THE VIRGINIAN-PILOT
Copyright (c) 1997, Landmark Communications, Inc.
DATE: Wednesday, January 8, 1997 TAG: 9701080379
SECTION: FRONT PAGE: A14 EDITION: FINAL
SOURCE: STAFF AND WIRE REPORTS
DATELINE: WASHINGTON LENGTH: 56 lines
A drug company announced Tuesday that it is offering children infected with the AIDS virus free doses of an experimental drug known as a ``protease inhibitor,'' the first time American children could get this type of medicine outside small, doctor-run tests.
Agouron Pharmaceuticals, based in La Jolla, Ca., is seeking Food and Drug Administration approval of its Viracept, known chemically as nelfinavir.
If approved, the drug could become the nation's fourth protease inhibitor, a powerful class of AIDS drugs credited with revolutionizing AIDS care. Yet none of these drugs is available in pediatric form, sparking protests from parents who say they're watching their children die.
Norfolk infectious disease specialist Douglas K. Mitchell, who, along with infectious disease director Thomas Rubio, cares for most of the region's HIV-infected children at Children's Hospital of The King's Daughters, said he is obtaining more information about the drug to see if any of his patients can take it.
But before it can be prescribed, he said, it must be approved by a committee at Eastern Virginia Medical School that reviews the use of all experimental drugs.
``There are options. We'll just have to look at the information they send us and see if it's suitable for our patients,'' Mitchell said.
The drug is available to any child age 2 to 13 infected with the virus, said Agouron spokeswoman Joy Schmitt. Doctors don't have to follow any specific protocol, she said, and may prescribe the drug in combination with other medications the child may be taking.
``They just have to report significant adverse events,'' she said.
So far, 52 children have participated in controlled studies, she said, which showed the drug to be safe and effective. The most common side effect is diarrhea.
Last month, Agouron became the first company to seek simultaneous FDA approval for adult and child forms of a protease inhibitor. While the FDA is evaluating the drug, it gave Agouron permission to run an ``expanded access'' program offering Viracept free to any HIV-infected child age 2 to 13. Schmitt said FDA approval is expected within six months. Simultaneous approval has always been a priority, she said. ``It was clearly the right thing to do.''
Because most children cannot take pills, Agouron had to devise a different form of the medication, a stumbling block for the other three drug companies that have received FDA approval for their protease inhibitors.
Agouron's pediatric version is a powder that can be mixed into milk, formula or soft foods such as pudding. MEMO: This story was compiled from reports by The Associated Press and
staff writer Debra Gordon. ILLUSTRATION: Graphic
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