Real World Evidence of the Effectiveness of Paritaprevir/r - Ombitasvir, ± Dasabuvir, ± Ribavirin in Patients With Chronic Hepatitis C in Colombia (outCome)

August 12, 2019 updated by: AbbVie

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

This is a prospective, multi-center observational study in adult participants chronically infected with hepatitis C virus (HCV) receiving the interferon-free ABBVIE REGIMEN (ombitasvir/paritaprevir/ritonavir with or without dasabuvir) with or without ribavirin (RBV). The prescription of a treatment regimen was at the discretion of the physician in accordance with local clinical practice and label.

This study focused on collecting real world data. Follow-up visits, treatment, procedures and diagnostic methods followed physicians' routine clinical practice using a 12-week treatment regimen (four visits plus two interim data collection windows) or a 24-week treatment regimen (four visits plus three interim data collection windows) and is based on the anticipated regular follow-up for patients undergoing treatment for chronic hepatitis C (CHC). Participants are observed for the duration of the ABBVIE REGIMEN therapy and for up to 24 weeks after treatment completion.

Study Overview

Status

Completed

Conditions

Detailed Description

This prospective, multi-center observational study in adult participants chronically infected with hepatitis C virus (HCV), receiving the interferon-free ABBVIE REGIMEN with or without RBV are offered the opportunity to participate in this study during a routine clinical visit at the participating sites at the discretion of the physician and is made independently from this observational study and preceded the decision to offer the participant the opportunity to participate in this study.

After written informed consent is obtained, demographics, HCV disease characteristics, co-morbidities, co-medication, treatment details, and laboratory assessments as recorded in the participant's medical records (source documentation) are documented in the electronic case report form (eCRF). Participants are observed for the duration of the ABBVIE REGIMEN therapy and for up to 24 weeks after treatment completion. No patient identifiable information was captured; a unique participant number was automatically allocated by the web based system once the investigator or designee created a new participant file.

This study focuses on collecting real world data. Follow-up visits, treatment, procedures and diagnostic methods follow physicians' routine clinical practice. The observational study period entailed the following data collection schemes:

  • 12-week treatment regimen: four visits plus two interim data collection windows
  • 24-week treatment regimen: four visits plus three interim data collection windows This schedule was based on the anticipated regular follow-up for patients undergoing treatment for CHC.

Study Type

Observational

Enrollment (Actual)

66

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Colombia
      • Bogotá, Colombia
        • Fundacion Cardioinfantil
      • Cali, Colombia, 760001
        • Cic Cali
      • Cali, Colombia
        • Centro Medico lmbanaco de Cali I
      • Cartagena, Colombia, 130013
        • Pharos Centro de Estudios Clin
      • Manizales, Colombia, 170004
        • IPS Medicos Internistas Del Ca I
      • Medellín, Colombia, 050010
        • Fundacion Hospitalaria San Vin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Participants with chronic hepatitis C (CHC), genotype 1, receiving combination therapy with the interferon-free ABBVIE REGIMEN ± RBV.

Description

Inclusion Criteria:

  • Treatment-naïve or -experienced adult male or female participants with confirmed CHC, genotype 1, receiving combination therapy with the interferon-free ABBVIE REGIMEN (ombitasvir/paritaprevir/ritonavir with or without dasabuvir) ± 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).
  • Participant must not be participating or intending to participate in a concurrent interventional therapeutic trial.

Exclusion Criteria:

- None

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Participants with Hepatitis C Virus Genotype 1 (HCV + GT1)
ABBVIE REGIMEN (ombitasvir/paritaprevir/ritonavir [25 mg/150 mg/100 mg once daily] with or without dasabuvir [250 mg twice daily]), and with or without weight-based ribavirin (± RBV; dosed 1,000 or 1,200 mg daily divided twice a day) for 12 or 24 weeks in HCV + GT1 participants.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants Achieving Sustained Virologic Response at 12 Weeks (SVR12) Post-treatment
Time Frame: 12 weeks (i.e. 70 to 126 days) after the last dose of study drug (up to 24 weeks)
SVR12 was defined as plasma hepatitis C virus (HCV) ribonucleic acid (RNA) level ˂50 IU/mL 12 weeks after end of treatment (EoT) (defined as after last actual dose of the ABBVIE REGIMEN [paritaprevir/ritonavir - ombitasvir ± dasabuvir] or ribavirin [RBV]).
12 weeks (i.e. 70 to 126 days) after the last dose of study drug (up to 24 weeks)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants With Virologic Response at End of Treatment (EoT)
Time Frame: Up to EoT, maximum of 24 weeks
Virologic response is defined as HCV RNA level <50 IU/mL.
Up to EoT, maximum of 24 weeks
Number of Participants Meeting Premature Study Drug Discontinuation
Time Frame: Up to EoT, maximum of 24 weeks
Premature study drug discontinuation was defined as participants who prematurely discontinued study drug (ABBVIE REGIMEN or RBV) and who experienced no on-treatment virologic failure (defined as breakthrough [at least 1 documented HCV RNA ˂50 IU/mL followed by HCV RNA ≥50 IU/mL during treatment] or failure to suppress [each measured on-treatment HCV RNA value ≥50 IU/mL]).
Up to EoT, maximum of 24 weeks
Percentage of Participants Meeting Each and Any SVR12 Non-response Criteria
Time Frame: During treatment and 12 weeks (i.e. at least 70 days) after the last dose of study drug (up to 24 weeks)

