Ignite Creation Date:
2025-12-26 @ 10:20 PM
Ignite Modification Date:
2026-04-08 @ 8:11 AM
Study NCT ID:
NCT02480712
Status:
COMPLETED
Last Update Posted:
2018-11-16
First Post:
2015-06-22
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Efficacy and Safety of Sofosbuvir/Velpatasvir Fixed Dose Combination for 12 Weeks in Adults With Chronic Hepatitis C Virus (HCV) and Human Immunodeficiency Virus (HIV)-1 Coinfection
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006526', 'term': 'Hepatitis C'}], 'ancestors': [{'id': 'D000086982', 'term': 'Blood-Borne Infections'}, {'id': 'D003141', 'term': 'Communicable Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D006525', 'term': 'Hepatitis, Viral, Human'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D018178', 'term': 'Flaviviridae Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D006505', 'term': 'Hepatitis'}, {'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000611331', 'term': 'sofosbuvir-velpatasvir drug combination'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTrialDisclosures@gilead.com', 'title': 'Clinical Trial Disclosures', 'organization': 'Gilead Sciences'}, 'certainAgreement': {'otherDetails': 'After conclusion of the study and without prior written approval from Gilead, investigators in this study may communicate, orally present, or publish in scientific journals or other media only after the following conditions have been met:\n\n* The results of the study in their entirety have been publicly disclosed by or with the consent of Gilead in an abstract, manuscript, or presentation form; or\n* The study has been completed at all study sites for at least 2 years', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Up to 12 Weeks Plus 30 Days', 'description': 'Safety Analysis Set', 'eventGroups': [{'id': 'EG000', 'title': 'SOF/VEL 12 Weeks (Boosted TDF Containing Regimens)', 'description': 'SOF/VEL (400/100 mg) FDC tablet orally once daily in HCV treatment-naive and treatment-experienced (including treatment intolerant) participants with chronic HCV infection who were coinfected with HIV-1. Data for participants who took boosted TDF-containing regimens (defined as regimens containing TDF and RTV or COBI-boosted PIs or other agents (eg, EVG/COBI)) are summarized in this group.', 'otherNumAtRisk': 56, 'otherNumAffected': 34, 'seriousNumAtRisk': 56, 'seriousNumAffected': 2}, {'id': 'EG001', 'title': 'SOF/VEL 12 Weeks (Non-Boosted TDF Containing Regimens)', 'description': 'SOF/VEL (400/100 mg) FDC tablet orally once daily in HCV treatment-naive and treatment-experienced (including treatment intolerant) participants with chronic HCV infection who were coinfected with HIV-1. Data are summarized for participants who took non-boosted TDF-containing regimens (defined as regimens containing TDF and non-RTV or COBI-boosted PIs or other agents).', 'otherNumAtRisk': 35, 'otherNumAffected': 19, 'seriousNumAtRisk': 35, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'SOF/VEL 12 Weeks (Non TDF Containing Regimens)', 'description': 'SOF/VEL (400/100 mg) FDC tablet orally once daily in HCV treatment-naive and treatment-experienced (including treatment intolerant) participants with chronic HCV infection who were coinfected with HIV-1. Data are summarized for participants taking regimens that do not contain TDF.', 'otherNumAtRisk': 15, 'otherNumAffected': 9, 'seriousNumAtRisk': 15, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Abdominal distension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 56, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 35, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 15, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 56, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 35, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 15, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 56, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 35, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 15, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 56, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 35, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 15, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Toothache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 56, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 15, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 56, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 35, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 15, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Chest discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 56, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 35, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 15, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 56, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 35, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 15, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Seasonal