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Inclusion Criteria:
To be eligible for this trial, patients must have documentation of the following:
- Male or female > 18 years old
- HCV genotype-1 infection
- Liver biopsy consistent with Chronic Hepatitis C (CHC) within the last 3 years
- No previous treatment with any anti-HCV therapy (approved or investigational)
- For women of childbearing potential, a negative urine pregnancy test result
documented within 24 hours prior to the first dose of any study drug (BOC, PEG-INF
alfa-2b, or ribavirin). Additionally, all female patients of childbearing potential
and all males with female partners of childbearing potential must use two forms of
effective contraception (combined) during study treatment and for 6 months after
treatment.
- Willingness to give written informed consent and to participate in and comply with
requirements of the study
Exclusion Criteria:
Patients with any of the following will not be eligible for participation:
- Infection with HCV other than genotype 1
- History or other evidence of a medical condition associated with chronic liver
disease other than CHC (e.g., hemochromatosis, autoimmune hepatitis, metabolic liver
disease, alcoholic liver disease, toxin exposures)
- History or other evidence of decompensated liver disease (e.g., coagulopathy,
hyperbilirubinemia, hepatic encephalopathy, hypoalbuminemia, ascites, bleeding from
esophageal varices) or a Child-Pugh score > 6 (see Appendix 1)
- Infection with hepatitis A virus (HAV), hepatitis B virus (HBV), or HIV as
demonstrated by a positive test at screening for anti-HAV immunoglobulin M (IgM)
antibodies (Ab), hepatitis B surface antigen, anti-hepatitis B core protein IgM Ab,
or anti-HIV antibodies
- History of having received IFN, PEG-IFN, ribavirin, viramidine, levovirin, or
investigational HCV protease or polymerase inhibitors at any previous time, or any
other systemic antiviral therapy with established or perceived activity against HCV
within 3 months prior to enrollment.
- Pregnant or breastfeeding
- Male partners of females who are pregnant or breastfeeding
- Hemoglobin concentration < 12 g/dL in females or < 13 g/dL in males or any patient
with an increased risk for anemia (e.g., thalassemia, sickle cell anemia,
spherocytosis, history of gastrointestinal bleeding) or for whom anemia would be
medically problematic
- Absolute neutrophil count (ANC) < 1000 cells/mm3
- Platelet count < 70,000 cells/mm3
- Receipt of stimulating factors such as granulocyte colony stimulating factor (G-CSF),
erythropoietin, or other therapeutic agents to elevate hematology parameters to
facilitate patient entry into the study
- Serum creatinine concentration > 1.5 times the upper limit of normal (ULN)
- History of severe psychiatric disease, including psychosis and/or depression,
characterized by a suicide attempt, hospitalization for psychiatric disease, or a
period of disability as a result of psychiatric disease
- Poorly controlled thyroid dysfunction
- History of cardiac disease (e.g., New York Heart Association functional class II,
III, or IV, myocardial infarction within the last 6 months, ventricular
tachyarrhythmias requiring ongoing treatment, unstable angina, or other significant
cardiovascular diseases. In addition, patients with documented or presumed coronary
artery disease or cerebrovascular disease should not be enrolled if, in the judgment
of the investigator, an acute decrease in hemoglobin by up to 4 g/dL (as may be seen
with ribavirin therapy) would not be well tolerated.
- History of uncontrolled severe seizure disorder within the last year
- Patients treated previously with protease or polymerase inhibitors
- Coadministration of drugs that are highly dependent on CYP3A4/5 for clearance, and
for which elevated plasma concentrations are associated with serious and/or
life-threatening events including those in Appendix 2.
- Coadministration with potent CYP3A4/5 inducers, where significantly reduced
boceprevir plasma concentrations may be associated with reduced efficacy.
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