Ignite Creation Date:
2025-12-26 @ 11:11 AM
Ignite Modification Date:
2026-02-02 @ 5:39 AM
Study NCT ID:
NCT02618928
Status:
COMPLETED
Last Update Posted:
2019-06-17
First Post:
2015-11-24
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
The Effectiveness of Paritaprevir/Ritonavir - Ombitasvir, ± Dasabuvir, ± Ribavirin in France
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D019698', 'term': 'Hepatitis C, Chronic'}], 'ancestors': [{'id': 'D006526', 'term': 'Hepatitis C'}, {'id': 'D000086982', 'term': 'Blood-Borne Infections'}, {'id': 'D003141', 'term': 'Communicable Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D006525', 'term': 'Hepatitis, Viral, Human'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D018178', 'term': 'Flaviviridae Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D006521', 'term': 'Hepatitis, Chronic'}, {'id': 'D006505', 'term': 'Hepatitis'}, {'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'abbvieclinicaltrials@abbvie.com', 'phone': '800-633-9110', 'title': 'Global Medical Services', 'organization': 'AbbVie'}, 'certainAgreement': {'otherDetails': 'AbbVie requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. AbbVie requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if AbbVie needs to secure patent or proprietary protection.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Deaths are reported up to 24 weeks after end of treatment (a maximum of 48 weeks). Adverse events are reported from first dose of study drug through 30 days after last dose (12 to 28 weeks depending on treatment regimen). The median (minimum, maximum) duration of treatment was 84 (4, 167) days.', 'eventGroups': [{'id': 'EG000', 'title': 'Paritaprevir/Ritonavir + Ombitasvir Without RBV', 'description': 'Participants received paritaprevir/ritonavir and ombitasvir without ribavirin for either 12 weeks.', 'otherNumAtRisk': 4, 'deathsNumAtRisk': 4, 'otherNumAffected': 1, 'seriousNumAtRisk': 4, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Paritaprevir/Ritonavir + Ombitasvir With RBV', 'description': 'Participants received paritaprevir/ritonavir and ombitasvir with ribavirin for either 12 weeks.', 'otherNumAtRisk': 209, 'deathsNumAtRisk': 209, 'otherNumAffected': 33, 'seriousNumAtRisk': 209, 'deathsNumAffected': 5, 'seriousNumAffected': 1}, {'id': 'EG002', 'title': 'Paritaprevir/Ritonavir + Ombitasvir + Dasabuvir Without RBV', 'description': 'Participants received paritaprevir/ritonavir, ombitasvir, and dasabuvir without ribavirin for 8 or 12 weeks.', 'otherNumAtRisk': 429, 'deathsNumAtRisk': 429, 'otherNumAffected': 38, 'seriousNumAtRisk': 429, 'deathsNumAffected': 1, 'seriousNumAffected': 13}, {'id': 'EG003', 'title': 'Paritaprevir/Ritonavir + Ombitasvir + Dasabuvir With RBV', 'description': 'Participants received paritaprevir/ritonavir, ombitasvir, and dasabuvir with ribavirin for 12 or 24 weeks.', 'otherNumAtRisk': 86, 'deathsNumAtRisk': 86, 'otherNumAffected': 11, 'seriousNumAtRisk': 86, 'deathsNumAffected': 2, 'seriousNumAffected': 6}], 'otherEvents': [{'term': 'ANAEMIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 209, 'numEvents': 22, 'numAffected': 22}, {'groupId': 'EG002', 'numAtRisk': 429, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 86, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Versions 21.0'}, {'term': 'ASTHENIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 209, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 429, 'numEvents': 26, 'numAffected': 26}, {'groupId': 'EG003', 'numAtRisk': 86, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Versions 21.0'}, {'term': 'FATIGUE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 209, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 429, 'numEvents': 12, 'numAffected': 12}, {'groupId': 'EG003', 'numAtRisk': 86, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Versions 21.0'}, {'term': 'PRURITUS GENERALISED', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 209, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 429, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 86, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Versions 21.0'}], 'seriousEvents': [{'term': 'ANAEMIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 209, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 429, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 86, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Versions 21.0'}, {'term': 'CARDIAC FAILURE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 209, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 429, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 86, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Versions 21.0'}, {'term': 'MYOCARDIAL INFARCTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 209, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 429, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 86, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Versions 21.0'}, {'term': 'INTESTINAL OBSTRUCTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 209, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 429, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 86, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Versions 21.0'}, {'term': 'OESOPHAGEAL VARICES HAEMORRHAGE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 209, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 429, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 86, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Versions 21.0'}, {'term': 'PANCREATITIS ACUTE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 209, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 429, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 86, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Versions 21.0'}, {'term': 'PYREXIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 209, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 429, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 86, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Versions 21.0'}, {'term': 'HEPATOTOXICITY', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 209, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 429, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 86, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Versions 21.0'}, {'term': 'APPENDICITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 209, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 429, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 86, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Versions 21.0'}, {'term': 'PNEUMONIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 209, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 429, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 86, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Versions 21.0'}, {'term': 'ANKLE FRACTURE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 209, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 429, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 86, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Versions 21.0'}, {'term': 'JOINT DISLOCATION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 209, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 429, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 86, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Versions 21.0'}, {'term': 'PROTHROMBIN TIME PROLONGED', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 209, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 429, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 86, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Versions 21.0'}, {'term': 'DEHYDRATION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 209, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 429, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 86, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Versions 21.0'}, {'term': 'FOOD INTOLERANCE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 209, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 429, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 86, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Versions 21.0'}, {'term': 'HEPATIC CANCER', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 209, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 429, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 86, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Versions 21.0'}, {'term': 'CAROTID ANEURYSM RUPTURE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 209, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 429, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 86, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Versions 21.0'}, {'term': 'CEREBROVASCULAR ACCIDENT', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 209, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 429, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 86, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Versions 21.0'}, {'term': 'ACUTE PSYCHOSIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 209, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 429, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 86, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Versions 21.0'}, {'term': 'HYPOMANIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 209, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 429, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 86, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Versions 21.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Participants Achieving Sustained Virological Response 12 Weeks Post-treatment (SVR12)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '720', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Paritaprevir/Ritonavir + Ombitasvir ± Dasabuvir ± Ribavirin', 'description': 'Participants in this observational study received treatment with paritaprevir/ritonavir (r) and ombitasvir with or without dasabuvir ± ribavirin (RBV) for 8, 12, or 24 weeks for the treatment of chronic hepatitis C (CHC), according to hepatitis C virus (HCV) genotype/subtype and stage of liver disease.'}], 'classes': [{'categories': [{'measurements': [{'value': '90.7', 'groupId': 'OG000', 'lowerLimit': '88.4', 'upperLimit': '92.6'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '12 weeks after the last dose of study drug (week 20, 24, or 36 depending on the treatment regimen)', 'description': 'Sustained virologic response was defined as hepatitis C virus ribonucleic acid (HCV RNA) levels less than 50 IU/mL 12 weeks after the last dose of study drug. Participants with missing HCV RNA were counted as virological failure.