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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).
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)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Spanish cohort with HCV treated with DAA |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Spanish cohort with HCV treated in real practice with Elbasvir/Grazoprevir | Other | Spanish cohort with HCV treated in real practice with Elbasvir/Grazoprevir |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
-
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Patients with HCV who are treated in real practice with Elbasvir/Grazoprevir
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| HepaC | Madrid | 28020 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30265418 | Result | Hernandez-Conde M, Fernandez I, Perello C, Gallego A, Bonacci M, Pascasio JM, Romero-Gomez M, Llerena S, Fernandez-Rodriguez C, Castro Urda JL, Garcia Buey L, Carmona I, Morillas RM, Garcia ND, Gea F, Carrion JA, Castellote J, Moreno-Planas JM, Piqueras Alcol B, Molina E, Diago M, Montoliu S, de la Vega J, Menendez F, Sanchez Ruano JJ, Garcia-Samaniego J, Rosales-Zabal JM, Anton MD, Badia E, Souto-Rodriguez R, Salmeron FJ, Fernandez-Bermejo M, Figueruela B, Moreno-Palomares JJ, Calleja JL. Effectiveness and safety of elbasvir/grazoprevir therapy in patients with chronic HCV infection: Results from the Spanish HEPA-C real-world cohort. J Viral Hepat. 2019 Jan;26(1):55-64. doi: 10.1111/jvh.13008. Epub 2018 Oct 25. |
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| ID | Term |
|---|---|
| D006526 | Hepatitis C |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D006525 | Hepatitis, Viral, Human |
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| ID | Term |
|---|---|
| C000589335 | elbasvir |
| C578009 | grazoprevir |
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| 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 |
| D014777 |
| Virus Diseases |
| D018178 | Flaviviridae Infections |
| D012327 | RNA Virus Infections |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |