Vaccination News Home Page

http://www.nytimes.com/2002/08/21/health/21NILE.html

F.D.A. Approves Trial for Interferon to Treat West Nile Virus

By LAWRENCE K. ALTMAN

he Food and Drug Administration said yesterday that it had approved a national trial of a drug to determine whether it could become the first specific therapy against the West Nile virus.

The drug is alpha interferon, which Schering-Plough sells as Intron A. It is licensed for hepatitis C and a few other conditions.

No patient has entered the trial, which the F.D.A. allowed on Monday, said Dr. James Rahal, the chief of infectious diseases at New York Hospital Queens and a leader of the study. Dr. Rahal was one of the first American physicians to study West Nile virus in 1999, when the illness, which is carried by mosquitoes, was first detected in this hemisphere.

The nation is experiencing its worst epidemic of West Nile virus. As of Monday, the Centers for Disease Control and Prevention said, it has reports of 251 cases, including 11 deaths, from 11 states and the District of Columbia.

This week, officials in Kentucky, Missouri and Texas said they were investigating the deaths of three patients as possible West Nile cases.

Under federal rules, doctors may prescribe a licensed drug for unapproved uses. Some doctors have prescribed Intron A for West Nile patients. But the effectiveness of the drug has not been documented in a scientific trial.

Researchers running the Intron study hope to enroll at least 40 patients who have been hospitalized with the virus. Cooperating doctors can enroll any West Nile patient 50 years and older within four days of hospital admission. Patients younger than 50 will be eligible if they have meningitis and encephalitis. Outpatients are not eligible.

In such a randomized controlled trial, half the patients will receive Intron A injections and the other half will receive standard care without Intron A. To enroll, a patient has to agree to allow the choice to be made by the statistical equivalent of a coin toss. The doctors and patients will know who is receiving Intron A.

Participants will be treated at the hospital where they initially sought care. Schering-Plough will pay for the drug.

Vaccination News Home Page

ALL INFORMATION, DATA, AND MATERIAL CONTAINED, PRESENTED, OR PROVIDED HERE IS FOR GENERAL INFORMATION PURPOSES ONLY AND IS NOT TO BE CONSTRUED AS REFLECTING THE KNOWLEDGE OR OPINIONS OF THE PUBLISHER, AND IS NOT TO BE CONSTRUED OR INTENDED AS PROVIDING MEDICAL OR LEGAL ADVICE.  THE DECISION WHETHER OR NOT TO VACCINATE IS AN IMPORTANT AND COMPLEX ISSUE AND SHOULD BE MADE BY YOU, AND YOU ALONE, IN CONSULTATION WITH YOUR HEALTH CARE PROVIDER.