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Saturday, October 31, 2015

Stribild (tm): No Thanks!


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.

Stribild (tm): No Thanks!
Stribild ®: no thank you!

Whew, I dodged!

My doctor, yet rather no evokes Stribild ®, without enthusiasm ... A wide range of side effects ... And besides, I did not ask him ... It fills the conversation. The idea of ​​trying even that modest 4/7 with INI first generation of Raltegravir me-too, did not inspire me too. (See Article hilarious on me-too-climb, the copies marginal improvement).

Especially as exposure to an INI first generation (RAL or EVG) exposed to mutations, which, for once, are embarrassing: they facilitate resistance INI second generation (including DTG)

HYPO-DOLU EACS 2015 Barcelona monotherapy Tivicay dolutegravir Rojas Barcelona Paddle The results of monotherapy Tivicay ® are trying to filter 100% success in naïve patients or RAL EVG (ie user never Isentress ® or Stribild ®). Too bad for them ...

Users Isentress ® or Stribild ®, second line, have nothing to regret.

The arguments which placed Stribild ® first choice (among the 3 or 4 recommended as first line treatment recommendations) were admissible. Are they still? Indeed, the opinion of the HAS should interpellate patients and physicians:
If it simplifies the administration of antiretroviral regimen (1 cp / d) STRIBILD ® has not shown improved efficiency, has a low genetic barrier to resistance, many drug interactions and requires kidney surveillance.

Stribild ® costing the community 950 Euros / month. But with no possibility of reduction or simplification: it is 11400 Euros / year, at least 20 years (at least 20, because of the co-formulation patents with TAF) or 228,000 Euros.
I hope that this calculation can reflect souls frightened by the price of Sovaldi ®: 45.000 for a treatment that heals him, at least. 3 months of treatment and basta, it's over!
Stribild ® is for life! No remission. The perfect trap.

One would consider militant actions for the state put up then these health heist: the opinion of the HAS (no clinical benefit, low barrier to resistance, ...) should have been enough to justify considering its partial withdrawal from the market, which, at least in its partial delisting (or selective).

The negligence of the state, and the CEPS, has not escaped anyone. But now ... Gain case Stribild ® is being relegation. Nobody wants to frontline for the impasse, which was already perceptible now obvious:
HYPO-DOLU EACS 2015 Barcelona monotherapy Tivicay dolutegravir Katlama

For patients who have never been exposed to these INI first generation monotherapy DTG, maintenance walking ... 100%. The results are intermediaries (24 Weeks). They were presented at EACS-2015. See summaries in English. The French translation will be available soon.

The ViiV Healthcare ® marketing teams will go Trompeter everywhere.

We bet they forget to remember that the effect of DTG in monotherapy continues several days after the arrest, and that the half-life of inhibition is ... 4 days.

As the infected cell does not survive that long in practice, inhibition is irreversible.

QED.

It's simple: the infected cell dies before DTG coming off integrase. (This is a simplification, to illustrate the general concept)
4 days of inhibition of integrase (at least ...) ... Why gorging Tivicay ® every day?

A good dose once a week, and voila.

Of course, if one has already taken Stribild ®, it will not be that simple ...

If, you, you did not read in the "Media" you read, make no mistake, in the headquarters, it's gossip. Besides ... Why have you not read in your media? The information she interfere? Yet it is detailed in this article about i-base.

I, who remember my refusal Stribild ®, I so please, a posteriori: I was right to refuse Stribild ® and same goes for Genvoya ®.

The position of CEPS, which reflects the relative position of drugs with each other, will power (duty?) To be reassessed, since the relative position of Stribild ® will power (duty?) To be reevaluated ...

Triple therapy for Dad: it's over! Read this article on i-base

To repeat: 95% of patients, stable and undetectable, are unnecessary and harmful on-medication!

Saturday, October 24, 2015

Our data are robust


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.

Our data are robust

Who cares ... Our data is robust ...

