PI Perspective 29: ddI, d4T and Hydroxyurea Side Effect Warning!

Important note: Information in this article was accurate in April 2000. The state of the art may have changed since the publication date.

ddI, d4T and Hydroxyurea Side Effect Warning!

Project Inform Perspectives 29 - April, 2000

The FDA recently issued a warning that when using ddI (didanosine, Videx), some people may develop pancreatitis (a potentially life-threatening inflammation of the pancreas). An early symptom includes severe abdominal pain, which should be carefully diagnosed. Adding d4T (stavudine, Zerit) and/or hydroxyurea (Hydrea, Droxia) to ddI may further increase the risk of pancreatitis.

Results from ACTG A5025 suggest that people taking ddI, d4T and hydroxyurea together are more likely to develop this side effect than those taking AZT (zidovudine, Retrovir) and 3TC (lamivudine, Epivir). All people had been on stable treatment with AZT+ 3TC+indinavir, and after six months, either stayed on AZT+3TC+indinavir or switched to d4T+ddI+indinavir with or without hydroxyurea.

After 24 weeks there were no differences in viral load changes among the groups, but people taking ddI+ d4T+hydroxyurea+indinavir were more likely to have side effects. These included pancreatitis, neuropathy and increased liver enzymes. Further, the group taking hydroxyurea had about a hundred CD4+ cell loss compared to a slight increase in the other two groups.

There are several possible reasons why those taking hydroxyurea had more side effects. The most obvious is that they took four drugs while the others used three. Another is that the dose of hydroxyurea used was higher than the standard dose (1,200mg vs 1,000mg) and it was not adjusted for weight. Also, hydroxyurea causes more ddI to get into cells, increasing the risk of ddI-related side effects, like pancreatitis. Additionally, regular monitoring was not done by the researchers but by their primary physicians, who may have been less familiar with the procedures for monitoring and responding to early signs of pancreatitis.

These findings suggest that people should be cautious if they're taking ddI and hydroxyurea together. If they experience any type of pain in the stomach, they should immediately notify their healthcare provider.

000401
PI000402

©2000. This document is copyrighted by Project Inform, 205 13th Street, #2001, San Francisco, CA 94103. Treatment Hotline: 800-822-7422 (toll-free) or 415-558-9051 (in the San Francisco Bay Area and internationally) All Project Inform materials may be reprinted and/or distributed without prior permission. However, reprints may not be edited and must include the following text: "From Project Inform, for more information contact the Project Inform National HIV/AIDS Treatment Hotline, 800-822-7422." For permission to edit any Project Inform material for further publication, contact David Evans at the Project Inform office.

AEGiS is made possible through unrestricted grants from Roxane Laboratories, Inc., iMetrikus, Inc., the National Library of Medicine, and donations from users like you. Always watch for outdated information. This article first appeared in 1988. This material is designed to support, not replace, the relationship that exists between you and your doctor.

AEGiS presents published material, reprinted with permission and neither endorses nor opposes any material. All information contained on this website, including information relating to health conditions, products, and treatments, is for informational purposes only. It is often presented in summary or aggregate form. It is not meant to be a substitute for the advice provided by your own physician or other medical professionals. Always discuss treatment options with a doctor who specializes in treating HIV.

Copyright ©1985, 2000. AEGiS & the Sisters of Saint Elizabeth of Hungary. All materials appearing on AEGiS are protected by copyright as a collective work or compilation under U.S. copyright and other laws and are the property of AEGiS and the Sisters of Saint. Elizabeth of Hungary, or the party credited as the provider of the content.