Treatment of hepatitis B e antigen - Positive chronic hepatitis with telbivudine or adefovir

被引:144
作者
Chan, Henry L. Y.
Heathcote, E. Jenny
Marcellin, Patrick
Lai, Ching-Lung
Cho, Mong
Moon, Young M.
Chao, You-Chen
Myers, Robert P.
Minuk, Gerald Y.
Jeffers, Lennox
Sievert, William
Bzowej, Natalie
Harb, George
Kaiser, Ralf
Qiao, Xin-Jian
Brown, Nathaniel A.
机构
[1] Chinese Univ Hong Kong, Shatin, Hong Kong, Peoples R China
[2] Univ Toronto, Toronto, ON, Canada
[3] Hop Beaujon, Clichy, France
[4] Pusan Natl Univ Hosp, Pusan, South Korea
[5] Severance Hosp, Seoul, South Korea
[6] Tri Serv Gen Hosp, Taipei, Taiwan
[7] Univ Calgary, Calgary, AB, Canada
[8] Univ Manitoba, Winnipeg, MB, Canada
[9] Univ Miami, Miami, FL 33152 USA
[10] Monash Univ, Melbourne, Vic 3004, Australia
[11] Calif Pacific Med Ctr, San Francisco, CA USA
[12] Novartis Pharmaceut, Hanover, NH USA
[13] Idenix Pharmaceut, Cambridge, MA USA
关键词
D O I
10.7326/0003-4819-147-11-200712040-00183
中图分类号
R5 [内科学];
学科分类号
1002 ; 100201 ;
摘要
Background: The efficacy of nucleoside and nucleotide analogues for hepatitis B has been linked to the magnitude and durability of hepatitis B virus (HBV) suppression. Objective: To compare the antiviral efficacy of telbivudine and adefovir dipivoxil, and the effects of switching from adefovir to telbivudine, in hepatitis B e antigen (HBeAg)-positive patients with chronic hepatitis B. Design: Randomized, controlled, open-label trial. Setting: 16 outpatient clinics. Patients: 135 treatment-naive, HBeAg-positive adults with chronic hepatitis B. Intervention: Patients were randomly assigned in a 1: 1: 1 ratio to 52 weeks of telbivudine (group A) or adefovir (group B), or 24 weeks of adefovir and then telbivudine for the remaining 28 weeks ( group C). One hundred thirty-one patients completed 52 weeks of treatment. Measurements: The primary efficacy comparison was serum HBV DNA reduction at week 24, with a secondary comparison at week 52. Results: At week 24, mean HBV DNA reduction was greater in group A than in pooled groups B and C (-6.30 vs. -4.97 log(10) copies/mL; difference, -1.33 log(10) copies/mL [95% Cl, 1.99 to 0.66 log(10) copies/mL]; P < 0.001), and more patients in group A were polymerase chain reaction - negative (39% vs. 12%; odds ratio, 4.46 [Cl, 1.86 to 10.72]; P = 0.001). At week 52, the mean residual HBV DNA level was lower in group A and group C than in group B (3.01 log(10) copies/mL [group A] and 3.02 log(10) copies/mL [group C] vs. 4.00 log(10) copies/mL [group B]; difference, 0 0.99 log(10) copies/mL [Cl, -1.67 to -0.32 log(10) copies/mL] and -0.98 log(10) copies/mL [Cl, -1.64 to -0.32 log(10) copies/mL]; P -0.004). Adverse events were similar across groups; the most common were upper respiratory symptoms, headache, back pain, and diarrhea. Limitations: The trial was open-label and was not of sufficient size or duration to compare clinical outcomes and long-term efficacy. Conclusion: Telbivudine demonstrated greater and more consistent HBV DNA suppression than adefovir after 24 weeks of treatment. After 52 weeks, HBV DNA suppression was greater in patients who had received continuous telbivudine or were switched to telbivudine after 24 weeks than in those who received continuous adefovir.
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收藏
页码:745 / U14
页数:11
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