allergy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 56, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 35, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 15, 'numAffected': 0}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 56, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 15, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Fungal infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 56, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 15, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 56, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 35, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 15, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 56, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 35, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 15, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 56, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 15, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 56, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 35, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 15, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 56, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 35, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 15, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Flank pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 56, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 15, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Muscle spasms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 56, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 15, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Osteoarthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 56, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 15, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 56, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 35, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 15, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 56, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 35, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 15, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Abnormal dreams', 'stats': [{'groupId': 'EG000', 'numAtRisk': 56, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 35, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 15, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 56, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 35, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 15, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 56, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 35, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 15, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Nervousness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 56, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 15, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 56, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 35, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 15, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Sinus congestion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 56, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 35, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 15, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 56, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 15, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 56, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 15, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}], 'seriousEvents': [{'term': 'Localised infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 56, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 15, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 56, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 15, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Urinary tract infection bacterial', 'stats': [{'groupId': 'EG000', 'numAtRisk': 56, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 15, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Radial nerve palsy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 56, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 15, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Participants With Sustained Virologic Response 12 Weeks After Discontinuation of Therapy (SVR12)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '106', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'SOF/VEL 12 Weeks', 'description': 'SOF/VEL (400/100 mg) FDC tablet orally once daily in HCV treatment-naive and treatment-experienced (including treatment intolerant) participants with chronic HCV infection who were coinfected with HIV-1'}], 'classes': [{'categories': [{'measurements': [{'value': '95.3', 'groupId': 'OG000', 'lowerLimit': '89.3', 'upperLimit': '98.5'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Posttreatment Week 12', 'description': 'SVR12 was defined as HCV RNA \\< the lower limit of quantitation (LLOQ) 12 weeks following the last dose of study drug.