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The Core population includes enrolled participants who were adequately treated according to the standard of care and within local label recommendations for their specific disease characteristics (cirrhotic status, genotype).'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Achieving Virological Response at End of Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '720', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Paritaprevir/Ritonavir + Ombitasvir ± Dasabuvir ± Ribavirin', 'description': 'Participants in this observational study received treatment with paritaprevir/ritonavir (r) and ombitasvir with or without dasabuvir ± ribavirin (RBV) for 8, 12, or 24 weeks for the treatment of chronic hepatitis C (CHC), according to hepatitis C virus (HCV) genotype/subtype and stage of liver disease.'}], 'classes': [{'categories': [{'measurements': [{'value': '94.4', 'groupId': 'OG000', 'lowerLimit': '92.5', 'upperLimit': '95.9'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'End of treatment (week 8, 12, or 24 depending on the treatment regimen)', 'description': 'Virologic response was defined as hepatitis C virus ribonucleic acid (HCV RNA) levels less than 50 IU/mL.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The Core population includes enrolled participants who were adequately treated according to the standard of care and within local label recommendations for their specific disease characteristics (cirrhotic status, genotype).'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Sufficient Follow-up Who Achieved Sustained Virological Response 12 Weeks Post-treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '684', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Paritaprevir/Ritonavir + Ombitasvir ± Dasabuvir ± Ribavirin', 'description': 'Participants in this observational study received treatment with paritaprevir/ritonavir (r) and ombitasvir with or without dasabuvir ± ribavirin (RBV) for 8, 12, or 24 weeks for the treatment of chronic hepatitis C (CHC), according to hepatitis C virus (HCV) genotype/subtype and stage of liver disease.'}], 'classes': [{'categories': [{'measurements': [{'value': '95.5', 'groupId': 'OG000', 'lowerLimit': '93.6', 'upperLimit': '96.8'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '12 weeks after the last dose of study drug (week 20, 24, or 36 depending on the treatment regimen)', 'description': 'Sustained virologic response was defined as hepatitis C virus ribonucleic acid (HCV RNA) levels less than 50 IU/mL 12 weeks after the last dose of study drug.\n\nThe Core Population with sufficient follow-up data regarding SVR12 included all core population participants who\n\n* had evaluable HCV RNA data ≥ 70 days after the last actual dose of the ABBVIE REGIMEN\n* or a HCV RNA value ≥ 50 IU/mL at the last measurement post-baseline\n* or had HCV RNA \\< 50 IU/mL at the last measurement post-baseline, but no HCV RNA measurement ≥ 70 days after the last actual dose of the ABBVIE REGIMEN due to reasons related to safety (e.g. dropped out due to adverse event) or virologic failure.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The Core population with sufficient follow-up data regarding SVR12'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Relapse', 'denoms': [{'units': 'Participants', 'counts': [{'value': '648', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Paritaprevir/Ritonavir + Ombitasvir ± Dasabuvir ± Ribavirin', 'description': 'Participants in this observational study received treatment with paritaprevir/ritonavir (r) and ombitasvir with or without dasabuvir ± ribavirin (RBV) for 8, 12, or 24 weeks for the treatment of chronic hepatitis C (CHC), according to hepatitis C virus (HCV) genotype/subtype and stage of liver disease.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.2', 'groupId': 'OG000', 'lowerLimit': '0.6', 'upperLimit': '2.4'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'End of treatment (week 8, 12, or 24 depending on the treatment regimen) and up to 24 weeks after the end of treatment.', 'description': 'Relapse was defined as participants with a virologic response (VR; HCV RNA \\< 50 IU/mL) at end of treatment (EOT) followed by HCV RNA ≥ 50 IU/mL at any time after the end of treatment.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The Core population with VR at EOT, who completed treatment, and had ≥ 1 HCV RNA measurement ≥ 70 days post-treatment or were a treatment failure between EOT and day 70.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Breakthrough', 'denoms': [{'units': 'Participants', 'counts': [{'value': '404', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Paritaprevir/Ritonavir + Ombitasvir ± Dasabuvir ± Ribavirin', 'description': 'Participants in this observational study received treatment with paritaprevir/ritonavir (r) and ombitasvir with or without dasabuvir ± ribavirin (RBV) for 8, 12, or 24 weeks for the treatment of chronic hepatitis C (CHC), according to hepatitis C virus (HCV) genotype/subtype and stage of liver disease.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.5', 'groupId': 'OG000', 'lowerLimit': '0.1', 'upperLimit': '1.8'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '8, 12, or 24 weeks (depending on the treatment regimen)', 'description': 'Breakthrough was defined as at least one documented HCV RNA \\< 50 IU/mL followed by HCV RNA ≥ 50 IU/mL during treatment.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The Core population with virological response on-treatment and with at least one on-treatment measurement thereafter (including EOT).'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Rapid Virological Response at Week 4 (RVR4)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '720', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Paritaprevir/Ritonavir + Ombitasvir ± Dasabuvir ± Ribavirin', 'description': 'Participants in this observational study received treatment with paritaprevir/ritonavir (r) and ombitasvir with or without dasabuvir ± ribavirin (RBV) for 8, 12, or 24 weeks for the treatment of chronic hepatitis C (CHC), according to hepatitis C virus (HCV) genotype/subtype and stage of liver disease.'}], 'classes': [{'categories': [{'measurements': [{'value': '49.0', 'groupId': 'OG000', 'lowerLimit': '45.4', 'upperLimit': '52.7'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 4', 'description': 'RVR 4 was defined as participants with HCV RNA \\< 50 IU/mL at week 4.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The Core population includes enrolled participants who were adequately treated according to the standard of care and within local label recommendations for their specific disease characteristics (cirrhotic status, genotype).'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Sufficient Follow-up Who Achieved Sustained Virological Response 24 Weeks Post-treatment (SVR24)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '616', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Paritaprevir/Ritonavir + Ombitasvir ± Dasabuvir ± Ribavirin', 'description': 'Participants in this observational study received treatment with paritaprevir/ritonavir (r) and ombitasvir with or without dasabuvir ± ribavirin (RBV) for 8, 12, or 24 weeks for the treatment of chronic hepatitis C (CHC), according to hepatitis C virus (HCV) genotype/subtype and stage of liver disease.'}], 'classes': [{'categories': [{'measurements': [{'value': '94.8', 'groupId': 'OG000', 'lowerLimit': '92.8', 'upperLimit': '96.3'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '24 weeks after the last dose of study drug (week 32, 36, or 48 depending on the treatment regimen)', 'description': 'Sustained virologic response was defined as hepatitis C virus ribonucleic acid (HCV RNA) levels less than 50 IU/mL 24 weeks after the last dose of study drug.\n\nThe Core population with sufficient follow-up data regarding SVR24 included all core population participants who\n\n* had evaluable HCV RNA data ≥ 126 days after the last actual dose of the ABBVIE REGIMEN\n* or a HCV RNA value ≥ 50 IU/mL at the last measurement post-baseline\n* or had HCV RNA \\< 50 IU/mL at the last measurement post-baseline, but no HCV RNA measurement ≥ 126 days after the last actual dose of the ABBVIE REGIMEN due to reasons related to safety (e.g. dropped out due to adverse event) or virologic failure.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The Core population with sufficient follow-up data regarding SVR24'}, {'type': 'SECONDARY', 'title': 'Number of Participants in Each Non-response Category 12 Weeks Post-treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '720', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Paritaprevir/Ritonavir + Ombitasvir ± Dasabuvir ± Ribavirin', 'description': 'Participants in this observational study received treatment with paritaprevir/ritonavir (r) and ombitasvir with or without dasabuvir ± ribavirin (RBV) for 8, 12, or 24 weeks for the treatment of chronic hepatitis C (CHC), according to hepatitis C virus (HCV) genotype/subtype and stage of liver disease.'}], 'classes': [{'title': 'On-treatment virological failure', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}]}]}, {'title': 'Relapse', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}]}]}, {'title': 'Death', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'Premature treatment discontinuation', 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}]}]}, {'title': 'Insufficient virological response reported', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}, {'title': 'Missing/none of the above', 'categories': [{'measurements': [{'value': '30', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '12 weeks after the last dose of study drug (week 20, 24, or 36 depending on the treatment regimen)', 'description': 'SVR12 non-response was categorized according to the following:\n\n* On-treatment virologic failure (breakthrough \\[at least one documented HCV RNA \\< 50 IU/mL followed by HCV RNA ≥ 50 IU/mL during treatment\\] or failure to suppress \\[each measured on-treatment HCV RNA value ≥ 50 IU/mL\\]);\n* Relapse, defined as HCV RNA \\< 50 IU/mL at EOT followed by HCV RNA ≥ 50 IU/mL post-treatment in patients who completed treatment (not more than 7 days shortened);\n* Death\n* Premature treatment discontinuation with no on-treatment virologic failure;\n* Insufficient virological response reported or HCV RNA ≥ 50 IU/mL post-EOT and none of the above criteria\n* Missing SVR12 data and/or none of the above criteria.