Entecavir treatment for up to 5 years in patients with hepatitis B e antigen-positive chronic hepatitis B.

Abstract

UNLABELLED:

Sustained virologic suppression is a primary goal of therapy for chronic hepatitis B (CHB). In study entecavir (ETV)-022, 48 weeks of entecavir 0.5 mg was superior to lamivudine for virologic suppression for hepatitis B e antigen (HBeAg)-positive CHB. A total of 183 entecavir-treated patients from ETV-022 subsequently enrolled in study ETV-901. We present the results after up to 5 years (240 weeks) of continuous entecavir therapy. The entecavir long-term cohort consists of patients who received >or=1 year of entecavir 0.5 mg in ETV-022 and then entered ETV-901 with a treatment gap <or=35 days. In ETV-901 the entecavir dose was 1.0 mg daily. For patients with samples available at Year 5, proportions with hepatitis B virus (HBV) DNA <300 copies/mL, normal alanine aminotransferase (ALT) levels, HBeAg loss, and HBeAg seroconversion were determined. In all, 146 patients met criteria for inclusion in the entecavir long-term cohort. At Year 5, 94% (88/94) had HBV DNA <300 copies/mL and 80% (78/98) had normal ALT levels. In addition to patients who achieved serologic responses during study ETV-022, 23% (33/141) achieved HBeAg seroconversion and 1.4% (2/145) lost hepatitis B surface antigen (HBsAg) during study ETV-901. Through 5 years, entecavir resistance emerged in one patient. The safety profile of entecavir was consistent with previous reports.

CONCLUSION:

Extended therapy with entecavir through 5 years maintained or increased rates of HBV DNA suppression and ALT normalization. Additional patients also achieved HBeAg loss and seroconversion. Entecavir provides sustained viral suppression with minimal resistance during long-term treatment of HBeAg-positive CHB.

• Authors: Ting-Tsung Chang, Ching-Lung Lai, Seung Kew Yoon, Samuel S Lee, Henrique Sergio M Coelho, Flair Jose Carrilho, Fred Poordad, Waldemar Halota, Yves Horsmans, Naoky Tsai, Hui Zhang, Daniel J Tenney, Ricardo Tamez, Uchenna Iloeje
• Journal: Hepatology (Baltimore, Md.) (Hepatology) Vol. 51 Issue 2 Pg. 422-30 (Feb 2010) ISSN: 1527-3350 [Electronic] United States
• PMID: 20049753 (Publication Type: Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Antiviral Agents
• Hepatitis B e Antigens
• entecavir
• Guanine

Topics

• Adult
• Antiviral Agents (therapeutic use)
• Double-Blind Method
• Female
• Guanine (analogs & derivatives, therapeutic use)
• Hepatitis B e Antigens (blood)
• Hepatitis B, Chronic (blood, drug therapy)
• Humans
• Male
• Time Factors