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set: All enrolled participants who received at least one dose of study drug.'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event', 'denoms': [{'units': 'Participants', 'counts': [{'value': '106', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'SOF/VEL 12 Weeks', 'description': 'SOF/VEL (400/100 mg) FDC tablet orally once daily in HCV treatment-naive and treatment-experienced (including treatment intolerant) participants with chronic HCV infection who were coinfected with HIV-1'}], 'classes': [{'categories': [{'measurements': [{'value': '1.9', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 12 weeks', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Analysis Set'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Sustained Virologic Response 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '106', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'SOF/VEL 12 Weeks', 'description': 'SOF/VEL (400/100 mg) FDC tablet orally once daily in HCV treatment-naive and treatment-experienced (including treatment intolerant) participants with chronic HCV infection who were coinfected with HIV-1'}], 'classes': [{'title': 'SVR4', 'categories': [{'measurements': [{'value': '95.3', 'groupId': 'OG000', 'lowerLimit': '89.3', 'upperLimit': '98.5'}]}]}, {'title': 'SVR24', 'categories': [{'measurements': [{'value': '95.3', 'groupId': 'OG000', 'lowerLimit': '89.3', 'upperLimit': '98.5'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Posttreatment Weeks 4 and 24', 'description': 'SVR4 and SVR24 were defined as HCV RNA \\< LLOQ at 4 and 24 weeks following the last dose of study drug, respectively.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With HCV RNA < LLOQ on Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '106', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'SOF/VEL 12 Weeks', 'description': 'SOF/VEL (400/100 mg) FDC tablet orally once daily in HCV treatment-naive and treatment-experienced (including treatment intolerant) participants with chronic HCV infection who were coinfected with HIV-1'}], 'classes': [{'title': 'Week 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '105', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '25.7', 'groupId': 'OG000', 'lowerLimit': '17.7', 'upperLimit': '35.2'}]}]}, {'title': 'Week 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '103', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '68.0', 'groupId': 'OG000', 'lowerLimit': '58.0', 'upperLimit': '76.8'}]}]}, {'title': 'Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '103', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '92.2', 'groupId': 'OG000', 'lowerLimit': '85.3', 'upperLimit': '96.6'}]}]}, {'title': 'Week 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '103', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '99.0', 'groupId': 'OG000', 'lowerLimit': '94.7', 'upperLimit': '100.0'}]}]}, {'title': 'Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '102', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000', 'lowerLimit': '96.4', 'upperLimit': '100.0'}]}]}, {'title': 'Week 10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '102', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000', 'lowerLimit': '96.4', 'upperLimit': '100.0'}]}]}, {'title': 'Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '102', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000', 'lowerLimit': '96.4', 'upperLimit': '100.0'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 12 Weeks', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in the Full Analysis Set with available data were analyzed.'}, {'type': 'SECONDARY', 'title': 'HCV RNA Change From Baseline/Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '106', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'SOF/VEL 12 Weeks', 'description': 'SOF/VEL (400/100 mg) FDC tablet orally once daily in HCV treatment-naive and treatment-experienced (including treatment intolerant) participants with chronic HCV infection who were coinfected with HIV-1'}], 'classes': [{'title': 'Change at Week 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '101', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-4.47', 'spread': '0.606', 'groupId': 'OG000'}]}]}, {'title': 'Change at Week 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '101', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-4.97', 'spread': '0.577', 'groupId': 'OG000'}]}]}, {'title': 'Change at Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '102', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-5.15', 'spread': '0.560', 'groupId': 'OG000'}]}]}, {'title': 'Change at Week 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '103', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-5.18', 'spread': '0.572', 