Possible cure? not yet ... But years of remission: some 405 (and soon 1045) patients included in Short Cycle trials show that we can go from daily HAART (HIV) , gradually, to less and keep the virus undetectable with a single weekly dosing. Patented ICCARRE, now recommanded by French Guidelines, and HYPO-DOLU: Why? For whom? How? It's explained here...
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Saturday, December 19, 2015
Jackpot
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.
Jackpot
Jackpot and small cachoteries
PADDLE, unveiled at the EACS-2015, and already commented here and there (see the slides) is the hot topic. For those who understood my page on monotherapy Tivicay ®, and my comments on its effectiveness, these results are not a surprise ... It works, illico monotherapy Tivicay, attack, on 7 patients on 10 of the trial NCT00708110 (ING111521), which lasted only 10 days ... So, obviously, we're not surprised.
And we are not after our surprises (which are not ...)
This is not only very powerful but also overdosed! Just wait ...
It will eventually come out ... If you read well ING111521 test is in it.
soon we will ask two questions:
- Stribild ® he still has a place on the front line?
- Triumeq ® it is a useless medicine?
And ... How did it happen? How is it that a clinician or Argentine ahead of the (alleged) 'flagship' American or French? There has not been a clinician in the US, the country's pharma-business, for having had the idea; idea that they denigrate the pretext that all these little tests are done off the 'declaration' official '. We, who cares ...
® Shionogi, ViiV Healthcare ®: Jackpot and other cachoteries
Sovaldi ® was made famous by its exorbitant price. Gilead Science has for itself in one year the acquisition of Pharmasset, small-scale company, with the sofosbuvir for 11 Billion Dollars. The insured the solvent world have felt pass. Stribild ®, the same manufacturer is 1/2 million dollar income per new patient enrolled: 2500 USD / month / patient: US $ 30,000 per year for the duration of patents ... What we will do last at least 20 years ... it's been at least $ 600,000 / patient.
Shionogi, with its dolutegravir will not be outdone. Unknown to the general public, Shionogi, Osaka, Japan, has already made famous for inventing the best inhibitor '3-coenzyme A reductase Hydroxymethylglutaryl' rosuvastatin. Rosuvastatin? Yes, the famous Crestor ®, as useless as dangerous, but has excellent potential inhibition. Marketing via the English Astra Zeneca (formerly Imperial Chemical) makes a blockbuster, one of the biggest profits of the pharmaceutical industry.
So to inhibit, inhibit Shionogi knows ... And it relates. It remains to find a business partner: this time it will ViiV Healthcare. Dolutegravir will generate huge profits at the expense of Stribild ® and insured, but that was already officially recorded. The squabble ViiV vs Gilead is hilarious, except that the victims are the patients and the financial statements (hence employment ...). With its excellent result, Shionogi will sell quite expensive to ViiV its molecule, in a deal that is of the same order as the acquisition of Pharmasset. Technically less obvious but of the same order of magnitude. Sales in 3 parts:
HYPO-DOLU monotherapy Tivicay dolutegravir Shionogi ViiV healthcare
- Shionogi is allocated, free of charge, 10% of ViiV Healthcare,
- Shionogi therefore recover 10% of all profits ViiV without deadline
- Shionogi also earn a royalty fee on its molecule for life.
ViiV Healthcare is estimated at 23 billion Euros, thus 2.3 billion live in the pocket of Shionogi. The agreement was sealed in 2012. Welcome gift. The course is multiplied by 5! This is the Jackpot! (Deserved or not according to the convictions of each).
At GSK, the main shareholder of ViiV Healthcare, we are happy, it was the molecule that kills, but was allowed to pass 2 billion, plus royalties. Then we have a plan (which, Shionogi, thief at the fair, will find nothing wrong, his silence is acquired, at great cost ...).
As Astra Zeneca (perfidious Albion ...), ViiV (GSK), is very familiar with the workings.
First, from there, the Japanese researchers are invited to return to their dear studies and not trumpeting the extraordinary power of DTG. The language elements are: DTG is good.
