Program of Screening, Prevention and Elimination of Hepatitis C in Penitentiary Institutions in Cantabria (JAILFREE-C)

• Status: Completed
• Trial end date: 2017-05-10
• Target enrollment: 0
• Participant gender: All

Summary

The objectives of this study are:

1. To perform a systematic screening and evaluation of the prevalence of infection by hepatitis C virus (HCV), hepatitis B virus (HBV) and human immunodeficiency virus (HIV) in the prison population.

2. To perform an adequate characterization of patients and the characteristics of HCV infection in this population.

3. To evaluate the effectiveness and security in the prison population of an interferon-free antiviral regimen.

4. To evaluate the impact of a strategy of systematic HCV treatment on the rates of persistent infection, reinfection and super-infection in a prison population, in the short, medium and long term.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Instituto de Investigación Marqués de Valdecilla
• Treatments: Ledipasvir; Ledipasvir, sofosbuvir drug combination; Ribavirin; Sofosbuvir

Criteria

Inclusion Criteria:

• Epidemiology study: All inmates at the El Dueso Penitentiary Centre including new admissions within the study period.

• Interventional study: All HCV infected patients with detectable viral load (HCV RNA)

• Informed consent signature

Exclusion Criteria:

• Not informed consent signature.

• Pregnant or breastfeeding women

• Hypersensitivity or any temporary or permanent absolute contraindication to either drug that should be prescribed according to clinical and virological characteristics of the patient.