Chronic Hepatitis C, Genotype 1
Conditions
Keywords
Ombitasvir, Dasabuvir, Paritaprevir
Brief summary
This study seeks to assess the effectiveness, patient reported outcomes, work productivity and healthcare resource utilization of the interferon-free regimen of paritaprevir /ritonavir (r) - ombitasvir, ± dasabuvir ± ribavirin (RBV) in participants with chronic hepatitis C in a real life setting across clinical practice populations.
Interventions
None listed
Sponsors
AbbVie
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No
Inclusion criteria
Patients are eligible for observation in this cohort if the following applies: * Treatment-naïve or -experienced adult male or female patients with confirmed chronic hepatitis C, genotype 1, receiving combination therapy with paritaprevir/r - ombitasvir with or without dasabuvir ± RBV according to standard of care and in line with the current local label * If RBV is co-administered with paritaprevir/r - ombitasvir with or without dasabuvir, it has been prescribed in line with the current local label (with special attention to contraception requirements and contraindication during pregnancy) * Patients must voluntarily sign and date informed consent prior to inclusion into the study
Exclusion criteria
* Patient must not be participating or intending to participate in a concurrent interventional therapeutic trial
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Achieving Sustained Virological Response 12 Weeks Post-Treatment (SVR12) | 12 weeks after the last actual dose of study drug | SVR12 is defined as hepatitis C virus ribonucleic acid (HCV RNA) levels \< 50 IU/mL 12 weeks after the last actual dose of paritaprevir/r - ombitasvir, ± dasabuvir, ± RBV. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| SVR12 Non-Response: Percentage of Participants With Breakthrough | 12 weeks after the last actual dose of study drug | Breakthrough is defined as at least 1 documented HCV RNA \<50 IU/mL followed by HCV RNA ≥50 IU/mL during treatment. |
| Percentage of Participants Meeting SVR12 Non-Response Categories of Breakthrough, Failure to Suppress, and/or Relapse | 12 weeks after last actual dose of study drug | Breakthrough is defined as at least 1 documented HCV RNA \<50 IU/mL followed by HCV RNA ≥50 IU/mL during treatment. Failure to suppress is defined as each measured on-treatment HCV RNA value ≥ 50 IU/mL. Relapse is defined as HCV RNA \< 50 IU/mL at end of treatment or at the last on-treatment HCV RNA measurement followed by HCV RNA ≧ 50 IU/mL posttreatment. |
| SVR12 Non-Response: Percentage of Participants With Failure to Suppress | 12 weeks after the last actual dose of study drug | Failure to suppress is defined as each measured on-treatment HCV RNA value ≥ 50 IU/mL. |
| SVR12 Non-Response: Percentage of Participants With Relapse | 12 weeks after last actual dose of study drug | Relapse is defined as HCV RNA \<50 IU/mL at EoT or at the last on-treatment HCV RNA measurement followed by HCV RNA ≧ 50 IU/mL posttreatment. |
| SVR12 Non-Response: Percentage of Participants With Premature Study Drug Discontinuation With No On-Treatment Virologic Failure | 12 weeks after last actual dose of study drug | On-treatment virologic failure included virological breakthrough and failure to suppress. Virological breakthrough was defined as at least one documented HCV RNA \< 50 IU/mL or undetectable/negative followed by HCV RNA ≥ 50 IU/mL during treatment. Failure to suppress was defined as each measured on-treatment HCV RNA value ≥ 50 IU/mL or positive. |
| SVR12 Non-Response: Percentage of Participants With Missing SVR12 Data | 12 weeks after last actual dose of study drug | — |
| Percentage of Participants Achieving Sustained Virologic Response 24 Weeks Post-Treatment (SVR24) | 24 weeks after last actual dose of study drug | SVR24 is defined as HCV RNA levels \< 50 IU/mL 24 weeks after the last actual dose of paritaprevir/r - ombitasvir, ± dasabuvir, ± RBV. |
| Percentage of Participants Achieving Virological Response at End of Treatment | From baseline until end of treatment (12 or 24 weeks after actual first dose) | Virologic response is defined as HCV RNA \< 50 IU/mL. |
Other
| Measure | Time frame | Description |
|---|---|---|
| SVR12 Non-Response: Percentage of Participants With Breakthrough: Additional Analysis | 12 weeks after the last actual dose of study drug | Breakthrough is defined as at least 1 documented HCV RNA \<50 IU/mL or undetectable/negative followed by HCV RNA ≥50 IU/mL or positive during treatment. |
| SVR12 Non-Response: Percentage of Participants With Failure to Suppress: Additional Analysis | 12 weeks after the last actual dose of study drug | Failure to suppress is defined as each measured on-treatment HCV RNA value ≥ 50 IU/mL or positive. |
| SVR12 Non-Response: Percentage of Participants With Relapse: Additional Analysis | 12 weeks after last actual dose of study drug | Relapse is defined as HCV RNA \< 50 IU/mL or undetectable/negative at end of treatment or at the last on-treatment HCV RNA measurement followed by HCV RNA ≧ 50 IU/mL or positive posttreatment. |
| Percentage of Participants Achieving SVR24: Additional Analysis | 24 weeks after last actual dose of study drug | SVR24 is defined as HCV RNA levels \< 50 IU/mL or undetectable/negative 24 weeks after the last actual dose of paritaprevir/r - ombitasvir, ± dasabuvir, ± RBV. |
