It's Achille's, Stupid!

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

I found this rather funny:

I love this shortcut: my doctor preferred not to play the sorcerer's apprentice: he added Edurant® .... Contemplating the result: Bravo! What did I not hear about the risk of alleviated treatments. As if adding more (or maintaining too high, it's the same ....) was safer !!! Physicians should take decisions together with patients, after explaining risks. But in practice, does the patient (or doctor) really understands what is at stake?

It is Achilles, stupid!

There are only 2 possibilities: either the risk is random, indiscriminate, or it is unevenly distributed, highest in one group, and therefore, lower or nihil in another.

It is in the best interest of Big Pharma and its relays to make believe that the risk is high and indiscriminate. This does not resist the accounting of known, documented and registered cases.

This is why we can not find anywhere this comprehensive, yet simple, accounting. It is described here: The Achilles heel.

If the risk is random: four failures out of 61 (33 + 28 Barcelona + Paris): 6.5%: it is not high ...

If it is not-random, it is based on risk categories: here, everyone speculates (without any evidence) one says the 'reservoir', this other the 'CD4 count', this one the 'Nadir', that one 'the dose'. Dr. Jacques Leibowitch proves that this is all bullshit. What about C. Katlama's presentation, which provides us very kindly, these parameters, including the historical presence of Achilles' heel? Let's fill the confusion tables, and see which one is the most relevant.

Let's build the confusion table ...

Everyone expresses an opinion on the conditions required before attempting dosage reduction. Most times, this is not consistent with the evidence from clinical trials. For example: make of a good immune reconstitution a necessary requirement: then one comes up with a threshold of CD4 = 350, another 500, another says 800, and why not 2000 while you are at it?

Let fill the confusion table for the criteria 'good restoration' with a threshold of 624 CD4 count (for that is the median, published by C. Katlama EACS-2015, in her trial patient pool).

Is a criterion of good immune reconstitution, before switching to maintenance monotherapy with Tivicay®, effective? NO!

Proponents of this (false) criterion would have excluded half of patients (14), barred, unduly, 13 patients fromt from this strategy beneficial to the patient; They would not have prevented 2 of the 3 failures!

To have a 'criterion' sensitive enough, they should have set the bar at CD4 = 1200; ie virtually exclude everyone! Exclude everyone from a strategy that works for more than 93%: what are they thinking ?!

Well... Who knows of our Parisian virologists will not be surprised.

Fortunately, Pr. C. Katlama saves our face despite this incompetent clique:

The criterion 'Achilles heel' has a sensitivity of 100%.

The criterion 'Achilles heel' has a 100% sensitivity (accounting source C. Katlama EACS-2015)

There is room for improvment, since specificity is only 60%. If we follow blindly this criterion, we unnecessarily exclude 10 of 13 patients, i.e. 75-80%.

Nevertheless, when we put side by side the tables for the (bad) 'criterion' reconstitution and the (good) criterion 'Achilles heel': there is no much room for discussion!

Paraphrasing the famous 'it's the economy, stupid !', and despite being a modestly specific criterion: it is the Achilles heel, stupid !

As for bystanders, leave them to their useless speculations, which are as many superstitions.

Science is the poetry of reality. (Richard Dawkins)

Upcoming posts: How to get a script for 1 year, why avoid the TruLight trial, how to wean antidepressants, dose-reducing doctors ...

Do not hesitate to leave your comments and questions...

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.

Minidolu

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

From one of our regular readers, following our post : Exclusive!

Well reasoned! We are getting there, we are getting there ... Elsewhere, you had never heard of the Achilles heel, HypoDolu, dose reduction by the WHO, Tivicay® monotherapy in First Line, etc. You have never heard of the snowman-melting. Here, we are getting there, and, why not as early as... today!

MiniDolu: dolutegravir 12 mg: 1/4 of a Tivicay ® pill, daily

For about a year, I keep saying that there are only two questions to ask oneself:

1 - Is Tivicay ® monotherapy possible ? and if so, 2 - For maintenance, is 10 mg just as good as 50 mg?

I have validated Hypodolu, once-weekly Tivicay ®, so, the first question, for me, is history: it's in the pocket! (Especially since I was not at risk of the so-called Achilles heel).

For Hypodolu, one question remains: Which dose? As we have no specific guide, and as I can stand it very well, I had opted for 4 pills at one time: so 200 mg: 4 tablets every Sunday.

HypoDolu: makes me very happy! It is so easy! And equally as good as ICCARRE 1/7 (with 4 molecules).

But then, in the meantime, something else happened to me, and I have to take a daily pill for another pathology: 1 daily tablet anyway. Damn ... Before, my weekly Tivicay® was my only constraint. But life is life ...

All the same, only the second question remains :

1 - Tivicay ® monotherapy: is it possible? 2 - For maintenance, is 10 mg as good as 50 mg?

Well, there you go:

So after my analytical interruption (to know my time to rebound ...), I resuppressed the virus with Tivicay® 7/7 50 mg for 15 days. The rebound, which was the whole purpose of the measurement, was very low, so after 15 days, I was undetectable, as usual.

I started with 1/2 of a pill (25 mg) and did a quick validation, then, I moved to 1/4 of a pill, daily.

