Individualized Triple-therapy Using Boceprevir in HIV-positive Patients With Hepatitis C

Exclusion Criteria

• •HCV-GT other than HCV-GT 1.
• •Cirrhotic patients (as defined by METAVIR F4 in liver biopsy or liver stiffness \>12.3 kPa) with decompensated liver disease (Child-Pugh stage B/C).
• •Chronic liver diseases other than hepatitis C virus infection (hepatitis B virus infection: HBsAg positivity, nonalcoholic steatohepatitis, autoimmune hepatitis, primary biliary cirrhosis, hemochromatosis, Wilson's disease, alpha-1 antitrypsin deficiency, cystic fibrosis).
• •Significant cardiac disease (ejection fraction \<40% at echocardiography).
• •Significant pulmonary disease (COPD stage GOLD III/IV).
• •Significant renal disease (serum creatinine \>1.5 mg/dL).
• •Subjects taking medication(s) that is/are highly dependent on CYP3A4/5 for clearance, and for which elevated plasma concentrations are associated with serious and/or life-threatening events such as but not limited to, orally administered midazolam, pimozide, amiodarone, flecainide, propafenone, quinidine, and ergot derivatives (dihydroergotamine, ergonovine, ergotamine, methylergonovine).
• •Contraindications for boceprevir (Victrelis®, MSD), pegylated interferon alpha-2a (Pegasys®, Roche) or ribavirin (Copegus®, Roche), as listed in section 4.3 of the respective summary of product characteristics (SmPCs).
• •Ongoing alcohol abuse (average daily alcohol consumption \>50g).
• •Ongoing illicit drug abuse.
• •Unwillingness to give written informed consent.
• •Pregnancy and breastfeeding.
• •Women wishing to become pregnant.