BREATHER multicenter, randomized, with control arm, 100 patients in each arm: concrete

FOTO ICCARRE ANRS-162-4D anthony faucy breather

A BREATHER alone counts as much as any other combined tests.

I thought part of an ultra-minority, sectarian drift, with an improbable guru and listen (loop) the interview; I transcribed and translated here.
Bibliography: www.tinyurl.com/CHE-BREATHER This doctor, pragmatic, Notre-Dame Hospital of it is the very Catholic Dublin as a guru? Where is the forked tail?
Our data is robust ... So no need for speculations, conjectures, hypotheses, handle effect ...

life of the molecule? The question he is asked by Dr. Cal Cohen (emotion ... it's the doctor who 'invented' FOTO, the 5/7 ...).

Dr. K. Butler, is comfortable. Its data are robust ... Yes, EFV (efavirenz) may be favorable, but half of the patients was on AZT [whose life is short] ...

Concentration of the molecule? Phil interview tries his luck ...
Dr. K. Butler, is comfortable. It has well-preserved specimens ... No dosage ... What good ... Who cares, after all ... The data are robust ... What else?

With a test as well built, it was confidence. One does not read the coffee grounds.

Breather HIV Efavirenz Atripla HIV virologic failure Butler virologic failure viral rebound? Mutations? Yes and so ???

resistors ?? : Nay! In this essay, here too, all in 5/7 patients, who had viral rebound (with or without detectable mutation) were all re-deleted by a simple return to 7/7. How simple?

In this trial, as in all others (FOTO, FAUCY), all patients who do not validate the 5/7, resuppriment a simple return to 7/7.

No change of TRI. There is no exception! 210 patients, and not one who finds himself in trouble.

Infected at birth: 8, 10, 15, 20 years of HIV in boots. Probably even more than my doctor!

So our doctors are they at fault? And what are we waiting for ??

Mine, he knows Leibowitch, he respects, he does not denigrate it waits ... He is waiting for what ??

Marisol make a decision or is fired? ... A decision ??? Marisol, a decision ???
For him, Breather, Foto, Faucy is Chinese ... He does not even know it exists!

Normal ... Who would talk to him? A health visitor? A hospital Mandarin? ... You dream.
And the patient, she is waiting for what ?? Thawing ???

I have taken care to gather the short cycle test: FOTO, FAUCY, ICCARRE-1, BREATHER, ICCARRE-2.

The press BREATHER is not kosher for Anthony Faucy, ICCARRE not Kasher, for Butler, Leibo, Foto, Faucy? Never mentioned!

And each of these tests are in an impenetrable English, on blast media, to years apart. Here, at least, you have everything at hand!

Are our physicians at fault? Our media are they at fault?

For Dr. Leibowitch,

"It is possible to fight against the over-medicalization, to break the dogma of continuous treatment without waiting for the endless rewriting of new regulatory recommendations."

The patient is clueless ... You amaze me! ...
We said, "Wait ... Wait ... An ongoing trial ..." C'mon! Courage! ... Flee! ... Who to say that there is not a current test 4 but conclusive tests and, in addition, it is true, is in progress ...
Me ... On my almost deserted island in 1/7, I leave to come ... The cuts will win and convince.

What patient, after confirming its x / 7, will, of itself back to 7/7? Viral rebound may compel ... certainly ... but surely not fabrications, speculation, denigration, and other nonsense witch trials and medium-ageuses.

The consequences of poor management of HAART? The stop ... and ... DEATH. The late Kevin Gagneul (†) left us his testimony, inheritance. It reads:

I mismanaged my bet on triple therapy [...] I did everything ultimately shatter [...] Now this was my biggest mistake. [...]
I mismanaged ... I ... I ...

In 2015, the range of treatment options is such that the fault is not the government, not the doctor, but I, the patient ... Well ... yes!

That non-decision makers, those who decide not, have the conscience suicides, deaths, complications consecutive to the rupture of the protective undetectable.

