Trizivir-Alone Arm Of NIH Trial Halted Due To Greater Effect In Sustiva Combos
This article was originally published in Pharmaceutical Approvals Monthly
Executive Summary
First-line use of GlaxoSmithKline’s Trizivir is inferior to two treatment regimens containing Bristol-Myers Squibb’s Sustiva, according to interim results of a 1,147-patient NIH study of protease-inhibitor-sparing regimens for initial treatment of HIV.
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Call for GSK Trizivir withdrawal
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...
FDA Priority Review Voucher Redemption Fee Set At $4.6 Million In FY 2011
Redeeming a priority review voucher obtained by developing a drug for a tropical disease will cost companies $6.1 million in fiscal 2011
September 2010 Approvals
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