- The Washington Times - Thursday, December 22, 2005

Two Vietnamese patients infected with bird flu died after developing a resistance to Tamiflu, the antiviral drug considered the best defense against the virus, according to a medical report being released today.

Doctors, in the report published in the New England Journal of Medicine, studied eight Vietnamese patients who were given oseltamivir, the anti-influenza medicine marketed as Tamiflu by F. Hoffman-La Roche Ltd., a Basel, Switzerland, pharmaceutical company.

Two of the patients, who died, developed a resistance to the drug.

One patient, a 13-year-old girl, died seven days after getting the virus, despite being put on the recommended Tamiflu dosage one day after showing symptoms, the report said.

“Since human clinical trials have not been conducted with the H5N1 avian-flu strain, case reports such as those cited in the [article] are helpful in the ongoing study of this severe disease and viral resistance,” Roche said.

The company plans to conduct clinical trials with the National Institutes of Health (NIH) and the World Health Organization to see whether a higher dosage of Tamiflu would be more effective against severe influenza, which includes the avian-flu strain seen in Southeast Asia.

Those studies are expected to start in February or March while Roche plans to release results of higher Tamiflu dosing tests on animals early next year, said spokesman Terry Hurley.

Roche also announced yesterday that Tamiflu won approval from the Food and Drug Administration to prevent influenza infections in children ages 1 and older.

China, which has reported two bird-flu deaths, said yesterday that it began human trials of its homegrown bird-flu vaccine, with six volunteers receiving shots, according to the official Xinhua news agency.

A total of 120 persons, ages 18 to 60, volunteered to take part in the trials, the agency said. Initial results are expected within the next three months.

Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases at NIH, said he wasn’t surprised by the findings in the New England Journal of Medicine.

“This is disconcerting, but not surprising. We anticipated ultimately there would be an emergence of resistance. The question of resistance is will it become pervasive?” Dr. Fauci said.

The federal government’s plan to stockpile Tamiflu for a potential pandemic has not changed, he said, adding the government has about 4.3 million doses and expects a million more by January.

But Dr. Anne Moscona, a professor at the Weill Medical College at Cornell University, said the new research was “alarmingly underscored.”

“This frightening report should inspire us to devise pandemic strategies that do not favor the development of oseltamivir-resistant strains,” Dr. Moscona said in a commentary in today’s issue of the New England Journal of Medicine.

To date, 31 patients infected with the current bird-flu strain have been treated with Tamiflu, with three patients showing resistance to the drug, Mr. Hurley said.

A report published in October by the University of Wisconsin at Madison told of drug-resistant virus strains in a 14-year-old-girl who survived the disease after being treated with Tamiflu.

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