Effectiveness, Safety and Clinical Outcomes of Elbasvir/Grazoprevir: Results From a Spanish Real World Cohort

Study Overview
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Brief Summary
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This is a multicentre, descriptive, observational and ambispective study carried out in patients who are treated with Elbasvir/Grazoprevir in hospitals that included their data in Hepa-C Registry (directed by the Spanish Association for the Study of the Liver and the Networked Biomedical Research Centre for Hepatic and Digestive Diseases).

Detailed Description
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This is a multicentre, descriptive, observational and ambispective study carried out in patients who are treated with Elbasvir/Grazoprevir in hospitals that included their data in Hepa-C Registry (directed by the Spanish Association for the Study of the Liver and the Networked Biomedical Research Centre for Hepatic and Digestive Diseases)

Official Title
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Effectiveness, Safety and Clinical Outcomes of Elbasvir/Grazoprevir: Results From a Spanish Real World Cohort

Conditions
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Hepatitis C

Intervention / Treatment
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* Other: Spanish cohort with HCV treated in real practice with Elbasvir/Grazoprevir


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age: 18 years to 100 years (adult). Sexes: all Healthy volunteers: no Chronic hepatitis C (anti-HCV antibodies and detectable HCV-RNA). Exclusion Criteria: -

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> | Other: Spanish cohort with HCV treated in real practice with Elbasvir/Grazoprevir<br>* Spanish cohort with HCV treated in real practice with Elbasvir/Grazoprevir<br>|

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 |
| --- | --- | --- |
| virologic failure | 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 or previous unquantifiable HCV up to 12 weeks after last dose of drug | Up to 8 weeks while on treatment | 
| SVR 12 and patients with mild fibrosis | 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 | 
| low baseline viral load and SVR12 | Percentage of participants with low baseline viral load who achieve sustained • 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