恩替卡韦 AI463048 临床试验结果update（vs 阿德福韦酯）

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Section 14 CLINICAL STUDIES was updated to include data from study AI463048 in subjects with decompensated liver disease as follows:
Subjects with Decompensated Liver Disease
Study AI463048 was a randomized, open-label study of BARACLUDE 1 mg once daily versus adefovir dipivoxil 10 mg once daily in 191 (of 195 randomized) adult subjects with HBeAg-positive or ‑negative chronic HBV infection and evidence of hepatic decompensation, defined as a Child-Turcotte-Pugh (CTP) score of 7 or higher. Subjects were either HBV-treatment-naïve or previously treated, predominantly with lamivudine or interferon-α.
In Study AI463048, 100 subjects were randomized to treatment with BARACLUDE and 91 subjects to treatment with adefovir dipivoxil. Two subjects randomized to treatment with adefovir dipivoxil actually received treatment with BARACLUDE for the duration of the study. The mean age of subjects was 52 years, 74% were male, 54% were Asian, 33% were Caucasian, and 5% were Black/African American. At baseline, subjects had a mean serum HBV DNA by PCR of 7.83 log10 copies/mL and mean ALT level of 100 U/L; 54% of subjects were HBeAg-positive; 35% had genotypic evidence of lamivudine resistance. The baseline mean CTP score was 8.6. Results for selected study endpoints at Week 48 are shown in Table 10 of the package insert. In summary at Week 48 the proportion of patients with undetectable HBV DAN (< 300 copies/mL) was 57% for BARACLUDE 1 mg compared to 20% for adefovir dipivoxil 10 mg. Proportion of BARACLUDE patients with stable or improvied CTP score, HBsAG loss or normalization of ALT (< 1 x ULN) was 61%, 5% and 63%, respectively compared to 67%, 0% and 46% for patients receiving adefovir dipivoxil, respectively.

AI463048临床研究针对HBeAg阳性和阴性的失代偿性慢性乙肝患者（CTP评分>=7），采用随机开放试验设计，评价恩替卡韦1mg/天与阿德福韦酯10mg/天的治疗效果。
治疗48周，HBV DNA<300的比例分别为恩替57%和阿德20%。同时观察到HBsAg消失和ALT恢复正常的比例分别为：恩替 5% 63% vs 阿德 0% 46%。

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Also, the fllowing is the adverse effects in the clinical trails.  According to no contribution to negative attitude, no translation will be better. Thank you.
Among the 102 subjects receiving BARACLUDE, the most common treatment-emergent adverse events of any severity, regardless of causality, occurring through Week 48 were peripheral edema (16%), ascites [accumulation of fluid in the abdomen] (15%), pyrexia [fever] (14%), hepatic encephalopathy [brain malfunction] (10%), and upper respiratory infection (10%). Clinical adverse reactions not listed in Table 2 that were observed through Week 48 include blood bicarbonate decreased (2%) and renal failure (<1%).
Eighteen of 102 (18%) subjects treated with BARACLUDE and 18/89 (20%) subjects treated with adefovir dipivoxil died during the first 48 weeks of therapy. The majority of deaths (11 in the BARACLUDE group and 16 in the adefovir dipivoxil group) were due to liver-related causes such as hepatic failure, hepatic encephalopathy, hepatorenal syndrome, and upper gastrointestinal hemorrhage.  The rate of hepatocellular carcinoma (HCC) through Week 48 was 6% (6/102) for subjects treated with BARACLUDE and 8% (7/89) for subjects treated with adefovir dipivoxil.  Five percent of subjects in either treatment arm discontinued therapy due to an adverse event through Week 48.
No subject in either treatment arm experienced an on-treatment hepatic flare (ALT > 2 X baseline and > 10 X ULN) through Week 48.  Eleven of 102 (11%) subjects treated with BARACLUDE and 11/89 (13%) subjects treated with adefovir dipivoxil had a confirmed increase in serum creatinine of 0.5 mg/dL through Week 48.

lyq2003526

病毒量高的，似乎不用阿德福韦酯了。

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现在做临床比较喜欢跟阿德比

poorhbv

interdetect 发表于 2011-4-19 13:03
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现在做临床比较喜欢跟阿德比

柿子捡软的捏，哈哈