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Is Hydroxyurea Hazardous to Your Health?
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written by Mark A. Wainberg, Ph.D.
published on HIVresistanceWeb: February 1. 2000
A recent FDA decision took Bristol-Myers Squibb, the manufacturer of Hydrea (hydroxyurea, HU), to task over the deaths from pancreatitis of two patients who had been treated with a combination regimen of d4T/ddI /HU (click here to read a PDF version of the FDA's Warning Letter to BMS). While concerns over the use of this combination and its potential toxicity are doubtless warranted, it is worth noting that the international perspective regarding the use of HU is very different from that which prevails in most Western countries. Few individuals in the developing world are able to afford triple therapy with antiretroviral drugs. Consequently, HIV-infected individuals commonly purchase only two antiviral compounds and combine these with HU, in the hope of sustaining antiviral benefits over a protracted period. Indeed, it is not an exaggeration to state that HU has come to represent a glimmer of hope for millions of HIV-infected individuals around the globe who live in countries where access to antiretroviral therapy is limited by the high cost of the drugs. Hence, combinations of d4T/ddI/HU and AZT/ddI/HU have been commonplace in many developing nations. Indeed, large proportions of individuals have also resorted to combinations of ddI and HU alone, under circumstances in which they cannot afford the addition of even a single new antiretroviral drug to their regimen.
The reasons that such a high proportion of patients and physicians in developing countries have opted for HU are simple:
- The synergy of HU with a variety of NRTI provides a strong rationale for use of HU-containing regimens.
- HU has been shown to synergize with NRTI even in the context of drug-resistant variants of HIV.
- HU costs only pennies per day, in contrast to the far greater financial burden imposed by other antiretroviral medications.
Hopefully, the valid concerns of the FDA with respect to HU-containing regimens in the U.S. will not translate into the abandonment of such an approach by the tens of thousands of people worldwide who have little choice but to continue on an HU-containing regime. At the same time, it is obvious that patients in developing countries who take HU should be carefully monitored to ensure that development of pancreatitis does not occur and to eliminate HU if considerations of pancreatitis or other toxicities become important. In this context, the approach to HU in developing countries vs. the U.S. need not be dissimilar.
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