Abstract

Aim: The study was designed to evaluate the efficacy and safety of peginterferon α-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 α-2a 180 µg 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<0.05)  increasing to 11.62% 24 weeks after end of therapy (n=5; p<0.05). The rate of viral supression at levels below 100,000 copies/mL was 23.25% (n=10; p< 0.05) at end-of-treatment, and 16.3% (n=7; p<0.05) at end of follow-up. ALT normalization was obtained in 20.9% (p<0.05) of patients at end-of-treatment, the percentage being  significantly higher - 37.2% (p<0.05) at the end of follow-up.

Conclusions: Even in a difficult-to-treat patient population with HBeAg-positive chronic hepatitis B,  peginterferon alfa 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 α-2a.

Keywords

Alanine aminotransferase, chronic hepatitis B, hepatitis B e antigen, hepatitis B virus, interferon α-2a, viral DNA