| Percentage of Participants Achieving Virological Response at End of Treatment: Additional Analysis | From baseline until end of treatment (12 or 24 weeks after actual first dose) | Virologic response is defined as HCV RNA \< 50 IU/mL or undetectable/negative. |
| Percentage of Participants Meeting SVR12 Non-Response Categories of Breakthrough, Failure to Suppress, and/or Relapse: Additional Analysis | 12 weeks after last actual dose of study drug | Breakthrough is defined as at least 1 documented HCV RNA \<50 IU/mL or undetectable/negative followed by HCV RNA ≥50 IU/mL or positive during treatment. Failure to suppress is defined as each measured on-treatment HCV RNA value ≥ 50 IU/mL or positive. Relapse is defined as HCV RNA \< 50 IU/mL or undetectable/negative at end of treatment or at the last on-treatment HCV RNA measurement followed by HCV RNA ≧ 50 IU/mL or positive posttreatment. |
| Percentage of Participants Achieving SVR12: Additional Analysis | 12 weeks after the last actual dose of study drug | SVR12 is defined as hepatitis C virus ribonucleic acid (HCV RNA) levels \< 50 IU/mL or undetectable/negative 12 weeks after the last actual dose of paritaprevir/r - ombitasvir, ± dasabuvir, ± RBV. |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Paritaprevir/r - Ombitasvir, ± Dasabuvir + RBV Participants with confirmed chronic hepatitis C genotype 1 receiving combination therapy with paritaprevir/r - ombitasvir with or without dasabuvir with RBV according to standard of care and in line with the current local label. | 63 |
| Paritaprevir/r - Ombitasvir, ± Dasabuvir - RBV Participants with confirmed chronic hepatitis C genotype 1 receiving combination therapy with paritaprevir/r - ombitasvir with or without dasabuvir without RBV according to standard of care and in line with the current local label. | 93 |
| Total | 156 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Failure to return | 0 | 3 |
| Overall Study | Insufficient follow-up data | 1 | 0 |
Baseline characteristics
| Characteristic | Paritaprevir/r - Ombitasvir, ± Dasabuvir + RBV | Paritaprevir/r - Ombitasvir, ± Dasabuvir - RBV | Total |
|---|---|---|---|
| Age, Continuous | 50.8 years STANDARD_DEVIATION 11.38 | 46.2 years STANDARD_DEVIATION 11.59 | 48.1 years STANDARD_DEVIATION 11.69 |
| Race/Ethnicity, Customized Asian/Oriental | 1 Participants | 1 Participants | 2 Participants |
| Race/Ethnicity, Customized White/Caucasian | 62 Participants | 92 Participants | 154 Participants |
| Sex: Female, Male Female | 34 Participants | 45 Participants | 79 Participants |
| Sex: Female, Male Male | 29 Participants | 48 Participants | 77 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 63 | 0 / 95 | 0 / 158 |
| other Total, other adverse events | 14 / 63 | 16 / 95 | 30 / 158 |
| serious Total, serious adverse events | 2 / 63 | 0 / 93 | 2 / 156 |
Outcome results
Primary
Percentage of Participants Achieving Sustained Virological Response 12 Weeks Post-Treatment (SVR12)
SVR12 is defined as hepatitis C virus ribonucleic acid (HCV RNA) levels \< 50 IU/mL 12 weeks after the last actual dose of paritaprevir/r - ombitasvir, ± dasabuvir, ± RBV.
Time frame: 12 weeks after the last actual dose of study drug
Population: Core population: eligible, enrolled participants with known fibrosis status who started the treatment combination recommended in the current local label for their disease characteristics, and remained on treatment for \>55 days (for 12-week treatment) or \>139 days (for 24-week treatment). Subgroup: excludes participants with missing SVR12 results.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Paritaprevir/r - Ombitasvir, ± Dasabuvir + RBV | Percentage of Participants Achieving Sustained Virological Response 12 Weeks Post-Treatment (SVR12) | Core Population | 22.2 percentage of participants |
| Paritaprevir/r - Ombitasvir, ± Dasabuvir + RBV | Percentage of Participants Achieving Sustained Virological Response 12 Weeks Post-Treatment (SVR12) | Core Population Subgroup | 23.3 percentage of participants |
| Paritaprevir/r - Ombitasvir, ± Dasabuvir - RBV | Percentage of Participants Achieving Sustained Virological Response 12 Weeks Post-Treatment (SVR12) | Core Population | 16.1 percentage of participants |
| Paritaprevir/r - Ombitasvir, ± Dasabuvir - RBV | Percentage of Participants Achieving Sustained Virological Response 12 Weeks Post-Treatment (SVR12) | Core Population Subgroup | 17.0 percentage of participants |
| Paritaprevir/r - Ombitasvir, ± Dasabuvir, ± RBV | Percentage of Participants Achieving Sustained Virological Response 12 Weeks Post-Treatment (SVR12) | Core Population | 18.6 percentage of participants |
| Paritaprevir/r - Ombitasvir, ± Dasabuvir, ± RBV | Percentage of Participants Achieving Sustained Virological Response 12 Weeks Post-Treatment (SVR12) | Core Population Subgroup | 19.6 percentage of participants |
Secondary
Percentage of Participants Achieving Sustained Virologic Response 24 Weeks Post-Treatment (SVR24)
SVR24 is defined as HCV RNA levels \< 50 IU/mL 24 weeks after the last actual dose of paritaprevir/r - ombitasvir, ± dasabuvir, ± RBV.
