Ignite Creation Date:
2025-12-25 @ 4:01 AM
Ignite Modification Date:
2026-03-03 @ 3:04 AM
Study NCT ID:
NCT02807402
Status:
COMPLETED
Last Update Posted:
2019-01-25
First Post:
2016-06-16
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Effectiveness of Paritaprevir/Ritonavir, Ombitasvir, + Dasabuvir, ± Ribavirin in Patients With Chronic Hepatitis C in Romania
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Romania']}, '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': 'From first dose of study drug through 30 days after last dose (16 or 28 weeks depending on the treatment regimen). The overall median (minimum, maximum) duration of treatment was 84 (28, 175) days.', 'description': 'The safety population included all enrolled participants who received at least one dose of paritaprevir/ritonavir, ombitasvir, with or without dasabuvir.', 'eventGroups': [{'id': 'EG000', 'title': 'Paritaprevir/Ritonavir + Ombitasvir With RBV', 'description': 'Participants received paritaprevir/ritonavir and ombitasvir plus ribavirin for either 12 or 24 weeks.', 'otherNumAtRisk': 3, 'deathsNumAtRisk': 3, 'otherNumAffected': 0, 'seriousNumAtRisk': 3, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Paritaprevir/Ritonavir + Ombitasvir + Dasabuvir Without RBV', 'description': 'Participants received paritaprevir/ritonavir, ombitasvir, and dasabuvir without ribavirin for 12 weeks.', 'otherNumAtRisk': 73, 'deathsNumAtRisk': 73, 'otherNumAffected': 0, 'seriousNumAtRisk': 73, 'deathsNumAffected': 0, 'seriousNumAffected': 3}, {'id': 'EG002', 'title': 'Paritaprevir/Ritonavir + Ombitasvir + Dasabuvir With R+ RBV', 'description': 'Participants received paritaprevir/ritonavir, ombitasvir, and dasabuvir with ribavirin for 12 or 24 weeks.', 'otherNumAtRisk': 446, 'deathsNumAtRisk': 446, 'otherNumAffected': 44, 'seriousNumAtRisk': 446, 'deathsNumAffected': 3, 'seriousNumAffected': 17}], 'otherEvents': [{'term': 'ANAEMIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 73, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 446, 'numEvents': 44, 'numAffected': 44}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}], 'seriousEvents': [{'term': 'ANAEMIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 73, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 446, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'ATRIAL FIBRILLATION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 73, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 446, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'ENTEROCOLITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 73, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 446, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'GASTRIC VARICES HAEMORRHAGE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 73, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 446, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'GASTRITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 73, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 446, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'GASTROINTESTINAL HAEMORRHAGE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 73, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 446, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'NAUSEA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 73, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 446, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'CHOLANGITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 73, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 446, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'HEPATIC FAILURE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 73, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 446, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'JAUNDICE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 73, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 446, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'ESCHERICHIA URINARY TRACT INFECTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 73, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 446, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'PYELONEPHRITIS ACUTE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 73, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 446, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'PYONEPHROSIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 73, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 446, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'HYPERKALAEMIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 73, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 446, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'HYPONATRAEMIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 73, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 446, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'BLADDER CANCER', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 73, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 446, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'HAEMATURIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 73, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 446, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Participants Achieving Sustained Virological Response 12 Weeks Post-treatment (SVR12)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '519', '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 dasabuvir ± ribavirin (RBV) for 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': '98.1', 'groupId': 'OG000', 'lowerLimit': '96.5', 'upperLimit': '99.0'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '12 weeks after the last dose of study drug (week 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.