Welcome to 20...1/7
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.
What should be monitored in 2017?
By Charles Edward!
This year will be in our favor: 1/7
Hello Charles-Edouard,
I tried on 3/7 and 2 consecutive days [Ndr: Triumeq®], but the effects are too heavy.
Even 2/7 spaced is already difficult.
So I will continue on Tuesday and Friday, and hope for the 1/7!
Good day and Happy New Year.
Quartet
Announced by ANRS in July 2016, this very big trial of the 4/7 is announced for this beginning of the year. Especially since IAS 2017 will be held in Paris ... High visibility!
Morlat 2017?
The update of the dissensus consensus report is announced here by the SFLS: there will be sport!
Genvoya
Not allowed in 2016 (so de facto prohibited ...). Price negotiation is tricky ... Gilead does not lower his claims. Legitimate? What does it matter? The basic issue is the Trojan Horse: authorizing an agent suspected of AIDS-2, would be a decision of the same nature as the tainted blood scandal. No less ... So to follow closely!
The Achilles heel
Precaution: as long as the suspicion remains, stay away from Isentress ®, Stribild ® or Genvoya ®
DOMONO
The complete analysis of DOMONO is expected; We will see more clearly soon ... Bémol pending
Lanzafame
We expect new publications from the very creative Dr. Lanzafame.
The biithérapies
Let's talk about Tivicay®. ViiV is going to give it to heart joy and Les Bithérapies will conquer market share. This post from Dr. David Alain Wohl gives a foretaste of the upcoming commercial foot change. To conquer a market without destroying it, the soldier must be saved! We will follow with delight the maneuver ... It promises here
Sonigo at the party, Leibowitch too!
The duo Kupiec / Sonigo enjoyed a great consecration here. Finally! Sonigo? It was he who conceptualized the Eclipse, concretized by Leibowitch: it is very dear to us ... To follow, then ...
Trump and Big Pharma
Yes! Donald Trump promised to attack the price of the medoc caviars, it is at the minute 5: 20ici! With us, no denunciation of this type and yet! The scandal is doubled by a negligence on the price of generics: to follow!
Transparency
Doctors and patients require less opacity in clinical trials. A wonderful example is given to us by Chaffetz: it's delicious: his "Trust but verify" leads him to assign the FBI: to savor! We did not go to the end of the Cahuzac scandal and the corrupters. Corruption is like the Chernobyl cloud: it does not stop at the Border (moreover, there is no more, or so little): one must accept the idea that Exists and is prejudicial to us. The corporatist between us, therefore the Council of Order is the archaic symbol is harmful to us!
Social Security:
We must save the security! The alternative proposed (Fillon ...) is the insurance company. So costly, juicy, and unsuitable (see USA!). Already remembering where it comes from, where does the chronic deficit come from? (Cf Dr. Gérard Delépine, Even Professor Grimaldi is there, then!) The issue will be debated during the presidential election, Will also invite!
My freedom:
More rights and less Freedom: the quinquennium is contrasted. Freedom is attacked from every side: the Internet has become a tool of propaganda in the hands of the powerful:
Ask yourself a question, at the time of copying / pasting fast-made: this blog is unique in its content. Why unique?
Contribute! Comment on it! Likez! Share it!
Bah yes ... Do not spread relief to all, is to deprive them of a better treatment. So move a little!
In short ... of the TAF in perspective. Bon Week-End and Bonne Bourre!
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.
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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Monday, January 23, 2017
Welcome to 20...1/7
Saturday, December 31, 2016
2016 is over
2016 is over
This paper was originally published here, in French. We provide this translation for your convenience. Some practical aspects may differ where you live.
This blog is a useful read, it was a good idea to move your ass!
Patients are interested by Tivicay ® monotherapy, as expected! If you had a failure with Stribild® / Genvoya® or Isentress® do not even risk it: it's in the red. Does the red zone extend to previous users of Stribild® / Genvoya® or Isentress® without failure? In a first approach (Katlama), this is a gray zone, dark gray ... With 20% of failures in this population, it is risky! For those who have never taken Isentress ® or Stribild ® / Genvoya ®, the risk is lower. Is it zero? We will see ... Especially since the Achille's Heel is written on the patient's DNA, therefore, can be transmitted.
