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| Name | Class |
|---|---|
| IST GmbH, Germany | INDUSTRY |
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The interferon-free combination regimen of ombitasvir/paritaprevir/ritonavir/ with or without dasabuvir (ABBVIE REGIMEN) ± ribavirin (RBV) for the treatment of chronic hepatitis C (CHC) has been shown to be safe and effective in randomized controlled clinical trials with strict inclusion and exclusion criteria under well-controlled conditions. This observational study was the first effectiveness research examining the ABBVIE REGIMEN ± RBV, used according to local label, under real world conditions in Belgium in a clinical practice patient population.
This was a prospective, multi-center observational study in participants receiving the interferon-free ABBVIE REGIMEN ± RBV in Belgium. The prescription of a treatment regimen was at the discretion of the physician in accordance with local clinical practice and label, was made independently from this observational study and preceded the decision to offer the participant the opportunity to participate in this study. Adults chronically infected with hepatitis C virus (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.Follow-up visits, treatment, procedures, and diagnostic methods followed physicians' routine clinical practice. Data were collected at the following time windows: baseline, early on-treatment visit, mid-treatment visit (for participants with a treatment duration of 24 weeks), end of treatment (EoT), early post-treatment, and 12 and 24 weeks after the end of treatment (representing sustained virologic response 12 weeks after the end of treatment [SVR12] and sustained virologic response 24 weeks after the end of treatment [SVR24]).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Participants with HCV genotype 1 or 4 | Ombitasvir/paritaprevir/ritonavir (two 12.5 mg/75 mg/50 mg co-formulated tablets once daily); ± dasabuvir (tablet; 250 mg twice daily); ± weight-based ribavirin (tablet; 1000 or 1200 mg divided twice a day) up to 24 weeks |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ombitasvir/paritaprevir/ritonavir | Drug | Co-formulated tablet |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Achieving Sustained Virologic Response 12 Weeks Post-treatment (SVR12) | SVR12 was defined as hepatitis C virus ribonucleic acid (HCV RNA) level less than 50 IU/mL 12 weeks after the last actual dose of study drug. The core population (CP) consisted of participants who met all inclusion criteria and were adequately treated according to the standard of care and within local label recommendations for their specific disease characteristics (cirrhotic status, genotype). The core population with sufficient follow-up data 12 weeks after the last actual dose of study drug (CPSFU12) was defined as all CP participants who fulfilled one of the following criteria:
| 12 weeks after the last actual dose of study drug |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Virologic Response at End of Treatment (EoT) | Virologic response was defined as hepatitis C virus ribonucleic acid (HCV RNA) level less than 50 IU/mL at the end of treatment. | Up to 24 weeks |
| Percentage of Participants With Relapse |
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Inclusion Criteria:
Exclusion Criteria:
• None
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Participants with chronic hepatitis C virus infection, genotype 1 or 4, receiving combination therapy with the interferon-free ABBVIE REGIMEN ± ribavirin
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| Name | Affiliation | Role |
|---|---|---|
| AbbVie Inc. | AbbVie | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30739368 | Derived | 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. |
| Label | URL |
|---|---|
| Related Info | View source |
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Safety population: all enrolled participants receiving at least 1 dose of the ABBVIE REGIMEN. The prescribed ABBVIE REGIMEN needed to be known. 314 participants enrolled; treatment start date was missing in 2 participants; 1 withdrew consent and no start of treatment was recorded.
