jking

hao

cfz5

每天要多少钱？

kuka

我本来就是DNA阴性的，我因此我不觉得特别开心，sorry

liver411

今天, 星期二, 8月6日(中国7日, 星期三), 路透社和道琼工业新闻报道:

FDA的一个审核团以不计名投票方式支持抗乙肝新药adefovir dipivoxil, 一般认为FDA会在自己的审核团支持后通过; 特别是目前还没有其它方法阻止拉米夫丁的抗药现象;

在审核团中担任顾问的医生们强调, 乙肝是一个严重, 发展厉害的疾病. 目前我们所应用的药效果都不显著; adefovir dipivoxil是一个加入治疗乙肝武器基本阵营的一员而已;

医生又强调, adefovir dipivoxil 是一个有潜力挽救生命, 提高生活质量的药物, 它是一个非常重要的药物, 但它不是一个"仙丹妙药";

医生又说, adefovir dipivoxil 需要吃很久, 因为目前对乙肝没有治愈的药物, 而adefovir dipivoxil 只是抗病毒药物, 不是治愈药物, 这一点应该是每个未来给病人开药医生头脑中的关键;

目前FDA还想观察, 审核的是长期用药的副作用, 不是因为它其效应慢; 因为目前用药最久的是48个周, 他们很想知道超出48个周后的反应, 是否狡猾的病毒又会变异;

艾滋病病毒感染者, 乙肝患者, 肝脏移植接受者, 乙肝, 艾滋病运动活动人士 Larry Kramer 在听政会上讲话陈述, 药厂没有给他钱, 也没有提供它的机票来这里发言; 他想为 adefovir dipivoxil 说一句公道话就是, 他增经参加过 adefovir dipivoxil 得失药, 当时曾一度推迟了他的肝脏移植需求日期; 他认为 adefovir dipivoxil  是 "奇异的药物"; Larry Kramer 66岁接受肝脏移植, 成为全世界年级最老的共染有HIV, HBV, 肝硬化的肝脏移植接收者;

就目前来讲 adefovir dipivoxil  在48个周的试药中没有发生变异的现象, 这是好现象; 而 adefovir dipivoxil  可能是近期治疗Lamivudine抗药的唯一治疗途径... .

*************

谢谢阅读. 刚刚收到, 草草翻译大意; 两篇原文在下边, 大家可继续帮忙翻译, 补充, 阅读;



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USA: UPDATE 1-U.S. FDA panel backs Gilead hepatitis drug.

08/06/2002
Reuters English News Service

BETHESDA, Md., Aug 6 (Reuters) - A U.S. advisory panel on Tuesday backed Gilead Sciences Inc.'s adefovir drug for treating chronic hepatitis B, an infection that attacks the liver.
The panel unanimously voted to urge the Food and Drug Administration to approve adefovir. The FDA usually follows the advice of its advisory panels.


The FDA in 1999 turned down Gilead's application to market adefovir for treating HIV infection, citing concerns about kidney toxicity. Gilead now is seeking approval for a dosage lower than was studied for HIV.
Chronic hepatitis B, a blood-borne viral infection, can lead to cirrhosis, liver cancer and death. Currently available treatments have limitations, Gilead told the panel.

Gilead, maker of HIV treatment Viread, is based in Foster City, California. Trading in Gilead shares was halted during the panel's meeting.

******************

FDA Panel Backs Gilead Sciences Hepatitis B Drug
By Otesa Middleton

08/06/2002
Dow Jones News Service

WASHINGTON -(Dow Jones)- Gilead Sciences Inc.'s (GILD) adefovir
dipivoxil gained unanimous support from a federal panel as a chronic
hepatitis B agent Tuesday, almost three years after failing to win
approval as an HIV treatment.

The experimental once-a-day pill, which doesn't have a brand name yet, is now likely to secure Food and Drug Administration approval, as the agency typically follows the recommendations of its advisory panels.
The panel of infectious-disease experts said there aren't enough options for patients who don't improve after using the only two approved drugs for hepatitis B, interferon and GlaxoSmithKline PLC's (GSK) Epivir.

Dr. Kenneth E. Sherman, who directs the Hepatology & Liver Transplant Medicine Section at the University of Cincinnati College of Medicine and sat on the panel as a consultant, said hepatitis B is a "serious, progressive disease."

"The drugs we have aren't sufficient," added Sherman, who is not a voting committee member. "This is a drug that belongs in our primary armamentarium.

"This is a potentially lifesaving drug. It is an important drug, but it's not a magic bullet."

Dr. W. Thomas London, a panelist from the Division of Population Science at the Fox Chase Cancer Center in Philadelphia, said if approved, adefovir dipivoxil will have to be taken a long time since there is no cure for hepatitis B. "This is a suppressive drug, not a curative drug," London said.

Gilead assuaged the panel's concerns about the drug's potential to harm the kidney, a drawback that led the 1999 panel to issue its first rejection of a proposed HIV treatment.

Elevated kidney enzyme levels, which indicate damage to the organ, weren't as prominent once Gilead significantly lowered the drug's dose, originally a high of 120 milligrams proposed for fighting HIV, to the 10-milligram pill for the hepatitis B application.

Hepatitis B is a highly infectious virus transmitted via blood and bodily fluids that contain blood. In the U.S., 1.25 million people have the chronic disease, which threatens to destroy the liver.

Larry Kramer, a longtime AIDS activist and writer, told the panel that adefovir dipivoxil is a "wonder drug." Kramer said he wasn't paid by Gilead, nor did the company provide his transportation to the meeting.

Kramer, who learned he was HIV-positive and infected with hepatitis B in 1988, believes he contracted both viruses a decade earlier. The hepatitis B severely damaged his liver, requiring him at age 66 to become the oldest liver transplant recipient infected with both HIV and hepatitis B. Kramer told the panel he considered delaying his liver transplant because his condition improved so much once he started taking adefovir dipivoxil during one of the trials.

Now, almost eight months after transplantation, he said, "I feel wonderful."

Although the panelists voted unanimously that Gilead demonstrated adefovir dipivoxil is safe and effective, some said they want more information on patients using the drug longer than 48 weeks since infected patients probably will need to take the drug for years.

The drug was compared with a placebo and also tested in patients whose hepatitis B infection had mutated and grown resistant to Epivir, which is also a common anti-HIV drug known as 3TC.

"Adefovir may be the only treatment available for patients who harbor resistant hepatitis B," said Dr. Tan T. Nguyen, an FDA medical officer who reviewed Gilead's data.

Panelist Dr. Sharilyn K. Stanley, associate commissioner of Disease Control and Prevention at the Texas Department of Health, said there hasn't been enough information gathered on resistance.

"I want more than 48-week data," Stanley said.

Panelist Dr. Jonathan M. Schapiro, clinical assistant medical professor at Stanford University School of Medicine's Center for AIDS Research, said more information would be necessary for Gilead to claim that the virus doesn't become resistant to the drug.

"We have to be very careful in what we say about this," Schapiro said. "We don't yet know if there is resistance. It is encouraging that mutations didn't jump out over 48 weeks."

-By Otesa Middleton, Dow Jones Newswires; 202-862-6654; [email protected]


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[此贴子已经被liver411于2002-8-8 2:19:06编辑过]

better

有没有新信息

xb

哦哦哦哦，手舞足蹈，张牙舞爪

xb

照推理，应该是9月底阿的会出来吧？