News (Updated August 19,
2007)
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CHICAGO (Reuters) - U.S. health regulators on Thursday warned doctors of the potential for Bristol-Myers Squibb Co.'s hepatitis B treatment to lead to resistance to the HIV virus in patients with both diseases.
The U.S. Food and Drug Administration also added a black boxed warning, the strongest caution wielded by regulators, to the labeling of the treatment, known as Baraclude, or generically as entecavir.
In a letter to doctors, Bristol warned that patients co-infected with both the hepatitis B and the human immunodeficiency virus (HIV) should not take Baraclude unless they are also being treated with the standard anti-retroviral therapy. Resistance to the HIV virus can develop if a patient is not being treated for HIV, the warning said.
HIV antibody testing should be offered to any potential patient to get Baraclude, Bristol said. The most advanced stage of HIV infection is AIDS, or acquired immunodeficiency virus.
Hepatitis B is caused by a virus attacking the liver. It can lead to infection, scarring of the liver, liver failure and death. Those at greatest risk are drug abusers, gay men and health care workers.
About 1.25 million Americans are chronically infected, although the number of new infections has been declining, according to the U.S. Centers for Disease Control and Prevention.
Worldwide it is a much graver problem, infecting 2 billion people, according to the World Health Organization. The WHO calls it "one of the major diseases of mankind and ... a serious global health problem."
Bristol reported sales of $59 million from the drug in the second quarter, up from $14 million a year earlier. It also named the drug as a growth driver.
(Reporting by Kim Dixon)
Tuesday August 14, 10:49 am ET
Abbott reminded health care providers that children should receive less than a 5 milliliter dose of its Kaletra oral solution, after learning of an accidental overdose in an infant.
The infant, born with HIV, died nine days after receiving a 6.5 milliliter dose of the company's drug, according to an Aug. 6 letter posted to the Food and Drug Administration's Web site.
"Special attention must be paid to accurate calculation of the dose, transcription of the medication order, dispensing information and dosing instructions to minimize the risk of medication errors," states Abbott.
Kaletra, which prevents the reproduction of HIV, is one of the most commonly used treatments for fighting the virus.
Wed Aug 15, 2007 1:39 PM ET
WASHINGTON (Reuters) - The AIDS virus damages the brain in two ways, by not only
killing brain cells but by preventing the birth of new cells, U.S. researchers
reported on Wednesday.
The study, published in the journal Cell Stem Cell, helps shed light on a condition known as HIV-associated dementia, which can cause confusion, sleep disturbances and memory loss in people infected with the virus.
It is less common in people taking drug cocktails to suppress the virus, and why HIV damages brain function is not clearly understood.
The virus kills brain cells but it also appears to stop progenitor cells, known as stem cells, from dividing, the team at Burnham Institute for Medical Research and the University of California at San Diego found.
"It's a double hit to the brain," researcher Marcus Kaul said in a statement. "The HIV protein both causes brain injury and prevents its repair."
The cocktail of drugs known as highly active antiretroviral therapy or HAART that treats HIV does not infiltrate the brain well, allowing for a "secret reservoir" of virus, said Stuart Lipton, who worked on the study.
HIV-associated dementia is becoming more common, as patients survive into their older years.
Working in mice, the researchers found that the virus directly interferes with the birth of new brain cells from stem cells.
"The breakthrough here is that the AIDS virus prevents stem cells in the brain from dividing; it hangs them up," Lipton said. "It's the first time that the virus has ever been shown to affect stem cells."
The culprit is gp120 -- a protein found on the outside of the AIDS virus, the researchers found.
"Knowing the mechanism, we can start to approach this therapeutically," Lipton said.
"This indicates that we might eventually treat this form of dementia by either ramping up brain repair or protecting the repair mechanism," Kaul added.
WASHINGTON (Reuters) - A three-in-one AIDS pill for children was cleared on Monday by the U.S. Food and Drug Administration for use in a global U.S. AIDS relief program.
The generic pill made by India's Cipla Ltd combines the generic HIV-fighting drugs lamivudine, stavudine and nevirapine.
This is the first pill of its kind that will be available for children under age 12 under the U.S. program.
FDA officials said the combination pill was a major advance because it can be stored, distributed and administered easily to children. The pill can be swallowed or dissolved in water.
The generic pill cannot be sold in the United States because the components are still protected by patents and available from brand-name makers. But the FDA's tentative approval of the drug makes it eligible for purchase and use in other countries under President George W. Bush's AIDS relief program.
The FDA also said it gave tentative approval to generic nevirapine tablets made by Hetero Drugs Ltd of India, which will also be available for the program.
Bush launched the five-year, $15 billion program in 2003 that aims to pay for treatment for 2 million AIDS sufferers and provide care for 10 million others in 15 countries, mostly in Africa.