An observational study in Chronic Hepatitis C, sponsored by AbbVie. Completed at 6 sites in Colombia. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-09-18.
Sponsored by AbbVie · Observational
This is a prospective, multi-center observational study in adult participants chronically infected with hepatitis C virus (HCV) receiving the interferon-free ABBVIE REGIMEN (ombitasvir/paritaprevir/ritonavir with or without dasabuvir) with or without ribavirin (RBV). The prescription of a treatment regimen was at the discretion of the physician in accordance with local clinical practice and label.
This study focused on collecting real world data. Follow-up visits, treatment, procedures and diagnostic methods followed physicians' routine clinical practice using a 12-week treatment regimen (four visits plus two interim data collection windows) or a 24-week treatment regimen (four visits plus three interim data collection windows) and is based on the anticipated regular follow-up for patients undergoing treatment for chronic hepatitis C (CHC). Participants are observed for the duration of the ABBVIE REGIMEN therapy and for up to 24 weeks after treatment completion.
This prospective, multi-center observational study in adult participants chronically infected with hepatitis C virus (HCV), receiving the interferon-free ABBVIE REGIMEN with or without RBV are offered the opportunity to participate in this study during a routine clinical visit at the participating sites at the discretion of the physician and is made independently from this observational study and preceded the decision to offer the participant the opportunity to participate in this study.
After written informed consent is obtained, demographics, HCV disease characteristics, co-morbidities, co-medication, treatment details, and laboratory assessments as recorded in the participant's medical records (source documentation) are documented in the electronic case report form (eCRF). Participants are observed for the duration of the ABBVIE REGIMEN therapy and for up to 24 weeks after treatment completion. No patient identifiable information was captured; a unique participant number was automatically allocated by the web based system once the investigator or designee created a new participant file.
This study focuses on collecting real world data. Follow-up visits, treatment, procedures and diagnostic methods follow physicians' routine clinical practice. The observational study period entailed the following data collection schemes:
2,709 studies on the registry are indexed under Hepatitis A; 142 are open to participants now.
This study's enrollment of 66 is below the median of 250 across 687 observational studies indexed under Hepatitis A.
Browse Hepatitis A studies →AbbVie is the lead sponsor of 953 studies on the registry; 136 are open to participants now.
Of its 350 completed or terminated interventional studies of FDA-regulated products, 210 (60%) have results posted.
Counted across the registry records on this site, refreshed daily.
Participants with chronic hepatitis C (CHC), genotype 1, receiving combination therapy with the interferon-free ABBVIE REGIMEN ± RBV.
Exclusion Criteria:
ABBVIE REGIMEN (ombitasvir/paritaprevir/ritonavir \[25 mg/150 mg/100 mg once daily\] with or without dasabuvir \[250 mg twice daily\]), and with or without weight-based ribavirin (± RBV; dosed 1,000 or 1,200 mg daily divided twice a day) for 12 or 24 weeks in HCV + GT1 participants.
Percentage of Participants Achieving Sustained Virologic Response at 12 Weeks (SVR12) Post-treatment
SVR12 was defined as plasma hepatitis C virus (HCV) ribonucleic acid (RNA) level ˂50 IU/mL 12 weeks after end of treatment (EoT) (defined as after last actual dose of the ABBVIE REGIMEN \[paritaprevir/ritonavir - ombitasvir ± dasabuvir\] or ribavirin \[RBV\]).
Time frame: 12 weeks (i.e. 70 to 126 days) after the last dose of study drug (up to 24 weeks)
Percentage of Participants With Virologic Response at End of Treatment (EoT)
Virologic response is defined as HCV RNA level \<50 IU/mL.
Time frame: Up to EoT, maximum of 24 weeks
Number of Participants Meeting Premature Study Drug Discontinuation
Premature study drug discontinuation was defined as participants who prematurely discontinued study drug (ABBVIE REGIMEN or RBV) and who experienced no on-treatment virologic failure (defined as breakthrough \[at least 1 documented HCV RNA ˂50 IU/mL followed by HCV RNA ≥50 IU/mL during treatment\] or failure to suppress \[each measured on-treatment HCV RNA value ≥50 IU/mL\]).
