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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Chronic Hepatitis C

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Participants with Hepatitis C Virus Genotype 1 (HCV + GT1)<br>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?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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) | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Chronic Hepatitis C, Paritaprevir/r - Ombitasvir, ± Dasabuvir, Sustained Virological Response, Observational Study, Chronic Hepatitis C genotype 1