Being Alive Newsletter; February 1992
Mark Katz, MD, reported by Warren Jones and Walt Senterfitt

As many of you know, DDI was approved by the FDA in October 1991 as only the second antiretroviral agent. Its approval was surprising, given that approximately 40% of those who took DDI for a period of time in various studies developed peripheral neuropathy perceived as a painful tingling or "pins and needles" feeling, usually occurring first in the feet (usually both feet). If the drug is stopped, the neuropathy usually goes away. We know that DDC may also cause neuropathy but with much lower frequency, probably in single-digit percentages.

Confusing the picture is that HIV infection itself, with no antiretroviral therapy, can cause neuropathy with the same manifestations. We as clinicians, and perhaps many of you as patients, are sometimes faced with a quandary by the appearance of neuropathy. Do we stop the DDI or DDC if the person is already on those drugs? Do we treat with lots of AZT to get rid of it?

The authors of this study looked at what those experiencing neuropathy while on DDI had in common. They found that the onset of symptoms is usually gradual but then reaches a point where it worsens dramatically over one to two weeks. Each person described a feeling of pain, especially on the soles of the feet. In 70% of them, the pain became worse on walking and worse at night. Only a small number showed improvement with treatment by either a mild painkiller like ibuprofen or an antidepressant like amitriptyline or Elavil (sometimes helpful in treating chronic pain). When DDI was stopped, the symptoms worsened in about 25% before they got better, but began to improve immediately in the majority. Twenty percent still had some symptoms as prolonged as two to six months after stopping DDI.

The most important and hopeful thing about the study, however, is that there was no peripheral neuropathy in patients who received a daily dose of less than 10 milligrams per kilogram of body weight. This translates into 500 to 700 milligrams a day in persons who weigh between 110 and about 160 pounds. As many of you know, when DDI was available from Bristol-Myers through the expanded access program, the upper limit of dosing was 375 milligrams twice a day, or 750 milligrams a day.

Since FDA approval, DDI has been reformulated, with a different kind of buffering additive. The equivalent upper dose limit in the new form is figured at about 300 milligrams a day. We hope that with this or smaller doses, in the weight ranges mentioned above, we will find much less frequent occurence of this painful side effect with DDI.

920201
BA920203

Copyright © 1992 - Beings Alive. Permission granted for noncommercial reproduction, provided that our address and phone number are included if more than short quotations are used. Subscription lists are kept confidential. Being Alive, 621 N. San Vicente Blvd., West Hollywood, CA 90069, Tel - 310.289.2551; FAX - 310.289.9866; Email: BeiAlive@aol.com  http://www.beingalivela.org/