Time frame: 24 weeks after last actual dose of study drug
Population: Core population: eligible, enrolled participants with known fibrosis status who started the treatment combination recommended in the current local label for their disease characteristics, and remained on treatment for \> 55 days (for 12-week treatment) or \> 139 days (for 24-week treatment). Subgroup: excludes participants with missing SVR12 results.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Paritaprevir/r - Ombitasvir, ± Dasabuvir + RBV | Percentage of Participants Achieving Sustained Virologic Response 24 Weeks Post-Treatment (SVR24) | Core Population | 20.6 percentage of participants |
| Paritaprevir/r - Ombitasvir, ± Dasabuvir + RBV | Percentage of Participants Achieving Sustained Virologic Response 24 Weeks Post-Treatment (SVR24) | Core Population Subgroup | 20.0 percentage of participants |
| Paritaprevir/r - Ombitasvir, ± Dasabuvir - RBV | Percentage of Participants Achieving Sustained Virologic Response 24 Weeks Post-Treatment (SVR24) | Core Population | 14.0 percentage of participants |
| Paritaprevir/r - Ombitasvir, ± Dasabuvir - RBV | Percentage of Participants Achieving Sustained Virologic Response 24 Weeks Post-Treatment (SVR24) | Core Population Subgroup | 13.6 percentage of participants |
| Paritaprevir/r - Ombitasvir, ± Dasabuvir, ± RBV | Percentage of Participants Achieving Sustained Virologic Response 24 Weeks Post-Treatment (SVR24) | Core Population | 16.7 percentage of participants |
| Paritaprevir/r - Ombitasvir, ± Dasabuvir, ± RBV | Percentage of Participants Achieving Sustained Virologic Response 24 Weeks Post-Treatment (SVR24) | Core Population Subgroup | 16.2 percentage of participants |
Secondary
Percentage of Participants Achieving Virological Response at End of Treatment
Virologic response is defined as HCV RNA \< 50 IU/mL.
Time frame: From baseline until end of treatment (12 or 24 weeks after actual first dose)
Population: Core population: eligible, enrolled participants with known fibrosis status who started the treatment combination recommended in the current local label for their disease characteristics, and remained on treatment for \> 55 days (for 12-week treatment) or \> 139 days (for 24-week treatment). Subgroup: excludes participants with missing SVR12 results.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Paritaprevir/r - Ombitasvir, ± Dasabuvir + RBV | Percentage of Participants Achieving Virological Response at End of Treatment | Core Population Subgroup | 31.7 percentage of participants |
| Paritaprevir/r - Ombitasvir, ± Dasabuvir + RBV | Percentage of Participants Achieving Virological Response at End of Treatment | Core Population | 31.7 percentage of participants |
| Paritaprevir/r - Ombitasvir, ± Dasabuvir - RBV | Percentage of Participants Achieving Virological Response at End of Treatment | Core Population | 30.1 percentage of participants |
| Paritaprevir/r - Ombitasvir, ± Dasabuvir - RBV | Percentage of Participants Achieving Virological Response at End of Treatment | Core Population Subgroup | 30.7 percentage of participants |
| Paritaprevir/r - Ombitasvir, ± Dasabuvir, ± RBV | Percentage of Participants Achieving Virological Response at End of Treatment | Core Population | 30.8 percentage of participants |
| Paritaprevir/r - Ombitasvir, ± Dasabuvir, ± RBV | Percentage of Participants Achieving Virological Response at End of Treatment | Core Population Subgroup | 31.1 percentage of participants |
Secondary
Percentage of Participants Meeting SVR12 Non-Response Categories of Breakthrough, Failure to Suppress, and/or Relapse
Breakthrough is defined as at least 1 documented HCV RNA \<50 IU/mL followed by HCV RNA ≥50 IU/mL during treatment. Failure to suppress is defined as each measured on-treatment HCV RNA value ≥ 50 IU/mL. Relapse is defined as HCV RNA \< 50 IU/mL at end of treatment or at the last on-treatment HCV RNA measurement followed by HCV RNA ≧ 50 IU/mL posttreatment.
