Search This Blog

Sunday, October 23, 2016

Quatuor: what for ?

Quatuor: what for ?
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


Following our suggestion: he goes to de Truchis; was disappointed ...


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.

In the test of hypothesis, we test the negation of which would be favorable (null hypothesis), hence the inversion in the expression: we invalidate the negation (I know ... It's not easy ...)

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
ConditionsICCARREANRS-4DQuatuor
CD4 at baseline> 200 > 250 > x (CD4-Quatuor)
perfect adherenceprerequisiterequested
(controlled by dosage)
Quatuor ?
reservoir (proviral DNA)Not requiredNot required?
Nadir (CD4) Not requiredNot required?
CD4/CD8 RatioNot requiredNot 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 ?


In a future post, we will discuss other aspects:
- 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.

Saturday, October 15, 2016

The Montreal patient

The Montreal patient

Stribild® as Achille's Heel


This paper was originally published here, in French. We provide this translation for your convenience. Some practical aspects may differ where you live.

A patient at Clinique l'Actuel, screwed by Stribild ®

A case reported by the so lovely Dr. Réjean Thomas:

Development of a G118R mutation in HIV-1 integrase Following a switch to monotherapy dolutegravir ...

Montreal: another victim of Achille's Heel:




Poor patient ... HLA * 5701 positive ... This may have helped him be asymptomatic for so long. Why enter the treatment on the basis of a single reading of CD4 < 350? Ah ... Yes ... The new US recommendations, with, as first choice, Stribild ®. Why start so early with the Tivicay® mono-therapy, whereas a Dual Therapy Tivicay® + Lamivudine could have made a reasonable step? See how the Doctor (Dr Thomas?), puts the blame on the patient? He would have learned about the mono Tivicay ®? Where so? On the internet probably. Oh ... Naughty boy! ... And he is pushing, despite admonitions by his doctor ... Yes ... But without prescription, the patient can do nothing ...

In the discussion, the authors note:


Science, showing the Achilles Heel Trojan Horse, only took place in Oct. 2015, and, rare, very rare, too rare are those who relayed the discovery, made in Paris. The damage is done, and the pill is bitter to swallow ... And also for the prescribing doctor ... Stribild ®, once again, challenged ... Poor Quebec ... Its First-in-class biologists were the first to pinpoint the mono Tivicay® ...

Bad luck, the marketing teams from their Southern neighbors had already managed to position the Trojan Horse Stribild® as best choice, without the faintest history. Finally, this patients ends up with PIs. Holy shit ...

You read, here, and nowhere else, about the Achilles heel, the Mono Tivicay as first Line, the extraordinary success of ANRS-4D, the negative recommendation by the HAS for Genvoya ®, the Montreal patient (another exclusive ...), then you begin to see the broad picture. That's it, you think you have it all!

Not so fast! You do not know yet the Munich patient, DoluMono, Domono (later, this October!), how the snowman melts, suicides during the START trial ... I have more! And the best!

The Achille's Heel Trojan Horse has been widely discussed here. It was presented by C. Katlama at EACS-2015 and published in June 2016. Our regular readers had a head start ...

Hop! (as Achille Talon would say) Good weekend and good fuck!


This paper was originally published here, in French. We provide this translation for your convenience. Some practical aspects may differ where you live.

Saturday, October 1, 2016

Gvt Health body torpedoes Genvoya(tm)

Gvt Health body torpedoes Genvoya(tm)
This paper was originally published here, in French. We provide the google translation for your convenience. Proper translation will come soon. Some practical aspects may differ where you live.

From a patient who has poorly maneuvered:

What a journey! You toasted almost all your treatment options simply because of toxicity that you, and you alone, allowed to break in... Bravo!

Apart from the initial phase, your new combo has a very low dropout rate. This one remains widely used, to the chagrin of merchands. The Genvoya ® proposal will then have no interest.


If the patient has a proactive doctor: the 'promise' for relief that was made to encourage the patient to enter early in treatment, will be held. If the doctor is of the reactive type (relief only if under duress) the promise of yesterday will quickly retracted.
Remember to ask about what happens next before running to the slippery slope

In the first few years of its release, no one had seen the toxicity caused by TDF (which is in Truvada®). No one. No one; neither phase 3 trials or systematic monitoring done by D: A: D: S. And this, everyone has forgotten.

