PARTNERS subgroup of cisgender women found they appear to respond to Viread (TDF) more than Truvada for PREP. We need a powered Phase 3 with evidence bc so far there could be differences.https://www.ncbi.nlm.nih.gov/m/pubmed/26417954/ …
And what do we do now? Can Descovy be approved for women without data? If not, will women ever get equal access? Hoping whatever @US_FDA decides, data in women will be an urgent part of the plan. @CarlosdelRio7 @HIVpxresearch @JuliaLMarcus @jenkatesdchttps://twitter.com/CarlosdelRio7/status/1177623962173546497 …
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Kiitos. Käytämme tätä aikajanasi parantamiseen. KumoaKumoa
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I’m frustrated bc cisgender women deserve MORE than PK data. If we keep assuming they are like MSM and TGW.... then how are we also not creating treatment disparities without powered Phase 3 proof?
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Agree!
Kiitos. Käytämme tätä aikajanasi parantamiseen. KumoaKumoa
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Agree with you
@RWalensky having two drugs (Truvada & Descovy) approved for PrEP in men and TG women and only one (Truvada) approved for cis-Women would be an inequity, wrong and send a bad public health message. -
Agree, the decision to go the FDA without any data for cis women for F/TAF PrEP was unforgivable. But worried that if we establish the precedent of PrEP getting indications for cis women without any data, we incentivize other PrEP applicants from ever studying this population.
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Sadly this is not new. Women have largely been excluded from key trials in the past—hiv, hcv, etc. each time this happens, the disparities grow further. Hopefully the
@US_FDA does the right thing. -
There have been some bright spots, e.g. ACTG 076, and subsequent studies showing that treating mom optimally is best for baby.
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