AIDS group seeks Trizivir withdrawal
Executive Summary
AIDS Healthcare Foundation asks FDA to withdraw approval of GlaxoSmithKline's HIV combination therapy Trizivir (abacavir/lamivudine/zidovudine) based on results from an NIH study reported in March. The study compared patients taking Trizivir alone to patients on Trizivir plus Bristol-Myers Squibb's Sustiva and patients on Sustiva and GSK's Combivir. NIH suspended the Trizivir-only arm after patients in that arm "experienced virologic failure...sooner and more often than patients in the other two arms of the study." GSK warned against use of its Ziagen (abacavir) and Epivir (lamivudine) in combination with Gilead's Viread (tenofovir) in a recent "Dear Doctor" letter (1"The Pink Sheet" Aug. 4, 2003, In Brief)...
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AIDS Healthcare Foundation asks FDA to withdraw approval of GlaxoSmithKline's HIV combination therapy Trizivir (abacavir/lamivudine/zidovudine) based on results from an NIH study reported in March. The study compared patients taking Trizivir alone to patients on Trizivir plus Bristol-Myers Squibb's Sustiva and patients on Sustiva and GSK's Combivir . NIH suspended the Trizivir-only arm after patients in that arm "experienced virologic failure...sooner and more often than patients in the other two arms of the study." GSK warned against use of its Ziagen (abacavir) and Epivir (lamivudine) in combination with Gilead's Viread (tenofovir) in a recent "Dear Doctor" letter (1 'The Pink Sheet' Aug. 4, 2003, In Brief).... |