Chronic Hepatitis C
Conditions
Keywords
HCV, Chronic Hepatitis C
Brief summary
This study seeks to determine the effectiveness of the interferon-free ABBVIE REGIMEN ± ribavirin (RBV) in participants with chronic hepatitis C (CHC) virus in clinical practices across France.
Interventions
None listed
Sponsors
AbbVie
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Treatment-naïve or -experienced participants with confirmed CHC, genotype 1 or 4 * Participants receiving or who will receive the interferon-free ABBVIE REGIMEN ± RBV according to product label * RBV prescribed in line with the current local label
Exclusion criteria
* Participant is not 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 dose of study drug (week 20, 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. Participants with missing HCV RNA were counted as virological failure. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Sufficient Follow-up Who Achieved Sustained Virological Response 12 Weeks Post-treatment | 12 weeks after the last dose of study drug (week 20, 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 With Relapse | End of treatment (week 8, 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 | 8, 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 Rapid Virological Response at Week 4 (RVR4) | Week 4 | RVR 4 was defined as participants with HCV RNA \< 50 IU/mL at week 4. |
| Percentage of Participants With Sufficient Follow-up Who Achieved Sustained Virological Response 24 Weeks Post-treatment (SVR24) | 24 weeks after the last dose of study drug (week 32, 36, or 48 depending on the treatment regimen) | Sustained virologic response was defined as hepatitis C virus ribonucleic acid (HCV RNA) levels less than 50 IU/mL 24 weeks after the last dose of study drug. The Core population with sufficient follow-up data regarding SVR24 included all core population participants who * had evaluable HCV RNA data ≥ 126 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 ≥ 126 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. |
| Number of Participants in Each Non-response Category 12 Weeks Post-treatment | 12 weeks after the last dose of study drug (week 20, 24, or 36 depending on the treatment regimen) | SVR12 non-response was categorized according to the following: * On-treatment virologic failure (breakthrough \[at least one documented HCV RNA \< 50 IU/mL followed by HCV RNA ≥ 50 IU/mL during treatment\] or failure to suppress \[each measured on-treatment HCV RNA value ≥ 50 IU/mL\]); * 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 virologic failure; * Insufficient virological response reported or HCV RNA ≥ 50 IU/mL post-EOT and none of the above criteria * Missing SVR12 data and/or none of the above criteria. |
| Percentage of Participants With Adherence to the ABBVIE Regimen, by Adherence Category | From first dose of study drug to end of treatment, 8 to 24 weeks depending on the treatment regimen. | Adherence to the ABBVIE treatment regimen is expressed as a percentage of the target dose and was calculated as: Cumulative dose taken / (initial prescribed dose \* planned duration) \* 100 The ABBVIE regimen consists of paritaprevir/r and ombitasvir with or without dasabuvir. |
| Percentage of Participants With Adherence to Ribavirin by Adherence Category | From first dose of study drug to end of treatment, 8 to 24 weeks depending on the treatment regimen. | Adherence to ribavirin is expressed as a percentage of the target dose, and was calculated as: Cumulative dose taken / (initial prescribed dose \* planned duration) \* 100 |
| Percentage of Ribavirin Treatment Days in Relation to the Target Number of Ribavirin Treatment Days | From first dose of study drug to end of treatment, 8 to 24 weeks depending on the treatment regimen. | — |
| Number of Participants Who Received Concomitant Medications | From first dose of study drug to end of treatment, 8 to 24 weeks depending on the treatment regimen | Concomitant medication other than for chronic hepatitis C used from the time when the decision was made to initiate treatment with paritaprevir/ritonavir and ombitasvir with or without dasabuvir 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 (12 to 28 weeks depending on treatment regimen). The median (minimum, maximum) duration of treatment was 84 (4, 167) days. | — |
| Percentage of Participants Achieving Virological Response at End of Treatment | End of treatment (week 8, 12, or 24 depending on the treatment regimen) | Virologic response was defined as hepatitis C virus ribonucleic acid (HCV RNA) levels less than 50 IU/mL. |
