': 'OG007', 'title': 'Group 8: SOF+RBV 12 wk: GT 1, TN', 'description': 'SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-naive participants with genotype 1 HCV infection'}, {'id': 'OG008', 'title': 'Group 9: SOF+RBV 12 wk: GT 2 or 3, TE', 'description': 'SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-experienced participants with genotype 2 or 3 HCV infection'}, {'id': 'OG009', 'title': 'Group 10: SOF+RBV 8 wk: GT 2 or 3, TN', 'description': 'SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 8 weeks in treatment-naive participants with genotype 2 or 3 HCV infection'}, {'id': 'OG010', 'title': 'Group 11: SOF+RBV 12 wk: GT 2 or 3, TN', 'description': 'SOF 400 mg once daily plus split-dose RBV (800 mg in a divided daily dose) for 12 weeks in treatment-naive participants with genotype 2 or 3 HCV infection'}, {'id': 'OG011', 'title': 'Group 12: SOF+RBV+LDV 12 wk: GT 1, TE', 'description': 'SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus LDV 90 mg once daily for 12 weeks in treatment-experienced participants with genotype 1 HCV infection who did not respond to prior treatment'}, {'id': 'OG012', 'title': 'Group 13: SOF+RBV+LDV 12 wk: GT 1, TN', 'description': 'SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus LDV 90 mg once daily for 12 weeks in treatment-naive participants with genotype 1 HCV infection'}, {'id': 'OG013', 'title': 'Group 14: SOF+RBV+GS-9669 12 wk: GT 1, TE', 'description': 'SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus GS-9669 500 mg once daily for 12 weeks in treatment-experienced participants with genotype 1 HCV infection who did not respond to prior treatment'}, {'id': 'OG014', 'title': 'Group 15: SOF+RBV+GS-9669 12 wk: GT 1, TN', 'description': 'SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus GS-9669 500 mg once daily for 12 weeks in treatment-naive participants with genotype 1 HCV infection'}, {'id': 'OG015', 'title': 'Group 16: LDV/SOF FDC 12 wk: GT 1, Fibrosis', 'description': 'LDV 90 mg/SOF 400 mg FDC once daily for 12 weeks in treatment-experienced participants with genotype 1 HCV infection with Stage F4 fibrosis who did not respond to prior treatment'}, {'id': 'OG016', 'title': 'Group 17: LDV/SOF FDC+RBV 12 wk: GT 1, Fibrosis', 'description': 'LDV 90 mg/SOF 400 mg FDC once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-experienced participants with genotype 1 HCV infection with Stage F4 fibrosis who did not respond to prior treatment'}, {'id': 'OG017', 'title': 'Group 18: LDV/SOF FDC 12 wk: GT 2 or 3, TN', 'description': 'LDV 90 mg/SOF 400 mg FDC once daily for 12 weeks in treatment-naive participants with genotype 2 or 3 HCV infection'}, {'id': 'OG018', 'title': 'Group 20: LDV/SOF FDC+RBV 12 wk: GT 1, Hemophiliac', 'description': 'LDV 90 mg/SOF 400 mg FDC once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in hemophiliac participants with genotype 1 HCV infection'}], 'classes': [{'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000'}, {'value': '100.0', 'groupId': 'OG001'}, {'value': '100.0', 'groupId': 'OG002'}, {'value': '100.0', 'groupId': 'OG003'}, {'value': '100.0', 'groupId': 'OG004'}, {'value': '100.0', 'groupId': 'OG005'}, {'value': '100.0', 'groupId': 'OG006'}, {'value': '100.0', 'groupId': 'OG007'}, {'value': '100.0', 'groupId': 'OG008'}, {'value': '100.0', 'groupId': 'OG009'}, {'value': '100.0', 'groupId': 'OG010'}, {'value': '100.0', 'groupId': 'OG011'}, {'value': '100.0', 'groupId': 'OG012'}, {'value': '100.0', 'groupId': 'OG013'}, {'value': '100.0', 'groupId': 'OG014'}, {'value': '100.0', 'groupId': 'OG015'}, {'value': '100.0', 'groupId': 'OG016'}, {'value': '100.0', 'groupId': 'OG017'}, {'value': '100.0', 'groupId': 'OG018'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 8', 'description': 'Data are not presented for Group 21 which ended treatment after Week 6.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in the Safety Analysis Set with available data were analyzed.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With HCV RNA < LOD at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '11', 'groupId': 'OG003'}, {'value': '10', 'groupId': 'OG004'}, {'value': '10', 'groupId': 'OG005'}, {'value': '25', 'groupId': 'OG006'}, {'value': '25', 'groupId': 'OG007'}, {'value': '10', 'groupId': 'OG008'}, {'value': '9', 'groupId': 'OG009'}, {'value': '24', 'groupId': 'OG010'}, {'value': '10', 'groupId': 'OG011'}, {'value': '25', 'groupId': 'OG012'}, {'value': '10', 'groupId': 'OG013'}, {'value': '9', 'groupId': 'OG014'}, {'value': '10', 'groupId': 'OG015'}, {'value': '14', 'groupId': 'OG016'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1: SOF+RBV 12 wk: GT 2 or 3, TN', 'description': 'SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-naive (TN) participants with genotype (GT) 2 or 3 HCV infection'}, {'id': 'OG001', 'title': 'Group 2: SOF+RBV 12 wk +PEG 4 wk: GT 2 or 3, TN', 'description': 'SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks plus PEG 180 µg once weekly for 4 weeks in treatment-naive participants with genotype 2 or 3 HCV infection'}, {'id': 'OG002', 'title': 'Group 3: SOF+RBV 12 wk+PEG 8 wk: GT 2 or 3, TN', 'description': 'SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks plus PEG 180 µg once weekly for 8 weeks in treatment-naive participants with genotype 2 or 3 HCV infection'}, {'id': 'OG003', 'title': 'Group 4: SOF+RBV+PEG 12 wk: GT 2 or 3, TN', 'description': 'SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus PEG 180 µg once weekly for 12 weeks in treatment-naive participants with genotype 2 or 3 HCV infection'}, {'id': 'OG004', 'title': 'Group 5: SOF 12 wk: GT 2 or 3, TN', 'description': 'SOF 400 mg once daily for 12 weeks in treatment-naive participants with genotype 2 or 3 HCV infection'}, {'id': 'OG005', 'title': 'Group 7: SOF+RBV 12 wk: GT 1, TE', 'description': 'SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-experienced (TE) participants with genotype 1 HCV infection who did not respond to prior treatment'}, {'id': 'OG006', 'title': 'Group 8: SOF+RBV 12 wk: GT 1, TN', 'description': 'SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-naive participants with genotype 1 HCV infection'}, {'id': 'OG007', 'title': 'Group 9: SOF+RBV 12 wk: GT 2 or 3, TE', 'description': 'SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-experienced participants with genotype 2 or 3 HCV infection'}, {'id': 'OG008', 'title': 'Group 11: SOF+RBV 12 wk: GT 2 or 3, TN', 'description': 'SOF 400 mg once daily plus split-dose RBV (800 mg in a divided daily dose) for 12 weeks in treatment-naive participants with genotype 2 or 3 HCV infection'}, {'id': 'OG009', 'title': 'Group 12: SOF+RBV+LDV 12 wk: GT 1, TE', 'description': 'SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus LDV 90 mg once daily for 12 weeks in treatment-experienced participants with genotype 1 HCV infection who did not respond to prior treatment'}, {'id': 'OG010', 'title': 'Group 13: SOF+RBV+LDV 12 wk: GT 1, TN', 'description': 'SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus LDV 90 mg once daily for 12 weeks in treatment-naive participants with genotype 1 HCV infection'}, {'id': 'OG011', 'title': 'Group 14: SOF+RBV+GS-9669 12 wk: GT 1, TE', 'description': 'SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus GS-9669 500 mg once daily for 12 weeks in treatment-experienced participants with genotype 1 HCV infection who did not respond to prior treatment'}, {'id': 'OG012', 'title': 'Group 15: SOF+RBV+GS-9669 12 wk: GT 1, TN', 'description': 'SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus GS-9669 500 mg once daily for 12 weeks in treatment-naive participants with genotype 1 HCV infection'}, {'id': 'OG013', 'title': 'Group 16: LDV/SOF FDC 12 wk: GT 1, Fibrosis', 'description': 'LDV 90 mg/SOF 400 mg FDC once daily for 12 weeks in treatment-experienced participants with genotype 1 HCV infection with Stage F4 fibrosis who did not respond to prior treatment'}, {'id': 'OG014', 'title': 'Group 17: LDV/SOF FDC+RBV 12 wk: GT 1, Fibrosis', 'description': 'LDV 90 mg/SOF 400 mg FDC once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-experienced participants with genotype 1 HCV infection with Stage F4 fibrosis who did not respond to prior treatment'}, {'id': 'OG015', 'title': 'Group 18: LDV/SOF FDC 12 wk: GT 2 or 3, TN', 'description': 'LDV 90 mg/SOF 400 mg FDC once daily for 12 weeks in treatment-naive participants with genotype 2 or 3 HCV infection'}, {'id': 'OG016', 'title': 'Group 20: LDV/SOF FDC+RBV 12 wk: GT 1, Hemophiliac', 'description': 'LDV 90 mg/SOF 400 mg FDC once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in hemophiliac participants with genotype 1 HCV infection'}], 'classes': [{'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000'}, {'value': '100.0', 'groupId': 'OG001'}, {'value': '100.0', 'groupId': 'OG002'}, {'value': '100.0', 'groupId': 'OG003'}, {'value': '100.0', 'groupId': 'OG004'}, {'value': '100.0', 'groupId': 'OG005'}, {'value': '100.0', 'groupId': 'OG006'}, {'value': '100.0', 'groupId': 'OG007'}, {'value': '100.0', 'groupId': 'OG008'}, {'value': '100.0', 'groupId': 'OG009'}, {'value': '100.0', 'groupId': 'OG010'}, {'value': '100.0', 'groupId': 'OG011'}, {'value': '100.0', 'groupId': 'OG012'}, {'value': '100.0', 'groupId': 'OG013'}, {'value': '100.0', 'groupId': 'OG014'}, {'value': '100.0', 'groupId': 'OG015'}, {'value': '100.0', 'groupId': 'OG016'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 12', 'description': 'Data are not presented for Groups 6, 10, and 21 which ended treatment after Week 8 or Week 6.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in the Safety Analysis Set with available data were analyzed.