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发表于 2002-12-15 09:41
原文由zasxz发表于英文版 （LDT=telbivudine）
SIX-MONTH PHASE IIB DATA OF TELBIVUDINE (LDT) FOR THE
TREATMENT OF HEPATITIS B I
TELBIVUDINE (LDT) 为期 6个月的 IIB 期肝炎治疗临床数据
FOR IMMEDIATE RELEASE
Contact:
如需转载，请联系以下单位：
Idenix Pharmaceuticals, Inc.
(617) 250-3119
Teri Babine
Idenix Public Relations Noonan/Russo Presence Euro RSCG
(212) 845-4200
Amy Garay (investor) ext. 4261
Lynn Blenkhorn (media) ext. 4276
IDENIX PHARMACEUTICALS PRESENTS SIX-MONTH PHASE IIB DATA OF
TELBIVUDINE (LDT) FOR THE TREATMENT OF HEPATITIS B INFECTION
IDENIX药品公司发布了LDT——6个月 IIB 期肝炎治疗临床数据
- Clinical data demonstrating marked antiviral activity presented at the
- Annual Meeting of the American Association for the Study of Liver
- Diseases (AASLD) –
- 在美国肝病年会(AASLD)上发布的临床数据显示出显著的抗病毒能力
Boston, MA, November 5, 2002 - Idenix Pharmaceuticals, Inc. announced
yesterday interim 24-week data from an ongoing international phase IIb
clinical trial of telbivudine (LdT), the Company's lead drug candidate for the
treatment of chronic hepatitis B virus (HBV) infection. This clinical trial
compares telbivudine therapy with lamivudine, the current standard of care,
and with the combination of telbivudine plus lamivudine.
马萨诸赛州，波士顿，2002，11月5日——昨天，Idenix药品公司公布了正在进行的LDT
国际Iib期临床实验的中期24周的数据。这是该公司治疗慢性HBV感染的首要候选药物。
这项临床实验将telbivudine（LDT）同拉米夫定（目前的标准疗法）对比，并比较
telbivudine和拉米的联合治疗。
The interim study results indicate a strong antiviral response coupled with
substantial improvement in ALT level (a serum marker of liver disease) in
patients receiving telbivudine, either alone or in combination with lamivudine.
The median reduction in serum virus load for all LdT-containing arms was
greater than 6 log10 or a million fold. In patients receiving lamivudine alone,
a median reduction of 4.67 log10 occurred. To date, LdT treatment appears
to have been well tolerated by patients and no treatment-limiting or
dose-related adverse events have been observed.
该中期研究结果显示出telbivudine（LDT）很强的抗病毒反应，并拌有ALT实质性改善，
并且不论是单用telbivudine（LDT）还是结合拉米。所有使用LDT的血清病毒载量中值
减少超过6个数量级（百万倍）。单用拉米的患者，中值减少是4.67数量级。迄今，LDT
治疗显示出良好的耐受性，没有发现治疗限制，或与剂量相关的副作用。
"Results from this study confirm the safety profile and potent viral
suppression we have seen in previous clinical trials of LdT," said Ching-Lung
Lai, M.D., Professor of Medicine at the University of Hong Kong and a principal
study investigator who presented the new data at the annual conference of
the American Association for the Study of Liver Diseases (AASLD). "Among
patients receiving an LdT-containing treatment, greater viral suppression has
been achieved during the 24 weeks of treatment than in previous shorter
duration studies. We look forward to evaluating the effects of longer
treatment in the final 48-week data."
香港大学医学教授Ching-Lung Lai（他负责的一项研究报告在AASLD年会上发表）说：
“该研究结果证实了我们在LDT临床前实验中观察到的安全性和有效的病毒抑制力。”
“使用LDT的患者中，24周的治疗比过去短期治疗获得了更大的病毒抑制效果。我们期望
评估最终的48周治疗数据的结果。”
Study Description
研究描述
Telbivudine is a nucleoside that exhibits marked and selective activity against
HBV replication in laboratory assays. The randomized, blinded, international
multicenter phase IIb clinical trial is comparing the safety and antiviral
effectiveness of telbivudine, and telbivudine in combination with lamivudine,
to a control arm of lamivudine alone. The study enrolled 104 adults with
chronic hepatitis B and an average age of 37 years (range: 16-68 years). The
trial is being conducted at 19 sites in Hong Kong, Singapore, France, Canada
and the United States. The study includes five treatment arms as follows:
telbivudine 400 mg, telbivudine 600 mg, telbivudine 400 mg + lamivudine
100 mg, telbivudine 600 mg + lamivudine 100 mg and lamivudine 100 mg. At
baseline, patients had a median serum HBV DNA of 9.28 log10. All patients
are to be dosed orally once daily for a treatment period of one year.
Treatment groups are well matched for demographic and disease features.
Telbivudine是一种核苷，在实验室中显示出显著的，选择性的抗HBV病毒复制能力。随
机，双盲，国际性，多中心的IIb期临床实验，比较Telbivudine的安全性核抗病毒效果，
并同单用拉米夫定的控制组对比。该研究征集了104名成年慢性HBV患者，平均年龄37
岁（范围16~68岁）。该研究在包括香港，新加坡，法国，加拿大，美国等19个地区实
施。该研究包括5个治疗组：Telbivudine 400mg;
Telbivudine600mg;Telbivudine400mg+拉米100mg; Telbivudine600mg+拉米
100mg;拉米100mg. 最初，患者的中值HBV DNA 血清载量是9.28 log10.在一年的治
疗期间，所有患者每天一次口服给药。治疗组同人口统计学和疾病特征相符。
Study Results
研究结果
In the five treatment groups, median reductions in viral load (serum HBV
DNA) after 24 weeks are as follows: 6.08 log10 for telbivudine 400 mg; 6.11
log10 for telbivudine 600 mg; 6.21 log10 for telbivudine 400 mg +
lamivudine; 6.24 log10 for telbivudine 600 mg + lamivudine; and 4.67 log10
for lamivudine alone.
