Pegylated Interferon Therapy for Acute Hepatitis C Infection in HIV-infected Patients

Inclusion Criteria:

• Documented acute hepatitis C infection with detectable HCV-RNA (PCR-assay) and elevated serum alanine transferase (ALT) levels. An acute infection is defined by fulfilling two of the following 3 criteria within the preceding four months:

  1. known or suspected exposure to HCV,
  2. documented seroconversion to positivity for antibodies against HCV,
  3. a serum alanine transferase (ALT) level of more than 350 U/l with a documented normal level during the year before infection.
• Documented HIV-infection
• CD4 cells > 300 /µl
• Ability to understand and sign a written consent form
• Women of child-bearing age: negative pregnancy test

Exclusion Criteria:

• Autoimmune hepatitis or other autoimmune disease
• Decompensated liver disease
• Decompensated renal disease, i.e. creatinine clearance < 50 ml/min, according to Cockcroft-Gault
• Acute or chronic hepatitis B infection
• Acute infection with hepatitis A or other hepatotropic viruses
• New AIDS defining event less than 1 month prior to enrolment
• Malignancy other than cutaneous kaposi sarcoma treated with systemic chemo-therapy
• History of severe psychiatric conditions, in particular severe depression
• History of seizures
• History of organ transplantation
• Thyroid disease not medically compensable
• Severe heart disease
• Severe retinopathy
• Known allergy to the study drug or one of the galenic compounds
• Hypersensitivity to interferon a
• Thrombocytes < 90 G/l, neutrophils < 1.5 G/l, hemoglobin must not be < 12g/dl (female) or < 13 g/dl (male)
• Treatment with corticosteroids less than 3 months prior to enrolment
• Alcohol abuse or use of other recreational drugs
• Older than 65 years of age, younger than 18 years of age
• Pregnancy, breast-feeding