Efficacy and Safety of Therapy Against HCV Based on Direct-acting Antivirals in Real-life Conditions
Status:
Unknown status
Trial end date:
2020-12-01
Target enrollment:
Participant gender:
Summary
Objectives: 1) To evaluate la proportion of hepatitic C virus (HCV)-monoinfected patients who
show sustained virologic response (SVR) to treatment including direct-acting antivirals
(DAAs) in the clinical practice in clinical units that treat infectious diseases and 2) to
determine the frequency of adverse events, including those that are severe and/or cause
treatment interruption, in DAA-based therapy in this setting.
Design: Multicentric, prospective post-authorised cohort study. Setting: Hospitals of the
Hepatitis Study Group (GEHEP) of the Spanish Society of Infectious Diseases and Microbiology
(SEIMC).
Study population: HCV-monoinfected patients that initiate DAA-based treatment outside
clinical trials.
Variables: The primary efficacy outcome variable is the proportion of patients who reach
undetectable HCV-RNA 12 weeks after the scheduled end of therapy (SVR12). The primary safety
outcome variable is the percentage of subjects who discontinue therapy due to adverse events.
Statistical analysis: A descriptive study will be performed, as well as a double sensibility
analysis of the frequency of SVR12 using both an intention-to-treat and an on-treatment
approach. Those variables that are associated with SVR12 with a p-value <0.2 will be included
in a logistic regression analysis in which SVR12 will be the dependent variable.
Details
Lead Sponsor:
Valme University Hospital
Collaborators:
Centro Penitenciario Alicante 1 Clinica Universidad de Navarra, Universidad de Navarra Complejo Hospitalario Universitario de Huelva Complejo Hospitalario Universitario de Vigo Complexo Hospitalario Universitario de A Coruña Complexo Hospitalario Universitario de Vigo Hospital Clinico Universitario San Cecilio Hospital de Figueres Hospital del SAS de Jerez Hospital General Universitario de Alicante Hospital General Universitario de Castellón Hospital General Universitario de Valencia Hospital General Universitario Elche Hospital General Universitario Santa Lucía Hospital La Línea de la Concepción Hospital Parc Taulí, Sabadell Hospital Regional Universitario Carlos Haya Hospital Royo Vilanova Hospital Universitario Araba Hospital Universitario de Burgos Hospital Universitario de Canarias Hospital Universitario de Gran Canaria Hospital Universitario Infanta Leonor Hospital Universitario La Fe Hospital Universitario Puerto Real Hospital Universitario Reina Sofia Hospital Universitario Reina Sofia de Cordoba Hospital Universitario Virgen de la Victoria Hospital Universitario Virgen Macarena Hospital Virgen de la Luz