| Change From Baseline in EuroQol 5 Dimension 5 Level (EQ-5D-5L) Index Score | Baseline, end of treatment (week 8, 12, or 24 depending on the treatment regimen), 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 (week 8, 12, or 24 depending on the treatment regimen), 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 (week 8, 12, or 24 depending on the treatment regimen), 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. 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 (week 8, 12, or 24 depending on the treatment regimen), 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 (week 8, 12, or 24 depending on the treatment regimen), 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 (week 8, 12, or 24 depending on the treatment regimen), 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. |
| Change From Baseline in Beliefs Medication Questionnaire - (18-item BMQ) | Baseline and end of treatment (week 8, 12, or 24 depending on the treatment regimen) | The BMQ consists of 2 sections and 18 questions to screen for patients' beliefs, attitudes and concerns about their medication. The BMQ-Specific section comprises two 5-item subscales assessing the necessity of and concerns about the prescribed medication (Specific-Necessity and Specific-Concerns). The BMQ-General section comprises two 4-item subscales assessing beliefs that medicines are harmful and overused by doctors in general (General-Harm and General-Overuse). The 18 items are rated on a Likert scale from 1 (strongly disagree) to 5 (strongly agree). Each subscale score ranges from 1 to 5. High scores in the Specific-Concerns scale represent the notion that adverse reactions are potentially harmful when taking medication on a regular basis, and high scores in the Specific-Necessity scale indicate the patient's need to adhere to medication to maintain health. High scores in the General-Harm and General-Overuse scales represent an overall negative perception of medication. |
| Change From Baseline in Patient Activation Measure 13 (PAM-13) | Baseline and end of treatment (week 8, 12, or 24 depending on the treatment regimen) | PAM 13 is a measure used to assess the patient knowledge, skill, and confidence for self-management, consisting of 13 questions. Each of the 13 items can be answered with one of four possible response options, which are disagree strongly (1), disagree (2), agree (3), agree strongly (4). Scores were summed to calculate the overall raw score, then transformed to a scale with a theoretical range 0 to 100, based on calibration tables, with higher PAM scores indicating higher patient activation. |
| Number of Participants With Outpatient Consultations Due to Liver Disease by Category | From first dose of study drug through 30 days after last dose (12 to 28 weeks depending on treatment regimen). The median (minimum, maximum) duration of treatment was 84 (4, 167) days. | — |
| Number of Participants With Hospitalizations Due to Liver Disease by Category | From first dose of study drug through 30 days after last dose (12 to 28 weeks depending on treatment regimen). The median (minimum, maximum) duration of treatment was 84 (4, 167) days. | — |
| Change From Baseline in Percent Glycosylated Hemoglobin (HbA1c) | Baseline and end of treatment (week 8, 12, or 24 depending on the treatment regimen) | — |
| Change From Baseline in Fatigue Impact Scale Total Score | Baseline, end of treatment (week 8, 12, or 24 depending on the treatment regimen), and at 12 and 24 weeks after end of treatment | The Fatigue Impact Scale (FIS) questionnaire was used to assess the impact of fatigue on the quality of life of patients. The FIS consists of 40 items, each of which is scored 0 (no problem) to 4 (extreme problem), providing a total score from of 0 to 160, where a lower score = less fatigue impact |
Countries
France
Participant flow
Recruitment details
This observational study was conducted in 69 medical centers in France experienced in the treatment of chronic hepatitis C (CHC). The first participant entered the study on 15 December 2015, last patient last visit was on 29 March 2018.
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 8, 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. | 728 |
| Total | 728 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Death | 3 |
| Overall Study | Failure to Return | 28 |
| Overall Study | Insufficient Virological Response | 1 |
| Overall Study | Missing | 6 |
| Overall Study | Other | 11 |
| Overall Study | Treatment Never Started | 7 |
| Overall Study | Withdrawal by Subject | 2 |
Baseline characteristics
| Characteristic | Paritaprevir/Ritonavir + Ombitasvir ± Dasabuvir ± Ribavirin |
|---|---|
| Age, Continuous | 56 years STANDARD_DEVIATION 12.1 |
| Age, Customized 18 to 65 years | 570 Participants |
| Age, Customized 66 to 84 years | 151 Participants |
| Age, Customized 85 years or older | 7 Participants |
