Treatment of Hepatitis C in Psychiatric Patients

Charité University Medicine Berlin

Status: Completed

Conditions: Mental Disorders; Drug Addiction

Study type: Observational

Funder types: Other

Identifiers

NCT00751426

Psy 225/98

Details and patient eligibility

About

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).

Full description

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.

Enrollment: 81 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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