Hepatitis C Treatment of Inmates
Hepatitis C Treatment of Inmates
Hepatitis C infection is a prevalent chronic disease. It is particularly prevalent among
 intravenous drug abusers. Bergen fengsel is a regional prison housing 250 inmates, of which
 as many as 70 are recorded HCV RNA PCR positive annuallly. In this study inmate males and
 females will be randomized to standard screening and initiation procedure, or to a rapid
 initiation procedure in the hospital's infectious diseases outpatient clinic. The study aims
 at studying if rapid inclusion will increase the possibility to conclude treatment while the
 prisoner still is incarcerated, thus improve the chances of reaching a sustained virologic
 response, compared to standard inclusion, where prisoners, as other out patients will wait
 for inclusion for several months.
Inclusion Criteria:

 -  Serologic evidence of chronic hepatitis C infection by an anti-HCV test

 -  Serum HCV-RNA quantifiable at > 600 IU/mL or 1000 copies/mL by the Roche AMPLICOR HCV
 MONITOR Test, v2.0

 -  Patients with both normal or elevated serum ALT are eligible

 -  Compensated liver disease (Child-Pugh grade A clinical classification)

 -  Patients with cirrhosis or transition to cirrhosis must have an abdominal
 ultrasonography, CT scan or MRI scan without evidence of hepatocellular carcinoma and
 a serum AFP < 100 ng/mL within 2 months of randomization

 -  Negative urine or blood pregnancy test (for women of childbearing potential)
 documented within the 24 hour period prior to first dose of study drug

 -  All fertile males and females receiving RBV must be using two forms of effective
 contraception during treatment and during the 6 months after treatment ends

 Exclusion Criteria:

 -  Women with ongoing pregnancy or breat feeding

 -  Therapy with any systemic anti-viral, anti-neoplastic or immunomodulatory treatment
 (including supraphysiologic soses of steroids and radiation) < 6 months prior to the
 first dose of study drug

 -  Any investigational drug < 6 weeks prior to the first dose of study drug Positive test
 at screening for anti-HAV IgM Ab, HBsAg, anti-HBsAg, anti-HBc Ab, anti-HIV Ab.

 -  History or evidence of a medical condition associated with chronic liver disease other
 than HCV (e.g. hemochromatosis, autoimmune hepatitis, metabolic liver disease,
 alcoholic liver disease, toxin exposures)

 -  History or evidence of bleeding from esophageal varices or other conditions consistent
 with decompensated liver disease

 -  Neutrophil count < 1500/mm or platelet count < 90,000 cells/mm at screening

 -  Serum creatinine level > 1,5 times the ULN at screening

 -  History of severe psychiatric disease, especially depression. Severe psychiatric
 disease is defined as treatment with an antidepressant medication or neuroleptica at
 therapeutic doses for major depression or psychosis, respectively for at least 3
 months at any previous time, or any history of the following; a suicidal attempt,
 hospitalization for psychiatric disease or a period of disability due to psychiatric
 disease

 -  History of severe seizure disorder or current anticonvulsant disease

 -  History of immunologically mediated disease (e.g. IBD, ITP, LED, AIHA, scleroderma,
 severe psoriasis or RA etc.)

 -  History or other evidence of chronic pulmonary disease associated with functional
 limitation

 -  History of major organ transplantation with an existing functional graft

 -  History of severe cardiac disease (e.g. NYHA Functional Class III or IV, myocardial
 infarction within 6 months of ventricular arrhythmias requiring ongoing treatment,
 unstable angina or other significant CVD)

 -  History or other evidence of severe illness, malignancy or other conditions which
 would make the patient, in the opinion of the investigator, unsuitable for the study

 -  Evidence of severe retinopathy (e.g. CMV retinitis, macula degeneration)

 -  Evidence of ongoing drug abuse (including excessive alcohol consumption)

 -  Inability or unwillingness to provide informed consent or abide by the requirements of
 the study

 -  Male partners of women who are pregnant

 -  Hemoglobin < 12 g/dL in women or < 13g/dL in men at screening

 -  Any patient with an increased baseline risk for anemia or for whom anemia would be
 medically problematic

 -  Patients with documented or presumed coronary artery disease or cerebrovascular
 disease should not be enrolled if, in the judgement of the investigator, an acuter
 decrease in hemoglobin by up to 4 g/dL would not be well-tolerated