Time frame: 12 weeks after last actual dose of study drug
Population: Core population: eligible, enrolled participants with known fibrosis status who started the treatment combination recommended in the current local label for their disease characteristics, and remained on treatment for \> 55 days (for 12-week treatment) or \> 139 days (for 24-week treatment). Subgroup: excludes participants with missing SVR12 results.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Paritaprevir/r - Ombitasvir, ± Dasabuvir + RBV | Percentage of Participants Meeting SVR12 Non-Response Categories of Breakthrough, Failure to Suppress, and/or Relapse | Core Population | 73.0 percentage of participants |
| Paritaprevir/r - Ombitasvir, ± Dasabuvir + RBV | Percentage of Participants Meeting SVR12 Non-Response Categories of Breakthrough, Failure to Suppress, and/or Relapse | Core Population Subgroup | 76.7 percentage of participants |
| Paritaprevir/r - Ombitasvir, ± Dasabuvir - RBV | Percentage of Participants Meeting SVR12 Non-Response Categories of Breakthrough, Failure to Suppress, and/or Relapse | Core Population | 78.5 percentage of participants |
| Paritaprevir/r - Ombitasvir, ± Dasabuvir - RBV | Percentage of Participants Meeting SVR12 Non-Response Categories of Breakthrough, Failure to Suppress, and/or Relapse | Core Population Subgroup | 83.0 percentage of participants |
| Paritaprevir/r - Ombitasvir, ± Dasabuvir, ± RBV | Percentage of Participants Meeting SVR12 Non-Response Categories of Breakthrough, Failure to Suppress, and/or Relapse | Core Population | 76.3 percentage of participants |
| Paritaprevir/r - Ombitasvir, ± Dasabuvir, ± RBV | Percentage of Participants Meeting SVR12 Non-Response Categories of Breakthrough, Failure to Suppress, and/or Relapse | Core Population Subgroup | 80.4 percentage of participants |
Secondary
SVR12 Non-Response: Percentage of Participants With Breakthrough
Breakthrough is defined as at least 1 documented HCV RNA \<50 IU/mL followed by HCV RNA ≥50 IU/mL during treatment.
Time frame: 12 weeks after the last actual dose of study drug
Population: Core population: eligible, enrolled participants with known fibrosis status who started the treatment combination recommended in the current local label for their disease characteristics, and remained on treatment for \> 55 days (for 12-week treatment) or \> 139 days (for 24-week treatment). Subgroup: excludes participants with missing SVR12 results.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Paritaprevir/r - Ombitasvir, ± Dasabuvir + RBV | SVR12 Non-Response: Percentage of Participants With Breakthrough | Core Population | 1.6 percentage of participants |
| Paritaprevir/r - Ombitasvir, ± Dasabuvir + RBV | SVR12 Non-Response: Percentage of Participants With Breakthrough | Core Population Subgroup | 1.7 percentage of participants |
| Paritaprevir/r - Ombitasvir, ± Dasabuvir - RBV | SVR12 Non-Response: Percentage of Participants With Breakthrough | Core Population | 3.2 percentage of participants |
| Paritaprevir/r - Ombitasvir, ± Dasabuvir - RBV | SVR12 Non-Response: Percentage of Participants With Breakthrough | Core Population Subgroup | 3.4 percentage of participants |
| Paritaprevir/r - Ombitasvir, ± Dasabuvir, ± RBV | SVR12 Non-Response: Percentage of Participants With Breakthrough | Core Population | 2.6 percentage of participants |
| Paritaprevir/r - Ombitasvir, ± Dasabuvir, ± RBV | SVR12 Non-Response: Percentage of Participants With Breakthrough | Core Population Subgroup | 2.7 percentage of participants |
Secondary
SVR12 Non-Response: Percentage of Participants With Failure to Suppress
Failure to suppress is defined as each measured on-treatment HCV RNA value ≥ 50 IU/mL.