Time frame: Up to EoT, maximum of 24 weeks
Percentage of Participants Meeting Each and Any SVR12 Non-response Criteria
For a participant to be include in this analysis, the participant needed to meet each and any of the following SVR12 non-response categories: * On-treatment virologic failure (breakthrough \[defined as at least one documented HCV RNA \<50 IU/mL followed by HCV RNA ≥50 IU/mL during treatment\] or failure to suppress \[each measured on-treatment HCV RNA value ≥50 IU/mL\]); * Relapse (defined as HCV RNA \<50 IU/mL at actual EoT followed by HCV RNA ≥50 IU/mL post-treatment for participants who completed treatment \[not more than 7 days shortened\]); * Premature study drug discontinuation with no on-treatment virologic failure; * Missing SVR12 data and/or none of the above criteria (including participants with missing SVR12 data). Abbreviations: EoT=end of treatment.
Time frame: During treatment and 12 weeks (i.e. at least 70 days) after the last dose of study drug (up to 24 weeks)
Percentage of Participants With Relapse
Relapse was defined as confirmed HCV RNA \<50 IU/mL at EoT or at the last on-treatment HCV RNA measurement followed by HCV RNA ≥50 IU/mL post-treatment in participants who were treated.
Time frame: 12 weeks (i.e. at least 70 days) after the last dose of study drug
Percentage of Participants With Relapse at EoT
Relapse was defined as confirmed HCV RNA \<50 IU/mL at EoT followed by HCV RNA ≥50 IU/mL post treatment in participants who completed treatment (actual duration of ABBVIE REGIMEN is not shortened more than 7 days) and had HCV RNA results available in the SVR12 window.
Time frame: 12 weeks (i.e. at least 70 days) after the last dose of study drug
Percentage of Participants With Viral Breakthrough
Viral breakthrough was defined as at least 1 documented HCV RNA \<50 IU/mL followed by HCV RNA ≥ 50 IU/mL during treatment.
Time frame: Up to EoT, maximum of 24 weeks
Percentage of Participants Meeting On-treatment Virologic Failure
On-treatment virologic failure was defined as breakthrough (at least 1 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).
Time frame: Up to EoT, maximum of 24 weeks
Percentage of Participants With Rapid Virologic Response at Week 4 (RVR4)
RVR4 was defined as HCV RNA \< 50 IU/mL at Week 4.
Time frame: Week 4
Percentage of Participants With Sustained Virologic Response at 24 Weeks (SVR24) After EoT
SVR24 was defined as HCV RNA \< 50 IU/mL 24 weeks after EoT. During the course of the study, standard of care was changing and it was no longer common practice to assess SVR24.
Time frame: 24 weeks after EoT (up to 24 weeks)
EuroQol 5 Dimension 5 Level (EQ-5D-5L) Questionnaire Index Score: Change From Baseline to EoT
The EQ-5D-5L is a 2-part instrument for use as a measure of health outcome, designed for self-completion by participants. The 5 items in the questionnaire 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 VAS. The higher the score, the worse the quality of life. For the VAS, the higher the score, the better the quality of life. Participant responses to the EQ-5D-5L were used to generate a health status index (HSI). HSI ranges is anchored at 0 (dead) and 1 (full health).
Time frame: EoT (up to 24 weeks)
EQ-5D-5L Questionnaire Index Score: Change From Baseline to 12 Weeks Post EoT
The EQ-5D-5L is a 2-part instrument for use as a measure of health outcome, designed for self-completion by participants. The 5 items in the questionnaire 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 VAS. The higher the score, the worse the quality of life. For the VAS, the higher the score, the better the quality of life. Participant responses to the EQ-5D-5L were used to generate a HSI. HSI ranges is anchored at 0 (dead) and 1 (full health).
Time frame: 12 weeks post EoT (up to 24 weeks)
EQ-5D-5L Questionnaire Index Score: Change From Baseline to 24 Weeks Post EoT
The EQ-5D-5L is a 2-part instrument for use as a measure of health outcome, designed for self-completion by participants. The 5 items in the questionnaire 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 VAS. The higher the score, the worse the quality of life. For the VAS, the higher the score, the better the quality of life. Participant responses to the EQ-5D-5L were used to generate a HSI. HSI ranges is anchored at 0 (dead) and 1 (full health).
Time frame: 24 weeks post EoT (up to 24 weeks)
EQ-5D-5L Questionnaire VAS: Change From Baseline to EoT
The EQ-5D-5L is a 2-part instrument for use as a measure of health outcome, designed for self-completion by participants. Participants also rated their perception of their overall health on a separate VAS. The scale is numbered from 0 to 100. The higher the score, the better the quality of life.