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': '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). Three participants with genotype 1 prescribed paritaprevir/r and ombitasvir instead of paritaprevir/r, ombitasvir and dasabuvir (3DAA) were excluded.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Achieving Virological Response at End of Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '519', '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 dasabuvir ± ribavirin (RBV) for 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': '99.6', 'groupId': 'OG000', 'lowerLimit': '98.6', 'upperLimit': '99.9'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'End of treatment (week 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': '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 in the Core Population With Sufficient Follow-up Data for SVR12 Who Achieved Sustained Virological Response 12 Weeks Post-treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '517', '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 dasabuvir ± ribavirin (RBV) for 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', 'groupId': 'OG000', 'lowerLimit': '97.0', 'upperLimit': '99.2'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '12 weeks after the last dose of study drug (week 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 paritaprevir/ritonavir, ombitasvir and dasabuvir\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 paritaprevir/ritonavir, ombitasvir with dasabuvir 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': '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), and with sufficient follow-up data regarding SVR12.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Relapse', 'denoms': [{'units': 'Participants', 'counts': [{'value': '512', '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 dasabuvir ± ribavirin (RBV) for 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': '0.8', 'groupId': 'OG000', 'lowerLimit': '0.3', 'upperLimit': '2.0'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'End of treatment (week 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': 'Enrolled participants who were adequately treated according to the standard of care and within local label recommendations for their specific disease characteristics, and with VR at EOT and who completed treatment, and had ≥ 1 HCV RNA measurement ≥ 70 days post-treatment and were a treatment failure between EOT and post-treatment day 70.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Breakthrough', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', '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 dasabuvir ± ribavirin (RBV) for 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': '0.00', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '9.6'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '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': '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) with virological response on-treatment and with at least one on-treatment measurement (including EOT) thereafter.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants in Each Non-response Category 12 Weeks Post-treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '519', '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 dasabuvir ± ribavirin (RBV) for 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 virologic failure', 'categories': [{'measurements': [{'value': '0.2', 'groupId': 'OG000'}]}]}, {'title': 'Relapse', 'categories': [{'measurements': [{'value': '0.8', 'groupId': 'OG000'}]}]}, {'title': 'Death', 'categories': [{'measurements': [{'value': '0.6', 'groupId': 'OG000'}]}]}, {'title': 'Premature treatment discontinuation', 'categories': [{'measurements': [{'value': '0.2', 'groupId': 'OG000'}]}]}, {'title': 'None of the above criteria', 'categories': [{'measurements': [{'value': '0.2', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '12 weeks after the last dose of study drug (week 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 virological failure;\n* Missing SVR12 data and/or none of the above criteria.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': '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': 'Assigned Treatment Regimen', 'denoms': [{'units': 'Participants', 'counts': [{'value': '519', '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 dasabuvir ± ribavirin (RBV) for 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': '3 DAA without RBV (12 weeks)', 'measurements': [{'value': '73', 'groupId': 'OG000'}]}, {'title': '3 DAA + RBV (12 weeks)', 'measurements': [{'value': '438', 'groupId': 'OG000'}]}, {'title': '3 DAA + RBV (24 weeks)', 'measurements': [{'value': '8', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline', 'description': 'Treatment regimen was assigned by the physician according to local practice and label. Participants could receive three direct-acting antiviral (DAA) drugs (paritaprevir/ritonavir, ombitasvir, and dasabuvir) with or without RBV for 12 or 24 weeks.