| Assigned Treatment Regimen 2 DAA without RBV for 12 weeks | 4 Participants |
| Assigned Treatment Regimen 2 DAA with RBV for 12 weeks | 209 Participants |
| Assigned Treatment Regimen 3 DAA without RBV for 12 weeks | 334 Participants |
| Assigned Treatment Regimen 3 DAA without RBV for 8 weeks | 95 Participants |
| Assigned Treatment Regimen 3 DAA with RBV for 12 weeks | 84 Participants |
| Assigned Treatment Regimen 3 DAA with RBV for 24 weeks | 2 Participants |
| Cirrhosis Status Cirrhosis | 111 Participants |
| Cirrhosis Status No cirrhosis | 520 Participants |
| Cirrhosis Status Transition to cirrhosis | 97 Participants |
| Co-morbidities Any co-morbidity or co-infection | 387 Participants |
| Co-morbidities Hepatitis B co-infection | 7 Participants |
| Co-morbidities Human immunodeficiency virus (HIV) co-infection | 13 Participants |
| Co-morbidities Tuberculosis co-infection | 1 Participants |
| Drug Users Active injection drug use | 5 Participants |
| Drug Users Opiate substitution | 33 Participants |
| Drug Users Psychoactive drug dependency | 45 Participants |
| HCV Genotype Genotype 1/4, subtype unknown | 1 Participants |
| HCV Genotype Genotype 1a | 78 Participants |
| HCV Genotype Genotype 1a/1b | 3 Participants |
| HCV Genotype Genotype 1b | 427 Participants |
| HCV Genotype Genotype 1d | 1 Participants |
| HCV Genotype Genotype 1e | 2 Participants |
| HCV Genotype Genotype 1l | 1 Participants |
| HCV Genotype Genotype 1, subtype unknown | 1 Participants |
| HCV Genotype Genotype 4a | 39 Participants |
| HCV Genotype Genotype 4a/4c/4d | 11 Participants |
| HCV Genotype Genotype 4c | 3 Participants |
| HCV Genotype Genotype 4c/4d | 5 Participants |
| HCV Genotype Genotype 4d | 14 Participants |
| HCV Genotype Genotype 4e | 2 Participants |
| HCV Genotype Genotype 4f | 7 Participants |
| HCV Genotype Genotype 4h | 1 Participants |
| HCV Genotype Genotype 4k | 1 Participants |
| HCV Genotype Genotype 4r | 2 Participants |
| HCV Genotype Genotype 4, subtype unknown | 129 Participants |
| HCV RNA Concentration | 6.13 log10 IU/mL |
| Pretreatment Status Experienced | 238 Participants |
| Pretreatment Status Missing | 1 Participants |
| Pretreatment Status Naive | 489 Participants |
| Race/Ethnicity, Customized Asian | 28 Participants |
| Race/Ethnicity, Customized Black | 90 Participants |
| Race/Ethnicity, Customized Native American | 1 Participants |
| Race/Ethnicity, Customized Other | 32 Participants |
| Race/Ethnicity, Customized White | 577 Participants |
| Sex: Female, Male Female | 372 Participants |
| Sex: Female, Male Male | 356 Participants |
| Years Since Diagnosis of HCV Infection | 13.8 years STANDARD_DEVIATION 10.57 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 4 | 5 / 209 | 1 / 429 | 2 / 86 |
| other Total, other adverse events | 1 / 4 | 33 / 209 | 38 / 429 | 11 / 86 |
| serious Total, serious adverse events | 0 / 4 | 1 / 209 | 13 / 429 | 6 / 86 |
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. Participants with missing HCV RNA were counted as virological failure.
Time frame: 12 weeks after the last dose of study drug (week 20, 24, or 36 depending on the treatment regimen)
Population: The Core population includes enrolled participants who were adequately treated according to the standard of care and within local label recommendations for their specific disease characteristics (cirrhotic status, genotype).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Paritaprevir/Ritonavir + Ombitasvir ± Dasabuvir ± Ribavirin | Percentage of Participants Achieving Sustained Virological Response 12 Weeks Post-treatment (SVR12) | 90.7 percentage of participants |
Secondary
Change From Baseline in Beliefs Medication Questionnaire - (18-item BMQ)
The BMQ consists of 2 sections and 18 questions to screen for patients' beliefs, attitudes and concerns about their medication. The BMQ-Specific section comprises two 5-item subscales assessing the necessity of and concerns about the prescribed medication (Specific-Necessity and Specific-Concerns). The BMQ-General section comprises two 4-item subscales assessing beliefs that medicines are harmful and overused by doctors in general (General-Harm and General-Overuse). The 18 items are rated on a Likert scale from 1 (strongly disagree) to 5 (strongly agree). Each subscale score ranges from 1 to 5. High scores in the Specific-Concerns scale represent the notion that adverse reactions are potentially harmful when taking medication on a regular basis, and high scores in the Specific-Necessity scale indicate the patient's need to adhere to medication to maintain health. High scores in the General-Harm and General-Overuse scales represent an overall negative perception of medication.
