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AIDS Treatment News
3TC: Now Available Again Up To CD4 of 300
John S. James
August 4, 1995
AIDS Treatment News Issue #228, August 4, 1995

In April, Glaxo (now Glaxo Wellcome) restricted its expanded- access program for 3TC, due to unexpected demand and a resulting shortage of the drug. The most important restriction instituted at that time is that patients had to have a CD4 (T-helper count) under 100, instead of under 300, to qualify. But now there is more drug, and starting in late August, persons with a CD4 up to 300 can qualify again -- but those with counts under 100 will still be given priority.

A total of 650 new participants per week will be allowed in the program, instead of only 350, as has been the case from April until late August. Physicians will still need to submit lab slips to verify CD4 count, as they have had to do since April.

Note: The decision to give priority to persons under 100 reflects sentiment at two community meetings of persons with HIV and their advocates, which Glaxo called to discuss how best to handle the unexpected drug shortage. It was not an a priori decision of the company.

A Glaxo spokesperson told us that since the beginning of the open-label program, over 24,000 people have been enrolled. A large but unspecified number of them are also taking AZT. The spokesperson acknowledged that many participants are also combining 3TC with ddI, ddC, or d4T, or with various non-FDA approved treatments, such as NAC or hydroxyurea. She said that Glaxo cannot endorse or encourage these other combinations.

Meanwhile, enough data has been collected from controlled trials of 3TC that a New Drug Application (NDA) was filed with the FDA on June 30. Glaxo Wellcome, the newly merged company, is requesting that 3TC, combined with AZT, be approved for treating individuals with CD4 counts below 500.

To register as a clinical investigator in the 3TC Open Label Program, physicians should call 800/248-9757. Registering new patients can be done by fax, and the drug is shipped within a few weeks. The blood draws required by the protocol are largely routine, and the paperwork required to monitor participants is not unreasonable.