And above all, we do not go further ...
Cachoteries:
Was the article cited above, published three years after the trial (3 years! ...), And its formalism imposed (Table patient characteristics before treatment), we would not be aware of anything ... only this table allows us to affirm that Emax is higher than the 2.6 announced (and probably much higher ...). If you do not have the picture, you can not you realize qu'Emax is underestimated. So do not worry ... This table will disappear.
HYPO-DOLU monotherapy Tivicay dolutegravir Emax NCT00708110 ING111521 undetectable Will also disappear 7 patients (70%) undetectable after just 10 days. monotherapy.
Shionogi while its complacency, brings up the 7 Samurai in the body of the article and in the table. They are there ... But once the agreement is signed, they are silenced: the article is completed by a pharmacokinetic graph, where the designer has made two mistakes; an erratum will be also published to correct an error (but not the other ...). In short, the authors and auditors (reviewers) have missed without seeing the error. The most obvious is that the 7 Samurai became the 3 Musketeers, who, as everyone knows, were 4 ...
In all communication that follows, especially monographs submitted to the FDA, the original table is withdrawn in favor of a differential picture, and 3 of the 7 undetectable through the cracks. It buries ... The FDA does not even mention, and in the documentation provided to the HAS (. See p 11), the ING111521 trial is not even subject: as it is even simpler!
The ViiV plan will allow recovery of the 2 Billion (and more): adding a junk 2 francs 6 under (Kivexa = ABC + 3TC), généricable and manufactured at very low cost, and increases in the price of the drug 50%. In coformulant diamond and glass beads, it increases the profit of 50%. Combined with DTG, here valued at 350 Euros per month ... For patients and potential side effects, too bad for them ...
And now ... Life is beautiful ...
Good weekend and good fuck!
Saturday, December 5, 2015
Stribild ®, EACS-2015, Hocqueloux
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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 ®, EACS-2015, Hocqueloux
Stribild ®, EACS-2015 Hocqueloux
Here is a comment that leaves me speechless (with Stribild ®, soon Genvoya ®)
I just read on this blog that the monotherapy Tivicay (tm) was not recommended for people being already under Stribild (tm). Under Stribild (tm), I currently oscillates between 3/7 and 4/7 and I have no problem except that renal function is in steady decline since the beginning of treatment there 1½ years , decrease in low but still constant proportions. Stribild (tm) is my first treatment.
The question is a good reply to the frightened souls (and subsidized).
Prudence they say! Sure ... But also prudent to preserve his organs, all his organs. Renal disease can not be overlooked. A kidney is more important than profits.
Tenofovir (included in Stribild ®) is the most likely cause. There are so many options to transfer Tenofovir ... The proposal to replace the difumarate Tenofovir alafénamide by tenofovir (in Genvoya ®) more commercially attractive than therapeutic.
Anyway, we must descend into the valley polluted from 7/7 to properly validate any new strategy. And, as both do, get rid once and for all tenofovir. Basta!
I will return soon on the results of Ch Katlama at EACS-2015. It might (the conditional!) That users (past or present) first generation INI (RAL or EVG) are required to advance in single strategies Tivicay ® therapy with redoubled caution. For others, it's nickel in nickel ...
The manufacturers know the on-medication (ie legal poisoning): They will therefore propose 'copies' of their généricables molecules, at lower dosages, but a greater strain on the patient: obligation meals and observance 7/7 : it maximizes profits while there are proven solutions that relieve the patient at all levels. First generation INI were helpful, thank you ... Let's move on!
Nothing is easier than to be prescribed Tivicay ® + Lamivudine:
Since EACS, it goes like a letter in the mail. And if you do not succeed, take Rdv at: Reynes (Montpellier), Hocqueloux (Orléans), Lafeuillade (Toulon), Katlama (Paris): there are spoiled for choice. Once confirmed undetectable, is simple to continue: we do not change a winning team!
HYPO-DOLU EACS 2015 monotherapy Tivicay dolutegravir cohen Pedro Cahn Paddle
Dr. Pedro Cahn (PADDLE trial), he has the honesty to provide raw data.