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': '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 the Direct Acting Antiviral (DAA) Dose Taken in Relation to the Target Dose of DAA', 'denoms': [{'units': 'Participants', 'counts': [{'value': '519', '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 dasabuvir ± ribavirin (RBV) for 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': '6', 'groupId': 'OG000'}]}, {'title': '> 95% to ≤ 105%', 'measurements': [{'value': '483', 'groupId': 'OG000'}]}, {'title': '> 80% to ≤ 95%', 'measurements': [{'value': '28', 'groupId': 'OG000'}]}, {'title': '> 50% to ≤ 80%', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}, {'title': '≤ 50%', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From first dose of study drug to end of treatment, 12 to 24 weeks depending on the treatment regimen.', 'description': 'Adherence to study treatment was calculated as:\n\nCumulative dose taken / (initial prescribed dose \\* planned duration)', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': '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 the Ribavirin Dose Taken in Relation to the Target Dose of Ribavirin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '445', '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 dasabuvir ± ribavirin (RBV) for 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': '6', 'groupId': 'OG000'}]}, {'title': '> 95% to ≤ 105%', 'measurements': [{'value': '349', 'groupId': 'OG000'}]}, {'title': '> 80% to ≤ 95%', 'measurements': [{'value': '39', 'groupId': 'OG000'}]}, {'title': '> 50% to ≤ 80%', 'measurements': [{'value': '22', 'groupId': 'OG000'}]}, {'title': '≤ 50%', 'measurements': [{'value': '29', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From first dose of study drug to end of treatment, 12 to 24 weeks depending on the treatment regimen', 'description': 'Adherence to study treatment was calculated as:\n\nCumulative dose taken / (initial prescribed dose \\* planned duration)', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': '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), who were prescribed ribavirin, and with available data.'}, {'type': 'SECONDARY', 'title': 'Percentage of Ribavirin (RBV) Treatment Days in Relation to the Target Number of Ribavirin Treatment Days', 'denoms': [{'units': 'Participants', 'counts': [{'value': '446', '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 dasabuvir ± ribavirin (RBV) for 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': '94.5', 'spread': '19.12', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'From first dose of study drug to end of treatment, 12 to 24 weeks depending on the treatment regimen.', 'unitOfMeasure': 'percentage of days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '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), who were prescribed ribavirin.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Comorbidities', 'denoms': [{'units': 'Participants', 'counts': [{'value': '519', '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 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 comorbidity or coinfection', 'categories': [{'measurements': [{'value': '335', 'groupId': 'OG000'}]}]}, {'title': 'Any coinfection', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}]}]}, {'title': 'Coinfection with human immunodeficiency virus (HIV', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}, {'title': 'Coinfection with hepatitis B virus', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': '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': 'Number of Participants Who Received Concomitant Medications', 'denoms': [{'units': 'Participants', 'counts': [{'value': '522', '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 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': '263', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From first dose of study drug to end of treatment, 12 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': 'Enrolled patients who received at least one dose of paritaprevir/ritonavir and ombitasvir with or without dasabuvir.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in EuroQol 5 Dimension 5 Level (EQ-5D-5L) Index Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}, {'value': '319', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Paritaprevir/Ritonavir + Ombitasvir + Dasabuvir Without RBV', 'description': 'Participants received paritaprevir/ritonavir, ombitasvir, and dasabuvir without ribavirin for 12 weeks.'}, {'id': 'OG001', 'title': 'Paritaprevir/Ritonavir + Ombitasvir + Dasabuvir With RBV', 'description': 'Participants received paritaprevir/ritonavir, ombitasvir, and dasabuvir with ribavirin for 12 or 24 weeks.'}], 'classes': [{'title': 'End of Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '294', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.07', 'groupId': 'OG000', 'lowerLimit': '0.04', 'upperLimit': '0.10'}, {'value': '0.04', 'groupId': 'OG001', 'lowerLimit': '0.03', 'upperLimit': '0.06'}]}]}, {'title': '12 weeks post treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '291', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.09', 'groupId': 'OG000', 'lowerLimit': '0.06', 'upperLimit': '0.13'}, {'value': '0.08', 'groupId': 'OG001', 'lowerLimit': '0.07', 'upperLimit': '0.10'}]}]}, {'title': '24 weeks post treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '206', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.09', 'groupId': 'OG000', 'lowerLimit': '0.01', 'upperLimit': '0.16'}, {'value': '0.10', 'groupId': 'OG001', 'lowerLimit': '0.08', 'upperLimit': '0.11'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, end of treatment (week 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': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': '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) and 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': '56', 'groupId': 'OG000'}, {'value': '332', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Paritaprevir/Ritonavir + Ombitasvir + Dasabuvir Without RBV', 'description': 'Participants received paritaprevir/ritonavir, ombitasvir, and dasabuvir without ribavirin for 12 weeks.'