Chronic Hepatitis C
Conditions
Keywords
Chronic Hepatitis C, Dasabuvir, Paritaprevir/r/Ombitasvir, Observational Study, Quality of Life, Fibrosis, Cirrhosis, Work Ability
Brief summary
This study seeks to provide evidence of the effectiveness and obtain patient reported outcomes (PRO) and work productivity data of the interferon-free regimen of paritaprevir (PTV)/ritonavir (r) + ombitasvir (OBV), +/- dasabuvir (DSV), +/- ribavirin (RBV) in chronic hepatitis C virus infected patients.
Interventions
None listed
Sponsors
IST GmbH, Germany
AbbVie
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No
Inclusion criteria
* Treatment-naïve or -experienced adult male or female patients with confirmed CHC, genotype 1 or 4, receiving combination therapy with the interferon-free ABBVIE REGIMEN ± RBV according to standard of care and in line with the current local label. * If RBV is co-administered with the ABBVIE REGIMEN, 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 a patient authorization to use and/or disclose his/her anonymized health data prior to inclusion into the study. * Patient must not be participating or intending to participate in a concurrent interventional therapeutic trial
Exclusion criteria
-None
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 or 36 depending on the treatment regimen) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Relapse | End of treatment (week 12 or 24 depending on the treatment regimen) and up to 24 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 or 24 weeks (depending on the treatment regimen) | 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 a Rapid Virological Response at Week 4 | Week 4 | Rapid virological response at week 4 (RVR4) was defined as participants with HCV RNA \< 50 IU/mL at week 4. Due to the non-interventional character of the study, many participants did not have an HCV RNA assessed at treatment week 4 since this is not generally recommended in the label. Participants with missing data at the RVR4 time point were considered as virological failures. |
| Percentage of Participants Achieving Sustained Virological Response 24 Weeks Post-treatment (SVR24) | 24 weeks after the last dose of study drug (week 36 or 48 depending on the treatment regimen) | Sustained virologic response is defined as hepatitis C virus ribonucleic acid (HCV RNA) levels less than 50 IU/mL 24 weeks after the last dose of study drug. |
| Percentage of Participants in the Core Population With Sufficient Follow-up Data for SVR12 Who Achieved Sustained Virological Response 12 Weeks Post-treatment (SVR12) | 12 weeks after the last dose of study drug (week 24 or 36 depending on the treatment regimen) | 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 regarding SVR12 included all core population participants who * had evaluable HCV RNA data ≥ 70 days after the last actual dose of the ABBVIE regimen, * or a HCV RNA value ≥ 50 IU/mL at the last measurement post-baseline * or had 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 adverse event) or virologic failure. |
| Percentage of Participants in Each Non-response Category 12 Weeks Post-treatment | 12 weeks after the last dose of study drug (week 24 or 36 depending on the treatment regimen) | SVR12 non-response was categorized according to the following: * Relapse, defined as HCV RNA \< 50 IU/mL at EOT followed by HCV RNA ≥ 50 IU/mL post-treatment in patients who completed treatment (not more than 7 days shortened); * Death; * Premature treatment discontinuation with no on-treatment virological failure; * Missing SVR12 data and/or none of the above criteria. |
| Assigned Treatment Regimen | Baseline | Treatment regimen was assigned by the physician according to local practice and label. Participants could receive two direct-acting antiviral (DAA) drugs (paritaprevir/ritonavir and ombitasvir) plus ribavirin (RBV) for either 12 or 24 weeks, or three DAAs (paritaprevir/ritonavir, ombitasvir, and dasabuvir) with or without RBV for 12 or 24 weeks. |
| Percentage of the Direct Acting Antiviral (DAA) Dose Taken in Relation to the Target Dose of DAA | From first dose of study drug to end of treatment, 12 to 24 weeks depending on the treatment regimen | Adherence to study treatment was calculated as: Cumulative dose taken / (initial prescribed dose \* planned duration) |
| Percentage of the Ribavirin (RBV) Dose Taken in Relation to the Target Dose of RBV | From first dose of study drug to end of treatment, 12 to 24 weeks depending on the treatment regimen | Adherence to study treatment was calculated as: Cumulative dose taken / (initial prescribed dose \* planned duration) |
| Percentage of Participants Achieving Virological Response at End of Treatment | End of treatment (week 12 or 24 depending on the treatment regimen) | Virologic response is defined as hepatitis C virus ribonucleic acid (HCV RNA) levels less than 50 IU/mL. |
| Number of Participants Who Received Concomitant Medications | From first dose of study drug to end of treatment, 12 to 24 weeks depending on the treatment regimen | Concomitant medication other than for chromic hepatitis C used from the time when the decision was made to initiate treatment with the ABBVIE REGIMEN until after the last dose. |
| Number of Participants With Adverse Events, Serious Adverse Events, or Pregnancies | From first dose of study drug through 30 days after last dose. The median duration of treatment was 84 days. | — |
| Change From Baseline in EuroQol 5 Dimension 5 Level (EQ-5D-5L) Index Score | Baseline, end of treatment, and at 12 and 24 weeks after end of treatment | The EQ-5D-5L is a health state utility instrument that evaluates preference for health status. The 5 items in the EQ-5D-5L comprise 5 dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) each of which are rated on 5 levels of severity (1: indicating no problem, 2: indicating slight problems, 3: indicating moderate problems, 4: indicating severe problems, 5: indicating extreme problems), and a separate visual analog scale (VAS). Responses to the 5 dimension scores were combined and converted into a single preference-weighted health utility index score by applying country-specific weights.The range for EQ-5D-5L index score is 0 to 1 where '0' is defined as a health state equivalent to being dead and '1' is full health.The higher the score the better the health status. |
| Change From Baseline in EuroQol 5 Dimension 5 Level (EQ-5D-5L) VAS Score | Baseline, end of treatment, and at 12 and 24 weeks after end of treatment | The EQ-5D-5L is a health state utility instrument that evaluates preference for health status. with a separate visual analog scale (VAS). The VAS assesses overall health on a scale from 0 (worst health imaginable) to 100 (best health imaginable). |
