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Efficacy and safety of peginterferon alpha-2a (40KD) in HBeAg-positive chronic hepatitis B patients.
- Source :
-
Journal of gastrointestinal and liver diseases : JGLD [J Gastrointestin Liver Dis] 2009 Dec; Vol. 18 (4), pp. 425-31. - Publication Year :
- 2009
-
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.<br />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.<br />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.<br />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.
- Subjects :
- Adult
Alanine Transaminase blood
Antiviral Agents adverse effects
Biomarkers blood
DNA, Viral blood
Female
Hepatitis B Antibodies blood
Hepatitis B virus genetics
Hepatitis B virus growth & development
Hepatitis B virus immunology
Hepatitis B, Chronic diagnosis
Hepatitis B, Chronic immunology
Humans
Interferon alpha-2
Interferon-alpha adverse effects
Male
Polyethylene Glycols adverse effects
Prospective Studies
Recombinant Proteins
Romania
Time Factors
Treatment Outcome
Viral Load drug effects
Young Adult
Antiviral Agents therapeutic use
Hepatitis B e Antigens blood
Hepatitis B virus drug effects
Hepatitis B, Chronic drug therapy
Interferon-alpha therapeutic use
Polyethylene Glycols therapeutic use
Subjects
Details
- Language :
- English
- ISSN :
- 1841-8724
- Volume :
- 18
- Issue :
- 4
- Database :
- MEDLINE
- Journal :
- Journal of gastrointestinal and liver diseases : JGLD
- Publication Type :
- Academic Journal
- Accession number :
- 20076814