1592: Small Distribution Programs Begin June, July

On April 29 Glaxo Wellcome announced that it will begin three small compassionate-use programs for access to 1592, an experimental antiretroviral. A pediatric program is planned to start in June, and dementia and adult programs in July.

1592 is a nucleoside analog -- a drug in the same class as AZT -- but it appears to give much better viral suppression than AZT. Also, its resistance profile is different. About 250 people have been treated with 1592 so far. About 20 additional trials are planned, involving more than 2,000 people.

The three programs and their entry criteria are:

* Pediatric program (ages 90 days through 12 years): To enter, patients must have a viral load greater than 100,000 copies/ml, CD4 percent less than 15, and have failed at least one nucleoside analog drug (e.g. AZT, ddI).

* AIDS dementia complex (ages 18 through 65): Patients must have severe dementia (MSK grades 3-4) diagnosed by a neurologist. They must have had prior treatment with AZT(which is known to be effective in treating AIDS dementia in some cases).

* Other adults: Patients must have viral load greater than 50,000 copies, CD4 count under 100, and they must have previously failed at least two nucleoside analog drugs and one protease inhibitor.

The pediatric and dementia programs will have a central registration procedure; physicians will call to register patients. The other adult program will be conducted at centers in North America, countries in Europe which are currently running trials of 1592, and Australia. The list of centers is not yet final.

2,500 slots will be available in all three programs together worldwide.

Comment

There is widespread concern that 2,500 slots will be entirely inadequate -- that the adult program especially could fill up in days. In that case the drug will be available to those with connections and luck -- those whose physicians can have someone stand by the phone or fax to get them in line first.

There is also concern that the development of this drug has proceeded too slowly (see "Why Isn't Glaxo's New AIDS Drug Ready Yet" in THE WALL STREET JOURNAL , November 12, 1996, page B1). Current plans are to apply for FDA approval well into 1998. Glaxo hopes to have a larger expanded access program starting in early 1998.

The company has given two reasons for the small size of the current program: some supply limits due to unexpected difficulties in scaling up the production process to make large batches, and concern about distributing a drug very widely when it has been tested on few people so far.

1592 is expected to be most useful to people who have limited treatment options and need to find a combination which works for them to suppress HIV replication.