Wall Street Journal - Tuesday, 7 January 1997.
Rhonda L. Rundle, Staff Reporter of The Wall Street Journal

The drug, Viracept, is a member of the protease inhibitor family that, when used in combination with some older drugs, has made the AIDS virus undetectable in the blood of some adults. Small preliminary studies among children under the age of 13 suggest that Viracept has comparable benefits in youngsters, Agouron said.

Pediatricians and parents of infected children are increasingly frustrated that protease inhibitors have been available to only a handful of children enrolled in clinical trials, despite the inhibitors' proven powers. Critics have accused drug makers of being slow to act because children make up only a small proportion of infected individuals.

Viracept is awaiting approval by the U.S. Food and Drug Administration following Agouron's request last month to market the drug both as a tablet for adults and a pediatric powder for children. Protease inhibitors made by three other companies are being sold now, but none is approved for pediatric use. Agouron, based in San Diego, is the first company to seek approval for a pediatric formulation of a protease inhibitor.

Under FDA rules, protease inhibitors already approved for adults can be prescribed for children, but some pediatricians have been reluctant to use them without scientific studies into such issues as the proper dosage.

People in an advanced stage of AIDS who have exhausted treatments with the approved protease inhibitors have been receiving Viracept since September under an "expanded access" program. Now Agouron plans to also give the drug free of charge to infected children aged two to 13. Both programs will end as soon as the drug is approved for sale, but Agouron says patients in the program won't be cut off if they don't have insurance or funds to pay for the drug.

There were about 7,300 children under age 13 with AIDS in the U.S. as of June 1996, according to the U.S. Centers for Disease Control. There are as many as 20,000 HIV-infected children nationwide, according to the Pediatric AIDS Foundation in Santa Monica, Calif.

The giveaway program is "great news" because "I have a waiting list," said Andrew Wiznia, director of the pediatric HIV program at Bronx Lebanon Hospital in New York. Dr. Wiznia has treated 12 children with Viracept during the past three months. "This is a real good drug, it may be a great drug, we don't know. It seems to be well tolerated by children taking it," and "only occasionally do kids say `yukky,'" he said.

Parents with children in the study were "ecstatic," Dr. Wiznia said. "We've had parents come in and say it was like a lightbulb went on in the child. Within one or two weeks of starting therapy, some children are showing dramatic changes, going from apathetic to interactive."

However, clinical data on such critical measures as virus levels in the blood of treated children haven't been disclosed yet. Agouron says that virus-level drops have been equivalent to those in adults, but data on the 52 children treated to date won't be available until later this month.

One mother said her six-year-old daughter has gained three or four pounds and is more active since starting Viracept treatment in September. "Raven eats a tremendous amount of food now and her energy level has improved a lot," said her mother, Michelle Lopez. The girl has switched to Viracept tablets, cut in two for easier swallowing, because she didn't like the taste of the powder.

The pediatric formulation of Viracept is a sandy, white powder that can be scooped out of the bottle and mixed with milk, formula or soft foods such as pudding. Agouron said parents and doctors seeking information about the giveaway program can call 1-800-621-7111.

Some other drug makers have had trouble formulating their protease inhibitors into effective medications that children can take. Abbott Laboratories, whose Norvir drug was approved for adult use last March, appears to be ahead of the other two companies with protease inhibitors on the market, Merck & Co. and Roche Holding. Abbott said it expects to soon amend its label for Norvir to include children.

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