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in HCV RNA at Week 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '11', 'groupId': 'OG003'}, {'value': '10', 'groupId': 'OG004'}, {'value': '10', 'groupId': 'OG005'}, {'value': '10', 'groupId': 'OG006'}, {'value': '25', 'groupId': 'OG007'}, {'value': '25', 'groupId': 'OG008'}, {'value': '25', 'groupId': 'OG009'}, {'value': '10', 'groupId': 'OG010'}, {'value': '9', 'groupId': 'OG011'}, {'value': '25', 'groupId': 'OG012'}, {'value': '10', 'groupId': 'OG013'}, {'value': '25', 'groupId': 'OG014'}, {'value': '10', 'groupId': 'OG015'}, {'value': '9', 'groupId': 'OG016'}, {'value': '10', 'groupId': 'OG017'}, {'value': '14', 'groupId': 'OG018'}, {'value': '25', 'groupId': 'OG019'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1: SOF+RBV 12 wk: GT 2 or 3, TN', 'description': 'SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-naive (TN) participants with genotype (GT) 2 or 3 HCV infection'}, {'id': 'OG001', 'title': 'Group 2: SOF+RBV 12 wk +PEG 4 wk: GT 2 or 3, TN', 'description': 'SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks plus PEG 180 µg once weekly for 4 weeks in treatment-naive participants with genotype 2 or 3 HCV infection'}, {'id': 'OG002', 'title': 'Group 3: SOF+RBV 12 wk+PEG 8 wk: GT 2 or 3, TN', 'description': 'SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks plus PEG 180 µg once weekly for 8 weeks in treatment-naive participants with genotype 2 or 3 HCV infection'}, {'id': 'OG003', 'title': 'Group 4: SOF+RBV+PEG 12 wk: GT 2 or 3, TN', 'description': 'SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus PEG 180 µg once weekly for 12 weeks in treatment-naive participants with genotype 2 or 3 HCV infection'}, {'id': 'OG004', 'title': 'Group 5: SOF 12 wk: GT 2 or 3, TN', 'description': 'SOF 400 mg once daily for 12 weeks in treatment-naive participants with genotype 2 or 3 HCV infection'}, {'id': 'OG005', 'title': 'Group 6: SOF+RBV+PEG 8 wk: GT 2 or 3, TN', 'description': 'SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus PEG 180 µg once weekly for 8 weeks in treatment-naive participants with genotype 2 or 3 HCV infection'}, {'id': 'OG006', 'title': 'Group 7: SOF+RBV 12 wk: GT 1, TE', 'description': 'SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-experienced (TE) participants with genotype 1 HCV infection who did not respond to prior treatment'}, {'id': 'OG007', 'title': 'Group 8: SOF+RBV 12 wk: GT 1, TN', 'description': 'SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-naive participants with genotype 1 HCV infection'}, {'id': 'OG008', 'title': 'Group 9: SOF+RBV 12 wk: GT 2 or 3, TE', 'description': 'SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-experienced participants with genotype 2 or 3 HCV infection'}, {'id': 'OG009', 'title': 'Group 10: SOF+RBV 8 wk: GT 2 or 3, TN', 'description': 'SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 8 weeks in treatment-naive participants with genotype 2 or 3 HCV infection'}, {'id': 'OG010', 'title': 'Group 11: SOF+RBV 12 wk: GT 2 or 3, TN', 'description': 'SOF 400 mg once daily plus split-dose RBV (800 mg in a divided daily dose) for 12 weeks in treatment-naive participants with genotype 2 or 3 HCV infection'}, {'id': 'OG011', 'title': 'Group 12: SOF+RBV+LDV 12 wk: GT 1, TE', 'description': 'SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus LDV 90 mg once daily for 12 weeks in treatment-experienced participants with genotype 1 HCV infection who did not respond to prior treatment'}, {'id': 'OG012', 'title': 'Group 13: SOF+RBV+LDV 12 wk: GT 1, TN', 'description': 'SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus LDV 90 mg once daily for 12 weeks in treatment-naive participants with genotype 1 HCV infection'}, {'id': 'OG013', 'title': 'Group 14: SOF+RBV+GS-9669 12 wk: GT 1, TE', 'description': 'SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus GS-9669 500 mg once daily for 12 weeks in treatment-experienced participants with genotype 1 HCV infection who did not respond to prior treatment'}, {'id': 'OG014', 'title': 'Group 15: SOF+RBV+GS-9669 12 wk: GT 1, TN', 'description': 'SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus GS-9669 500 mg once daily for 12 weeks in treatment-naive participants with genotype 1 HCV infection'}, {'id': 'OG015', 'title': 'Group 16: LDV/SOF FDC 12 wk: GT 1, Fibrosis', 'description': 'LDV 90 mg/SOF 400 mg FDC once daily for 12 weeks in treatment-experienced participants with genotype 1 HCV infection with Stage F4 fibrosis who did not respond to prior treatment'}, {'id': 'OG016', 'title': 'Group 17: LDV/SOF FDC+RBV 12 wk: GT 1, Fibrosis', 'description': 'LDV 90 mg/SOF 400 mg FDC once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-experienced participants with genotype 1 HCV infection with Stage F4 fibrosis who did not respond to prior treatment'}, {'id': 'OG017', 'title': 'Group 18: LDV/SOF FDC 12 wk: GT 2 or 3, TN', 'description': 'LDV 90 mg/SOF 400 mg FDC once daily for 12 weeks in treatment-naive participants with genotype 2 or 3 HCV infection'}, {'id': 'OG018', 'title': 'Group 20: LDV/SOF FDC+RBV 12 wk: GT 1, Hemophiliac', 'description': 'LDV 90 mg/SOF 400 mg FDC once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in hemophiliac participants with genotype 1 HCV infection'}, {'id': 'OG019', 'title': 'Group 21: LDV/SOF FDC+RBV 6 wk: GT 1, TN', 'description': 'LDV 90 mg/SOF 400 mg FDC once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 6 weeks in treatment-naive participants with genotype 1 HCV infection'}], 'classes': [{'categories': [{'measurements': [{'value': '-5.52', 'spread': '0.418', 'groupId': 'OG000'}, {'value': '-5.44', 'spread': '0.519', 'groupId': 'OG001'}, {'value': '-5.23', 'spread': '0.571', 'groupId': 'OG002'}, {'value': '-5.20', 'spread': '0.756', 'groupId': 'OG003'}, {'value': '-6.23', 'spread': '0.892', 'groupId': 'OG004'}, {'value': '-4.94', 'spread': '0.885', 'groupId': 'OG005'}, {'value': '-5.70', 'spread': '0.550', 'groupId': 'OG006'}, {'value': '-4.95', 'spread': '0.746', 'groupId': 'OG007'}, {'value': '-5.38', 'spread': '0.660', 'groupId': 'OG008'}, {'value': '-4.92', 'spread': '0.803', 'groupId': 'OG009'}, {'value': '-5.01', 'spread': '0.962', 'groupId': 'OG010'}, {'value': '-5.74', 'spread': '0.203', 'groupId': 'OG011'}, {'value': '-4.80', 'spread': '0.851', 'groupId': 'OG012'}, {'value': '-5.84', 'spread': '0.383', 'groupId': 'OG013'}, {'value': '-5.19', 'spread': '0.536', 'groupId': 'OG014'}, {'value': '-5.36', 'spread': '0.575', 'groupId': 'OG015'}, {'value': '-5.18', 'spread': '0.781', 'groupId': 'OG016'}, {'value': '-4.93', 'spread': '0.942', 'groupId': 'OG017'}, {'value': '-5.35', 'spread': '0.510', 'groupId': 'OG018'}, {'value': '-5.39', 'spread': '0.559', 'groupId': 'OG019'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to Week 6', 'unitOfMeasure': 'log10 IU/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Analysis Set'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in HCV RNA at Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '11', 'groupId': 'OG003'}, {'value': '10', 'groupId': 'OG004'}, {'value': '10', 'groupId': 'OG005'}, {'value': '10', 'groupId': 'OG006'}, {'value': '25', 'groupId': 'OG007'}, {'value': '25', 'groupId': 'OG008'}, {'value': '25', 'groupId': 'OG009'}, {'value': '10', 'groupId': 'OG010'}, {'value': '9', 'groupId': 'OG011'}, {'value': '25', 'groupId': 'OG012'}, {'value': '10', 'groupId': 'OG013'}, {'value': '25', 'groupId': 'OG014'}, {'value': '10', 'groupId': 'OG015'}, {'value': '9', 'groupId': 'OG016'}, {'value': '10', 'groupId': 'OG017'}, {'value': '14', 'groupId': 'OG018'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1: SOF+RBV 12 wk: GT 2 or 3, TN', 'description': 'SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-naive (TN) participants with genotype (GT) 2 or 3 HCV infection'}, {'id': 'OG001', 'title': 'Group 2: SOF+RBV 12 wk +PEG 4 wk: GT 2 or 3, TN', 'description': 'SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks plus PEG 180 µg once weekly for 4 weeks in treatment-naive participants with genotype 2 or 3 HCV infection'}, {'id': 'OG002', 'title': 'Group 3: SOF+RBV 12 wk+PEG 8 wk: GT 2 or 3, TN', 'description': 'SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks plus PEG 180 µg once weekly for 8 weeks in treatment-naive participants with genotype 2 or 3 HCV infection'}, {'id': 'OG003', 'title': 'Group 4: SOF+RBV+PEG 12 wk: GT 2 or 3, TN', 'description': 'SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus PEG 180 µg once weekly for 12 weeks in treatment-naive participants with genotype 2 or 3 HCV infection'}, {'id': 'OG004', 'title': 'Group 5: SOF 12 wk: GT 2 or 3, TN', 'description': 'SOF 400 mg once daily for 12 weeks in treatment-naive participants with genotype 2 or 3 HCV infection'}, {'id': 'OG005', 'title': 'Group 6: SOF+RBV+PEG 8 wk: GT 2 or 3, TN', 'description': 'SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus PEG 180 µg once weekly for 8 weeks in treatment-naive participants with genotype 2 or 3 HCV infection'}, {'id': 'OG006', 'title': 'Group 7: SOF+RBV 12 wk: GT 1, TE', 'description': 'SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-experienced (TE) participants with genotype 1 HCV infection who did not respond to prior treatment'}, {'id': 'OG007', 'title': 'Group 8: SOF+RBV 12 wk: GT 1, TN', 'description': 'SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-naive participants with genotype 1 HCV infection'}, {'id': 'OG008', 'title': 'Group 9: SOF+RBV 12 wk: GT 2 or 3, TE', 'description': 'SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-experienced participants with genotype 2 or 3 HCV infection'}, {'id': 'OG009', 'title': 'Group 10: SOF+RBV 8 wk: GT 2 or 3, TN', 'description': 'SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 8 weeks in treatment-naive participants with genotype 2 or 3 HCV infection'}, {'id': 'OG010', 'title': 'Group 11: SOF+RBV 12 wk: GT 2 or 3, TN', 'description': 'SOF 400 mg once daily plus split-dose RBV (800 mg in a divided daily dose) for 12 weeks in treatment-naive participants with genotype 2 or 3 HCV infection'}, {'id': 'OG011', 'title': 'Group 12: SOF+RBV+LDV 12 wk: GT 1, TE', 'description': 'SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus LDV 90 mg once daily for 12 weeks in treatment-experienced participants with genotype 1 HCV infection who did not respond to prior treatment'}, {'id': 'OG012', 'title': 'Group 13: SOF+RBV+LDV 12 wk: GT 1, TN', 'description': 'SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus LDV 90 mg once daily for 12 weeks in treatment-naive participants with genotype 1 HCV infection'}, {'id': 'OG013', 'title': 'Group 14: SOF+RBV+GS-9669 12 wk: GT 1, TE', 'description': 'SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus GS-9669 500 mg once daily for 12 weeks in treatment-experienced participants with genotype 1 HCV infection who did not respond to prior treatment'}, {'id': 'OG014', 'title': 'Group 15: SOF+RBV+GS-9669 12 wk: GT 1, TN', 'description': 'SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus GS-9669 500 mg once daily for 12 weeks in treatment-naive participants with genotype 1 HCV infection'}, {'id': 'OG015', 'title': 'Group 16: LDV/SOF FDC 12 wk: GT 1, Fibrosis', 'description': 'LDV 90 mg/SOF 400 mg FDC once daily for 12 weeks in treatment-experienced participants with genotype 1 HCV infection with Stage F4 fibrosis who did not respond to prior treatment'}, {'id': 'OG016', 'title': 'Group 17: LDV/SOF FDC+RBV 12 wk: GT 1, Fibrosis', 'description': 'LDV 90 mg/SOF 400 mg FDC once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-experienced participants with genotype 