We, we advance ... Whatever ... Our data is robust ... And I, always in 1/7, on Monday ...

Why bother?

Saturday, October 17, 2015

Lamidol : Tivicay/Lamivudine


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.

Lamidol : Tivicay/Lamivudine

Retry: Lamidol (Tivicay ® / Lamivudine)

LAMIDOL: Maintenance Dual Therapy Lamivudine (GS) + Tivicay ®

The ANRS has released the launch of the ANRS 167 trial Lamidol, registered under number NCT02527096. Read its description in French here.

Given what I am writing about Tivicay ® monotherapy, dual therapy of Tivicay ® (dolutegravir) + Lamivudine (available generically and under the brand Epivir ®), it makes little player, but he has it reason to rush it. Who can do less, can do more: see the results in attack monotherapy maintenance of combination therapy, this should do it!
There is a similar test: PADDLE, whose results are expected in April 2016.

LAMIDOL dolutegravir Tivicay cure trial Yazdan Yazdanpanah
It is a well bordered test, where the risk is mini-mini, and, above all, that will continue with this dual therapy which leaves the way clear for the monotherapy Tivicay ®, and, in the process, to Hypo- dolu; ie the 5/7, 4/7 and 1/7 with Tivicay ® (dolutegravir).

And that, I can say that it is pure bliss.

Lamivudine (3TC), that everyone knows and that the vast majority are (in its original form or its copy, fluoridated FTC) is known for its safety (see report of the WHO). It is inexpensive and, in itself, very little 'strong'. It potentiates the other NRTIs (eg TDF or ABC AZT and also ...). The intracellular chemistry explains. I have not read anything that suggests a synergistic effect or potentiation with dolutegravir (DTG).

This is more interesting than the Dual Therapy DTG + VPN (Rilpivirine), whose essay, commercial, is underway (SWORD SWORD-1 and-2), which should lead to coformulated maintenance, of course patented, and unnecessarily lengthening, at great cost to the insured, the manufacturer exclusivity period ... So pump Dollar.

DTG + 3TC will be also coformulated one day, but until it is not, it helps to have Tivicay ®, without it being crossed with beads: and that's fine for HYPO-DOLU do!

There are only 110 seats: so manifest now!

The condition of inclusions (see the complete specification for the exclusion or contact the organizers: Véronique Joly at 0140257807, Roland Landman 01 40 25 63 54 or at Yazdan Yazdanpanah 0140257803)
[...]
• Age ≥ 18 years
• nadir CD4> 200 cells / mm3
• Have a genotype prior antiretroviral therapy showing no resistance mutations to reverse transcriptase, protease and, if available, the integrase
• Have a first-line antiretroviral therapy combining two NRTIs and a PI or two NRTIs and one NNRTI or two NRTIs and an INI. A change in treatment for intolerance and / or simplification is allowed. The treatment must not have been changed in the last 6 months
• Having a plasma HIV RNA ≤ 50 copies / mL, this for at least 2 years with at least two viral load measurements per year. The blips (HIV RNA between 50 and 200 copies / mL on a sample but HIV RNA following ≤50 copies / mL) are allowed, except in the last 6 me
• The total number of blips must not exceed 3 during the last two years
• Have a negative HBsAg (*)
• Effective contraception in women of childbearing potential
[...]
(*: 3TC is used for hepatitis B, usually with TDF)

This is a test, so it is more restrictive than the eligibility conditions 4/7
Practical Guide.
I made the turn toward Tivicay ® monotherapy well before the announcement of this trial, and I have kept the virus under control, therefore, I would encourage an interest in this Dual Therapy. No need to be enrolled in the trial, however, to be interested and engage with their regular doctor if one is not a place for you.
For those who try, in the ANRS 167 LAMIDOL or outside, good practice is to make a CV in one month, then 2 months in the month 4, 6, 8, 10, 12. The test provides that month 2, 8 and 12 ... Those who want to ensure, as recommended for the other entries in relief, will make additional CV, at their expense, as explained in the handbook. (Better ... especially in anticipation of the move towards a single agent and, following the entry into the short cycle).