Monitoring patients (DTG attack treatment + 3TC, 3TC which serves as decoration ...) allows to put into perspective a little quick affirmation of the manufacturer: the higher the dose is high undetectable soon be reached. The 50 mg dose of the original horse, provides undetectable every time.
It is especially obvious here that the time the virus remains detectable is in proportion to the initial viral load.
Therefore, keep the horse initial dose (50 mg to 22 Euros per day), to life, to hold a lentivirus, confined to his tank, is a question more legitimate.
Treaties: YES, processed and taken for idiots: NO ...
DTG + 3TC is a virtual monotherapy. Farewell resistance implies that DTG is super-efficient and that the dose can be optimized once the infection subsided.
If you come across a clinician who does not understand this, take your legs to your neck, and leave the poisoner in white coats.
Simplification dolutegravir in mono- or dual therapy maintains viral suppression in treatment-experienced patients, Laurent Hocqueloux
HYPO-DOLU EACS 2015 monotherapy Tivicay dolutegravir Laurent Hocqueloux bitherapy
His post at EACS includes such impressive results for 52 patients pretreated using dolutegravir in mono (n = 21) or combination therapy (n = 31).
Here, nine people had prior experience with an integrase inhibitor. median follow-up of 27 (IQR 24-40) and 45 (IQR 25-70) weeks in mono and dual therapies, respectively, all but one participant maintained viral suppression <50 copies / ml (96% of CV < 20 copies / ml). Only one case of viral rebound in a patient, very few observing under dual therapy DTG / Maraviroc.
Note, 2016-10-09 : the complete report is available:
Dolutegravir-based monotherapyor dual therapy maintains a high proportion of viral suppression even in highly experienced HIV-1-infected patients
To repeat: 95% of patients, stable and undetectable, are unnecessary and harmful on-medication!
Saturday, November 28, 2015
individual testimonies
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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.
individual testimonies
personal experiences
Posted in the face of Charles-Edouard:
... I have a friend who starts following the experiences that are read on the forums, and in the end he is grilled with a molecule resistant to the virus ...
This is why it should not be limited to read reviews, personal stories on the internet! ... The good and the bad ... Why ?
Bad experiences:
They are rare, which is normal: the failure rate in tests is low. (5% when following a random selection protocol, and 0% if it is known navigate)
In addition, the one who tried would not lead off, he finds himself rather con; and do not brag. Too bad they do not testify, themselves, directly.
The man who saw the man who saw the man who saw the bear ... that's interesting but it does not count!
Good experiences:
iccarre friends richard cross cuts garches hiv
There are many, but the advantage is that one that makes relief feels better, including in his head ... the motivation to testify diminishes! One sentence, testimony, sums up:
Obsessed with HIV and its host of side effects are just a bad memory for me. Today HIV is not present in my life.
Leibo among patients, some gathered their testimonies in a book published, of great aesthetic quality; others have gone on TV: what more?
Clinical trials:
They are led by 'investigators' ... responsible for ensuring that we do not tell everything and anything. You have to read the tests, read the eligibility requirements, and reserves written by the investigators: they are certified testimonies.
Is it easy to read and understand?
NO. First have to find them, sometimes you have to pay for access, and is in English (technical). I still made the effort to collect and translate ALL ALL.
The latest is: www.tinyurl.com/CHE-FASEB2, and here on this blog.
Can we draw a line of conduct?
YES: there are now 4 trials published, documented and ongoing. 300 approx patients. it starts to make sales ... We will not wait until 1000 or 10000!
(The single IP therapy, validated by the report Morlat (ANRS) is 3 different options and it is only 1,200 patients ... it gives an order of magnitude)
But it is not easy to do ...
That is why I regret that no splint it and that, by, default, I formatted and available to all, proposal, argued, to discuss with her doctor.
Guideline is summed up in 3 words:
Effectiveness, progressiveness, close CV
- Carefully check the effectiveness of a strategy before moving to the next
- Getting there gradually
- Frequently check (to avoid a possible replication has bolted)
The individual testimonies are postcards. They make us perceive a territory.
