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: 0
• Participant gender: All

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.

• Accepts Healthy Volunteers?: No

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
• Treatments: Antiviral Agents; Grazoprevir; Ledipasvir; Ritonavir; Simeprevir; Sofosbuvir; Velpatasvir

Criteria

Inclusion Criteria:

• older than 18 years

• initiation of therapy including a direct-acting antiviral against HCV

Exclusion Criteria:

• HIV-infection

• unable to provide written informed consent