Time frame: 12 weeks after the last actual dose of study drug
Population: Core population: eligible, enrolled participants with known fibrosis status who started the treatment combination recommended in the current local label for their disease characteristics, and remained on treatment for \> 55 days (for 12-week treatment) or \> 139 days (for 24-week treatment). Subgroup: excludes participants with missing SVR12 results.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Paritaprevir/r - Ombitasvir, ± Dasabuvir + RBV | SVR12 Non-Response: Percentage of Participants With Failure to Suppress | Core Population | 61.9 percentage of participants |
| Paritaprevir/r - Ombitasvir, ± Dasabuvir + RBV | SVR12 Non-Response: Percentage of Participants With Failure to Suppress | Core Population Subgroup | 65.0 percentage of participants |
| Paritaprevir/r - Ombitasvir, ± Dasabuvir - RBV | SVR12 Non-Response: Percentage of Participants With Failure to Suppress | Core Population | 54.8 percentage of participants |
| Paritaprevir/r - Ombitasvir, ± Dasabuvir - RBV | SVR12 Non-Response: Percentage of Participants With Failure to Suppress | Core Population Subgroup | 58.0 percentage of participants |
| Paritaprevir/r - Ombitasvir, ± Dasabuvir, ± RBV | SVR12 Non-Response: Percentage of Participants With Failure to Suppress | Core Population | 57.7 percentage of participants |
| Paritaprevir/r - Ombitasvir, ± Dasabuvir, ± RBV | SVR12 Non-Response: Percentage of Participants With Failure to Suppress | Core Population Subgroup | 60.8 percentage of participants |
Secondary
SVR12 Non-Response: Percentage of Participants With Missing SVR12 Data
Time frame: 12 weeks after last actual dose of study drug
Population: Core population: eligible, enrolled participants with known fibrosis status who started the treatment combination recommended in the current local label for their disease characteristics, and remained on treatment for \> 55 days (for 12-week treatment) or \> 139 days (for 24-week treatment).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Paritaprevir/r - Ombitasvir, ± Dasabuvir + RBV | SVR12 Non-Response: Percentage of Participants With Missing SVR12 Data | 4.8 percentage of participants |
| Paritaprevir/r - Ombitasvir, ± Dasabuvir - RBV | SVR12 Non-Response: Percentage of Participants With Missing SVR12 Data | 5.4 percentage of participants |
| Paritaprevir/r - Ombitasvir, ± Dasabuvir, ± RBV | SVR12 Non-Response: Percentage of Participants With Missing SVR12 Data | 5.1 percentage of participants |
Secondary
SVR12 Non-Response: Percentage of Participants With Premature Study Drug Discontinuation With No On-Treatment Virologic Failure
On-treatment virologic failure included virological breakthrough and failure to suppress. Virological breakthrough was defined as at least one documented HCV RNA \< 50 IU/mL or undetectable/negative followed by HCV RNA ≥ 50 IU/mL during treatment. Failure to suppress was defined as each measured on-treatment HCV RNA value ≥ 50 IU/mL or positive.
Time frame: 12 weeks after last actual dose of study drug
Population: Core population: eligible, enrolled participants with known fibrosis status who started the treatment combination recommended in the current local label for their disease characteristics, and remained on treatment for \> 55 days (for 12-week treatment) or \> 139 days (for 24-week treatment). Subgroup: excludes participants with missing SVR12 results.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Paritaprevir/r - Ombitasvir, ± Dasabuvir + RBV | SVR12 Non-Response: Percentage of Participants With Premature Study Drug Discontinuation With No On-Treatment Virologic Failure | Core Population | 0 percentage of participants |
| Paritaprevir/r - Ombitasvir, ± Dasabuvir + RBV | SVR12 Non-Response: Percentage of Participants With Premature Study Drug Discontinuation With No On-Treatment Virologic Failure | Core Population Subgroup | 0 percentage of participants |
| Paritaprevir/r - Ombitasvir, ± Dasabuvir - RBV | SVR12 Non-Response: Percentage of Participants With Premature Study Drug Discontinuation With No On-Treatment Virologic Failure | Core Population | 0 percentage of participants |
| Paritaprevir/r - Ombitasvir, ± Dasabuvir - RBV | SVR12 Non-Response: Percentage of Participants With Premature Study Drug Discontinuation With No On-Treatment Virologic Failure | Core Population Subgroup | 0 percentage of participants |
| Paritaprevir/r - Ombitasvir, ± Dasabuvir, ± RBV | SVR12 Non-Response: Percentage of Participants With Premature Study Drug Discontinuation With No On-Treatment Virologic Failure | Core Population | 0 percentage of participants |
| Paritaprevir/r - Ombitasvir, ± Dasabuvir, ± RBV | SVR12 Non-Response: Percentage of Participants With Premature Study Drug Discontinuation With No On-Treatment Virologic Failure | Core Population Subgroup | 0 percentage of participants |
Secondary
SVR12 Non-Response: Percentage of Participants With Relapse
Relapse is defined as HCV RNA \<50 IU/mL at EoT or at the last on-treatment HCV RNA measurement followed by HCV RNA ≧ 50 IU/mL posttreatment.