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The Core population'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Adherence to the ABBVIE Regimen, by Adherence Category', 'denoms': [{'units': 'Participants', 'counts': [{'value': '720', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Paritaprevir/Ritonavir + Ombitasvir ± Dasabuvir ± Ribavirin', 'description': 'Participants in this observational study received treatment with paritaprevir/ritonavir (r) and ombitasvir with or without dasabuvir ± ribavirin (RBV) for 8, 12, or 24 weeks for the treatment of chronic hepatitis C (CHC), according to hepatitis C virus (HCV) genotype/subtype and stage of liver disease.'}], 'classes': [{'categories': [{'title': '> 105%', 'measurements': [{'value': '38', 'groupId': 'OG000'}]}, {'title': '> 95% to ≤ 105%', 'measurements': [{'value': '623', 'groupId': 'OG000'}]}, {'title': '> 80% to ≤ 95%', 'measurements': [{'value': '19', 'groupId': 'OG000'}]}, {'title': '> 50% to ≤ 80%', 'measurements': [{'value': '15', 'groupId': 'OG000'}]}, {'title': '≤ 50%', 'measurements': [{'value': '15', 'groupId': 'OG000'}]}, {'title': 'Missing', 'measurements': [{'value': '10', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From first dose of study drug to end of treatment, 8 to 24 weeks depending on the treatment regimen.', 'description': 'Adherence to the ABBVIE treatment regimen is expressed as a percentage of the target dose and was calculated as:\n\nCumulative dose taken / (initial prescribed dose \\* planned duration) \\* 100 The ABBVIE regimen consists of paritaprevir/r and ombitasvir with or without dasabuvir.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Core population'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Adherence to Ribavirin by Adherence Category', 'denoms': [{'units': 'Participants', 'counts': [{'value': '292', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Paritaprevir/Ritonavir + Ombitasvir ± Dasabuvir ± Ribavirin', 'description': 'Participants in this observational study received treatment with paritaprevir/ritonavir (r) and ombitasvir with or without dasabuvir ± ribavirin (RBV) for 8, 12, or 24 weeks for the treatment of chronic hepatitis C (CHC), according to hepatitis C virus (HCV) genotype/subtype and stage of liver disease.'}], 'classes': [{'categories': [{'title': '> 105%', 'measurements': [{'value': '22', 'groupId': 'OG000'}]}, {'title': '> 95% to ≤ 105%', 'measurements': [{'value': '219', 'groupId': 'OG000'}]}, {'title': '> 80% to ≤ 95%', 'measurements': [{'value': '20', 'groupId': 'OG000'}]}, {'title': '> 50% to ≤ 80%', 'measurements': [{'value': '15', 'groupId': 'OG000'}]}, {'title': '≤ 50%', 'measurements': [{'value': '10', 'groupId': 'OG000'}]}, {'title': 'Missing', 'measurements': [{'value': '6', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From first dose of study drug to end of treatment, 8 to 24 weeks depending on the treatment regimen.', 'description': 'Adherence to ribavirin is expressed as a percentage of the target dose, and was calculated as:\n\nCumulative dose taken / (initial prescribed dose \\* planned duration) \\* 100', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Core population who were prescribed ribavirin'}, {'type': 'SECONDARY', 'title': 'Percentage of Ribavirin Treatment Days in Relation to the Target Number of Ribavirin Treatment Days', 'denoms': [{'units': 'Participants', 'counts': [{'value': '288', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Paritaprevir/Ritonavir + Ombitasvir ± Dasabuvir ± Ribavirin', 'description': 'Participants in this observational study received treatment with paritaprevir/ritonavir (r) and ombitasvir with or without dasabuvir ± ribavirin (RBV) for 8, 12, or 24 weeks for the treatment of chronic hepatitis C (CHC), according to hepatitis C virus (HCV) genotype/subtype and stage of liver disease.'}], 'classes': [{'categories': [{'measurements': [{'value': '98.5', 'spread': '13.96', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'From first dose of study drug to end of treatment, 8 to 24 weeks depending on the treatment regimen.', 'unitOfMeasure': 'percentage of days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Core population who were prescribed ribavirin and with non-missing data'}, {'type': 'SECONDARY', 'title': 'Number of Participants Who Received Concomitant Medications', 'denoms': [{'units': 'Participants', 'counts': [{'value': '728', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Paritaprevir/Ritonavir + Ombitasvir ± Dasabuvir ± Ribavirin', 'description': 'Participants in this observational study received treatment with paritaprevir/ritonavir (r) and ombitasvir with or without dasabuvir ± ribavirin (RBV) for 8, 12, or 24 weeks for the treatment of chronic hepatitis C (CHC), according to hepatitis C virus (HCV) genotype/subtype and stage of liver disease.'}], 'classes': [{'title': 'Any co-medication', 'categories': [{'measurements': [{'value': '351', 'groupId': 'OG000'}]}]}, {'title': 'Beta blocking agents', 'categories': [{'measurements': [{'value': '60', 'groupId': 'OG000'}]}]}, {'title': 'Analgesics', 'categories': [{'measurements': [{'value': '58', 'groupId': 'OG000'}]}]}, {'title': 'Thyroid therapy', 'categories': [{'measurements': [{'value': '46', 'groupId': 'OG000'}]}]}, {'title': 'Peptic ulcer / gastro-oesophageal reflux disease', 'categories': [{'measurements': [{'value': '45', 'groupId': 'OG000'}]}]}, {'title': 'Benzodiazepine derivatives', 'categories': [{'measurements': [{'value': '40', 'groupId': 'OG000'}]}]}, {'title': 'ACE inhibitors', 'categories': [{'measurements': [{'value': '39', 'groupId': 'OG000'}]}]}, {'title': 'Diuretics', 'categories': [{'measurements': [{'value': '37', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From first dose of study drug to end of treatment, 8 to 24 weeks depending on the treatment regimen', 'description': 'Concomitant medication other than for chronic hepatitis C used from the time when the decision was made to initiate treatment with paritaprevir/ritonavir and ombitasvir with or without dasabuvir until after the last dose.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All treated participants'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Adverse Events, Serious Adverse Events, or Pregnancies', 'denoms': [{'units': 'Participants', 'counts': [{'value': '728', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Paritaprevir/Ritonavir + Ombitasvir ± Dasabuvir ± Ribavirin', 'description': 'Participants in this observational study received treatment with paritaprevir/ritonavir (r) and ombitasvir with or without dasabuvir ± ribavirin (RBV) for 8, 12, or 24 weeks for the treatment of chronic hepatitis C (CHC), according to hepatitis C virus (HCV) genotype/subtype and stage of liver disease.'}], 'classes': [{'title': 'Any adverse event', 'categories': [{'measurements': [{'value': '163', 'groupId': 'OG000'}]}]}, {'title': 'Serious adverse event', 'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000'}]}]}, {'title': 'Pregnancy', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From first dose of study drug through 30 days after last dose (12 to 28 weeks depending on treatment regimen). The median (minimum, maximum) duration of treatment was 84 (4, 167) days.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All treated participants'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Fatigue Impact Scale Total Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '629', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Paritaprevir/Ritonavir + Ombitasvir ± Dasabuvir ± Ribavirin', 'description': 'Participants in this observational study received treatment with paritaprevir/ritonavir (r) and ombitasvir with or without dasabuvir ± ribavirin (RBV) for 8, 12, or 24 weeks for the treatment of chronic hepatitis C (CHC), according to hepatitis C virus (HCV) genotype/subtype and stage of liver disease.'}], 'classes': [{'title': 'End of treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '471', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-6.78', 'spread': '31.80', 'groupId': 'OG000'}]}]}, {'title': '12 weeks after end of treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '406', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-18.27', 'spread': '32.06', 'groupId': 'OG000'}]}]}, {'title': '24 weeks after end of treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '340', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-16.75', 'spread': '32.34', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, end of treatment (week 8, 12, or 24 depending on the treatment regimen), and at 12 and 24 weeks after end of treatment', 'description': 'The Fatigue Impact Scale (FIS) questionnaire was used to assess the impact of fatigue on the quality of life of patients.\n\nThe FIS consists of 40 items, each of which is scored 0 (no problem) to 4 (extreme problem), providing a total score from of 0 to 160, where a lower score = less fatigue impact', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Core population with non-missing data at baseline and each time point'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in EuroQol 5 Dimension 5 Level (EQ-5D-5L) Index Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '604', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Paritaprevir/Ritonavir + Ombitasvir ± Dasabuvir ± Ribavirin', 'description': 'Participants in this observational study received treatment with paritaprevir/ritonavir (r) and ombitasvir with or without dasabuvir ± ribavirin (RBV) for 8, 12, or 24 weeks for the treatment of chronic hepatitis C (CHC), according to hepatitis C virus (HCV) genotype/subtype and stage of liver disease.'}], 'classes': [{'title': 'End of treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '452', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.044', 'spread': '0.208', 'groupId': 'OG000'}]}]}, {'title': '12 weeks after end of treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '384', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.088', 'spread': '0.202', 'groupId': 'OG000'}]}]}, {'title': '24 weeks after end of treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '325', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.087', 'spread': '0.196', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, end of treatment (week 8, 12, or 24 depending on the treatment regimen), and at 12 and 24 weeks after end of treatment', 'description': "The EQ-5D-5L is a health state utility instrument that evaluates preference for health status. The 5 items in the EQ-5D-5L comprise 5 dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) each of which are rated on 5 levels of severity (1: indicating no problem, 2: indicating slight problems, 3: indicating moderate problems, 4: indicating severe problems, 5: indicating extreme problems), and a separate visual analog scale (VAS).