Achille's Heel ... Achille's Heel ... Yes ... For those who have it, de facto, they are not at fault... We did not know ... It is the Fault to Noone. But this was before: now we know: For the newbies, it is no more an Achilles's Heel, but a Trojan Horse!
This inefficiency of Dolutegravir (mono) is either acquired, transmitted or innate.
Transmitted or innate, the patient or the doctor can do not nothing: it is an Achille's heel.
Acquired, it's not the same! Today we know ... And when they prescribe, it is knowingly! So it's a Trojan horse, a ruse...
Acquired Inefficiency Dolutegravir Syndrome: A.I.D.S. Yes ... All this affair is that of an underhanded attack of your natural barriers by an infiltrated agent, acquired by negligence. In its construction, it looks very much like a AIDS-2: letting in an agent that can render your barrier ineffective, natural for AIDS-1, pharmaceutical in case of a possible AIDS-2.
Not final at this point, it deserves full attention and preparedness.
Genvoya® did not receive the final thumbs up from French Ministry, in 2016 ... It may surprise some... But not our readers who understood the 2 stumbling blocks, not just one, as it would be too easy to make believe.
Gilead communicates on the only pitfall that constitutes the weak level of the ASMR (additional medical service) (publication by HAS, French Health Authority).
Communication is not Information.
The price negotiation failed: if Gilead had lowered its claims, it would not have failed. It's a price negotiation. It fails, then, it's a little easy to put responsibility on the buyer, alone. There is always a good price where the buyer could accept. The economic committee is the only barrier against voracity: it is the only one ... Apart from a possible Trojan horse, within it, it defends us. With the transparency commission (SunShine Act like), it is still more difficult than before to place your 'buddies' ... The new system (Xavier Bertrand) defends itself better.
If HAS is followed, the prescription should not be considered as a continuation prescription after Stribild® / Genvoya® or Isentress®. And only in that context! How to give a marketing authorization, in the broad sense, without associating an effective restriction?
For now, the problem is temporarily solved: there is no marketing authorization ... If Gilead manages to remove obstacle number 1 (the weak ASMR), how will our administrative authorities react? How will they protect the naive patient? Well, we'll see in 2017.
For now, the institutional barrier has played its role.
If interested in Tivicay® monotherapy, you can wait for a clarification.
For the more adventurous, those who have successfully used Tivicay® monotherapy (1 year validation), they can consider the ICCARRE reduction or reduce the dose.
Me, I like Minidolu, it worked well (validation over 6 months) ...
I also like the Short Cycle... We will see in 2017 (in fact I already started a new thing ... Tivicay® + Lamivudine (DTG + 3TC) on Saturday and Sunday.)
For the 96 patients who were eligible and who followed, without cheating, the protocol, the success has been total: zero failure.
This proves that Leibowitch did not deceive us ... well ... ANRS goes full scale: better late than never, but so much time wasted! And suffering inflicted! Not to mention the exorbitant cost! Ah, we'll do the counting! ANRS-4D: trial 600.000 Euros, annual savings 400.000 Euros: the best investment for our government!
By spending less, wisely, on can fill the deficit, maintained, of our Socialed Health and save it, without putting France on its knees, as proposed by F. Fillon.
Goodbye, sad clown! ... We won? Not sure! What a loss of time! A five-year period of which he only has one regret (keep well seated...): the false debate on citizenship. In the meantime, the 1.5 million additional unemployed will appreciate and will vote. Not so simple when you read the Fillon program for social security (kindly published by the Canard), and of which the Senate Channel has broadcasted the implementation project.
It's sure game! Finally, we have put behind us a casting error: the casting method is a real catastrophy: the primary is used to eliminate: remains the most idiot ... We have been fooled! Pffff ...
C'est la vie! Champagne!!!
This paper was originally published here, in French. We provide this translation for your convenience. Some practical aspects may differ where you live.
Our take on 2016
by Charles-Edouard!|
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This paper was originally published here, in French. We provide this translation for your convenience. Some practical aspects may differ where you live.
Hello Charles Edouard,
I was under STRIBILD for 16 months.
After reading your blog, I went to Dr. Pierre de Truchis.
He proposed TIVICAY® and EMTRIVA® to my specialist who took offence and sent me another infectious disease specialist who was very open, obviously knows Dr. Pierre de Truchis and validated his recommendations.
