Treatment of Hepatitis C in Psychiatric Patients

Study Overview
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Brief Summary
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Psychiatric disorders or drug addiction are often regarded as contraindications against the use of Interferon-alpha in patients with chronic hepatitis C. The investigators aim is/was to get prospective data about adherence, efficacy and mental side effects of IFN-alpha treatment in different psychiatric risk groups compared to controls. In a prospective trial, 81 patients with chronic hepatitis C (positive HCV-RNA and elevated ALT) and psychiatric disorders (n=16), methadone substitution (n=21), former drug addiction (n=21) or controls without psychiatric history or addiction (n=23) should be/were treated with a combination of IFN-alpha-2a 3 x 3 Mio U/week and ribavirin (1000-1200 mg/day).

Detailed Description
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Patients from the Munich University outpatient department of psychiatry or gastroenterology as well as inpatients with elevated transaminases were tested for HCV-infection and considered for our trial to avoid a positive or negative selection. Medical inclusion criteria were a detectable serum HCV-RNA level in a PCR-based assay (AMPLICOR®, Roche Diagnostics, Branchburg, NJ) for more than 6 months and an elevated alanine aminotransferase (ALT > 30 U/L, normal <24 U/L). General exclusion criteria were the presence of other liver disease, Child B or C cirrhosis, severe cardiac or neurological disease, co-infection with hepatitis B or HIV, hepatocellular carcinoma evaluated by ultrasound and alpha-fetoprotein, autoimmune disorders, a neutrophil count below 1500 per cubic millimetre, and a platelet count below 75000 per cubic millimetre.

Official Title
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Treatment of Chronic Hepatitis c With Interferon-Alpha 2a and Ribavirin: a Comparison of Patients With Psychiatric Disorders and Controls

Conditions
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Mental Disorders, Drug Addiction

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Medical inclusion criteria were a detectable serum HCV-RNA level in a PCR-based assay (AMPLICOR®, Roche Diagnostics, Branchburg, NJ) for more than 6 months and an elevated alanine aminotransferase (ALT > 30 U/L, normal <24 U/L). Exclusion Criteria: General exclusion criteria were the presence of other liver disease Child B or C cirrhosis Severe cardiac or neurological disease Co-infection with hepatitis B or HIV Hepatocellular carcinoma evaluated by ultrasound and alpha-fetoprotein Autoimmune disorders Neutrophil count below 1500 per cubic millimetre Platelet count below 75000 per cubic millimetre

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Response |  |  | 
| Sustained Virological Response |  |  | 
| Adherence |  |  | 
| Occurrence of depression |  |  | 
| Occurrence of other psychiatric side effects |  |  | 
| Long term outcome |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Psychiatric side effects (group comparison) |  |  | 
| Long term outcome after treatment |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Interferon-alpha, hepatitis c, Drug addiction, methadone, psychiatric disorder, Safety and efficacy of Interferon-alpha i patients with a psychiatric disorder.