Observational, Multi-Center Study of the Real World Evidence of the Effectiveness of Paritaprevir/r - Ombitasvir, ± Dasabuvir, ± Ribavirin in Patients With Chronic Hepatitis C in the Russian Federation (HCV RWE)

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

This study seeks to assess the effectiveness, patient reported outcomes, work productivity and healthcare resource utilization of the interferon-free regimen of paritaprevir /ritonavir (r) - ombitasvir, ± dasabuvir ± ribavirin (RBV) in participants with chronic hepatitis C in a real life setting across clinical practice populations.

Study Overview

• Status: Completed
• Conditions: Chronic Hepatitis C; Genotype 1

• Study Type: Observational
• Enrollment (Actual): 158

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Treatment-naïve or -experienced adult male or female patients with confirmed chronic hepatitis C genotype 1, receiving combination therapy with paritaprevir/r - ombitasvir with or without dasabuvir ± RBV according to standard of care and in line with the current local label.

Description

Inclusion Criteria:

Patients are eligible for observation in this cohort if the following applies:

• Treatment-naïve or -experienced adult male or female patients with confirmed chronic hepatitis C, genotype 1, receiving combination therapy with paritaprevir/r - ombitasvir with or without dasabuvir ± RBV according to standard of care and in line with the current local label
• If RBV is co-administered with paritaprevir/r - ombitasvir with or without 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 informed consent prior to inclusion into the study

Exclusion Criteria:

• Patient must not be participating or intending to participate in a concurrent interventional therapeutic trial

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Participants With Chronic Hepatitis C Genotype 1; Participants with confirmed chronic hepatitis C genotype 1 receiving combination therapy with paritaprevir/r - ombitasvir with or without dasabuvir ± RBV according to standard of care and in line with the current local label.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 paritaprevir/r - ombitasvir, ± dasabuvir, ± RBV.	12 weeks after the last actual dose of study drug