}, {'id': 'OG001', 'title': 'Paritaprevir/Ritonavir + Ombitasvir + Dasabuvir With RBV', 'description': 'Participants received paritaprevir/ritonavir, ombitasvir, and dasabuvir with ribavirin for 12 or 24 weeks.'}], 'classes': [{'title': 'End of Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '317', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '10.9', 'groupId': 'OG000', 'lowerLimit': '6.40', 'upperLimit': '15.3'}, {'value': '8.36', 'groupId': 'OG001', 'lowerLimit': '6.55', 'upperLimit': '10.2'}]}]}, {'title': '12 weeks post treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}, {'value': '305', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '13.9', 'groupId': 'OG000', 'lowerLimit': '9.71', 'upperLimit': '18.0'}, {'value': '12.7', 'groupId': 'OG001', 'lowerLimit': '11.1', 'upperLimit': '14.4'}]}]}, {'title': '24 weeks post treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '220', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '18.8', 'groupId': 'OG000', 'lowerLimit': '9.45', 'upperLimit': '28.1'}, {'value': '15.2', 'groupId': 'OG001', 'lowerLimit': '13.2', 'upperLimit': '17.2'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, end of treatment (week 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': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': '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) and 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': '10', 'groupId': 'OG000'}, {'value': '67', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Paritaprevir/Ritonavir + Ombitasvir + Dasabuvir Without RBV', 'description': 'Participants received paritaprevir/ritonavir, ombitasvir, and dasabuvir without ribavirin for 12 weeks.'}, {'id': 'OG001', 'title': 'Paritaprevir/Ritonavir + Ombitasvir + Dasabuvir With RBV', 'description': 'Participants received paritaprevir/ritonavir, ombitasvir, and dasabuvir with ribavirin for 12 or 24 weeks.'}], 'classes': [{'title': 'End of Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-1.3', 'spread': '3.1', 'groupId': 'OG000'}, {'value': '-1.4', 'spread': '11.0', 'groupId': 'OG001'}]}]}, {'title': '12 weeks post treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-15.4', 'spread': '37.4', 'groupId': 'OG000'}, {'value': '-3.8', 'spread': '29.0', 'groupId': 'OG001'}]}]}, {'title': '24 weeks post treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-7.5', 'spread': 'NA', 'comment': 'Could not be calculated for one participant', 'groupId': 'OG000'}, {'value': '-8.7', 'spread': '34.4', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, end of treatment (week 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': '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). Participants who were employed with available data at baseline and each time point are included.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Work Productivity and Activity Impairment (WPAI): Presenteeism', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '68', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Paritaprevir/Ritonavir + Ombitasvir + Dasabuvir Without RBV', 'description': 'Participants received paritaprevir/ritonavir, ombitasvir, and dasabuvir without ribavirin for 12 weeks.'}, {'id': 'OG001', 'title': 'Paritaprevir/Ritonavir + Ombitasvir + Dasabuvir With RBV', 'description': 'Participants received paritaprevir/ritonavir, ombitasvir, and dasabuvir with ribavirin for 12 or 24 weeks.'}], 'classes': [{'title': 'End of Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-23.3', 'spread': '29.4', 'groupId': 'OG000'}, {'value': '-8.5', 'spread': '27.1', 'groupId': 'OG001'}]}]}, {'title': '12 weeks post treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-16.7', 'spread': '30.1', 'groupId': 'OG000'}, {'value': '-10.4', 'spread': '31.3', 'groupId': 'OG001'}]}]}, {'title': '24 weeks post treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-70.0', 'spread': 'NA', 'comment': 'Could not be calculated for one participant', 'groupId': 'OG000'}, {'value': '-9.3', 'spread': '21.4', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, end of treatment (week 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': '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). Participants who were employed with available data at baseline and each time point are included.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Work Productivity and Activity Impairment (WPAI): Total Work Productivity Impairment (TWP)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Paritaprevir/Ritonavir + Ombitasvir + Dasabuvir Without RBV', 'description': 'Participants received paritaprevir/ritonavir, ombitasvir, and dasabuvir without ribavirin for 12 weeks.'}, {'id': 'OG001', 'title': 'Paritaprevir/Ritonavir + Ombitasvir + Dasabuvir With RBV', 'description': 'Participants received paritaprevir/ritonavir, ombitasvir, and dasabuvir with ribavirin for 12 or 24 weeks.'}], 'classes': [{'title': 'End of Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-18.5', 'spread': '30.5', 'groupId': 'OG000'}, {'value': '-8.7', 'spread': '25.4', 'groupId': 'OG001'}]}]}, {'title': '12 weeks post treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-17.0', 'spread': '30.6', 'groupId': 'OG000'}, {'value': '-11.5', 'spread': '39.4', 'groupId': 'OG001'}]}]}, {'title': '24 weeks post treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-72.3', 'spread': 'NA', 'comment': 'Could not be calculated for one participant', 'groupId': 'OG000'}, {'value': '-20.7', 'spread': '31.4', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, end of treatment (week 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': '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). Participants who were employed with available data at baseline and each time point are included.