Management and treatment of patients with a (previous) substance dependency and/or marginally housed patients with chronic hepatitis C: a prospective observational registry

The treatment of chronic hepatitis C with peginterferon and ribavirin is highly
effective but is hampered by side effects like flu-like symtpoms and
peginterferon-induced psychopathology. Compliance to therapy is of major
importance in achieving a good clinical outcome of treatment (sustained
virological respons)(1-4). For these reasons patients with a current or recent
history of substance abuse and/or other social and health concerns like
homelessness were excluded for therapy in the past. However there is growing
evidence in literature from previous studies that treatment with peginterferon
and ribavirin can be safe and effective in this group of patients. In these
studies several models for optimum HCV treatment delivery were developed in
multidisciplinary teams. (5-8)
As a result, the National Institutes of Health (NIH) consensus statement
recommended in 2002 that individuals with active injection drug use could be
considered for HCV treatment. These recommendations were reinforced by the most
recent practice guidelines of the American Association for the Study of Liver
Disease.(9,10)

The aim of Project Active Testing is to stimulate HIV, HBV and HCV testing, and
if necessary treatment or vaccination of (former) drug users and homeless
groups. It focuses on close cooperation between the different organizations
offering help to the patient group mentioned above and the treating physician
in the (academic) hospital in order to lower barriers in the treatment of
chronic hepatitis C in this patient group. In this project nurses in different
organizations in the care for patients with substance abuse and social work are
trained to get clients motivated to get tested for hepatitis C (and HIV), and
if necessary motivate and accompany patients during their therapy.

The Project is divided in three different phases:
Phase 1:
· pre- and post test counseling
Phase 2:
· Medical: staging liver disease: indication treatment
· Social-economical: further education, evaluation and (if possible) solving
problems that hinder treatment
· Final decision treatment
Phase 3:
· Professional care and social support during treatment: medication log, stop
registration, evaluation substance abuse etc.


The Project Active Testing further enables the opportunity to start treatment
in this *difficult-to-treat-population* within a structured and professional
healthcare system.

To register the feasibility of treatment with peginterferon and ribavirin for
chronic hepatitis C in (previous) substance users and other difficult to treat
patients within the Project Active Testing.

This is a multicentre prospective observational registry from the Foundation
for Liver Research at the department of Gastroenterology & Hepatology of the
Erasmus MC, Rotterdam, the Netherlands in cooperation with the Municipal Public
Health Service.Rotterdam-Rijnmond.

Prospective observational registry with 80 patients receiving standard dosing
of peginterferon alfa-2b (Pegintronâ) and ribavirin (Rebetolâ twice daily).

REGISTRY TIMELINE
Start patient entry : 15-05-2008
End patient entry : 15-11-2009
End of treatment : 15-10-2010
End of registry : 15-04-2011

REGISTRY DURATION
Treatment will start on day 0 for 24 or 48 weeks depending on genotype and
virological response to treatment. Two follow-up visits are scheduled 4 weeks
and 24 weeks after the end of treatment.

For this specific patientpopulation treatment with proper counselling is made
possible.