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants Meeting SVR12 Non-Response Categories of Breakthrough, Failure to Suppress, and/or Relapse	Breakthrough is defined as at least 1 documented HCV RNA <50 IU/mL followed by HCV RNA ≥50 IU/mL during treatment. Failure to suppress is defined as each measured on-treatment HCV RNA value ≥ 50 IU/mL. Relapse is defined as HCV RNA < 50 IU/mL at end of treatment or at the last on-treatment HCV RNA measurement followed by HCV RNA ≧ 50 IU/mL posttreatment.	12 weeks after last actual dose of study drug
SVR12 Non-Response: Percentage of Participants With Breakthrough	Breakthrough is defined as at least 1 documented HCV RNA <50 IU/mL followed by HCV RNA ≥50 IU/mL during treatment.	12 weeks after the last actual dose of study drug
SVR12 Non-Response: Percentage of Participants With Failure to Suppress	Failure to suppress is defined as each measured on-treatment HCV RNA value ≥ 50 IU/mL.	12 weeks after the last actual dose of study drug
SVR12 Non-Response: Percentage of Participants With Relapse	Relapse is defined as HCV RNA <50 IU/mL at EoT or at the last on-treatment HCV RNA measurement followed by HCV RNA ≧ 50 IU/mL posttreatment.	12 weeks after last actual dose of study drug
SVR12 Non-Response: Percentage of Participants With Premature Study Drug Discontinuation With No On-Treatment Virologic Failure	On-treatment virologic failure included virological breakthrough and failure to suppress. Virological breakthrough was defined as at least one documented HCV RNA < 50 IU/mL or undetectable/negative followed by HCV RNA ≥ 50 IU/mL during treatment. Failure to suppress was defined as each measured on-treatment HCV RNA value ≥ 50 IU/mL or positive.	12 weeks after last actual dose of study drug
SVR12 Non-Response: Percentage of Participants With Missing SVR12 Data		12 weeks after last actual dose of study drug
Percentage of Participants Achieving Sustained Virologic Response 24 Weeks Post-Treatment (SVR24)	SVR24 is defined as HCV RNA levels < 50 IU/mL 24 weeks after the last actual dose of paritaprevir/r - ombitasvir, ± dasabuvir, ± RBV.	24 weeks after last actual dose of study drug
Percentage of Participants Achieving Virological Response at End of Treatment	Virologic response is defined as HCV RNA < 50 IU/mL.	From baseline until end of treatment (12 or 24 weeks after actual first dose)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants Achieving SVR12: Additional Analysis	SVR12 is defined as hepatitis C virus ribonucleic acid (HCV RNA) levels < 50 IU/mL or undetectable/negative 12 weeks after the last actual dose of paritaprevir/r - ombitasvir, ± dasabuvir, ± RBV.	12 weeks after the last actual dose of study drug
Percentage of Participants Meeting SVR12 Non-Response Categories of Breakthrough, Failure to Suppress, and/or Relapse: Additional Analysis	Breakthrough is defined as at least 1 documented HCV RNA <50 IU/mL or undetectable/negative followed by HCV RNA ≥50 IU/mL or positive during treatment. Failure to suppress is defined as each measured on-treatment HCV RNA value ≥ 50 IU/mL or positive. Relapse is defined as HCV RNA < 50 IU/mL or undetectable/negative at end of treatment or at the last on-treatment HCV RNA measurement followed by HCV RNA ≧ 50 IU/mL or positive posttreatment.	12 weeks after last actual dose of study drug
SVR12 Non-Response: Percentage of Participants With Breakthrough: Additional Analysis	Breakthrough is defined as at least 1 documented HCV RNA <50 IU/mL or undetectable/negative followed by HCV RNA ≥50 IU/mL or positive during treatment.	12 weeks after the last actual dose of study drug
SVR12 Non-Response: Percentage of Participants With Failure to Suppress: Additional Analysis	Failure to suppress is defined as each measured on-treatment HCV RNA value ≥ 50 IU/mL or positive.	12 weeks after the last actual dose of study drug
SVR12 Non-Response: Percentage of Participants With Relapse: Additional Analysis	Relapse is defined as HCV RNA < 50 IU/mL or undetectable/negative at end of treatment or at the last on-treatment HCV RNA measurement followed by HCV RNA ≧ 50 IU/mL or positive posttreatment.	12 weeks after last actual dose of study drug
Percentage of Participants Achieving SVR24: Additional Analysis	SVR24 is defined as HCV RNA levels < 50 IU/mL or undetectable/negative 24 weeks after the last actual dose of paritaprevir/r - ombitasvir, ± dasabuvir, ± RBV.	24 weeks after last actual dose of study drug
Percentage of Participants Achieving Virological Response at End of Treatment: Additional Analysis	Virologic response is defined as HCV RNA < 50 IU/mL or undetectable/negative.	From baseline until end of treatment (12 or 24 weeks after actual first dose)

Collaborators and Investigators

• Sponsor: AbbVie
• Investigators: Study Director: Andrey Strugovschikov, MD, AbbVie

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (Actual): April 15, 2016
• Primary Completion (Actual): July 4, 2017
• Study Completion (Actual): July 4, 2017

Study Registration Dates

• First Submitted: January 28, 2016
• First Submitted That Met QC Criteria: January 28, 2016
• First Posted (Estimate): February 1, 2016

Study Record Updates

• Last Update Posted (Actual): November 14, 2018
• Last Update Submitted That Met QC Criteria: October 18, 2018
• Last Verified: July 1, 2018

More Information

Terms related to this study

• Keywords: Ombitasvir; Paritaprevir; Dasabuvir
• Additional Relevant MeSH Terms: Digestive System Diseases; RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Liver Diseases; Flaviviridae Infections; Hepatitis, Viral, Human; Enterovirus Infections; Picornaviridae Infections; Hepatitis; Hepatitis A; Hepatitis C; Hepatitis, Chronic; Hepatitis C, Chronic
• Other Study ID Numbers: P15-743