'groupId': 'OG000'}]}]}, {'title': 'Change at Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '102', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-5.17', 'spread': '0.575', 'groupId': 'OG000'}]}]}, {'title': 'Change at Week 10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '102', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-5.17', 'spread': '0.575', 'groupId': 'OG000'}]}]}, {'title': 'Change at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '102', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-5.17', 'spread': '0.575', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to Week 12', 'unitOfMeasure': 'log10 IU/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in the Full Analysis Set with available data were analyzed.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Virologic Failure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '106', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'SOF/VEL 12 Weeks', 'description': 'SOF/VEL (400/100 mg) FDC tablet orally once daily in HCV treatment-naive and treatment-experienced (including treatment intolerant) participants with chronic HCV infection who were coinfected with HIV-1'}], 'classes': [{'categories': [{'measurements': [{'value': '1.9', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to Posttreatment Week 24', 'description': 'Virologic failure was defined as:\n\n* On-treatment virologic failure:\n\n * Breakthrough (confirmed HCV RNA ≥ LLOQ after having previously had HCV RNA \\< LLOQ while on treatment), or\n * Rebound (confirmed \\> 1 log10 IU/mL increase in HCV RNA from nadir while on treatment), or\n * Non-response (HCV RNA persistently ≥ LLOQ through 8 weeks of treatment)\n* Virologic relapse:\n\n * Confirmed HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA \\< LLOQ at last on-treatment visit', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants That Maintained HIV-1 RNA < 50 Copies/mL While On HCV Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'SOF/VEL 12 Weeks (Boosted TDF Containing Regimens)', 'description': 'SOF/VEL (400/100 mg) FDC tablet orally once daily in HCV treatment-naive and treatment-experienced (including treatment intolerant) participants with chronic HCV infection who were coinfected with HIV-1. Data for participants who took boosted TDF-containing regimens (defined as regimens containing TDF and ritonavir (RTV) or cobicistat (COBI)-boosted protease inhibitors (PIs) or other agents (eg, elvitegravir (EVG)/COBI)) are summarized in this group.'}, {'id': 'OG001', 'title': 'SOF/VEL 12 Weeks (Non-Boosted TDF Containing Regimens)', 'description': 'SOF/VEL (400/100 mg) FDC tablet orally once daily in HCV treatment-naive and treatment-experienced (including treatment intolerant) participants with chronic HCV infection who were coinfected with HIV-1. Data are summarized for participants who took non-boosted TDF-containing regimens (defined as regimens containing TDF and non-RTV or COBI-boosted PIs or other agents).'}, {'id': 'OG002', 'title': 'SOF/VEL 12 Weeks (Non TDF Containing Regimens)', 'description': 'SOF/VEL (400/100 mg) FDC tablet orally once daily in HCV treatment-naive and treatment-experienced (including treatment intolerant) participants with chronic HCV infection who were coinfected with HIV-1. Data are summarized for participants taking regimens that do not contain TDF.'}], 'classes': [{'title': 'Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '94.4', 'groupId': 'OG000'}, {'value': '97.1', 'groupId': 'OG001'}, {'value': '100', 'groupId': 'OG002'}]}]}, {'title': 'Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '96.3', 'groupId': 'OG000'}, {'value': '97.1', 'groupId': 'OG001'}, {'value': '100', 'groupId': 'OG002'}]}]}, {'title': 'Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '96.2', 'groupId': 'OG000'}, {'value': '100', 'groupId': 'OG001'}, {'value': '92.9', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 12 Weeks', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in the Safety Analysis Set with available data were analyzed by TDF-containing ART at baseline:\n\n* Boosted TDF-containing regimens\n* Non-boosted TDF-containing regimens\n* Non TDF-containing regimens'}, {'type': 'SECONDARY', 'title': 'Serum Creatinine Change From Baseline At the End of Treatment and At Posttreatment Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'SOF/VEL 12 Weeks (Boosted TDF Containing Regimens)', 'description': 'SOF/VEL (400/100 mg) FDC tablet orally once daily in HCV treatment-naive and treatment-experienced (including treatment intolerant) participants with chronic HCV infection who were coinfected with HIV-1. Data for participants who took boosted TDF-containing regimens (defined as regimens containing TDF and RTV or COBI-boosted PIs or other agents (eg, EVG/COBI)) are summarized in this group.'