在5个治疗组中，24周后病毒载量（血清HBV DNA）中值减少情况如下：
telbivudine 400 mg **************** 6.08 log10
telbivudine 600 mg *************** 6.11 log10
telbivudine 400 mg + lamivudine ************* 6.21 log10
telbivudine 600 mg + lamivudine ************* 6.24 log10
单独lamivudine **************** 4.67 log10
After 24 weeks of treatment, 92% of patients receiving an LdT-containing
regimen had achieved suppression of viral load below 5 log10, a level
associated with clinical improvements in liver disease according to the
hepatitis B Practice Guidelines published by the AASLD 1. Among patients
receiving lamivudine alone, 63% of such patients achieved suppression of
viral load below 5 log10. Further, a significant proportion of patients on LdT
treatment achieved reductions in viral levels below the limit of detection of a
highly sensitive polymerase chain reaction (PCR) assay. Patients achieving
undetectable virus levels at week 24 of the study accounted for 32% of
patients receiving LdT monotherapy, 32% of patients receiving LdT in
combination with lamivudine and 16% of patients receiving lamivudine
monotherapy.
24周治疗后，接受LDT的患者中，92%患者病毒载量抑制率超过5个数量级；根据在
AASLD 1上发表的《HBV治疗实践指导》，这一水平与肝病临床改善相关联。在单用拉米
夫定的患者中，63%的人达到了病毒载量抑制5个数量级。另外，接受LDT的患者，有显
著比例病毒水平减少达到了高敏感的聚合酶连锁反应法(PCR)化验的敏感极限以下。在24
周治疗中，达到病毒水平探测不到的患者，单用LDT的有32%，LDT和拉米联用的有32%，
单用拉米的只有16%.
Study results also show that a high proportion of LdT-treated patients
achieved early normalization of serum ALT. Among patients receiving LdT
monotherapy, 49% demonstrated normalized ALT levels within 12 weeks of
treatment, which increased to 75% by 24 weeks.
研究结果还显示LDT治疗有很高比例的患者得到了血清ALT的及早正常。单用LDT的患
者，在12周后显示49% ALT变水平正常，24周后有75%变正常。
This interim 24-week data supports the strong safety profile demonstrated in
previous studies of LdT. With all patients reaching 24 weeks of treatment,
there have been no serious treatment-related adverse events (AE), no
discontinuations for AEs and no dose-related AEs or laboratory abnormalities.
24周中期数据支持了LDT在预先研究中表现的很强的安全性。所有达到24周治疗的患者，
没有与治疗相关的严重副作用(AE)，没有因副作用终止治疗，没有与剂量相关的副作用和
实验室理化指标异常。
"These interim results of the phase IIb study support our plans for a large
phase III clinical trial of telbivudine, which will be conducted globally in North
America, Europe and Asia," commented Nathaniel Brown, M.D., Idenix's
Senior Vice President of Hepatitis Clinical Research. "We hope that the safety
profile and antiviral activity demonstrated thus far for LdT will translate into
long-term clinical benefits for hepatitis B patients."
Idenix 公司负责肝病临床研究的的副总裁Nathaniel Brown 评论说：“该中期结果支持
我们计划中的更大的telbivudine的III期临床实验，这将在包括北美，欧洲，亚洲等全球
范围进行，”“我们希望LDT显示出的安全性和抗病毒能力会在长期的治疗中助益HBV
患者。”
There are approximately 350 million people worldwide with chronic hepatitis B
virus infection, of whom approximately 33% have potentially progressive and
life-threatening liver disease associated with their chronic HBV infection.
Chronic hepatitis B can lead to cirrhosis, liver failure and hepatocellular
carcinoma (liver cancer). Globally, hepatitis B accounts for over one million
deaths annually, making it the ninth leading cause of death worldwide.
全球大约350 million人有慢性HBV感染，其中大约33%的人有潜在发展的或危及生命
的肝病与慢性HBV感染有关。慢性HBV能导致肝硬化，肝衰竭，和肝癌。全球每年有超
过百万的HBV死亡，使它成为世界上第9大致死因素。
About Idenix:
Idenix Pharmaceuticals, Inc., formerly Novirio Pharmaceuticals Limited, is a
biopharmaceutical company engaged in the discovery and development of
drugs for the treatment of human viral and other infectious diseases. Idenix's
current focus is on the treatment of infections caused by hepatitis B virus,
hepatitis C virus and human immunodeficiency virus (HIV). Idenix is
developing telbivudine in collaboration with Sumitomo Pharmaceuticals Co.
Ltd. for Japan and selected Asian markets.
关于Idenix：
Idenix药品公司的前身是Novirio公司。这是一家生物制药公司，涉及研发治疗人类病毒或
其他感染性疾病。Idenix公司目前关注治疗HBV，HCV，HIV感染。Idenix正同Sumitomo
药品公司合作开发telbivudine在日本和部分亚洲市场。
[此贴子已经被特深沉于2002-12-14 19:41:42编辑过]
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