Trial Outcomes & Findings for Real World Evidence of the Effectiveness of Paritaprevir/r - Ombitasvir, ± Dasabuvir, ± Ribavirin and Patient Support Program in Patients With Chronic Hepatitis C (NCT NCT02803138)
NCT ID: NCT02803138
Last Updated: 2019-10-11
Results Overview
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.
Recruitment status
COMPLETED
Target enrollment
256 participants
Primary outcome timeframe
12 weeks after the last actual dose of study drug
Results posted on
2019-10-11
Participant Flow
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.
Participant milestones
| Measure |
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
|
|---|---|
|
Overall Study
STARTED
|
236
|
|
Overall Study
COMPLETED
|
166
|
|
Overall Study
NOT COMPLETED
|
70
|
Reasons for withdrawal
| Measure |
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
|
|---|---|
|
Overall Study
Failure to return
|
38
|
|
Overall Study
Insufficient virological response
|
2
|
|
Overall Study
Withdrawn consent
|
1
|
|
Overall Study
Death
|
1
|
|
Overall Study
Other, not specified
|
28
|
Baseline Characteristics
Real World Evidence of the Effectiveness of Paritaprevir/r - Ombitasvir, ± Dasabuvir, ± Ribavirin and Patient Support Program in Patients With Chronic Hepatitis C
Baseline characteristics by cohort
| Measure |
Participants With HCV Genotype 1 or 4
n=236 Participants
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
|
|---|---|
|
Age, Continuous
|
56 years
STANDARD_DEVIATION 12.7 • n=39 Participants
|
|
Sex: Female, Male
Female
|
105 Participants
n=39 Participants
|
|
Sex: Female, Male
Male
|
131 Participants
n=39 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=39 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=39 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=39 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=39 Participants
|
|
Race (NIH/OMB)
White
|
236 Participants
n=39 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=39 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=39 Participants
|
|
Hepatitis C genotype
Genotype 1a
|
12 Participants
n=39 Participants
|
|
Hepatitis C genotype
Genotype 1a/1b
|
1 Participants
n=39 Participants
|
|
Hepatitis C genotype
Genotype 1b
|
222 Participants
n=39 Participants
|
|
Hepatitis C genotype
Genotype 4
|
1 Participants
n=39 Participants
|
PRIMARY outcome
Timeframe: 12 weeks after the last actual dose of study drugPopulation: 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)
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.
Outcome measures
| Measure |
Participants With HCV Genotype 1 or 4
n=228 Participants
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
|
|---|---|
|
Percentage of Participants Achieving Sustained Virologic Response 12 Weeks Post-treatment (SVR12)
|
70.6 percentage of participants
Interval 64.4 to 76.1
|
SECONDARY outcome
Timeframe: Up to 24 weeksPopulation: 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)
Virologic response was defined as hepatitis C virus ribonucleic acid (HCV RNA) level less than 50 IU/mL at the end of treatment.
Outcome measures
| Measure |
Participants With HCV Genotype 1 or 4
n=228 Participants
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
|
|---|---|
|
Percentage of Participants With Virologic Response at End of Treatment (EoT)
|
82.0 percentage of participants
Interval 76.5 to 86.5
|
SECONDARY outcome
Timeframe: 12 weeks (at least 70 days) after the last actual dose of study drugPopulation: Core population with sufficient follow-up data regarding SVR12
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
Outcome measures
| Measure |
Participants With HCV Genotype 1 or 4
n=168 Participants
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
|
|---|---|
|
Percentage of Participants With Sufficient Follow-up Who Achieved Sustained Virological Response 12 Weeks Posttreatment
|
95.8 percentage of participants
Interval 91.7 to 98.0
|
SECONDARY outcome
Timeframe: Up to 48 weeks after the last actual dose of study drugPopulation: 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)
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.
Outcome measures
| Measure |
Participants With HCV Genotype 1 or 4
n=228 Participants
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
|
|---|---|
|
Percentage of Participants With Relapse
|
0.0 percentage of participants
Interval 0.0 to 2.4
|
SECONDARY outcome
Timeframe: Up to 24 weeksPopulation: 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
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.
Outcome measures
| Measure |
Participants With HCV Genotype 1 or 4
n=228 Participants
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
|
|---|---|
|
Percentage of Participants With Viral Breakthrough
|
0.0 percentage of participants
Interval 0.0 to 3.7
|
SECONDARY outcome
Timeframe: 12 weeks after the last actual dose of study drugPopulation: 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)
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).
Outcome measures
| Measure |
Participants With HCV Genotype 1 or 4
n=228 Participants
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
|
|---|---|
|
Percentage of Participants With On-treatment Virologic Failure
|
1.3 percentage of participants
|
SECONDARY outcome
Timeframe: 12 weeks after the last actual dose of study drugPopulation: 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)
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.
Outcome measures
| Measure |
Participants With HCV Genotype 1 or 4
n=228 Participants
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
|
|---|---|
|
Percentage of Participants Meeting Relapse Criteria
|
0 percentage of participants
|
SECONDARY outcome
Timeframe: 12 weeks after the last actual dose of study drugPopulation: 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)
Premature study drug discontinuation was defined as participants who prematurely discontinued study drug with no on-treatment virologic failure.
