The purpose of the study is to demonstrate the noninferiority of BIP48 (48 kDa peginterferon alfa-2b) compared to Pegasys ® (40 kDa peginterferon alfa-2a) associated with ribavirin, in naive patients with chronic hepatitis C.
The study will be an open, multicenter, randomized, controlled phase II - III trial. Patients (n = 740) will be randomized (1:1) to receive BIP48 (peginterferon alfa-2b 48kDa) or Pegasys ® (peginterferon alfa-2a 40kDa) 180 micrograms ,subcutaneously,once a week,associated with ribavirin at a dose 1000-1250 mg, orally, daily. For genotype 1 treatment time will be 48 to 72 weeks and for genotypes 2 and 3, 24 to 48 weeks. The study's population will be naive patients, of both sex, between 18 and 70 years old, with chronic hepatitis C (HCV), genotypes 1, 2 or 3, from 18 to 25 Brazilian research centers. Diagnostic criteria will be as followed: positive anti-HCV and qualitative PCR, liver biopsy showing any degree of fibrosis and at least mild inflammatory activity, performed in the last 24 months. The interruption Criteria will be: no partial virological response at 12 weeks and positive quantitative PCR at week 24.The primary outcome will be the rate of sustained virologic response and the secondary endpoints will be the quality of life during treatment, frequency of adverse events and cost-effectiveness. As a substudy, will be performed a comparative assessment in 24 patients, evaluating viral kinetics, pharmacokinetics and pharmacodynamics of repeated doses of both alfapeginterferons .
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
740
BIP 48 (Peginterferon alfa 2b 48kDA)will be administered in a dose of 180 micrograms, once a week, subcutaneous, for 24 to 48 weeks to genotypes 2 and 3, and for 48 to 72 weeks to genotype 1.
Patients will receive Pegasys ® in a dosage of 180 micrograms, once a week, subcutaneous, for 24 to 48 weeks to genotypes 2 and 3 and for 48 to 72 weeks to genotype 1.
Patients will receive BIP 48 in a dosage of 180 micrograms, once a week, subcutaneous, for 24 to 48 weeks to genotypes 2 and 3 and for 48 to 72 weeks to genotype 1.
Ufrgs/Hcpa
Porto Alegre, Rio Grande do Sul, Brazil
RECRUITINGThe rate of sustained virologic response - SVR - measured by PCR at 24 weeks after treatment.
Time frame: HCV PCR will be measured at 24 weeks after the end of therapy (week 48 for genotypes 2 and 3 and week 72 for genotype 1)
Frequency of adverse events
Blood tests included: ALT, AST, Creatinine and complete blood count. Anti-interferon immunoglobulin and thyroid-stimulating hormone (TSH) will be measured in the weeks 12, 24, 36, 48, 60 and 72 of the study.
Time frame: Clinical exam, blood tests and immunogenicity evaluation will be done twice monthly, in the first month, and then monthly until the end of treatment( week 24 for genotypes 2 and 3 and week 48 for genotype 1).
Virologic response at the end of treatment
Viral load will be measured by quantitative PCR at the end of treatment.
Time frame: Viral load will be measured at the end of treatment (week 24 for genotypes 2 and 3 and week 48 for genotype 1)
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