Clinical trials are a mapping.
To resume a fashionable author: map has more value than the territory ...
The route is a path on the map; down the road postcards.
The reliable route is made possible by the card.
The practical guide 4/7, most popular document will soon be 1 year. I honed, but the important thing remains intact. If one day we have an RTU, RTU will be accompanied by a "Therapeutic Use Guide", inspired by the GTU proposed by the instigators of the RTU, in the opinion of the ministry.
It is based on the same card. It leads you to the same place. Wait a GTU (is it written?), It is expected that Marisol Touraine can read a map ...
Vast program ...
Explore a territory requires a conceptual corpus' and even the appearance of a new concept. Ch. Columbus westward from the East to find because believe that the earth is round, it's new.
Our newness, our paradigm shift is simple:
On a virus without mutation integrase (wild i.e. in terms integrase), the selectable mutations dolutegravir lead the virus reproductive impasse resistance never appears. 2 consequences:
- The efficiency is much higher than the usual glass beads
- Efficiency is independent of dose
Any dosage undetectable now is admissible. Understanding the nature of the dose dependence is made difficult because we are obsessed with the inefficiency of old molecules. This will require to change our vision, but facts are stubborn: the course is undetectable, and this can be achieved and maintained, even with low dosages.
I was comfortable with my ICCARRE 1/7 in quadruple, economical and effective. I ruled the world. From this height, the view opens, other peaks are nearby. I go back down in the dark valley polluted (7/7 ... yuck!), I'm going to climb another peak: it is not higher, but the way is without pitfalls ...
And I, still 1/7, on Monday ...
Good weekend and good fuck!
Saturday, November 21, 2015
DOLULAM and EACS-2015
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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.
DOLULAM and EACS-2015
DOLULAM and other mono-bi therapies: EACS-2015
One of our readers asks:
If dolutegravir does not change why not take one?
Very good question ... Which leads to another:
If dolutegravir does not change why take in life, the initial dose of horse?
Indeed, 50 mg is a useless overdose.
The 2 questions and 2 answers are linked: my discussion of the extraordinary efficiency of DTG, which is independent of dose, monotherapy, leads to its logical consequence:
-1 Monotherapy Tivicay ® (DOMONO): possible
-2 Dose reduction (HYPO-DOLU): possible
Everything flows efficiency, independent of dose, the DTG. And as one does not go without the other, the same clinicians who understand that monotherapy is possible, understand, sooner or later, that dose reduction in practice: in short cycle is possible. This will be necessary ... Only fools never change their opinion: Even Dr. Molina has become the PreP: that says it all!
And in retrospect, the converts include ICCARRE. And even if they do not understand ... What's important is that the patient, she has everything to gain from this competition between clinicians.
For clinicians, independent, even, indeed, their only and last chance to exist: with injectables, more issues to experiment, regardless of firms. How to experience the Cabotegravir injection in monotherapy if the manufacturer does not provide you? You will buy an injectable combination therapy and separate the nanoparticles encapsulated with your little fingers ???
And that is the triumph of ICCARRE: the short cycle, with a super efficient therapy: the 4-T (quadruple) generic or dolutegravir (and perhaps Bictégravir - GS-9883) ... Whatever ...
Me too, I turned my cuti several attempts to pass the 1/7: if we do not change its software is becoming obsolete.
The downside is that it takes dolutegravir be fully effective ... So there is no mutation (INI due to first generation: RAL and EVG): This is why we must avoid taking Stribild Genvoya ® or ®. For those who have not taken them: Tivicay ® walk alone ... That's Christine Katlama who will give the coup de grace, as we shall see in the coming months ... Evolve or disappear ...
EACS (and / or mono-bi DTG): how much of study: 1, 2 ... No: 7 (not least ...)
PADDLE, DOMONO, Rojas (Barcelona), Katlama (Salpêtrière) Hoqueloux (Orléans), Lamidol, Dolulam (excluding Sword Sword-1 and-2). Translations are available here.
