July 27, 2006 (AIDSmeds)—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.
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