}, {'id': 'OG001', 'title': 'SOF/VEL 12 Weeks (Non-Boosted TDF Containing Regimens)', 'description': 'SOF/VEL (400/100 mg) FDC tablet orally once daily in HCV treatment-naive and treatment-experienced (including treatment intolerant) participants with chronic HCV infection who were coinfected with HIV-1. Data are summarized for participants who took non-boosted TDF-containing regimens (defined as regimens containing TDF and non-RTV or COBI-boosted PIs or other agents).'}, {'id': 'OG002', 'title': 'SOF/VEL 12 Weeks (Non TDF Containing Regimens)', 'description': 'SOF/VEL (400/100 mg) FDC tablet orally once daily in HCV treatment-naive and treatment-experienced (including treatment intolerant) participants with chronic HCV infection who were coinfected with HIV-1. Data are summarized for participants taking regimens that do not contain TDF.'}], 'classes': [{'title': 'Change at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.09', 'spread': '0.196', 'groupId': 'OG000'}, {'value': '0.04', 'spread': '0.107', 'groupId': 'OG001'}, {'value': '0.00', 'spread': '0.083', 'groupId': 'OG002'}]}]}, {'title': 'Change at Posttreatment Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.04', 'spread': '0.153', 'groupId': 'OG000'}, {'value': '0.02', 'spread': '0.142', 'groupId': 'OG001'}, {'value': '-0.06', 'spread': '0.204', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 12; Posttreatment Week 12', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in the Safety Analysis Set with available data were analyzed by TDF-containing ART at baseline:\n\n* Boosted TDF-containing regimens\n* Non-boosted TDF-containing regimens\n* Non TDF-containing regimens'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'SOF/VEL 12 Weeks', 'description': 'Sofosbuvir/velpatasvir (SOF/VEL; Epclusa®) (400/100 mg) fixed-dose combination (FDC) tablet orally once daily in HCV treatment-naive and treatment-experienced (including treatment intolerant) participants with chronic HCV infection who were coinfected with HIV-1'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '107'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '96'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '11'}]}], 'dropWithdraws': [{'type': 'Enrolled but Never Treated', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}]}, {'type': 'Withdrew Consent', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'Participants were enrolled at 17 study sites in the United States. The first participant was screened on 01 July 2015. The last study visit occurred on 22 June 2016.', 'preAssignmentDetails': '149 participants were screened.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '106', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'SOF/VEL 12 Weeks', 'description': 'SOF/VEL (400/100 mg) FDC tablet orally once daily in HCV treatment-naive and treatment-experienced (including treatment intolerant) participants with chronic HCV infection who were coinfected with HIV-1'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '106', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '54', 'spread': '9.0', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '106', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '15', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '91', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Black or African American', 'denoms': [{'units': 'Participants', 'counts': [{'value': '106', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '48', 'groupId': 'BG000'}]}]}, {'title': 'White', 'denoms': [{'units': 'Participants', 'counts': [{'value': '106', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '54', 'groupId': 'BG000'}]}]}, {'title': 'Asian', 'denoms': [{'units': 'Participants', 'counts': [{'value': '106', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}]}]}, {'title': 'Other', 'denoms': [{'units': 'Participants', 'counts': [{'value': '106', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Hispanic or Latino', 'denoms': [{'units': 'Participants', 'counts': [{'value': '106', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '15', 'groupId': 'BG000'}]}]}, {'title': 'Not Hispanic or Latino', 'denoms': [{'units': 'Participants', 'counts': [{'value': '106', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '91', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'IL28b Status', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '106', 'groupId': 'BG000'}]}], 'categories': [{'title': 'CC', 'measurements': [{'value': '24', 'groupId': 'BG000'}]}, {'title': 'CT', 'measurements': [{'value': '52', 'groupId': 'BG000'}]}, {'title': 'TT', 'measurements': [{'value': '30', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'The CC, CT, and TT alleles are different forms of the IL28b gene.', 'unitOfMeasure': 'Participants'}, {'title': 'HCV RNA', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '106', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '6.3', 'spread': '0.57', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'log10 IU/mL', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'HCV