| Change From Baseline in Work Productivity and Activity Impairment (WPAI): Absenteeism | Baseline, end of treatment, and at 12 and 24 weeks post treatment | The WPAI Hepatitis C V2.0 is an HCV specific questionnaire used to measure work absenteeism, work presenteeism, and daily activity impairment. Respondents were asked about time missed from work and time while at work during which productivity was impaired in the past seven days. Results of WPAI are expressed as a percentage of impairment from 0 to 100, with higher percentages indicating greater impairment and less productivity. Absenteeism indicates the percentage of work time missed due to health problems. |
| Change From Baseline in Work Productivity and Activity Impairment (WPAI): Presenteeism | Baseline, end of treatment, and at 12 and 24 weeks after end of treatment | The WPAI Hepatitis C V2.0 is an HCV specific questionnaire used to measure work absenteeism, work presenteeism, and daily activity impairment. Respondents were asked about time missed from work and time while at work during which productivity was impaired in the past seven days. Results of WPAI are expressed as a percentage of impairment from 0 to 100, with higher percentages indicating greater impairment and less productivity. Presenteeism indicates the percentage of impairment while working due to health problems. |
| Change From Baseline in Work Productivity and Activity Impairment (WPAI): Total Work Productivity Impairment (TWP) | Baseline, end of treatment, and at 12 and 24 weeks after end of treatment | The WPAI Hepatitis C V2.0 is an HCV specific questionnaire used to measure work absenteeism, work presenteeism, and daily activity impairment. Respondents were asked about time missed from work and time while at work during which productivity was impaired in the past seven days. Results of WPAI are expressed as a percentage of impairment from 0 to 100, with higher percentages indicating greater impairment and less productivity. Total work productivity impairment (TWP) indicates the percentage of overall work impairment due to health problems. |
| Change From Baseline in Work Productivity and Activity Impairment (WPAI): Total Activity Impairment | Baseline, end of treatment, and at 12 and 24 weeks after end of treatment | The WPAI Hepatitis C V2.0 is an HCV specific questionnaire used to measure work absenteeism, work presenteeism, and daily activity impairment. Respondents were asked about time missed from work and time while at work during which productivity was impaired in the past seven days. Results of WPAI are expressed as a percentage of impairment from 0 to 100, with higher percentages indicating greater impairment and less productivity. Total activity impairment (TAI) indicates the percentage of general (non-work) activity impairment due to health problems. |
| Number of Participants With Comorbidities | Baseline | — |
Participant flow
Recruitment details
In this prospective, multi-center observational study a total of 394 adult patients chronically infected with hepatitis C virus (HCV) were enrolled at 17 centers in Poland.
Pre-assignment details
Effectiveness analyses of clinical outcomes are reported by HCV genotype. Safety variables were analyzed by treatment regimen.
Participants by arm
| Arm | Count |
|---|---|
| Paritaprevir/Ritonavir + Ombitasvir ± Dasabuvir ± Ribavirin Participants in this observational study received treatment with paritaprevir/ritonavir (r) and ombitasvir with or without dasabuvir ± ribavirin (RBV) for 12 or 24 weeks for the treatment of chronic hepatitis C (CHC), according to hepatitis C virus (HCV) genotype/subtype and stage of liver disease.
The prescription of 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 patient the opportunity to participate in this study. | 394 |
| Total | 394 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Death | 6 |
| Overall Study | Failure to Return | 1 |
| Overall Study | Miscellaneous | 3 |
| Overall Study | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | Paritaprevir/Ritonavir + Ombitasvir ± Dasabuvir ± Ribavirin |
|---|---|
| Age, Continuous | 54 years STANDARD_DEVIATION 14.3 |
| Age, Customized 18 to 65 years | 316 Participants |
| Age, Customized 66 to 84 years | 78 Participants |
| Cirrhosis Status Cirrhosis | 125 Participants |
| Cirrhosis Status No cirrhosis | 211 Participants |
| Cirrhosis Status Transition to cirrhosis | 58 Participants |
| HCV Genotype Genotype 1a | 24 Participants |
| HCV Genotype Genotype 1a/1b | 1 Participants |
| HCV Genotype Genotype 1b | 349 Participants |
| HCV Genotype Genotype 4 | 20 Participants |
| Race/Ethnicity, Customized White | 394 Participants |
| Sex: Female, Male Female | 196 Participants |
| Sex: Female, Male Male | 198 Participants |
| Years Since Diagnosis of HCV Infection | 6.6 years STANDARD_DEVIATION 5.94 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 19 | 0 / 229 | 2 / 146 |
| other Total, other adverse events | 8 / 19 | 2 / 229 | 26 / 146 |
| serious Total, serious adverse events | 3 / 19 | 3 / 229 | 8 / 146 |
Outcome results
Primary
Percentage of Participants Achieving Sustained Virological Response 12 Weeks Post-treatment (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.
Time frame: 12 weeks after the last dose of study drug (week 24 or 36 depending on the treatment regimen)
Population: Enrolled participants who received adequate treatment with paritaprevir/ritonavir (r) and ombitasvir with or without dasabuvir (ABBVIE REGIMEN) ± ribavirin (RBV) according to standard of care and within local label recommendations for their specific disease characteristics.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Genotype 1 (Total) | Percentage of Participants Achieving Sustained Virological Response 12 Weeks Post-treatment (SVR12) | 96.8 percentage of participants |
| Genotype 1a | Percentage of Participants Achieving Sustained Virological Response 12 Weeks Post-treatment (SVR12) | 100.0 percentage of participants |
| Genotype 1b | Percentage of Participants Achieving Sustained Virological Response 12 Weeks Post-treatment (SVR12) | 96.6 percentage of participants |
| Genotype 4 | Percentage of Participants Achieving Sustained Virological Response 12 Weeks Post-treatment (SVR12) | 95.0 percentage of participants |
Secondary
Assigned Treatment Regimen
Treatment regimen was assigned by the physician according to local practice and label. Participants could receive two direct-acting antiviral (DAA) drugs (paritaprevir/ritonavir and ombitasvir) plus ribavirin (RBV) for either 12 or 24 weeks, or three DAAs (paritaprevir/ritonavir, ombitasvir, and dasabuvir) with or without RBV for 12 or 24 weeks.