Nothing prevents to test for oneself, if one has no chance to be included. LAMIDOL dolutegravir Tivicay Lamivudine Emtricitabine Truvada Yazdan Yazdanpanah

Should we consider the short cycle with this combination therapy, bypassing monotherapy?

Tivicay ® has an inherent power that allows to consider HYPO-DOLU, and the advantage not to take Lamivudine is not to develop resistance to it from hence to the reserve for ICCARRE 'classic' , if any.

This bi-therapy LAMIDOL, is not relief; Indeed, the combination therapy which it was formed (DTG / AB / 3TC) is, for the vast majority of patients, unnecessary on-on-on-medication by itself. Lamidol ... too! The relief starts with effective therapy such as the monotherapy dolutegravir, not by artificial over-medication, concocted solely for market share and optimization of financial income.
This combination therapy can serve as a stepping stone to HYPO-DOLU (weekly intake). This is probably his only interest.

Emax of dolutegravir: Understand that maximum efficiency, Emax was estimated in an experimental setting where the calculation is illegitimate, imposes the question: what is the true value of Emax? and even: there he has a Emax?
Toxicity or resistance is what may cap efficiency. But with Tivicay ®, alone, there is neither one nor the other. And if there is neither one nor the other, then there is no Emax, no limit to efficiency.

A Dual Therapy, out of the combination therapy for dad, over-medication: YES!
Leave it at that: NO! We must get out of the on-medication!

To repeat: 95% of patients, stable and undetectable, are unnecessary and harmful on-medication!


Another new blog will soon have an English edition

Note added 10.22.2015: the first results start to come out at EACS 2015

Saturday, October 10, 2015

Breather: Trial compares 5/7 to 7/7


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.

Breather: Trial compares 5/7 to 7/7

Breather Comparative Test 5/7

In my country ... What matters to the attentive ...

Breather is richer than it seems ...

The first feat of Dr. K. Butler has been able to present his essay to the great mass: CROI. Sly, last minute, in a subordinate surrender in minimizing the scope and speaking only of non-inferiority.

The presentation was very sober, very technical, without enthusiasm and pathos. In English with an accent to cut with a knife, without publication date, without reference to previous tests FOTO, Faucy or ICCARRE.
Everything that could excite controversy, the public interest was erased ... and it's past, it is recorded, anchored in the digital marble.

An Irish saint of sobriety, unassailable, either in form or in substance. And inaccessible to ordinary mortals.

So you better get into Breather by the interview that Dr. Butler was then given. It is less technical and the air not to touch it, it balance atomic missiles with a British monarch impassivity.

Breather HIV HIV Efavirenz Butler youtube video interview
The interview is here: https://www.youtube.com/watch?v=KZsd87G86LE
Its transcription and translation in French here:
http://tinyurl.com/CHE-BREATHER
and here on this blog: 5/7 Clinical Trial BREATHER
In the reports and copies of copies, comments were placed the rigor of warning: do not do this at home. C'mon! ... Courage! ... Flee! ...
This is part of the 'demonization' of 5/7, it makes marginal, almost insignificant, very politically correct: it passes the US-media censorship.
Well ... it happened ... So in the interview, you can let go a little ...

There, the issue of Phil service is coated but ... The question is clear:
[...] Can we establish with certainty what was done, so that doctors feel comfortable and can prescribe this strategy?

Answer: They can, but you're absolutely right when you say that some people have already done this on their own ...

And further:

... And on an individual basis, if it is done, which could lead, in certain circumstances, some comfort, but it can be done only where there is a virological surveillance. So individually, some people might be able to do so, our data are robust ...

Breather HIV Efavirenz Atripla HIV virologic failure Butler virologic failure

(Reminder: the study is made exclusively Efavirenz (Sustiva in Atripla or ...))

