Clinical trial NCT02582658: Paritaprevir/r - Ombitasvir, ± Dasabuvir, ± Ribavirin in Patients With Chronic Hepatitis C - An Observational Study in Austria (REAL)
Official title: Real World Evidence of the Effectiveness of Paritaprevir/r - Ombitasvir, ± Dasabuvir, ± Ribavirin in Patients With Chronic Hepatitis C -An Observational Study in Austria (REAL)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Hepatitis C
Keywords: Paritaprevir
Dasabuvir
Ombitasvir
Chronic Hepatitis C
HCV
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2015-10-21
Enrollment: 173
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with chronic infection of HCV Genotype 1 (GT1) or Genotype 4 (GT4)

Brief summary: The study seeks to provide evidence of the effectiveness and obtain patient reported outcome (PRO) and work productivity data of the interferon-free ABBVIE REGIMEN (ombitasvir/paritaprevir/ritonavir +/- dasabuvir) +/- Ribavirin (RBV) in chronic hepatitis C virus (HCV) infected participants in Austria.


Eligibility criteria: Inclusion Criteria:

Treatment-naïve or -experienced adult male or female patients with confirmed chronic hepatitis C, genotype (GT)1 or GT4, receiving combination therapy with the interferon-free ABBVIE REGIMEN ± Ribavirin (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 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

Primary outcomes:
measure: Percentage of Participants Achieving Sustained Virological Response 12 Weeks Post-treatment (SVR12)
timeFrame: 12 Weeks after the last dose of study drug
Secondary outcomes:
measure: Percentage of Participants With Virological Response at End of Treatment (EoTR)
timeFrame: Up to 24 weeks of treatment
measure: Percentage of Participants With On-treatment Virologic Failure (Breakthrough)
timeFrame: Up to approximately 24 weeks
measure: Percentage of Participants Achieving SVR12 (Core Population Sufficient Follow-up)
timeFrame: 12 weeks after last dose of study drug
measure: Percentage of Participants With Post-treatment Relapse
timeFrame: Up to 12 weeks after last dose of study drug
Other outcomes:
measure: Percentage of Planned Duration of Ribavirin (RBV) Taken
timeFrame: Up to 24 weeks of treatment
measure: Total Score of Participant Activation According to the Patient Activation Measure (PAM-13) Questionnaire
timeFrame: Day 0 and End of Treatment (EoT)
measure: Percentage of Participants With Concomitant Medications
timeFrame: Day 0 to end of treatment (up to 24 weeks)
measure: Percentage of Participants With Co-morbidities and/or Co-infections
timeFrame: Day 0
measure: Quality of Life Measured With the EuroQol 5 Dimension 5 Level (EQ-5D-5L) Questionnaire
timeFrame: Day 0 and post treatment week 12
measure: Change in Mean Score From Baseline to 12 Weeks After End of Treatment (EOT) in Work Productivity and Activity Impairment (WPAI) Version 2: Hepatitis C Questionnaire
timeFrame: Day 0 to post treatment week 12
measure: Patient Support Program (PSP) Utilization and Satisfaction Assessment
timeFrame: Up to 24 weeks of treatment
measure: Percentage of Participants With Adherence to Planned RBV Target Dose Taken
timeFrame: Up to 24 weeks of treatment
measure: Percentage of Participants Deviating From the Target ABBVIE Regimen Duration
timeFrame: Up to 24 weeks of treatment
measure: Percentage of Participants With Adherence to Planned ABBVIE Regimen Target Dose Taken
timeFrame: Up to 24 weeks of treatment
Locations:
Study officials:
affiliation: AbbVie Austria
name: Alexander P Dorr, PhD
role: STUDY_DIRECTOR
References:
citation: Ferenci P, Bourgeois S, Buggisch P, Norris S, Curescu M, Larrey D, Marra F, Kleine H, Dorr P, Charafeddine M, Crown E, Bondin M, Back D, Flisiak R. Real-world safety and effectiveness of ombitasvir/paritaprevir/ritonavir +/- dasabuvir +/- ribavirin in hepatitis C virus genotype 1- and 4-infected patients with diverse comorbidities and comedications: A pooled analysis of post-marketing observational studies from 13 countries. J Viral Hepat. 2019 Jun;26(6):685-696. doi: 10.1111/jvh.13080. Epub 2019 Mar 5.