Boceprevir-based Therapy to Rescue HCV Genotype 1/HBV Infected Patients Refractory to Combination Therapy
Condition: Hepatitis C, Chronic
MeSH terms: Hepatitis C; Hepatitis C, Chronic; Hepatitis
Intervention: Stop trial intervention for boceprevir, PEG-IFN and RBV
Intervention description: Stop trial intervention for patients with 32 week therapy (arm A): for all patients, if HCV RNA is more than 100 IU/ml at week 12 or HCV RNA is detectable at week 24, therapy will be stopped.
Stop trial intervention for patients with 48 weeks therapy (arm B): for all patients, if HCV RNA is more than 100 IU/ml at week 12 or HCV RNA is detectable at week 24, therapy will be stopped.
Stop trial intervention for for null responder or cirrhotic patients: (arm C) for all patients, if HCV RNA is more than 100 IU/ml at week 12 or HCV RNA is detectable at week 24, therapy will be stopped.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 12.0
Sex: All
Minimum age: 20 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: hepatitis C virus; hepatitis B virus; boceprevir; null responder; partial responder; relapser

Summary:

      The aim of this study is to explore the efficacy and safety of boceprevir -based triple
      therapy to rescue HCV genotype 1 (HCV GT1)/HBV dually infected patients refractory to
      previous peginterferon (PEG-IFN) plus ribavirin (RBV) combination therapy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  1. Patient must be 20 years or older

          -  2. Patient must have HCV GT1 infection combined with HBV infection.

          -  3. Patients must be serum HCV RNA detectable, anti-HCV positive, HBsAg positive and
             HBeAg negative.

          -  4. Patient has previously failed treatment with PEG-IFN-α 2a or 2b/RBV for minimum of
             12 weeks of treatment.

          -  5. Patient must have compensated liver disease consistent with CHC and/or CHB, and no
             other etiology. Note: patients with cirrhosis should have a liver imaging study (e.g.
             ultrasound, CT scan or MRI) within the preceding 6 months showing no evidence of
             hepatocellular carcinoma.

          -  6. Patient meets all of the requirements and none of the contra-indications for
             treatment with PEG-IFN alpha-2b/RBV or boceprevir defined in the labels for the
             PEG-IFN/RBV to be used in combination with boceprevir.

          -  7. Patient is able and willing to provide signed informed consent (prepared by and
             administered by the physician) as required by local country requirements.

        Exclusion Criteria:

          -  1. Mixed genotypes including HCV genotype other than genotype 1.

          -  2. Patient has received boceprevir, narlaprevir, telaprevir, or any other HCV protease
             inhibitor treatment.

          -  3. Patient has evidence of decompensated liver disease including but not limited to, a
             history or presence of clinical ascites, bleeding varices, or hepatic encephalopathy.

          -  4. Patient meets any of the following exclusionary hematologic and biochemical
             criteria (documentation required) Hemoglobin <12 gm/dL for females and <13 gm/dL for
             males Neutrophils <1500/mm3 Platelets <100,000/mm3

          -  5. Patient has an organ transplant other than cornea or hair.

          -  6. Patient is co-infected with human immunodeficiency virus (HIV)

          -  7. Patient requires or is anticipated to require any of the following prohibited
             medications: midazolam, pimozide, amiodarone, flecainide, propafenone, quinidine, and
             ergot derivatives

          -  8. Patient with clinical diagnosis or evidence of substance abuse involving alcohol,
             intravenous drugs, inhalational psychotropics, narcotics, cocaine prescription or
             over-the-counter drugs.

          -  9. Patient previously demonstrated clinically significant hypersensitivity or other
             contraindication to any component of the boceprevir formulation. This drug contains
             lactose. Patients with rare hereditary problems of galactose intolerance, the Lapp
             lactase deficiency, or glucose-galactose malabsorption should not take this medicine.

          -  10. Serious illness, including malignancy, active coronary artery disease or cardiac
             dysfunction within 24 weeks prior to study entry, that in the opinion of the site
             investigator may preclude completion of the treatment regimen.

          -  11. Major hemoglobinopathy (e.g., thalassemia major), coagulopathy or any other cause
             of or tendency to hemolysis or bleeding