This paper was originally published here, in French. We provide this translation for your convenience. Some practical aspects may differ where you live.
Quatuor and Strategy # 1
Excellent move! Finally, we have doctors who know about lighter treatments (most are in France):
http://once-weekly-hiv-therapies.blogspot.fr/p/experienced-doctors.html
7/7 triple therapy followed by 4/7, triple therapy has advantages: it is perfectly mastered at Garches Hospital (by de Truchis) and is based on solid science: 0 intrinsic failures in 190 patients! It opens to 1/7: weekly dosing, which is great, psychologically speaking.
The Mono Tivicay ®, practiced by some in 4/7, is an attractive compromise.
De Truchis offers a strategy where he excels: There is no reason for disappointment ... If you want to be disappointed, for sure, then, you go to Molina! There, you'll be served!
For mono Tivicay®: Katlama (Salpêtrière, Paris), Hocqueloux (Orléans), Lafeuillade (Toulon)
Quatuor? Why is that?
The ANRS feeds Big Pharma and this is no good for patients. Leibowitch is an outspoken opponent of the ANRS since its creation: why would you want the ANRS make him a bed of roses? These squabbles Parisian are at the expense of patients! Please, stop!
The enemy, defeated by ICCARRE, comes back through the window: ANRS, wants to limit the bombastic effect and deprive ICCARRE its atomic class victory atomic class.
A trial is a test of hypothesis: always keep an eye on terms and conditions for inclusion. The hypothesis tested in ANRS-4D: Leibowitch he lied? The answer is no! So ICCARRE-2 results (94 patients) and ANRS-4D (96 legitimate patients) can be aggregated: 190 patients!
What is then the hypothesis tested in the Quatuor?
When the ANRS publicized Quatuor, it sees in ANRS-4D 4 failures. These failures were lies, as it has been found out later. 4 failures that can not teach us anything about any inclusion criteria (always the harmful influence of Rouzioux-of-Criterias), especially as they are 'failures' without any other cause than cowardice and toxicity (the reduction of which is the target ...). 4 pseudo-failures, how to analyze them? We need more ... How Many more? Well ... 25 ... 25 divided by 4% falls on 625.
Did not you find the size of this trial: 640 patients, a bit unusual? 640? Why not 600 or 800, no... 640 ...
640 So ... That is rounding 25 divided by the failure rate (which were pseudo-failures, remember)
If there had been only three failures (ie if virologist-saboteur had been excluded), the trial would have been set at 840 ... The size of the test depends on the presumed failure rate (by ANRS, here misguided by anti-ICCARRE lobby). This failure rate (which was revised lower) made them very upset: the anti-ICCARRE lobby anticipated 5 or 10.
They have been screwed ... So they screw us ...
The intrinsic failure rate was 0 in the 96 'real' ANRS-4D participants, therefore, the 94 patients at Garches are valid: 190 patients, 0 failure: 0 among 190. Quatuor is only 3 times ICCARRE + ANRS-4D. ZERO was the observed rate, perhaps a bit lucky ... A bit of favorable luck.
The main hypothesis tested is: the low rate of failure in ANRS-4D was due to chance. A secondary hypothesis is tested: INIS are not suitable for 4/7.
We want to ensure the true rate (1 or 2%?) Or ... But, then, we should look at the REAL rate of intrinsic failures, and put an end to cheating and sabotage. Especially as test of two hypotheses is tricky.
One of the stated objectives is to open the process to as many patients as possible. Of course, we do not believe a word: the avowed purpose is to delay, limit the impact of ICCARRE.
Let's compare inclusion criteria
Compare, differential conditions for inclusion ICCARRE, ANRS-4D and Quatuor
| Conditions | ICCARRE | ANRS-4D | Quatuor |
| CD4 at baseline | > 200 | > 250 | > x (CD4-Quatuor) |
| perfect adherence | prerequisite | requested (controlled by dosage) | Quatuor ? |
| reservoir (proviral DNA) | Not required | Not required | ? |
| Nadir (CD4) | Not required | Not required | ? |
| CD4/CD8 Ratio | Not required | Not required | ? |
| pregnancy | ? | to be avoided | ? |
| duration under current molecules | > 6 months | 4 months | ? |
| Is Nevirapine eligible ? | Yes | No | ? |
| Is Issentress eligible ? | Yes | No | ? |
| Is Stribild® eligible ? | non avail. | No | ? |
| Is Triumeq (ou T&T) eligible ? | non avail. | non avail. | ? |
| is Tivicay® Bithérapie eligible ? | non avail. | non avail. | ? |
| Is Tivicay® Monothérapie eligible ? | non avail. | non avail. | ? |
| Eclipse (Time to rebound) | not published | no | ? |
- Avoid cheating
- Include as many therapies as possible
- Avoid changing the key criteria
- Dare to be transparent
- The problem of Premium eligibility: observation of Eclipse
Until then: be compassionate ! Millions of patients in need suffering overmedication, when millions do not have access, the cost of a million death each year!
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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