PADDLE test
Presented by Dr. Pedro Cahn (here in discussion with Dr. Cal Cohen, inventor of 5/7) HYPO-DOLU EACS 2015 monotherapy Tivicay dolutegravir cohen Pedro Cahn Paddle Summary: 1066: dolutegravir-Lamivudine as initial therapy in naive patients infected with HIV: first results of the trial PADDLE
Objectives: Based on the results of the test Gardel, we designed a test, proof of concept, which is to assess antiviral efficacy, safety and tolerability of combination therapy of lamivudine (3TC) and dolutegravir (DTG ) in initial therapy.
Methods: A pilot study of 20 HIV-1 infected adult ARV naive. Eligible participants had no resistance INI and CV <100,000 and negative hepatitis B. Viral load was measured at first, then the days 2,4,7,10,14,21,28 then every two weeks until week 12. later, the CV was measured every 12 weeks. The primary endpoint was SVR, defined as the proportion of patients with VL <50 copies / mL at 48 weeks. (Algorithm FDA-snapshot). The interim analysis (S 24) is presented ici.Les patients will be followed for up to 96 weeks.
Results: Participants received 50 mg + DTG LMV 300 mg once daily. Baseline characteristics were: the median CV 24.128 copies / mL (IQR: from 11.686 to 36.794). Four patients = 100,000 copies / mL at the base. Median CD4 count of 407 cells / mm3 (IQR 296-517). Rapid antiviral response was observed. (Median decrease in CV, at week 12 was 2.74 Logs). All subjects achieved a viral load <400 copies and 50 copies / mL. at week 3 and 12, respectively. The observed viral decay rate is similar to that reported in SINGLE-1. Fifteen patients completed their 24 weeks maintaining viral suppression <50 copies. No tolerance / toxicity problems were observed.
Conclusion: During the first 12 weeks of the study PADDLE, dual therapy with lamivudine plus DTG enabled rapid virologic suppression with a safety profile / tolerability favorably in individuals infected with HIV-1, naive treatment. This is the first report of a successful Lamivudine + INI [NdT DTG], combination therapy, in treatment-naïve patients.
DOLULAM Study: DTG + 3TC combination therapy in maintenance
HYPO-DOLU EACS 2015 Dolulam dolutegravir Dr Jacques Reynes Montpellier
Presented by Dr. J. Reynes, this pilot study evaluates a switch to a combination therapy DTG 50mg / 3TC 300 mg, taken once a day for maintenance.
Interim results (S24) were presented at EACS (27 patients). Patients mostly older, heavily pretreated.
No virologic failure were observed, 3 patients discontinued therapy (2 for adverse events) and 1 due to intensified following a blip [NdCh-E yet a blip is not a good reason to change strategy, but ...].
CD4 remained unchanged.
To repeat: 95% of patients, stable and undetectable, are unnecessary and harmful on-medication!
Friday, November 13, 2015
Iccarre and reservoirs
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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.
Iccarre and reservoirs
Iccarre and reservoirs
(Nb: 2 tickets complement this: dolutegravir & reservoir and how to measure its reservoir)
Candidates for relief could be against this type of account ... should prevent manipulation tendentious.
The Septistes (the defending dogma 7/7, maintenance) have 2 'pseudo-objection':
1- there would be 'criteria' tank to qualify for relief,
2- relief might fill the tank.
Fuelling fear, such is their credo.
Any objective, factual, not just support these incantations, quite the contrary.
In drafting the handbook 4/7, I took care not to involve the 'tank' as a condition of eligibility. This is not an oversight. I found nothing that would justify ... I'm interested ... if it exists ...
Dismantle the first argument:
The criteria would type: tank and / or immunological. Are sometimes offered:
- HIV-DNA <2.5 log (why 2.5 ... where is the confusion table What is the sensitivity or specificity of this criterion can?)
- CD4> 500 and Nadir> 200 CD4 / CD8> 1: there is the height: when you read carefully the description of 94 Garches (all success with 4/7), we would have excluded 95% ! (Only 7% had a ratio> 1 to the entrance, it is to say ...)