Time frame: Baseline
Population: Enrolled participants who received adequate treatment with paritaprevir/ritonavir (r) and ombitasvir with or without dasabuvir (ABBVIE REGIMEN) ± ribavirin (RBV) according to standard of care and within local label recommendations for their specific disease characteristics.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Genotype 1 (Total) | Assigned Treatment Regimen | 3 DAA + RBV (12 weeks) | 141 Participants |
| Genotype 1 (Total) | Assigned Treatment Regimen | 3 DAA without RBV (12 weeks) | 229 Participants |
| Genotype 1 (Total) | Assigned Treatment Regimen | 3 DAA + RBV (24 weeks) | 4 Participants |
| Genotype 1 (Total) | Assigned Treatment Regimen | 2 DAA + RBV (24 weeks) | 0 Participants |
| Genotype 1 (Total) | Assigned Treatment Regimen | 2 DAA + RBV (12 weeks) | 0 Participants |
| Genotype 1a | Assigned Treatment Regimen | 2 DAA + RBV (24 weeks) | 0 Participants |
| Genotype 1a | Assigned Treatment Regimen | 3 DAA + RBV (12 weeks) | 22 Participants |
| Genotype 1a | Assigned Treatment Regimen | 3 DAA without RBV (12 weeks) | 0 Participants |
| Genotype 1a | Assigned Treatment Regimen | 2 DAA + RBV (12 weeks) | 0 Participants |
| Genotype 1a | Assigned Treatment Regimen | 3 DAA + RBV (24 weeks) | 3 Participants |
| Genotype 1b | Assigned Treatment Regimen | 3 DAA + RBV (12 weeks) | 119 Participants |
| Genotype 1b | Assigned Treatment Regimen | 2 DAA + RBV (12 weeks) | 0 Participants |
| Genotype 1b | Assigned Treatment Regimen | 2 DAA + RBV (24 weeks) | 0 Participants |
| Genotype 1b | Assigned Treatment Regimen | 3 DAA without RBV (12 weeks) | 229 Participants |
| Genotype 1b | Assigned Treatment Regimen | 3 DAA + RBV (24 weeks) | 1 Participants |
| Genotype 4 | Assigned Treatment Regimen | 2 DAA + RBV (24 weeks) | 11 Participants |
| Genotype 4 | Assigned Treatment Regimen | 2 DAA + RBV (12 weeks) | 8 Participants |
| Genotype 4 | Assigned Treatment Regimen | 3 DAA + RBV (12 weeks) | 1 Participants |
| Genotype 4 | Assigned Treatment Regimen | 3 DAA + RBV (24 weeks) | 0 Participants |
| Genotype 4 | Assigned Treatment Regimen | 3 DAA without RBV (12 weeks) | 0 Participants |
Secondary
Change From Baseline in EuroQol 5 Dimension 5 Level (EQ-5D-5L) Index Score
The EQ-5D-5L is a health state utility instrument that evaluates preference for health status. The 5 items in the EQ-5D-5L comprise 5 dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) each of which are rated on 5 levels of severity (1: indicating no problem, 2: indicating slight problems, 3: indicating moderate problems, 4: indicating severe problems, 5: indicating extreme problems), and a separate visual analog scale (VAS). Responses to the 5 dimension scores were combined and converted into a single preference-weighted health utility index score by applying country-specific weights.The range for EQ-5D-5L index score is 0 to 1 where '0' is defined as a health state equivalent to being dead and '1' is full health.The higher the score the better the health status.
Time frame: Baseline, end of treatment, and at 12 and 24 weeks after end of treatment
Population: Enrolled participants who received adequate treatment with paritaprevir/r and ombitasvir with or without dasabuvir (ABBVIE REGIMEN) ± ribavirin (RBV) according to standard of care and within local label recommendations for their specific disease characteristics. Participants with available data at baseline and each time point are included.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| Genotype 1 (Total) | Change From Baseline in EuroQol 5 Dimension 5 Level (EQ-5D-5L) Index Score | 24 weeks post treatment | 0.05 units on a scale |
| Genotype 1 (Total) | Change From Baseline in EuroQol 5 Dimension 5 Level (EQ-5D-5L) Index Score | End of treatment | 0.06 units on a scale |
| Genotype 1 (Total) | Change From Baseline in EuroQol 5 Dimension 5 Level (EQ-5D-5L) Index Score | 12 weeks post treatment | 0.07 units on a scale |
| Genotype 1a | Change From Baseline in EuroQol 5 Dimension 5 Level (EQ-5D-5L) Index Score | End of treatment | 0.04 units on a scale |
| Genotype 1a | Change From Baseline in EuroQol 5 Dimension 5 Level (EQ-5D-5L) Index Score | 12 weeks post treatment | 0.05 units on a scale |
| Genotype 1a | Change From Baseline in EuroQol 5 Dimension 5 Level (EQ-5D-5L) Index Score | 24 weeks post treatment | 0.07 units on a scale |
| Genotype 1b | Change From Baseline in EuroQol 5 Dimension 5 Level (EQ-5D-5L) Index Score | 24 weeks post treatment | 0.04 units on a scale |
| Genotype 1b | Change From Baseline in EuroQol 5 Dimension 5 Level (EQ-5D-5L) Index Score | 12 weeks post treatment | 0.04 units on a scale |
| Genotype 1b | Change From Baseline in EuroQol 5 Dimension 5 Level (EQ-5D-5L) Index Score | End of treatment | 0.04 units on a scale |
Secondary
Change From Baseline in EuroQol 5 Dimension 5 Level (EQ-5D-5L) VAS Score
The EQ-5D-5L is a health state utility instrument that evaluates preference for health status. with a separate visual analog scale (VAS). The VAS assesses overall health on a scale from 0 (worst health imaginable) to 100 (best health imaginable).
