Douglas Krakower, MD, raises questions of benefit vs value
I was going to talk today on a piece that a group of wrote for the annals of internal medicine in february of this year that related to the question about used to know for vir alfetta mind versus to know fear which is approximate or taff versus tdf based regimens for daily pre-exposure prophylaxis hiv and the background for this is that there’s been a robust
Evidence for saying tdf/ftc a–‘s daily prep for multiple populations including fda approval and guidance for many years and in october the 9th there was fda approval of daily use of taf ftc for prep and this was baitin the results of the discover study which was a large non-inferiority study that was amongst several thousand msm and transgender women comparing
The efficacy and safety of daily taft ec versus tdf/ftc for and the study showed that taft ftc for prep was non-inferior meaning it was as protective as tdf/ftc which was a great result in terms of new crowd options for the population study and the question really has been about is one or the other regimen or safe heather and in that study discover they found
That there was a slight improvement relative to tdf in renal bone biomarkers for people who are randomized to use the taf regimen and people randomized to use the tdf regimen had slight increases in their overall body weight and also some poorer lipid profiles including more people being prescribed statins over the course the study the group randomized to taf so
The reason we wrote this piece in the annals of internal medicine was to try and summarize all this for frontline clinicians who may be thinking about what’s the appropriate rep for patients they may see in clinic and initially we heard a lot of anecdotal reports from colleagues that a lot of people were taking the results at the discover study which had been
Presented an abstract form at croi in 2019 and also the international aids society conference and we’re talking about making switches from tf2 taff based on some of the reports on the slight improvements in renal and bone markers but as we dug into some of the data presented to the fda in october we thought it would be important to point out that in fact there
Wasn’t really a safety difference that made one or the other option better for all people who may be opting for a prepuce but in fact there were differences in the safety profiles and that task seemed to be or role for people who might have renal and bone conditions or be at risk for adverse outcomes but that people who were more concerned about their body weight
Or cardiovascular preventive health in terms of lipid profiles then sticking with tdf might be a better option so we really wanted to point out that there wasn’t a safer option but there were just differences in the safety profiles this is all really relevant because there will be availability of generic tdf/ftc starting in the fall of this year and then probably to
Pull generics on the market in early 2021 and we will the a of generics who wanted to point out that the price would probably drop substantially 40c versus taff ftc and so the cost-effectiveness it greatly improved with the use of a generic formulation when those multiple market and given that the access to prep in this country has been affected quite substantially
By cost limitations we thought it was really important to highlight for society that a on mass switch from tdf to taff based regimens would not necessarily be cost-effective and in fact since we moved this piece of me annals of internal medicine there was another piece in this name journal by rochelle olinsky and her group in march of this year which was time to be
Presented around croix and they found that the cost effectiveness of switching people to taff after you see versus tdf/ftc was really not there and in fact the amount of money would have to pay to improve one quality adjusted life year which is a metric of cost-effectiveness be somewhere between three and seven million dollars depending on the baseline condition
And comorbidities of an individual patient and that in fact the most that should we should pay as a society for using tat versus tdf is about three or four hundred dollars per year per person so all this is to say that as clinicians think about taff versus tf prep it really seems like on a societal level a large scale switching doesn’t make good sense and some
Of my legs from the new york city department of health demetri dass calacas who as a co-author on our paper have put out statements on behalf of their public health guidance suggesting that tdf/ftc remain the first line prep for most people for whom it’s indicated with a small percentage of people with renal and bone issues having taf ft see it as a great backup
Option so we just thought it’d be really helpful for collisions who may not be as familiar with all the nuances of the discover study and the fda approval and some of the data around cost-effectiveness in terms of thinking about which are the best options for their patients and that’s really what we wanted to convey you
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Should PrEP Users Switch From Truvada to Descovy? – Medpage Today By MedPage Today
