Peginterferon α-2a (40 kDa): an advance in the treatment of hepatitis B e antigen-positive chronic hepatitis B

• Published in: Journal of viral hepatitis Vol. 10; no. 4; pp. 298 - 305
• Main Authors: Cooksley, W. G. E., Piratvisuth, T., Lee, S.-D., Mahachai, V., Chao, Y.-C., Tanwandee, T., Chutaputti, A., Chang, W. Yu, Zahm, F. E., Pluck, N.
• Format: Journal Article
• Language: English
• Published: Oxford, UK Blackwell Science Ltd 01.07.2003
• Subjects: alanine transaminase; chronic hepatitis B; hepatitis B e antigen; hepatitis B virus; interferon α-2a; viral DNA
• ISSN: 1352-0504; 1365-2893
• DOI: 10.1046/j.1365-2893.2003.00450.x

Current therapies for chronic hepatitis B (CHB) have a number of limitations, and better treatment options are needed. Peginterferon α‐2a (40 kDa) is superior to conventional interferon α‐2a in the treatment of chronic hepatitis C. This is the first report on peginterferon α‐2a (40 kDa) in the treatment of CHB. In this phase II study, 194 patients with CHB not previously treated with conventional interferon‐α were randomized to receive weekly subcutaneous doses of peginterferon α‐2a (40 kDa) 90, 180 or 270 μg, or conventional interferon α‐2a 4.5 MIU three times weekly. Twenty‐four weeks of therapy were followed by 24 weeks of treatment‐free follow‐up. All subjects were assessed for loss of hepatitis B e antigen (HBeAg), presence of hepatitis B antibody (anti‐HBe), suppression of hepatitis B virus (HBV) DNA, and normalization of serum alanine transaminase (ALT) after follow‐up. At the end of follow‐up, HBeAg was cleared in 37, 35 and 29% of patients receiving peginterferon α‐2a (40 kDa) 90, 180 and 270 μg, respectively, compared with 25% of patients on conventional interferon α‐2a. The combined response (HBeAg loss, HBV DNA suppression, and ALT normalization) of all peginterferon α‐2a (40 kDa) doses combined was twice that achieved with conventional interferon α‐2a (24%vs 12%; P = 0.036). All treatment groups were similar with respect to frequency and severity of adverse events. These results indicate that peginterferon α‐2a (40 kDa) is superior in efficacy to conventional interferon α‐2a in chronic hepatitis B based on clearance of HBeAg, suppression of HBV DNA, and normalization of ALT.