RNA Category', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '106', 'groupId': 'BG000'}]}], 'categories': [{'title': '< 800,000 IU/mL', 'measurements': [{'value': '28', 'groupId': 'BG000'}]}, {'title': '≥ 800,000 IU/mL', 'measurements': [{'value': '78', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'HIV RNA category', 'classes': [{'title': 'Boosted TDF Containing Regimens', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'BG000'}]}], 'categories': [{'title': 'HIV RNA < 50 copies/mL', 'measurements': [{'value': '55', 'groupId': 'BG000'}]}, {'title': 'HIV RNA ≥ 50 copies/mL', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}, {'title': 'Non-Boosted TDF Containing Regimens', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'BG000'}]}], 'categories': [{'title': 'HIV RNA < 50 copies/mL', 'measurements': [{'value': '35', 'groupId': 'BG000'}]}, {'title': 'HIV RNA ≥ 50 copies/mL', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}, {'title': 'Non TDF Containing Regimens', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'BG000'}]}], 'categories': [{'title': 'HIV RNA < 50 copies/mL', 'measurements': [{'value': '14', 'groupId': 'BG000'}]}, {'title': 'HIV RNA ≥ 50 copies/mL', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Participants in the Safety Analysis Set were analyzed by tenofovir disoproxil fumarate(TDF)-containing antiretroviral therapy (ART) at baseline:\n\n* Boosted TDF-containing regimens\n* Non-boosted TDF-containing regimens\n* Non TDF-containing regimens'}, {'title': 'Serum Creatinine', 'classes': [{'title': 'Boosted TDF Containing Regimens', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '1.02', 'spread': '0.194', 'groupId': 'BG000'}]}]}, {'title': 'Non-Boosted TDF Containing Regimens', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '0.98', 'spread': '1.44', 'groupId': 'BG000'}]}]}, {'title': 'Non TDF Containing Regimens', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '1.02', 'spread': '0.255', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Participants in the Safety Analysis Set were analyzed by TDF-containing ART at baseline:\n\n* Boosted TDF-containing regimens\n* Non-boosted TDF-containing regimens\n* Non TDF-containing regimens'}], 'populationDescription': 'Safety Analysis Set: Participants who received at least one dose of study drug.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 107}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-04', 'completionDateStruct': {'date': '2016-06-22', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-10-19', 'studyFirstSubmitDate': '2015-06-22', 'resultsFirstSubmitDate': '2017-04-26', 'studyFirstSubmitQcDate': '2015-06-22', 'lastUpdatePostDateStruct': {'date': '2018-11-16', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-04-26', 'studyFirstPostDateStruct': {'date': '2015-06-24', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-06-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-04-29', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Participants With Sustained Virologic Response 12 Weeks After Discontinuation of Therapy (SVR12)', 'timeFrame': 'Posttreatment Week 12', 'description': 'SVR12 was defined as HCV RNA \\< the lower limit of quantitation (LLOQ) 12 weeks following the last dose of study drug.'}, {'measure': 'Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event', 'timeFrame': 'Up to 12 weeks'}], 'secondaryOutcomes': [{'measure': 'Percentage of Participants With Sustained Virologic Response 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)', 'timeFrame': 'Posttreatment Weeks 4 and 24', 'description': 'SVR4 and SVR24 were defined as HCV RNA \\< LLOQ at 4 and 24 weeks following the last dose of study drug, respectively.'}, {'measure': 'Percentage of Participants With HCV RNA < LLOQ on Treatment', 'timeFrame': 'Up to 12 Weeks'}, {'measure': 'HCV RNA Change From Baseline/Day 1', 'timeFrame': 'Baseline to Week 12'}, {'measure': 'Percentage of Participants With Virologic Failure', 'timeFrame': 'Up to Posttreatment Week 24', 'description': 'Virologic failure was defined as:\n\n* On-treatment virologic failure:\n\n * Breakthrough (confirmed HCV RNA ≥ LLOQ after having previously had HCV RNA \\< LLOQ while on treatment), or\n * Rebound (confirmed \\> 1 log10 IU/mL increase in HCV RNA from nadir while on treatment), or\n * Non-response (HCV RNA persistently ≥ LLOQ through 8 weeks of treatment)\n* Virologic relapse:\n\n * Confirmed HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA \\< LLOQ at last on-treatment visit'}, {'measure': 'Percentage of Participants That Maintained HIV-1 RNA < 50 Copies/mL While On HCV Treatment', 'timeFrame': 'Up to 12 Weeks'}, {'measure': 'Serum Creatinine Change From Baseline At the End of Treatment and At Posttreatment Week 12', 'timeFrame': 'Week 12; Posttreatment Week 12'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hepatitis C Virus Infection']}, 'referencesModule': {'references': [{'type': 'RESULT', 'citation': 'Wyles D, Brau N, Kottilil S, Daar E, Workowski K, Luetkemeyer A, et al. Sofosbuvir/Velpatasvir Fixed Dose Combination for 12 Weeks in Patients Co-Infected with HCV and HIV-1: The Phase 3 ASTRAL-5 Study [Abstract PS104]. 