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
The Chinese University of Hong Kong, Shatin, Hong Kong, China.
Ann Intern Med. 2007 Dec 4;147(11):745-54. doi: 10.7326/0003-4819-147-11-200712040-00183. Epub 2007 Oct 1.
The efficacy of nucleoside and nucleotide analogues for hepatitis B has been linked to the magnitude and durability of hepatitis B virus (HBV) suppression.
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.
Randomized, controlled, open-label trial.
16 outpatient clinics.
135 treatment-naive, HBeAg-positive adults with chronic hepatitis B.
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.
The primary efficacy comparison was serum HBV DNA reduction at week 24, with a secondary comparison at week 52.
At week 24, mean HBV DNA reduction was greater in group A than in pooled groups B and C (-6.30 vs. -4.97 log10 copies/mL; difference, -1.33 log10 copies/mL [95% CI, -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 [CI, 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 log10 copies/mL [group A] and 3.02 log10 copies/mL [group C] vs. 4.00 log10 copies/mL [group B]; difference, -0.99 log10 copies/mL [CI, -1.67 to -0.32 log10 copies/mL] and -0.98 log10 copies/mL [CI, -1.64 to -0.32 log10 copies/mL]; P = 0.004). Adverse events were similar across groups; the most common were upper respiratory symptoms, headache, back pain, and diarrhea.
The trial was open-label and was not of sufficient size or duration to compare clinical outcomes and long-term efficacy.
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.
核苷和核苷酸类似物对乙型肝炎的疗效与乙型肝炎病毒（HBV）抑制的程度和持久性有关。
比较替比夫定和阿德福韦酯在慢性乙型肝炎e抗原（HBeAg）阳性患者中的抗病毒疗效，以及从阿德福韦转换为替比夫定的效果。
随机、对照、开放标签试验。
16个门诊诊所。
135例初治、HBeAg阳性的慢性乙型肝炎成年患者。
患者按1:1:1比例随机分配，接受52周替比夫定治疗（A组）或阿德福韦治疗（B组），或先接受24周阿德福韦治疗，然后在剩余28周接受替比夫定治疗（C组）。131例患者完成了52周治疗。
主要疗效比较为第24周时血清HBV DNA下降情况，次要比较为第52周时的情况。
第24周时，A组的平均HBV DNA下降幅度大于B组和C组合并组（-6.30对-4.97 log10拷贝/mL；差值为-1.33 log10拷贝/mL [95%CI，-1.99至-0.66 log(10)拷贝/mL]；P<0.001），A组更多患者聚合酶链反应阴性（39%对12%；优势比为4.46 [CI，1.86至10.72]；P = 0.001）。第52周时，A组和C组的平均残余HBV DNA水平低于B组（A组为3.01 log10拷贝/mL，C组为3.02 log10拷贝/mL，B组为4.00 log10拷贝/mL；差值分别为-0.99 log10拷贝/mL [CI，-1.67至-0.32 log10拷贝/mL]和-0.98 log10拷贝/mL [CI，-1.64至-0.32 log10拷贝/mL]；P = 0.004）。各组不良事件相似；最常见的是上呼吸道症状、头痛、背痛和腹泻。
该试验为开放标签，规模和持续时间不足以比较临床结局和长期疗效。
治疗24周后，替比夫定比阿德福韦表现出更强且更持续的HBV DNA抑制作用。52周后，接受持续替比夫定治疗或在24周后转换为替比夫定治疗的患者，其HBV DNA抑制作用大于接受持续阿德福韦治疗的患者。
