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)

AbbVie0 sites394 target enrollmentNovember 26, 2015

ConditionsChronic Hepatitis C

Overview

Phase: N/A
Intervention: Not specified
Conditions: Chronic Hepatitis C
Sponsor: AbbVie
Enrollment: 394
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 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.

Registry

clinicaltrials.gov

Start Date

November 26, 2015

End Date

March 29, 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 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

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 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 a Rapid Virological Response at Week 4(Week 4)
Percentage of Participants Achieving 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))
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 Breakthrough(12 or 24 weeks (depending on the treatment regimen))
Assigned Treatment Regimen(Baseline)
Percentage of Participants in the Core Population With Sufficient Follow-up Data for SVR12 Who Achieved Sustained Virological Response 12 Weeks Post-treatment (SVR12)(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))
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)
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 the Ribavirin (RBV) Dose Taken in Relation to the Target Dose of RBV(From first dose of study drug to end of treatment, 12 to 24 weeks depending on the treatment regimen)
Number of Participants With Comorbidities(Baseline)
Number of Participants With Adverse Events, Serious Adverse Events, or Pregnancies(From first dose of study drug through 30 days after last dose. The median duration of treatment was 84 days.)
Change From Baseline in EuroQol 5 Dimension 5 Level (EQ-5D-5L) Index Score(Baseline, end of treatment, 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, 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, and at 12 and 24 weeks post treatment)
Change From Baseline in Work Productivity and Activity Impairment (WPAI): Presenteeism(Baseline, end of treatment, 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, 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, and at 12 and 24 weeks after end of treatment)