Time frame: Baseline, end of treatment, and at 12 and 24 weeks after end of treatment
Population: Enrolled participants who received adequate treatment with paritaprevir/r and ombitasvir with or without dasabuvir (ABBVIE REGIMEN) ± RBV according to standard of care and within local label recommendations for their specific disease characteristics. Participants with available data at baseline and each time point are included.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| Genotype 1 (Total) | Change From Baseline in EuroQol 5 Dimension 5 Level (EQ-5D-5L) VAS Score | 12 weeks post treatment | 7.93 units on a scale |
| Genotype 1 (Total) | Change From Baseline in EuroQol 5 Dimension 5 Level (EQ-5D-5L) VAS Score | End of treatment | 4.10 units on a scale |
| Genotype 1 (Total) | Change From Baseline in EuroQol 5 Dimension 5 Level (EQ-5D-5L) VAS Score | 24 weeks post treatment | 6.54 units on a scale |
| Genotype 1a | Change From Baseline in EuroQol 5 Dimension 5 Level (EQ-5D-5L) VAS Score | 12 weeks post treatment | 9.11 units on a scale |
| Genotype 1a | Change From Baseline in EuroQol 5 Dimension 5 Level (EQ-5D-5L) VAS Score | End of treatment | 7.41 units on a scale |
| Genotype 1a | Change From Baseline in EuroQol 5 Dimension 5 Level (EQ-5D-5L) VAS Score | 24 weeks post treatment | 11.8 units on a scale |
| Genotype 1b | Change From Baseline in EuroQol 5 Dimension 5 Level (EQ-5D-5L) VAS Score | End of treatment | 5.13 units on a scale |
| Genotype 1b | Change From Baseline in EuroQol 5 Dimension 5 Level (EQ-5D-5L) VAS Score | 24 weeks post treatment | 9.20 units on a scale |
| Genotype 1b | Change From Baseline in EuroQol 5 Dimension 5 Level (EQ-5D-5L) VAS Score | 12 weeks post treatment | 7.01 units on a scale |
Secondary
Change From Baseline in Work Productivity and Activity Impairment (WPAI): Absenteeism
The WPAI Hepatitis C V2.0 is an HCV specific questionnaire used to measure work absenteeism, work presenteeism, and daily activity impairment. Respondents were asked about time missed from work and time while at work during which productivity was impaired in the past seven days. Results of WPAI are expressed as a percentage of impairment from 0 to 100, with higher percentages indicating greater impairment and less productivity. Absenteeism indicates the percentage of work time missed due to health problems.
Time frame: Baseline, end of treatment, and at 12 and 24 weeks post treatment
Population: Enrolled participants who received adequate treatment with paritaprevir/r and ombitasvir with or without dasabuvir (ABBVIE REGIMEN) ± RBV according to standard of care and within local label recommendations for their specific disease characteristics. Participants who were employed with available data at baseline and each time point are included.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Genotype 1 (Total) | Change From Baseline in Work Productivity and Activity Impairment (WPAI): Absenteeism | 24 weeks post treatment | 0.0 percent impairment |
| Genotype 1 (Total) | Change From Baseline in Work Productivity and Activity Impairment (WPAI): Absenteeism | 12 weeks post treatment | 0.0 percent impairment |
| Genotype 1 (Total) | Change From Baseline in Work Productivity and Activity Impairment (WPAI): Absenteeism | End of treatment | 0.0 percent impairment |
| Genotype 1a | Change From Baseline in Work Productivity and Activity Impairment (WPAI): Absenteeism | 24 weeks post treatment | 0.0 percent impairment |
| Genotype 1a | Change From Baseline in Work Productivity and Activity Impairment (WPAI): Absenteeism | 12 weeks post treatment | 0.0 percent impairment |
| Genotype 1a | Change From Baseline in Work Productivity and Activity Impairment (WPAI): Absenteeism | End of treatment | 0.0 percent impairment |
| Genotype 1b | Change From Baseline in Work Productivity and Activity Impairment (WPAI): Absenteeism | 24 weeks post treatment | 0.0 percent impairment |
| Genotype 1b | Change From Baseline in Work Productivity and Activity Impairment (WPAI): Absenteeism | End of treatment | 0.0 percent impairment |
| Genotype 1b | Change From Baseline in Work Productivity and Activity Impairment (WPAI): Absenteeism | 12 weeks post treatment | 0.0 percent impairment |
Secondary
Change From Baseline in Work Productivity and Activity Impairment (WPAI): Presenteeism
The WPAI Hepatitis C V2.0 is an HCV specific questionnaire used to measure work absenteeism, work presenteeism, and daily activity impairment. Respondents were asked about time missed from work and time while at work during which productivity was impaired in the past seven days. Results of WPAI are expressed as a percentage of impairment from 0 to 100, with higher percentages indicating greater impairment and less productivity. Presenteeism indicates the percentage of impairment while working due to health problems.