Time frame: End of Treatment (up to 24 weeks)
EQ-5D-5L Questionnaire VAS: Change From Baseline to 12 Weeks Post EoT
The EQ-5D-5L is a 2-part instrument for use as a measure of health outcome, designed for self-completion by participants. Participants also rated their perception of their overall health on a separate VAS. The scale is numbered from 0 to 100. The higher the score, the better the quality of life.
Time frame: 12 weeks post EoT (up to 24 weeks)
EQ-5D-5L Questionnaire VAS: Change From Baseline to 24 Weeks Post EoT
The EQ-5D-5L is a 2-part instrument for use as a measure of health outcome, designed for self-completion by participants. Participants also rated their perception of their overall health on a separate VAS. The scale is numbered from 0 to 100. The higher the score, the better the quality of life.
Time frame: 24 weeks post EoT (up to 24 weeks)
Number of Participants With Co-morbidities at Baseline (Day 0)
Co-morbidities/co-infections were defined as hepatitis C virus (HCV) co-infections (human immunodeficiency virus \[HIV\] or hepatitis B virus \[HBV\], tuberculosis, schistosomiasis), liver/chronic hepatitis C (CHC) related co-morbidities (liver transplantation, hepatocellular carcinoma, non-alcoholic steatosis, alcoholic liver disease, primary biliary cirrhosis, auto-immune hepatitis, Wilson disease, cryoglobulinemia, porphyria cutanea tarda, auto-immune skin disease), and other co-morbidities (chronic kidney disease, psychiatric disorders, diabetes mellitus, insulin resistance, metabolic syndrome, lipid disorder, cardiovascular disease, immunologically mediated disease, hyper-/hypothyroidism, hemophilia, Thalassemia, sickle cell anemia, V. Willebrand disease, psychoactive substance dependency, kidney transplant, or other).
Time frame: Baseline (Day 0)
Number of Participants With Concomitant Medications
This includes all participants that took at least 1 concomitant medication from the time when the decision was made to initiate treatment with the ABBVIE REGIMEN until after the last dose. Abbreviations: ACE= angiotensin-converting-enzyme; GERD=gastroesophageal reflux.
Time frame: Day 0 to EoT, maximum 24 weeks
| Milestone | ABBVIE REGIMEN ± Ribavirin (RBV) |
|---|---|
| Started | 65 |
| Completed | 59 |
| Not completed | 6 |
| Withdrew: Failure to return | 3 |
| Withdrew: Other | 3 |
SVR12 was defined as plasma hepatitis C virus (HCV) ribonucleic acid (RNA) level ˂50 IU/mL 12 weeks after end of treatment (EoT) (defined as after last actual dose of the ABBVIE REGIMEN \[paritaprevir/ritonavir - ombitasvir ± dasabuvir\] or ribavirin \[RBV\]).
| percentage of participants | ABBVIE REGIMEN ± Ribavirin (RBV) |
|---|---|
| Percentage of Participants Achieving Sustained Virologic Response at 12 Weeks (SVR12) Post-treatment | 87.7 (77.5 to 93.6) |
Virologic response is defined as HCV RNA level \<50 IU/mL.
| percentage of participants | ABBVIE REGIMEN ± Ribavirin (RBV) |
|---|---|
| Percentage of Participants With Virologic Response at End of Treatment (EoT) | 95.4 (87.3 to 98.4) |
Premature study drug discontinuation was defined as participants who prematurely discontinued study drug (ABBVIE REGIMEN or RBV) and who experienced no on-treatment virologic failure (defined as breakthrough \[at least 1 documented HCV RNA ˂50 IU/mL followed by HCV RNA ≥50 IU/mL during treatment\] or failure to suppress \[each measured on-treatment HCV RNA value ≥50 IU/mL\]).
| participants | ABBVIE REGIMEN ± Ribavirin (RBV) |
|---|---|
| Premature Termination ABBVIE REGIMEN | 4 |
| No Premature Termination ABBVIE REGIMEN | 61 |
For a participant to be include in this analysis, the participant needed to meet each and any of the following SVR12 non-response categories: * On-treatment virologic failure (breakthrough \[defined as at least one documented HCV RNA \<50 IU/mL followed by HCV RNA ≥50 IU/mL during treatment\] or failure to suppress \[each measured on-treatment HCV RNA value ≥50 IU/mL\]); * Relapse (defined as HCV RNA \<50 IU/mL at actual EoT followed by HCV RNA ≥50 IU/mL post-treatment for participants who completed treatment \[not more than 7 days shortened\]); * Premature study drug discontinuation with no on-treatment virologic failure; * Missing SVR12 data and/or none of the above criteria (including participants with missing SVR12 data). Abbreviations: EoT=end of treatment.
