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

<jats:title>Summary.</jats:title><jats:p>Current therapies for chronic hepatitis B (CHB) have a number of limitations, and better treatment options are needed. Peginterferon <jats:italic>α</jats:italic>‐2a (40 kDa) is superior to conventional interferon <jats:italic>α</jats:italic>‐2a in the treatment of chronic hepatitis C. This is the first report on peginterferon <jats:italic>α</jats:italic>‐2a (40 kDa) in the treatment of CHB. In this phase II study, 194 patients with CHB not previously treated with conventional interferon‐<jats:italic>α</jats:italic> were randomized to receive weekly subcutaneous doses of peginterferon <jats:italic>α</jats:italic>‐2a (40 kDa) 90, 180 or 270 <jats:italic>μ</jats:italic>g, or conventional interferon <jats:italic>α</jats:italic>‐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.</jats:p><jats:p>At the end of follow‐up, HBeAg was cleared in 37, 35 and 29% of patients receiving peginterferon <jats:italic>α</jats:italic>‐2a (40 kDa) 90, 180 and 270 <jats:italic>μ</jats:italic>g, respectively, compared with 25% of patients on conventional interferon <jats:italic>α</jats:italic>‐2a. The combined response (HBeAg loss, HBV DNA suppression, and ALT normalization) of all peginterferon <jats:italic>α</jats:italic>‐2a (40 kDa) doses combined was twice that achieved with conventional interferon <jats:italic>α</jats:italic>‐2a (24%<jats:italic>vs</jats:italic> 12%; <jats:italic>P</jats:italic> = 0.036). All treatment groups were similar with respect to frequency and severity of adverse events. These results indicate that peginterferon <jats:italic>α</jats:italic>‐2a (40 kDa) is superior in efficacy to conventional interferon <jats:italic>α</jats:italic>‐2a in chronic hepatitis B based on clearance of HBeAg, suppression of HBV DNA, and normalization of ALT.</jats:p>