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Sunday, November 27, 2016

Quatuor, Premium and Eclipse

Quatuor et Stratégie #2

By Charles-Edouard!

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

A reader's question illustrates the reluctance ...


This will grant him a detailed answer, later. To complicate the thing, he has a small resistance to Edurant® (which one ???). Obviously, there are solutions, and in particular to leave this dictator-liar doctor ... The question illustrates well the distress of patients and reminds our ANRS its Quatuor commitment.

Quatuor and Strategy # 2


This post follows this previous post. We can also read our page on ANRS-4D.

Avoid cheating


Cheating occurred in ANRS-4D trial. Sabotage too. So, it's going to happen again, we need to be aware and protect accordingly. Obviously, a good support for patients would help! And not an support by the usual seronegatives idiots: conviction and credibility is required!

People should not want to enter the trials in order to interrupt their treatment. This should be the first criterion of non-inclusion in the trial. Exclude anyone who wants to get into the trial in order to stop treatment.

Monitoring and even excluding "cheating" sites, and, for the sake of precaution, preventing one or two hospitals from providing more than the others, with, as is easily understandable, increased caution regarding Bichat and Salpêtrière, known ennemis of ICCARRE.

Include the maximum number of therapies



Non inclusion of usual therapies (eg Nevirapine), means forbidding the patients who use them to do the 4/7. As a result, this distorts the market, already largely distorted in favor of Big Pharma.

I hope that the Quartet will not distort ICCARRE by setting too many barriers.

It is very important to open up to as many patients as possible. It is also important to have as little failure as possible.

To choose between the two, I prefer the least possible failure: if the medico-administrative registration is a bit too restrictive, it will be possible to open the window, thereafter.

If the medico-administrative registration can not take place, then we will not be able to do anything any more ...

If INIs based therapies (Isentress ®, Stribild ®, Triumeq ®) blow the whole trial, then, we are f**ked once more. The safety instructions should distinguish between proven therapies (including Nevirapine) and INI-based therapies. We must be careful that Bichat and Salpêtrière are not directly or indirectly involved in the safety oversight committee: they can be the instrument of cheating.

Avoid moving cursors


The famous criteria by Rouzioux-des-Critères got it in the neck, thanks to ANRS-4D: they will want to come back: it is necessary to avoid that these stupid criteria (Nadir, proviral DNA, CD4 level > X) at the inclusion, do not resurface. If they are relevant, it will show at the conclusion. No one gives them any credit, but hey ... Better be careful with the Parisian virology clique!

Dare Transparency


The existence of cheating and, we believe, sabotage (voluntary cheating), calls for absolute transparency: real-time publication, patient-by-patient, anonymized by assigning a unique and confidential identifier, VLs, recruitment centers, inclusion assessments, treatments, etc.

We are tired of crooked trials, practices and conclusions: Vioxx, Jupiter, SMART, START, YperGay, GS-US-236-0102, etc. Enough!

We're in 2016! Internet has become a reality! The patient's anonymity can be guaranteed while offering transparency: patients and physicians require new transparency and better practices in scientific research. See this article in le monde By Luc Perino (General practitioner): Advocating for more science in medicine ... Doctors are tired of crookery. Patients too!

The problem of Premium inclusion: Eclipse observation


The inclusion Premium (see practical guide) is the a priori verification of the effectiveness, on the Genotype (aka Resistance test). At inclusion in ANRS-4D approximately 4% of patients could not produce their genotype.

conditions Simple Eligibility Premium Eligibility
a priori efficiency validation No Yes (genotype required)
validation of usage efficacy
 
2 successives UD VL
 
3 times VL < 50
(make sure it is undetectable)
minimal duration of current ART 12 months 4 months
Advantages
 
no Genotype
 
4/7 direct
frequent VL unnecessary?
disadvantages 6/7, 5/7; frequent VL Genotype required or redone


In France, we will know how to redo a missing genotype. In Zimbabwe, no ...

Knowing what to do in the absence of the Genotype is a matter of global importance. this issue will show up as soon as we want to extend ICCARRE away from our immediate borders.

In France, we can redo this genotype: it will suffice to do an analytical interruption, going beyond the simple resurgence of the virus. Instead of going to the simple T50, we go as far as T500 ... (the rebound time up to 500 copies). This gives a tremendous opportunity to study, for the first time in France, the T50, i.e. time to viral rebound, that foreign studies estimate to an average of 14-21 days.

The Eclipse, in this context, is exactly this phenomenon observed universally: when we stop taking the drugs, the virus remains under the rug, and takes several days or weeks to become detectable again. Knowledge worth using!

Animation



Patients are mobilized, and it would help to have a network animation, funded by (and therefore indebted to) public funds (not BigPharma, of course, that already exists, just see in North America, a true Scandal!), so to support all this little world, especially since Social Security would be a big winner!

Good Weekend and good Fuck!

Comments


Jim Dec. 4 2016 à 05:39


Charles-Edouard Dec 5 2016



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

Saturday, November 19, 2016

Four days ON

Four days ON, three days OFF on prime time state TV
This paper was originally published here, in French. We provide this translation for your convenience. Some practical aspects may differ where you live.

ANRS-4D on prime time state TV:
a commented transcript

By Charles Edouard!

Breaking News, 22/11: Soon the french Guidelines HIV 2016 and the counter report will be published; we will keep you posted, here ...


AIDS: Can treatment be reduced?


Richard Cross is a well-known singing teacher on television. But in recent years, this seropositive activist also tries to attract attention on another method of treatment.