Time frame: Baseline and end of treatment (week 8, 12, or 24 depending on the treatment regimen)
Population: The Core population with available data at baseline and end of treatment.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Paritaprevir/Ritonavir + Ombitasvir ± Dasabuvir ± Ribavirin | Change From Baseline in Beliefs Medication Questionnaire - (18-item BMQ) | Specific Concerns | -0.100 units on a scale | Standard Deviation 0.871 |
| Paritaprevir/Ritonavir + Ombitasvir ± Dasabuvir ± Ribavirin | Change From Baseline in Beliefs Medication Questionnaire - (18-item BMQ) | Specific Necessity | -0.099 units on a scale | Standard Deviation 0.739 |
| Paritaprevir/Ritonavir + Ombitasvir ± Dasabuvir ± Ribavirin | Change From Baseline in Beliefs Medication Questionnaire - (18-item BMQ) | General Overuse | 0.119 units on a scale | Standard Deviation 0.685 |
| Paritaprevir/Ritonavir + Ombitasvir ± Dasabuvir ± Ribavirin | Change From Baseline in Beliefs Medication Questionnaire - (18-item BMQ) | General Harm | 0.135 units on a scale | Standard Deviation 0.67 |
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 (week 8, 12, or 24 depending on the treatment regimen), and at 12 and 24 weeks after end of treatment
Population: Core population with available data at baseline and each time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Paritaprevir/Ritonavir + Ombitasvir ± Dasabuvir ± Ribavirin | Change From Baseline in EuroQol 5 Dimension 5 Level (EQ-5D-5L) Index Score | End of treatment | 0.044 units on a scale | Standard Deviation 0.208 |
| Paritaprevir/Ritonavir + Ombitasvir ± Dasabuvir ± Ribavirin | Change From Baseline in EuroQol 5 Dimension 5 Level (EQ-5D-5L) Index Score | 12 weeks after end of treatment | 0.088 units on a scale | Standard Deviation 0.202 |
| Paritaprevir/Ritonavir + Ombitasvir ± Dasabuvir ± Ribavirin | Change From Baseline in EuroQol 5 Dimension 5 Level (EQ-5D-5L) Index Score | 24 weeks after end of treatment | 0.087 units on a scale | Standard Deviation 0.196 |
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 (week 8, 12, or 24 depending on the treatment regimen), and at 12 and 24 weeks after end of treatment
Population: Core population with available data at baseline and each time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Paritaprevir/Ritonavir + Ombitasvir ± Dasabuvir ± Ribavirin | Change From Baseline in EuroQol 5 Dimension 5 Level (EQ-5D-5L) VAS Score | End of treatment | 6.8 units on a scale | Standard Deviation 18.92 |
| Paritaprevir/Ritonavir + Ombitasvir ± Dasabuvir ± Ribavirin | Change From Baseline in EuroQol 5 Dimension 5 Level (EQ-5D-5L) VAS Score | 12 weeks after end of treatment | 10.6 units on a scale | Standard Deviation 17.6 |
| Paritaprevir/Ritonavir + Ombitasvir ± Dasabuvir ± Ribavirin | Change From Baseline in EuroQol 5 Dimension 5 Level (EQ-5D-5L) VAS Score | 24 weeks after end of treatment | 10.4 units on a scale | Standard Deviation 17.7 |
Secondary
Change From Baseline in Fatigue Impact Scale Total Score
The Fatigue Impact Scale (FIS) questionnaire was used to assess the impact of fatigue on the quality of life of patients. The FIS consists of 40 items, each of which is scored 0 (no problem) to 4 (extreme problem), providing a total score from of 0 to 160, where a lower score = less fatigue impact
Time frame: Baseline, end of treatment (week 8, 12, or 24 depending on the treatment regimen), and at 12 and 24 weeks after end of treatment
Population: Core population with non-missing data at baseline and each time point
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Paritaprevir/Ritonavir + Ombitasvir ± Dasabuvir ± Ribavirin | Change From Baseline in Fatigue Impact Scale Total Score | End of treatment | -6.78 units on a scale | Standard Deviation 31.8 |
| Paritaprevir/Ritonavir + Ombitasvir ± Dasabuvir ± Ribavirin | Change From Baseline in Fatigue Impact Scale Total Score | 12 weeks after end of treatment | -18.27 units on a scale | Standard Deviation 32.06 |
| Paritaprevir/Ritonavir + Ombitasvir ± Dasabuvir ± Ribavirin | Change From Baseline in Fatigue Impact Scale Total Score | 24 weeks after end of treatment | -16.75 units on a scale | Standard Deviation 32.34 |
Secondary
Change From Baseline in Patient Activation Measure 13 (PAM-13)
PAM 13 is a measure used to assess the patient knowledge, skill, and confidence for self-management, consisting of 13 questions. Each of the 13 items can be answered with one of four possible response options, which are disagree strongly (1), disagree (2), agree (3), agree strongly (4). Scores were summed to calculate the overall raw score, then transformed to a scale with a theoretical range 0 to 100, based on calibration tables, with higher PAM scores indicating higher patient activation.