\n\nResponses to the 5 dimension scores were combined and converted into a single preference-weighted health utility index score by applying country-specific weights.The range for EQ-5D-5L index score is 0 to 1 where '0' is defined as a health state equivalent to being dead and '1' is full health.The higher the score the better the health status.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Core population with available data at baseline and each time point.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in EuroQol 5 Dimension 5 Level (EQ-5D-5L) VAS Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '630', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Paritaprevir/Ritonavir + Ombitasvir ± Dasabuvir ± Ribavirin', 'description': 'Participants in this observational study received treatment with paritaprevir/ritonavir (r) and ombitasvir with or without dasabuvir ± ribavirin (RBV) for 8, 12, or 24 weeks for the treatment of chronic hepatitis C (CHC), according to hepatitis C virus (HCV) genotype/subtype and stage of liver disease.'}], 'classes': [{'title': 'End of treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '476', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '6.8', 'spread': '18.92', 'groupId': 'OG000'}]}]}, {'title': '12 weeks after end of treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '407', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '10.6', 'spread': '17.60', 'groupId': 'OG000'}]}]}, {'title': '24 weeks after end of treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '350', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '10.4', 'spread': '17.70', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, end of treatment (week 8, 12, or 24 depending on the treatment regimen), and at 12 and 24 weeks after end of treatment', 'description': 'The EQ-5D-5L is a health state utility instrument that evaluates preference for health status with a separate visual analog scale (VAS).\n\nThe VAS assesses overall health on a scale from 0 (worst health imaginable) to 100 (best health imaginable).', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Core population with available data at baseline and each time point.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Work Productivity and Activity Impairment (WPAI): Absenteeism', 'denoms': [{'units': 'Participants', 'counts': [{'value': '258', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Paritaprevir/Ritonavir + Ombitasvir ± Dasabuvir ± Ribavirin', 'description': 'Participants in this observational study received treatment with paritaprevir/ritonavir (r) and ombitasvir with or without dasabuvir ± ribavirin (RBV) for 8, 12, or 24 weeks for the treatment of chronic hepatitis C (CHC), according to hepatitis C virus (HCV) genotype/subtype and stage of liver disease.'}], 'classes': [{'title': 'End of treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '151', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '5.2', 'spread': '24.2', 'groupId': 'OG000'}]}]}, {'title': '12 weeks after end of treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '139', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.4', 'spread': '20.5', 'groupId': 'OG000'}]}]}, {'title': '24 weeks after end of treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '107', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-1.5', 'spread': '16.8', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, end of treatment (week 8, 12, or 24 depending on the treatment regimen), and at 12 and 24 weeks after end of treatment', 'description': 'The WPAI Hepatitis C V2.0 is an HCV specific questionnaire used to measure work absenteeism, work presenteeism, and daily activity impairment. Respondents were asked about time missed from work and time while at work during which productivity was impaired in the past seven days. Results of WPAI are expressed as a percentage of impairment from 0 to 100, with higher percentages indicating greater impairment and less productivity.\n\nAbsenteeism indicates the percentage of work time missed due to health problems.', 'unitOfMeasure': 'percent impairment', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The Core population who were employed and with available data at baseline and each time point.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Work Productivity and Activity Impairment (WPAI): Presenteeism', 'denoms': [{'units': 'Participants', 'counts': [{'value': '259', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Paritaprevir/Ritonavir + Ombitasvir ± Dasabuvir ± Ribavirin', 'description': 'Participants in this observational study received treatment with paritaprevir/ritonavir (r) and ombitasvir with or without dasabuvir ± ribavirin (RBV) for 8, 12, or 24 weeks for the treatment of chronic hepatitis C (CHC), according to hepatitis C virus (HCV) genotype/subtype and stage of liver disease.'}], 'classes': [{'title': 'End of treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '148', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-1.2', 'spread': '28.0', 'groupId': 'OG000'}]}]}, {'title': '12 weeks after end of treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '137', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-5.5', 'spread': '25.2', 'groupId': 'OG000'}]}]}, {'title': '24 weeks after end of treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '105', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-7.4', 'spread': '22.9', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, end of treatment (week 8, 12, or 24 depending on the treatment regimen), and at 12 and 24 weeks after end of treatment', 'description': 'The WPAI Hepatitis C V2.0 is an HCV specific questionnaire used to measure work absenteeism, work presenteeism, and daily activity impairment. Respondents were asked about time missed from work and time while at work during which productivity was impaired in the past seven days. Results of WPAI are expressed as a percentage of impairment from 0 to 100, with higher percentages indicating greater impairment and less productivity.\n\nPresenteeism indicates the percentage of impairment while working due to health problems.', 'unitOfMeasure': 'percent impairment', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The Core population who were employed and with available data at baseline and each time point.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Work Productivity and Activity Impairment (WPAI): Total Work Productivity Impairment (TWP)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '253', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Paritaprevir/Ritonavir + Ombitasvir ± Dasabuvir ± Ribavirin', 'description': 'Participants in this observational study received treatment with paritaprevir/ritonavir (r) and ombitasvir with or without dasabuvir ± ribavirin (RBV) for 8, 12, or 24 weeks for the treatment of chronic hepatitis C (CHC), according to hepatitis C virus (HCV) genotype/subtype and stage of liver disease.'}], 'classes': [{'title': 'End of treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '144', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.3', 'spread': '33.6', 'groupId': 'OG000'}]}]}, {'title': '12 weeks after end of treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '132', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-4.9', 'spread': '30.1', 'groupId': 'OG000'}]}]}, {'title': '24 weeks after end of treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '101', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-8.7', 'spread': '25.4', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, end of treatment (week 8, 12, or 24 depending on the treatment regimen), and at 12 and 24 weeks after end of treatment', 'description': 'The WPAI Hepatitis C V2.0 is an HCV specific questionnaire used to measure work absenteeism, work presenteeism, and daily activity impairment. Respondents were asked about time missed from work and time while at work during which productivity was impaired in the past seven days. Results of WPAI are expressed as a percentage of impairment from 0 to 100, with higher percentages indicating greater impairment and less productivity.\n\nTotal work productivity impairment (TWP) indicates the percentage of overall work impairment due to health problems.', 'unitOfMeasure': 'percent impairment', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The Core population who were employed and with available data at baseline and each time point.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Work Productivity and Activity Impairment (WPAI): Total Activity Impairment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '615', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Paritaprevir/Ritonavir + Ombitasvir ± Dasabuvir ± Ribavirin', 'description': 'Participants in this observational study received treatment with paritaprevir/ritonavir (r) and ombitasvir with or without dasabuvir ± ribavirin (RBV) for 8, 12, or 24 weeks for the treatment of chronic hepatitis C (CHC), according to hepatitis C virus (HCV) genotype/subtype and stage of liver disease.'}], 'classes': [{'title': 'End of treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '441', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.6', 'spread': '33.0', 'groupId': 'OG000'}]}]}, {'title': '12 weeks after end of treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '386', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-7.2', 'spread': '32.8', 'groupId': 'OG000'}]}]}, {'title': '24 weeks after end of treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '315', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-9.5', 'spread': '29.0', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, end of treatment (week 8, 12, or 24 depending on the treatment regimen), and at 12 and 24 weeks after end of treatment', 'description': 'The WPAI Hepatitis C V2.0 is an HCV specific questionnaire used to measure work absenteeism, work presenteeism, and daily activity impairment. Respondents were asked about time missed from work and time while at work during which productivity was impaired in the past seven days. Results of WPAI are expressed as a percentage of impairment from 0 to 100, with higher percentages indicating greater impairment and less productivity.