1 HCV infection with Stage F4 fibrosis who did not respond to prior treatment'}, {'id': 'OG017', 'title': 'Group 18: LDV/SOF FDC 12 wk: GT 2 or 3, TN', 'description': 'LDV 90 mg/SOF 400 mg FDC once daily for 12 weeks in treatment-naive participants with genotype 2 or 3 HCV infection'}, {'id': 'OG018', 'title': 'Group 20: LDV/SOF FDC+RBV 12 wk: GT 1, Hemophiliac', 'description': 'LDV 90 mg/SOF 400 mg FDC once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in hemophiliac participants with genotype 1 HCV infection'}], 'classes': [{'categories': [{'measurements': [{'value': '-5.52', 'spread': '0.418', 'groupId': 'OG000'}, {'value': '-5.44', 'spread': '0.519', 'groupId': 'OG001'}, {'value': '-5.23', 'spread': '0.571', 'groupId': 'OG002'}, {'value': '-5.20', 'spread': '0.756', 'groupId': 'OG003'}, {'value': '-4.59', 'spread': '0.892', 'groupId': 'OG004'}, {'value': '-4.94', 'spread': '0.885', 'groupId': 'OG005'}, {'value': '-5.70', 'spread': '0.550', 'groupId': 'OG006'}, {'value': '-4.95', 'spread': '0.746', 'groupId': 'OG007'}, {'value': '-5.38', 'spread': '0.660', 'groupId': 'OG008'}, {'value': '-4.92', 'spread': '0.803', 'groupId': 'OG009'}, {'value': '-5.01', 'spread': '0.962', 'groupId': 'OG010'}, {'value': '-5.74', 'spread': '0.203', 'groupId': 'OG011'}, {'value': '-4.80', 'spread': '0.851', 'groupId': 'OG012'}, {'value': '-5.84', 'spread': '0.383', 'groupId': 'OG013'}, {'value': '-5.19', 'spread': '0.536', 'groupId': 'OG014'}, {'value': '-5.36', 'spread': '0.575', 'groupId': 'OG015'}, {'value': '-5.18', 'spread': '0.781', 'groupId': 'OG016'}, {'value': '-4.93', 'spread': '0.942', 'groupId': 'OG017'}, {'value': '-5.35', 'spread': '0.510', 'groupId': 'OG018'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to Week 8', 'description': 'Data are not presented for Group 21 which ended treatment after Week 6.', 'unitOfMeasure': 'log10 IU/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in the Safety Analysis Set with available data were analyzed.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in HCV RNA at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '11', 'groupId': 'OG003'}, {'value': '10', 'groupId': 'OG004'}, {'value': '10', 'groupId': 'OG005'}, {'value': '25', 'groupId': 'OG006'}, {'value': '25', 'groupId': 'OG007'}, {'value': '10', 'groupId': 'OG008'}, {'value': '9', 'groupId': 'OG009'}, {'value': '24', 'groupId': 'OG010'}, {'value': '10', 'groupId': 'OG011'}, {'value': '25', 'groupId': 'OG012'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1: SOF+RBV 12 wk: GT 2 or 3, TN', 'description': 'SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-naive (TN) participants with genotype (GT) 2 or 3 HCV infection'}, {'id': 'OG001', 'title': 'Group 2: SOF+RBV 12 wk +PEG 4 wk: GT 2 or 3, TN', 'description': 'SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks plus PEG 180 µg once weekly for 4 weeks in treatment-naive participants with genotype 2 or 3 HCV infection'}, {'id': 'OG002', 'title': 'Group 3: SOF+RBV 12 wk+PEG 8 wk: GT 2 or 3, TN', 'description': 'SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks plus PEG 180 µg once weekly for 8 weeks in treatment-naive participants with genotype 2 or 3 HCV infection'}, {'id': 'OG003', 'title': 'Group 4: SOF+RBV+PEG 12 wk: GT 2 or 3, TN', 'description': 'SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus PEG 180 µg once weekly for 12 weeks in treatment-naive participants with genotype 2 or 3 HCV infection'}, {'id': 'OG004', 'title': 'Group 5: SOF 12 wk: GT 2 or 3, TN', 'description': 'SOF 400 mg once daily for 12 weeks in treatment-naive participants with genotype 2 or 3 HCV infection'}, {'id': 'OG005', 'title': 'Group 7: SOF+RBV 12 wk: GT 1, TE', 'description': 'SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-experienced (TE) participants with genotype 1 HCV infection who did not respond to prior treatment'}, {'id': 'OG006', 'title': 'Group 8: SOF+RBV 12 wk: GT 1, TN', 'description': 'SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-naive participants with genotype 1 HCV infection'}, {'id': 'OG007', 'title': 'Group 9: SOF+RBV 12 wk: GT 2 or 3, TE', 'description': 'SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-experienced participants with genotype 2 or 3 HCV infection'}, {'id': 'OG008', 'title': 'Group 11: SOF+RBV 12 wk: GT 2 or 3, TN', 'description': 'SOF 400 mg once daily plus split-dose RBV (800 mg in a divided daily dose) for 12 weeks in treatment-naive participants with genotype 2 or 3 HCV infection'}, {'id': 'OG009', 'title': 'Group 12: SOF+RBV+LDV 12 wk: GT 1, TE', 'description': 'SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus LDV 90 mg once daily for 12 weeks in treatment-experienced participants with genotype 1 HCV infection who did not respond to prior treatment'}, {'id': 'OG010', 'title': 'Group 13: SOF+RBV+LDV 12 wk: GT 1, TN', 'description': 'SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus LDV 90 mg once daily for 12 weeks in treatment-naive participants with genotype 1 HCV infection'}, {'id': 'OG011', 'title': 'Group 14: SOF+RBV+GS-9669 12 wk: GT 1, TE', 'description': 'SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus GS-9669 500 mg once daily for 12 weeks in treatment-experienced participants with genotype 1 HCV infection who did not respond to prior treatment'}, {'id': 'OG012', 'title': 'Group 15: SOF+RBV+GS-9669 12 wk: GT 1, TN', 'description': 'SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus GS-9669 500 mg once daily for 12 weeks in treatment-naive participants with genotype 1 HCV infection'}], 'classes': [{'categories': [{'measurements': [{'value': '-5.52', 'spread': '0.418', 'groupId': 'OG000'}, {'value': '-5.44', 'spread': '0.519', 'groupId': 'OG001'}, {'value': '-5.23', 'spread': '0.571', 'groupId': 'OG002'}, {'value': '-5.20', 'spread': '0.756', 'groupId': 'OG003'}, {'value': '-4.59', 'spread': '0.892', 'groupId': 'OG004'}, {'value': '-5.70', 'spread': '0.550', 'groupId': 'OG005'}, {'value': '-4.95', 'spread': '0.746', 'groupId': 'OG006'}, {'value': '-5.39', 'spread': '0.660', 'groupId': 'OG007'}, {'value': '-2.01', 'spread': '0.962', 'groupId': 'OG008'}, {'value': '-5.74', 'spread': '0.203', 'groupId': 'OG009'}, {'value': '-4.85', 'spread': '0.823', 'groupId': 'OG010'}, {'value': '-5.84', 'spread': '0.383', 'groupId': 'OG011'}, {'value': '-5.19', 'spread': '0.536', 'groupId': 'OG012'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to Week 12', 'description': 'Data are not presented for Groups 6, 10, and 21 which ended treatment after Week 8 or Week 6. Data are not presented for Groups 16, 17, 18, and 20 because participants with detectable HCV RNA discontinued due to protocol-specified stopping rules.', 'unitOfMeasure': 'log10 IU/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in the Safety Analysis Set with available data were analyzed.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Virologic Failure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '11', 'groupId': 'OG003'}, {'value': '10', 'groupId': 'OG004'}, {'value': '10', 'groupId': 'OG005'}, {'value': '10', 'groupId': 'OG006'}, {'value': '25', 'groupId': 'OG007'}, {'value': '25', 'groupId': 'OG008'}, {'value': '25', 'groupId': 'OG009'}, {'value': '10', 'groupId': 'OG010'}, {'value': '9', 'groupId': 'OG011'}, {'value': '25', 'groupId': 'OG012'}, {'value': '10', 'groupId': 'OG013'}, {'value': '25', 'groupId': 'OG014'}, {'value': '10', 'groupId': 'OG015'}, {'value': '9', 'groupId': 'OG016'}, {'value': '10', 'groupId': 'OG017'}, {'value': '14', 'groupId': 'OG018'}, {'value': '25', 'groupId': 'OG019'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1: SOF+RBV 12 wk: GT 2 or 3, TN', 'description': 'SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-naive (TN) participants with genotype (GT) 2 or 3 HCV infection'}, {'id': 'OG001', 'title': 'Group 2: SOF+RBV 12 wk +PEG 4 wk: GT 2 or 3, TN', 'description': 'SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks plus PEG 180 µg once weekly for 4 weeks in treatment-naive participants with genotype 2 or 3 HCV infection'}, {'id': 'OG002', 'title': 'Group 3: SOF+RBV 12 wk+PEG 8 wk: GT 2 or 3, TN', 'description': 'SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks plus PEG 180 µg once weekly for 8 weeks in treatment-naive participants with genotype 2 or 3 HCV infection'}, {'id': 'OG003', 'title': 'Group 4: SOF+RBV+PEG 12 wk: GT 2 or 3, TN', 'description': 'SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus PEG 180 µg once weekly for 12 weeks in treatment-naive participants with genotype 2 or 3 HCV infection'}, {'id': 'OG004', 'title': 'Group 5: SOF 12 wk: GT 2 or 3, TN', 'description': 'SOF 400 mg once daily for 12 weeks in treatment-naive participants with genotype 2 or 3 HCV infection'}, {'id': 'OG005', 'title': 'Group 6: SOF+RBV+PEG 8 wk: GT 2 or 3, TN', 'description': 'SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus PEG 180 µg once weekly for 8 weeks in treatment-naive participants with genotype 2 or 3 HCV infection'}, {'id': 'OG006', 'title': 'Group 7: SOF+RBV 12 wk: GT 1, TE', 'description': 'SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-experienced (TE) participants with genotype 1 HCV infection who did not respond to prior treatment'}, {'id': 'OG007', 'title': 'Group 8: SOF+RBV 12 wk: GT 1, TN', 'description': 'SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-naive participants with genotype 1 HCV infection'}, {'id': 'OG008', 'title': 'Group 9: SOF+RBV 12 wk: GT 2 or 3, TE', 'description': 'SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-experienced participants with genotype 2 or 3 HCV infection'}, {'id': 'OG009', 'title': 'Group 10: SOF+RBV 8 wk: GT 2 or 3, TN', 'description': 'SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 8 weeks in treatment-naive participants with genotype 2 or 3 HCV infection'}, {'id': 'OG010', 'title': 'Group 11: SOF+RBV 12 wk: GT 2 or 3, TN', 'description': 'SOF 400 mg once daily plus split-dose RBV (800 mg in a divided daily dose) for 12 weeks in treatment-naive participants with genotype 2 or 3 HCV infection'}, {'id': 'OG011', 'title': 'Group 12: SOF+RBV+LDV 12 wk: GT 1, TE', 'description': 'SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus LDV 90 mg once daily for 12 weeks in treatment-experienced participants with genotype 1 HCV infection who did not respond to prior treatment'}, {'id': 'OG012', 'title': 'Group 13: SOF+RBV+LDV 12 wk: GT 1, TN', 'description': 'SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus LDV 90 mg once daily for 12 weeks in treatment-naive participants with genotype 1 HCV infection'}, {'id': 'OG013', 'title': 'Group 14: SOF+RBV+GS-9669 12 wk: GT 1, TE', 'description': 'SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus GS-9669 500 mg once daily for 12 weeks in treatment-experienced participants with genotype 1 HCV infection who did not respond to prior treatment'}, {'id': 'OG014', 'title': 'Group 15: SOF+RBV+GS-9669 12 wk: GT 1, TN', 'description': 'SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus GS-9669 500 mg once daily for 12 weeks in treatment-naive participants with genotype 1 HCV infection'}, {'id': 'OG015', 'title': 'Group 16: LDV/SOF FDC 12 wk: GT 1, Fibrosis', 'description': 'LDV 90 mg/SOF 400 mg FDC once daily for 12 weeks in treatment-experienced participants with genotype 1 HCV infection with Stage F4 fibrosis who did not respond to prior treatment'}, {'id': 'OG016', 'title': 'Group 17: LDV/SOF FDC+RBV 12 wk: GT 1, Fibrosis', 'description': 'LDV 90 mg/SOF 400 mg FDC once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-experienced participants with genotype 1 HCV infection with Stage F4 fibrosis who did not respond to prior treatment'}, {'id': 'OG017', 'title': 'Group 18: LDV/SOF FDC 12 wk: GT 2 or 3, TN', 'description': 'LDV 90 mg/SOF 400 mg FDC once daily for 12 weeks in treatment-naive participants with genotype 2 or 3 HCV infection'}, {'id': 'OG018', 'title': 'Group 20: LDV/SOF FDC+RBV 12 wk: GT 1, Hemophiliac', 'description': 'LDV 90 mg/SOF 400 mg FDC once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in hemophiliac participants with genotype 1 HCV infection'}, {'id': 'OG019', 'title': 'Group 21: LDV/SOF FDC+RBV 6 wk: GT 1, TN', 'description': 'LDV 90 mg/SOF 400 mg FDC once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 6 weeks in treatment-naive participants with genotype 1 HCV infection'}], 'classes': [{'title': 'On-treatment virologic failure', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}, {'value': '0.0', 'groupId': 'OG002'}, {'value': '0.0', 'groupId': 'OG003'}, {'value': '0.0', 'groupId': 'OG004'}, {'value': '0.0', 'groupId': 'OG005'}, {'value': '0.0', 'groupId': 'OG006'}, {'value': '0.0', 'groupId': 'OG007'}, {'value': '0.0', 'groupId': 'OG008'}, {'value': '0.0', 'groupId': 'OG009'}, {'value': '0.0', 'groupId': 'OG010'}, {'value': '0.0', 'groupId': 'OG011'}, {'value': '0.0', 'groupId': 'OG012'}, {'value': '0.0', 'groupId': 'OG013'}, {'value': '0.0', 'groupId': 'OG014'}, {'value': '0.0', 'groupId': 'OG015'}, {'value': '0.0', 'groupId': 'OG016'}, {'value': '0.0', 'groupId': 'OG017'}, {'value': '0.0', 'groupId': 'OG018'}, {'value': '0.0', 'groupId': 'OG019'}]}]}, {'title': 'Viral relapse', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}, {'value': '0.0', 'groupId': 'OG002'}, {'value': '0.0', 'groupId': 'OG003'}, {'value': '40.0', 'groupId': 'OG004'}, {'value': '0.0', 'groupId': 'OG005'}, {'value': '90.0', 'groupId': 'OG006'}, {'value': '16.0', 'groupId': 'OG007'}, {'value': '32.0', 'groupId': 'OG008'}, {'value': '36.0', 'groupId': 'OG009'}, {'value': '40.0', 'groupId': 'OG010'}, {'value': '0.0', 'groupId': 'OG011'}, {'value': '0.0', 'groupId': 'OG012'}, {'value': '0.0', 'groupId': 'OG013'}, {'value': '8.0', 'groupId': 'OG014'}, {'value': '30.0', 'groupId': 'OG015'}, {'value': '0.0', 'groupId': 'OG016'}, {'value': '20.0', 'groupId': 'OG017'}, {'value': '0.0', 'groupId': 'OG018'}, {'value': '32.0', 'groupId': 'OG019'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to Posttreatment Week 24', 'description': 'The percentage of participants with on-treatment virologic failure (viral breakthrough, rebound, or nonresponse) or following treatment (viral relapse) was summarized.\n\nOn-treatment virologic failure was defined as:\n\n* Viral breakthrough (confirmed HCV RNA ≥ LOD after having previously had HCV RNA \\< LOD while on treatment),\n* Viral rebound (confirmed \\> 1 log10 IU/mL increase in HCV RNA from nadir while on treatment, or\n* Nonresponse (HCV RNA persistently ≥ LOD through 6 weeks of treatment)\n\nViral relapse was defined as confirmed HCV RNA ≥ LOD during the posttreatment period having achieved HCV RNA \\< LOD at the last on-treatment visit.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Analysis Set'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Group 1: SOF+RBV 12 wk: GT 2 or 3, TN', 'description': 'Sofosbuvir (SOF) 400 mg once daily plus weight-based ribavirin (RBV) (1000-1200 in a divided daily dose) for 12 weeks in treatment-naive (TN) participants with genotype (GT) 2 or 3 HCV infection'}, {'id': 'FG001', 'title': 'Group 2: SOF+RBV 12 wk +PEG 4 wk: GT 2 or 3, TN', 'description': 'SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks plus PEG 180 µg once weekly for 4 weeks in treatment-naive participants with genotype 2 or 3 HCV infection'}, {'id': 'FG002', 'title': 'Group 3: SOF+RBV 12 wk+PEG 8 wk: GT 2 or 3, TN', 'description': 'SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks plus PEG 180 µg once weekly for 8 weeks in treatment-naive participants with genotype 2 or 3 HCV infection'}, {'id': 'FG003', 'title': 'Group 4: SOF+RBV+PEG 12 wk: GT 2 or 3, TN', 'description': 'SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus PEG 180 µg once weekly for 12 weeks in treatment-naive participants with genotype 2 or 3 HCV infection'}, {'id': 'FG004', 'title': 'Group 5: SOF 12 wk: GT 2 or 3, TN', 'description': 'SOF 400 mg once daily for 12 weeks in treatment-naive participants with genotype 2 or 3 HCV infection'}, {'id': 'FG005', 'title': 'Group 6: SOF+RBV+PEG 8 wk: GT 2 or 3, TN', 'description': 'SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus PEG 180 µg once weekly for 8 weeks in treatment-naive participants with genotype 2 or 3 HCV infection'}, {'id': 'FG006', 'title': 'Group 7: SOF+RBV 12 wk: GT 1, TE', 'description': 'SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-experienced (TE) participants with genotype 1 HCV infection who did not respond to prior treatment'}, {'id': 'FG007', 'title': 'Group 8: SOF+RBV 12 wk: GT 1, TN', 'description': 'SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-naive participants with genotype 1 HCV infection'}, {'id': 'FG008', 'title': 'Group 9: SOF+RBV 12 wk: GT 2 or 3, TE', 'description': 'SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-experienced participants with genotype 2 or 3 HCV infection'}, {'id': 'FG009', 'title': 'Group 10: SOF+RBV 8 wk: GT 2 or 3, TN', 'description': 'SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 8 weeks in treatment-naive participants with genotype 2 or 3 HCV infection'}, {'id': 'FG010', 'title': 'Group 11: SOF+RBV 12 wk: GT 2 or 3, TN', 'description': 'SOF 400 mg once daily plus split-dose RBV (800 mg in a divided daily dose) for 12 weeks in treatment-naive participants with genotype 2 or 3 HCV infection'}, {'id': 'FG011', 'title': 'Group 12: SOF+RBV+LDV 12 wk: GT 1, TE', 'description': 'SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus ledipasvir (LDV) 90 mg once daily for 12 weeks in treatment-experienced participants with genotype 1 HCV infection who did not respond to prior treatment'}, {'id': 'FG012', 'title': 'Group 13: SOF+RBV+LDV 12 wk: GT 1, TN', 'description': 'SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus LDV 90 mg once daily for 12 weeks in treatment-naive participants with genotype 1 HCV infection'}, {'id': 'FG013', 'title': 'Group 14: SOF+RBV+GS-9669 12 wk: GT 1, TE', 'description': 'SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus GS-9669 500 mg once daily for 12 weeks in treatment-experienced participants with genotype 1 HCV infection who did not respond to prior treatment'}, {'id': 'FG014', 'title': 'Group 15: SOF+RBV+GS-9669 12 wk: GT 1, TN', 'description': 'SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus GS-9669 500 mg once daily for 12 weeks in treatment-naive participants with genotype 1 HCV infection'}, {'id': 'FG015', 'title': 'Group 16: LDV/SOF FDC 12 wk: GT 1, Fibrosis', 'description': 'LDV 90 mg/SOF 400 mg fixed-dose combination (FDC) once daily for 12 weeks in treatment-experienced participants with genotype 1 HCV infection with Stage F4 fibrosis who did not respond to prior treatment'}, {'id': 'FG016', 'title': 'Group 17: LDV/SOF FDC+RBV 12 wk: GT 1, Fibrosis', 'description': 'LDV 90 mg/SOF 400 mg FDC once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-experienced participants with genotype 1 HCV infection with Stage F4 fibrosis who did not respond to prior treatment'}, {'id': 'FG017', 'title': 'Group 18: LDV/SOF FDC 12 wk: GT 2 or 3, TN', 'description': 'LDV 90 mg/SOF 400 mg FDC once daily for 12 weeks in treatment-naive participants with genotype 2 or 3 HCV infection'}, {'id': 'FG018', 'title': 'Group 19: LDV/SOF FDC 12 wk: GT 2 or 3, TE', 'description': 'LDV 90 mg/SOF 400 mg FDC once daily for 12 weeks in treatment-experienced participants with genotype 2 or 3 HCV infection'}, {'id': 'FG019', 'title': 'Group 20: LDV/SOF FDC+RBV 12 wk: GT 1, Hemophiliac', 'description': 'LDV 90 mg/SOF 400 mg FDC once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in hemophiliac participants with genotype 1 HCV infection'}, {'id': 'FG020', 'title': 'Group 21: LDV/SOF FDC+RBV 6 wk: GT 1, TN', 'description': 'LDV 90 mg/SOF 400 mg FDC once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 6 weeks in treatment-naive participants with genotype 1 HCV infection'}, {'id': 'FG021', 'title': 'Group 22: LDV/SOF FDC 6 wk: GT 1, TN', 'description': 'Treatment-naive participants with genotype 1 HCV infection were randomized to receive LDV 90 mg/SOF 400 mg FDC once daily for 6 weeks.