Time frame: Baseline and end of treatment (week 8, 12, or 24 depending on the treatment regimen)
Population: The Core population with available data at baseline and end of treatment.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Paritaprevir/Ritonavir + Ombitasvir ± Dasabuvir ± Ribavirin | Change From Baseline in Patient Activation Measure 13 (PAM-13) | 0.44 units on a scale | Standard Deviation 9.43 |
Secondary
Change From Baseline in Percent Glycosylated Hemoglobin (HbA1c)
Time frame: Baseline and end of treatment (week 8, 12, or 24 depending on the treatment regimen)
Population: Treated participants with available data at baseline and end of treatment.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Paritaprevir/Ritonavir + Ombitasvir ± Dasabuvir ± Ribavirin | Change From Baseline in Percent Glycosylated Hemoglobin (HbA1c) | -7.07 percent glycosylated hemoglobin | Standard Deviation 10.7 |
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 (week 8, 12, or 24 depending on the treatment regimen), and at 12 and 24 weeks after end of treatment
Population: The Core population who were employed and with available data at baseline and each time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Paritaprevir/Ritonavir + Ombitasvir ± Dasabuvir ± Ribavirin | Change From Baseline in Work Productivity and Activity Impairment (WPAI): Absenteeism | End of treatment | 5.2 percent impairment | Standard Deviation 24.2 |
| Paritaprevir/Ritonavir + Ombitasvir ± Dasabuvir ± Ribavirin | Change From Baseline in Work Productivity and Activity Impairment (WPAI): Absenteeism | 12 weeks after end of treatment | 0.4 percent impairment | Standard Deviation 20.5 |
| Paritaprevir/Ritonavir + Ombitasvir ± Dasabuvir ± Ribavirin | Change From Baseline in Work Productivity and Activity Impairment (WPAI): Absenteeism | 24 weeks after end of treatment | -1.5 percent impairment | Standard Deviation 16.8 |
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 (week 8, 12, or 24 depending on the treatment regimen), and at 12 and 24 weeks after end of treatment
Population: The Core population who were employed and with available data at baseline and each time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Paritaprevir/Ritonavir + Ombitasvir ± Dasabuvir ± Ribavirin | Change From Baseline in Work Productivity and Activity Impairment (WPAI): Presenteeism | End of treatment | -1.2 percent impairment | Standard Deviation 28 |
| Paritaprevir/Ritonavir + Ombitasvir ± Dasabuvir ± Ribavirin | Change From Baseline in Work Productivity and Activity Impairment (WPAI): Presenteeism | 12 weeks after end of treatment | -5.5 percent impairment | Standard Deviation 25.2 |
| Paritaprevir/Ritonavir + Ombitasvir ± Dasabuvir ± Ribavirin | Change From Baseline in Work Productivity and Activity Impairment (WPAI): Presenteeism | 24 weeks after end of treatment | -7.4 percent impairment | Standard Deviation 22.9 |
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 (week 8, 12, or 24 depending on the treatment regimen), and at 12 and 24 weeks after end of treatment
Population: The Core population with available data at baseline and each time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Paritaprevir/Ritonavir + Ombitasvir ± Dasabuvir ± Ribavirin | Change From Baseline in Work Productivity and Activity Impairment (WPAI): Total Activity Impairment | End of treatment | 1.6 percent impairment | Standard Deviation 33 |
| Paritaprevir/Ritonavir + Ombitasvir ± Dasabuvir ± Ribavirin | Change From Baseline in Work Productivity and Activity Impairment (WPAI): Total Activity Impairment | 12 weeks after end of treatment | -7.2 percent impairment | Standard Deviation 32.8 |
| Paritaprevir/Ritonavir + Ombitasvir ± Dasabuvir ± Ribavirin | Change From Baseline in Work Productivity and Activity Impairment (WPAI): Total Activity Impairment | 24 weeks after end of treatment | -9.5 percent impairment | Standard Deviation 29 |
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 (week 8, 12, or 24 depending on the treatment regimen), and at 12 and 24 weeks after end of treatment
Population: The Core population who were employed and with available data at baseline and each time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Paritaprevir/Ritonavir + Ombitasvir ± Dasabuvir ± Ribavirin | Change From Baseline in Work Productivity and Activity Impairment (WPAI): Total Work Productivity Impairment (TWP) | End of treatment | 1.3 percent impairment | Standard Deviation 33.6 |
| Paritaprevir/Ritonavir + Ombitasvir ± Dasabuvir ± Ribavirin | Change From Baseline in Work Productivity and Activity Impairment (WPAI): Total Work Productivity Impairment (TWP) | 12 weeks after end of treatment | -4.9 percent impairment | Standard Deviation 30.1 |
| Paritaprevir/Ritonavir + Ombitasvir ± Dasabuvir ± Ribavirin | Change From Baseline in Work Productivity and Activity Impairment (WPAI): Total Work Productivity Impairment (TWP) | 24 weeks after end of treatment | -8.7 percent impairment | Standard Deviation 25.4 |
Secondary
Number of Participants in Each Non-response Category 12 Weeks Post-treatment
SVR12 non-response was categorized according to the following: * On-treatment virologic failure (breakthrough \[at least one documented HCV RNA \< 50 IU/mL followed by HCV RNA ≥ 50 IU/mL during treatment\] or failure to suppress \[each measured on-treatment HCV RNA value ≥ 50 IU/mL\]); * 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 virologic failure; * Insufficient virological response reported or HCV RNA ≥ 50 IU/mL post-EOT and none of the above criteria * Missing SVR12 data and/or none of the above criteria.