Especially she adds:
... 21% were over 18 years; So this was also a study that would be applicable to young adults, which was not just about the kids ...
Like what, when you scratch ...
Applaud this feat: large (the largest of all) test in 5/7 passes the barrier of censorship and the implications for the average patient have occurred, air to touch it ...

On another note, I did well to deepen the intriguing question of Emax in my page on monotherapy Tivicay ®. The time spent sifting raw information is time well spent. And rediscover that the earth is round; there is no unsurpassable horizon ... I will come back ... There is so much new on the forehead of relief ... including one that m ' honors and flatters me (some): Dr. J. Leibowitch left comments, including this one: Dear Charles Edward yes you hit the nail ... thousand billion ports ...

As I validated and kept in reserve ICCARRE 1/7 (which I am very pleased, incidentally) for HYPO-DOLU I speak here of my experience with both. Both deserve interested. The more supply, the wider public will be receptive. HYPO-DOLU and ICCARRE 1/7 win each of their coexistence.

The ICCARRIENs Garches do an amazing job ... ICCARRE released me: I am a free lightering, non-inset, which is its freedom.

To date nobody has published officially, monotherapy dolutegravir, 'direct' in attack treatment on chronic patient ... An experiment which however take a good month to achieve. (And that would close the valve to the ANRS and maintenance bitherapies ...) But ... I am working on my project, mine, and it already occupies me.

To repeat: 95% of patients, stable and undetectable, are unnecessary and harmful on-medication!

No taking meds this weekend: the weekly dose is Monday ...

In my country ... What matters to the attentive ...

Saturday, October 3, 2015

DOMONO trial


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.

DOMONO trial

DOMONO test: Tivicay ® monotherapy

Before Hypo-Dolu ... go through Mono-Dolu: a revolutionary single agent, I have undertaken to detail here ...

The way to get to 1/7 (weekly jack) involves passing by boxes, and breaks (like the board game): Case undetectable, pause 1 year to start.

In Hypo-Dolu proposal, the path is simple and continues:
MONO-DOLU box, pause 1 year. etc.
It may be possible to consider SINGLE DOLU as attack treatment without going through the tri-therapy box.
The latter, in maintenance therapy, is now available in experimental clinical trial registered under number: NCT02401828, detailed here: www.tinyurl.com/CHE-HYPO-DOLU

Iccarre DOMONO HIV HIV treatment dolutegravir NCT02401828 thebody Hypodolu

Test 48 weeks, unmasked, randomized phase IV. The aim of this study is to evaluate if the removal can be maintained by DTG monotherapy.

104 adults infected with HIV-1 will be randomized into 2 experimental arm. The first arm will undertake the direct passage. This population will pass directly from the stable triple therapy to monotherapy DTG.

The second arms undertake, but later, after 24 weeks. This group will remain on HAART, waiting for 24 weeks and then go after those 24 weeks IGT monotherapy.

The main objective is to verify that dolutegravir mono-therapy, maintenance is non-inferior to conventional maintenance triple therapy.

With a test on a patient hundred, proposal, transcribed into French, Dr. Mark Wainberg, arrives in the clinic.

That alone would be a major improvement, and accessible to all, not just a small clique of well-connected people.
Go Jan. In 2017 ... Things are moving ...
Note that the ANRS LAMIDOL is announced ... Bi-therapy Tivicay ® and Lamivudine (Epivir ® or generic). It's less glamorous, but with the support of ANRS, visibility is better. We also move there ...
The maintenance of undetectable monotherapy DTG is interesting, but not an insurmountable horizon: it is necessary to consider continuing with the reduction 5/7, 4/7 up to 1/7 ...

Among the things that do not move under weekly single dose in HYPO-DOLU, on Monday ... is the immunological response, still good.
That reassures me a little ... Everything was already very well in quadruple 1/7 (ICCARRE)
ICCARRE immunology tank ratio CD4 CD8 immune system cells lymphogramme

Note added 10.22.2015: the first results start to come out at EACS 2015

Good weekend and good fuck!