Clinical trial NCT02851069: Real World Evidence of the Effectiveness of Paritaprevir/r - Ombitasvir, ± Dasabuvir, ± Ribavirin in Patients With Chronic Hepatitis C in Colombia
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)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Hepatitis C
Keywords: Chronic Hepatitis C
Paritaprevir/r - Ombitasvir, ± Dasabuvir
Sustained Virological Response
Observational Study
Chronic Hepatitis C genotype 1
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2016-08-01
Enrollment: 66
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Percentage of Participants Achieving Sustained Virologic Response at 12 Weeks (SVR12) Post-treatment
timeFrame: 12 weeks (i.e. 70 to 126 days) after the last dose of study drug (up to 24 weeks)
Secondary outcomes:
measure: Percentage of Participants With Virologic Response at End of Treatment (EoT)
timeFrame: Up to EoT, maximum of 24 weeks
measure: Number of Participants Meeting Premature Study Drug Discontinuation
timeFrame: Up to EoT, maximum of 24 weeks
measure: Percentage of Participants Meeting Each and Any SVR12 Non-response Criteria
timeFrame: During treatment and 12 weeks (i.e. at least 70 days) after the last dose of study drug (up to 24 weeks)
measure: Percentage of Participants With Relapse
timeFrame: 12 weeks (i.e. at least 70 days) after the last dose of study drug
measure: Percentage of Participants With Relapse at EoT
timeFrame: 12 weeks (i.e. at least 70 days) after the last dose of study drug
measure: Percentage of Participants With Viral Breakthrough
timeFrame: Up to EoT, maximum of 24 weeks
measure: Percentage of Participants Meeting On-treatment Virologic Failure
timeFrame: Up to EoT, maximum of 24 weeks
measure: Percentage of Participants With Rapid Virologic Response at Week 4 (RVR4)
timeFrame: Week 4
measure: Percentage of Participants With Sustained Virologic Response at 24 Weeks (SVR24) After EoT
timeFrame: 24 weeks after EoT (up to 24 weeks)
Other outcomes:
measure: EuroQol 5 Dimension 5 Level (EQ-5D-5L) Questionnaire Index Score: Change From Baseline to EoT
timeFrame: EoT (up to 24 weeks)
measure: EQ-5D-5L Questionnaire Index Score: Change From Baseline to 12 Weeks Post EoT
timeFrame: 12 weeks post EoT (up to 24 weeks)
measure: EQ-5D-5L Questionnaire Index Score: Change From Baseline to 24 Weeks Post EoT
timeFrame: 24 weeks post EoT (up to 24 weeks)
measure: EQ-5D-5L Questionnaire VAS: Change From Baseline to EoT
timeFrame: End of Treatment (up to 24 weeks)
measure: EQ-5D-5L Questionnaire VAS: Change From Baseline to 12 Weeks Post EoT
timeFrame: 12 weeks post EoT (up to 24 weeks)
measure: EQ-5D-5L Questionnaire VAS: Change From Baseline to 24 Weeks Post EoT
timeFrame: 24 weeks post EoT (up to 24 weeks)
measure: Number of Participants With Co-morbidities at Baseline (Day 0)
timeFrame: Baseline (Day 0)
measure: Number of Participants With Concomitant Medications
timeFrame: Day 0 to EoT, maximum 24 weeks
Locations:
city: Bogotá
country: Colombia
facility: Fundacion Cardioinfantil
city: Cali
country: Colombia
facility: Cic Cali
city: Cali
country: Colombia
facility: Centro Medico lmbanaco de Cali I
city: Cartagena
country: Colombia
facility: Pharos Centro de Estudios Clin
city: Manizales
country: Colombia
facility: IPS Medicos Internistas Del Ca I
city: Medellín
country: Colombia
facility: Fundacion Hospitalaria San Vin
Study officials:
affiliation: AbbVie
name: AbbVie Inc.
role: STUDY_DIRECTOR
References:
citation: Ferenci P, Bourgeois S, Buggisch P, Norris S, Curescu M, Larrey D, Marra F, Kleine H, Dorr P, Charafeddine M, Crown E, Bondin M, Back D, Flisiak R. Real-world safety and effectiveness of ombitasvir/paritaprevir/ritonavir +/- dasabuvir +/- ribavirin in hepatitis C virus genotype 1- and 4-infected patients with diverse comorbidities and comedications: A pooled analysis of post-marketing observational studies from 13 countries. J Viral Hepat. 2019 Jun;26(6):685-696. doi: 10.1111/jvh.13080. Epub 2019 Mar 5.