Time frame: 12 weeks after the last dose of study drug (week 20, 24, or 36 depending on the treatment regimen)
Population: The Core population
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Paritaprevir/Ritonavir + Ombitasvir ± Dasabuvir ± Ribavirin | Number of Participants in Each Non-response Category 12 Weeks Post-treatment | On-treatment virological failure | 11 Participants |
| Paritaprevir/Ritonavir + Ombitasvir ± Dasabuvir ± Ribavirin | Number of Participants in Each Non-response Category 12 Weeks Post-treatment | Relapse | 7 Participants |
| Paritaprevir/Ritonavir + Ombitasvir ± Dasabuvir ± Ribavirin | Number of Participants in Each Non-response Category 12 Weeks Post-treatment | Death | 2 Participants |
| Paritaprevir/Ritonavir + Ombitasvir ± Dasabuvir ± Ribavirin | Number of Participants in Each Non-response Category 12 Weeks Post-treatment | Premature treatment discontinuation | 14 Participants |
| Paritaprevir/Ritonavir + Ombitasvir ± Dasabuvir ± Ribavirin | Number of Participants in Each Non-response Category 12 Weeks Post-treatment | Insufficient virological response reported | 3 Participants |
| Paritaprevir/Ritonavir + Ombitasvir ± Dasabuvir ± Ribavirin | Number of Participants in Each Non-response Category 12 Weeks Post-treatment | Missing/none of the above | 30 Participants |
Secondary
Number of Participants Who Received Concomitant Medications
Concomitant medication other than for chronic hepatitis C used from the time when the decision was made to initiate treatment with paritaprevir/ritonavir and ombitasvir with or without dasabuvir until after the last dose.
Time frame: From first dose of study drug to end of treatment, 8 to 24 weeks depending on the treatment regimen
Population: All treated participants
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Paritaprevir/Ritonavir + Ombitasvir ± Dasabuvir ± Ribavirin | Number of Participants Who Received Concomitant Medications | Any co-medication | 351 Participants |
| Paritaprevir/Ritonavir + Ombitasvir ± Dasabuvir ± Ribavirin | Number of Participants Who Received Concomitant Medications | Beta blocking agents | 60 Participants |
| Paritaprevir/Ritonavir + Ombitasvir ± Dasabuvir ± Ribavirin | Number of Participants Who Received Concomitant Medications | Analgesics | 58 Participants |
| Paritaprevir/Ritonavir + Ombitasvir ± Dasabuvir ± Ribavirin | Number of Participants Who Received Concomitant Medications | Thyroid therapy | 46 Participants |
| Paritaprevir/Ritonavir + Ombitasvir ± Dasabuvir ± Ribavirin | Number of Participants Who Received Concomitant Medications | Peptic ulcer / gastro-oesophageal reflux disease | 45 Participants |
| Paritaprevir/Ritonavir + Ombitasvir ± Dasabuvir ± Ribavirin | Number of Participants Who Received Concomitant Medications | Benzodiazepine derivatives | 40 Participants |
| Paritaprevir/Ritonavir + Ombitasvir ± Dasabuvir ± Ribavirin | Number of Participants Who Received Concomitant Medications | ACE inhibitors | 39 Participants |
| Paritaprevir/Ritonavir + Ombitasvir ± Dasabuvir ± Ribavirin | Number of Participants Who Received Concomitant Medications | Diuretics | 37 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 (12 to 28 weeks depending on treatment regimen). The median (minimum, maximum) duration of treatment was 84 (4, 167) days.
Population: All treated participants
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Paritaprevir/Ritonavir + Ombitasvir ± Dasabuvir ± Ribavirin | Number of Participants With Adverse Events, Serious Adverse Events, or Pregnancies | Serious adverse event | 20 Participants |
| Paritaprevir/Ritonavir + Ombitasvir ± Dasabuvir ± Ribavirin | Number of Participants With Adverse Events, Serious Adverse Events, or Pregnancies | Any adverse event | 163 Participants |
| Paritaprevir/Ritonavir + Ombitasvir ± Dasabuvir ± Ribavirin | Number of Participants With Adverse Events, Serious Adverse Events, or Pregnancies | Pregnancy | 1 Participants |
Secondary
Number of Participants With Hospitalizations Due to Liver Disease by Category
Time frame: From first dose of study drug through 30 days after last dose (12 to 28 weeks depending on treatment regimen). The median (minimum, maximum) duration of treatment was 84 (4, 167) days.