\n\nTotal activity impairment (TAI) indicates the percentage of general (non-work) activity impairment due to health problems.', 'unitOfMeasure': 'percent impairment', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The Core population with available data at baseline and each time point.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Beliefs Medication Questionnaire - (18-item BMQ)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '720', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Paritaprevir/Ritonavir + Ombitasvir ± Dasabuvir ± Ribavirin', 'description': 'Participants in this observational study received treatment with paritaprevir/ritonavir (r) and ombitasvir with or without dasabuvir ± ribavirin (RBV) for 8, 12, or 24 weeks for the treatment of chronic hepatitis C (CHC), according to hepatitis C virus (HCV) genotype/subtype and stage of liver disease.'}], 'classes': [{'title': 'Specific Concerns', 'denoms': [{'units': 'Participants', 'counts': [{'value': '445', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.100', 'spread': '0.871', 'groupId': 'OG000'}]}]}, {'title': 'Specific Necessity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '449', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.099', 'spread': '0.739', 'groupId': 'OG000'}]}]}, {'title': 'General Overuse', 'denoms': [{'units': 'Participants', 'counts': [{'value': '477', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.119', 'spread': '0.685', 'groupId': 'OG000'}]}]}, {'title': 'General Harm', 'denoms': [{'units': 'Participants', 'counts': [{'value': '480', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.135', 'spread': '0.670', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and end of treatment (week 8, 12, or 24 depending on the treatment regimen)', 'description': "The BMQ consists of 2 sections and 18 questions to screen for patients' beliefs, attitudes and concerns about their medication. The BMQ-Specific section comprises two 5-item subscales assessing the necessity of and concerns about the prescribed medication (Specific-Necessity and Specific-Concerns). The BMQ-General section comprises two 4-item subscales assessing beliefs that medicines are harmful and overused by doctors in general (General-Harm and General-Overuse). The 18 items are rated on a Likert scale from 1 (strongly disagree) to 5 (strongly agree). Each subscale score ranges from 1 to 5. High scores in the Specific-Concerns scale represent the notion that adverse reactions are potentially harmful when taking medication on a regular basis, and high scores in the Specific-Necessity scale indicate the patient's need to adhere to medication to maintain health. High scores in the General-Harm and General-Overuse scales represent an overall negative perception of medication.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The Core population with available data at baseline and end of treatment.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Patient Activation Measure 13 (PAM-13)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '433', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Paritaprevir/Ritonavir + Ombitasvir ± Dasabuvir ± Ribavirin', 'description': 'Participants in this observational study received treatment with paritaprevir/ritonavir (r) and ombitasvir with or without dasabuvir ± ribavirin (RBV) for 8, 12, or 24 weeks for the treatment of chronic hepatitis C (CHC), according to hepatitis C virus (HCV) genotype/subtype and stage of liver disease.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.44', 'spread': '9.43', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and end of treatment (week 8, 12, or 24 depending on the treatment regimen)', 'description': 'PAM 13 is a measure used to assess the patient knowledge, skill, and confidence for self-management, consisting of 13 questions. Each of the 13 items can be answered with one of four possible response options, which are "disagree strongly" (1), "disagree" (2), "agree" (3), "agree strongly" (4). Scores were summed to calculate the overall raw score, then transformed to a scale with a theoretical range 0 to 100, based on calibration tables, with higher PAM scores indicating higher patient activation.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The Core population with available data at baseline and end of treatment.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Outpatient Consultations Due to Liver Disease by Category', 'denoms': [{'units': 'Participants', 'counts': [{'value': '694', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Paritaprevir/Ritonavir + Ombitasvir ± Dasabuvir ± Ribavirin', 'description': 'Participants in this observational study received treatment with paritaprevir/ritonavir (r) and ombitasvir with or without dasabuvir ± ribavirin (RBV) for 8, 12, or 24 weeks for the treatment of chronic hepatitis C (CHC), according to hepatitis C virus (HCV) genotype/subtype and stage of liver disease.'}], 'classes': [{'categories': [{'title': 'No outpatient consultations', 'measurements': [{'value': '515', 'groupId': 'OG000'}]}, {'title': 'One outpatient consultation', 'measurements': [{'value': '80', 'groupId': 'OG000'}]}, {'title': 'Two or three outpatient consultations', 'measurements': [{'value': '94', 'groupId': 'OG000'}]}, {'title': 'Four or more outpatient consultations', 'measurements': [{'value': '5', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From first dose of study drug through 30 days after last dose (12 to 28 weeks depending on treatment regimen). The median (minimum, maximum) duration of treatment was 84 (4, 167) days.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Core population with available data'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Hospitalizations Due to Liver Disease by Category', 'denoms': [{'units': 'Participants', 'counts': [{'value': '694', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Paritaprevir/Ritonavir + Ombitasvir ± Dasabuvir ± Ribavirin', 'description': 'Participants in this observational study received treatment with paritaprevir/ritonavir (r) and ombitasvir with or without dasabuvir ± ribavirin (RBV) for 8, 12, or 24 weeks for the treatment of chronic hepatitis C (CHC), according to hepatitis C virus (HCV) genotype/subtype and stage of liver disease.'}], 'classes': [{'categories': [{'title': 'No hospitalizations', 'measurements': [{'value': '685', 'groupId': 'OG000'}]}, {'title': 'One hospitalization', 'measurements': [{'value': '9', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From first dose of study drug through 30 days after last dose (12 to 28 weeks depending on treatment regimen). The median (minimum, maximum) duration of treatment was 84 (4, 167) days.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Core population with available data'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Percent Glycosylated Hemoglobin (HbA1c)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Paritaprevir/Ritonavir + Ombitasvir ± Dasabuvir ± Ribavirin', 'description': 'Participants in this observational study received treatment with paritaprevir/ritonavir (r) and ombitasvir with or without dasabuvir ± ribavirin (RBV) for 8, 12, or 24 weeks for the treatment of chronic hepatitis C (CHC), according to hepatitis C virus (HCV) genotype/subtype and stage of liver disease.'}], 'classes': [{'categories': [{'measurements': [{'value': '-7.07', 'spread': '10.70', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and end of treatment (week 8, 12, or 24 depending on the treatment regimen)', 'unitOfMeasure': 'percent glycosylated hemoglobin', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Treated participants with available data at baseline and end of treatment.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Paritaprevir/Ritonavir + Ombitasvir ± Dasabuvir ± Ribavirin', 'description': 'Participants in this observational study received treatment with paritaprevir/ritonavir (r) and ombitasvir with or without dasabuvir ± ribavirin (RBV) for 8, 12, or 24 weeks for the treatment of chronic hepatitis C (CHC), according to hepatitis C virus (HCV) genotype/subtype and stage of liver disease.\n\nThe prescription of treatment regimen was at the discretion of the physician in accordance with local clinical practice and label, and was made independently from this observational study and preceded the decision to offer the patient the opportunity to participate in this study.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '735'}]}, {'type': 'Received Treatment', 'achievements': [{'groupId': 'FG000', 'numSubjects': '728'}]}, {'type': 'COMPLETED', 'comment': 'HCV ribonucleic acid (RNA) treatment assessment performed at least 10 weeks post-treatment', 'achievements': [{'groupId': 'FG000', 'numSubjects': '677'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '58'}]}], 'dropWithdraws': [{'type': 'Failure to Return', 'reasons': [{'groupId': 'FG000', 'numSubjects': '28'}]}, {'type': 'Insufficient Virological Response', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '11'}]}, {'type': 'Missing', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}]}, {'type': 'Treatment Never Started', 'reasons': [{'groupId': 'FG000', 'numSubjects': '7'}]}]}], 'recruitmentDetails': 'This observational study was conducted in 69 medical centers in France experienced in the treatment of chronic hepatitis C (CHC). The first participant entered the study on 15 December 2015, last patient last visit was on 29 March 2018.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '728', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Paritaprevir/Ritonavir + Ombitasvir ± Dasabuvir ± Ribavirin', 'description': 'Participants in this observational study received treatment with paritaprevir/ritonavir (r) and ombitasvir with or without dasabuvir ± ribavirin (RBV) for 8, 12, or 24 weeks for the treatment of chronic hepatitis C (CHC), according to hepatitis C virus (HCV) genotype/subtype and stage of liver disease.