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).
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)
Study Type
OBSERVATIONAL
Enrollment
130
Spanish cohort with HCV treated in real practice with Elbasvir/Grazoprevir
HepaC
Madrid, Spain
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.
Time frame: 12 weeks after the last dose of study drug
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
Time frame: 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
Time frame: 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.
Time frame: Baseline and 12 weeks after the last dose of drug
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