Time frame: 12 weeks after last actual dose of study drug
Population: Core population: eligible, enrolled participants with known fibrosis status who started the treatment combination recommended in the current local label for their disease characteristics, and remained on treatment for \> 55 days (for 12-week treatment) or \> 139 days (for 24-week treatment). Subgroup: excludes participants with missing SVR12 results.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Paritaprevir/r - Ombitasvir, ± Dasabuvir + RBV | SVR12 Non-Response: Percentage of Participants With Relapse | Core Population | 9.5 percentage of participants |
| Paritaprevir/r - Ombitasvir, ± Dasabuvir + RBV | SVR12 Non-Response: Percentage of Participants With Relapse | Core Population Subgroup | 10.0 percentage of participants |
| Paritaprevir/r - Ombitasvir, ± Dasabuvir - RBV | SVR12 Non-Response: Percentage of Participants With Relapse | Core Population | 20.4 percentage of participants |
| Paritaprevir/r - Ombitasvir, ± Dasabuvir - RBV | SVR12 Non-Response: Percentage of Participants With Relapse | Core Population Subgroup | 21.6 percentage of participants |
| Paritaprevir/r - Ombitasvir, ± Dasabuvir, ± RBV | SVR12 Non-Response: Percentage of Participants With Relapse | Core Population | 16.0 percentage of participants |
| Paritaprevir/r - Ombitasvir, ± Dasabuvir, ± RBV | SVR12 Non-Response: Percentage of Participants With Relapse | Core Population Subgroup | 16.9 percentage of participants |
Other Pre-specified
Percentage of Participants Achieving SVR12: Additional Analysis
SVR12 is defined as hepatitis C virus ribonucleic acid (HCV RNA) levels \< 50 IU/mL or undetectable/negative 12 weeks after the last actual dose of paritaprevir/r - ombitasvir, ± dasabuvir, ± RBV.
Time frame: 12 weeks after the last actual dose of study drug
Population: Core population: eligible, enrolled participants with known fibrosis status who started the treatment combination recommended in the current local label for their disease characteristics, and remained on treatment for \>55 days (for 12-week treatment) or \>139 days (for 24-week treatment). Subgroup: excludes participants with missing SVR12 results.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Paritaprevir/r - Ombitasvir, ± Dasabuvir + RBV | Percentage of Participants Achieving SVR12: Additional Analysis | Core Population | 93.7 percentage of participants |
| Paritaprevir/r - Ombitasvir, ± Dasabuvir + RBV | Percentage of Participants Achieving SVR12: Additional Analysis | Core Population Subgroup | 98.3 percentage of participants |
| Paritaprevir/r - Ombitasvir, ± Dasabuvir - RBV | Percentage of Participants Achieving SVR12: Additional Analysis | Core Population | 93.5 percentage of participants |
| Paritaprevir/r - Ombitasvir, ± Dasabuvir - RBV | Percentage of Participants Achieving SVR12: Additional Analysis | Core Population Subgroup | 98.9 percentage of participants |
| Paritaprevir/r - Ombitasvir, ± Dasabuvir, ± RBV | Percentage of Participants Achieving SVR12: Additional Analysis | Core Population | 93.6 percentage of participants |
| Paritaprevir/r - Ombitasvir, ± Dasabuvir, ± RBV | Percentage of Participants Achieving SVR12: Additional Analysis | Core Population Subgroup | 98.6 percentage of participants |
Other Pre-specified
Percentage of Participants Achieving SVR24: Additional Analysis
SVR24 is defined as HCV RNA levels \< 50 IU/mL or undetectable/negative 24 weeks after the last actual dose of paritaprevir/r - ombitasvir, ± dasabuvir, ± RBV.
Time frame: 24 weeks after last actual dose of study drug
Population: Core population: eligible, enrolled participants with known fibrosis status who started the treatment combination recommended in the current local label for their disease characteristics, and remained on treatment for \> 55 days (for 12-week treatment) or \> 139 days (for 24-week treatment). Subgroup: excludes participants with missing SVR12 results.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Paritaprevir/r - Ombitasvir, ± Dasabuvir + RBV | Percentage of Participants Achieving SVR24: Additional Analysis | Core Population | 93.7 percentage of participants |
| Paritaprevir/r - Ombitasvir, ± Dasabuvir + RBV | Percentage of Participants Achieving SVR24: Additional Analysis | Core Population Subgroup | 95.0 percentage of participants |
| Paritaprevir/r - Ombitasvir, ± Dasabuvir - RBV | Percentage of Participants Achieving SVR24: Additional Analysis | Core Population | 92.5 percentage of participants |
| Paritaprevir/r - Ombitasvir, ± Dasabuvir - RBV | Percentage of Participants Achieving SVR24: Additional Analysis | Core Population Subgroup | 95.5 percentage of participants |
| Paritaprevir/r - Ombitasvir, ± Dasabuvir, ± RBV | Percentage of Participants Achieving SVR24: Additional Analysis | Core Population | 92.9 percentage of participants |
| Paritaprevir/r - Ombitasvir, ± Dasabuvir, ± RBV | Percentage of Participants Achieving SVR24: Additional Analysis | Core Population Subgroup | 95.3 percentage of participants |
Other Pre-specified
Percentage of Participants Achieving Virological Response at End of Treatment: Additional Analysis
Virologic response is defined as HCV RNA \< 50 IU/mL or undetectable/negative.