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '728', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '56', 'spread': '12.1', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Age, Customized', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '728', 'groupId': 'BG000'}]}], 'categories': [{'title': '18 to 65 years', 'measurements': [{'value': '570', 'groupId': 'BG000'}]}, {'title': '66 to 84 years', 'measurements': [{'value': '151', 'groupId': 'BG000'}]}, {'title': '85 years or older', 'measurements': [{'value': '7', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '728', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '372', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '356', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '728', 'groupId': 'BG000'}]}], 'categories': [{'title': 'White', 'measurements': [{'value': '577', 'groupId': 'BG000'}]}, {'title': 'Black', 'measurements': [{'value': '90', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '28', 'groupId': 'BG000'}]}, {'title': 'Native American', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Other', 'measurements': [{'value': '32', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Years Since Diagnosis of HCV Infection', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '728', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '13.8', 'spread': '10.57', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'HCV Genotype', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '728', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Genotype 1a', 'measurements': [{'value': '78', 'groupId': 'BG000'}]}, {'title': 'Genotype 1a/1b', 'measurements': [{'value': '3', 'groupId': 'BG000'}]}, {'title': 'Genotype 1b', 'measurements': [{'value': '427', 'groupId': 'BG000'}]}, {'title': 'Genotype 1d', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Genotype 1e', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}, {'title': 'Genotype 1l', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Genotype 1, subtype unknown', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Genotype 1/4, subtype unknown', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Genotype 4a', 'measurements': [{'value': '39', 'groupId': 'BG000'}]}, {'title': 'Genotype 4a/4c/4d', 'measurements': [{'value': '11', 'groupId': 'BG000'}]}, {'title': 'Genotype 4c', 'measurements': [{'value': '3', 'groupId': 'BG000'}]}, {'title': 'Genotype 4c/4d', 'measurements': [{'value': '5', 'groupId': 'BG000'}]}, {'title': 'Genotype 4d', 'measurements': [{'value': '14', 'groupId': 'BG000'}]}, {'title': 'Genotype 4e', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}, {'title': 'Genotype 4f', 'measurements': [{'value': '7', 'groupId': 'BG000'}]}, {'title': 'Genotype 4h', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Genotype 4k', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Genotype 4r', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}, {'title': 'Genotype 4, subtype unknown', 'measurements': [{'value': '129', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Cirrhosis Status', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '728', 'groupId': 'BG000'}]}], 'categories': [{'title': 'No cirrhosis', 'measurements': [{'value': '520', 'groupId': 'BG000'}]}, {'title': 'Transition to cirrhosis', 'measurements': [{'value': '97', 'groupId': 'BG000'}]}, {'title': 'Cirrhosis', 'measurements': [{'value': '111', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Pretreatment Status', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '728', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Naive', 'measurements': [{'value': '489', 'groupId': 'BG000'}]}, {'title': 'Experienced', 'measurements': [{'value': '238', 'groupId': 'BG000'}]}, {'title': 'Missing', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'HCV RNA Concentration', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '720', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '6.13', 'groupId': 'BG000', 'lowerLimit': '2.32', 'upperLimit': '8.24'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'log10 IU/mL', 'dispersionType': 'FULL_RANGE', 'populationDescription': 'The core population included all enrolled participants who were adequately treated according to the standard of care and within local label recommendations for their specific disease characteristics (cirrhotic status, genotype).'}, {'title': 'Assigned Treatment Regimen', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '728', 'groupId': 'BG000'}]}], 'categories': [{'title': '2 DAA without RBV for 12 weeks', 'measurements': [{'value': '4', 'groupId': 'BG000'}]}, {'title': '2 DAA with RBV for 12 weeks', 'measurements': [{'value': '209', 'groupId': 'BG000'}]}, {'title': '3 DAA without RBV for 8 weeks', 'measurements': [{'value': '95', 'groupId': 'BG000'}]}, {'title': '3 DAA without RBV for 12 weeks', 'measurements': [{'value': '334', 'groupId': 'BG000'}]}, {'title': '3 DAA with RBV for 12 weeks', 'measurements': [{'value': '84', 'groupId': 'BG000'}]}, {'title': '3 DAA with RBV for 24 weeks', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Treatment regimen was assigned by the physician according to local practice and label. Participants could receive two (paritaprevir/ritonavir and ombitasvir) or three (paritaprevir/ritonavir, ombitasvir, and dasabuvir) direct-acting antiviral (DAA) drugs with or without ribavirin (RBV) for 8, 12, or 24 weeks.', 'unitOfMeasure': 'Participants'}, {'title': 'Co-morbidities', 'classes': [{'title': 'Any co-morbidity or co-infection', 'denoms': [{'units': 'Participants', 'counts': [{'value': '728', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '387', 'groupId': 'BG000'}]}]}, {'title': 'Human immunodeficiency virus (HIV) co-infection', 'denoms': [{'units': 'Participants', 'counts': [{'value': '728', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '13', 'groupId': 'BG000'}]}]}, {'title': 'Hepatitis B co-infection', 'denoms': [{'units': 'Participants', 'counts': [{'value': '728', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}]}]}, {'title': 'Tuberculosis co-infection', 'denoms': [{'units': 'Participants', 'counts': [{'value': '728', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Drug Users', 'classes': [{'title': 'Psychoactive drug dependency', 'denoms': [{'units': 'Participants', 'counts': [{'value': '728', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '45', 'groupId': 'BG000'}]}]}, {'title': 'Active injection drug use', 'denoms': [{'units': 'Participants', 'counts': [{'value': '728', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}]}]}, {'title': 'Opiate substitution', 'denoms': [{'units': 'Participants', 'counts': [{'value': '728', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '33', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'All treated participants'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-01-10', 'size': 2604471, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2019-01-08T15:54', 'hasProtocol': True}, {'date': '2018-02-15', 'size': 659248, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2019-01-08T15:55', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 735}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-12-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-02', 'completionDateStruct': {'date': '2018-03-29', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-03-13', 'studyFirstSubmitDate': '2015-11-24', 'resultsFirstSubmitDate': '2019-03-13', 'studyFirstSubmitQcDate': '2015-11-30', 'lastUpdatePostDateStruct': {'date': '2019-06-17', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-03-13', 'studyFirstPostDateStruct': {'date': '2015-12-02', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-06-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-03-29', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Participants Achieving Sustained Virological Response 12 Weeks Post-treatment (SVR12)', 'timeFrame': '12 weeks after the last dose of study drug (week 20, 24, or 36 depending on the treatment regimen)', 'description': 'Sustained virologic response was defined as hepatitis C virus ribonucleic acid (HCV RNA) levels less than 50 IU/mL 12 weeks after the last dose of study drug. Participants with missing HCV RNA were counted as virological failure.'}], 'secondaryOutcomes': [{'measure': 'Percentage of Participants Achieving Virological Response at End of Treatment', 'timeFrame': 'End of treatment (week 8, 12, or 24 depending on the treatment regimen)', 'description': 'Virologic response was defined as hepatitis C virus ribonucleic acid (HCV RNA) levels less than 50 IU/mL.'}, {'measure': 'Percentage of Participants With Sufficient Follow-up Who Achieved Sustained Virological Response 12 Weeks Post-treatment', 'timeFrame': '12 weeks after the last dose of study drug (week 20, 24, or 36 depending on the treatment regimen)', 'description': 'Sustained virologic response was defined as hepatitis C virus ribonucleic acid (HCV RNA) levels less than 50 IU/mL 12 weeks after the last dose of study drug.\n\nThe Core Population with sufficient follow-up data regarding SVR12 included all core population participants who\n\n* had evaluable HCV RNA data ≥ 70 days after the last actual dose of the ABBVIE REGIMEN\n* or a HCV RNA value ≥ 50 IU/mL at the last measurement post-baseline\n* or had HCV RNA \\< 50 IU/mL at the last measurement post-baseline, but no HCV RNA measurement ≥ 70 days after the last actual dose of the ABBVIE REGIMEN due to reasons related to safety (e.g. dropped out due to adverse event) or virologic failure.'}, {'measure': 'Percentage of Participants With Relapse', 'timeFrame': 'End of treatment (week 8, 12, or 24 depending on the treatment regimen) and up to 24 weeks after the end of treatment.', 'description': 'Relapse was defined as participants with a virologic response (VR; HCV RNA \\< 50 IU/mL) at end of treatment (EOT) followed by HCV RNA ≥ 50 IU/mL at any time after the end of treatment.'}, {'measure': 'Percentage of Participants With Breakthrough', 'timeFrame': '8, 12, or 24 weeks (depending on the treatment regimen)', 'description': 'Breakthrough was defined as at least one documented HCV RNA \\< 50 IU/mL followed by HCV RNA ≥ 50 IU/mL during treatment.'}, {'measure': 'Percentage of Participants With Rapid Virological Response at Week 4 (RVR4)', 'timeFrame': 'Week 4', 'description': 'RVR 4 was defined as participants with HCV RNA \\< 50 IU/mL at week 4.'}, {'measure': 'Percentage of Participants With Sufficient Follow-up Who Achieved Sustained Virological Response 24 Weeks Post-treatment (SVR24)', 'timeFrame': '24 weeks after the last dose of study drug (week 32, 36, or 48 depending on the treatment regimen)', 'description': 'Sustained virologic response was defined as hepatitis C virus ribonucleic acid (HCV RNA) levels less than 50 IU/mL 24 weeks after the last dose of study drug.