Real World Evidence of the Effectiveness of Paritaprevir/r - Ombitasvir, ± Dasabuvir, ± Ribavirin in Patients With Chronic Hepatitis C - An Observational Study in Germany (LIFE-C)

Study Overview
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Brief Summary
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The interferon-free combination regimen of paritaprevir/r - ombitasvir with or without dasabuvir (ABBVIE REGIMEN) ± ribavirin (RBV) for the treatment of chronic hepatitis C (CHC) has been shown to be safe and effective in randomized controlled clinical trials with strict inclusion and exclusion criteria under well controlled conditions. This observational study is the first effectiveness research examining the ABBVIE REGIMEN ± RBV, used according to local label, under real world conditions in Germany in a clinical practice patient population.

Official Title
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Real World Evidence of the Effectiveness of Paritaprevir/r - Ombitasvir, ± Dasabuvir, ± Ribavirin in Patients With Chronic Hepatitis C - An Observational Study in Germany (LIFE-C)

Conditions
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Chronic Hepatitis C

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Treatment-naïve or -experienced 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 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 pseudonymized 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: • Adolescents; people not treated according to label

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Genotype 1a (G1a) Participants<br>Treatment-naïve or -experienced participants with confirmed chronic hepatitis C (CHC) genotype 1a (G1a, includes all GT1-participants except participants with GT1b or GT1b/4), receiving combination therapy with the interferon-free paritaprevir/ritonavir - ombitasvir with dasabuvir (ABBVIE REGIMEN) + ribavirin (RBV) according to standard of care and in line with the current local label. The prescription of a treatment regimen is at the discretion of the physician in accordance with local clinical practice and label, is made independently from this observational study and precedes the decision to offer the patient the opportunity to participate in this study. | |
| Genotype 1b (G1b) Participants<br>Treatment-naïve or -experienced participants with confirmed CHC genotype 1b (G1b; includes G1b/Genotype 4 [G4]), receiving combination therapy with the interferon-free paritaprevir/ritonavir - ombitasvir with dasabuvir (ABBVIE REGIMEN) according to standard of care and in line with the current local label. The prescription of a treatment regimen is at the discretion of the physician in accordance with local clinical practice and label, is made independently from this observational study and precedes the decision to offer the patient the opportunity to participate in this study. | |
| Genotype 4 (G4) Participants<br>Treatment-naïve or -experienced participants with confirmed CHC genotype 4 (G4; non-G1), receiving combination therapy with the interferon-free paritaprevir/ritonavir - ombitasvir (ABBVIE REGIMEN) + RBV according to standard of care and in line with the current local label. The prescription of a treatment regimen is at the discretion of the physician in accordance with local clinical practice and label, is made independently from this observational study and precedes the decision to offer the patient the opportunity to participate in this study. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants With Sustained Virologic Response (SVR12) | SVR12 is defined as hepatitis C virus (HCV) ribonucleic acid (RNA) less than the lower limit of quantification (< 50 IU/mL) 12 weeks after the last actual dose of the ABBVIE REGIMEN. | 12 weeks after the last dose of study drug (treatment period was 12 or 24 weeks) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants With Virological Response at End of Treatment (EoTR) | Virological response is defined as HCV RNA < 50 IU/mL. End of Treatment (EoT) is defined as the last intake of ABBVIE REGIMEN or RBV. | EoT, (treatment period was 12 weeks or 24 weeks) | 
| Number of Participants With On-Treatment Virological Failure or Relapse | The number of participants meeting the following SVR12 non-response categories: On-treatment virological failure (breakthrough) defined >= 1 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 participants who completed treatment (<= 7 days shortened). | Up to post-treatment Week 12 (treatment period was 12 or 24 weeks) | 
| Percentage of Participants With Rapid Virological Response at Week 4 (RVR4) | RVR4 is defined as participants with HCV RNA < 50 IU/mL at Week 4. | Week 4 | 
| Percentage of Participants With Sustained Virological Response 24 Weeks After EoT (SVR24) | SVR24 is defined as HCV RNA < 50 IU/mL 24 Weeks After EoT. | 24 Weeks After EoT (treatment period was 12 or 24 weeks) | 
| Percentage of Participants With Sustained Virological Response 48 Weeks After EoT (SVR48) | SVR48 is defined as participants with HCV RNA < 50 IU/mL 48 weeks after EoT. | 48 Weeks After EoT (treatment period was 12 or 24 weeks) | 
| Change From Baseline in PRISM Over Time | PRISM is a visual quantitative method to assess the perceived burden of suffering due to illness. The distance between the center of the self (yellow disk) and the illness disk (red disk) is called self-illness separation (SIS) and is measured in cm (range is 0 - 27). The smaller the distance, the higher the burden of suffering. | Baseline, 12 and 48 weeks after EoT (treatment period was 12 or 24 weeks) | 
| Percentage of Participants With ≥ 1 Comorbidity and/or Co-Infection |  | up to post-treatment Week 48 (treatment period was 12 or 24 weeks) | 
| Percentage of Participants Taking ≥ 1 Co-Medication |  | up to post-treatment Week 48 (treatment period was 12 or 24 weeks) | 
| Mean Duration of of ABBVIE REGIMEN and RBV Taken | Documented by participant interview and/or participant diary. | Up to Week 12 or Week 24 | 
| Percentage of Planned Duration of ABBVIE REGIMEN and RBV Taken | Planned duration of treatment was 12 or 24 weeks. | Up to Week 12 or Week 24 | 
| Change From Baseline in FACIT-F Scale Over Time | The FACIT-F Scale is a 13-item questionnaire that assesses self-reported fatigue during the past 7 days and its impact upon daily activities and function. Scores range from 0 - 100, with higher scores indicating a lesser degree of fatigue. | Baseline, EoT (treatment period was 12 or 24 weeks), 12 and 48 weeks after EoT | 
| Change From Baseline to EoT in PAM-13 Questionnaire | The PAM-13 item scale is a measure used to assess the patient knowledge, skill, and confidence for self-management. Scores range from 0 to 100. Higher scores indicate a higher level of knowledge, skill and confidence. | Baseline, EoT (treatment period was 12 or 24 weeks) | 
| Change From Baseline Over Time in WPAI: Total Work Productivity 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 work productivity impairment indicates the percentage of overall work impairment due to health problems. | Baseline, EoT (treatment period was 12 or 24 weeks),12 and 24 weeks after EoT | 
| Change From Baseline Over Time in 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 indicates the percentage of general (non-work) activity impairment due to health problems. | Baseline, EoT (treatment period was 12 or 24 weeks),12 and 24 weeks after EoT | 
| Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs and/or Pregnancies | An adverse event (AE) is defined as any untoward medical occurrence. If an AE meets any of the following criteria, it is considered serious: results in death, is life threatening, results in hospitalization or prolongation of hospitalization, is a congenital anomaly, results in significant disability/incapacity, or is an important medical event. TEAEs are defined as any reported event that begins or worsens in severity after initiation of study drug through 30 days post-study drug dosing. | up to 30 days post treatment (treatment period was 12 weeks or 24 weeks) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Chronic Hepatitis C, Dasabuvir, Ombitasvir+Paritaprevir+Ritonavir, Observational Study, Quality of life, Work-ability, Fibrosis, Cirrhosis