Time frame: Baseline, end of treatment, and at 12 and 24 weeks after end of treatment
Population: Enrolled participants who received adequate treatment with paritaprevir/r and ombitasvir with or without dasabuvir (ABBVIE REGIMEN) ± RBV according to standard of care and within local label recommendations for their specific disease characteristics. Participants who were employed with available data at baseline and each time point are included.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Genotype 1 (Total) | Change From Baseline in Work Productivity and Activity Impairment (WPAI): Presenteeism | End of treatment | -5.0 percent impairment |
| Genotype 1 (Total) | Change From Baseline in Work Productivity and Activity Impairment (WPAI): Presenteeism | 24 weeks post treatment | -10.0 percent impairment |
| Genotype 1 (Total) | Change From Baseline in Work Productivity and Activity Impairment (WPAI): Presenteeism | 12 weeks post treatment | -5.0 percent impairment |
| Genotype 1a | Change From Baseline in Work Productivity and Activity Impairment (WPAI): Presenteeism | End of treatment | 0.0 percent impairment |
| Genotype 1a | Change From Baseline in Work Productivity and Activity Impairment (WPAI): Presenteeism | 24 weeks post treatment | -10.0 percent impairment |
| Genotype 1a | Change From Baseline in Work Productivity and Activity Impairment (WPAI): Presenteeism | 12 weeks post treatment | 0.0 percent impairment |
| Genotype 1b | Change From Baseline in Work Productivity and Activity Impairment (WPAI): Presenteeism | 24 weeks post treatment | 0.0 percent impairment |
| Genotype 1b | Change From Baseline in Work Productivity and Activity Impairment (WPAI): Presenteeism | 12 weeks post treatment | 0.0 percent impairment |
| Genotype 1b | Change From Baseline in Work Productivity and Activity Impairment (WPAI): Presenteeism | End of treatment | 0.0 percent impairment |
Secondary
Change From Baseline in Work Productivity and Activity Impairment (WPAI): Total Activity Impairment
The WPAI Hepatitis C V2.0 is an HCV specific questionnaire used to measure work absenteeism, work presenteeism, and daily activity impairment. Respondents were asked about time missed from work and time while at work during which productivity was impaired in the past seven days. Results of WPAI are expressed as a percentage of impairment from 0 to 100, with higher percentages indicating greater impairment and less productivity. Total activity impairment (TAI) indicates the percentage of general (non-work) activity impairment due to health problems.
Time frame: Baseline, end of treatment, and at 12 and 24 weeks after end of treatment
Population: Enrolled participants who received adequate treatment with paritaprevir/r and ombitasvir with or without dasabuvir (ABBVIE REGIMEN) ± RBV according to standard of care and within local label recommendations for their specific disease characteristics. Participants with available data at baseline and each time point are included.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Genotype 1 (Total) | Change From Baseline in Work Productivity and Activity Impairment (WPAI): Total Activity Impairment | 12 weeks post treatment | 0.0 percent impairment |
| Genotype 1 (Total) | Change From Baseline in Work Productivity and Activity Impairment (WPAI): Total Activity Impairment | End of treatment | 0.0 percent impairment |
| Genotype 1 (Total) | Change From Baseline in Work Productivity and Activity Impairment (WPAI): Total Activity Impairment | 24 weeks post treatment | -5.0 percent impairment |
| Genotype 1a | Change From Baseline in Work Productivity and Activity Impairment (WPAI): Total Activity Impairment | 12 weeks post treatment | 0.0 percent impairment |
| Genotype 1a | Change From Baseline in Work Productivity and Activity Impairment (WPAI): Total Activity Impairment | End of treatment | 0.0 percent impairment |
| Genotype 1a | Change From Baseline in Work Productivity and Activity Impairment (WPAI): Total Activity Impairment | 24 weeks post treatment | -10.0 percent impairment |
| Genotype 1b | Change From Baseline in Work Productivity and Activity Impairment (WPAI): Total Activity Impairment | End of treatment | 0.0 percent impairment |
| Genotype 1b | Change From Baseline in Work Productivity and Activity Impairment (WPAI): Total Activity Impairment | 24 weeks post treatment | 0.0 percent impairment |
| Genotype 1b | Change From Baseline in Work Productivity and Activity Impairment (WPAI): Total Activity Impairment | 12 weeks post treatment | 0.0 percent impairment |
Secondary
Change From Baseline in Work Productivity and Activity Impairment (WPAI): Total Work Productivity Impairment (TWP)
The WPAI Hepatitis C V2.0 is an HCV specific questionnaire used to measure work absenteeism, work presenteeism, and daily activity impairment. Respondents were asked about time missed from work and time while at work during which productivity was impaired in the past seven days. Results of WPAI are expressed as a percentage of impairment from 0 to 100, with higher percentages indicating greater impairment and less productivity. Total work productivity impairment (TWP) indicates the percentage of overall work impairment due to health problems.
Time frame: Baseline, end of treatment, and at 12 and 24 weeks after end of treatment
Population: Enrolled participants who received adequate treatment with paritaprevir/r and ombitasvir with or without dasabuvir (ABBVIE REGIMEN) ± RBV according to standard of care and within local label recommendations for their specific disease characteristics. Participants who were employed with available data at baseline and each time point are included.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Genotype 1 (Total) | Change From Baseline in Work Productivity and Activity Impairment (WPAI): Total Work Productivity Impairment (TWP) | 12 weeks post treatment | -5.0 percent impairment |
| Genotype 1 (Total) | Change From Baseline in Work Productivity and Activity Impairment (WPAI): Total Work Productivity Impairment (TWP) | 24 weeks post treatment | -10.0 percent impairment |
| Genotype 1 (Total) | Change From Baseline in Work Productivity and Activity Impairment (WPAI): Total Work Productivity Impairment (TWP) | End of treatment | -5.0 percent impairment |
| Genotype 1a | Change From Baseline in Work Productivity and Activity Impairment (WPAI): Total Work Productivity Impairment (TWP) | 12 weeks post treatment | 0.0 percent impairment |
| Genotype 1a | Change From Baseline in Work Productivity and Activity Impairment (WPAI): Total Work Productivity Impairment (TWP) | End of treatment | 0.0 percent impairment |
| Genotype 1a | Change From Baseline in Work Productivity and Activity Impairment (WPAI): Total Work Productivity Impairment (TWP) | 24 weeks post treatment | -10.0 percent impairment |
| Genotype 1b | Change From Baseline in Work Productivity and Activity Impairment (WPAI): Total Work Productivity Impairment (TWP) | End of treatment | 0.0 percent impairment |
| Genotype 1b | Change From Baseline in Work Productivity and Activity Impairment (WPAI): Total Work Productivity Impairment (TWP) | 24 weeks post treatment | 0.0 percent impairment |
| Genotype 1b | Change From Baseline in Work Productivity and Activity Impairment (WPAI): Total Work Productivity Impairment (TWP) | 12 weeks post treatment | 0.0 percent impairment |
Secondary
Number of Participants Who Received Concomitant Medications
Concomitant medication other than for chromic hepatitis C used from the time when the decision was made to initiate treatment with the ABBVIE REGIMEN until after the last dose.
