The purpose of the study is to demonstrate the noninferiority of Algeron in combination with ribavirin compared to Pegasys in combination with ribavirin in the treatment of chronic hepatitis C.
The course of treatment in both groups shall be 12 weeks, and efficacy analysis, i.e. rate of rapid (after the 4th week) and early (after the 12th week) virologic response will be based on PCR data. For patients with treatment failure after the 12th week the antiviral therapy shall be discontinued. All patients who require further anti-viral treatment will receive a combination treatment with Algeron / Pegasys and ribavirin for another 12 or 36 weeks (depending on the HCV genotype). Sustained virologic response will be assessed 24 weeks after last dose of study treatment.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
170
Gomel Regional Clinical Hospital
Homyel, Belarus
EVR
Proportion of randomized patients achieving early virologic response (EVR) - negative PCR result for HCV RNA (\< 15 IU/ml) or ≥ 2log10 decrease of viral load after 12 weeks of study treatment
Time frame: 12 weeks
RVR
Proportion of randomized patients achieving rapid virologic response (RVR) - negative PCR result for HCV RNA (\< 15 IU/ml) after 4 weeks of treatment.
Time frame: 4 weeks
SVR (24)
Proportion of randomized patients achieving sustained virologic response (SVR) - negative PCR result for HCV RNA (\< 15 IU/ml) 24 weeks after last dose of study treatment
Time frame: 24 weeks after last dose of study treatment
EOT
Proportion of randomized patients achieving end-of-treatment response (EOT) -undetectable HCV RNA (\< 15 IU/ml) at the end of treatment (after 24 weeks of treatment for patients with genotype 2 or 3 and after 48 weeks of treatment for patients with genotype 1 or 4).
Time frame: After 24 weeks of treatment for patients with genotype 2 or 3 and after 48 weeks of treatment for patients with genotype 1 or 4
Biochemical Response
Proportion of patients who have ALT level ≤ than upper normal level after 12 weeks of treatment, at the end of treatment (after 24 weeks of treatment for patients with genotype 2 or 3 and after 48 weeks of treatment for patients with genotype 1 or 4) and 24 weeks after last dose of study treatment.
Time frame: 12, 24, 48 weeks of treatment, and 24 weeks after last dose of study treatment
Histological Response
Proportion of patients who have histological response, defined by a 1 level decrease in total METAVIR score measured on Fibroscan
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Time frame: 12 weeks of treatment and 24 weeks after last dose of study treatment