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '9'}, {'groupId': 'FG002', 'numSubjects': '10'}, {'groupId': 'FG003', 'numSubjects': '11'}, {'groupId': 'FG004', 'numSubjects': '10'}, {'groupId': 'FG005', 'numSubjects': '10'}, {'groupId': 'FG006', 'numSubjects': '10'}, {'groupId': 'FG007', 'numSubjects': '25'}, {'groupId': 'FG008', 'numSubjects': '25'}, {'groupId': 'FG009', 'numSubjects': '25'}, {'groupId': 'FG010', 'numSubjects': '10'}, {'groupId': 'FG011', 'numSubjects': '9'}, {'groupId': 'FG012', 'numSubjects': '25'}, {'groupId': 'FG013', 'numSubjects': '10'}, {'groupId': 'FG014', 'numSubjects': '25'}, {'groupId': 'FG015', 'numSubjects': '10'}, {'groupId': 'FG016', 'numSubjects': '9'}, {'groupId': 'FG017', 'numSubjects': '10'}, {'groupId': 'FG018', 'numSubjects': '0'}, {'groupId': 'FG019', 'numSubjects': '14'}, {'groupId': 'FG020', 'numSubjects': '25'}, {'groupId': 'FG021', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '9'}, {'groupId': 'FG002', 'numSubjects': '10'}, {'groupId': 'FG003', 'numSubjects': '11'}, {'groupId': 'FG004', 'numSubjects': '10'}, {'groupId': 'FG005', 'numSubjects': '10'}, {'groupId': 'FG006', 'numSubjects': '10'}, {'groupId': 'FG007', 'numSubjects': '25'}, {'groupId': 'FG008', 'numSubjects': '24'}, {'groupId': 'FG009', 'numSubjects': '25'}, {'groupId': 'FG010', 'numSubjects': '10'}, {'groupId': 'FG011', 'numSubjects': '9'}, {'groupId': 'FG012', 'numSubjects': '25'}, {'groupId': 'FG013', 'numSubjects': '10'}, {'groupId': 'FG014', 'numSubjects': '25'}, {'groupId': 'FG015', 'numSubjects': '10'}, {'groupId': 'FG016', 'numSubjects': '9'}, {'groupId': 'FG017', 'numSubjects': '9'}, {'groupId': 'FG018', 'numSubjects': '0'}, {'groupId': 'FG019', 'numSubjects': '14'}, {'groupId': 'FG020', 'numSubjects': '22'}, {'groupId': 'FG021', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '1'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '0'}, {'groupId': 'FG012', 'numSubjects': '0'}, {'groupId': 'FG013', 'numSubjects': '0'}, {'groupId': 'FG014', 'numSubjects': '0'}, {'groupId': 'FG015', 'numSubjects': '0'}, {'groupId': 'FG016', 'numSubjects': '0'}, {'groupId': 'FG017', 'numSubjects': '1'}, {'groupId': 'FG018', 'numSubjects': '0'}, {'groupId': 'FG019', 'numSubjects': '0'}, {'groupId': 'FG020', 'numSubjects': '3'}, {'groupId': 'FG021', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '0'}, {'groupId': 'FG012', 'numSubjects': '0'}, {'groupId': 'FG013', 'numSubjects': '0'}, {'groupId': 'FG014', 'numSubjects': '0'}, {'groupId': 'FG015', 'numSubjects': '0'}, {'groupId': 'FG016', 'numSubjects': '0'}, {'groupId': 'FG017', 'numSubjects': '1'}, {'groupId': 'FG018', 'numSubjects': '0'}, {'groupId': 'FG019', 'numSubjects': '0'}, {'groupId': 'FG020', 'numSubjects': '3'}, {'groupId': 'FG021', 'numSubjects': '0'}]}, {'type': 'Did Not Complete Follow-up 12 Visit', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '1'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '0'}, {'groupId': 'FG012', 'numSubjects': '0'}, {'groupId': 'FG013', 'numSubjects': '0'}, {'groupId': 'FG014', 'numSubjects': '0'}, {'groupId': 'FG015', 'numSubjects': '0'}, {'groupId': 'FG016', 'numSubjects': '0'}, {'groupId': 'FG017', 'numSubjects': '0'}, {'groupId': 'FG018', 'numSubjects': '0'}, {'groupId': 'FG019', 'numSubjects': '0'}, {'groupId': 'FG020', 'numSubjects': '0'}, {'groupId': 'FG021', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Participants were enrolled in a total of 2 study sites in New Zealand. The first participant was screened on 18 November 2010. The last participant observation was on 23 December 2013.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}, {'value': '11', 'groupId': 'BG003'}, {'value': '10', 'groupId': 'BG004'}, {'value': '10', 'groupId': 'BG005'}, {'value': '10', 'groupId': 'BG006'}, {'value': '25', 'groupId': 'BG007'}, {'value': '25', 'groupId': 'BG008'}, {'value': '25', 'groupId': 'BG009'}, {'value': '10', 'groupId': 'BG010'}, {'value': '9', 'groupId': 'BG011'}, {'value': '25', 'groupId': 'BG012'}, {'value': '10', 'groupId': 'BG013'}, {'value': '25', 'groupId': 'BG014'}, {'value': '10', 'groupId': 'BG015'}, {'value': '9', 'groupId': 'BG016'}, {'value': '10', 'groupId': 'BG017'}, {'value': '14', 'groupId': 'BG018'}, {'value': '25', 'groupId': 'BG019'}, {'value': '292', 'groupId': 'BG020'}]}], 'groups': [{'id': 'BG000', 'title': 'Group 1: SOF+RBV 12 wk: GT 2 or 3, TN', 'description': 'SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-naive (TN) participants with genotype (GT) 2 or 3 HCV infection'}, {'id': 'BG001', 'title': 'Group 2: SOF+RBV 12 wk +PEG 4 wk: GT 2 or 3, TN', 'description': 'SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks plus PEG 180 µg once weekly for 4 weeks in treatment-naive participants with genotype 2 or 3 HCV infection'}, {'id': 'BG002', 'title': 'Group 3: SOF+RBV 12 wk+PEG 8 wk: GT 2 or 3, TN', 'description': 'SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks plus PEG 180 µg once weekly for 8 weeks in treatment-naive participants with genotype 2 or 3 HCV infection'}, {'id': 'BG003', 'title': 'Group 4: SOF+RBV+PEG 12 wk: GT 2 or 3, TN', 'description': 'SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus PEG 180 µg once weekly for 12 weeks in treatment-naive participants with genotype 2 or 3 HCV infection'}, {'id': 'BG004', 'title': 'Group 5: SOF 12 wk: GT 2 or 3, TN', 'description': 'SOF 400 mg once daily for 12 weeks in treatment-naive participants with genotype 2 or 3 HCV infection'}, {'id': 'BG005', 'title': 'Group 6: SOF+RBV+PEG 8 wk: GT 2 or 3, TN', 'description': 'SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus PEG 180 µg once weekly for 8 weeks in treatment-naive participants with genotype 2 or 3 HCV infection'}, {'id': 'BG006', 'title': 'Group 7: SOF+RBV 12 wk: GT 1, TE', 'description': 'SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-experienced (TE) participants with genotype 1 HCV infection who did not respond to prior treatment'}, {'id': 'BG007', 'title': 'Group 8: SOF+RBV 12 wk: GT 1, TN', 'description': 'SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-naive participants with genotype 1 HCV infection'}, {'id': 'BG008', 'title': 'Group 9: SOF+RBV 12 wk: GT 2 or 3, TE', 'description': 'SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-experienced participants with genotype 2 or 3 HCV infection'}, {'id': 'BG009', 'title': 'Group 10: SOF+RBV 8 wk: GT 2 or 3, TN', 'description': 'SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 8 weeks in treatment-naive participants with genotype 2 or 3 HCV infection'}, {'id': 'BG010', 'title': 'Group 11: SOF+RBV 12 wk: GT 2 or 3, TN', 'description': 'SOF 400 mg once daily plus split-dose RBV (800 mg in a divided daily dose) for 12 weeks in treatment-naive participants with genotype 2 or 3 HCV infection'}, {'id': 'BG011', 'title': 'Group 12: SOF+RBV+LDV 12 wk: GT 1, TE', 'description': 'SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus LDV 90 mg once daily for 12 weeks in treatment-experienced participants with genotype 1 HCV infection who did not respond to prior treatment'}, {'id': 'BG012', 'title': 'Group 13: SOF+RBV+LDV 12 wk: GT 1, TN', 'description': 'SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus LDV 90 mg once daily for 12 weeks in treatment-naive participants with genotype 1 HCV infection'}, {'id': 'BG013', 'title': 'Group 14: SOF+RBV+GS-9669 12 wk: GT 1, TE', 'description': 'SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus GS-9669 500 mg once daily for 12 weeks in treatment-experienced participants with genotype 1 HCV infection who did not respond to prior treatment'}, {'id': 'BG014', 'title': 'Group 15: SOF+RBV+GS-9669 12 wk: GT 1, TN', 'description': 'SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus GS-9669 500 mg once daily for 12 weeks in treatment-naive participants with genotype 1 HCV infection'}, {'id': 'BG015', 'title': 'Group 16: LDV/SOF FDC 12 wk: GT 1, Fibrosis', 'description': 'LDV 90 mg/SOF 400 mg FDC once daily for 12 weeks in treatment-experienced participants with genotype 1 HCV infection with Stage F4 fibrosis who did not respond to prior treatment'}, {'id': 'BG016', 'title': 'Group 17: LDV/SOF FDC+RBV 12 wk: GT 1, Fibrosis', 'description': 'LDV 90 mg/SOF 400 mg FDC once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-experienced participants with genotype 1 HCV infection with Stage F4 fibrosis who did not respond to prior treatment'}, {'id': 'BG017', 'title': 'Group 18: LDV/SOF FDC 12 wk: GT 2 or 3, TN', 'description': 'LDV 90 mg/SOF 400 mg FDC once daily for 12 weeks in treatment-naive participants with genotype 2 or 3 HCV infection'}, {'id': 'BG018', 'title': 'Group 20: LDV/SOF FDC+RBV 12 wk: GT 1, Hemophiliac', 'description': 'LDV 90 mg/SOF 400 mg FDC once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in hemophiliac participants with genotype 1 HCV infection'}, {'id': 'BG019', 'title': 'Group 21: LDV/SOF FDC+RBV 6 wk: GT 1, TN', 'description': 'LDV 90 mg/SOF 400 mg FDC once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 6 weeks in treatment-naive participants with genotype 1 HCV infection'}, {'id': 'BG020', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '47', 'spread': '6.0', 'groupId': 'BG000'}, {'value': '47', 'spread': '10.2', 'groupId': 'BG001'}, {'value': '49', 'spread': '9.9', 'groupId': 'BG002'}, {'value': '46', 'spread': '6.3', 'groupId': 'BG003'}, {'value': '43', 'spread': '13.5', 'groupId': 'BG004'}, {'value': '39', 'spread': '12.2', 'groupId': 'BG005'}, {'value': '48', 'spread': '10.4', 'groupId': 'BG006'}, {'value': '48', 'spread': '11.4', 'groupId': 'BG007'}, {'value': '53', 'spread': '7.9', 'groupId': 'BG008'}, {'value': '48', 'spread': '9.4', 'groupId': 'BG009'}, {'value': '39', 'spread': '8.9', 'groupId': 'BG010'}, {'value': '50', 'spread': '13.0', 'groupId': 'BG011'}, {'value': '45', 'spread': '9.2', 'groupId': 'BG012'}, {'value': '55', 'spread': '6.0', 'groupId': 'BG013'}, {'value': '46', 'spread': '9.3', 'groupId': 'BG014'}, {'value': '61', 'spread': '4.9', 'groupId': 'BG015'}, {'value': '57', 'spread': '5.2', 'groupId': 'BG016'}, {'value': '39', 'spread': '10.8', 'groupId': 'BG017'}, {'value': '54', 'spread': '13.0', 'groupId': 'BG018'}, {'value': '51', 'spread': '9.0', 'groupId': 'BG019'}, {'value': '48', 'spread': '10.6', 'groupId': 'BG020'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '6', 'groupId': 'BG004'}, {'value': '5', 'groupId': 'BG005'}, {'value': '3', 'groupId': 'BG006'}, {'value': '10', 'groupId': 'BG007'}, {'value': '6', 'groupId': 'BG008'}, {'value': '8', 'groupId': 'BG009'}, {'value': '3', 'groupId': 'BG010'}, {'value': '2', 'groupId': 'BG011'}, {'value': '17', 'groupId': 'BG012'}, {'value': '3', 'groupId': 'BG013'}, {'value': '12', 'groupId': 'BG014'}, {'value': '0', 'groupId': 'BG015'}, {'value': '1', 'groupId': 'BG016'}, {'value': '7', 'groupId': 'BG017'}, {'value': '2', 'groupId': 'BG018'}, {'value': '12', 'groupId': 'BG019'}, {'value': '110', 'groupId': 'BG020'}]}, {'title': 'Male', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '9', 'groupId': 'BG003'}, {'value': '4', 'groupId': 'BG004'}, {'value': '5', 'groupId': 'BG005'}, {'value': '7', 'groupId': 'BG006'}, {'value': '15', 'groupId': 'BG007'}, {'value': '19', 'groupId': 'BG008'}, {'value': '17', 'groupId': 'BG009'}, {'value': '7', 'groupId': 'BG010'}, {'value': '7', 'groupId': 'BG011'}, {'value': '8', 'groupId': 'BG012'}, {'value': '7', 'groupId': 'BG013'}, {'value': '13', 'groupId': 'BG014'}, {'value': '10', 'groupId': 'BG015'}, {'value': '8', 'groupId': 'BG016'}, {'value': '3', 'groupId': 'BG017'}, {'value': '12', 'groupId': 'BG018'}, {'value': '13', 'groupId': 'BG019'}, {'value': '182', 'groupId': 'BG020'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', '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': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '0', 'groupId': 'BG009'}, {'value': '0', 'groupId': 