CITRINE: Real World Evidence of the Effectiveness of Paritaprevir/r - Ombitasvir, ± Dasabuvir, ± Ribavirin and Patient Support Program in Patients With Chronic Hepatitis C
Study Details
Study Description
Brief Summary
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 Israel in a clinical practice patient population.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
Detailed Description
This was a prospective, multi-center observational study in participants receiving the interferon-free ABBVIE REGIMEN ± RBV in Israel. 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 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]).
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
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 (tablets; 1000 or 1200 mg divided twice a day) up to 24 weeks |
Drug: Ombitasvir/paritaprevir/ritonavir
Co-formulated tablet
Other Names:
Drug: Dasabuvir
Tablet
Other Names:
Drug: Ribavirin
Tablet
Behavioral: Patient support program
Supportive services provided to participants included reminder calls, emails, text messages, a Care Coach, and educational/informational materials.
|
Outcome Measures
Primary Outcome Measures
- Percentage of Participants Achieving Sustained Virologic Response 12 Weeks Post-treatment (SVR12) [12 weeks after the last actual dose of study drug]
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.
Secondary Outcome Measures
- Percentage of Participants With Virologic Response at End of Treatment (EoT) [Up to 24 weeks]
Virologic response was defined as hepatitis C virus ribonucleic acid (HCV RNA) level less than 50 IU/mL at the end of treatment.
- Percentage of Participants With Sufficient Follow-up Who Achieved Sustained Virological Response 12 Weeks Posttreatment [12 weeks (at least 70 days) after the last actual dose of study drug]
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. The core population with sufficient follow-up data 12 weeks after the last actual dose of study drug (CPSFU12) was defined as all participants who fulfilled one of the following criteria: evaluable HCV RNA data ≥70 days after the last actual dose of the ABBVIE REGIMEN an HCV RNA value ≥50 IU/mL at the last measurement post-baseline HCV RNA <50 IU/mL at the last measurement post-baseline, but no HCV RNA measurement ≥70 days after the last actual dose of the ABBVIE REGIMEN due to reasons related to safety (e.g. dropped out due to AE) or virologic failure
- Percentage of Participants With Relapse [Up to 48 weeks after the last actual dose of study drug]
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.
- Percentage of Participants With Viral Breakthrough [Up to 24 weeks]
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.
- Percentage of Participants With On-treatment Virologic Failure [12 weeks after the last actual dose of study drug]
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).
- Percentage of Participants Meeting Relapse Criteria [12 weeks after the last actual dose of study drug]
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.
- Percentage of Participants Meeting Premature Study Drug Discontinuation Criteria [12 weeks after the last actual dose of study drug]
Premature study drug discontinuation was defined as participants who prematurely discontinued study drug with no on-treatment virologic failure.
- 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 [12 weeks after the last actual dose of study drug]
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.
Eligibility Criteria
Criteria
-
Treatment-naïve or -experienced adult male or female participants with confirmed chronic hepatitis C (CHC), genotype 1 or 4, receiving combination therapy with the interferon-free ABBVIE REGIMEN ± ribavirin (RBV) according to standard of care and in line with the current local label
-
If RBV was co-administered with the ABBVIE REGIMEN, it had to be prescribed in line with the current local label (with special attention to contraception requirements and contraindication during pregnancy)
-
Participants had to voluntarily sign and date an informed consent form prior to inclusion into the study
-
Participants must not have participated or intended to participate in a concurrent interventional therapeutic trial
Exclusion Criteria:
- None
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Soroka Medical Center /ID# 169357 | Be'er Sheva | HaDarom | Israel | 84101 |
2 | Rabin Medical Center /ID# 153696 | Petakh Tikva | Tel-Aviv | Israel | 4941492 |