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| ID | Title | Description |
|---|---|---|
| FG000 | Participants With HCV Genotype 1 or 4 | Ombitasvir/paritaprevir/ritonavir (two 12.5 mg/75 mg/50 mg co-formulated tablets once daily); ± dasabuvir (tablet; 250 mg twice daily); ± weight-based ribavirin (tablet; 1000 or 1200 mg divided twice a day) up to 24 weeks |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jun 9, 2015 | Dec 18, 2018 |
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| Dasabuvir | Drug | Tablet |
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| Ribavirin | Drug | Tablet |
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Relapse was defined as hepatitis C virus ribonucleic acid (HCV RNA) level less than 50 IU/mL at the end of treatment followed by HCV RNA level greater than or equal to 50 IU/mL. |
| Up to 48 weeks after the last actual dose of study drug |
| Percentage of Participants With Viral Breakthrough | Viral breakthrough was defined as at least 1 documented hepatitis C virus ribonucleic acid (HCV RNA) level less than 50 IU/mL followed by HCV RNA level greater than or equal to 50 IU/mL during treatment. | Up to 24 weeks |
| Percentage of Participants With On-treatment Virologic Failure | On-treatment virologic failure was defined as breakthrough (at least 1 documented hepatitis C virus ribonucleic acid (HCV RNA) less than 50 IU/mL followed by HCV RNA greater than or equal to 50 IU/mL during treatment) or failure to suppress (each measured on-treatment HCV RNA value greater than or equal to 50 IU/mL). | 12 weeks after the last actual dose of study drug |
| Percentage of Participants Meeting Relapse Criteria | Relapse was defined as hepatitis C virus ribonucleic acid (HCV RNA) less than 50 IU/mL at end of treatment or at the last on-treatment HCV RNA measurement followed by HCV RNA greater than or equal to 50 IU/mL post-treatment. | 12 weeks after the last actual dose of study drug |
| Percentage of Participants Meeting Premature Study Drug Discontinuation Criteria | Premature study drug discontinuation was defined as participants who prematurely discontinued study drug with no on-treatment virologic failure. | 12 weeks after the last actual dose of study drug |
| Percentage of Participants With Missing Sustained Virologic Response 12 Weeks Post-Treatment (SVR12) Data and/or Nonresponders Who Did Not Meet Specific SVR12 Nonresponder Criteria | The number of participants with missing SVR12 data or SVR12 nonresponder participants who did not meet criteria for on-treatment virologic failure, relapse, premature treatment discontinuation, and who did not have an Insufficient virological response reported was documented. | 12 weeks after the last actual dose of study drug |
| COMPLETED |
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| NOT COMPLETED |
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Safety population: all enrolled participants who received at least one dose of the ABBVIE REGIMEN. The prescribed ABBVIE REGIMEN needed to be known.
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| ID | Title | Description |
|---|---|---|
| BG000 | Participants With HCV Genotype 1 or 4 | Ombitasvir/paritaprevir/ritonavir (two 12.5 mg/75 mg/50 mg co-formulated tablets once daily); ± dasabuvir (tablet; 250 mg twice daily); ± weight-based ribavirin (tablet; 1000 or 1200 mg divided twice a day) up to 24 weeks |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| ||||||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants | No |
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| Race/Ethnicity, Customized | Count of Participants | Participants | No |
| ||||||||||||||||||||||
| Hepatitis C genotype | Count of Participants | Participants | No |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Participants Achieving Sustained Virologic Response 12 Weeks Post-treatment (SVR12) | SVR12 was defined as hepatitis C virus ribonucleic acid (HCV RNA) level less than 50 IU/mL 12 weeks after the last actual dose of study drug. The core population (CP) consisted of participants who met all inclusion criteria and were adequately treated according to the standard of care and within local label recommendations for their specific disease characteristics (cirrhotic status, genotype). The core population with sufficient follow-up data 12 weeks after the last actual dose of study drug (CPSFU12) was defined as all CP participants who fulfilled one of the following criteria:
| Core population (CP) and core population with sufficient follow-up data 12 weeks after the last actual dose of study drug (CPSFU12) are defined in the outcome measure description. | Posted | Number | 95% Confidence Interval | percentage of participants | 12 weeks after the last actual dose of study drug |