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Work Productivity and Activity Impairment (WPAI): Total Activity Impairment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}, {'value': '320', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Paritaprevir/Ritonavir + Ombitasvir + Dasabuvir Without RBV', 'description': 'Participants received paritaprevir/ritonavir, ombitasvir, and dasabuvir without ribavirin for 12 weeks.'}, {'id': 'OG001', 'title': 'Paritaprevir/Ritonavir + Ombitasvir + Dasabuvir With RBV', 'description': 'Participants received paritaprevir/ritonavir, ombitasvir, and dasabuvir with ribavirin for 12 or 24 weeks.'}], 'classes': [{'title': 'End of Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '282', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-2.9', 'spread': '29.7', 'groupId': 'OG000'}, {'value': '-10.4', 'spread': '33.7', 'groupId': 'OG001'}]}]}, {'title': '12 weeks post treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '268', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-9.5', 'spread': '31.0', 'groupId': 'OG000'}, {'value': '-10.5', 'spread': '36.6', 'groupId': 'OG001'}]}]}, {'title': '24 weeks post treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '186', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-8.9', 'spread': '49.9', 'groupId': 'OG000'}, {'value': '-11.5', 'spread': '37.7', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, end of treatment (week 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': '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) with available data at baseline and each time point.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Patient Activation Measure 13 (PAM-13)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '184', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Paritaprevir/Ritonavir + Ombitasvir + Dasabuvir Without RBV', 'description': 'Participants received paritaprevir/ritonavir, ombitasvir, and dasabuvir without ribavirin for 12 weeks.'}, {'id': 'OG001', 'title': 'Paritaprevir/Ritonavir + Ombitasvir + Dasabuvir With RBV', 'description': 'Participants received paritaprevir/ritonavir, ombitasvir, and dasabuvir with ribavirin for 12 or 24 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-3.94', 'groupId': 'OG000', 'lowerLimit': '-8.77', 'upperLimit': '0.89'}, {'value': '-4.00', 'groupId': 'OG001', 'lowerLimit': '-5.92', 'upperLimit': '-2.08'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and end of treatment (week 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': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': '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) with available data at baseline and end of treatment.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Beliefs Medication Questionnaire - (18-item BMQ)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}, {'value': '312', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Paritaprevir/Ritonavir + Ombitasvir + Dasabuvir Without RBV', 'description': 'Participants received paritaprevir/ritonavir, ombitasvir, and dasabuvir without ribavirin for 12 weeks.'}, {'id': 'OG001', 'title': 'Paritaprevir/Ritonavir + Ombitasvir + Dasabuvir With RBV', 'description': 'Participants received paritaprevir/ritonavir, ombitasvir, and dasabuvir with ribavirin for 12 or 24 weeks.'}], 'classes': [{'title': 'Specific Concerns', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '287', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.26', 'groupId': 'OG000', 'lowerLimit': '-0.49', 'upperLimit': '-0.03'}, {'value': '0.06', 'groupId': 'OG001', 'lowerLimit': '-0.03', 'upperLimit': '0.16'}]}]}, {'title': 'Specific Necessity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '299', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.07', 'groupId': 'OG000', 'lowerLimit': '-0.26', 'upperLimit': '0.12'}, {'value': '-0.21', 'groupId': 'OG001', 'lowerLimit': '-0.28', 'upperLimit': '-0.13'}]}]}, {'title': 'General Overuse', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '295', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.01', 'groupId': 'OG000', 'lowerLimit': '-0.20', 'upperLimit': '0.23'}, {'value': '0.01', 'groupId': 'OG001', 'lowerLimit': '-0.08', 'upperLimit': '0.10'}]}]}, {'title': 'General Harm', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '291', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.02', 'groupId': 'OG000', 'lowerLimit': '-0.21', 'upperLimit': '0.18'}, {'value': '0.10', 'groupId': 'OG001', 'lowerLimit': '0.02', 'upperLimit': '0.19'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and end of treatment (week 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': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': '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) with available data at baseline and end of treatment.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Adverse Events, Serious Adverse Events, or Pregnancies', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '73', 'groupId': 'OG001'}, {'value': '446', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Paritaprevir/Ritonavir + Ombitasvir With RBV', 'description': 'Participants received paritaprevir/ritonavir and ombitasvir plus ribavirin for either 12 or 24 weeks.'