3 | Rabin Medical Center /ID# 158648 | Petakh Tikva | Tel-Aviv | Israel | 4941492 |
4 | Tel Aviv Sourasky Medical Ctr /ID# 153693 | Tel Aviv-Yafo | Tel-Aviv | Israel | 6423906 |
5 | Ha'Emek Medical Center /ID# 153695 | Afula | Israel | 18341 | |
6 | Soroka Medical Ctr /ID# 153697 | Be'er Sheva | Israel | 84101 | |
7 | Assaf Harofeh Medical Center /ID# 153708 | Be'er Ya'akov | Israel | 70300 | |
8 | Maccabi Health Services /ID# 158647 | Gush Dan | Israel | 7565016 | |
9 | Hillel Yaffe Medical Center /ID# 153702 | Hadera | Israel | 38100 | |
10 | Rambam Health Care Campus /ID# 153694 | Haifa | Israel | 3109601 | |
11 | Bnai Zion Medical Center /ID# 153700 | Haifa | Israel | 3339419 | |
12 | The Lady Davis Carmel MC /ID# 153692 | Haifa | Israel | 3436212 | |
13 | The Edith Wolfson Medical Cent /ID# 153706 | Holon | Israel | 58100 | |
14 | Shaare Zedek Medical Center /ID# 153699 | Jerusalem | Israel | 91031 | |
15 | Hadassah /ID# 153701 | Jerusalem | Israel | 91120 | |
16 | Meir Medical Center /ID# 153698 | Kfar Saba | Israel | 44281 | |
17 | Western Galilee Medical Center /ID# 153705 | Nahariya | Israel | 22100 | |
18 | Sheba Medical Center /ID# 153707 | Ramat Gan | Israel | 5262100 |
Sponsors and Collaborators
- AbbVie
Investigators
- Study Director: AbbVie Inc., AbbVie
Study Documents (Full-Text)
More Information
Additional Information:
Publications
None provided.- P16-014
Study Results
Participant Flow
Recruitment Details | |
---|---|
Pre-assignment Detail | Safety population: all enrolled participants who received at least 1 dose of the ABBVIE REGIMEN. The prescribed ABBVIE REGIMEN needed to be known. 256 participants enrolled; treatment was not started in 20 participants. The death noted below occurred during the SAE collection period. |
Arm/Group Title | Participants With HCV Genotype 1 or 4 |
---|---|
Arm/Group Description | 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 (tablets; 1000 or 1200 mg divided twice a day) up to 24 weeks |
Period Title: Overall Study | |
STARTED | 236 |
COMPLETED | 166 |
NOT COMPLETED | 70 |
Baseline Characteristics
Arm/Group Title | Participants With HCV Genotype 1 or 4 |
---|---|
Arm/Group Description | 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 (tablets; 1000 or 1200 mg divided twice a day) up to 24 weeks |
Overall Participants | 236 |
Age (years) [Mean (Standard Deviation) ] | |
Mean (Standard Deviation) [years] |
56
(12.7)
|
Sex: Female, Male (Count of Participants) | |
Female |
105
44.5%
|
Male |
131
55.5%
|
Race (NIH/OMB) (Count of Participants) | |
American Indian or Alaska Native |
0
0%
|
Asian |
0
0%
|
Native Hawaiian or Other Pacific Islander |
0
0%
|
Black or African American |
0
0%
|
White |
236
100%
|
More than one race |
0
0%
|
Unknown or Not Reported |
0
0%
|
Hepatitis C genotype (Count of Participants) | |
Genotype 1a |
12
5.1%
|
Genotype 1a/1b |
1
0.4%
|
Genotype 1b |
222
94.1%
|
Genotype 4 |
1
0.4%
|
Outcome Measures
Title | Percentage of Participants Achieving Sustained Virologic Response 12 Weeks Post-treatment (SVR12) |
---|---|
Description | 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. |
Time Frame | 12 weeks after the last actual dose of study drug |
Outcome Measure Data
Analysis Population Description |
---|
Core population (CP): all participants of the target population (all participants in the safety population who met all 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) |
Arm/Group Title | Participants With HCV Genotype 1 or 4 |
---|---|
Arm/Group Description | 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 (tablets; 1000 or 1200 mg divided twice a day) up to 24 weeks |
Measure Participants | 228 |
Number (95% Confidence Interval) [percentage of participants] |
70.6
29.9%
|
Title | Percentage of Participants With Virologic Response at End of Treatment (EoT) |
---|---|
Description | Virologic response was defined as hepatitis C virus ribonucleic acid (HCV RNA) level less than 50 IU/mL at the end of treatment. |
Time Frame | Up to 24 weeks |
Outcome Measure Data
Analysis Population Description |
---|
Core population (CP): all participants of the target population (all participants in the safety population who met all 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) |
Arm/Group Title | Participants With HCV Genotype 1 or 4 |
---|---|
Arm/Group Description | 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 (tablets; 1000 or 1200 mg divided twice a day) up to 24 weeks |
Measure Participants | 228 |
Number (95% Confidence Interval) [percentage of participants] |
82.0