I put it in a gel-cap along with the other medication I have to take, some sort of 'home-made' co-formulation, and here I am, with my daily intake of the other medication without any visible HIV treatment: 0 intake!

(Let's be honest, the 1/4 Tivicay® pill is hidden in the gel-cap ...)

But still ... it becomes completely invisible.

And a daily 1/4 of a pill amounts to 87.5 mg / week: can't beat that!

And, here I am, with my second VL, under this new strategy, and, still undetectable!

Already three months of experience; I'll just wait 6-9 months and my new baby comes! And since CD4 (1000) and CD4/CD8 ratio (close to 2) are stable, I have no fear ...

Until then, I have lots of new and exciting things

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.

Exclusive

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

I pruned a bit (sorry ...), but this is the spirit:


If you think you or your doctor know how to talk to the virus, you live in delusion: The virus is deaf. Yet, with a good molecule (finally !...) and a good method, it is 'defeated'. The method is conceived from the accumulated evidence and those coming. Opinions, feelings that ignore the evidence are superstition! Don't be afraid ...!

The first line with Tivicay® monotherapy: Exclusive news

This post follows our post on "Tivicay ® monotherapy as induction", where I announced what was foreseeable: Tivicay ® monotherapy as first treatment.

Do not confuse these monotherapy results with maintenance monotherapy (clinical trial: DOMONO) which results are expected late 2016: Congress on HIV Therapy (Glasgow 2016), because of delays in recruitment.

Since the induction monotherapy is for treatment-naïve patients, they do not have the Achille's heel. And all those, who do not have the Achille's heel, are in fact naïve to first generation INSTIs (Isentress® or Stribild® / Genvoya®).

The results are published: this is therefore not, strictly speaking, an exclusive. But since no one has noticed this crucial information, well ... yes ... You hear about it for the first time, here.

Just as you had never heard of Achilles or WHO's approval of Efavirenz 400 mg, it is time to ask yourself some questions about your favorite media!

Lanzafame: the frontrunner!

Dott. Massimiliano Lanzafame?? He is no stranger to us. He appears in this post: "WHO proves us right !". He is to Italy what Leibowitch is to France. His method is a little different, though: he reduces a dose, without any pre-requisite on reservoir, CD4 count, etc. (these prerequisite belong to the 'Parisian', subsidized, bullshit), and demonstrates that efavirenz reduced to 400mg, or nevirapine, reduced to 200 mg, just works as well. No other prerequisite than having undetectable Viral Load for 1 year. Same with Protease Inhibitors.

This is less ambitious than Dr. Leibowitch but Dr. Lanzafame has managed a get his recipe, albeit modest, throught the yoke of international trials and reach, without any reservation, its approval by the WHO. Neither Leibowitch (with his wonderful ICCARRE) nor Katlama (with her shaddy PI monotherapy) ever got even close.

He works in a small hospital (Verona ... That's no New York), so has only few patients: he has good insights, good methods, just a smaller army ! Who cares ? ... Besides we love his way of asking, falsely naively, questions that are of prime importance: If maintenance works with a half dose, then, what use are those famed blood dosage for ? What is it? If not pure bullshit ... I just love it!

Of course, among the small, Peytavin-fed, Parisian clique, he is not popular. But with patients, this working very well. And, let's add, the validation of his Efavirenz 400mg by the WHO (following the ENCORE-1 trial), is really a major success!

So, off he goes, as we did here, with the results of the clinical trial ING 111521, which I commented here.

This trial showed that 90% of patients reach the 400 copies beacon (the final leg to undetectability) in less than 10 days!

Then he will repeat the ING 111521 trial (which dates back to 2008! ...), but, without interrupting at day 10. Same as ING 111521, he goes with 9 patients. The trial ING 111521 protocol required to stop the mono-therapy at day 10 : this time he just goes as far as undetectability... and, obviously, if the VL becomes undetectable, he carries on. There is no reason to stop.

A bit like Dr. Lafeuillade, whose patient by himself, in first line, in primary infection, started with mono Tivicay ® ... and it worked, so why change his regimen.

In my humble opinion, he scored earlier than Salpetriere (a Parisian Hospital)... Blame it on Voltaire, if you want: they'd better move their ass a little faster.

So, our Lanzafame started with 9 patients for first line Tivicay ® monotherapy.

This is far from well greased, slow collusion of our North American clinicians. But where are those Canadians, who had pinpointed the great surprise of the test ING 111521 first ? Not to mention, of course, Dolutegravir's inventors. Here, it is easier to understand: it's a big business. But Canadians? Disqualified, despite having had the pole position?

There you go. It is published here:
http://www.ncbi.nlm.nih.gov/pubmed/27097366
Dolutegravir Monotherapy in HIV-Infected Patients With Naive <100,000 copies / mL HIV RNA Load. It's from Lanzafame (so it's good ... see his résumé); this is with 9 patients, and I will publish the results in a coming post: it's great!

Say, there are only two questions to ask oneself:

1 - is Tivicay ® monotherapy possible, and if so... 2 - for maintenance, is 10 mg as good as 50 mg?

Soon there will be only one left: the second ...

Next posts: Why avoid the TruLight trial, how to wean antidepressants, Yes, This is Achille's !, best doctors ...

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.