For a participant to be include in this analysis, the participant needed to meet each and any of the following SVR12 non-response categories:

  • 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] or failure to suppress [each measured on-treatment HCV RNA value ≥50 IU/mL]);
  • Relapse (defined as HCV RNA <50 IU/mL at actual EoT followed by HCV RNA ≥50 IU/mL post-treatment for participants who completed treatment [not more than 7 days shortened]);
  • Premature study drug discontinuation with no on-treatment virologic failure;
  • Missing SVR12 data and/or none of the above criteria (including participants with missing SVR12 data).

Abbreviations: EoT=end of treatment.
During treatment and 12 weeks (i.e. at least 70 days) after the last dose of study drug (up to 24 weeks)
Percentage of Participants With Relapse
Time Frame: 12 weeks (i.e. at least 70 days) after the last dose of study drug
Relapse was defined as confirmed HCV RNA <50 IU/mL at EoT or at the last on-treatment HCV RNA measurement followed by HCV RNA ≥50 IU/mL post-treatment in participants who were treated.
12 weeks (i.e. at least 70 days) after the last dose of study drug
Percentage of Participants With Relapse at EoT
Time Frame: 12 weeks (i.e. at least 70 days) after the last dose of study drug
Relapse was defined as confirmed HCV RNA <50 IU/mL at EoT followed by HCV RNA ≥50 IU/mL post treatment in participants who completed treatment (actual duration of ABBVIE REGIMEN is not shortened more than 7 days) and had HCV RNA results available in the SVR12 window.
12 weeks (i.e. at least 70 days) after the last dose of study drug
Percentage of Participants With Viral Breakthrough
Time Frame: Up to EoT, maximum of 24 weeks
Viral breakthrough was defined as at least 1 documented HCV RNA <50 IU/mL followed by HCV RNA ≥ 50 IU/mL during treatment.
Up to EoT, maximum of 24 weeks
Percentage of Participants Meeting On-treatment Virologic Failure
Time Frame: Up to EoT, maximum of 24 weeks
On-treatment virologic failure was defined as breakthrough (at least 1 documented HCV RNA <50 IU/mL followed by HCV RNA≥ 50 IU/mL during treatment) or failure to suppress (each measured on-treatment HCV RNA value ≥50 IU/mL).
Up to EoT, maximum of 24 weeks
Percentage of Participants With Rapid Virologic Response at Week 4 (RVR4)
Time Frame: Week 4
RVR4 was defined as HCV RNA < 50 IU/mL at Week 4.
Week 4
Percentage of Participants With Sustained Virologic Response at 24 Weeks (SVR24) After EoT
Time Frame: 24 weeks after EoT (up to 24 weeks)
SVR24 was defined as HCV RNA < 50 IU/mL 24 weeks after EoT. During the course of the study, standard of care was changing and it was no longer common practice to assess SVR24.
24 weeks after EoT (up to 24 weeks)

