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.
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
66
Fundacion Cardioinfantil
Bogotá, Colombia
Cic Cali
Cali, Colombia
Centro Medico lmbanaco de Cali I
Cali, Colombia
Pharos Centro de Estudios Clin
Cartagena, Colombia
IPS Medicos Internistas Del Ca I
Manizales, Colombia
Fundacion Hospitalaria San Vin
Medellín, Colombia
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 \[RBV\]).
Time frame: 12 weeks (i.e. 70 to 126 days) after the last dose of study drug (up to 24 weeks)
Percentage of Participants With Virologic Response at End of Treatment (EoT)
Virologic response is defined as HCV RNA level \<50 IU/mL.
Time frame: 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 \[each measured on-treatment HCV RNA value ≥50 IU/mL\]).
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: 24 weeks after EoT (up to 24 weeks)
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