Outcome measures
| Measure |
Participants With HCV Genotype 1 or 4
n=228 Participants
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
|
|---|---|
|
Percentage of Participants Meeting Premature Study Drug Discontinuation Criteria
|
1.8 percentage of participants
|
SECONDARY outcome
Timeframe: 12 weeks after the last actual dose of study drugPopulation: 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)
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.
Outcome measures
| Measure |
Participants With HCV Genotype 1 or 4
n=228 Participants
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
|
|---|---|
|
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
|
25.9 percentage of participants
|
Adverse Events
Ombitasvir/Paritaprevir/Ritonavir + Dasabuvir
Serious events: 4 serious events
Other events: 15 other events
Deaths: 1 deaths
Ombitasvir/Paritaprevir/Ritonavir
Serious events: 1 serious events
Other events: 2 other events
Deaths: 0 deaths
Ombitasvir/Paritaprevir/Ritonavir + Dasabuvir + Ribavirin
Serious events: 1 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Ombitasvir/Paritaprevir/Ritonavir + Dasabuvir
n=216 participants at risk
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
n=6 participants at risk
Ombitasvir/paritaprevir/ritonavir (two 12.5 mg/75 mg/50 mg co-formulated tablets once daily) up to 24 weeks
|
Ombitasvir/Paritaprevir/Ritonavir + Dasabuvir + Ribavirin
n=14 participants at risk
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
|
|---|---|---|---|
|
Cardiac disorders
ATRIAL FIBRILLATION
|
0.46%
1/216 • Number of events 1 • 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.
|
0.00%
0/6 • 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.
|
0.00%
0/14 • 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.
|
|
Gastrointestinal disorders
ASCITES
|
0.00%
0/216 • 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.
|
16.7%
1/6 • Number of events 1 • 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.
|
0.00%
0/14 • 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.
|
|
Hepatobiliary disorders
HEPATIC FAILURE
|
0.00%
0/216 • 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.
|
0.00%
0/6 • 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.
|
7.1%
1/14 • Number of events 1 • 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.
|
|
Injury, poisoning and procedural complications
TOXICITY TO VARIOUS AGENTS
|
0.46%
1/216 • Number of events 1 • 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.
|
0.00%
0/6 • 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.
|
0.00%
0/14 • 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.
|
|
Injury, poisoning and procedural complications
UPPER LIMB FRACTURE
|
0.46%
1/216 • Number of events 1 • 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.
|
0.00%
0/6 • 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.
|
0.00%
0/14 • 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.
|
|
Musculoskeletal and connective tissue disorders
SYNOVIAL CYST
|
0.46%
1/216 • Number of events 1 • 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.
|
0.00%
0/6 • 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.
|
0.00%
0/14 • 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.
|
|
Nervous system disorders
HEPATIC ENCEPHALOPATHY
|
0.00%
0/216 • 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.
|
0.00%
0/6 • 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.
|
7.1%
1/14 • Number of events 1 • 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.
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNOEA
|
0.00%
0/216 • 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.
|
16.7%
1/6 • Number of events 1 • 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.
|
0.00%
0/14 • 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.
|
Other adverse events
| Measure |
Ombitasvir/Paritaprevir/Ritonavir + Dasabuvir
n=216 participants at risk
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
n=6 participants at risk
Ombitasvir/paritaprevir/ritonavir (two 12.5 mg/75 mg/50 mg co-formulated tablets once daily) up to 24 weeks
|
Ombitasvir/Paritaprevir/Ritonavir + Dasabuvir + Ribavirin
n=14 participants at risk
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
|
|---|---|---|---|
|
Skin and subcutaneous tissue disorders
PRURITUS
|
2.3%
5/216 • Number of events 5 • 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.
|
16.7%
1/6 • Number of events 1 • 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.
|
7.1%
1/14 • Number of events 1 • 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.
|
|
Blood and lymphatic system disorders
ANAEMIA
|
0.00%
0/216 • 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.
|
0.00%
0/6 • 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.
|
7.1%
1/14 • Number of events 1 • 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.
|
|
Eye disorders
VISION BLURRED
|
0.00%
0/216 • 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.
|
16.7%
1/6 • Number of events 1 • 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.
|
7.1%
1/14 • Number of events 1 • 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.
|
|
General disorders
ASTHENIA
|
2.3%
5/216 • Number of events 5 • 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.
|
0.00%
0/6 • 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.
|
7.1%
1/14 • Number of events 1 • 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.
|
|
General disorders
OEDEMA PERIPHERAL
|
0.93%
2/216 • Number of events 2 • 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.
|
33.3%
2/6 • Number of events 2 • 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.
|
0.00%
0/14 • 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.
|
|
Infections and infestations
PHARYNGITIS
|
0.00%
0/216 • 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.
|
0.00%
0/6 • 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.
|
7.1%
1/14 • Number of events 1 • 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.
|
|
Nervous system disorders
DIZZINESS
|
1.9%
4/216 • Number of events 4 • 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.
|
0.00%
0/6 • 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.
|
7.1%
1/14 • Number of events 1 • 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.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER