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The objectives of this study are:
Full 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
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:
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)
Enrollment
Sex
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64 participants in 1 patient group
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Data sourced from clinicaltrials.gov
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