Mitochondrial toxicity - new adverse drug effects
Article Abstract:
The tragic results of a clinical trial of fialuridine (FIAU) shed light on how clinical trials should be conducted to reduce their inherent risks. FIAU is an antiviral nucleoside analog that had been shown effective in short-term treatment of hepatitis B. A 1995 study reported on a long-term clinical trial of FIAU in which treatment for more than 2 months caused liver failure in seven people, five of whom died. FIAU appeared to have toxic effects because it altered mitochondrial DNA, injuring mitochondria. Lamivudine is another nucleoside analog that has been safely used to treat HIV infection, and may be safe and effective for long-term treatment of hepatitis B. Future trials of drugs, particularly of those that alter DNA, should involve extended follow-up periods. Furthermore, before drugs are tested on people, they should be tested on cell-lines and animals and their affect on mitochondria should be appropriately observed.
Publication Name: The New England Journal of Medicine
Subject: Health
ISSN: 0028-4793
Year: 1995
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Treatment of chronic hepatitis B infection
Article Abstract:
Long-term treatment of hepatitis B is needed to prevent liver cirrhosis and liver cancer. A 1998 study found that one year of treatment with the drug lamivudine blocks viral reproduction and reduces liver inflammation. However, there are two steps in hepatitis B virus reproduction and lamivudine would only block one of those steps. In addition, it may not work on viral DNA that has been integrated into host DNA. The virus may become reactivated once the drug is stopped. Drugs are needed that are safe for long-term use.
Publication Name: The New England Journal of Medicine
Subject: Health
ISSN: 0028-4793
Year: 1998
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A one-year trial of lamivudine for chronic hepatitis B
Article Abstract:
The drug lamivudine appears to be beneficial in patients with chronic hepatitis B. Researchers randomly assigned 358 hepatitis B patients to take 25 milligrams of lamivudine daily, 100 milligrams, or a placebo for one year. Liver biopsies done before and at one year showed that lamivudine reduced liver inflammation and suppressed hepatitis B virus reproduction. The 100-milligram dose was most effective. The drug produced few serious side effects.
Publication Name: The New England Journal of Medicine
Subject: Health
ISSN: 0028-4793
Year: 1998
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