\n\nThe Core population with sufficient follow-up data regarding SVR24 included all core population participants who\n\n* had evaluable HCV RNA data ≥ 126 days after the last actual dose of the ABBVIE REGIMEN\n* or a HCV RNA value ≥ 50 IU/mL at the last measurement post-baseline\n* or had HCV RNA \\< 50 IU/mL at the last measurement post-baseline, but no HCV RNA measurement ≥ 126 days after the last actual dose of the ABBVIE REGIMEN due to reasons related to safety (e.g. dropped out due to adverse event) or virologic failure.'}, {'measure': 'Number of Participants in Each Non-response Category 12 Weeks Post-treatment', 'timeFrame': '12 weeks after the last dose of study drug (week 20, 24, or 36 depending on the treatment regimen)', 'description': 'SVR12 non-response was categorized according to the following:\n\n* On-treatment virologic failure (breakthrough \\[at least one documented HCV RNA \\< 50 IU/mL followed by HCV RNA ≥ 50 IU/mL during treatment\\] or failure to suppress \\[each measured on-treatment HCV RNA value ≥ 50 IU/mL\\]);\n* Relapse, defined as HCV RNA \\< 50 IU/mL at EOT followed by HCV RNA ≥ 50 IU/mL post-treatment in patients who completed treatment (not more than 7 days shortened);\n* Death\n* Premature treatment discontinuation with no on-treatment virologic failure;\n* Insufficient virological response reported or HCV RNA ≥ 50 IU/mL post-EOT and none of the above criteria\n* Missing SVR12 data and/or none of the above criteria.'}, {'measure': 'Percentage of Participants With Adherence to the ABBVIE Regimen, by Adherence Category', 'timeFrame': 'From first dose of study drug to end of treatment, 8 to 24 weeks depending on the treatment regimen.', 'description': 'Adherence to the ABBVIE treatment regimen is expressed as a percentage of the target dose and was calculated as:\n\nCumulative dose taken / (initial prescribed dose \\* planned duration) \\* 100 The ABBVIE regimen consists of paritaprevir/r and ombitasvir with or without dasabuvir.'}, {'measure': 'Percentage of Participants With Adherence to Ribavirin by Adherence Category', 'timeFrame': 'From first dose of study drug to end of treatment, 8 to 24 weeks depending on the treatment regimen.', 'description': 'Adherence to ribavirin is expressed as a percentage of the target dose, and was calculated as:\n\nCumulative dose taken / (initial prescribed dose \\* planned duration) \\* 100'}, {'measure': 'Percentage of Ribavirin Treatment Days in Relation to the Target Number of Ribavirin Treatment Days', 'timeFrame': 'From first dose of study drug to end of treatment, 8 to 24 weeks depending on the treatment regimen.'}, {'measure': 'Number of Participants Who Received Concomitant Medications', 'timeFrame': 'From first dose of study drug to end of treatment, 8 to 24 weeks depending on the treatment regimen', 'description': 'Concomitant medication other than for chronic hepatitis C used from the time when the decision was made to initiate treatment with paritaprevir/ritonavir and ombitasvir with or without dasabuvir until after the last dose.'}, {'measure': 'Number of Participants With Adverse Events, Serious Adverse Events, or Pregnancies', 'timeFrame': 'From first dose of study drug through 30 days after last dose (12 to 28 weeks depending on treatment regimen). The median (minimum, maximum) duration of treatment was 84 (4, 167) days.'}, {'measure': 'Change From Baseline in Fatigue Impact Scale Total Score', 'timeFrame': 'Baseline, end of treatment (week 8, 12, or 24 depending on the treatment regimen), and at 12 and 24 weeks after end of treatment', 'description': 'The Fatigue Impact Scale (FIS) questionnaire was used to assess the impact of fatigue on the quality of life of patients.\n\nThe FIS consists of 40 items, each of which is scored 0 (no problem) to 4 (extreme problem), providing a total score from of 0 to 160, where a lower score = less fatigue impact'}, {'measure': 'Change From Baseline in EuroQol 5 Dimension 5 Level (EQ-5D-5L) Index Score', 'timeFrame': 'Baseline, end of treatment (week 8, 12, or 24 depending on the treatment regimen), and at 12 and 24 weeks after end of treatment', 'description': "The EQ-5D-5L is a health state utility instrument that evaluates preference for health status. The 5 items in the EQ-5D-5L comprise 5 dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) each of which are rated on 5 levels of severity (1: indicating no problem, 2: indicating slight problems, 3: indicating moderate problems, 4: indicating severe problems, 5: indicating extreme problems), and a separate visual analog scale (VAS).\n\nResponses to the 5 dimension scores were combined and converted into a single preference-weighted health utility index score by applying country-specific weights.The range for EQ-5D-5L index score is 0 to 1 where '0' is defined as a health state equivalent to being dead and '1' is full health.The higher the score the better the health status."}, {'measure': 'Change From Baseline in EuroQol 5 Dimension 5 Level (EQ-5D-5L) VAS Score', 'timeFrame': 'Baseline, end of treatment (week 8, 12, or 24 depending on the treatment regimen), and at 12 and 24 weeks after end of treatment', 'description': 'The EQ-5D-5L is a health state utility instrument that evaluates preference for health status with a separate visual analog scale (VAS).\n\nThe VAS assesses overall health on a scale from 0 (worst health imaginable) to 100 (best health imaginable).'}, {'measure': 'Change From Baseline in Work Productivity and Activity Impairment (WPAI): Absenteeism', 'timeFrame': 'Baseline, end of treatment (week 8, 12, or 24 depending on the treatment regimen), and at 12 and 24 weeks after end of treatment', 'description': 'The WPAI Hepatitis C V2.0 is an HCV specific questionnaire used to measure work absenteeism, work presenteeism, and daily activity impairment. Respondents were asked about time missed from work and time while at work during which productivity was impaired in the past seven days. Results of WPAI are expressed as a percentage of impairment from 0 to 100, with higher percentages indicating greater impairment and less productivity.\n\nAbsenteeism indicates the percentage of work time missed due to health problems.'}, {'measure': 'Change From Baseline in Work Productivity and Activity Impairment (WPAI): Presenteeism', 'timeFrame': 'Baseline, end of treatment (week 8, 12, or 24 depending on the treatment regimen), and at 12 and 24 weeks after end of treatment', 'description': 'The WPAI Hepatitis C V2.0 is an HCV specific questionnaire used to measure work absenteeism, work presenteeism, and daily activity impairment. Respondents were asked about time missed from work and time while at work during which productivity was impaired in the past seven days. Results of WPAI are expressed as a percentage of impairment from 0 to 100, with higher percentages indicating greater impairment and less productivity.\n\nPresenteeism indicates the percentage of impairment while working due to health problems.'}, {'measure': 'Change From Baseline in Work Productivity and Activity Impairment (WPAI): Total Work Productivity Impairment (TWP)', 'timeFrame': 'Baseline, end of treatment (week 8, 12, or 24 depending on the treatment regimen), and at 12 and 24 weeks after end of treatment', 'description': 'The WPAI Hepatitis C V2.0 is an HCV specific questionnaire used to measure work absenteeism, work presenteeism, and daily activity impairment. Respondents were asked about time missed from work and time while at work during which productivity was impaired in the past seven days. Results of WPAI are expressed as a percentage of impairment from 0 to 100, with higher percentages indicating greater impairment and less productivity.\n\nTotal work productivity impairment (TWP) indicates the percentage of overall work impairment due to health problems.'}, {'measure': 'Change From Baseline in Work Productivity and Activity Impairment (WPAI): Total Activity Impairment', 'timeFrame': 'Baseline, end of treatment (week 8, 12, or 24 depending on the treatment regimen), and at 12 and 24 weeks after end of treatment', 'description': 'The WPAI Hepatitis C V2.0 is an HCV specific questionnaire used to measure work absenteeism, work presenteeism, and daily activity impairment. Respondents were asked about time missed from work and time while at work during which productivity was impaired in the past seven days. Results of WPAI are expressed as a percentage of impairment from 0 to 100, with higher percentages indicating greater impairment and less productivity.\n\nTotal activity impairment (TAI) indicates the percentage of general (non-work) activity impairment due to health problems.'}, {'measure': 'Change From Baseline in Beliefs Medication Questionnaire - (18-item BMQ)', 'timeFrame': 'Baseline and end of treatment (week 8, 12, or 24 depending on the treatment regimen)', 'description': "The BMQ consists of 2 sections and 18 questions to screen for patients' beliefs, attitudes and concerns about their medication. The BMQ-Specific section comprises two 5-item subscales assessing the necessity of and concerns about the prescribed medication (Specific-Necessity and Specific-Concerns). The BMQ-General section comprises two 4-item subscales assessing beliefs that medicines are harmful and overused by doctors in general (General-Harm and General-Overuse). The 18 items are rated on a Likert scale from 1 (strongly disagree) to 5 (strongly agree). Each subscale score ranges from 1 to 5. High scores in the Specific-Concerns scale represent the notion that adverse reactions are potentially harmful when taking medication on a regular basis, and high scores in the Specific-Necessity scale indicate the patient's need to adhere to medication to maintain health. High scores in the General-Harm and General-Overuse scales represent an overall negative perception of medication."}, {'measure': 'Change From Baseline in Patient Activation Measure 13 (PAM-13)', 'timeFrame': 'Baseline and end of treatment (week 8, 12, or 24 depending on the treatment regimen)', 'description': 'PAM 13 is a measure used to assess the patient knowledge, skill, and confidence for self-management, consisting of 13 questions. Each of the 13 items can be answered with one of four possible response options, which are "disagree strongly" (1), "disagree" (2), "agree" (3), "agree strongly" (4). Scores were summed to calculate the overall raw score, then transformed to a scale with a theoretical range 0 to 100, based on calibration tables, with higher PAM scores indicating higher patient activation.'