Population: Core population with available data
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Paritaprevir/Ritonavir + Ombitasvir ± Dasabuvir ± Ribavirin | Number of Participants With Hospitalizations Due to Liver Disease by Category | No hospitalizations | 685 Participants |
| Paritaprevir/Ritonavir + Ombitasvir ± Dasabuvir ± Ribavirin | Number of Participants With Hospitalizations Due to Liver Disease by Category | One hospitalization | 9 Participants |
Secondary
Number of Participants With Outpatient Consultations Due to Liver Disease by Category
Time frame: From first dose of study drug through 30 days after last dose (12 to 28 weeks depending on treatment regimen). The median (minimum, maximum) duration of treatment was 84 (4, 167) days.
Population: Core population with available data
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Paritaprevir/Ritonavir + Ombitasvir ± Dasabuvir ± Ribavirin | Number of Participants With Outpatient Consultations Due to Liver Disease by Category | No outpatient consultations | 515 Participants |
| Paritaprevir/Ritonavir + Ombitasvir ± Dasabuvir ± Ribavirin | Number of Participants With Outpatient Consultations Due to Liver Disease by Category | One outpatient consultation | 80 Participants |
| Paritaprevir/Ritonavir + Ombitasvir ± Dasabuvir ± Ribavirin | Number of Participants With Outpatient Consultations Due to Liver Disease by Category | Two or three outpatient consultations | 94 Participants |
| Paritaprevir/Ritonavir + Ombitasvir ± Dasabuvir ± Ribavirin | Number of Participants With Outpatient Consultations Due to Liver Disease by Category | Four or more outpatient consultations | 5 Participants |
Secondary
Percentage of Participants Achieving Virological Response at End of Treatment
Virologic response was defined as hepatitis C virus ribonucleic acid (HCV RNA) levels less than 50 IU/mL.
Time frame: End of treatment (week 8, 12, or 24 depending on the treatment regimen)
Population: The Core population includes enrolled participants who were adequately treated according to the standard of care and within local label recommendations for their specific disease characteristics (cirrhotic status, genotype).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Paritaprevir/Ritonavir + Ombitasvir ± Dasabuvir ± Ribavirin | Percentage of Participants Achieving Virological Response at End of Treatment | 94.4 percentage of participants |
Secondary
Percentage of Participants With Adherence to Ribavirin by Adherence Category
Adherence to ribavirin is expressed as a percentage of the target dose, and was calculated as: Cumulative dose taken / (initial prescribed dose \* planned duration) \* 100
Time frame: From first dose of study drug to end of treatment, 8 to 24 weeks depending on the treatment regimen.
Population: Core population who were prescribed ribavirin
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Paritaprevir/Ritonavir + Ombitasvir ± Dasabuvir ± Ribavirin | Percentage of Participants With Adherence to Ribavirin by Adherence Category | ≤ 50% | 10 Participants |
| Paritaprevir/Ritonavir + Ombitasvir ± Dasabuvir ± Ribavirin | Percentage of Participants With Adherence to Ribavirin by Adherence Category | > 105% | 22 Participants |
| Paritaprevir/Ritonavir + Ombitasvir ± Dasabuvir ± Ribavirin | Percentage of Participants With Adherence to Ribavirin by Adherence Category | > 95% to ≤ 105% | 219 Participants |
| Paritaprevir/Ritonavir + Ombitasvir ± Dasabuvir ± Ribavirin | Percentage of Participants With Adherence to Ribavirin by Adherence Category | > 80% to ≤ 95% | 20 Participants |
| Paritaprevir/Ritonavir + Ombitasvir ± Dasabuvir ± Ribavirin | Percentage of Participants With Adherence to Ribavirin by Adherence Category | > 50% to ≤ 80% | 15 Participants |
| Paritaprevir/Ritonavir + Ombitasvir ± Dasabuvir ± Ribavirin | Percentage of Participants With Adherence to Ribavirin by Adherence Category | Missing | 6 Participants |
Secondary
Percentage of Participants With Adherence to the ABBVIE Regimen, by Adherence Category
Adherence to the ABBVIE treatment regimen is expressed as a percentage of the target dose and was calculated as: Cumulative dose taken / (initial prescribed dose \* planned duration) \* 100 The ABBVIE regimen consists of paritaprevir/r and ombitasvir with or without dasabuvir.
