Effectiveness of Paritaprevir/r - Ombitasvir, ± Dasabuvir, ± Ribavirin in Patients With Chronic Hepatitis C in Canada

Chronic Hepatitis C Clinical Trial

— AMBER  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02581189
• Other study ID #: P15-651
• Status: Completed
• Start date: October 13, 2015
• Est. completion date: December 20, 2017

Study information

• Verified date: March 2019
• Source: AbbVie
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The interferon-free combination regimen of ombitasvir/paritaprevir/ritonavir/ with or without dasabuvir (ABBVIE REGIMEN) ± ribavirin (RBV) for the treatment of chronic hepatitis C (CHC) has been shown to be safe and effective in randomized controlled clinical trials with strict inclusion and exclusion criteria under well-controlled conditions. This observational study was the first effectiveness research examining the ABBVIE REGIMEN ± RBV, used according to local label, under real world conditions in Canada in a clinical practice patient population.

Description:

This was a prospective, multi-center observational study in participants receiving the interferon-free ABBVIE REGIMEN ± RBV in Canada. The prescription of a treatment regimen was at the discretion of the physician in accordance with local clinical practice and label, was made independently from this observational study and preceded the decision to offer the participant the opportunity to participate in this study. Adults chronically infected with HCV, receiving the interferon-free ABBVIE REGIMEN, were offered the opportunity to participate in this study during a routine clinical visit at the participating sites. Follow-up visits, treatment, procedures, and diagnostic methods followed physicians' routine clinical practice. Data were collected at the following time windows: baseline, early on-treatment visit, mid-treatment visit (for participants with a treatment duration of 24 weeks), end of treatment (EoT), early post-treatment and 12 and 24 weeks after the end of treatment (representing sustained virologic response 12 weeks after the end of treatment [SVR12] and sustained virologic response 24 weeks after the end of treatment [SVR24]).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 565
• Est. completion date: December 20, 2017
• Est. primary completion date: December 20, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

Inclusion Criteria:

• Treatment-naïve or -experienced adult male or female participants with confirmed chronic hepatitis C (CHC), genotype 1 or 4, 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 was co-administered with the ABBVIE REGIMEN, it had to be prescribed in line with the current local label (with special attention to contraception requirements and contraindication during pregnancy)

• Participants had to voluntarily sign and date an informed consent form prior to inclusion into the study

• Participants must not have participated or intended to participate in a concurrent interventional therapeutic trial

Exclusion Criteria:

Related Conditions & MeSH terms

• Chronic Hepatitis C
• Hepatitis
• Hepatitis A
• Hepatitis C
• Hepatitis C, Chronic
• Hepatitis, Chronic

Intervention

Drug:
• Ombitasvir/paritaprevir/ritonavir
Co-formulated tablet
• Dasabuvir
Tablet
• Ribavirin
Tablet

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
AbbVie	Cato Research, IST GmbH, Germany

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants Achieving Sustained Virologic Response 12 Weeks Post-treatment (SVR12)	SVR12 was defined as hepatitis C virus ribonucleic acid (HCV RNA) level less than 50 IU/mL 12 weeks after the last actual dose of study drug. The core population (CP) consisted of participants who met all inclusion criteria and were adequately treated according to the standard of care and within local label recommendations for their specific disease characteristics (cirrhotic status, genotype). The core population with sufficient follow-up data 12 weeks after the last actual dose of study drug (CPSFU12) was defined as all CP participants who fulfilled one of the following criteria: evaluable HCV RNA data =70 days after the last actual dose of the ABBVIE REGIMEN; an HCV RNA value =50 IU/mL at the last measurement post-baseline; HCV RNA <50 IU/mL at the last measurement post-baseline, but no HCV RNA measurement =70 days after the last actual dose of the ABBVIE REGIMEN due to reasons related to safety (e.g. dropped out due to AE) or virologic failure	12 weeks after the last actual dose of study drug
Secondary	Percentage of Participants With Virologic Response at End of Treatment (EoT)	Virologic response was defined as hepatitis C virus ribonucleic acid (HCV RNA) level less than 50 IU/mL at the end of treatment.	Up to 24 weeks
Secondary	Percentage of Participants With Relapse	Relapse was defined as hepatitis C virus ribonucleic acid (HCV RNA) level less than 50 IU/mL at the end of treatment followed by HCV RNA level greater than or equal to 50 IU/mL.	Up to 48 weeks after the last actual dose of study drug
Secondary	Percentage of Participants With Viral Breakthrough	Viral breakthrough was defined as at least 1 documented hepatitis C virus ribonucleic acid (HCV RNA) level less than 50 IU/mL followed by HCV RNA level greater than or equal to 50 IU/mL during treatment.	Up to 24 weeks
Secondary	Percentage of Participants With On-treatment Virologic Failure	On-treatment virologic failure was defined as breakthrough (at least 1 documented hepatitis C virus ribonucleic acid (HCV RNA) less than 50 IU/mL followed by HCV RNA greater than or equal to 50 IU/mL during treatment) or failure to suppress (each measured on-treatment HCV RNA value greater than or equal to 50 IU/mL).	12 weeks after the last actual dose of study drug
Secondary	Percentage of Participants Meeting Relapse Criteria	Relapse was defined as hepatitis C virus ribonucleic acid (HCV RNA) less than 50 IU/mL at end of treatment or at the last on-treatment HCV RNA measurement followed by HCV RNA greater than or equal to 50 IU/mL post-treatment.	12 weeks after the last actual dose of study drug
Secondary	Percentage of Participants Meeting Premature Study Drug Discontinuation Criteria	Premature study drug discontinuation was defined as participants who prematurely discontinued study drug with no on-treatment virologic failure.	12 weeks after the last actual dose of study drug
Secondary	Percentage of Participants With Missing Sustained Virologic Response 12 Weeks Post-Treatment (SVR12) Data and/or Nonresponders Who Did Not Meet Specific SVR12 Nonresponder Criteria	The number of participants with missing SVR12 data or SVR12 nonresponder participants who did not meet criteria for on-treatment virologic failure, relapse, premature treatment discontinuation, and who did not have an Insufficient virological response reported was documented.	12 weeks after the last actual dose of study drug

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