}, {'id': 'OG001', 'title': 'Paritaprevir/Ritonavir + Ombitasvir + Dasabuvir Without RBV', 'description': 'Participants received paritaprevir/ritonavir, ombitasvir, and dasabuvir without RBV for 12 weeks.'}, {'id': 'OG002', 'title': 'Paritaprevir/Ritonavir + Ombitasvir + Dasabuvir With RBV', 'description': 'Participants received paritaprevir/ritonavir, ombitasvir, and dasabuvir with ribavirin for 12 or 24 weeks.'}], 'classes': [{'title': 'Any adverse event', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '82', 'groupId': 'OG002'}]}]}, {'title': 'Serious adverse events', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}]}]}, {'title': 'Pregnancies', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From first dose of study drug through 30 days after last dose (16 or 28 weeks depending on the treatment regimen). The over all median (minimum, maximum) duration of treatment was 84 (28, 175) days.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All enrolled participants who received at least one dose of paritaprevir/ritonavir and ombitasvir with or without dasabuvir.'}]}, '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 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': '522'}]}, {'type': 'COMPLETED', 'comment': 'HCV ribonucleic acid (RNA) treatment assessment performed at least 10 weeks post-treatment', 'achievements': [{'groupId': 'FG000', 'numSubjects': '516'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}]}], 'dropWithdraws': [{'type': 'Failure to Return', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}]}]}], 'recruitmentDetails': 'In this prospective, multi-center observational study a total of 522 adult patients chronically infected with hepatitis C virus (HCV) genotype 1 were enrolled by 22 centers in Romania.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '522', '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 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.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '522', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '60', 'spread': '9.5', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Age, Customized', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '522', 'groupId': 'BG000'}]}], 'categories': [{'title': '18-65 years', 'measurements': [{'value': '374', 'groupId': 'BG000'}]}, {'title': '66-84 years', 'measurements': [{'value': '147', 'groupId': 'BG000'}]}, {'title': '>=85 years', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '522', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '283', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '239', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'White', 'denoms': [{'units': 'Participants', 'counts': [{'value': '522', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '522', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Years Since Diagnosis of HCV Infection', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '522', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '6.8', 'spread': '5.69', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'HCV Genotype', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '522', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Genotype 1a', 'measurements': [{'value': '4', 'groupId': 'BG000'}]}, {'title': 'Genotype 1b', 'measurements': [{'value': '517', 'groupId': 'BG000'}]}, {'title': 'Genotype 1, Subtype Unknown', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Cirrhosis Status', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '522', 'groupId': 'BG000'}]}], 'categories': [{'title': 'No cirrhosis', 'measurements': [{'value': '9', 'groupId': 'BG000'}]}, {'title': 'Transition to cirrhosis', 'measurements': [{'value': '32', 'groupId': 'BG000'}]}, {'title': 'Cirrhosis', 'measurements': [{'value': '481', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'HCV RNA', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '519', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '5.87', 'groupId': 'BG000', 'lowerLimit': '1.53', 'upperLimit': '7.14'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'log10 IU/mL', 'dispersionType': 'FULL_RANGE', 'populationDescription': '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).'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2016-03-16', 'size': 1463925, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2018-07-16T13:39', 'hasProtocol': True}, {'date': '2017-07-28', 'size': 589318, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2018-07-16T13:39', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 522}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-07-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-08', 'completionDateStruct': {'date': '2017-08-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-08-02', 'studyFirstSubmitDate': '2016-06-16', 'resultsFirstSubmitDate': '2018-08-02', 'studyFirstSubmitQcDate': '2016-06-16', 'lastUpdatePostDateStruct': {'date': '2019-01-25', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-08-02', 'studyFirstPostDateStruct': {'date': '2016-06-21', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-01-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-08-04', '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 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.'