'BG010'}, {'value': '0', 'groupId': 'BG011'}, {'value': '0', 'groupId': 'BG012'}, {'value': '0', 'groupId': 'BG013'}, {'value': '0', 'groupId': 'BG014'}, {'value': '2', 'groupId': 'BG015'}, {'value': '0', 'groupId': 'BG016'}, {'value': '0', 'groupId': 'BG017'}, {'value': '0', 'groupId': 'BG018'}, {'value': '0', 'groupId': 'BG019'}, {'value': '3', 'groupId': 'BG020'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}, {'value': '11', 'groupId': 'BG003'}, {'value': '10', 'groupId': 'BG004'}, {'value': '9', 'groupId': 'BG005'}, {'value': '10', 'groupId': 'BG006'}, {'value': '25', 'groupId': 'BG007'}, {'value': '25', 'groupId': 'BG008'}, {'value': '25', 'groupId': 'BG009'}, {'value': '10', 'groupId': 'BG010'}, {'value': '9', 'groupId': 'BG011'}, {'value': '25', 'groupId': 'BG012'}, {'value': '10', 'groupId': 'BG013'}, {'value': '25', 'groupId': 'BG014'}, {'value': '8', 'groupId': 'BG015'}, {'value': '9', 'groupId': 'BG016'}, {'value': '10', 'groupId': 'BG017'}, {'value': '14', 'groupId': 'BG018'}, {'value': '25', 'groupId': 'BG019'}, {'value': '289', 'groupId': 'BG020'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '0', 'groupId': 'BG009'}, {'value': '0', 'groupId': 'BG010'}, {'value': '0', 'groupId': 'BG011'}, {'value': '0', 'groupId': 'BG012'}, {'value': '0', 'groupId': 'BG013'}, {'value': '0', 'groupId': 'BG014'}, {'value': '0', 'groupId': 'BG015'}, {'value': '0', 'groupId': 'BG016'}, {'value': '0', 'groupId': 'BG017'}, {'value': '0', 'groupId': 'BG018'}, {'value': '0', 'groupId': 'BG019'}, {'value': '0', 'groupId': 'BG020'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'White', 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '9', 'groupId': 'BG003'}, {'value': '10', 'groupId': 'BG004'}, {'value': '7', 'groupId': 'BG005'}, {'value': '9', 'groupId': 'BG006'}, {'value': '20', 'groupId': 'BG007'}, {'value': '17', 'groupId': 'BG008'}, {'value': '20', 'groupId': 'BG009'}, {'value': '9', 'groupId': 'BG010'}, {'value': '9', 'groupId': 'BG011'}, {'value': '23', 'groupId': 'BG012'}, {'value': '9', 'groupId': 'BG013'}, {'value': '20', 'groupId': 'BG014'}, {'value': '8', 'groupId': 'BG015'}, {'value': '9', 'groupId': 'BG016'}, {'value': '7', 'groupId': 'BG017'}, {'value': '12', 'groupId': 'BG018'}, {'value': '22', 'groupId': 'BG019'}, {'value': '239', 'groupId': 'BG020'}]}]}, {'title': 'Asian', 'categories': [{'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': '0', 'groupId': 'BG006'}, {'value': '2', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '1', 'groupId': 'BG009'}, {'value': '1', 'groupId': 'BG010'}, {'value': '0', 'groupId': 'BG011'}, {'value': '0', 'groupId': 'BG012'}, {'value': '0', 'groupId': 'BG013'}, {'value': '1', 'groupId': 'BG014'}, {'value': '0', 'groupId': 'BG015'}, {'value': '0', 'groupId': 'BG016'}, {'value': '3', 'groupId': 'BG017'}, {'value': '1', 'groupId': 'BG018'}, {'value': '0', 'groupId': 'BG019'}, {'value': '11', 'groupId': 'BG020'}]}]}, {'title': 'Native Hawaiian of Other Pacific Islander', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '2', 'groupId': 'BG008'}, {'value': '1', 'groupId': 'BG009'}, {'value': '0', 'groupId': 'BG010'}, {'value': '0', 'groupId': 'BG011'}, {'value': '1', 'groupId': 'BG012'}, {'value': '0', 'groupId': 'BG013'}, {'value': '0', 'groupId': 'BG014'}, {'value': '0', 'groupId': 'BG015'}, {'value': '0', 'groupId': 'BG016'}, {'value': '0', 'groupId': 'BG017'}, {'value': '0', 'groupId': 'BG018'}, {'value': '1', 'groupId': 'BG019'}, {'value': '5', 'groupId': 'BG020'}]}]}, {'title': 'American Indian or Alaska Native', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '0', 'groupId': 'BG009'}, {'value': '0', 'groupId': 'BG010'}, {'value': '0', 'groupId': 'BG011'}, {'value': '0', 'groupId': 'BG012'}, {'value': '0', 'groupId': 'BG013'}, {'value': '0', 'groupId': 'BG014'}, {'value': '0', 'groupId': 'BG015'}, {'value': '0', 'groupId': 'BG016'}, {'value': '0', 'groupId': 'BG017'}, {'value': '0', 'groupId': 'BG018'}, {'value': '0', 'groupId': 'BG019'}, {'value': '1', 'groupId': 'BG020'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '3', 'groupId': 'BG005'}, {'value': '1', 'groupId': 'BG006'}, {'value': '3', 'groupId': 'BG007'}, {'value': '6', 'groupId': 'BG008'}, {'value': '3', 'groupId': 'BG009'}, {'value': '0', 'groupId': 'BG010'}, {'value': '0', 'groupId': 'BG011'}, {'value': '1', 'groupId': 'BG012'}, {'value': '1', 'groupId': 'BG013'}, {'value': '4', 'groupId': 'BG014'}, {'value': '2', 'groupId': 'BG015'}, {'value': '0', 'groupId': 'BG016'}, {'value': '0', 'groupId': 'BG017'}, {'value': '1', 'groupId': 'BG018'}, {'value': '2', 'groupId': 'BG019'}, {'value': '36', 'groupId': 'BG020'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Hepatitis C Virus (HCV) RNA', 'classes': [{'categories': [{'measurements': [{'value': '6.7', 'spread': '0.42', 'groupId': 'BG000'}, {'value': '6.6', 'spread': '0.52', 'groupId': 'BG001'}, {'value': '6.4', 'spread': '0.57', 'groupId': 'BG002'}, {'value': '6.3', 'spread': '0.76', 'groupId': 'BG003'}, {'value': '5.7', 'spread': '0.89', 'groupId': 'BG004'}, {'value': '6.1', 'spread': '0.88', 'groupId': 'BG005'}, {'value': '6.8', 'spread': '0.55', 'groupId': 'BG006'}, {'value': '6.1', 'spread': '0.75', 'groupId': 'BG007'}, {'value': '6.5', 'spread': '0.66', 'groupId': 'BG008'}, {'value': '6.1', 'spread': '0.80', 'groupId': 'BG009'}, {'value': '6.2', 'spread': '0.96', 'groupId': 'BG010'}, {'value': '6.9', 'spread': '0.20', 'groupId': 'BG011'}, {'value': '5.9', 'spread': '0.85', 'groupId': 'BG012'}, {'value': '7.0', 'spread': '0.38', 'groupId': 'BG013'}, {'value': '6.3', 'spread': '0.54', 'groupId': 'BG014'}, {'value': '6.5', 'spread': '0.57', 'groupId': 'BG015'}, {'value': '6.3', 'spread': '0.78', 'groupId': 'BG016'}, {'value': '6.1', 'spread': '0.94', 'groupId': 'BG017'}, {'value': '6.5', 'spread': '0.51', 'groupId': 'BG018'}, {'value': '6.5', 'spread': '0.56', 'groupId': 'BG019'}, {'value': '6.3', 'spread': '0.73', 'groupId': 'BG020'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'log10 IU/mL', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'HCV RNA Category', 'classes': [{'title': '< 6 log10 IU/mL', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '5', 'groupId': 'BG004'}, {'value': '5', 'groupId': 'BG005'}, {'value': '1', 'groupId': 'BG006'}, {'value': '10', 'groupId': 'BG007'}, {'value': '5', 'groupId': 'BG008'}, {'value': '12', 'groupId': 'BG009'}, {'value': '4', 'groupId': 'BG010'}, {'value': '0', 'groupId': 'BG011'}, {'value': '11', 'groupId': 'BG012'}, {'value': '0', 'groupId': 'BG013'}, {'value': '8', 'groupId': 'BG014'}, {'value': '2', 'groupId': 'BG015'}, {'value': '3', 'groupId': 'BG016'}, {'value': '5', 'groupId': 'BG017'}, {'value': '2', 'groupId': 'BG018'}, {'value': '6', 'groupId': 'BG019'}, {'value': '87', 'groupId': 'BG020'}]}]}, {'title': '≥ 6 log10 IU/mL', 'categories': [{'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}, {'value': '8', 'groupId': 'BG003'}, {'value': '5', 'groupId': 'BG004'}, {'value': '5', 'groupId': 'BG005'}, {'value': '9', 'groupId': 'BG006'}, {'value': '15', 'groupId': 'BG007'}, {'value': '20', 'groupId': 'BG008'}, {'value': '13', 'groupId': 'BG009'}, {'value': '6', 'groupId': 'BG010'}, {'value': '9', 'groupId': 'BG011'}, {'value': '14', 'groupId': 'BG012'}, {'value': '10', 'groupId': 'BG013'}, {'value': '17', 'groupId': 'BG014'}, {'value': '8', 'groupId': 'BG015'}, {'value': '6', 'groupId': 'BG016'}, {'value': '5', 'groupId': 'BG017'}, {'value': '12', 'groupId': 'BG018'}, {'value': '19', 'groupId': 'BG019'}, {'value': '205', 'groupId': 'BG020'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'HCV Genotype', 'classes': [{'title': 'Genotype 1', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '10', 'groupId': 'BG006'}, {'value': '25', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '0', 'groupId': 'BG009'}, {'value': '0', 'groupId': 'BG010'}, {'value': '9', 'groupId': 'BG011'}, {'value': '25', 'groupId': 'BG012'}, {'value': '10', 'groupId': 'BG013'}, {'value': '25', 'groupId': 'BG014'}, {'value': '10', 'groupId': 'BG015'}, {'value': '9', 'groupId': 'BG016'}, {'value': '0', 'groupId': 'BG017'}, {'value': '14', 'groupId': 'BG018'}, {'value': '25', 'groupId': 'BG019'}, {'value': '162', 'groupId': 'BG020'}]}]}, {'title': 'Genotype 2', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '6', 'groupId': 'BG008'}, {'value': '5', 'groupId': 'BG009'}, {'value': '0', 'groupId': 'BG010'}, {'value': '0', 'groupId': 'BG011'}, {'value': '0', 'groupId': 'BG012'}, {'value': '0', 'groupId': 'BG013'}, {'value': '0', 'groupId': 'BG014'}, {'value': '0', 'groupId': 'BG015'}, {'value': '0', 'groupId': 'BG016'}, {'value': '2', 'groupId': 'BG017'}, {'value': '0', 'groupId': 'BG018'}, {'value': '0', 'groupId': 'BG019'}, {'value': '31', 'groupId': 'BG020'}]}]}, {'title': 'Genotype 3', 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '7', 'groupId': 'BG003'}, {'value': '7', 'groupId': 'BG004'}, {'value': '10', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '19', 'groupId': 'BG008'}, {'value': '20', 'groupId': 'BG009'}, {'value': '10', 'groupId': 'BG010'}, {'value': '0', 'groupId': 'BG011'}, {'value': '0', 'groupId': 'BG012'}, {'value': '0', 'groupId': 'BG013'}, {'value': '0', 'groupId': 'BG014'}, {'value': '0', 'groupId': 'BG015'}, {'value': '0', 'groupId': 'BG016'}, {'value': '8', 'groupId': 'BG017'}, {'value': '0', 'groupId': 'BG018'}, {'value': '0', 'groupId': 'BG019'}, {'value': '99', 'groupId': 'BG020'}]}]}], 'paramType': 'NUMBER', 'description': 'There are variations of HCV which are all similar enough to be called HCV, but are distinct enough to be referred to as HCV genotypes.', 'unitOfMeasure': 'participants'}, {'title': 'IL28b Genotype', 'classes': [{'title': 'CC', 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}, {'value': '3', 'groupId': 'BG005'}, {'value': '10', 'groupId': 'BG006'}, {'value': '25', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '13', 'groupId': 'BG009'}, {'value': '4', 'groupId': 'BG010'}, {'value': '0', 'groupId': 'BG011'}, {'value': '9', 'groupId': 'BG012'}, {'value': '1', 'groupId': 'BG013'}, {'value': '7', 'groupId': 'BG014'}, {'value': '4', 'groupId': 'BG015'}, {'value': '2', 'groupId': 'BG016'}, {'value': '3', 'groupId': 'BG017'}, {'value': '4', 'groupId': 'BG018'}, {'value': '5', 'groupId': 'BG019'}, {'value': '109', 'groupId': 'BG020'}]}]}, {'title': 'CT', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}, {'value': '6', 'groupId': 'BG004'}, {'value': '6', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '6', 'groupId': 'BG008'}, {'value': '12', 'groupId': 'BG009'}, {'value': '5', 'groupId': 'BG010'}, {'value': '7', 'groupId': 'BG011'}, {'value': '14', 'groupId': 