Toast an option due to resistance or due to toxicity, it is the same shit!

If the doctor is seasoned and proactive; the 'promise' of a lower medication burden that entices the patient to early treatment, will be fulfilled. If the doctor is of reactive type (lesser medication load only if under pressure) the promise of yesterday will quickly be retracted.

You want to take a second opinion (in a perspective a lower burden): you are proactive.

And, if you go to a reactive doctor, same as your current doctor, you are fooled again. And you can not know in advance: doctors not to put their 'profile' under their name

HAS torpedoes Genvoya®


Translation Note: the HAS (Haute Autorité de Santé) is a French gvt body, established in the wake of the Vioxx and mediator scandals; An equivalent to Britain's NICE. It aims at protecting patients and doctors again falatious claims.

The HAS ruling concerning Stribild® was already severe: it had positioned Stribild® in second line.

It points: [...] the low genetic barrier to resistance to elvitegravir and the lack of demonstration superiority in terms of effectiveness compared to other available INI (Dolutegravir, Raltegravir), and the need for a pharmacokinetic enhancer, Cobicistat, [...]

Genvoya® is nothing but Stribild® where TDF was substituted by TAF. Here is piece in Pharmaceutical that introduces the trick: This is an incremental innovation, which the Transparency Commission of the HAS has also denounced no improvement in actual benefit (although benefit is important)

The 2 reference documents are:

TRANSPARENCY COMMITTEE, Avis and March 2, 2016 and SUMMARY OF OPINION OF THE TRANSPARENCY COMMITTEE; General access is here.

About Genvoya®, it says: When a treatment strategy with integrase inhibitor is considered, Genvoya ® is a second-line treatment option.

In short: Say, you are under Atripla ®, and your doctor offers Genvoya®. If you want to follow the opinion of the HAS (or simply if you want to avoid Genvoya® food obligation): simply show this ruling to the doctor. Does s/he considers a treatment strategy with integrase inhibitor? Obviously, yes. Can s/he suggest Genvoya®? Well no ! It should first try the alternatives: Raltegravir (Isentress ®) or Dolutegravir (in Triumeq® or Tivicay ® ®)

If we follow the HAS (May 2016), Genvoya ® should only be considered as a replacement to Stribild® or Isentress ® . HAS denies the use of Genvoya® outside this context of historical continuity.

If you go by the HAS, Genvoya ® should never be your first treatment, or even, in the vast majority of cases, your second. At the earliest, this will be your third ...

For a relegation, that is a relegation! ...

And that nobody talks about ...

HAS: schizophrenic and obsequious


Having thus torpedoed Genvoya®, HAS will engage in an exercise of unprecedented baseness.
So, it had just disqualified for lack of improvement (TAF weak evidence of toxicity reduction), but, in the same document, it pleads the manufacturer to promptly substitute TDF by TAF, in other products . It has nothing to do with Genvoya®, but they write it there, in the ruling on Genvoya ®: message well received or a shot in the dark?

France, now a pharmaceutical dwarf, forced to supplication.

As if the US were to return a favor as they just sunk their flagship to the sea floor!

Genvoya ® HAS got it right: the trap is set for you


HAS saw it coming: in a future post, I 'll report how a Quebec doctor screwed a patient. For him, the pill is bitter: if he had read us, he would have thought twice.
This case illustrates a scandal being put in place: it is the same order of magnitude as the tainted blood scandal: the problem is known, but the alarm is not sounded.

By definition, the trap is concealed: it is enough to reveal the mechanism for curdling terror. To be continued...

Comical: the Seroneg's coming-out



Seronegative explain life to poz, as read on the Web, and worth reflecting upon:
Weird story about the 'AIDS' organizations: An official at a local 'conference' (AIDES) talks to about twenty HIVers on how to approach life ... I ask him if he is HIV positive, to what he replied that he preferred to keep the answer for himself! ... I left the room, protesting that announcing one's HIV status could be a problem that adds to the one of announcing one's HIV negative status!


Have a good week-end and good fuck!


This paper was originally published here, in French. We provide the google translation for your convenience. Proper translation will come soon. Some practical aspects may differ where you live.