Clinical trial NCT02640547: Real World Evidence of the Effectiveness of Paritaprevir/Ritonavir, Ombitasvir, ± Dasabuvir, ± Ribavirin in Patients With Chronic Hepatitis C
Official title: Real World Evidence (RWE) of the Effectiveness of Paritaprevir/r - Ombitasvir, ± Dasabuvir, ± Ribavirin in Patients With Chronic Hepatitis C - An Observational Study in Poland (HCV RWE PMOS)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Hepatitis C
Keywords: Chronic Hepatitis C
Dasabuvir
Paritaprevir/r/Ombitasvir
Observational Study
Quality of Life
Fibrosis
Cirrhosis
Work Ability
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
Collaborators: name: IST GmbH, Germany
First posted: 2015-12-29
Enrollment: 394
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: Chronic Hepatitis C (CHC)

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.


Eligibility criteria: 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

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 (week 24 or 36 depending on the treatment regimen)
Secondary outcomes:
measure: Percentage of Participants Achieving Virological Response at End of Treatment
timeFrame: End of treatment (week 12 or 24 depending on the treatment regimen)
measure: Percentage of Participants With Relapse
timeFrame: End of treatment (week 12 or 24 depending on the treatment regimen) and up to 24 weeks after the end of treatment.
measure: Percentage of Participants With Breakthrough
timeFrame: 12 or 24 weeks (depending on the treatment regimen)
measure: Percentage of Participants With a Rapid Virological Response at Week 4
timeFrame: Week 4
measure: Percentage of Participants Achieving Sustained Virological Response 24 Weeks Post-treatment (SVR24)
timeFrame: 24 weeks after the last dose of study drug (week 36 or 48 depending on the treatment regimen)
measure: Percentage of Participants in the Core Population With Sufficient Follow-up Data for SVR12 Who Achieved Sustained Virological Response 12 Weeks Post-treatment (SVR12)
timeFrame: 12 weeks after the last dose of study drug (week 24 or 36 depending on the treatment regimen)
measure: Percentage of Participants in Each Non-response Category 12 Weeks Post-treatment
timeFrame: 12 weeks after the last dose of study drug (week 24 or 36 depending on the treatment regimen)
measure: Assigned Treatment Regimen
timeFrame: Baseline
measure: Percentage of the Direct Acting Antiviral (DAA) Dose Taken in Relation to the Target Dose of DAA
timeFrame: From first dose of study drug to end of treatment, 12 to 24 weeks depending on the treatment regimen
measure: Percentage of the Ribavirin (RBV) Dose Taken in Relation to the Target Dose of RBV
timeFrame: From first dose of study drug to end of treatment, 12 to 24 weeks depending on the treatment regimen
measure: Number of Participants With Comorbidities
timeFrame: Baseline
measure: Number of Participants Who Received Concomitant Medications
timeFrame: From first dose of study drug to end of treatment, 12 to 24 weeks depending on the treatment regimen
measure: Number of Participants With Adverse Events, Serious Adverse Events, or Pregnancies
timeFrame: From first dose of study drug through 30 days after last dose. The median duration of treatment was 84 days.
measure: Change From Baseline in EuroQol 5 Dimension 5 Level (EQ-5D-5L) Index Score
timeFrame: Baseline, end of treatment, and at 12 and 24 weeks after end of treatment
measure: Change From Baseline in EuroQol 5 Dimension 5 Level (EQ-5D-5L) VAS Score
timeFrame: Baseline, end of treatment, and at 12 and 24 weeks after end of treatment
measure: Change From Baseline in Work Productivity and Activity Impairment (WPAI): Absenteeism
timeFrame: Baseline, end of treatment, and at 12 and 24 weeks post treatment
measure: Change From Baseline in Work Productivity and Activity Impairment (WPAI): Presenteeism
timeFrame: Baseline, end of treatment, and at 12 and 24 weeks after end of treatment
measure: Change From Baseline in Work Productivity and Activity Impairment (WPAI): Total Work Productivity Impairment (TWP)
timeFrame: Baseline, end of treatment, and at 12 and 24 weeks after end of treatment
measure: Change From Baseline in Work Productivity and Activity Impairment (WPAI): Total Activity Impairment
timeFrame: Baseline, end of treatment, and at 12 and 24 weeks after end of treatment
Other outcomes:
Locations:
Study officials:
affiliation: AbbVie
name: AbbVie Inc.
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.