This paper was originally published here, in French. We provide this translation for your convenience. Some practical aspects may differ where you live.
Efavirenz 400 mg: Dose Reduction
No one is a prophet in his own country...
There you go ... You are right on ...
Efavirenz 400 mg: an history of overdosing
This post follows the WHO recommandation update, presented for the first time in France, in the pst: WHO proves us right!
Everyone has heard about the new WHO recommendations. It was even in mainstream newspapers. Including Prep, launched with great buzz. This one, which will improve the care of millions of patients, the first relief endorsed by WHO, only appears in two lines, and has not been commented anywhere (it can be found here, p.9) .
It is true that when it is necessary to correct the situation, it is hardly glorious!
In first line, Efavirenz from 600 mg to 400 mg.
400 mg ... Why 400? Why not 300 or even 200? Who will remember that in DMP 266-005 trial, the 200 mg worked BETTER than 400 mg or 600 mg. Who decided for 600? It is the manufacturer (DuPont Merck) ... And noone ever questionned this decision. Why 400 and not 500? Because there is a packaging as a 200 mg capsule, so it's convenient for a trial.
In the DMP 266-005 trial, each arm had 36 volunteers: 81% of those receiving 200 mg, compared to 71% of those under 600 mg, achieved < 400 copies / mL, and 2 times more odd effects in the brains have been odserved in the 600 mg group (44% vs. 19% in the 200 mg group).
Why are they doing Phase II trials if we do not take them into account !!!
And what help is a doctor if he does not adjust the dosage ???
As people will remain under treatment for another 10, 20, 30, 40, 50 years, the day will come where they will ask , again: why 400 mg?
Going from 600 mg to 400 mg, saves 0.2 x 365 g / patient / year or 73 grams. There are several million patients using EFV. For 1 million patients this amounts 73 tonnes. Say, 10 years for 10 million patients: 7300 tons!
The initial mistake resulted in a waste of more than 7 300 tonnes of active ingredient!
And, 400 mg (rather than 200 mg) is another waste of 7300 tons of active principle!
Efavirenz ...
Why revisit the recommendation for Efavirenz only? In China 80% of patients are under Nevirapine. In Lanzafame confirms that dose reduction was as effective with Efavirenz and with Nevirapine. After backtracking on EFV (efavirenz, which is found in Atripla), will the WHO draw conclusions and look into other molecules? Or are we going to wait for another 10, 20 years?
TLE-400, FDA & Marketing
Okay ... Do you really think that a system, which failed to make amends and apologize to the victims of Efavirenz 600 mg, and victims of the shortage arising from such wrong dosage, will fix itself ?
No way it will amend itself so that dosage decisions are better thought out.
The FDA will approve the TLE-400, as required for the deployment of this strategy. This strategy is better than EFV-600, but we will, once again, ignore the savings that are possible in maintenance mode, ie the rest of life ... And life is long ...
The FDA will approve TLE-400 ... So, it's only a matter of time that TLE-400 is made available ... But wait... No! They will repeat the DUTREBIS trick, which is duly authorized. Authorized by our agencies, certainly, but not authorized for sales at home!
TLE-400 is in the starting block, it even may already be marketed, who knows, and the French pigeons will not be entitled to this NNRTI dose correction nor to the short cycle reduction (ICCARRE).
The oligarchy, locks up the media and you will never hear about it! Let them enjoy skiing in nice resorts and yachting on the Greek coast.
If you find the information and analysis in your media, just let me know! (most lekely you won't!)
This paper was originally published here, in French. We provide this translation for your convenience. Some practical aspects may differ where you live.
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