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
EuroQol 5 Dimension 5 Level (EQ-5D-5L) Questionnaire Index Score: Change From Baseline to EoT
Time Frame: EoT (up to 24 weeks)
The EQ-5D-5L is a 2-part instrument for use as a measure of health outcome, designed for self-completion by participants. The 5 items in the questionnaire comprise 5 dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) each of which are rated on 5 levels of severity (1: indicating no problem, 2: indicating slight problems, 3: indicating moderate problems, 4: indicating severe problems, 5: indicating extreme problems), and a separate VAS. The higher the score, the worse the quality of life. For the VAS, the higher the score, the better the quality of life. Participant responses to the EQ-5D-5L were used to generate a health status index (HSI). HSI ranges is anchored at 0 (dead) and 1 (full health).
EoT (up to 24 weeks)
EQ-5D-5L Questionnaire Index Score: Change From Baseline to 12 Weeks Post EoT
Time Frame: 12 weeks post EoT (up to 24 weeks)
The EQ-5D-5L is a 2-part instrument for use as a measure of health outcome, designed for self-completion by participants. The 5 items in the questionnaire comprise 5 dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) each of which are rated on 5 levels of severity (1: indicating no problem, 2: indicating slight problems, 3: indicating moderate problems, 4: indicating severe problems, 5: indicating extreme problems), and a separate VAS. The higher the score, the worse the quality of life. For the VAS, the higher the score, the better the quality of life. Participant responses to the EQ-5D-5L were used to generate a HSI. HSI ranges is anchored at 0 (dead) and 1 (full health).
12 weeks post EoT (up to 24 weeks)
EQ-5D-5L Questionnaire Index Score: Change From Baseline to 24 Weeks Post EoT
Time Frame: 24 weeks post EoT (up to 24 weeks)
The EQ-5D-5L is a 2-part instrument for use as a measure of health outcome, designed for self-completion by participants. The 5 items in the questionnaire comprise 5 dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) each of which are rated on 5 levels of severity (1: indicating no problem, 2: indicating slight problems, 3: indicating moderate problems, 4: indicating severe problems, 5: indicating extreme problems), and a separate VAS. The higher the score, the worse the quality of life. For the VAS, the higher the score, the better the quality of life. Participant responses to the EQ-5D-5L were used to generate a HSI. HSI ranges is anchored at 0 (dead) and 1 (full health).
24 weeks post EoT (up to 24 weeks)
EQ-5D-5L Questionnaire VAS: Change From Baseline to EoT
Time Frame: End of Treatment (up to 24 weeks)
The EQ-5D-5L is a 2-part instrument for use as a measure of health outcome, designed for self-completion by participants. Participants also rated their perception of their overall health on a separate VAS. The scale is numbered from 0 to 100. The higher the score, the better the quality of life.
End of Treatment (up to 24 weeks)
EQ-5D-5L Questionnaire VAS: Change From Baseline to 12 Weeks Post EoT
Time Frame: 12 weeks post EoT (up to 24 weeks)
The EQ-5D-5L is a 2-part instrument for use as a measure of health outcome, designed for self-completion by participants. Participants also rated their perception of their overall health on a separate VAS. The scale is numbered from 0 to 100. The higher the score, the better the quality of life.
12 weeks post EoT (up to 24 weeks)
EQ-5D-5L Questionnaire VAS: Change From Baseline to 24 Weeks Post EoT
Time Frame: 24 weeks post EoT (up to 24 weeks)
The EQ-5D-5L is a 2-part instrument for use as a measure of health outcome, designed for self-completion by participants. Participants also rated their perception of their overall health on a separate VAS. The scale is numbered from 0 to 100. The higher the score, the better the quality of life.
24 weeks post EoT (up to 24 weeks)
Number of Participants With Co-morbidities at Baseline (Day 0)
Time Frame: Baseline (Day 0)
Co-morbidities/co-infections were defined as hepatitis C virus (HCV) co-infections (human immunodeficiency virus [HIV] or hepatitis B virus [HBV], tuberculosis, schistosomiasis), liver/chronic hepatitis C (CHC) related co-morbidities (liver transplantation, hepatocellular carcinoma, non-alcoholic steatosis, alcoholic liver disease, primary biliary cirrhosis, auto-immune hepatitis, Wilson disease, cryoglobulinemia, porphyria cutanea tarda, auto-immune skin disease), and other co-morbidities (chronic kidney disease, psychiatric disorders, diabetes mellitus, insulin resistance, metabolic syndrome, lipid disorder, cardiovascular disease, immunologically mediated disease, hyper-/hypothyroidism, hemophilia, Thalassemia, sickle cell anemia, V. Willebrand disease, psychoactive substance dependency, kidney transplant, or other).
Baseline (Day 0)
Number of Participants With Concomitant Medications
Time Frame: Day 0 to EoT, maximum 24 weeks

This includes all participants that took at least 1 concomitant medication from the time when the decision was made to initiate treatment with the ABBVIE REGIMEN until after the last dose.

Abbreviations: ACE= angiotensin-converting-enzyme; GERD=gastroesophageal reflux.
Day 0 to EoT, maximum 24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AbbVie

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 23, 2017

Primary Completion (Actual)

August 30, 2018

Study Completion (Actual)

August 30, 2018

Study Registration Dates

First Submitted

July 28, 2016

First Submitted That Met QC Criteria

July 29, 2016

First Posted (Estimate)

August 1, 2016

Study Record Updates

Last Update Posted (Actual)

September 18, 2019

Last Update Submitted That Met QC Criteria

August 12, 2019

Last Verified

May 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P16-024

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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