Time frame: From baseline until end of treatment (12 or 24 weeks after actual first dose)
Population: Core population: eligible, enrolled participants with known fibrosis status who started the treatment combination recommended in the current local label for their disease characteristics, and remained on treatment for \> 55 days (for 12-week treatment) or \> 139 days (for 24-week treatment). Subgroup: excludes participants with missing SVR12 results.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Paritaprevir/r - Ombitasvir, ± Dasabuvir + RBV | Percentage of Participants Achieving Virological Response at End of Treatment: Additional Analysis | Core Population | 93.7 percentage of participants |
| Paritaprevir/r - Ombitasvir, ± Dasabuvir + RBV | Percentage of Participants Achieving Virological Response at End of Treatment: Additional Analysis | Core Population Subgroup | 95.0 percentage of participants |
| Paritaprevir/r - Ombitasvir, ± Dasabuvir - RBV | Percentage of Participants Achieving Virological Response at End of Treatment: Additional Analysis | Core Population Subgroup | 96.6 percentage of participants |
| Paritaprevir/r - Ombitasvir, ± Dasabuvir - RBV | Percentage of Participants Achieving Virological Response at End of Treatment: Additional Analysis | Core Population | 95.7 percentage of participants |
| Paritaprevir/r - Ombitasvir, ± Dasabuvir, ± RBV | Percentage of Participants Achieving Virological Response at End of Treatment: Additional Analysis | Core Population | 94.9 percentage of participants |
| Paritaprevir/r - Ombitasvir, ± Dasabuvir, ± RBV | Percentage of Participants Achieving Virological Response at End of Treatment: Additional Analysis | Core Population Subgroup | 95.9 percentage of participants |
Other Pre-specified
Percentage of Participants Meeting SVR12 Non-Response Categories of Breakthrough, Failure to Suppress, and/or Relapse: Additional Analysis
Breakthrough is defined as at least 1 documented HCV RNA \<50 IU/mL or undetectable/negative followed by HCV RNA ≥50 IU/mL or positive during treatment. Failure to suppress is defined as each measured on-treatment HCV RNA value ≥ 50 IU/mL or positive. Relapse is defined as HCV RNA \< 50 IU/mL or undetectable/negative at end of treatment or at the last on-treatment HCV RNA measurement followed by HCV RNA ≧ 50 IU/mL or positive posttreatment.
Time frame: 12 weeks after last actual dose of study drug
Population: Core population: eligible, enrolled participants with known fibrosis status who started the treatment combination recommended in the current local label for their disease characteristics, and remained on treatment for \> 55 days (for 12-week treatment) or \> 139 days (for 24-week treatment). Subgroup: excludes participants with missing SVR12 results.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Paritaprevir/r - Ombitasvir, ± Dasabuvir + RBV | Percentage of Participants Meeting SVR12 Non-Response Categories of Breakthrough, Failure to Suppress, and/or Relapse: Additional Analysis | Core Population | 1.6 percentage of participants |
| Paritaprevir/r - Ombitasvir, ± Dasabuvir + RBV | Percentage of Participants Meeting SVR12 Non-Response Categories of Breakthrough, Failure to Suppress, and/or Relapse: Additional Analysis | Core Population Subgroup | 1.7 percentage of participants |
| Paritaprevir/r - Ombitasvir, ± Dasabuvir - RBV | Percentage of Participants Meeting SVR12 Non-Response Categories of Breakthrough, Failure to Suppress, and/or Relapse: Additional Analysis | Core Population | 1.1 percentage of participants |
| Paritaprevir/r - Ombitasvir, ± Dasabuvir - RBV | Percentage of Participants Meeting SVR12 Non-Response Categories of Breakthrough, Failure to Suppress, and/or Relapse: Additional Analysis | Core Population Subgroup | 1.1 percentage of participants |
| Paritaprevir/r - Ombitasvir, ± Dasabuvir, ± RBV | Percentage of Participants Meeting SVR12 Non-Response Categories of Breakthrough, Failure to Suppress, and/or Relapse: Additional Analysis | Core Population | 1.3 percentage of participants |
| Paritaprevir/r - Ombitasvir, ± Dasabuvir, ± RBV | Percentage of Participants Meeting SVR12 Non-Response Categories of Breakthrough, Failure to Suppress, and/or Relapse: Additional Analysis | Core Population Subgroup | 1.4 percentage of participants |
Other Pre-specified
SVR12 Non-Response: Percentage of Participants With Breakthrough: Additional Analysis
Breakthrough is defined as at least 1 documented HCV RNA \<50 IU/mL or undetectable/negative followed by HCV RNA ≥50 IU/mL or positive during treatment.
