Effectiveness, Safety and Clinical Outcomes of Paritaprevir/Ombitasvir/r+Dasabuvir 8 Weeks

Study Overview
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Brief Summary
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The aim of the study is to evaluate in clinical practice the efficacy and safety of ombitasvir/paritaprevir/ ritonavir and dasabuvir administered for 8 weeks in treatment-naïve participants with genotype 1b hepatitis C virus (HCV).

Detailed Description
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HCV chronic infection affects 200 million people worldwide. HCV antiviral treatment has evolved rapidly since 2011. The introduction of direct-acting antivirals (DAAs) achieve great effectiveness with minimum SAEs and short treatment duration. However, studies evaluating efficacy and safety of ombitasvir/paritaprevir/ ritonavir and dasabuvir during 8 weeks are limited in real clinical practice. The aim of the study is to evaluate in clinical practice the efficacy and safety of ombitasvir/paritaprevir/ ritonavir and dasabuvir administered for 8 weeks in treatment-naïve participants with genotype 1b hepatitis C virus (HCV).

Official Title
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Efficacy and Safety in Clinical Practice of Ombitasvir/Paritaprevir/ Ritonavir and Dasabuvir Administered for 8 Weeks (3D8) in Treatment-naïve Genotype 1b Hepatitis C Virus Infected Patients: Analysis of Data From Hepa-C Registry.

Conditions
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Hepatitis C Infection

Intervention / Treatment
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* Drug: ombitasvir/paritaprevir/ritonavir 8 weeks
* Drug: dasabuvir 8 weeks


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Chronic hepatitis C (anti-HCV antibodies and detectable HCV-RNA). Genotype 1b infection Treatment-naïve and non-cirrhotic Exclusion Criteria: HCV genotype or subtype other than GT1b. Any current or past clinical evidence of cirrhosis.

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 |
| --- | --- |
| Spanish cohort with HCV treated with DAA<br>Spanish cohort with HCV treated in real practice with ombitasvir/paritaprevir/ritonavir 8 weeks and dasabuvir 8 weeks | Drug: ombitasvir/paritaprevir/ritonavir 8 weeks<br>* Spanish cohort with HCV treated in real practice with ombitasvir/paritaprevir/ ritonavir 8 weeks<br>* Other names: viekirax;Drug: dasabuvir 8 weeks<br>* Spanish cohort with HCV treated in real practice with dasabuvir 8 weeks<br>* Other names: exviera;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sustained virological response 12 weeks post-treatment (SVR12) | Percentage of participants who achieve sustained virological response 12 weeks post-treatment (SVR12) • Measure: Hepatitis C virus ribonucleic acid (HCV-RNA) levels less than the lower limit of quantification. | 12 weeks after the last dose of study drug | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of patients with virologic failure during treatment | Percentage of patients with virologic failure during treatment • Measure: Percentage of patients with confirmed >=1 log10 IU/mL increase from nadir in HCV RNA at any time point during treatment | Up to 12 weeks after last dose of study drug | 
| Mild fibrosis and sustained virological response 12 weeks post-treatment | Percentage of patients with mild fibrosis who achieve sustained virological response 12 (SVR12) weeks post-treatment • Measure: percentage of patients with a baseline transient elastography < 6 kPa | Up to 12 weeks after last dose of study drug | 
| Percentage of participants with low baseline viral load and SVR12 weeks post-treatment | Percentage of participants with low baseline viral load who achieve sustained virological response 12 (SVR12) weeks post-treatment • Measure: HCV RNA levels less than the lower limit of quantification. | Baseline and 12 weeks after the last dose of drug | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hepatitis C Infection, Ombitasvir/Paritaprevir/Ritonavir+dasabuvir