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| |||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Virologic Response at End of Treatment (EoT) | Virologic response was defined as hepatitis C virus ribonucleic acid (HCV RNA) level less than 50 IU/mL at the end of treatment. | Core population: Participants meeting all inclusion criteria and who were adequately treated according to the standard of care and within local label recommendations for their specific disease characteristics (cirrhotic status, genotype) | Posted | Number | 95% Confidence Interval | percentage of participants | Up to 24 weeks |
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| Secondary | Percentage of Participants With Relapse | Relapse was defined as hepatitis C virus ribonucleic acid (HCV RNA) level less than 50 IU/mL at the end of treatment followed by HCV RNA level greater than or equal to 50 IU/mL. | Participants meeting inclusion criteria, treated according to standard of care and within local label recommendations for their specific disease characteristics (cirrhotic status, genotype), with virologic response at end of treatment (EOT), completing Tx with ≥ 1 HCV RNA measurement ≥ 70 days post Tx or were a Tx failure between EOT and day 70 | Posted | Number | 95% Confidence Interval | percentage of participants | Up to 48 weeks after the last actual dose of study drug |
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| Secondary | Percentage of Participants With Viral Breakthrough | Viral breakthrough was defined as at least 1 documented hepatitis C virus ribonucleic acid (HCV RNA) level less than 50 IU/mL followed by HCV RNA level greater than or equal to 50 IU/mL during treatment. | Core population (those meeting inclusion criteria and treated according to the standard of care and w/in local label guidelines for specific disease characteristics [cirrhotic status, genotype]) who had at least 1 undetectable or unquantifiable, on-treatment HCV RNA measurement and at least 1 on-treatment or end of treatment measurement thereafter | Posted | Number | percentage of participants | Up to 24 weeks |
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| Secondary | Percentage of Participants With On-treatment Virologic Failure | On-treatment virologic failure was defined as breakthrough (at least 1 documented hepatitis C virus ribonucleic acid (HCV RNA) less than 50 IU/mL followed by HCV RNA greater than or equal to 50 IU/mL during treatment) or failure to suppress (each measured on-treatment HCV RNA value greater than or equal to 50 IU/mL). | Core population: Participants meeting all inclusion criteria and who were adequately treated according to the standard of care and within local label recommendations for their specific disease characteristics (cirrhotic status, genotype) | Posted | Number | percentage of participants | 12 weeks after the last actual dose of study drug |
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| Secondary | Percentage of Participants Meeting Relapse Criteria | Relapse was defined as hepatitis C virus ribonucleic acid (HCV RNA) less than 50 IU/mL at end of treatment or at the last on-treatment HCV RNA measurement followed by HCV RNA greater than or equal to 50 IU/mL post-treatment. | Core population: Participants meeting all inclusion criteria and who were adequately treated according to the standard of care and within local label recommendations for their specific disease characteristics (cirrhotic status, genotype) | Posted | Number | percentage of participants | 12 weeks after the last actual dose of study drug |
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| |||||||||||||||||||||||||||||
| Secondary | Percentage of Participants Meeting Premature Study Drug Discontinuation Criteria | Premature study drug discontinuation was defined as participants who prematurely discontinued study drug with no on-treatment virologic failure. | Core population: Participants meeting all inclusion criteria and who were adequately treated according to the standard of care and within local label recommendations for their specific disease characteristics (cirrhotic status, genotype) | Posted | Number | percentage of participants | 12 weeks after the last actual dose of study drug |
|
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| Secondary | Percentage of Participants With Missing Sustained Virologic Response 12 Weeks Post-Treatment (SVR12) Data and/or Nonresponders Who Did Not Meet Specific SVR12 Nonresponder Criteria | The number of participants with missing SVR12 data or SVR12 nonresponder participants who did not meet criteria for on-treatment virologic failure, relapse, premature treatment discontinuation, and who did not have an Insufficient virological response reported was documented. | Core population: Participants meeting all inclusion criteria and who were adequately treated according to the standard of care and within local label recommendations for their specific disease characteristics (cirrhotic status, genotype) | Posted | Number | percentage of participants | 12 weeks after the last actual dose of study drug |
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Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the time of study drug administration until 30 days after the last dose of study drug (up to 28 weeks).