Time frame: From first dose of study drug to end of treatment, 12 to 24 weeks depending on the treatment regimen
Population: All enrolled participants who received at least one dose of the ABBVIE REGIMEN.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Genotype 1 (Total) | Number of Participants Who Received Concomitant Medications | 10 Participants |
| Genotype 1a | Number of Participants Who Received Concomitant Medications | 103 Participants |
| Genotype 1b | Number of Participants Who Received Concomitant Medications | 64 Participants |
Secondary
Number of Participants With Adverse Events, Serious Adverse Events, or Pregnancies
Time frame: From first dose of study drug through 30 days after last dose. The median duration of treatment was 84 days.
Population: All enrolled participants who received at least one dose of the ABBVIE REGIMEN.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Genotype 1 (Total) | Number of Participants With Adverse Events, Serious Adverse Events, or Pregnancies | Serious adverse events | 3 Participants |
| Genotype 1 (Total) | Number of Participants With Adverse Events, Serious Adverse Events, or Pregnancies | Any adverse event | 8 Participants |
| Genotype 1 (Total) | Number of Participants With Adverse Events, Serious Adverse Events, or Pregnancies | Pregnancies | 0 Participants |
| Genotype 1a | Number of Participants With Adverse Events, Serious Adverse Events, or Pregnancies | Serious adverse events | 3 Participants |
| Genotype 1a | Number of Participants With Adverse Events, Serious Adverse Events, or Pregnancies | Any adverse event | 19 Participants |
| Genotype 1a | Number of Participants With Adverse Events, Serious Adverse Events, or Pregnancies | Pregnancies | 0 Participants |
| Genotype 1b | Number of Participants With Adverse Events, Serious Adverse Events, or Pregnancies | Any adverse event | 42 Participants |
| Genotype 1b | Number of Participants With Adverse Events, Serious Adverse Events, or Pregnancies | Pregnancies | 0 Participants |
| Genotype 1b | Number of Participants With Adverse Events, Serious Adverse Events, or Pregnancies | Serious adverse events | 8 Participants |
Secondary
Number of Participants With Comorbidities
Time frame: Baseline
Population: Enrolled participants who received adequate treatment with paritaprevir/ritonavir (r) and ombitasvir with or without dasabuvir (ABBVIE REGIMEN) ± ribavirin (RBV) according to standard of care and within local label recommendations for their specific disease characteristics.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Genotype 1 (Total) | Number of Participants With Comorbidities | Any coinfection | 15 Participants |
| Genotype 1 (Total) | Number of Participants With Comorbidities | Any comorbidity or coinfection | 224 Participants |
| Genotype 1 (Total) | Number of Participants With Comorbidities | Coinfection with hepatitis B virus | 8 Participants |
| Genotype 1 (Total) | Number of Participants With Comorbidities | Coinfection with human immunodeficiency virus (HIV | 8 Participants |
| Genotype 1a | Number of Participants With Comorbidities | Coinfection with human immunodeficiency virus (HIV | 2 Participants |
| Genotype 1a | Number of Participants With Comorbidities | Any comorbidity or coinfection | 10 Participants |
| Genotype 1a | Number of Participants With Comorbidities | Any coinfection | 2 Participants |
| Genotype 1a | Number of Participants With Comorbidities | Coinfection with hepatitis B virus | 0 Participants |
| Genotype 1b | Number of Participants With Comorbidities | Coinfection with human immunodeficiency virus (HIV | 6 Participants |
| Genotype 1b | Number of Participants With Comorbidities | Any coinfection | 13 Participants |
| Genotype 1b | Number of Participants With Comorbidities | Any comorbidity or coinfection | 214 Participants |
| Genotype 1b | Number of Participants With Comorbidities | Coinfection with hepatitis B virus | 8 Participants |
| Genotype 4 | Number of Participants With Comorbidities | Any coinfection | 4 Participants |
| Genotype 4 | Number of Participants With Comorbidities | Coinfection with human immunodeficiency virus (HIV | 4 Participants |
| Genotype 4 | Number of Participants With Comorbidities | Coinfection with hepatitis B virus | 0 Participants |
| Genotype 4 | Number of Participants With Comorbidities | Any comorbidity or coinfection | 16 Participants |
Secondary
Percentage of Participants Achieving Sustained Virological Response 24 Weeks Post-treatment (SVR24)
Sustained virologic response is defined as hepatitis C virus ribonucleic acid (HCV RNA) levels less than 50 IU/mL 24 weeks after the last dose of study drug.
Time frame: 24 weeks after the last dose of study drug (week 36 or 48 depending on the treatment regimen)
Population: Enrolled participants who received adequate treatment with paritaprevir/ritonavir (r) and ombitasvir with or without dasabuvir (ABBVIE REGIMEN) ± ribavirin (RBV) according to standard of care and within local label recommendations for their specific disease characteristics.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Genotype 1 (Total) | Percentage of Participants Achieving Sustained Virological Response 24 Weeks Post-treatment (SVR24) | 96.3 percentage of participants |
| Genotype 1a | Percentage of Participants Achieving Sustained Virological Response 24 Weeks Post-treatment (SVR24) | 100.0 percentage of participants |
| Genotype 1b | Percentage of Participants Achieving Sustained Virological Response 24 Weeks Post-treatment (SVR24) | 96.0 percentage of participants |
| Genotype 4 | Percentage of Participants Achieving Sustained Virological Response 24 Weeks Post-treatment (SVR24) | 95.0 percentage of participants |
Secondary
Percentage of Participants Achieving Virological Response at End of Treatment
Virologic response is defined as hepatitis C virus ribonucleic acid (HCV RNA) levels less than 50 IU/mL.
