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9/6/2002

N.Y. Hospital Provides West Nile Virus Study Protocol

Kate Traynor

Physician James Rahal of the New York Hospital, Queens, recently received approval from the Food and Drug Administration (FDA) to conduct a clinical trial of interferon alfa-2b for the treatment of West Nile virus infection.

The study brings New York Hospital back into the spotlight three years after the first U.S. cases of the mosquito-borne illness surfaced locally.

"We were at the epicenter of the [1999] outbreak," recalled Vito Cassata, the hospital's director of pharmacy. Cassata said that his institution and nearby Flushing Hospital and Medical Center had treated the first patients in the country who were hospitalized for the viral infection.

The virus seems to have established a firm foothold in the United States since 1999 and has been particularly problematic this year.

"There is a massive increase in West Nile virus activity this year, compared to previous years, over a wider geographic area," said Lyle Petersen, director of the Centers for Disease Control and Prevention (CDC) Division of Vector-Borne Infectious Diseases. During a Sept. 5 media briefing, Petersen said that CDC has received 854 reports of human West Nile virus infection from 28 states so far this year.

"Approximately 80 percent or so...of these cases reported to us do have encephalitis and meningitis," Petersen said, describing life-threatening complications of the infection.

The New York Hospital-led study will enroll 40 patients whose central-nervous-system infection is caused by the West Nile virus. According to the protocol, half of the patients in this open-label study will receive Schering Corp.'s interferon alfa-2b product, Intron A, for 14 days, and half will receive supportive therapy without the drug or a placebo. Patients anywhere in the country who meet the study's eligibility requirements can be enrolled.

Cassata described the study's dosage of interferon alfa-2b as "a special regimen" derived from previous work with the West Nile virus and the St. Louis encephalitis virus, a related flavivirus. Patients in the treatment group will initially receive an intravenous dose of 3 million units over 20 minutes. Twelve hours later and then at 24-hour intervals, the patients will receive 3 million units administered subcutaneously.

"The dose has been chosen to minimize side effects and maximize effectiveness," Cassata said. A detailed pharmacy protocol (PDF) that includes notes for the department's staff is available at the hospital's Web site. Also available from the hospital is the study protocol and information about enrolling patients.

Cassata speculated that, because interferon alfa-2b has FDA-approved labeling for the treatment of chronic hepatitis B and chronic hepatitis C and the drug is readily available, "some physicians may just choose to treat patients with the Intron A without enrolling them in the study." But, he added, New York Hospital will be able to offer "very little guidance" on the treatment outside of the context of the FDA-approved study.

Cassata said his staff is excited to be associated with the study because this puts the department "on the cutting edge of medicine."