Important note: Information in this article was accurate in September 2000. The state of the art may have changed since the publication date.
Hydroxyurea (Hydrea or HU) has been used as an anti-cancer drug for decades. In the 1990s researchers found that in lab experiments, HU increased the anti-HIV activity of ddI and d4T. Results from several short term HU studies are available and suggest that the drug does reduce production of HIV in people. Since HU impairs the production of cells from the bone marrow, large increases in CD4+ cells are usually not seen in people who use this drug. Moreover, HU has the potential to increase the toxicity of ddI and d4T. As a result, its not surprising that doctors found that after two years of use, subjects receiving HU were more likely to experience side effects than subjects not using this drug. As well, after two years, only 25% of subjects originally given HU continued to use the drug. According to the study researchers, HU does not appear to be as well tolerated or effective, over the long-term, as certain protease inhibitors or other anti-HIV drugs. As a result, HU may have limited use in PHAs. See our section on anti-cancer agents for other news on HU.
Researchers recruited 144 subjects (no details on gender were available) for their study. Subjects had the following characteristics at the start of the study:
Researchers randomly selected 72 subjects to receive ddI, d4T and fake HU (placebo). The remaining 72 subjects received ddI, d4T and HU. Subjects on placebo whose viral load remained above the 200 copy mark after three months could add HU to their combination. Since 30 subjects eventually chose this option, a total of 102 subjects received HU during the study.
During the course of the study 76% of subjects given HU stopped taking it for the following reasons:
Another 27 subjects chose to stop taking ddI and d4T for the following reasons:
Subjects who had never used anti-HIV therapy (about 30% of the group) were more likely to remain in the study than subjects with prior exposure to anti-HIV drugs (19%). About 73% of subjects who left the study went onto treatment that included protease inhibitor.
Comparing the data from this study to that in their database, the researchers suggest that subjects given nelfinavir or indinavir were far more likely to continue using these drugs than HU.
The following side effects were significantly more common among subjects using HU than those only using the double nuke regimen:
Not surprisingly, the rate of nerve damage (peripheral neuropathy) in people receiving the study regimens was as follows:
Fatigue was three times more common among people receiving HU than in those who did not use this drug. Moreover, sometimes the fatigue seen with HU was severe and disabling. This level of fatigue was not linked to the development of fewer red blood cells. In two subjects who stopped taking HU but continued use of ddI and d4T, their fatigue dramatically cleared.
After two years the following proportion of subjects in each regimen maintained a viral load below the 200 copy mark:
The increase in CD4+ counts over the course of the study were as follows:
Neither of these differences in viral load and CD4+ cells between the two treatment combinations were statistically significant.
The following number of subjects in each group developed fevers, night sweats, wasting, swollen lymph nodes while in the study:
As well the following number of subjects in each group developed Kaposi's sarcoma (KS):
Again, none of these differences in symptoms or KS was statistically significant.
According to the results from this study, HU does not appear to be a regimen that is highly effective and well tolerated over a period of two years in some subjects.
1. Rutschmann OT, Vernazza PL, Bucher HC, et al. Long-term hydroxyurea in combination with didanosine and stavudine for the treatment of HIV-1 infection. AIDS 2000 Sep 29;14(14):2145-51.
20000909
CATE11002
Copyright © 2000 - TreatmentUpdate. Reproduced with permission. Reproduction of this article (other than one copy for personal reference) must be cleared through the Editor, The Canadian AIDS Treatment Information Exchange, 555 Richmond St. West, Suite 505, Box 1104, Toronto, ON, M5V 3B1 • Phone: 416-203-7122 • Toll Free: 1-800-263-1638 • Fax: 416-203-8284 http://www.catie.ca.
ÆGiS is made possible through unrestricted grants from Boehringer Ingelheim, Elton John AIDS Foundation, iMetrikus, Inc., the National Library of Medicine, and donations from users like you. Always watch for outdated information. This article first appeared in 2000. This material is designed to support, not replace, the relationship that exists between you and your doctor.
ÆGiS 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 ©1990, 2000. ÆGiS & the Sisters of Saint Elizabeth of Hungary. All materials appearing on ÆGiS are protected by copyright as a collective work or compilation under U.S. copyright and other laws and are the property of ÆGIS, or the party credited as the provider of the content.