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In a letter sent to doctors late last month, Roche Pharmaceuticals announced that it will be ending the sale and distribution of Hivid® (zalcitabine, also known as ddC), a nucleoside reverse transcriptase inhibitor (NRTI) originally approved in 1992. The tablets will not be available in U.S. pharmacies after December 31, 2006.
At the time of Hivid's approval by the U.S. Food and Drug Administration (FDA), it was a much anticipated HIV drug. It was the first antiretroviral to receive accelerated approval by the FDA, a mechanism that is still used to rush promising agents to market for life-threatening diseases.
In a June "Dear Doctor" letter – sent to HIV-treating physicians alerting them to the end of Hivid's 14-year run as an NRTI option – Roche said that "Hivid represented a significant breakthrough" at the time of its approval. However, its praise as a breakthrough has long been a source of much controversy, particularly among treatment activists. As explained in a report authored by Mark Harrington of the Treatment Action Group (TAG), Hivid was approved "even though there was no evidence that ddC approved health or prolonged life. It was based on minute and transient increases in CD4 counts. ddC would go on to be the least widely used drug of its class."
Today, HIV treatment guidelines do not recommend Hivid and several discourage consideration of its use in favor of newer NRTIs. Furthermore, specific recommendations within these treatment guidelines state that Hivid should not be administered in combination with Videx® (didanosine), Zerit® (stavudine), Epivir® (lamivudine), or Retrovir® (zidovudine), further limiting the ability to construct a drug regimen containing Hivid.
In its letter to healthcare providers, Roche indicated that other NRTIs are available with more favorable risk/benefit profiles. Based on this fact, along with a decline in the use of the drug over the past ten years, the manufacturer has elected to discontinue its availability. Roche noted, however, that this decision is not the result of any new safety or efficacy issues.
Roche is encouraging healthcare providers to refrain from starting Hivid in any of their HIV-positive patients. For patients currently on Hivid, discussing appropriate treatment alternatives with their healthcare providers is now necessary.
