Reuters (08.19.03) - Wednesday, August 20, 2003
The nation's largest AIDS organization on Tuesday asked
federal regulators to withdraw approval for GlaxoSmithKline's
drug Trizivir in light of a study showing it was inferior to
other treatment combinations. The AIDS Healthcare Foundation
said keeping the drug on the market may be dangerous because
some doctors may be unaware of the new findings and continue
to prescribe Trizivir alone.
Trizivir is a single pill combining three HIV drugs - AZT, 3TC
and abacavir - into one twice-daily regimen.
The National Institutes of Health said in March it had halted
part of a trial comparing Trizivir alone to other drug
combinations because Trizivir by itself was less effective at
AHF said it was "apparent that Trizivir may be effective only
if it is taken with other HIV/AIDS drugs." "Trizivir's lack of
effectiveness renders it unsafe," the group wrote in a letter
to the Food and Drug Administration.
GlaxoSmithKline spokesperson Nancy Pekarek said AHF was
"acting irresponsibly" by seeking Trizivir's withdrawal. "What
they are trying to do is deny patients and physicians an
important weapon" against HIV, she said, adding that patients
should not stop treatment prescribed by their doctors. Pekarek
said the NIH study should be considered "in the context of
total available data, which proves the effectiveness of
Trizivir." She also said that a Department of Health and Human
Services expert panel had issued guidelines in July
recommending Trizivir as a first-choice option.
AHF said GlaxoSmithKline continues to aggressively market
Trizivir as a stand-alone treatment despite the NIH trial.
Trizivir is the fifth most-prescribed HIV medication, AHF
said. An FDA spokesperson said the agency will review the
request to pull Trizivir from the market. AHF provides HIV-
related medical care to some 12,000 patients in the United