REACH: The Effectiveness of ABT-450/r - Ombitasvir, ± Dasabuvir, ± Ribavirin in Patients With Chronic Hepatitis C -An Observational Study in Ireland
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 the local label, under real world conditions in Ireland 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 Ireland. 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 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 |
Drug: Ombitasvir/paritaprevir/ritonavir
Co-formulated tablet
Other Names:
Drug: Dasabuvir
Tablet
Other Names:
Drug: Ribavirin
Tablet
|
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. 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: 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
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 Relapse [From the end of treatment through the end of study (maximum of 48 weeks post-treatment)]
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 [Up to 24 weeks]
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 [Up to 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 [Up to 24 weeks]
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
Inclusion Criteria:
-
Treatment-naïve or -experienced adult male or female participants with confirmed chronic hepatitis C (CHC), genotype 1, 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
No locations specified.Sponsors and Collaborators
- AbbVie
Investigators
- Study Director: AbbVie Inc., AbbVie
Study Documents (Full-Text)
More Information
Additional Information:
Publications
None provided.- P15-702
Study Results
Participant Flow
Recruitment Details | |
---|---|
Pre-assignment Detail | Safety population: all enrolled participants who received at least one dose of the ABBVIE REGIMEN. The prescribed ABBVIE REGIMEN needed to be known. |
Arm/Group Title | Participants With HCV Genotype 1 |
---|---|
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 (tablet; 1000 or 1200 mg divided twice a day) up to 24 weeks |
Period Title: Overall Study | |
STARTED | 101 |
COMPLETED | 99 |
NOT COMPLETED | 2 |
Baseline Characteristics
Arm/Group Title | Participants With HCV Genotype 1 |
---|---|
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 (tablet; 1000 or 1200 mg divided twice a day) up to 24 weeks |
Overall Participants | 101 |
Age (years) [Mean (Standard Deviation) ] | |
Mean (Standard Deviation) [years] |
54
(13.8)
|
Sex: Female, Male (Count of Participants) | |
Female |
67
66.3%
|
Male |
34
33.7%
|
Race/Ethnicity, Customized (Count of Participants) | |
Black or African American |
1
1%
|
Hispanic/Latino |
1
1%
|
Non-Hispanic White |
99
98%
|
Hepatitis C genotype (Count of Participants) | |
Genotype 1a |
31
30.7%
|
Genotype 1b |
70
69.3%
|
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. 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: 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 after the last actual dose of study drug |
Outcome Measure Data
Analysis Population Description |
---|
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 |
Arm/Group Title | Participants With HCV Genotype 1 |
---|---|
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 (tablet; 1000 or 1200 mg divided twice a day) up to 24 weeks |
Measure Participants | 101 |
Core population (CP) |
97.0
96%
|
CPSFU12 |
98.0
97%
|
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: 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) |
Arm/Group Title | Participants With HCV Genotype 1 |
---|---|
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 (tablet; 1000 or 1200 mg divided twice a day) up to 24 weeks |
Measure Participants | 101 |
Number (95% Confidence Interval) [Percentage of participants] |
97.0
96%
|
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 | From the end of treatment through the end of study (maximum of 48 weeks post-treatment) |
Outcome Measure Data
Analysis Population Description |
---|
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) |
Arm/Group Title | Participants With HCV Genotype 1 |
---|---|
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 (tablet; 1000 or 1200 mg divided twice a day) up to 24 weeks |
Measure Participants | 96 |
Number (95% Confidence Interval) [percentage of participants] |