Time frame: 12 weeks after the last actual dose of study drug
Population: Core population: eligible, enrolled participants with known fibrosis status who started the treatment combination recommended in the current local label for their disease characteristics, and remained on treatment for \> 55 days (for 12-week treatment) or \> 139 days (for 24-week treatment). Subgroup: excludes participants with missing SVR12 results.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Paritaprevir/r - Ombitasvir, ± Dasabuvir + RBV | SVR12 Non-Response: Percentage of Participants With Breakthrough: Additional Analysis | Core Population | 0 percentage of participants |
| Paritaprevir/r - Ombitasvir, ± Dasabuvir + RBV | SVR12 Non-Response: Percentage of Participants With Breakthrough: Additional Analysis | Core Population Subgroup | 0 percentage of participants |
| Paritaprevir/r - Ombitasvir, ± Dasabuvir - RBV | SVR12 Non-Response: Percentage of Participants With Breakthrough: Additional Analysis | Core Population | 0 percentage of participants |
| Paritaprevir/r - Ombitasvir, ± Dasabuvir - RBV | SVR12 Non-Response: Percentage of Participants With Breakthrough: Additional Analysis | Core Population Subgroup | 0 percentage of participants |
| Paritaprevir/r - Ombitasvir, ± Dasabuvir, ± RBV | SVR12 Non-Response: Percentage of Participants With Breakthrough: Additional Analysis | Core Population | 0 percentage of participants |
| Paritaprevir/r - Ombitasvir, ± Dasabuvir, ± RBV | SVR12 Non-Response: Percentage of Participants With Breakthrough: Additional Analysis | Core Population Subgroup | 0 percentage of participants |
Other Pre-specified
SVR12 Non-Response: Percentage of Participants With Failure to Suppress: Additional Analysis
Failure to suppress is defined as each measured on-treatment HCV RNA value ≥ 50 IU/mL or positive.
Time frame: 12 weeks after the last actual dose of study drug
Population: Core population: eligible, enrolled participants with known fibrosis status who started the treatment combination recommended in the current local label for their disease characteristics, and remained on treatment for \> 55 days (for 12-week treatment) or \> 139 days (for 24-week treatment). Subgroup: excludes participants with missing SVR12 results.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Paritaprevir/r - Ombitasvir, ± Dasabuvir + RBV | SVR12 Non-Response: Percentage of Participants With Failure to Suppress: Additional Analysis | Core Population | 1.6 percentage of participants |
| Paritaprevir/r - Ombitasvir, ± Dasabuvir + RBV | SVR12 Non-Response: Percentage of Participants With Failure to Suppress: Additional Analysis | Core Population Subgroup | 1.7 percentage of participants |
| Paritaprevir/r - Ombitasvir, ± Dasabuvir - RBV | SVR12 Non-Response: Percentage of Participants With Failure to Suppress: Additional Analysis | Core Population | 0 percentage of participants |
| Paritaprevir/r - Ombitasvir, ± Dasabuvir - RBV | SVR12 Non-Response: Percentage of Participants With Failure to Suppress: Additional Analysis | Core Population Subgroup | 0 percentage of participants |
| Paritaprevir/r - Ombitasvir, ± Dasabuvir, ± RBV | SVR12 Non-Response: Percentage of Participants With Failure to Suppress: Additional Analysis | Core Population | 0.6 percentage of participants |
| Paritaprevir/r - Ombitasvir, ± Dasabuvir, ± RBV | SVR12 Non-Response: Percentage of Participants With Failure to Suppress: Additional Analysis | Core Population Subgroup | 0.7 percentage of participants |
Other Pre-specified
SVR12 Non-Response: Percentage of Participants With Relapse: Additional Analysis
Relapse is defined as HCV RNA \< 50 IU/mL or undetectable/negative at end of treatment or at the last on-treatment HCV RNA measurement followed by HCV RNA ≧ 50 IU/mL or positive posttreatment.
Time frame: 12 weeks after last actual dose of study drug
Population: Core population: eligible, enrolled participants with known fibrosis status who started the treatment combination recommended in the current local label for their disease characteristics, and remained on treatment for \> 55 days (for 12-week treatment) or \> 139 days (for 24-week treatment). Subgroup: excludes participants with missing SVR12 results.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Paritaprevir/r - Ombitasvir, ± Dasabuvir + RBV | SVR12 Non-Response: Percentage of Participants With Relapse: Additional Analysis | Core Population | 0 percentage of participants |
| Paritaprevir/r - Ombitasvir, ± Dasabuvir + RBV | SVR12 Non-Response: Percentage of Participants With Relapse: Additional Analysis | Core Population Subgroup | 0 percentage of participants |
| Paritaprevir/r - Ombitasvir, ± Dasabuvir - RBV | SVR12 Non-Response: Percentage of Participants With Relapse: Additional Analysis | Core Population | 1.1 percentage of participants |
| Paritaprevir/r - Ombitasvir, ± Dasabuvir - RBV | SVR12 Non-Response: Percentage of Participants With Relapse: Additional Analysis | Core Population Subgroup | 1.1 percentage of participants |
| Paritaprevir/r - Ombitasvir, ± Dasabuvir, ± RBV | SVR12 Non-Response: Percentage of Participants With Relapse: Additional Analysis | Core Population | 0.6 percentage of participants |
| Paritaprevir/r - Ombitasvir, ± Dasabuvir, ± RBV | SVR12 Non-Response: Percentage of Participants With Relapse: Additional Analysis | Core Population Subgroup | 0.7 percentage of participants |