Paritaprevir/r - Ombitasvir, ± Dasabuvir, ± Ribavirin in Patients With Chronic Hepatitis C - An Observational Study in Austria (REAL)

Completed

• Conditions: Chronic Hepatitis C

• Registration Number: NCT02582658
• Lead Sponsor: AbbVie

Brief Summary

The study seeks to provide evidence of the effectiveness and obtain patient reported outcome (PRO) and work productivity data of the interferon-free ABBVIE REGIMEN (ombitasvir/paritaprevir/ritonavir +/- dasabuvir) +/- Ribavirin (RBV) in chronic hepatitis C virus (HCV) infected participants in Austria.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-10-06
• Study First Submitted: 2015-10-20
• Study First Submitted QC: 2015-10-20
• Study First Posted: 2015-10-21
• Primary Completion: 2017-01-12
• Study Completion: 2017-01-12
• Results First Submitted: 2018-01-08
• Status Verified: 2018-10
• Results First Submitted QC: 2019-02-28
• Last Update Submitted: 2019-02-28
• Results First Posted: 2019-06-05
• Last Update Posted: 2019-06-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 173

Inclusion Criteria

Treatment-naïve or -experienced adult male or female patients with confirmed chronic hepatitis C, genotype (GT)1 or GT4, receiving combination therapy with the interferon-free ABBVIE REGIMEN ± Ribavirin (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 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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Percentage of Participants Achieving Sustained Virological Response 12 Weeks Post-treatment (SVR12)	12 Weeks after the last dose of study drug	SVR12 is defined as hepatitis C virus ribonucleic acid (HCV RNA) levels \< 50 IU/mL 12 weeks after the last actual dose of study drug.

Secondary Outcome Measures

Name	Time	Method
Percentage of Participants With Virological Response at End of Treatment (EoTR)	Up to 24 weeks of treatment	The percentage of participants with virological response (HCV RNA \<50 IU/mL) at end of treatment (EoT, defined as last intake of ABBVIE REGIMEN or ribavirin \[RBV\]).
Percentage of Participants Achieving SVR12 (Core Population Sufficient Follow-up)	12 weeks after last dose of study drug	SVR12 is defined as HCV RNA levels \< 50 IU/mL 12 weeks after the last actual dose of study drug in the Core Population Sufficient Follow-up (CPSFU).
Percentage of Participants With On-treatment Virologic Failure (Breakthrough)	Up to approximately 24 weeks	The percentage of participants with on-treatment virologic failure (breakthrough \[defined as at least one documented HCV RNA \<50 IU/mL followed by HCV RNA \>= 50 IU/mL during treatment\]).
Percentage of Participants With Post-treatment Relapse	Up to 12 weeks after last dose of study drug	The percentage of participants with relapse (defined as HCV RNA \<50 IU/mL at EoT followed by HCV RNA ≥50 IU/mL)