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

• Status: Completed
• Trial end date: 2015-06-01
• Target enrollment: 0
• Participant gender: All

Summary

Response-guided triple-therapy with boceprevir (BOC) in combination with pegylated interferon (PEGIFN) and ribavirin (RBV) is the current standard of care for HIV-negative patients infected with hepatitis C genotype (HCV-GT) 1. In contrast, in HIV-positive patients, a fixed treatment duration of 48 weeks is used.

The aim of this study is to assess efficacy and safety of response-guided triple-therapy with BOC in combination with PEGIFN and RBV in HIV-positive patients. Thus, treatment duration will be individualized based on HCV-RNA negativity at treatment week 8 (W8). All patients will receive 4 weeks of PEGIFN/RBV lead-in. Patients with undetectable HCV-RNA at W8 will be treated with 24 weeks of BOC/PEGIFN/RBV triple-therapy resulting in a total treatment duration of 28 weeks, while patients with detectable HCV-RNA at W8 will receive 44 weeks of BOC/PEGIFN/RBV triple-therapy and a total treatment duration of 48 weeks.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Markus Peck-Radosavljevic
• Collaborator: Medical University of Vienna
• Treatments: Interferon alpha-2; Interferon-alpha; Interferons; Peginterferon alfa-2a; Ribavirin

Criteria

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.