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Previous Volume 352:2682-2695 June 30, 2005 Number 26 Next

	Full Text PDF PDA Full Text PowerPoint Slide Set Editorial by Lok, A. S.-F. Letters Add to Personal Archive Add to Citation Manager Notify a Friend E-mail When Cited E-mail When Letters Appear PubMed Citation

ABSTRACT

Background Current treatments for chronic hepatitis B are suboptimal. In the search for improved therapies, we compared the efficacy and safety of pegylated interferon alfa plus lamivudine, pegylated interferon alfa without lamivudine, and lamivudine alone for the treatment of hepatitis B e antigen (HBeAg)–positive chronic hepatitis B.

Methods A total of 814 patients with HBeAg-positive chronic hepatitis B received either peginterferon alfa-2a (180 µg once weekly) plus oral placebo, peginterferon alfa-2a plus lamivudine (100 mg daily), or lamivudine alone. The majority of patients in the study were Asian (87 percent). Most patients were infected with hepatitis B virus (HBV) genotype B or C. Patients were treated for 48 weeks and followed for an additional 24 weeks.

Results After 24 weeks of follow-up, significantly more patients who received peginterferon alfa-2a monotherapy or peginterferon alfa-2a plus lamivudine than those who received lamivudine monotherapy had HBeAg seroconversion (32 percent vs. 19 percent [P<0.001] and 27 percent vs. 19 percent [P=0.02], respectively) or HBV DNA levels below 100,000 copies per milliliter (32 percent vs. 22 percent [P=0.01] and 34 percent vs. 22 percent [P=0.003], respectively). Sixteen patients receiving peginterferon alfa-2a (alone or in combination) had hepatitis B surface antigen (HBsAg) seroconversion, as compared with 0 in the group receiving lamivudine alone (P=0.001). The most common adverse events were those known to occur with therapies based on interferon alfa. Serious adverse events occurred in 4 percent, 6 percent, and 2 percent of patients receiving peginterferon alfa-2a monotherapy, combination therapy, and lamivudine monotherapy, respectively. Two patients receiving lamivudine monotherapy had irreversible liver failure after the cessation of treatment — one underwent liver transplantation, and the other died.

Conclusions In patients with HBeAg-positive chronic hepatitis B, peginterferon alfa-2a offers superior efficacy over lamivudine, on the basis of HBeAg seroconversion, HBV DNA suppression, and HBsAg seroconversion.

Source Information

From the Department of Medicine, Queen Mary Hospital, University of Hong Kong, Hong Kong SAR, China (G.K.K.L.); the Department of Medicine, Songklanakarin Hospital, Songkla, Thailand (T.P.); the Department of Infectious Diseases, Nangfang Hospital, Guangzhou, China (K.X.L.); the Service d'Hépatologie, INSERM Unité 481, and Centre de Recherches Claude Bernard sur les Hépatites Virales, Hôpital Beaujon, Clichy, France (P. Marcellin); the Department of Internal Medicine, Chiang Mai University, Chiang Mai, Thailand (S.T.); the Clinical Research Department, Royal Brisbane Hospital, Herston, Australia (G.C.); the Gastroenterology Department, Middlemore Hospital, Otahuhu, New Zealand (E.G.); the University of North Carolina Liver Program, University of North Carolina, Chapel Hill (M.W.F.); the Gastroenterology Department, Singapore General Hospital, Singapore (W.C.C.); the Division of Gastroenterology, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea (S.W.P.); the Department of Internal Medicine, Kaohsiung Medical University Hospital, Kaohsiung, Taiwan (W.Y.C.); Medizinische Klinik mit Schwerpunkt Hepatologie und Gastroenterologie, Charité, Universitätsmedizin Berlin, Campus Virchow-Klinikum, Berlin (T.B.); the Department of Infectious Diseases, Medical University of Bialystok, Bialystok, Poland (R.F.); Roche, Dee Why, Australia (P. McCloud); and Roche, Welwyn, United Kingdom (N.P.).

Address reprint requests to Dr. Lau at Rm. 1838, Block K, Queen Mary Hospital, University of Hong Kong, Hong Kong SAR, China, or at gkklau{at}netvigator.com.

Full Text of this Article

Related Letters:

Treatment of HBeAg-Positive Hepatitis B with Peginterferon and Lamivudine
Song K., Rajvanshi P., Orlent H., Lau G. K.K., the Peginterferon Alfa-2a HBeAg-Positive Chronic Hepatitis B Study Group
Extract | Full Text | PDF  
N Engl J Med 2005; 353:1630-1631, Oct 13, 2005. Correspondence

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