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Health Highlights: June 24, 2006

FDA Approves HIV Drug for Those Not Responding to Existing Drugs Rheumatoid Arthritis Diminishes Patients' Sex Lives Human Bird-Flu Transmission Confirmed in Indonesian Cluster FDA Approves Generic Version of Zocor

Here are some of the latest health and medical news developments, compiled by the editors of HealthDay:

HIV Drug Approved for Those Not Responding to Existing Drugs

The U.S. Food and Drug Administration on Friday approved Prezista (darunavir), a new drug for adults whose HIV infection hasn't responded to treatment with other antiretroviral drugs.

Prezista, a new protease inhibitor, is approved to be used with a low-dose of ritonavir and other active anti-HIV agents. Ritonavir, a protease inhibitor approved in 1996, slows the breakdown of Prezista in the body, increasing the concentration of Prezista in the patient's system, the FDA said.

HIV causes AIDS, which results in more than 15,000 premature deaths each year in the United States and more than 2.8 million deaths each year worldwide.

"This approval offers new hope to HIV patients who too often urgently need new therapies in order to maintain their health," said Dr. Andrew C. von Eschenbach, acting FDA commissioner. "This drug is not a cure, but when combined with other standard therapies, it presents one more major step in our effort to help patients combat the effects of the disease."

The most common side effects of the Prezista-ritonavir regimen include diarrhea, nausea and headache. The risks and benefits of Prezista have not been established for adults who have not been previously treated for HIV, or for children, the FDA said.

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Rheumatoid Arthritis Diminishes Patients' Sex Lives

One-third of patients with rheumatoid arthritis feel their condition has a "considerably" negative influence on their sex lives, new research finds.

"Today's findings indicate the need for increased attention on the effect of rheumatoid arthritis on sexual activity as well as reveal that sexual problems should be addressed as part of the general health care given to RA patients," said Ylva Helland, department of rheumatology at Diakonhjemmet Hospital in Oslo, Norway.

The findings were presented Saturday at the 2006 European League Against Rheumatism Congress, in Amsterdam, the Netherlands.

The study found that 31 percent of RA patients reported that the disease had no impact on sexual activity, with another 38 percent saying it had "little" impact. But, 21 percent said their condition had considerable impact on their sex lives, and 10 percent said RA made sexual activity either almost or totally impossible.

Compared to the female patients, men were more likely to report a significant impact on their sexual activity.

Rheumatoid arthritis is a chronic disease characterized by inflammation of the lining of the joints. It can produce long-term joint damage, resulting in chronic pain, loss of function and disability, according to the Arthritis Foundation.

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Human Bird-Flu Transmission Confirmed in Indonesian Cluster

The first case of human-to-human transmission of the bird flu virus has been confirmed in laboratory tests of samples taken from a 10-year-old Indonesian boy who died last month from the H5N1 avian influenza strain, a World Health Organization official said Friday.

Genetic sequencing of a virus sample taken from the boy showed a minute change that was also found in a sample taken from his father, who also later died, said Dick Thompson, a spokesman for the United Nations health agency in Geneva, Switzerland. Human-to-human transmission had been suspected as the cause of the infection in seven members of a family of eight from the island of Sumatra.

"We have seen a genetic change that confirms in a laboratory that the virus has moved from one human to another," Thompson told Bloomberg News. The change in the virus "doesn't seem to have any significance in terms of the pathology of the disease or how easily it's transmitted,' he said.

The Sumatran cluster attracted international attention because it represented the largest reported instance of bird-flu spread among people and the first evidence of a three-person chain of infection.

A 37-year-old woman suspected of being the first family member to die was buried before samples were taken. She reportedly mixed fowl manure with soil with her bare hands to fertilize her garden.

The woman's 10-year-old nephew, an 18-month-old niece, two teenage sons and a 29-year-old sister became sick between May 2 and May 4, and later died after having close contact with the woman during her illness, Bloomberg said. A 25-year-old brother was also infected but survived.

The New York Times reported that the first five family members to fall ill had identical strains of H5N1, but the virus had mutated slightly in the sixth victim, the 10-year-old boy, who passed it to his father. That mutation allowed the lab to confirm the route of transmission.

World health officials said there was no evidence that the mutated virus is any better adapted to human infection than before. In fact, the WHO has been following 54 neighbors and family members who lived near the family for a month, and none has contracted the virus, the newspaper said.

At least 130 of the 228 people known to be infected with bird flu since 2003 have died, according to the WHO. World health officials are tracking the spread of the virus in the event it becomes more adept at infecting people.

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FDA Approves Generic Version of Zocor

The U.S. Food and Drug Administration Friday approved the first generic version of Zocor, Merck & Co.'s popular cholesterol-lowering statin drug whose patent protection expires at midnight.

The FDA decision capped a difficult week for Merck, since Zocor generated $3.1 billion in sales in the United States and $4.4 billion worldwide last year for the firm. But Zocor's patent expiration also could mean fewer profits at drug maker Pfizer Inc., whose rival cholesterol drug, Lipitor, is the world's most popular medicine, with global sales last year of $12 billion. Lipitor's patent runs until 2011.

Stains drugs accounted for $16 billion in U.S. sales in 2005. Simvastatin (Zocor) is recommended for use with a diet restricted in saturated fat to treat high cholesterol and to reduce triglycerides and other fatty substances in the blood , the FDA said.

"Simvastatin is a widely used cholesterol lowering agent, and its generic version can bring significant savings to the millions of Americans with this disease," Gary J. Buehler, director of FDA's Office of Generic Drugs, said in a prepared statement.

Zocor has sold for about $3 a daily pill. As a result of the patent expiration, simvastatin's cost could drop 30 percent or more in the next few days, and by as much as 90 percent next year, to about 30 cents a pill, according to The New York Times.

In addition to approving simvastatin, the FDA approved three other generics this week:

  • Finasteride tablets, 1 mg (Propecia), for the treatment of mild to moderate male pattern hair loss in men between 18 and 41 years of age.
  • Finasteride tablets, 5 mg, (Proscar), for the treatment of benign prostatic hypertrophy (BPH) in men with an enlarged prostate to improve symptoms by reducing the size of the prostate.
  • Lamotrigine tablets (chewable), 5 mg and 25 mg (Lamictal), as therapy for treating patients with seizures due to epilepsy.
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