Chronic Hepatitis C
Conditions
Keywords
Paritaprevir, Dasabuvir, Ombitasvir, Ritonavir, Ribavirin free, Chronic Hepatitis C genotype 1b (GT1b), Cirrhosis, Compensated liver cirrhosis, Hepatitis
Brief summary
This prospective, multi-center, observational study is designed to assess the real world effectiveness of paritaprevir/r - ombitasvir with dasabuvir (3DAA \[direct-acting antiviral agent\] ABBVIE REGIMEN) without ribavirin (RBV) and to describe baseline characteristics of participants with chronic hepatitis C virus (HCV) genotype 1b (GT1b) infection and compensated liver cirrhosis in Russia.
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
* 3DAA ABBVIE REGIMEN will be prescribed by physicians according to the routine clinical practice * Treatment-naïve or interferon (IFN)/ribavirin (RBV)-experienced participants with confirmed CHC Gt1b and compensated liver cirrhosis, receiving therapy with the interferon-free 3DAA ABBVIE REGIMEN initiated not earlier than 2 weeks before the enrollment or the initiation is planned not later than 2 weeks after the day of enrollment in accordance to standard of care and in line with the current local label * Participants must not be participating or intending to participate in a concurrent interventional therapeutic trial
Exclusion criteria
* Co-administration ribavirin (RBV) with the 3DAA ABBVIE REGIMEN * Participants with Child Pugh B and C cirrhosis * Participants with a history of prior direct-acting antiviral agent (DAA) therapy * Any other contraindications to the administration of 3DAA ABBVIE REGIMEN according to the label
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Achieving Sustained Virological Response 12 Weeks Post-treatment (SVR12) | 12 weeks after the last dose of study drug (week 24) | SVR12 was defined as hepatitis C virus (HCV) ribonucleic acid (RNA) levels less than 50 IU/mL 12 weeks after the last dose of study drug. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Achieving Virological Response at End of Treatment (EoT) | End of treatment, maximum of 12 weeks | Virological response is defined as HCV RNA less than 50 IU/mL. |
| Percentage of Participants With Relapse | End of treatment (week 12) and up to 12 weeks after the end of treatment. | Relapse was defined as participants with a virologic response (VR; HCV RNA \< 50 IU/mL) at end of treatment (EOT) followed by HCV RNA ≥ 50 IU/mL at any time after the end of treatment. |
| Percentage of Participants With Breakthrough | 12 weeks | Breakthrough was defined as at least one documented HCV RNA \< 50 IU/mL followed by HCV RNA ≥ 50 IU/mL during treatment. |
| Percentage of Participants With Failure to Suppress | 12 weeks | Failure to suppress was defined as each measured on-treatment HCV RNA value ≥ 50 IU/mL. |
| Percentage of Participants With Missing SVR12 Data | 12 weeks after the last dose of study drug (week 24) | — |
Countries
Russia
Participant flow
Recruitment details
A total of 60 participants signed the written patient authorization form and were enrolled into the study in 7 investigational sites located in Russia.
Participants by arm
| Arm | Count |
|---|---|
| Paritaprevir/Ritonavir + Ombitasvir + Dasabuvir Participants with chronic hepatitis C (CHC) genotype 1b (GT1b) and compensated liver cirrhosis received paritaprevir/ritonavir (r), ombitasvir and dasabuvir (3DAA ABBVIE REGIMEN) for 12 weeks. | 59 |
| Total | 59 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Failure to Return | 1 |
Baseline characteristics
| Characteristic | Paritaprevir/Ritonavir + Ombitasvir + Dasabuvir |
|---|---|
| Age, Continuous | 50.3 years STANDARD_DEVIATION 11.4 |
| Race/Ethnicity, Customized White | 59 Participants |
| Sex: Female, Male Female | 30 Participants |
| Sex: Female, Male Male | 29 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 60 |
| other Total, other adverse events | 1 / 60 |
| serious Total, serious adverse events | 1 / 60 |
Outcome results
Primary
Percentage of Participants Achieving Sustained Virological Response 12 Weeks Post-treatment (SVR12)
SVR12 was defined as hepatitis C virus (HCV) ribonucleic acid (RNA) levels less than 50 IU/mL 12 weeks after the last dose of study drug.
Time frame: 12 weeks after the last dose of study drug (week 24)
Population: Core population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Paritaprevir/Ritonavir + Ombitasvir + Dasabuvir | Percentage of Participants Achieving Sustained Virological Response 12 Weeks Post-treatment (SVR12) | 98.3 percentage of participants |
Secondary
Percentage of Participants Achieving Virological Response at End of Treatment (EoT)
Virological response is defined as HCV RNA less than 50 IU/mL.
Time frame: End of treatment, maximum of 12 weeks
Population: Core population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Paritaprevir/Ritonavir + Ombitasvir + Dasabuvir | Percentage of Participants Achieving Virological Response at End of Treatment (EoT) | 100.0 percentage of participants |
Secondary
Percentage of Participants With Breakthrough
Breakthrough was defined as at least one documented HCV RNA \< 50 IU/mL followed by HCV RNA ≥ 50 IU/mL during treatment.
Time frame: 12 weeks
Population: Core population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Paritaprevir/Ritonavir + Ombitasvir + Dasabuvir | Percentage of Participants With Breakthrough | 0.0 percentage of participants |
Secondary
Percentage of Participants With Failure to Suppress
Failure to suppress was defined as each measured on-treatment HCV RNA value ≥ 50 IU/mL.
Time frame: 12 weeks
Population: Core population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Paritaprevir/Ritonavir + Ombitasvir + Dasabuvir | Percentage of Participants With Failure to Suppress | 0.0 percentage of participants |
Secondary
Percentage of Participants With Missing SVR12 Data
Time frame: 12 weeks after the last dose of study drug (week 24)
Population: Core population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Paritaprevir/Ritonavir + Ombitasvir + Dasabuvir | Percentage of Participants With Missing SVR12 Data | 1.7 percentage of participants |
Secondary
Percentage of Participants With Relapse
Relapse was defined as participants with a virologic response (VR; HCV RNA \< 50 IU/mL) at end of treatment (EOT) followed by HCV RNA ≥ 50 IU/mL at any time after the end of treatment.
Time frame: End of treatment (week 12) and up to 12 weeks after the end of treatment.
Population: Core population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Paritaprevir/Ritonavir + Ombitasvir + Dasabuvir | Percentage of Participants With Relapse | 0.0 percentage of participants |