Adherence, REMS expected AdCom focus for Gilead's Truvada in HIV PrEP
This article was originally published in Scrip
A US FDA advisory panel on 10 May not only will weigh the safety and effectiveness of Gilead Sciences' Truvada (emtricitabine/tenofovir disoproxil fumarate) as a pre-exposure prophylaxis (PrEP) therapy to reduce the risk of HIV-1 infection among uninfected adults, but will advise regulators on whether the firm's risk evaluation and mitigation strategy (REMS) plan is adequate for ensuring doctors and patients understand the importance of strict adherence to the recommended dosing regimen and regular monitoring.
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