'BG012'}, {'value': '8', 'groupId': 'BG013'}, {'value': '14', 'groupId': 'BG014'}, {'value': '4', 'groupId': 'BG015'}, {'value': '5', 'groupId': 'BG016'}, {'value': '6', 'groupId': 'BG017'}, {'value': '7', 'groupId': 'BG018'}, {'value': '15', 'groupId': 'BG019'}, {'value': '132', 'groupId': 'BG020'}]}]}, {'title': 'TT', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}, {'value': '1', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '19', 'groupId': 'BG008'}, {'value': '0', 'groupId': 'BG009'}, {'value': '1', 'groupId': 'BG010'}, {'value': '2', 'groupId': 'BG011'}, {'value': '2', 'groupId': 'BG012'}, {'value': '1', 'groupId': 'BG013'}, {'value': '4', 'groupId': 'BG014'}, {'value': '2', 'groupId': 'BG015'}, {'value': '2', 'groupId': 'BG016'}, {'value': '1', 'groupId': 'BG017'}, {'value': '3', 'groupId': 'BG018'}, {'value': '5', 'groupId': 'BG019'}, {'value': '51', 'groupId': 'BG020'}]}]}], 'paramType': 'NUMBER', 'description': 'CC, CT, and TT alleles are different forms of the IL28b gene.', 'unitOfMeasure': 'participants'}, {'title': 'Cirrhosis Status', 'classes': [{'title': 'Yes', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '0', 'groupId': 'BG009'}, {'value': '0', 'groupId': 'BG010'}, {'value': '0', 'groupId': 'BG011'}, {'value': '0', 'groupId': 'BG012'}, {'value': '0', 'groupId': 'BG013'}, {'value': '0', 'groupId': 'BG014'}, {'value': '10', 'groupId': 'BG015'}, {'value': '9', 'groupId': 'BG016'}, {'value': '0', 'groupId': 'BG017'}, {'value': '1', 'groupId': 'BG018'}, {'value': '0', 'groupId': 'BG019'}, {'value': '20', 'groupId': 'BG020'}]}]}, {'title': 'No', 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}, {'value': '11', 'groupId': 'BG003'}, {'value': '10', 'groupId': 'BG004'}, {'value': '10', 'groupId': 'BG005'}, {'value': '10', 'groupId': 'BG006'}, {'value': '25', 'groupId': 'BG007'}, {'value': '25', 'groupId': 'BG008'}, {'value': '25', 'groupId': 'BG009'}, {'value': '10', 'groupId': 'BG010'}, {'value': '9', 'groupId': 'BG011'}, {'value': '25', 'groupId': 'BG012'}, {'value': '10', 'groupId': 'BG013'}, {'value': '25', 'groupId': 'BG014'}, {'value': '0', 'groupId': 'BG015'}, {'value': '0', 'groupId': 'BG016'}, {'value': '10', 'groupId': 'BG017'}, {'value': '13', 'groupId': 'BG018'}, {'value': '25', 'groupId': 'BG019'}, {'value': '272', 'groupId': 'BG020'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'Safety Analysis Set: participants were randomized and received at least one dose of study medication.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 292}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-11', 'dispFirstSubmitDate': '2014-05-28', 'completionDateStruct': {'date': '2013-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-11-07', 'studyFirstSubmitDate': '2010-12-13', 'dispFirstSubmitQcDate': '2014-05-28', 'resultsFirstSubmitDate': '2014-11-07', 'studyFirstSubmitQcDate': '2010-12-13', 'dispFirstPostDateStruct': {'date': '2014-06-02', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2014-11-17', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2014-11-07', 'studyFirstPostDateStruct': {'date': '2010-12-15', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-11-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Participants Who Experienced Adverse Events', 'timeFrame': 'Up to 12 weeks plus 30 days', 'description': 'Adverse events (AEs) occurring from baseline (Day 1 for all groups) to 30 days following the last dose of study drug were summarized across the participant population. A participant was counted once if they had a qualifying event.'}], 'secondaryOutcomes': [{'measure': 'Percentage of Participants With Sustained Virologic Response 12 Weeks Following Completion of Treatment (SVR12)', 'timeFrame': 'Posttreatment Week 12', 'description': 'SVR12 was defined as HCV RNA \\< the limit of detection (LOD; \\< 15 IU/mL) 12 weeks after the last dose of study drug.'}, {'measure': 'Percentage of Participants With HCV RNA < LOD at Week 6', 'timeFrame': 'Week 6'}, {'measure': 'Percentage of Participants With HCV RNA < LOD at Week 8', 'timeFrame': 'Week 8', 'description': 'Data are not presented for Group 21 which ended treatment after Week 6.'}, {'measure': 'Percentage of Participants With HCV RNA < LOD at Week 12', 'timeFrame': 'Week 12', 'description': 'Data are not presented for Groups 6, 10, and 21 which ended treatment after Week 8 or Week 6.'}, {'measure': 'Change From Baseline in HCV RNA at Week 6', 'timeFrame': 'Baseline to Week 6'}, {'measure': 'Change From Baseline in HCV RNA at Week 8', 'timeFrame': 'Baseline to Week 8', 'description': 'Data are not presented for Group 21 which ended treatment after Week 6.'}, {'measure': 'Change From Baseline in HCV RNA at Week 12', 'timeFrame': 'Baseline to Week 12', 'description': 'Data are not presented for Groups 6, 10, and 21 which ended treatment after Week 8 or Week 6. Data are not presented for Groups 16, 17, 18, and 20 because participants with detectable HCV RNA discontinued due to protocol-specified stopping rules.'}, {'measure': 'Percentage of Participants With Virologic Failure', 'timeFrame': 'Up to Posttreatment Week 24', 'description': 'The percentage of participants with on-treatment virologic failure (viral breakthrough, rebound, or nonresponse) or following treatment (viral relapse) was summarized.\n\nOn-treatment virologic failure was defined as:\n\n* Viral breakthrough (confirmed HCV RNA ≥ LOD after having previously had HCV RNA \\< LOD while on treatment),\n* Viral rebound (confirmed \\> 1 log10 IU/mL increase in HCV RNA from nadir while on treatment, or\n* Nonresponse (HCV RNA persistently ≥ LOD through 6 weeks of treatment)\n\nViral relapse was defined as confirmed HCV RNA ≥ LOD during the posttreatment period having achieved HCV RNA \\< LOD at the last on-treatment visit.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['PSI-7977', 'Sofosbuvir', 'GS-7977', 'GS-5885', 'GS-9669', 'FDC', 'ribavirin', 'RBV', 'Pegylated Interferon', 'PEG-IFN', 'Chronic Hepatitis C Infection', 'HCV', 'Hepatitis', 'Genotype 1', 'Genotype 2', 'Genotype 3', 'GT 1', 'GT 2', 'GT 3', 'Hemophilia'], 'conditions': ['Chronic Hepatitis C Infection']}, 'referencesModule': {'references': [{'pmid': '24262278', 'type': 'RESULT', 'citation': 'Gane EJ, Stedman CA, Hyland RH, Ding X, Svarovskaia E, Subramanian GM, Symonds WT, McHutchison JG, Pang PS. Efficacy of nucleotide polymerase inhibitor sofosbuvir plus the NS5A inhibitor ledipasvir or the NS5B non-nucleoside inhibitor GS-9669 against HCV genotype 1 infection. Gastroenterology. 2014 Mar;146(3):736-743.e1. doi: 10.1053/j.gastro.2013.11.007. Epub 2013 Nov 18.'}, {'pmid': '23281974', 'type': 'RESULT', 'citation': 'Gane EJ, Stedman CA, Hyland RH, Ding X, Svarovskaia E, Symonds WT, Hindes RG, Berrey MM. Nucleotide polymerase inhibitor sofosbuvir plus ribavirin for hepatitis C. N Engl J Med. 2013 Jan 3;368(1):34-44. doi: 10.1056/NEJMoa1208953.'}]}, 'descriptionModule': {'briefSummary': 'This study is to assess the safety and tolerability of sofosbuvir (SOF) 400 mg with and without ribavirin (RBV) and/or with and without pegylated interferon alfa-2a (PEG) in subjects with genotype 1, 2 or 3 hepatitis C (HCV) infection.', 'detailedDescription': 'Part 1: HCV genotype 2 or 3: participants will receive SOF 400 mg once daily with weight-based RBV for 12 weeks. Participants will be randomized in equal proportions to: no PEG (Arm 1), PEG for 4 weeks (Arm 2), PEG for 8 weeks (Arm 3), or PEG for 12 weeks (Arm 4).\n\nPart 2: HCV genotype 2 or 3: participants will receive SOF 400 mg once daily (monotherapy) for 12 weeks (Arm 5), or SOF 400 mg once daily with PEG and weight-based RBV for 8 weeks (Arm 6); HCV genotype 1: null responders (did not respond to their prior treatment) will receive SOF 400 mg once daily with weight-based RBV for 12 weeks (Arm 7).\n\nPart 3: HCV genotype 1 treatment-naive (Arm 8) or HCV genotype 2 or 3 treatment-experienced participants (Arm 9) will receive SOF 400 mg once daily in combination with weight-based RBV for 12 weeks.\n\nPart 4: HCV genotype 2 or 3 treatment naive participants will receive SOF 400 mg once daily with weight-based RBV for 8 weeks (Arm 10) or SOF 400 mg once daily and 800 mg RBV for 12 weeks (Arm 11). HCV genotype 1 null responders will receive SOF 400 mg once daily, ledipasvir (LDV), and weight based RBV for 12 weeks (Arm 12). HCV genotype-1 treatment naive participants will receive SOF 400 mg once daily with weight-based RBV and LDV for 12 weeks (Arm 13).\n\nPart 5: HCV genotype 1 null responders will receive SOF 400 mg once daily with GS-9669 500 mg once daily and weight-based RBV for 12 weeks (Arm 14). HCV genotype-1 treatment naive participants receive SOF 400 mg once daily with GS-9669 500 mg once daily and weight-based RBV for 12 weeks (Arm 15).\n\nPart 6: HCV genotype 1 null responders with Stage F4 fibrosis will receive LDV/SOF FDC for 12 weeks (Arm 16) or LDV/SOF FDC with weight-based RBV for 12 weeks (Arm 17). HCV genotype 2 or 3 treatment-naive participants will receive LDV/SOF FDC for 12 weeks (Arm 18). HCV genotype 2 or 3 treatment-experienced participants will receive LDV/SOF FDC for 12 weeks (Arm 19). HCV genotype 1 hemophiliacs will receive LDV/SOF FDC with weight-based RBV for 12 weeks (Arm 20). HCV genotype 1 treatment-naive participants will receive LDV/SOF FDC with weight-based RBV for 6 weeks (Arm 21). HCV genotype 1 treatment-naive participants will receive LDV/SOF FDC for 6 weeks (Arm 22).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Chronic Genotype 2 or 3 HCV-infection or Genotype 1, serum HCV RNA ≥ 50,000 IU/mL\n* Not co-infected with HIV\n* Use of highly effective contraception methods if female of childbearing potential or sexually active male\n\nExclusion Criteria:\n\n* History of any other clinically significant chronic liver disease\n* Pregnant or nursing female or male with pregnant female partner\n* History of significant drug allergy to nucleoside/nucleotide analogs.