}, {'measure': 'Number of Participants With Outpatient Consultations Due to Liver Disease by Category', 'timeFrame': 'From first dose of study drug through 30 days after last dose (12 to 28 weeks depending on treatment regimen). The median (minimum, maximum) duration of treatment was 84 (4, 167) days.'}, {'measure': 'Number of Participants With Hospitalizations Due to Liver Disease by Category', 'timeFrame': 'From first dose of study drug through 30 days after last dose (12 to 28 weeks depending on treatment regimen). The median (minimum, maximum) duration of treatment was 84 (4, 167) days.'}, {'measure': 'Change From Baseline in Percent Glycosylated Hemoglobin (HbA1c)', 'timeFrame': 'Baseline and end of treatment (week 8, 12, or 24 depending on the treatment regimen)'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['HCV', 'Chronic Hepatitis C'], 'conditions': ['Chronic Hepatitis C']}, 'referencesModule': {'references': [{'pmid': '30739368', 'type': 'DERIVED', 'citation': 'Ferenci P, Bourgeois S, Buggisch P, Norris S, Curescu M, Larrey D, Marra F, Kleine H, Dorr P, Charafeddine M, Crown E, Bondin M, Back D, Flisiak R. Real-world safety and effectiveness of ombitasvir/paritaprevir/ritonavir +/- dasabuvir +/- ribavirin in hepatitis C virus genotype 1- and 4-infected patients with diverse comorbidities and comedications: A pooled analysis of post-marketing observational studies from 13 countries. J Viral Hepat. 2019 Jun;26(6):685-696. doi: 10.1111/jvh.13080. Epub 2019 Mar 5.'}], 'seeAlsoLinks': [{'url': 'http://www.rxabbvie.com', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': 'This study seeks to determine the effectiveness of the interferon-free ABBVIE REGIMEN ± ribavirin (RBV) in participants with chronic hepatitis C (CHC) virus in clinical practices across France.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Adult patients chronically infected with HCV, receiving the interferon-free ABBVIE REGIMEN, were offered the opportunity to participate in this study during a routine clinical visit at the participating sites.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Treatment-naïve or -experienced participants with confirmed CHC, genotype 1 or 4\n* Participants receiving or who will receive the interferon-free ABBVIE REGIMEN ± RBV according to product label\n* RBV prescribed in line with the current local label\n\nExclusion Criteria:\n\n* Participant is not participating or intending to participate in a concurrent interventional therapeutic trial'}, 'identificationModule': {'nctId': 'NCT02618928', 'acronym': 'OPALE', 'briefTitle': 'The Effectiveness of Paritaprevir/Ritonavir - Ombitasvir, ± Dasabuvir, ± Ribavirin in France', 'organization': {'class': 'INDUSTRY', 'fullName': 'AbbVie'}, 'officialTitle': 'Real World Evidence of the Effectiveness of Paritaprevir/r - Ombitasvir, ± Dasabuvir, ± Ribavirin in Patients With Chronic Hepatitis C - An Observational Study in France', 'orgStudyIdInfo': {'id': 'P15-405'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Paritaprevir/Ritonavir + Ombitasvir ± Dasabuvir ± Ribavirin', 'description': 'Participants in this observational study received treatment with paritaprevir/ritonavir (r) and ombitasvir with or without dasabuvir ± ribavirin (RBV) for 8, 12, or 24 weeks for the treatment of chronic hepatitis C (CHC), according to hepatitis C virus (HCV) genotype/subtype and stage of liver disease.\n\nThe prescription of treatment regimen was at the discretion of the physician in accordance with local clinical practice and label, and was made independently from this observational study and preceded the decision to offer the patient the opportunity to participate in this study.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '13285', 'city': 'Marseille', 'state': 'Bouches-du-Rhone', 'country': 'France', 'facility': 'Hopital Saint Joseph /ID# 144927', 'geoPoint': {'lat': 43.29695, 'lon': 5.38107}}, {'zip': '13285', 'city': 'Marseille', 'state': 'Bouches-du-Rhone', 'country': 'France', 'facility': 'Hopital Saint Joseph /ID# 145560', 'geoPoint': {'lat': 43.29695, 'lon': 5.38107}}, {'zip': '13285', 'city': 'Marseille', 'state': 'Bouches-du-Rhone', 'country': 'France', 'facility': 'Hopital Saint Joseph /ID# 145571', 'geoPoint': {'lat': 43.29695, 'lon': 5.38107}}, {'zip': '45067', 'city': 'Orléans', 'state': 'Centre-Val de Loire', 'country': 'France', 'facility': 'CHR Orleans - Hopital de la Source /ID# 147250', 'geoPoint': {'lat': 47.90248, 'lon': 1.90407}}, {'zip': '25000', 'city': 'Besançon', 'state': 'Doubs', 'country': 'France', 'facility': 'CHU de Besancon - Jean Minjoz /ID# 145884', 'geoPoint': {'lat': 47.24878, 'lon': 6.01815}}, {'zip': '87042', 'city': 'Limoges', 'state': 'Franche-Comte', 'country': 'France', 'facility': 'CHU Dupuytren /ID# 144920', 'geoPoint': {'lat': 45.83362, 'lon': 1.24759}}, {'zip': '31059', 'city': 'Toulouse', 'state': 'Haute-Garonne', 'country': 'France', 'facility': 'Hopital Universitaire Purpan /ID# 145869', 'geoPoint': {'lat': 43.60426, 'lon': 1.44367}}, {'zip': '31059', 'city': 'Toulouse', 'state': 'Haute-Garonne', 'country': 'France', 'facility': 'Hopital Universitaire Purpan /ID# 150141', 'geoPoint': {'lat': 43.60426, 'lon': 1.44367}}, {'zip': '34295', 'city': 'Montpellier', 'state': 'Herault', 'country': 'France', 'facility': 'Hopital Saint Eloi /ID# 144919', 'geoPoint': {'lat': 43.61093, 'lon': 3.87635}}, {'zip': '13385', 'city': 'Marseille', 'state': "Provence-Alpes-Côte d'Azur Region", 'country': 'France', 'facility': 'Hopital de la Timone /ID# 145558', 'geoPoint': {'lat': 43.29695, 'lon': 5.38107}}, {'zip': '13385', 'city': 'Marseille', 'state': "Provence-Alpes-Côte d'Azur Region", 'country': 'France', 'facility': 'Hopital de la Timone /ID# 145574', 'geoPoint': {'lat': 43.29695, 'lon': 5.38107}}, {'zip': '80054', 'city': 'Amiens', 'state': 'Somme', 'country': 'France', 'facility': 'CHU Amiens Picardie /ID# 145871', 'geoPoint': {'lat': 49.9, 'lon': 2.3}}, {'zip': '13090', 'city': 'Aix-en-Provence', 'country': 'France', 'facility': "C.H. du Pays d'Aix /ID# 144922", 'geoPoint': {'lat': 43.5283, 'lon': 5.44973}}, {'zip': '13100', 'city': 'Aix-en-Provence', 'country': 'France', 'facility': 'Cabinet medical /ID# 147359', 'geoPoint': {'lat': 43.5283, 'lon': 5.44973}}, {'zip': '49933', 'city': 'Angers', 'country': 'France', 'facility': "CHU d'Angers /ID# 145880", 'geoPoint': {'lat': 47.47156, 'lon': -0.55202}}, {'zip': '95107', 'city': 'Argenteuil', 'country': 'France', 'facility': 'Centre Hospitalier Victor Dupo /ID# 147241', 'geoPoint': {'lat': 48.94788, 'lon': 2.24744}}, {'zip': '84000', 'city': 'Avignon', 'country': 'France', 'facility': "Centre Hospitalier D'Avignon /ID# 151098", 'geoPoint': {'lat': 43.94834, 'lon': 4.80892}}, {'zip': '84000', 'city': 'Avignon', 'country': 'France', 'facility': "Centre Hospitalier D'Avignon /ID# 151343", 'geoPoint': {'lat': 43.94834, 'lon': 4.80892}}, {'zip': '25000', 'city': 'Besançon', 'country': 'France', 'facility': 'Cabinet Medical /ID# 147322', 'geoPoint': {'lat': 47.24878, 'lon': 6.01815}}, {'zip': '38300', 'city': 'Bourgoin', 'country': 'France', 'facility': 'Centre Endo Nord Isere /ID# 148694', 'geoPoint': {'lat': 45.59889, 'lon': 5.27236}}, {'zip': '14033', 'city': 'Caen', 'country': 'France', 'facility': 'Centre Hospitalier Universitai /ID# 147568', 'geoPoint': {'lat': 49.18585, 'lon': -0.35912}}, {'zip': '7301', 'city': 'Chambéry', 'country': 'France', 'facility': 'CH de Chambery /ID# 145573', 'geoPoint': {'lat': 45.56628, 'lon': 5.92079}}, {'zip': '92140', 'city': 'Clamart', 'country': 'France', 'facility': 'Hopital Antoine Beclere /ID# 149251', 'geoPoint': {'lat': 48.80299, 'lon': 2.26692}}, {'zip': '92140', 'city': 'Clamart', 'country': 'France', 'facility': 'Hopital Antoine Beclere /ID# 149252', 'geoPoint': {'lat': 48.80299, 'lon': 2.26692}}, {'zip': '94010', 'city': 'Créteil', 'country': 'France', 'facility': 'Centre Hosp Intercommunal /ID# 145876', 'geoPoint': {'lat': 48.79266, 'lon': 2.46569}}, {'zip': '94010', 'city': 'Créteil', 'country': 'France', 'facility': 'Hospital Henri Mondor /ID# 144918', 'geoPoint': {'lat': 48.79266, 'lon': 2.46569}}, {'zip': '06130', 'city': 'Grasse', 'country': 'France', 'facility': 'Clinique du Palais /ID# 145563', 'geoPoint': {'lat': 43.65783, 'lon': 6.92537}}, {'zip': '38043', 'city': 'Grenoble', 'country': 'France', 'facility': 'CHU de Grenoble - Albet Michal /ID# 145881', 'geoPoint': {'lat': 45.17869, 'lon': 5.71479}}, {'zip': '83407', 'city': 'Hyères', 'country': 'France', 'facility': "CH d'Hyeres /ID# 145870", 'geoPoint': {'lat': 43.12038, 'lon': 6.12857}}, {'zip': '72037', 'city': 'Le Mans', 'country': 'France', 'facility': 'Ch Du Mans /Id# 147415', 'geoPoint': {'lat': 48.0021, 'lon': 0.20251}}, {'zip': '97420', 'city': 'Le Port', 'country': 'France', 'facility': 'Dr. Cuissard, Le Port, FR /ID# 145565', 'geoPoint': {'lat': 42.86925, 'lon': 1.3725}}, {'zip': '33500', 'city': 'Libourne', 'country': 'France', 'facility': 'Centre Hospitalier de Libourne /ID# 145564', 'geoPoint': {'lat': 44.91449, 'lon': -0.24186}}, {'zip': '91161', 'city': 'Longjumeau', 'country': 'France', 'facility': 'CH Des Deux Vallees Longumeau /ID# 149336', 'geoPoint': {'lat': 48.69307, 'lon': 2.29431}}, {'zip': '69004', 'city': 'Lyon', 'country': 'France', 'facility': 'Hopital de la Croix Rousse /ID# 149776', 'geoPoint': {'lat': 45.74906, 'lon': 4.84789}}, {'zip': '69338', 'city': 'Lyon', 'country': 'France', 'facility': 'Ctr Consultations La Sauvegard /ID# 147236', 'geoPoint': {'lat': 45.74906, 'lon': 4.84789}}, {'zip': '13385', 'city': 'Marseille', 'country': 'France', 'facility': 'Hopital de la Timone /ID# 147237', 'geoPoint': {'lat': 43.29695, 'lon': 5.38107}}, {'zip': '26216', 'city': 'Montélimar', 'country': 'France', 'facility': 'Ctre Hosp de Montelimar /ID# 147239', 'geoPoint': {'lat': 44.55468, 'lon': 4.75469}}, {'zip': '92000', 'city': 'Nanterre', 'country': 'France', 'facility': 'Cabinet Medical, Boyer Darrigr /ID# 145562', 'geoPoint': {'lat': 48.89198, 'lon': 2.20675}}, {'zip': '06202', 'city': 'Nice', 'country': 'France', 'facility': 'CHU de Nice /ID# 144921', 'geoPoint': {'lat': 43.70313, 'lon': 7.26608}}, {'zip': '30900', 'city': 'Nîmes', 'country': 'France', 'facility': 'Cabinet Medical, Dr. Verdier, /ID# 145575', 'geoPoint': {'lat': 43.83665, 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