34.7%
|
Title | Percentage of Participants With Sufficient Follow-up Who Achieved Sustained Virological Response 12 Weeks Posttreatment |
---|---|
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. The core population with sufficient follow-up data 12 weeks after the last actual dose of study drug (CPSFU12) was defined as all participants who fulfilled one of the following criteria: evaluable HCV RNA data ≥70 days after the last actual dose of the ABBVIE REGIMEN an HCV RNA value ≥50 IU/mL at the last measurement post-baseline HCV RNA <50 IU/mL at the last measurement post-baseline, but no HCV RNA measurement ≥70 days after the last actual dose of the ABBVIE REGIMEN due to reasons related to safety (e.g. dropped out due to AE) or virologic failure |
Time Frame | 12 weeks (at least 70 days) after the last actual dose of study drug |
Outcome Measure Data
Analysis Population Description |
---|
Core population with sufficient follow-up data regarding SVR12 |
Arm/Group Title | Participants With HCV Genotype 1 or 4 |
---|---|
Arm/Group Description | 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 (tablets; 1000 or 1200 mg divided twice a day) up to 24 weeks |
Measure Participants | 168 |
Number (95% Confidence Interval) [percentage of participants] |
95.8
40.6%
|
Title | Percentage of Participants With Relapse |
---|---|
Description | 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. |
Time Frame | Up to 48 weeks after the last actual dose of study drug |
Outcome Measure Data
Analysis Population Description |
---|
Core population (CP): all participants of the target population (all participants in the safety population who met all 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) |
Arm/Group Title | Participants With HCV Genotype 1 or 4 |
---|---|
Arm/Group Description | 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 (tablets; 1000 or 1200 mg divided twice a day) up to 24 weeks |
Measure Participants | 228 |
Number (95% Confidence Interval) [percentage of participants] |
0.0
0%
|
Title | Percentage of Participants With Viral Breakthrough |
---|---|
Description | 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. |
Time Frame | Up to 24 weeks |
Outcome Measure Data
Analysis Population Description |
---|
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 |
Arm/Group Title | Participants With HCV Genotype 1 or 4 |
---|---|
Arm/Group Description | 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 (tablets; 1000 or 1200 mg divided twice a day) up to 24 weeks |
Measure Participants | 228 |
Number (95% Confidence Interval) [percentage of participants] |
0.0
0%
|
Title | Percentage of Participants With On-treatment Virologic Failure |
---|---|
Description | 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). |
Time Frame | 12 weeks after the last actual dose of study drug |
Outcome Measure Data
Analysis Population Description |
---|
Core population (CP): all participants of the target population (all participants in the safety population who met all 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) |
Arm/Group Title | Participants With HCV Genotype 1 or 4 |
---|---|
Arm/Group Description | 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 (tablets; 1000 or 1200 mg divided twice a day) up to 24 weeks |
Measure Participants | 228 |
Number [percentage of participants] |
1.3
0.6%
|
Title | Percentage of Participants Meeting Relapse Criteria |
---|---|
Description | 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. |
Time Frame | 12 weeks after the last actual dose of study drug |
Outcome Measure Data
Analysis Population Description |
---|
Core population (CP): all participants of the target population (all participants in the safety population who met all 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) |
Arm/Group Title | Participants With HCV Genotype 1 or 4 |
---|---|
Arm/Group Description | 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 (tablets; 1000 or 1200 mg divided twice a day) up to 24 weeks |
Measure Participants | 228 |
Number [percentage of participants] |
0
0%
|
Title | Percentage of Participants Meeting Premature Study Drug Discontinuation Criteria |
---|---|
Description | Premature study drug discontinuation was defined as participants who prematurely discontinued study drug with no on-treatment virologic failure. |
Time Frame | 12 weeks after the last actual dose of study drug |
Outcome Measure Data
Analysis Population Description |
---|
