Efficacy and safety of peginterferon alpha-2a (40KD) in HBeAg-positive chronic hepatitis B patients.
J Gastrointestin Liver Dis
; 18(4): 425-31, 2009 Dec.
Article
em En
| MEDLINE
| ID: mdl-20076814
ABSTRACT
AIM:
The study was designed to evaluate the efficacy and safety of peginterferon alpha-2a in HBeAg-positive chronic hepatitis B patients, nonresponders or relapsers after previous lamivudine or standard interferon therapy.METHODS:
This prospective, national, multicentric, open label, not randomized trial enrolled 43 HBeAg-positive chronic hepatitis B patients with detectable HBsAg for at least 6 months prior to screening, positive HBeAg and negative anti-HBe, serum HBV DNA levels of at least 500,000 copies/mL by PCR assay, elevated ALT up to 10 x ULN, no response or relapse after previous lamivudine or standard interferon therapy. All eligible patients received pegIFN alpha-2a 180 micrograms weekly for 48 weeks with 24 weeks treatment free follow-up. There were two main efficacy assessments HBeAg seroconversion and viral supression below 100,000 copies/mL.RESULTS:
HBeAg seroconversion rate at the end-of-treatment was 4.65% (n=2; p less than 0.05) increasing to 11.62% 24 weeks after end of therapy (n=5; p less than 0.05). The rate of viral supression at levels below 100,000 copies/mL was 23.25% (n=10; p less than 0.05) at end-of-treatment, and 16.3% (n=7; p less than 0.05) at end of follow-up. ALT normalization was obtained in 20.9% (p less than 0.05) of patients at end-of-treatment, the percentage being significantly higher - 37.2% (p less than 0.05) at the end of follow-up.CONCLUSIONS:
Even in a difficult-to-treat patient population with HBeAg-positive chronic hepatitis B, peginterferon alpha 2a proved to be efficient in a defined proportion of patients. The increase in HBeAg seroconversion rate from end-of-treatment (4.65%) to the end of follow-up period (11.62%) also proves the benefits of prolonged immunological effect of pegIFN alpha 2a.
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Base de dados:
MEDLINE
Assunto principal:
Antivirais
/
Polietilenoglicóis
/
Vírus da Hepatite B
/
Interferon-alfa
/
Hepatite B Crônica
/
Antígenos E da Hepatite B
Tipo de estudo:
Clinical_trials
/
Diagnostic_studies
/
Observational_studies
Limite:
Adult
/
Female
/
Humans
/
Male
País como assunto:
Europa
Idioma:
En
Ano de publicação:
2009
Tipo de documento:
Article