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

Chronic Hepatitis C Clinical Trial

— outCome  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02851069
• Other study ID #: P16-024
• Status: Completed
• Start date: February 23, 2017
• Est. completion date: August 30, 2018

Study information

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

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 66
• Est. completion date: August 30, 2018
• Est. primary completion date: August 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Locations

Country	Name	City	State
Colombia	Fundacion Cardioinfantil	Bogotá
Colombia	Centro Medico lmbanaco de Cali I	Cali
Colombia	Cic Cali	Cali
Colombia	Pharos Centro de Estudios Clin	Cartagena
Colombia	IPS Medicos Internistas Del Ca I	Manizales
Colombia	Fundacion Hospitalaria San Vin	Medellín

Sponsors (1)

Lead Sponsor	Collaborator
AbbVie

Country where clinical trial is conducted

Colombia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	EuroQol 5 Dimension 5 Level (EQ-5D-5L) Questionnaire Index Score: Change From Baseline to EoT	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)
Other	EQ-5D-5L Questionnaire Index Score: Change From Baseline to 12 Weeks Post EoT	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)
Other	EQ-5D-5L Questionnaire Index Score: Change From Baseline to 24 Weeks Post EoT	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)
Other	EQ-5D-5L Questionnaire VAS: Change From Baseline to EoT	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)
Other	EQ-5D-5L Questionnaire VAS: Change From Baseline to 12 Weeks Post EoT	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)
Other	EQ-5D-5L Questionnaire VAS: Change From Baseline to 24 Weeks Post EoT	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)
Other	Number of Participants With Co-morbidities at 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)
Other	Number of Participants With Concomitant Medications	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
Primary	Percentage of Participants Achieving Sustained Virologic Response at 12 Weeks (SVR12) Post-treatment	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	Percentage of Participants With Virologic Response at End of Treatment (EoT)	Virologic response is defined as HCV RNA level <50 IU/mL.	Up to EoT, maximum of 24 weeks
Secondary	Number of Participants Meeting Premature Study Drug Discontinuation	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
Secondary	Percentage of Participants Meeting Each and Any SVR12 Non-response Criteria	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)
Secondary	Percentage of Participants With Relapse	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
Secondary	Percentage of Participants With Relapse at EoT	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
Secondary	Percentage of Participants With Viral Breakthrough	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
Secondary	Percentage of Participants Meeting On-treatment Virologic Failure	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
Secondary	Percentage of Participants With Rapid Virologic Response at Week 4 (RVR4)	RVR4 was defined as HCV RNA < 50 IU/mL at Week 4.	Week 4
Secondary	Percentage of Participants With Sustained Virologic Response at 24 Weeks (SVR24) After EoT	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)