"We don't anticipate that there'll be resistance problems with peramivir," which seems to have a resistance profile similar to that of oseltamivir, Peters said. He noted that 9 oseltamivir-resistant H1N1 isolates have been found among more than 1,000 tested in the United States. Most of the resistant viruses were from patients with severe immunosuppression.
In response to a question, Peters said an IV formulation of zanamivir exists but is in a much earlier stage of clinical testing than peramivir. Under EIND rules, the formulation has been used in several patients because of concern about possible resistance to oseltamivir, he said.
"Peramivir and zanamivir are really two separate issues; it's not that one would be approved [for an EUA] and not the other," he commented. "With the body of evidence available at this time, the FDA felt there was enough information available on safety and efficacy to approve peramivir. Zanamivir could be approved in the future."
So far, between 6% and 25% of hospitalized H1N1 patients have required intensive care unit placement, Peters reported. He said three different types of clinical presentations have been seen in those cases: primary viral pneumonia, invasive bacterial co-infections, and a worsening of organ dysfunction in patients who had poor cardiopulmonary reserve because of preexisting conditions.
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