Program of Screening, Prevention and Elimination of Hepatitis C in Penitentiary Institutions in Cantabria (JAILFREE-C)
Condition: Hepatitis C
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis
Study type: Interventional
Phase: Phase 4

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.
    

Detailed description: 
      Background:

      Infections caused by hepatitis B, C and HIV viruses represent a serious health problem. The
      inmate population represents a reservoir with high prevalence of these kind of infections.
      The completion of a secondary prevention through early detection of infections in early
      stages, and tertiary prevention by treatment of diagnosed cases, constitutes one of the
      pillars of the approach to these diseases. This strategy is even more valuable in the inmate
      population because it can help eliminate a source of spread of these diseases in addition to
      relieving the burden of disease in this population. In this regard, one of the mandates of
      the recently adopted National Strategy Plan for the Hepatitis C in Spain emphasizes these
      strategies.

      Finally, a program of this nature is intended as a pilot experience that could be extended to
      other prison communities at national and European level.

      Endpoints

        1. - To estimate the prevalence of HBV, HCV and HIV in the inmate population of El Dueso.

        2. - To perform a systematic treatment of the inmate population against HCV infection. The
           treatment will be directed to both, the prevalent population and the new prisoners who
           enter the prison. The other detected infections will be also treated accordingly.

        3. - To carry out a descriptive evaluation of the efficacy and safety of an interferon-free
           regimen against the HCV infection in this population. This regimen will be mainly based
           on Sofosbuvir and ledipasvir (± RBV) according to the current clinical practice adopted
           in the National Strategy Plan for the Hepatitis C.

        4. - To evaluate the rates of persistent infection, reinfection and super-infection as
           defined.

      Projected Study Design

      The present study is divided in two parts. A transversal and observational one of
      epidemiological basis aimed to determine the prevalence of viral infections by hepatitis B
      and C viruses and also by HIV in the inmate population.

      In a second prospective phase of follow-up, a systematic treatment of the infected cohort
      will be carried out in accordance with the current clinical practice adopted in the National
      Strategy Plan for the Hepatitis C. Data on efficacy, safety and quality of life will be
      collected throughout the study. Finally, an evaluation of the rates of persistent infection,
      reinfection and super-infection will be also recorded. Treatment of new admissions throughout
      the study periods is also contemplated.

      Patients and Methods:

      Patients:

        1. - Epidemiological transversal phase: 435 subjects (the whole inmate population) will be
           included.

        2. - Prospective observational phase: 120 infected patients (taking into account a reported
           chronic HCV infection prevalence of 20% in the inmate population -data from the latest
           National Strategic Plan for addressing hepatitis C in the National Health Service "NHS"
           2015-) and that it is intended to treat newly infected inmate who enter in prison during
           the two years of study.

      Endpoints:

      Primary endpoint: Sustained Virological Response (SVR) at 12 weeks after the end of
      treatment.

      Secondary outcomes: SVR at 4 weeks, Safety issues, Quality of life, Serum prevalence of
      chronic HCV, HBV infection; re-infection/superinfection rates; cost-effectiveness

      Variables:

      Variables: HCV status by ELISA; Viral load (PCR) HCV IU / ml (primary), treatment type and
      duration, serological status of HBV infection; liver stiffness through Fibroscan. QoL
      variables, ultrasonographic variables. phylogenetic analysis of HCV genome in cases of
      non-response. costs

      Projected Number of Sites (if additional sites, please specify)

      1 (El Dueso Penitentiary Centre)

      Participating Countries

      1 (Spain)

      Anticipated First Patient In

      2-1-2016

      Projected Duration of Enrollment

      1 month for the prevalent inmate population. The entry of subjets (new inmates) will be open
      throughout the study

      Projected Duration of Treatment

      6 month (8-24 weeks according to patient and virological characteristics).

      Study Duration

      31 months (1 month enrollment + 6 months of treatment + 24 months observation and final
      evaluation of reinfections)
    

Intervention name(s): sofosbuvir; ledipasvir
Intervention type(s): Drug; Drug
Intervention description(s): Subjects will be treated according to the current guidelines on HCV treatment taking into account the stage of fibrosis, genotype, previous treatments, etc.
Sofosbuvir will be used in association with ledipasvir. In some cases, ribavirin can be added to this combination according to current guidelines; Subjects will be treated according to the current guidelines on HCV treatment taking into account the stage of fibrosis, genotype, previous treatments, etc.
Ledipasvir will be used in association with sofosbuvir. In some cases, ribavirin can be added to this combination according to current guidelines
Other intervention name(s): Harvoni; Harvoni
Intervention MeSH terms: Sofosbuvir; Ledipasvir, sofosbuvir drug combination; Ledipasvir
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: sofosbuvir; ledipasvir; ribavirin; prisoner; hepatitis c; prevalence; hepatitis b