| percentage of participants | ABBVIE REGIMEN ± Ribavirin (RBV) |
|---|---|
| Non-response 12 weeks after EoT | 12.3 |
| On-treatment virologic failure | 1.5 |
| Relapse | 1.5 |
| Premature treatment discontinuation | 4.6 |
| Missing SVR12 data/None of the above criteria | 4.6 |
Relapse was defined as confirmed HCV RNA \<50 IU/mL at EoT or at the last on-treatment HCV RNA measurement followed by HCV RNA ≥50 IU/mL post-treatment in participants who were treated.
| percentage of participants | ABBVIE REGIMEN ± Ribavirin (RBV) |
|---|---|
| Percentage of Participants With Relapse | 1.5 |
Relapse was defined as confirmed HCV RNA \<50 IU/mL at EoT followed by HCV RNA ≥50 IU/mL post treatment in participants who completed treatment (actual duration of ABBVIE REGIMEN is not shortened more than 7 days) and had HCV RNA results available in the SVR12 window.
| percentage of participants | ABBVIE REGIMEN ± Ribavirin (RBV) |
|---|---|
| Percentage of Participants With Relapse at EoT | 1.8 (0.3 to 9.3) |
Viral breakthrough was defined as at least 1 documented HCV RNA \<50 IU/mL followed by HCV RNA ≥ 50 IU/mL during treatment.
| percentage of participants | ABBVIE REGIMEN ± Ribavirin (RBV) |
|---|---|
| Percentage of Participants With Viral Breakthrough | 0.0 (0.0 to 7.4) |
On-treatment virologic failure was defined as breakthrough (at least 1 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).
| percentage of participants | ABBVIE REGIMEN ± Ribavirin (RBV) |
|---|---|
| Percentage of Participants Meeting On-treatment Virologic Failure | 1.5 |
RVR4 was defined as HCV RNA \< 50 IU/mL at Week 4.
| percentage of participants | ABBVIE REGIMEN ± Ribavirin (RBV) |
|---|---|
| Percentage of Participants With Rapid Virologic Response at Week 4 (RVR4) | 66.2 (54.0 to 76.5) |
SVR24 was defined as HCV RNA \< 50 IU/mL 24 weeks after EoT. During the course of the study, standard of care was changing and it was no longer common practice to assess SVR24.
| percentage of participants | ABBVIE REGIMEN ± Ribavirin (RBV) |
|---|---|
| Percentage of Participants With Sustained Virologic Response at 24 Weeks (SVR24) After EoT | 44.4 (18.9 to 73.3) |
The EQ-5D-5L is a 2-part instrument for use as a measure of health outcome, designed for self-completion by participants. The 5 items in the questionnaire 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 VAS. The higher the score, the worse the quality of life. For the VAS, the higher the score, the better the quality of life. Participant responses to the EQ-5D-5L were used to generate a health status index (HSI). HSI ranges is anchored at 0 (dead) and 1 (full health).
| units on a scale | ABBVIE REGIMEN ± Ribavirin (RBV) |
|---|---|
| EuroQol 5 Dimension 5 Level (EQ-5D-5L) Questionnaire Index Score: Change From Baseline to EoT | 0.005 ± 0.143 |
The EQ-5D-5L is a 2-part instrument for use as a measure of health outcome, designed for self-completion by participants. The 5 items in the questionnaire 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 VAS. The higher the score, the worse the quality of life. For the VAS, the higher the score, the better the quality of life. Participant responses to the EQ-5D-5L were used to generate a HSI. HSI ranges is anchored at 0 (dead) and 1 (full health).
| units on a scale | ABBVIE REGIMEN ± Ribavirin (RBV) |
|---|---|
| EQ-5D-5L Questionnaire Index Score: Change From Baseline to 12 Weeks Post EoT | 0.039 ± 0.122 |
The EQ-5D-5L is a 2-part instrument for use as a measure of health outcome, designed for self-completion by participants. The 5 items in the questionnaire 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 VAS. The higher the score, the worse the quality of life. For the VAS, the higher the score, the better the quality of life. Participant responses to the EQ-5D-5L were used to generate a HSI. HSI ranges is anchored at 0 (dead) and 1 (full health).
