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

AbbVie0 sites522 target enrollmentJuly 14, 2016

ConditionsChronic Hepatitis C

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Chronic Hepatitis C
Sponsor: AbbVie
Enrollment: 522
Primary Endpoint: Percentage of Participants Achieving Sustained Virological Response 12 Weeks Post-treatment (SVR12)
Status: Completed
Last Updated: 7 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

July 14, 2016

End Date

August 4, 2017

Last Updated

7 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

AbbVie

Responsible Party

Sponsor

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

Not provided

Outcomes

Primary Outcomes

Percentage of Participants Achieving Sustained Virological Response 12 Weeks Post-treatment (SVR12)

Time Frame: 12 weeks after the last dose of study drug (week 24 or 36 depending on the treatment regimen)

Sustained virologic response was defined as hepatitis C virus ribonucleic acid (HCV RNA) levels less than 50 IU/mL 12 weeks after the last dose of study drug.

Secondary Outcomes

Percentage of Participants Achieving Virological Response at End of Treatment(End of treatment (week 12 or 24 depending on the treatment regimen))
Percentage of Participants in the Core Population With Sufficient Follow-up Data for SVR12 Who Achieved Sustained Virological Response 12 Weeks Post-treatment(12 weeks after the last dose of study drug (week 24 or 36 depending on the treatment regimen))
Percentage of Participants in Each Non-response Category 12 Weeks Post-treatment(12 weeks after the last dose of study drug (week 24 or 36 depending on the treatment regimen))
Number of Participants Who Received Concomitant Medications(From first dose of study drug to end of treatment, 12 to 24 weeks depending on the treatment regimen)
Change From Baseline in Work Productivity and Activity Impairment (WPAI): Absenteeism(Baseline, end of treatment (week 12 or 24 depending on the treatment regimen), and at 12 and 24 weeks after end of treatment)
Percentage of Participants With Relapse(End of treatment (week 12 or 24 depending on the treatment regimen) and up to 24 weeks after the end of treatment.)
Percentage of the Direct Acting Antiviral (DAA) Dose Taken in Relation to the Target Dose of DAA(From first dose of study drug to end of treatment, 12 to 24 weeks depending on the treatment regimen.)
Percentage of the Ribavirin Dose Taken in Relation to the Target Dose of Ribavirin(From first dose of study drug to end of treatment, 12 to 24 weeks depending on the treatment regimen)
Change From Baseline in EuroQol 5 Dimension 5 Level (EQ-5D-5L) Index Score(Baseline, end of treatment (week 12 or 24 depending on the treatment regimen), and at 12 and 24 weeks after end of treatment)
Percentage of Participants With Breakthrough(12 or 24 weeks (depending on the treatment regimen))
Percentage of Ribavirin (RBV) Treatment Days in Relation to the Target Number of Ribavirin Treatment Days(From first dose of study drug to end of treatment, 12 to 24 weeks depending on the treatment regimen.)
Change From Baseline in EuroQol 5 Dimension 5 Level (EQ-5D-5L) VAS Score(Baseline, end of treatment (week 12 or 24 depending on the treatment regimen), and at 12 and 24 weeks after end of treatment)
Change From Baseline in Work Productivity and Activity Impairment (WPAI): Total Work Productivity Impairment (TWP)(Baseline, end of treatment (week 12 or 24 depending on the treatment regimen), and at 12 and 24 weeks after end of treatment)
Assigned Treatment Regimen(Baseline)
Number of Participants With Comorbidities(Baseline)
Change From Baseline in Patient Activation Measure 13 (PAM-13)(Baseline and end of treatment (week 12 or 24 depending on the treatment regimen))
Change From Baseline in Work Productivity and Activity Impairment (WPAI): Presenteeism(Baseline, end of treatment (week 12 or 24 depending on the treatment regimen), and at 12 and 24 weeks after end of treatment)
Change From Baseline in Work Productivity and Activity Impairment (WPAI): Total Activity Impairment(Baseline, end of treatment (week 12 or 24 depending on the treatment regimen), and at 12 and 24 weeks after end of treatment)
Number of Participants With Adverse Events, Serious Adverse Events, or Pregnancies(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.)
Change From Baseline in Beliefs Medication Questionnaire - (18-item BMQ)(Baseline and end of treatment (week 12 or 24 depending on the treatment regimen))