Unlike most patients, he no longer takes his daily treatment ...

"I take the medication just twice a week because the load by these drugs in the blood easily exceeds one week. When I take it on Monday and Tuesday, the effect of the drug will last until the week after and keep HIV at an undetectable level, so I have no interest in continuing to take medicines for five days, that are useless, it's an unnecessary over-medication," he explains.

The only requirement for Richard Cross is to have more frequent blood tests to monitor his viral load.

My comment: compared to the 1/7, isn't the 2/7 often an over-medication too? Once good efficiency is made certain (over 2-3 years ...), are bi-monthly VLs not an unnecessary over-medicalization?

Four days of treatment instead of seven


Richard has started this therapeutic alternative alone, to reduce side effects by antiretrovirals; despite the evolution of triple therapies, in recent years, their long-term impact remains uncertain.

Today, scientific studies are far from validating a medication two days a week. The latest, the ANRS-4D pilot study, evaluates the efficacy of triple therapy, taken four days a week.

"The 4D study consisted in giving reduced treatment to therapeutically successful people with an undetectable viral load at baseline, a reduced treatment where triple therapy was given four days a week," says Dr. Pierre de Truchis, an infectious disease specialist. Result: after one year, the researchers found a significant success of this reduced treatment strategy because "for the hundred patients who started with an undetectable viral load at the beginning, 96 of them kept their viral load undetectable, throughout the study for one year ".

My comment: De Truchis himself concluded that the 4 failures are due to cowardice, cheating and sabotage: will he finally take note of his own corrections?

But it is still too early to recommend this approach to patients. Especially since it requires strict medical supervision otherwise this reduction of drugs can prove dangerous as confirmed by Dr. de Truchis: "Many patients come to consult and have made of themselves a reduction by their own accord. In this case, there is a risk of resistant viruses ".

My comment: The infantilising discourse of de Truchis is probably false: he has never brought the slightest beginning of evidence. At the end, such evidence could be demanded!

My comment: strict medical supervision is a lunacy, a pro-domo, corporatist, castrating injunction, without the slightest factual justification: the initial, once and for all, determination of Premium Eligibility is enough. Viral load monitoring, more frequent at first, is desirable without being essential. What then about strict medical supervision? Pffff ...

Therapeutic and financial relief



To confirm this strategy, it is now necessary to produce a new double-blind trial that includes 700 patients.

"We will compare a group of patients who take the treatment all week with the one who takes the treatment four days, hence the name of 4D. And we will try to show that taking the four day treatment is as effective as taking it daily. This strategy is visible in France, patients wait for it, but it is absolutely not visible at the international level. Americans look at us with a lot of skepticism and for this reason we need to have extremely robust results "explains Professor Jean-François Delfraissy, infectiologist.

Finally, the last argument advanced by the proponents of this new therapeutic approach: the potential savings generated by a lower consumption of antiretrovirals.

My comment: R. cross had slipped an affectionate wink to J. Leibowitch, the inventor. The report could have mentioned the years of pharmaceutical remission thus obtained (more than 800 to date) and the enormous hope of being able to treat more patients, to tackle the million of deaths annually, especially with children.


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

Friday, November 11, 2016

time to rebound

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

An activist activist, unaware of ICCARRE, opens the box:


Blessed are our readers: here we also look at how to benefit, in practice, from what the facts show. Richard Jefferys seems to ignore all of the short cycle and years of pharmaceutical remission. This is even more laughable now that our good Siliciano recently acknowledged his errors on reservoir content, hardly capable of initiating a rapid reactivation.

The time needed to rebound is the keystone of ICCARRE 1/7. We started this discussion here, and show its practical use there.

We can now visualize the time-to-rebound



The DNA method tels us nothing. We will still devote a post just to have the pleasure to grill down the Rouzioux criteria, which caused so many pain to patients.
Mykola Pinkevych in HIV Reactivation from Latency after Treatment Interruption provides a better understanding.

An analytical interruption can be done easily, is a bit tedious, and sheds much light.

Pointless! said J. Leibowitch: since we know how to do 1/7, why bother with an analytical interruption!
He has a point... If we have better things to do, let's peep at the results of scientific research. There are a few trials, duly documented, with a hundred of patients:


Author  Date TitreLien
R. Davey / A. Faucy 1999 HIV and T-Cell dynamics afterread...
Marek Fischer 2003 HIV RNA in plasma rebounds within daysread...
Mark T. Bloc 2006 The Role of Hydroxyurea ...read...
Rothenberger 2012 Abstract_Brief_Interruption read...
Rasmussen 2014 Panobinostat_latentvirusread...
Kroon & Ananworanich 2016 160717 Ananworanich Abstract 10535read...

The time-to-detection: 21 days. on average!


To find the time to detection, we have to dig in eradication studies, since, at the end, they do an Analytical Interruption (the only valid method...), and, look at control patients. And, as the intervention is useless, why not consider also the patients that did undergo the failed reservoir intervention! See Ananworanich presentation.
Remember the pathetic sales pitch by Pr. Rouzioux-of-the-criteria, she does not mention it! Whichever: she does not know and this is incompetence, or, she knows, but prefers to wrong the audience.

The discreet sponsor does not mind... What about you?


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

Comments


Anonymous 14 Nov. 2016


Charles-Edouard 14 nov. 2016


Joey 20 Nov. 2016


Charles-Edouard 20 Nov. 2016


Joey 21 nov. 2016 à 05:39