}], 'secondaryOutcomes': [{'measure': 'Percentage of Participants Achieving Virological Response at End of Treatment', 'timeFrame': 'End of treatment (week 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 in the Core Population With Sufficient Follow-up Data for SVR12 Who Achieved Sustained Virological Response 12 Weeks Post-treatment', 'timeFrame': '12 weeks after the last dose of study drug (week 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 paritaprevir/ritonavir, ombitasvir and dasabuvir\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 paritaprevir/ritonavir, ombitasvir with dasabuvir 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 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': '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 in Each Non-response Category 12 Weeks Post-treatment', 'timeFrame': '12 weeks after the last dose of study drug (week 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 virological failure;\n* Missing SVR12 data and/or none of the above criteria.'}, {'measure': 'Assigned Treatment Regimen', 'timeFrame': 'Baseline', 'description': 'Treatment regimen was assigned by the physician according to local practice and label. Participants could receive three direct-acting antiviral (DAA) drugs (paritaprevir/ritonavir, ombitasvir, and dasabuvir) with or without RBV for 12 or 24 weeks.'}, {'measure': 'Percentage of the Direct Acting Antiviral (DAA) Dose Taken in Relation to the Target Dose of DAA', 'timeFrame': 'From first dose of study drug to end of treatment, 12 to 24 weeks depending on the treatment regimen.', 'description': 'Adherence to study treatment was calculated as:\n\nCumulative dose taken / (initial prescribed dose \\* planned duration)'}, {'measure': 'Percentage of the Ribavirin Dose Taken in Relation to the Target Dose of Ribavirin', 'timeFrame': 'From first dose of study drug to end of treatment, 12 to 24 weeks depending on the treatment regimen', 'description': 'Adherence to study treatment was calculated as:\n\nCumulative dose taken / (initial prescribed dose \\* planned duration)'}, {'measure': 'Percentage of Ribavirin (RBV) Treatment Days in Relation to the Target Number of Ribavirin Treatment Days', 'timeFrame': 'From first dose of study drug to end of treatment, 12 to 24 weeks depending on the treatment regimen.'}, {'measure': 'Number of Participants With Comorbidities', 'timeFrame': 'Baseline'}, {'measure': 'Number of Participants Who Received Concomitant Medications', 'timeFrame': 'From first dose of study drug to end of treatment, 12 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': 'Change From Baseline in EuroQol 5 Dimension 5 Level (EQ-5D-5L) Index Score', 'timeFrame': 'Baseline, end of treatment (week 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 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 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 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 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 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 Patient Activation Measure 13 (PAM-13)', 'timeFrame': 'Baseline and end of treatment (week 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': 'Change From Baseline in Beliefs Medication Questionnaire - (18-item BMQ)', 'timeFrame': 'Baseline and end of treatment (week 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': 'Number of Participants With Adverse Events, Serious Adverse Events, or Pregnancies', 'timeFrame': 'From first dose of study drug through 30 days after last dose (16 or 28 weeks depending on the treatment regimen). The over all median (minimum, maximum) duration of treatment was 84 (28, 175) days.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Chronic Hepatitis C', 'Paritaprevir', 'Ombitasvir', 'Dasabuvir', 'HCV'], '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': 'https://www.rxabbvie.com/', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': 'This study seeks to provide evidence of the effectiveness and obtain patient reported outcome (PRO) data for the interferon-free regimen of paritaprevir (PTV)/ritonavir (r) + ombitasvir (OBV), + dasabuvir (DSV), +/- ribavirin (RBV) in participants with chronic hepatitis C (CHC) in a real life setting across clinical practice patient populations in Romania.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Clinical practice patient populations with chronic infection of HCV Genotype 1 (GT1)', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nTreatment-naïve or -experienced adult male or female patients with confirmed CHC, genotype 1, receiving combination therapy with the interferon-free paritaprevir/ritonavir and ombitasvir with dasabuvir ± RBV according to standard of care and in line with the current local label\n\nIf RBV is co-administered with the paritaprevir/ritonavir and ombitasvir with dasabuvir, it has been prescribed in line with the current local label (with special attention to contraception requirements and contraindication during pregnancy)\n\nPatients must voluntarily sign and date a patient authorization to use and/or disclose his/her anonymized health data prior to inclusion into the study\n\nPatient must not be participating or intending to participate in a concurrent interventional therapeutic trial\n\nExclusion Criteria:\n\nNone'}, 'identificationModule': {'nctId': 'NCT02807402', 'briefTitle': 'Effectiveness of Paritaprevir/Ritonavir, Ombitasvir, + Dasabuvir, ± Ribavirin in Patients With Chronic Hepatitis C in Romania', '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 Romania', 'orgStudyIdInfo': {'id': 'P15-698'}}, '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 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': {'overallOfficials': [{'name': 'AbbVie Inc.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'AbbVie'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AbbVie', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'IST GmbH, Germany', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}