| units on a scale | ABBVIE REGIMEN ± Ribavirin (RBV) |
|---|---|
| EQ-5D-5L Questionnaire Index Score: Change From Baseline to 24 Weeks Post EoT | 0.046 ± 0.111 |
The EQ-5D-5L is a 2-part instrument for use as a measure of health outcome, designed for self-completion by participants. Participants also rated their perception of their overall health on a separate VAS. The scale is numbered from 0 to 100. The higher the score, the better the quality of life.
| units on a scale | ABBVIE REGIMEN ± Ribavirin (RBV) |
|---|---|
| EQ-5D-5L Questionnaire VAS: Change From Baseline to EoT | 5.7 ± 10.40 |
The EQ-5D-5L is a 2-part instrument for use as a measure of health outcome, designed for self-completion by participants. Participants also rated their perception of their overall health on a separate VAS. The scale is numbered from 0 to 100. The higher the score, the better the quality of life.
| units on a scale | ABBVIE REGIMEN ± Ribavirin (RBV) |
|---|---|
| EQ-5D-5L Questionnaire VAS: Change From Baseline to 12 Weeks Post EoT | 7.5 ± 16.12 |
The EQ-5D-5L is a 2-part instrument for use as a measure of health outcome, designed for self-completion by participants. Participants also rated their perception of their overall health on a separate VAS. The scale is numbered from 0 to 100. The higher the score, the better the quality of life.
| units on a scale | ABBVIE REGIMEN ± Ribavirin (RBV) |
|---|---|
| EQ-5D-5L Questionnaire VAS: Change From Baseline to 24 Weeks Post EoT | 4.0 ± 12.41 |
Co-morbidities/co-infections were defined as hepatitis C virus (HCV) co-infections (human immunodeficiency virus \[HIV\] or hepatitis B virus \[HBV\], tuberculosis, schistosomiasis), liver/chronic hepatitis C (CHC) related co-morbidities (liver transplantation, hepatocellular carcinoma, non-alcoholic steatosis, alcoholic liver disease, primary biliary cirrhosis, auto-immune hepatitis, Wilson disease, cryoglobulinemia, porphyria cutanea tarda, auto-immune skin disease), and other co-morbidities (chronic kidney disease, psychiatric disorders, diabetes mellitus, insulin resistance, metabolic syndrome, lipid disorder, cardiovascular disease, immunologically mediated disease, hyper-/hypothyroidism, hemophilia, Thalassemia, sickle cell anemia, V. Willebrand disease, psychoactive substance dependency, kidney transplant, or other).
| participants | ABBVIE REGIMEN ± Ribavirin (RBV) |
|---|---|
| All co-morbidities and co-infections | 58 |
| HCV Co-infections | 2 |
| Liver and/or CHC related co-morbidities | 5 |
| Other Co-morbidities | 57 |
| Kidney Transplantation | 3 |
| Chronic Kidney Disease | 7 |
| Psychiatric Disorders | 3 |
| Diabetes Mellitus | 14 |
| Lipid Disorder | 4 |
| Hypothyroidism | 17 |
| Cardiovascular disease | 28 |
| Hemophilia | 2 |
| Other | 40 |
This includes all participants that took at least 1 concomitant medication from the time when the decision was made to initiate treatment with the ABBVIE REGIMEN until after the last dose. Abbreviations: ACE= angiotensin-converting-enzyme; GERD=gastroesophageal reflux.
