Clinical trial NCT02636608: Real World Evidence of the Effectiveness of Paritaprevir/r - Ombitasvir, ± Dasabuvir, ± Ribavirin in Patients With Chronic Hepatitis C - An Observational Study in Hungary
Official title: Real World Evidence of the Effectiveness of Paritaprevir/r - Ombitasvir, ± Dasabuvir, ± Ribavirin in Patients With Chronic Hepatitis C - An Observational Study in Hungary - VERITAS
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: 2015-12-22
Enrollment: 244
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: The study seeks to provide evidence of the effectiveness and obtain patient reported outcome (PRO), work productivity and safety data of the interferon-free regimen of paritaprevir (PTV)/ritonavir (r) + ombitasvir (OBV), ± dasabuvir (DSV), ± ribavirin in chronic hepatitis C virus infected participants.


Eligibility criteria: Inclusion Criteria:

* Treatment-naïve or -experienced adult male or female patients with confirmed chronic hepatitis C (CHC), genotype 1 and 4, receiving combination therapy with the interferon-free paritaprevir (PTV)/ritonavir (r) + ombitasvir (OBV), ± dasabuvir (DSV), ± ribavirin (PTV/r+OBV±DSV±RBV) according to standard of care and in line with the current local label.
* If RBV is co-administered with the PTV/r+OBV±DSV±RBV, 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 Subject Information Form and Informed Consent Form prior to inclusion into the study.
* Patient must not be participating or intending to participate in a concurrent interventional therapeutic trial.
* Patient has been started on PTV/r+OBV±DSV±RBV therapy no more than one (1) month prior to the study enrollment.

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 With Sufficient Follow-up Who Achieved 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 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: Number of Participants With Breakthrough
timeFrame: 12 or 24 weeks (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: Percentage of Participants With Adherence to the ABBVIE Regimen, by Adherence Category
timeFrame: From first dose of study drug to end of treatment, 12 to 24 weeks depending on the treatment regimen.
measure: Percentage of Participants With Adherence to Ribavirin by Adherence Category
timeFrame: From first dose of study drug to end of treatment, 12 to 24 weeks depending on the treatment regimen
measure: Percentage of Ribavirin Treatment Days in Relation to the Target Number of Ribavirin Treatment Days
timeFrame: From first dose of study drug to end of treatment, 12 to 24 weeks depending on the treatment regimen.
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 (16 or 28 weeks depending on the treatment regimen)
measure: Change From Baseline in EuroQol 5 Dimension 5 Level (EQ-5D-5L) VAS Score
timeFrame: Baseline, end of treatment (week 12 or 24 depending on the treatment regimen), and at 12 and 24 weeks after end of treatment
measure: Change From Baseline in EuroQol 5 Dimension 5 Level (EQ-5D-5L) Index Score
timeFrame: Baseline, end of treatment (week 12 or 24 depending on the treatment regimen), 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 (week 12 or 24 depending on the treatment regimen), and at 12 and 24 weeks after end of treatment
measure: Change From Baseline in Work Productivity and Activity Impairment (WPAI): Presenteeism
timeFrame: Baseline, end of treatment (week 12 or 24 depending on the treatment regimen), 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 (week 12 or 24 depending on the treatment regimen), 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 (week 12 or 24 depending on the treatment regimen), and at 12 and 24 weeks after end of treatment
measure: Change From Baseline in Patient Activation Measure 13 (PAM-13)
timeFrame: Baseline and end of treatment (week 12 or 24 depending on the treatment regimen)
measure: Number of Participants Who Participated in the AbbVie Patient Support Program (PSP)
timeFrame: Up to post treatment week 24
measure: Utilization of the AbbVie Patient Support Program (PSP) Components
timeFrame: End of treatment (week 12 or 24 depending on the treatment regimen)
measure: Satisfaction With the AbbVie Patient Support Program (PSP) Components
timeFrame: End of treatment (weeks 12 or 24 depending on treatment regimen)
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.