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Call for GSK Trizivir withdrawal

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

The AIDS Healthcare Foundation is asking FDA to remove GlaxoSmithKline's HIV triple-combination therapy Trizivir (abacavir/lamivudine/zidovudine) from the market based on results from a 1,147-patient NIH study (ACTG 5095) comparing Trizivir alone to Trizivir plus Bristol's Sustiva or Sustiva (efavirenz) plus GSK's Combivir (zidovudine/lamivudine) in first-line patients. NIH suspended the Trizivir-only arm in March after findings of virologic failure "sooner and more often" than the other two arms (1Pharmaceutical Approvals Monthly April 1, 2003, p. 6). AHF claims that GSK continues to "aggressively market the questionable regimen." GSK issued a "Dear Doctor" letter in July warning against use of its Ziagen (abacavir) and Epivir (lamivudine) with Gilead's Viread (tenofovir) in treatment-naïve and -experienced patients...
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