| participants | ABBVIE REGIMEN ± Ribavirin (RBV) |
|---|---|
| Number taking at least 1 co-medication | 55 |
| Beta Blocking Agents | 18 |
| Thyroid Therapy | 17 |
| Vitamins | 16 |
| Angiotensin II Antagonists | 15 |
| Drugs for Peptic Ulcer and GERD | 13 |
| Blood glucose lowering | 11 |
| Diuretics | 11 |
| Analgesics | 9 |
| Calcium Channel Blockers | 8 |
| ACE Inhibitors | 5 |
| Mineral Supplements | 5 |
| Antidepressants | 4 |
| Corticosteroids | 4 |
| Drugs for treatment of bone disease | 4 |
| HMG COA Reductase Inhibitors | 4 |
| Anti-anemic | 3 |
| Antibacterials | 3 |
| Antithrombotic | 3 |
| Dermatologicals | 3 |
| Drugs for Constipation | 3 |
| Immunosuppressive agents | 3 |
| Anti-asthmatics | 2 |
| Insulin and Analogues | 2 |
| Anti-andrenergic Antihypertensives | 1 |
| Anti-arrhythmics | 1 |
| Antidiarrheals | 1 |
| Anti-inflammatory/antirheumatic products | 1 |
| Antineoplastic,immunomodulating agents, cytostatic | 1 |
| Antipsychotics | 1 |
| Antivirals for HIV, combinations | 1 |
| Antivirals, reverse transcriptase inhibitors HIV | 1 |
| Benzodiazepine derivatives | 1 |
| Bile therapy | 1 |
| Blood substitutes/perfusion solutions | 1 |
| Hemostatics/vitamin K | 1 |
| Lipotropics | 1 |
| Other antivirals, HIV treatment | 1 |
| Other Sex hormones | 1 |
| Vasoprotectives | 1 |
Collected over Safety was assessed only as treatment emergent adverse events (TEAEs) as recorded by the treating physician. TEAEs were collected after the first dose of study drug through 30 days after last dose of study drug.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| ABBVIE REGIMEN | 0/49 (0%) | 5/49 (10.2%) | 5/49 (10.2%) |
| ABBVIE REGIMEN Plus Ribavirin (RBV) | 0/16 (0%) | 2/16 (12.5%) | 9/16 (56.3%) |
| Event | ABBVIE REGIMEN | ABBVIE REGIMEN Plus Ribavirin (RBV) |
|---|---|---|
| HAEMORRHOIDAL HAEMORRHAGEGastrointestinal disorders | 0/49 | 1/16 |
| RECTAL HAEMORRHAGEGastrointestinal disorders | 0/49 | 1/16 |
| ANAEMIABlood and lymphatic system disorders | 1/49 | 0/16 |
| CORONARY ARTERY DISEASECardiac disorders | 1/49 | 0/16 |
| HEPATIC CIRRHOSISHepatobiliary disorders | 1/49 | 0/16 |
| HEPATIC FIBROSISHepatobiliary disorders | 1/49 | 0/16 |
| HEPATOTOXICITYHepatobiliary disorders | 1/49 | 0/16 |
| HYPERBILIRUBINAEMIAHepatobiliary disorders | 1/49 | 0/16 |
| PERITONITIS BACTERIALInfections and infestations | 1/49 | 0/16 |
| URINARY TRACT INFECTIONRenal and urinary disorders | 1/49 | 0/16 |
| Event | ABBVIE REGIMEN | ABBVIE REGIMEN Plus Ribavirin (RBV) |
|---|---|---|
| ANAEMIABlood and lymphatic system disorders | 0/49 | 2/16 |
| PRURITUSSkin and subcutaneous tissue disorders | 2/49 | 2/16 |
| OEDEMA PERIPHERALGeneral disorders | 0/49 | 1/16 |
| TREATMENT FAILUREGeneral disorders | 0/49 | 1/16 |
| HEPATITIS CHepatobiliary disorders | 0/49 | 1/16 |
| CYSTITISInfections and infestations | 0/49 | 1/16 |
| BACK PAINMusculoskeletal and connective tissue disorders | 0/49 | 1/16 |
| INSOMNIAPsychiatric disorders | 0/49 | 1/16 |
| COUGHRespiratory, thoracic and mediastinal disorders | 0/49 | 1/16 |
| DIARRHOEAGastrointestinal disorders | 3/49 | 0/16 |
The Core Population (CP): defined as all participants of the target population (all participants in the safety population who met inclusion criteria) who were adequately treated according to the standard of care and within local label recommendations for their specific disease characteristics (cirrhotic status, genotype).
| Age, Continuous(years) | ABBVIE REGIMEN ± Ribavirin (RBV) |
|---|---|
| Mean | 61 ± 11.2 |
| Sex: Female, Male(Participants) | ABBVIE REGIMEN ± Ribavirin (RBV) |
|---|---|
| Female | 45 |
| Male | 20 |
| Ethnicity (NIH/OMB)(Participants) | ABBVIE REGIMEN ± Ribavirin (RBV) |
|---|---|
| Hispanic or Latino | 0 |
| Not Hispanic or Latino | 0 |
| Unknown or Not Reported | 65 |
| Race (NIH/OMB)(Participants) | ABBVIE REGIMEN ± Ribavirin (RBV) |
|---|---|
| American Indian or Alaska Native | 1 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 0 |
| White | 2 |
| More than one race | 0 |
| Unknown or Not Reported | 62 |
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