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

AbbVie0 sites244 target enrollmentNovember 27, 2015

ConditionsChronic Hepatitis C

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Chronic Hepatitis C
Sponsor: AbbVie
Enrollment: 244
Primary Endpoint: Percentage of Participants Achieving Sustained Virological Response 12 Weeks Post-treatment (SVR12)
Status: Completed
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

November 27, 2015

End Date

May 23, 2018

Last Updated

6 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 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

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. Participants with missing HCV RNA were counted as virological failure.

Secondary Outcomes

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 Participants With Sufficient Follow-up Who Achieved Sustained Virological Response 24 Weeks Post-treatment (SVR24)(24 weeks after the last dose of study drug (week 36 or 48 depending on the treatment regimen))
Number of Participants With Breakthrough(12 or 24 weeks (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)
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 With Adherence to the ABBVIE Regimen, by Adherence Category(From first dose of study drug to end of treatment, 12 to 24 weeks depending on the treatment regimen.)
Percentage of Participants With Adherence to Ribavirin by Adherence Category(From first dose of study drug to end of treatment, 12 to 24 weeks depending on the treatment regimen)
Percentage of Ribavirin 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 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)
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))
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)
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)
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)
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 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)
Change From Baseline in Patient Activation Measure 13 (PAM-13)(Baseline and end of treatment (week 12 or 24 depending on the treatment regimen))
Number of Participants Who Participated in the AbbVie Patient Support Program (PSP)(Up to post treatment week 24)
Utilization of the AbbVie Patient Support Program (PSP) Components(End of treatment (week 12 or 24 depending on the treatment regimen))
Satisfaction With the AbbVie Patient Support Program (PSP) Components(End of treatment (weeks 12 or 24 depending on treatment regimen))