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 |
---|---|
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 (tablet; 1000 or 1200 mg divided twice a day) up to 24 weeks |
Measure Participants | 101 |
Number (95% Confidence Interval) [percentage of participants] |
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 | Up to 24 weeks |
Outcome Measure Data
Analysis Population Description |
---|
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) |
Arm/Group Title | Participants With HCV Genotype 1 |
---|---|
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 (tablet; 1000 or 1200 mg divided twice a day) up to 24 weeks |
Measure Participants | 101 |
Number [percentage of participants] |
0
0%
|
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 | Up to 12 weeks after the last actual dose of study drug |
Outcome Measure Data
Analysis Population Description |
---|
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) |
Arm/Group Title | Participants With HCV Genotype 1 |
---|---|
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 (tablet; 1000 or 1200 mg divided twice a day) up to 24 weeks |
Measure Participants | 96 |
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 | Up to 24 weeks |
Outcome Measure Data
Analysis Population Description |
---|
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). |
Arm/Group Title | Participants With HCV Genotype 1 |
---|---|
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 (tablet; 1000 or 1200 mg divided twice a day) up to 24 weeks |
Measure Participants | 101 |
Number [percentage of participants] |
2.0
2%
|
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: 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) |
Arm/Group Title | Participants With HCV Genotype 1 |
---|---|
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 (tablet; 1000 or 1200 mg divided twice a day) up to 24 weeks |
Measure Participants | 101 |
Number [percentage of participants] |
1.0
1%
|
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 | Participants Who Did Not Receive Ribavirin | Participants Who Received 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) | 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 | ||
All Cause Mortality |
||||
Participants Who Did Not Receive Ribavirin | Participants Who Received Ribavirin | |||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 0/66 (0%) | 0/35 (0%) | ||
Serious Adverse Events |
||||
Participants Who Did Not Receive Ribavirin | Participants Who Received Ribavirin | |||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 1/66 (1.5%) | 0/35 (0%) | ||
Eye disorders | ||||
MACULAR DEGENERATION | 1/66 (1.5%) | 1 | 0/35 (0%) | 0 |
Other (Not Including Serious) Adverse Events |
||||
Participants Who Did Not Receive Ribavirin | Participants Who Received Ribavirin | |||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 47/66 (71.2%) | 27/35 (77.1%) | ||
Blood and lymphatic system disorders | ||||
ANAEMIA | 0/66 (0%) | 0 | 5/35 (14.3%) | 5 |
Gastrointestinal disorders | ||||
CONSTIPATION | 2/66 (3%) | 2 | 3/35 (8.6%) | 3 |
DIARRHOEA | 8/66 (12.1%) | 8 | 4/35 (11.4%) | 4 |
DYSPEPSIA | 1/66 (1.5%) | 1 | 3/35 (8.6%) | 3 |
NAUSEA | 14/66 (21.2%) | 14 | 3/35 (8.6%) | 3 |
General disorders | ||||
FATIGUE | 27/66 (40.9%) | 27 | 13/35 (37.1%) | 13 |
Infections and infestations | ||||
LOWER RESPIRATORY TRACT INFECTION | 5/66 (7.6%) | 5 | 4/35 (11.4%) | 4 |
RESPIRATORY TRACT INFECTION | 0/66 (0%) | 0 | 2/35 (5.7%) | 2 |
Metabolism and nutrition disorders | ||||
DECREASED APPETITE | 1/66 (1.5%) | 1 | 2/35 (5.7%) | 2 |
Nervous system disorders | ||||
HEADACHE | 17/66 (25.8%) | 17 | 4/35 (11.4%) | 4 |
Psychiatric disorders | ||||
DEPRESSED MOOD | 3/66 (4.5%) | 3 | 3/35 (8.6%) | 3 |
INSOMNIA | 3/66 (4.5%) | 3 | 4/35 (11.4%) | 4 |
SLEEP DISORDER | 4/66 (6.1%) | 4 | 2/35 (5.7%) | 2 |
Respiratory, thoracic and mediastinal disorders | ||||
COUGH | 5/66 (7.6%) | 5 | 0/35 (0%) | 0 |
DYSPNOEA | 2/66 (3%) | 2 | 2/35 (5.7%) | 2 |
EPISTAXIS | 0/66 (0%) | 0 | 2/35 (5.7%) | 2 |
Skin and subcutaneous tissue disorders | ||||
DRY SKIN | 1/66 (1.5%) | 1 | 5/35 (14.3%) | 5 |
PRURITUS | 5/66 (7.6%) | 5 | 3/35 (8.6%) | 3 |
RASH | 5/66 (7.6%) | 5 | 2/35 (5.7%) | 2 |
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 |
- P15-702