Time frame: From first dose of study drug to end of treatment, 8 to 24 weeks depending on the treatment regimen.
Population: Core population
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Paritaprevir/Ritonavir + Ombitasvir ± Dasabuvir ± Ribavirin | Percentage of Participants With Adherence to the ABBVIE Regimen, by Adherence Category | > 80% to ≤ 95% | 19 Participants |
| Paritaprevir/Ritonavir + Ombitasvir ± Dasabuvir ± Ribavirin | Percentage of Participants With Adherence to the ABBVIE Regimen, by Adherence Category | > 105% | 38 Participants |
| Paritaprevir/Ritonavir + Ombitasvir ± Dasabuvir ± Ribavirin | Percentage of Participants With Adherence to the ABBVIE Regimen, by Adherence Category | > 95% to ≤ 105% | 623 Participants |
| Paritaprevir/Ritonavir + Ombitasvir ± Dasabuvir ± Ribavirin | Percentage of Participants With Adherence to the ABBVIE Regimen, by Adherence Category | > 50% to ≤ 80% | 15 Participants |
| Paritaprevir/Ritonavir + Ombitasvir ± Dasabuvir ± Ribavirin | Percentage of Participants With Adherence to the ABBVIE Regimen, by Adherence Category | ≤ 50% | 15 Participants |
| Paritaprevir/Ritonavir + Ombitasvir ± Dasabuvir ± Ribavirin | Percentage of Participants With Adherence to the ABBVIE Regimen, by Adherence Category | Missing | 10 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: 8, 12, or 24 weeks (depending on the treatment regimen)
Population: The Core population with virological response on-treatment and with at least one on-treatment measurement thereafter (including EOT).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Paritaprevir/Ritonavir + Ombitasvir ± Dasabuvir ± Ribavirin | Percentage of Participants With Breakthrough | 0.5 percentage of participants |
Secondary
Percentage of Participants With Rapid Virological Response at Week 4 (RVR4)
RVR 4 was defined as participants with HCV RNA \< 50 IU/mL at week 4.
Time frame: Week 4
Population: The Core population includes enrolled participants who were adequately treated according to the standard of care and within local label recommendations for their specific disease characteristics (cirrhotic status, genotype).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Paritaprevir/Ritonavir + Ombitasvir ± Dasabuvir ± Ribavirin | Percentage of Participants With Rapid Virological Response at Week 4 (RVR4) | 49.0 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 8, 12, or 24 depending on the treatment regimen) and up to 24 weeks after the end of treatment.
Population: The Core population with VR at EOT, 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) |
|---|---|---|
| Paritaprevir/Ritonavir + Ombitasvir ± Dasabuvir ± Ribavirin | Percentage of Participants With Relapse | 1.2 percentage of participants |
Secondary
Percentage of Participants With Sufficient Follow-up Who Achieved Sustained Virological Response 12 Weeks Post-treatment
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 20, 24, or 36 depending on the treatment regimen)
Population: The Core population with sufficient follow-up data regarding SVR12
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Paritaprevir/Ritonavir + Ombitasvir ± Dasabuvir ± Ribavirin | Percentage of Participants With Sufficient Follow-up Who Achieved Sustained Virological Response 12 Weeks Post-treatment | 95.5 percentage of participants |
Secondary
Percentage of Participants With Sufficient Follow-up Who Achieved Sustained Virological Response 24 Weeks Post-treatment (SVR24)
Sustained virologic response was defined as hepatitis C virus ribonucleic acid (HCV RNA) levels less than 50 IU/mL 24 weeks after the last dose of study drug. The Core population with sufficient follow-up data regarding SVR24 included all core population participants who * had evaluable HCV RNA data ≥ 126 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 ≥ 126 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: 24 weeks after the last dose of study drug (week 32, 36, or 48 depending on the treatment regimen)
Population: The Core population with sufficient follow-up data regarding SVR24
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Paritaprevir/Ritonavir + Ombitasvir ± Dasabuvir ± Ribavirin | Percentage of Participants With Sufficient Follow-up Who Achieved Sustained Virological Response 24 Weeks Post-treatment (SVR24) | 94.8 percentage of participants |
Secondary
Percentage of Ribavirin Treatment Days in Relation to the Target Number of Ribavirin Treatment Days
Time frame: From first dose of study drug to end of treatment, 8 to 24 weeks depending on the treatment regimen.
Population: Core population who were prescribed ribavirin and with non-missing data
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Paritaprevir/Ritonavir + Ombitasvir ± Dasabuvir ± Ribavirin | Percentage of Ribavirin Treatment Days in Relation to the Target Number of Ribavirin Treatment Days | 98.5 percentage of days | Standard Deviation 13.96 |