TEAEs and TESAEs are defined as any adverse event (AE) with an onset date that is after the first dose of study drug until 30 days after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Ombitasvir/Paritaprevir/Ritonavir + Ribavirin | Ombitasvir/paritaprevir/ritonavir (two 12.5 mg/75 mg/50 mg co-formulated tablets once daily); + weight-based ribavirin (tablet; 1000 or 1200 mg divided twice a day) up to 24 weeks | 1 | 59 | 6 | 59 | 30 | 59 |
| EG001 | Ombitasvir/Paritaprevir/Ritonavir + Dasabuvir | Ombitasvir/paritaprevir/ritonavir (two 12.5 mg/75 mg/50 mg co-formulated tablets once daily) + dasabuvir (tablet; 250 mg twice daily) up to 24 weeks | 2 | 195 | 6 | 195 | 56 | 195 |
| EG002 | Ombitasvir/Paritaprevir/Ritonavir | Ombitasvir/paritaprevir/ritonavir (two 12.5 mg/75 mg/50 mg co-formulated tablets once daily) up to 24 weeks | 0 | 3 | 0 | 3 | 1 | 3 |
| EG003 | Ombitasvir/Paritaprevir/Ritonavir + Dasabuvir + Ribavirin | Ombitasvir/paritaprevir/ritonavir (two 12.5 mg/75 mg/50 mg co-formulated tablets once daily) + dasabuvir (tablet; 250 mg twice daily); + weight-based ribavirin (tablet; 1000 or 1200 mg divided twice a day) up to 24 weeks | 0 | 54 | 3 | 54 | 24 | 54 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| HAEMOLYTIC ANAEMIA | Blood and lymphatic system disorders | MedDRA 20.1 | Systematic Assessment |
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| DRUG INTERACTION | General disorders | MedDRA 20.1 | Systematic Assessment |
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| MALAISE | General disorders | MedDRA 20.1 | Systematic Assessment |
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| SUDDEN DEATH | General disorders | MedDRA 20.1 | Systematic Assessment |
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| BILIARY DILATATION | Hepatobiliary disorders | MedDRA 20.1 | Systematic Assessment |
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| HEPATIC FAILURE | Hepatobiliary disorders | MedDRA 20.1 | Systematic Assessment |
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| CYSTITIS | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
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| MENINGOENCEPHALITIS BACTERIAL | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
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| PYELONEPHRITIS | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
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| SEPTIC SHOCK | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
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| HEPATOCELLULAR CARCINOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 20.1 | Systematic Assessment |
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| TRANSIENT ISCHAEMIC ATTACK | Nervous system disorders | MedDRA 20.1 | Systematic Assessment |
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| DEPRESSION | Psychiatric disorders | MedDRA 20.1 | Systematic Assessment |
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| AORTIC BYPASS | Surgical and medical procedures | MedDRA 20.1 | Systematic Assessment |
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| WRIST SURGERY | Surgical and medical procedures | MedDRA 20.1 | Systematic Assessment |
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| AORTIC ANEURYSM | Vascular disorders | MedDRA 20.1 | Systematic Assessment |
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| CRYOGLOBULINAEMIA | Vascular disorders | MedDRA 20.1 | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ANAEMIA | Blood and lymphatic system disorders | MedDRA 20.1 | Systematic Assessment |
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| ABDOMINAL PAIN | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
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| NAUSEA | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
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| ASTHENIA | General disorders | MedDRA 20.1 | Systematic Assessment |
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| FATIGUE | General disorders | MedDRA 20.1 | Systematic Assessment |
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| OEDEMA PERIPHERAL | General disorders | MedDRA 20.1 | Systematic Assessment |
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| MYALGIA | Musculoskeletal and connective tissue disorders | MedDRA 20.1 | Systematic Assessment |
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| HEADACHE | Nervous system disorders | MedDRA 20.1 | Systematic Assessment |
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| DYSPNOEA | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | Systematic Assessment |
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| PRURITUS | Skin and subcutaneous tissue disorders | MedDRA 20.1 | Systematic Assessment |
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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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Global Medical Services | AbbVie | 800-633-9110 | abbvieclinicaltrials@abbvie.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Nov 22, 2016 | Dec 18, 2018 | SAP_001.pdf |
| ID | Term |
|---|---|
| D019698 | Hepatitis C, Chronic |
| ID | Term |
|---|---|
| D006526 | Hepatitis C |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D006525 | Hepatitis, Viral, Human |
| D014777 | Virus Diseases |
| D018178 | Flaviviridae Infections |
| D012327 | RNA Virus Infections |
| D006521 | Hepatitis, Chronic |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C586094 | ombitasvir |
| C585405 | paritaprevir |
| C588260 | dasabuvir |
| D012254 | Ribavirin |
| ID | Term |
|---|---|
| D012263 | Ribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
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| Asian/Oriental |
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| Native American/American Indian |
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| Arab North Africa |
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| Arab, African |
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| Egyptian |
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| Moroccan |
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| North Africa Maghreb |
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| North Africa, Maghreb |
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| North African |
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| Persian |
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| Genotype 1, unknown subtype |
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| Genotype 4 |
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