\n* Participation in a clinical study within 3 months prior to first dose\n* Positive result for significant drug use at Screening'}, 'identificationModule': {'nctId': 'NCT01260350', 'briefTitle': 'Open-Labeled Study of PSI-7977 and RBV With and Without PEG-IFN in Treatment-Naïve Patients With HCV GT2 or GT3', 'organization': {'class': 'INDUSTRY', 'fullName': 'Gilead Sciences'}, 'officialTitle': 'A Multi-center, Open-Labeled Exploratory Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics Following Oral Administration of PSI-7977 400 mg and Ribavirin for 12 Weeks With and Without Pegylated Interferon in Treatment-Naïve Patients With Chronic HCV Infection Genotype 2 or Genotype 3', 'orgStudyIdInfo': {'id': 'P7977-0523'}, 'secondaryIdInfos': [{'id': 'Medsafe', 'type': 'OTHER', 'domain': 'Medsafe TT50-8648 (1133)'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group 1: SOF+RBV 12 wk: GT 2 or 3, TN', 'description': 'Treatment-naive (TN) participants with genotype (GT) 2 or 3 HCV infection will receive SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks.', 'interventionNames': ['Drug: SOF', 'Drug: RBV']}, {'type': 'EXPERIMENTAL', 'label': 'Group 2: SOF+RBV 12 wk+PEG 4 wk: GT 2 or 3, TN', 'description': 'Treatment-naive participants with genotype 2 or 3 HCV infection will receive SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks plus PEG 180 µg once weekly for 4 weeks.', 'interventionNames': ['Drug: SOF', 'Drug: RBV', 'Drug: PEG']}, {'type': 'EXPERIMENTAL', 'label': 'Group 3: SOF+RBV 12 wk+PEG 8 wk: GT 2 or 3, TN', 'description': 'Treatment-naive participants with genotype 2 or 3 HCV infection will receive SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks plus PEG 180 µg once weekly for 8 weeks.', 'interventionNames': ['Drug: SOF', 'Drug: RBV', 'Drug: PEG']}, {'type': 'EXPERIMENTAL', 'label': 'Group 4: SOF+RBV+PEG 12 wk: GT 2 or 3, TN', 'description': 'Treatment-naive participants with genotype 2 or 3 HCV infection will receive SOF 400 mg once daily+weight-based RBV (1000-1200 in a divided daily dose) plus PEG 180 µg once weekly for 12 weeks.', 'interventionNames': ['Drug: SOF', 'Drug: RBV', 'Drug: PEG']}, {'type': 'EXPERIMENTAL', 'label': 'Group 5: SOF 12 wk: GT 2 or 3, TN', 'description': 'Treatment-naive participants with genotype 2 or 3 HCV infection will receive SOF 400 mg once daily for 12 weeks.', 'interventionNames': ['Drug: SOF']}, {'type': 'EXPERIMENTAL', 'label': 'Group 6: SOF+RBV+PEG 8 wk: GT 2 or 3, TN', 'description': 'Treatment-naive participants with genotype 2 or 3 HCV infection will receive SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus PEG 180 µg once weekly for 8 weeks.', 'interventionNames': ['Drug: SOF', 'Drug: RBV', 'Drug: PEG']}, {'type': 'EXPERIMENTAL', 'label': 'Group 7: SOF+RBV 12 wk: GT 1, TE', 'description': 'Treatment-experienced (TE) participants with genotype 1 HCV infection who did not respond to prior treatment will receive SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks.', 'interventionNames': ['Drug: SOF', 'Drug: RBV']}, {'type': 'EXPERIMENTAL', 'label': 'Group 8: SOF+RBV 12 wk: GT 1, TN', 'description': 'Treatment-naive participants with genotype 1 HCV infection will receive SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks.', 'interventionNames': ['Drug: SOF', 'Drug: RBV']}, {'type': 'EXPERIMENTAL', 'label': 'Group 9: SOF+RBV 12 wk: GT 2 or 3, TE', 'description': 'Treatment-experienced participants with genotype 2 or 3 HCV infection will receive SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks.', 'interventionNames': ['Drug: SOF', 'Drug: RBV']}, {'type': 'EXPERIMENTAL', 'label': 'Group 10: SOF+RBV 8 wk: GT 2 or 3, TN', 'description': 'Treatment-naive participants with genotype 2 or 3 HCV infection will receive SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 8 weeks.', 'interventionNames': ['Drug: SOF', 'Drug: RBV']}, {'type': 'EXPERIMENTAL', 'label': 'Group 11: SOF+RBV 12 wk: GT 2 or 3, TN', 'description': 'Treatment-naive participants with genotype 2 or 3 HCV infection will receive SOF 400 mg once daily plus split-dose RBV (800 mg in a divided daily dose) for 12 weeks.', 'interventionNames': ['Drug: SOF', 'Drug: RBV']}, {'type': 'EXPERIMENTAL', 'label': 'Group 12: SOF+RBV+LDV 12 wk: GT 1, TE', 'description': 'Treatment-experienced participants with genotype 1 HCV infection who did not respond to prior treatment will receive SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus LDV 90 mg once daily for 12 weeks.', 'interventionNames': ['Drug: SOF', 'Drug: RBV', 'Drug: LDV']}, {'type': 'EXPERIMENTAL', 'label': 'Group 13: SOF+RBV+LDV 12 wk: GT 1, TN', 'description': 'Treatment-naive participants with genotype 1 HCV infection will receive SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus LDV 90 mg once daily for 12 weeks.', 'interventionNames': ['Drug: SOF', 'Drug: RBV', 'Drug: LDV']}, {'type': 'EXPERIMENTAL', 'label': 'Group 14: SOF+RBV+GS-9669 12 wk: GT 1, TE', 'description': 'Treatment-experienced participants with genotype 1 HCV infection who did not respond to prior treatment will receive SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus GS-9669 500 mg once daily for 12 weeks.', 'interventionNames': ['Drug: SOF', 'Drug: RBV', 'Drug: GS-9669']}, {'type': 'EXPERIMENTAL', 'label': 'Group 15: SOF+RBV+GS-9669 12 wk: GT 1, TN', 'description': 'Treatment-naive participants with genotype 1 HCV infection will receive SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus GS-9669 500 mg once daily for 12 weeks.', 'interventionNames': ['Drug: SOF', 'Drug: RBV', 'Drug: GS-9669']}, {'type': 'EXPERIMENTAL', 'label': 'Group 16: LDV/SOF FDC 12 wk: GT 1, fibrosis', 'description': 'Treatment-experienced participants with genotype 1 HCV infection and Stage F4 fibrosis who did not respond to prior treatment will receive LDV 90 mg/SOF 400 mg FDC once daily for 12 weeks.', 'interventionNames': ['Drug: LDV/SOF']}, {'type': 'EXPERIMENTAL', 'label': 'Group 17: LDV/SOF FDC+RBV 12 wk: GT 1, fibrosis', 'description': 'Treatment-experienced participants with genotype 1 HCV infection with Stage F4 fibrosis who did not respond to prior treatment will receive LDV 90 mg/SOF 400 mg FDC once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks.', 'interventionNames': ['Drug: RBV', 'Drug: LDV/SOF']}, {'type': 'EXPERIMENTAL', 'label': 'Group 18: LDV/SOF FDC 12 wk: GT 2 or 3, TN', 'description': 'Treatment-naive participants with genotype 2 or 3 HCV infection will receive LDV 90 mg/SOF 400 mg FDC once daily for 12 weeks.', 'interventionNames': ['Drug: LDV/SOF']}, {'type': 'EXPERIMENTAL', 'label': 'Group 19: LDV/SOF FDC 12 wk: GT 2 or 3, TE', 'description': 'Treatment-experienced participants with genotype 2 or 3 HCV infection will receive LDV 90 mg/SOF 400 mg FDC once daily for 12 weeks.', 'interventionNames': ['Drug: LDV/SOF']}, {'type': 'EXPERIMENTAL', 'label': 'Group 20: LDV/SOF FDC+RBV 12 wk: GT 1, hemophiliac', 'description': 'Hemophiliac participants with genotype 1 HCV infection will receive LDV 90 mg/SOF 400 mg FDC once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks.', 'interventionNames': ['Drug: RBV', 'Drug: LDV/SOF']}, {'type': 'EXPERIMENTAL', 'label': 'Group 21: LDV/SOF FDC+RBV 6 wk: GT 1, TN', 'description': 'Treatment-naive participants with genotype 1 HCV infection will receive LDV 90 mg/SOF 400 mg FDC once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 6 weeks.', 'interventionNames': ['Drug: RBV', 'Drug: LDV/SOF']}, {'type': 'EXPERIMENTAL', 'label': 'Group 22: LDV/SOF FDC 6 wk: GT 1, TN', 'description': 'Treatment-naive participants with genotype 1 HCV infection were randomized to receive LDV 90 mg/SOF 400 mg FDC once daily for 6 weeks.', 'interventionNames': ['Drug: LDV/SOF']}], 'interventions': [{'name': 'SOF', 'type': 'DRUG', 'otherNames': ['Sovaldi®', 'GS-7977', 'PSI-7977'], 'description': 'Sofosbuvir (SOF) tablets administered orally once daily', 'armGroupLabels': ['Group 10: SOF+RBV 8 wk: GT 2 or 3, TN', 'Group 11: SOF+RBV 12 wk: GT 2 or 3, TN', 'Group 12: SOF+RBV+LDV 12 wk: GT 1, TE', 'Group 13: SOF+RBV+LDV 12 wk: GT 1, TN', 'Group 14: SOF+RBV+GS-9669 12 wk: GT 1, TE', 'Group 15: SOF+RBV+GS-9669 12 wk: GT 1, TN', 'Group 1: SOF+RBV 12 wk: GT 2 or 3, TN', 'Group 2: SOF+RBV 12 wk+PEG 4 wk: GT 2 or 3, TN', 'Group 3: SOF+RBV 12 wk+PEG 8 wk: GT 2 or 3, TN', 'Group 4: SOF+RBV+PEG 12 wk: GT 2 or 3, TN', 'Group 5: SOF 12 wk: GT 2 or 3, TN', 'Group 6: SOF+RBV+PEG 8 wk: GT 2 or 3, TN', 'Group 7: SOF+RBV 12 wk: GT 1, TE', 'Group 8: SOF+RBV 12 wk: GT 1, TN', 'Group 9: SOF+RBV 12 wk: GT 2 or 3, TE']}, {'name': 'RBV', 'type': 'DRUG', 'otherNames': ['Copegus®'], 'description': 'Ribavirin (RBV) capsules administered orally in a divided daily dose', 'armGroupLabels': ['Group 10: SOF+RBV 8 wk: GT 2 or 3, TN', 'Group 11: SOF+RBV 12 wk: GT 2 or 3, TN', 'Group 12: SOF+RBV+LDV 12 wk: GT 1, TE', 'Group 13: SOF+RBV+LDV 12 wk: GT 1, TN', 'Group 14: SOF+RBV+GS-9669 12 wk: GT 1, TE', 'Group 15: SOF+RBV+GS-9669 12 wk: GT 1, TN', 'Group 17: LDV/SOF FDC+RBV 12 wk: GT 1, fibrosis', 'Group 1: SOF+RBV 12 wk: GT 2 or 3, TN', 'Group 20: LDV/SOF FDC+RBV 12 wk: GT 1, hemophiliac', 'Group 21: LDV/SOF FDC+RBV 6 wk: GT 1, TN', 'Group 2: SOF+RBV 12 wk+PEG 4 wk: GT 2 or 3, TN', 'Group 3: SOF+RBV 12 wk+PEG 8 wk: GT 2 or 3, TN', 'Group 4: SOF+RBV+PEG 12 wk: GT 2 or 3, TN', 'Group 6: SOF+RBV+PEG 8 wk: GT 2 or 3, TN', 'Group 7: SOF+RBV 12 wk: GT 1, TE', 'Group 8: SOF+RBV 12 wk: GT 1, TN', 'Group 9: SOF+RBV 12 wk: GT 2 or 3, TE']}, {'name': 'PEG', 'type': 'DRUG', 'otherNames': ['Pegasys®'], 'description': 'Peginterferon alfa-2a (PEG) administered via subcutaneous injection once weekly', 'armGroupLabels': ['Group 2: SOF+RBV 12 wk+PEG 4 wk: GT 2 or 3, TN', 'Group 3: SOF+RBV 12 wk+PEG 8 wk: GT 2 or 3, TN', 'Group 4: SOF+RBV+PEG 12 wk: GT 2 or 3, TN', 'Group 6: SOF+RBV+PEG 8 wk: GT 2 or 3, TN']}, {'name': 'LDV', 'type': 'DRUG', 'otherNames': ['GS-5885'], 'description': 'Ledipasvir (LDV) tablets administered orally once daily', 'armGroupLabels': ['Group 12: SOF+RBV+LDV 12 wk: GT 1, TE', 'Group 13: SOF+RBV+LDV 12 wk: GT 1, TN']}, {'name': 'GS-9669', 'type': 'DRUG', 'description': 'GS-9669 tablets administered orally once daily', 'armGroupLabels': ['Group 14: SOF+RBV+GS-9669 12 wk: GT 1, TE', 'Group 15: SOF+RBV+GS-9669 12 wk: GT 1, TN']}, {'name': 'LDV/SOF', 'type': 'DRUG', 'otherNames': ['Harvoni®'], 'description': 'LDV/SOF fixed-dose combination (FDC) tablet administered once daily', 'armGroupLabels': ['Group 16: LDV/SOF FDC 12 wk: GT 1, fibrosis', 'Group 17: LDV/SOF FDC+RBV 12 wk: GT 1, fibrosis', 'Group 18: LDV/SOF FDC 12 wk: GT 2 or 3, TN', 'Group 19: LDV/SOF FDC 12 wk: GT 2 or 3, TE', 'Group 20: LDV/SOF FDC+RBV 12 wk: GT 1, hemophiliac', 'Group 21: LDV/SOF FDC+RBV 6 wk: GT 1, TN', 'Group 22: LDV/SOF FDC 6 wk: GT 1, TN']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Auckland', 'country': 'New Zealand', 'facility': 'Auckland Clinical Studies Ltd.', 'geoPoint': {'lat': -36.84853, 'lon': 174.76349}}, {'city': 'Christchurch', 'country': 'New Zealand', 'facility': 'Christchurch Clinical Studies Trust', 'geoPoint': {'lat': -43.53333, 'lon': 172.63333}}], 'overallOfficials': [{'name': 'Robert H. Hyland, DPhil', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Gilead Sciences'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Gilead Sciences', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}