Time frame: End of treatment (week 12 or 24 depending on the treatment regimen)
Population: Enrolled participants who received adequate treatment with paritaprevir/r and ombitasvir with or without dasabuvir (ABBVIE REGIMEN) ± ribavirin according to standard of care and within local label recommendations for their specific disease characteristics.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Genotype 1 (Total) | Percentage of Participants Achieving Virological Response at End of Treatment | 95.5 percentage of participants |
| Genotype 1a | Percentage of Participants Achieving Virological Response at End of Treatment | 100.0 percentage of participants |
| Genotype 1b | Percentage of Participants Achieving Virological Response at End of Treatment | 95.1 percentage of participants |
| Genotype 4 | Percentage of Participants Achieving Virological Response at End of Treatment | 100.0 percentage of participants |
Secondary
Percentage of Participants in Each Non-response Category 12 Weeks Post-treatment
SVR12 non-response was categorized according to the following: * Relapse, defined as HCV RNA \< 50 IU/mL at EOT followed by HCV RNA ≥ 50 IU/mL post-treatment in patients who completed treatment (not more than 7 days shortened); * Death; * Premature treatment discontinuation with no on-treatment virological failure; * Missing SVR12 data and/or none of the above criteria.
Time frame: 12 weeks after the last dose of study drug (week 24 or 36 depending on the treatment regimen)
Population: Enrolled participants who received adequate treatment with paritaprevir/ritonavir (r) and ombitasvir with or without dasabuvir (ABBVIE REGIMEN) ± ribavirin (RBV) according to standard of care and within local label recommendations for their specific disease characteristics.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Genotype 1 (Total) | Percentage of Participants in Each Non-response Category 12 Weeks Post-treatment | Relapse | 0.5 percentage of participants |
| Genotype 1 (Total) | Percentage of Participants in Each Non-response Category 12 Weeks Post-treatment | Death | 1.6 percentage of participants |
| Genotype 1 (Total) | Percentage of Participants in Each Non-response Category 12 Weeks Post-treatment | Premature treatment discontinuation | 0.3 percentage of participants |
| Genotype 1 (Total) | Percentage of Participants in Each Non-response Category 12 Weeks Post-treatment | Missing SVR12 data/None of the above | 0.8 percentage of participants |
| Genotype 1a | Percentage of Participants in Each Non-response Category 12 Weeks Post-treatment | Relapse | 0.0 percentage of participants |
| Genotype 1a | Percentage of Participants in Each Non-response Category 12 Weeks Post-treatment | Premature treatment discontinuation | 0.0 percentage of participants |
| Genotype 1a | Percentage of Participants in Each Non-response Category 12 Weeks Post-treatment | Death | 0.0 percentage of participants |
| Genotype 1a | Percentage of Participants in Each Non-response Category 12 Weeks Post-treatment | Missing SVR12 data/None of the above | 0.0 percentage of participants |
| Genotype 1b | Percentage of Participants in Each Non-response Category 12 Weeks Post-treatment | Missing SVR12 data/None of the above | 0.9 percentage of participants |
| Genotype 1b | Percentage of Participants in Each Non-response Category 12 Weeks Post-treatment | Relapse | 0.6 percentage of participants |
| Genotype 1b | Percentage of Participants in Each Non-response Category 12 Weeks Post-treatment | Premature treatment discontinuation | 0.3 percentage of participants |
| Genotype 1b | Percentage of Participants in Each Non-response Category 12 Weeks Post-treatment | Death | 1.7 percentage of participants |
| Genotype 4 | Percentage of Participants in Each Non-response Category 12 Weeks Post-treatment | Relapse | 0.0 percentage of participants |
| Genotype 4 | Percentage of Participants in Each Non-response Category 12 Weeks Post-treatment | Death | 0.0 percentage of participants |
| Genotype 4 | Percentage of Participants in Each Non-response Category 12 Weeks Post-treatment | Premature treatment discontinuation | 5.0 percentage of participants |
| Genotype 4 | Percentage of Participants in Each Non-response Category 12 Weeks Post-treatment | Missing SVR12 data/None of the above | 0.0 percentage of participants |
Secondary
Percentage of Participants in the Core Population With Sufficient Follow-up Data for SVR12 Who Achieved Sustained Virological Response 12 Weeks Post-treatment (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 regarding SVR12 included all core population participants who * had evaluable HCV RNA data ≥ 70 days after the last actual dose of the ABBVIE regimen, * or a HCV RNA value ≥ 50 IU/mL at the last measurement post-baseline * or had 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 adverse event) or virologic failure.
Time frame: 12 weeks after the last dose of study drug (week 24 or 36 depending on the treatment regimen)
Population: The core population with sufficient follow-up data regarding SVR12
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Genotype 1 (Total) | Percentage of Participants in the Core Population With Sufficient Follow-up Data for SVR12 Who Achieved Sustained Virological Response 12 Weeks Post-treatment (SVR12) | 97.6 percentage of participants |
| Genotype 1a | Percentage of Participants in the Core Population With Sufficient Follow-up Data for SVR12 Who Achieved Sustained Virological Response 12 Weeks Post-treatment (SVR12) | 100.0 percentage of participants |
| Genotype 1b | Percentage of Participants in the Core Population With Sufficient Follow-up Data for SVR12 Who Achieved Sustained Virological Response 12 Weeks Post-treatment (SVR12) | 97.4 percentage of participants |
| Genotype 4 | Percentage of Participants in the Core Population With Sufficient Follow-up Data for SVR12 Who Achieved Sustained Virological Response 12 Weeks Post-treatment (SVR12) | 95.0 percentage of participants |
Secondary
Percentage of Participants With a Rapid Virological Response at Week 4
Rapid virological response at week 4 (RVR4) was defined as participants with HCV RNA \< 50 IU/mL at week 4. Due to the non-interventional character of the study, many participants did not have an HCV RNA assessed at treatment week 4 since this is not generally recommended in the label. Participants with missing data at the RVR4 time point were considered as virological failures.
