This observational study will evaluate the efficacy and safety of Pegasys (peginterferon alfa-2a) in patients with chronic hepatitis B who have failed antiviral treatment with nucleoside (nucleotide) analogues. Data will be collected from patients treated according to the current Summary of Product Characteristics and local standard of care and regulations during 48 weeks of treatment and 24 weeks of follow-up.
Study Type
OBSERVATIONAL
Enrollment
44
Unnamed facility
Bytom, Poland
Unnamed facility
Dębica, Poland
Unnamed facility
Gdansk, Poland
Unnamed facility
Krakow, Poland
Efficacy: HBsAg seroclearance/seroconversion rate at the end of Week 72 (48 weeks of treatment and 24 weeks of follow-up)
Time frame: approximately 2.5 years
HBs levels in correlation with treatment outcome
Time frame: approximately 2.5 years
For HBeAg positive patients: Proportion of patients with HBeAg loss and presence of anti HBe (HBeAg seroconversion) at the end of Week 72 (48 weeks of treatment and 24 weeks of follow-up)
Time frame: approximately 2.5 years
For HBeAg negative patients: Proportion of patients with HBV DNA </= 2000 IU/ml and ALT normalization
Time frame: approximately 2.5 years
Safety: Incidence of adverse events
Time frame: approximately 2.5 years
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Unnamed facility
Krakow, Poland
Unnamed facility
Mysłowice, Poland
Unnamed facility
Racibórz, Poland
Unnamed facility
Wroclaw, Poland
Unnamed facility
Łańcut, Poland