Core population (CP): all participants of the target population (all participants in the safety population who met all 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) |
Arm/Group Title | Participants With HCV Genotype 1 or 4 |
---|---|
Arm/Group Description | 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 (tablets; 1000 or 1200 mg divided twice a day) up to 24 weeks |
Measure Participants | 228 |
Number [percentage of participants] |
1.8
0.8%
|
Title | 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 |
---|---|
Description | 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. |
Time Frame | 12 weeks after the last actual dose of study drug |
Outcome Measure Data
Analysis Population Description |
---|
Core population (CP): all participants of the target population (all participants in the safety population who met all 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) |
Arm/Group Title | Participants With HCV Genotype 1 or 4 |
---|---|
Arm/Group Description | 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 (tablets; 1000 or 1200 mg divided twice a day) up to 24 weeks |
Measure Participants | 228 |
Number [percentage of participants] |
25.9
11%
|
Adverse Events
Time Frame | 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). | |||||
---|---|---|---|---|---|---|
Adverse Event Reporting Description | 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. | |||||
Arm/Group Title | Ombitasvir/Paritaprevir/Ritonavir + Dasabuvir | Ombitasvir/Paritaprevir/Ritonavir | Ombitasvir/Paritaprevir/Ritonavir + Dasabuvir + Ribavirin | |||
Arm/Group Description | 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 | Ombitasvir/paritaprevir/ritonavir (two 12.5 mg/75 mg/50 mg co-formulated tablets once daily) up to 24 weeks | 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 (tablets; 1000 or 1200 mg divided twice a day) up to 24 weeks | |||
All Cause Mortality |
||||||
Ombitasvir/Paritaprevir/Ritonavir + Dasabuvir | Ombitasvir/Paritaprevir/Ritonavir | Ombitasvir/Paritaprevir/Ritonavir + Dasabuvir + Ribavirin | ||||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 1/216 (0.5%) | 0/6 (0%) | 0/14 (0%) | |||
Serious Adverse Events |
||||||
Ombitasvir/Paritaprevir/Ritonavir + Dasabuvir | Ombitasvir/Paritaprevir/Ritonavir | Ombitasvir/Paritaprevir/Ritonavir + Dasabuvir + Ribavirin | ||||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 4/216 (1.9%) | 1/6 (16.7%) | 1/14 (7.1%) | |||
Cardiac disorders | ||||||
ATRIAL FIBRILLATION | 1/216 (0.5%) | 1 | 0/6 (0%) | 0 | 0/14 (0%) | 0 |
Gastrointestinal disorders | ||||||
ASCITES | 0/216 (0%) | 0 | 1/6 (16.7%) | 1 | 0/14 (0%) | 0 |
Hepatobiliary disorders | ||||||
HEPATIC FAILURE | 0/216 (0%) | 0 | 0/6 (0%) | 0 | 1/14 (7.1%) | 1 |
Injury, poisoning and procedural complications | ||||||
TOXICITY TO VARIOUS AGENTS | 1/216 (0.5%) | 1 | 0/6 (0%) | 0 | 0/14 (0%) | 0 |
UPPER LIMB FRACTURE | 1/216 (0.5%) | 1 | 0/6 (0%) | 0 | 0/14 (0%) | 0 |
Musculoskeletal and connective tissue disorders | ||||||
SYNOVIAL CYST | 1/216 (0.5%) | 1 | 0/6 (0%) | 0 | 0/14 (0%) | 0 |
Nervous system disorders | ||||||
HEPATIC ENCEPHALOPATHY | 0/216 (0%) | 0 | 0/6 (0%) | 0 | 1/14 (7.1%) | 1 |
Respiratory, thoracic and mediastinal disorders | ||||||
DYSPNOEA | 0/216 (0%) | 0 | 1/6 (16.7%) | 1 | 0/14 (0%) | 0 |
Other (Not Including Serious) Adverse Events |
||||||
Ombitasvir/Paritaprevir/Ritonavir + Dasabuvir | Ombitasvir/Paritaprevir/Ritonavir | Ombitasvir/Paritaprevir/Ritonavir + Dasabuvir + Ribavirin | ||||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 15/216 (6.9%) | 2/6 (33.3%) | 4/14 (28.6%) | |||
Blood and lymphatic system disorders | ||||||
ANAEMIA | 0/216 (0%) | 0 | 0/6 (0%) | 0 | 1/14 (7.1%) | 1 |
Eye disorders | ||||||
VISION BLURRED | 0/216 (0%) | 0 | 1/6 (16.7%) | 1 | 1/14 (7.1%) | 1 |
General disorders | ||||||
ASTHENIA | 5/216 (2.3%) | 5 | 0/6 (0%) | 0 | 1/14 (7.1%) | 1 |
OEDEMA PERIPHERAL | 2/216 (0.9%) | 2 | 2/6 (33.3%) | 2 | 0/14 (0%) | 0 |
Infections and infestations | ||||||
PHARYNGITIS | 0/216 (0%) | 0 | 0/6 (0%) | 0 | 1/14 (7.1%) | 1 |
Nervous system disorders | ||||||
DIZZINESS | 4/216 (1.9%) | 4 | 0/6 (0%) | 0 | 1/14 (7.1%) | 1 |
Skin and subcutaneous tissue disorders | ||||||
PRURITUS | 5/216 (2.3%) | 5 | 1/6 (16.7%) | 1 | 1/14 (7.1%) | 1 |
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
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.
Results Point of Contact
Name/Title | Global Medical Services |
---|---|
Organization | AbbVie |
Phone | 800-633-9110 |
abbvieclinicaltrials@abbvie.com |
- P16-014