Time frame: Week 4
Population: Enrolled participants who received adequate treatment with paritaprevir/ritonavir (r) and ombitasvir with or without dasabuvir (ABBVIE REGIMEN) ± ribavirin (RBV) according to standard of care and within local label recommendations for their specific disease characteristics.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Genotype 1 (Total) | Percentage of Participants With a Rapid Virological Response at Week 4 | 3.7 percentage of participants |
| Genotype 1a | Percentage of Participants With a Rapid Virological Response at Week 4 | 0.0 percentage of participants |
| Genotype 1b | Percentage of Participants With a Rapid Virological Response at Week 4 | 4.0 percentage of participants |
| Genotype 4 | Percentage of Participants With a Rapid Virological Response at Week 4 | 5.0 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 or 24 weeks (depending on the treatment regimen)
Population: Participants who received adequate treatment with the ABBVIE REGIMEN ± RBV according to standard of care and within local label recommendations for their specific disease characteristics, who had at least one undetectable HCV RNA measurement on-treatment and at least one measurement on-treatment thereafter
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Genotype 1 (Total) | Percentage of Participants With Breakthrough | 0.0 percentage of participants |
| Genotype 1a | Percentage of Participants With Breakthrough | 0.0 percentage of participants |
| Genotype 1b | Percentage of Participants With Breakthrough | 0.0 percentage of participants |
| Genotype 4 | Percentage of Participants With Breakthrough | 0.0 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 or 24 depending on the treatment regimen) and up to 24 weeks after the end of treatment.
Population: Participants who received adequate treatment with the ABBVIE REGIMEN ± RBV according to standard of care and within local label recommendations for their specific disease characteristics, and with VR at actual EOT and who completed treatment, and had ≥ 1 HCV RNA measurement ≥ 70 days post-treatment or were a treatment failure between EOT and day 70
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Genotype 1 (Total) | Percentage of Participants With Relapse | 0.6 percentage of participants |
| Genotype 1a | Percentage of Participants With Relapse | 0.0 percentage of participants |
| Genotype 1b | Percentage of Participants With Relapse | 0.6 percentage of participants |
| Genotype 4 | Percentage of Participants With Relapse | 0.0 percentage of participants |
Secondary
Percentage of the Direct Acting Antiviral (DAA) Dose Taken in Relation to the Target Dose of DAA
Adherence to study treatment was calculated as: Cumulative dose taken / (initial prescribed dose \* planned duration)
Time frame: From first dose of study drug to end of treatment, 12 to 24 weeks depending on the treatment regimen
Population: All enrolled participants who received at least one dose of the ABBVIE REGIMEN.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Genotype 1 (Total) | Percentage of the Direct Acting Antiviral (DAA) Dose Taken in Relation to the Target Dose of DAA | > 95% | 18 Participants |
| Genotype 1 (Total) | Percentage of the Direct Acting Antiviral (DAA) Dose Taken in Relation to the Target Dose of DAA | > 80 % to ≤ 95% | 0 Participants |
| Genotype 1 (Total) | Percentage of the Direct Acting Antiviral (DAA) Dose Taken in Relation to the Target Dose of DAA | > 50% to ≤ 80% | 0 Participants |
| Genotype 1 (Total) | Percentage of the Direct Acting Antiviral (DAA) Dose Taken in Relation to the Target Dose of DAA | ≤ 50% | 1 Participants |
| Genotype 1a | Percentage of the Direct Acting Antiviral (DAA) Dose Taken in Relation to the Target Dose of DAA | ≤ 50% | 1 Participants |
| Genotype 1a | Percentage of the Direct Acting Antiviral (DAA) Dose Taken in Relation to the Target Dose of DAA | > 95% | 227 Participants |
| Genotype 1a | Percentage of the Direct Acting Antiviral (DAA) Dose Taken in Relation to the Target Dose of DAA | > 50% to ≤ 80% | 1 Participants |
| Genotype 1a | Percentage of the Direct Acting Antiviral (DAA) Dose Taken in Relation to the Target Dose of DAA | > 80 % to ≤ 95% | 0 Participants |
| Genotype 1b | Percentage of the Direct Acting Antiviral (DAA) Dose Taken in Relation to the Target Dose of DAA | ≤ 50% | 2 Participants |
| Genotype 1b | Percentage of the Direct Acting Antiviral (DAA) Dose Taken in Relation to the Target Dose of DAA | > 80 % to ≤ 95% | 1 Participants |
| Genotype 1b | Percentage of the Direct Acting Antiviral (DAA) Dose Taken in Relation to the Target Dose of DAA | > 50% to ≤ 80% | 2 Participants |
| Genotype 1b | Percentage of the Direct Acting Antiviral (DAA) Dose Taken in Relation to the Target Dose of DAA | > 95% | 141 Participants |
Secondary
Percentage of the Ribavirin (RBV) Dose Taken in Relation to the Target Dose of RBV
Adherence to study treatment was calculated as: Cumulative dose taken / (initial prescribed dose \* planned duration)
Time frame: From first dose of study drug to end of treatment, 12 to 24 weeks depending on the treatment regimen
Population: All enrolled participants who received at least one dose of the ABBVIE REGIMEN that included ribavirin
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Genotype 1 (Total) | Percentage of the Ribavirin (RBV) Dose Taken in Relation to the Target Dose of RBV | > 95% | 14 Participants |
| Genotype 1 (Total) | Percentage of the Ribavirin (RBV) Dose Taken in Relation to the Target Dose of RBV | > 80% to ≤ 95% | 1 Participants |
| Genotype 1 (Total) | Percentage of the Ribavirin (RBV) Dose Taken in Relation to the Target Dose of RBV | > 50% to ≤ 80% | 0 Participants |
| Genotype 1 (Total) | Percentage of the Ribavirin (RBV) Dose Taken in Relation to the Target Dose of RBV | ≤ 50% | 4 Participants |
| Genotype 1b | Percentage of the Ribavirin (RBV) Dose Taken in Relation to the Target Dose of RBV | ≤ 50% | 14 Participants |
| Genotype 1b | Percentage of the Ribavirin (RBV) Dose Taken in Relation to the Target Dose of RBV | > 95% | 105 Participants |
| Genotype 1b | Percentage of the Ribavirin (RBV) Dose Taken in Relation to the Target Dose of RBV | > 50% to ≤ 80% | 19 Participants |
| Genotype 1b | Percentage of the Ribavirin (RBV) Dose Taken in Relation to the Target Dose of RBV | > 80% to ≤ 95% | 8 Participants |