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

被引:429
作者
Cooksley, WGE
Piratvisuth, T
Lee, SD
Mahachai, V
Chao, YC
Tanwandee, T
Chutaputti, A
Chang, WY
Zahm, FE
Pluck, N
机构
[1] Royal Brisbane Hosp, Herston, Qld, Australia
[2] Songklanakarin Hosp, Songkhla, Thailand
[3] Taipei Vet Gen Hosp, Taipei, Taiwan
[4] Chulalongkorn Hosp, Bangkok, Thailand
[5] Tri Serv Gen Hosp, Taipei, Taiwan
[6] Siriraj Hosp, Bangkok, Thailand
[7] Pramongkutklao Hosp, Bangkok, Thailand
[8] Kaohsiung Univ Hosp, Kaohsiung, Taiwan
[9] F Hoffmann La Roche & Co Ltd, CH-4002 Basel, Switzerland
[10] Roche Prod Ltd, Welwyn Garden City AL7 3AY, Herts, England
关键词
alanine transaminase; chronic hepatitis B; hepatitis B e antigen; hepatitis B virus; interferon alpha-2a; viral DNA;
D O I
10.1046/j.1365-2893.2003.00450.x
中图分类号
R57 [消化系及腹部疾病];
学科分类号
摘要
Current therapies for chronic hepatitis B (CHB) have a number of limitations, and better treatment options are needed. Peginterferon alpha -2a (40 kDa) is superior to conventional interferon alpha -2a in the treatment of chronic hepatitis C. This is the first report on peginterferon alpha -2a (40 kDa) in the treatment of CHB. In this phase II study, 194 patients with CHB not previously treated with conventional interferon-alpha were randomized to receive weekly subcutaneous doses of peginterferon alpha -2a (40 kDa) 90, 180 or 270 mu g, or conventional interferon alpha -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 alpha -2a (40 kDa) 90, 180 and 270 mu g, respectively, compared with 25% of patients on conventional interferon alpha -2a. The combined response (HBeAg loss, HBV DNA suppression, and ALT normalization) of all peginterferon alpha -2a (40 kDa) doses combined was twice that achieved with conventional interferon alpha -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 alpha -2a (40 kDa) is superior in efficacy to conventional interferon alpha -2a in chronic hepatitis B based on clearance of HBeAg, suppression of HBV DNA, and normalization of ALT.
引用
收藏
页码:298 / 305
页数:8
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