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

AbbVie173 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

173

Conditions

Chronic Hepatitis C

Eligibility

Sex: ALLMin age: 18 YearsMax age: 99 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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

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.

Time frame: 12 Weeks after the last dose of study drug

Secondary Outcomes

Percentage of Participants With Virological Response at End of Treatment (EoTR)

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 \[RBV\]).

Time frame: Up to 24 weeks of treatment

Percentage of Participants With On-treatment Virologic Failure (Breakthrough)

The percentage of participants with on-treatment virologic failure (breakthrough \[defined as at least one documented HCV RNA \<50 IU/mL followed by HCV RNA \>= 50 IU/mL during treatment\]).

Time frame: Up to approximately 24 weeks

Percentage of Participants Achieving SVR12 (Core Population Sufficient Follow-up)

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).

Time frame: 12 weeks after last dose of study drug

Percentage of Participants With Post-treatment Relapse

The percentage of participants with relapse (defined as HCV RNA \<50 IU/mL at EoT followed by HCV RNA ≥50 IU/mL)

Time frame: Up to 12 weeks after last dose of study drug

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.