Individualized Triple-therapy Using Boceprevir in HIV-positive Patients With Hepatitis C (HIVCOBOC-RGT)

Inclusion Criteria:

• Confirmed HIV infection (anti-HIV1/2 antibody positive).
• Chronic HCV infection (anti-HCV positive, HCV-RNA detectable for >6 months).
• HCV-GT 1 infection.
• Age ≥18 years and ≤65 years.
• No prior treatment with BOC/PEGIFN/RBV.
• CD4+ cell count >200 cells/µL.
• Stable antiretroviral therapy (ART) including tenofovir/emtricitabine (Truvada®, Gilead) and raltegravir (Isentress®, MSD) with HIV-RNA <50 copies/mL.
• Valid result on transient elastography or liver biopsy within 6 months prior to enrollment.
• Female patients of childbearing potential must agree to use an effective contraceptive during treatment and for 4 months after treatment has been concluded.
• Male patients or their female partners must agree to use an effective contraceptive during treatment and for 7 months after treatment has been concluded.

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.