2016 European Association for the Study of the Liver (EASL), Barcelona, Spain.'}, {'pmid': '28369210', 'type': 'DERIVED', 'citation': 'Wyles D, Brau N, Kottilil S, Daar ES, Ruane P, Workowski K, Luetkemeyer A, Adeyemi O, Kim AY, Doehle B, Huang KC, Mogalian E, Osinusi A, McNally J, Brainard DM, McHutchison JG, Naggie S, Sulkowski M; ASTRAL-5 Investigators. Sofosbuvir and Velpatasvir for the Treatment of Hepatitis C Virus in Patients Coinfected With Human Immunodeficiency Virus Type 1: An Open-Label, Phase 3 Study. Clin Infect Dis. 2017 Jul 1;65(1):6-12. doi: 10.1093/cid/cix260.'}]}, 'descriptionModule': {'briefSummary': 'The primary objectives of this study are to evaluate the efficacy, safety and tolerability of treatment with sofosbuvir/velpatasvir (SOF/VEL) for 12 weeks in participants with chronic HCV infection who were coinfected with HIV-1.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Key Inclusion Criteria:\n\n* HCV RNA ≥ 10\\^4 IU/mL at screening\n* HCV genotype 1, 2, 3, 4, 5, 6\n* Cirrhosis determination, a fibroscan or liver biopsy may be required\n* HIV-1 infection\n* Use of protocol specified method(s) of contraception\n* Screening laboratory values within defined thresholds\n\nKey Exclusion Criteria:\n\n* Clinically-significant illness (other than HCV or HIV) or any other major medical disorder that may interfere with individual's treatment, assessment or compliance with the protocol\n* Current or prior history of clinical hepatic decompensation, hepatocellular carcinoma (HCC) or other malignancy (with the exception of certain resolved skin cancers)\n* Screening ECG with clinically significant abnormalities\n* Pregnant or nursing female or male with pregnant female partner\n* Infection with hepatitis B virus (HBV)\n* Use of any prohibited concomitant medications as described in the protocol\n* Chronic use of systemically administered immunosuppressive agents\n\nNOTE: Other protocol defined Inclusion/ Exclusion criteria may apply."}, 'identificationModule': {'nctId': 'NCT02480712', 'acronym': 'ASTRAL-5', 'briefTitle': 'Efficacy and Safety of Sofosbuvir/Velpatasvir Fixed Dose Combination for 12 Weeks in Adults With Chronic Hepatitis C Virus (HCV) and Human Immunodeficiency Virus (HIV)-1 Coinfection', 'organization': {'class': 'INDUSTRY', 'fullName': 'Gilead Sciences'}, 'officialTitle': 'A Phase 3, Open-Label Study to Investigate the Efficacy and Safety of Sofosbuvir/GS-5816 Fixed Dose Combination for 12 Weeks in Subjects With Chronic Hepatitis C Virus (HCV) and Human Immunodeficiency Virus (HIV)-1 Coinfection', 'orgStudyIdInfo': {'id': 'GS-US-342-1202'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'SOF/VEL', 'description': 'Participants will receive SOF/VEL for 12 weeks', 'interventionNames': ['Drug: SOF/VEL']}], 'interventions': [{'name': 'SOF/VEL', 'type': 'DRUG', 'otherNames': ['GS-7977/GS-5816', 'Epclusa®'], 'description': '400/100 mg fixed-dose combination (FDC) tablet administered orally once daily', 'armGroupLabels': ['SOF/VEL']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'city': 'San Diego', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'city': 'Torrance', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 33.83585, 'lon': -118.34063}}, {'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'city': 'Lutherville', 'state': 'Maryland', 'country': 'United States', 'geoPoint': {'lat': 39.42122, 'lon': -76.62608}}, {'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'city': 'New York', 'state': 'New York', 'country': 'United States', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'city': 'The Bronx', 'state': 'New York', 'country': 'United States', 'geoPoint': {'lat': 40.84985, 'lon': -73.86641}}, {'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}, {'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}, {'city': 'Richmond', 'state': 'Virginia', 'country': 'United States', 'geoPoint': {'lat': 37.55376, 'lon': -77.46026}}], 'overallOfficials': [{'name': 'Gilead Study Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Gilead Sciences'}]}, 'ipdSharingStatementModule': {'url': 'http://www.gilead.com/research/disclosure-and-transparency', 'infoTypes': ['STUDY_PROTOCOL', 'SAP'], 'timeFrame': '18 months after study completion', 'ipdSharing': 'YES', 'description': 'Qualified external researchers may request IPD for this study after study completion. For more information, please visit our website at http://www.gilead.com/research/disclosure-and-transparency.', 'accessCriteria': 'A secured external environment with username, password, and RSA code.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Gilead Sciences', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}