How can people who have no experience of relief 5/7 Can construct a predictive table and pompously proclaim that if you do not meet a particular criterion, you may fail. How to identify a predictive criterion of failure when there is no failure? (Or very little, according to tests).
ICCARRE tank immunology CD4 Rouzioux relief septiste success criterion
The table in ICCARRE-2 study (94 patients) is clear: 50% were over 2.8 and 50% had less than 2.8; then put the bar 2.5 is put so low, that would have eliminated a priori more than 50 patients ... and in what name, please? The 50% and over who had more than 2.5 LOG, and who, like others, have passed the 4/7, you watch in amazement. From the top of this pyramid the majority of ICCARRIENs you 'contemptent ... And are laughing softly ...
Here, for once, to get to the bar, it is the fact ... and put the entire length
The definition, quantification of tanks is in its infancy ... and the clinical benefit of a small tank, if any, is poorly established.
confusion table deconfusion cheating specificity sensitivity test credulity HIV corruption If criterion ago, then build the confusion table!
Patients already ELISA, it was explained the concepts of sensitivity and specificity of a test: they understood. And include, thus, a criterion which one knows neither the sensitivity and specificity, this is not a criterion, the wind!
Stop smoking out: no confusion table? So ... no criteria!
For primary infected, the dynamics of the reservoir, starting treatment, abounds in favor of the non-deferred treatment initiation. The other, themselves, do not care because we do not know how to significantly reduce the reservoir. (We do not also know how to increase ...)
The drugs have no effect on the short-long tank: Then why get stuff?
The possibility of a 5/7 (or even better, 4/7 ...), is it a much better argument for the non-delayed initiation of treatment.
The 5/7 is even an argument pro-treatment more accessible and acceptable to the patient, all patients, the quibbles on the tank ...
Dismantle the second argument:
Poor woman ... You will want to make him believe that a viral rebound, low amplitude, remastered in 2-3 months max., returns to the tank initial levels, before treatment! Ridiculous!!
Back to the starting point ? Really ?? It will prove it before the state. And this ... this is not played ... We already know that it's wrong for small interruptions (research, surgery, ...).
adverse effect of (rare) viral rebound? Psychologically, yes ... but not death ... And the tank ... no patient has ever seen or felt ... a side effect? Really ??
Leibowitch, and that's the only ... publishes cellular DNA (a measure of the tank), in 7/7, before entering ICCARRE, then after every few years 4/7: no notorious increase.
I think the argument is unfounded, at the base, but who cares ...
Even the argument would be based, there still remain the following finding:
In tests with comparator arm (Faucy, Breather) rebounds were observed in the CV in the 2 arms (in 5/7 and 7/7 in). It was found more rebounds than 5/7 by 7/7 in each of the two trials.
In FOTO ICCARRE and no rebound in 5/7 trials.
The 7/7 were not more immune to this supposed re-filling ... If I'm wrong, thank you to tell me ...
We can anticipate the construction of arguments 'marketing', dependents against the 5/7, at the initiative of septistes, who have an interest, money or power, at 7/7.
But to date, no convincing ... They work there ... It's their job ... They are paid for! ... So far I have not seen ...
The attentive patient, he will not be fooled ... A careful reading tests will be useful. Here we find: www.tinyurl.com/maliberte, and, of course, on this blog.
The Practical Guide progresses ... The FAQ is enriched. This is the most downloaded document. I recommend presenting it to the doctor, as a basis for discussion.
And if they oppose you 'tank', you now know what the wrong medicine!
For myself, the 1/7 ICCARRE had no adverse effect ... Without any blipounet, zero to zero. This was true also of the vast majority of documented 5/7 ...
In Hypo-Dolu, too, still undetectable. And the tank? I did measure ... Yes, yes ... It makes me look good!
Good Night and Good Bourre!
Saturday, October 31, 2015
Stribild (tm): No Thanks!
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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
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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
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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.
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
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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.
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
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French (original) This blog is not a medical advise
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Breather: Trial compares 5/7 to 5/7 |
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.
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!
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