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...
You may also be interested in...
Trizivir-Alone Arm Of NIH Trial Halted Due To Greater Effect In Sustiva Combos
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.
US Q1 Consumer Health Earnings Preview: Label This One Historic And Challenging But Promising
US OTC drug and supplement firms’ reports of results for the first three months of 2024 began on April 19 with P&G. JP Morgan analysts say while “some retailers in the US in particular” are reducing consumer health inventories, for the overall sector they expect “a healthier balance of positive volume and lower pricing contribution.”
Keeping Track: Cancer Approvals From Lumisight Imaging To Adjuvant Alecensa
The US FDA’s approval of Lumicell’s optical imaging agent Lumisight makes a dozen novel approvals in 2024 for the Center for Drug Evaluation and Research.