Clinical trial NCT02807402: Effectiveness of Paritaprevir/Ritonavir, Ombitasvir, + Dasabuvir, ± Ribavirin in Patients With Chronic Hepatitis C in Romania
Official title: Real World Evidence of the Effectiveness of Paritaprevir/r - Ombitasvir, + Dasabuvir, ± Ribavirin in Patients With Chronic Hepatitis C - An Observational Study in Romania
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Hepatitis C
Keywords: Chronic Hepatitis C
Paritaprevir
Ombitasvir
Dasabuvir
HCV
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
Collaborators: name: IST GmbH, Germany
First posted: 2016-06-21
Enrollment: 522
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: Clinical practice patient populations with chronic infection of HCV Genotype 1 (GT1)

Brief summary: This study seeks to provide evidence of the effectiveness and obtain patient reported outcome (PRO) data for the interferon-free regimen of paritaprevir (PTV)/ritonavir (r) + ombitasvir (OBV), + dasabuvir (DSV), +/- ribavirin (RBV) in participants with chronic hepatitis C (CHC) in a real life setting across clinical practice patient populations in Romania.


Eligibility criteria: Inclusion Criteria:

Treatment-naïve or -experienced adult male or female patients with confirmed CHC, genotype 1, receiving combination therapy with the interferon-free paritaprevir/ritonavir and ombitasvir with dasabuvir ± RBV according to standard of care and in line with the current local label

If RBV is co-administered with the paritaprevir/ritonavir and ombitasvir with dasabuvir, 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 in the Core Population With Sufficient Follow-up Data for SVR12 Who Achieved Sustained Virological Response 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 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 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 Dose Taken in Relation to the Target Dose of Ribavirin
timeFrame: From first dose of study drug to end of treatment, 12 to 24 weeks depending on the treatment regimen
measure: Percentage of Ribavirin (RBV) 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 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: 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 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 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: Change From Baseline in Beliefs Medication Questionnaire - (18-item BMQ)
timeFrame: Baseline and end of treatment (week 12 or 24 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). The over all median (minimum, maximum) duration of treatment was 84 (28, 175) days.
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.