First month Super, good ridance to tendinous pains, digestive problems, fatigue ... [...]
I was under STRIBILD for 16 months.
After reading your blog, I went to Dr. Pierre de Truchis.
He proposed TIVICAY® and EMTRIVA® to my specialist who took offence and sent me another infectious disease specialist who was very open, obviously knows Dr. Pierre de Truchis and validated his recommendations.
First month Super, good ridance to tendinous pains, digestive problems, fatigue ... [...]
This blog is a useful read, it was a good idea to move your ass!
The Achilles heel
Patients are interested by Tivicay ® monotherapy, as expected! If you had a failure with Stribild® / Genvoya® or Isentress® do not even risk it: it's in the red. Does the red zone extend to previous users of Stribild® / Genvoya® or Isentress® without failure? In a first approach (Katlama), this is a gray zone, dark gray ... With 20% of failures in this population, it is risky! For those who have never taken Isentress ® or Stribild ® / Genvoya ®, the risk is lower. Is it zero? We will see ... Especially since the Achille's Heel is written on the patient's DNA, therefore, can be transmitted.
Achille's Heel ... Achille's Heel ... Yes ... For those who have it, de facto, they are not at fault... We did not know ... It is the Fault to Noone. But this was before: now we know: For the newbies, it is no more an Achilles's Heel, but a Trojan Horse!
This inefficiency of Dolutegravir (mono) is either acquired, transmitted or innate.
Transmitted or innate, the patient or the doctor can do not nothing: it is an Achille's heel.
Acquired, it's not the same! Today we know ... And when they prescribe, it is knowingly! So it's a Trojan horse, a ruse...
Acquired Inefficiency Dolutegravir Syndrome: A.I.D.S. Yes ... All this affair is that of an underhanded attack of your natural barriers by an infiltrated agent, acquired by negligence. In its construction, it looks very much like a AIDS-2: letting in an agent that can render your barrier ineffective, natural for AIDS-1, pharmaceutical in case of a possible AIDS-2.
Not final at this point, it deserves full attention and preparedness.
Genvoya® NOT authorized! Surprise!
Genvoya® did not receive the final thumbs up from French Ministry, in 2016 ... It may surprise some... But not our readers who understood the 2 stumbling blocks, not just one, as it would be too easy to make believe.
Gilead communicates on the only pitfall that constitutes the weak level of the ASMR (additional medical service) (publication by HAS, French Health Authority).
Communication is not Information.
The price negotiation failed: if Gilead had lowered its claims, it would not have failed. It's a price negotiation. It fails, then, it's a little easy to put responsibility on the buyer, alone. There is always a good price where the buyer could accept. The economic committee is the only barrier against voracity: it is the only one ... Apart from a possible Trojan horse, within it, it defends us. With the transparency commission (SunShine Act like), it is still more difficult than before to place your 'buddies' ... The new system (Xavier Bertrand) defends itself better.
If HAS is followed, the prescription should not be considered as a continuation prescription after Stribild® / Genvoya® or Isentress®. And only in that context! How to give a marketing authorization, in the broad sense, without associating an effective restriction?
For now, the problem is temporarily solved: there is no marketing authorization ... If Gilead manages to remove obstacle number 1 (the weak ASMR), how will our administrative authorities react? How will they protect the naive patient? Well, we'll see in 2017.
For now, the institutional barrier has played its role.
Minidolu: it worked
If interested in Tivicay® monotherapy, you can wait for a clarification.
For the more adventurous, those who have successfully used Tivicay® monotherapy (1 year validation), they can consider the ICCARRE reduction or reduce the dose.
Me, I like Minidolu, it worked well (validation over 6 months) ...
I also like the Short Cycle... We will see in 2017 (in fact I already started a new thing ... Tivicay® + Lamivudine (DTG + 3TC) on Saturday and Sunday.)
Total Success for 4/7 (ANRS-4D)
For the 96 patients who were eligible and who followed, without cheating, the protocol, the success has been total: zero failure.
This proves that Leibowitch did not deceive us ... well ... ANRS goes full scale: better late than never, but so much time wasted! And suffering inflicted! Not to mention the exorbitant cost! Ah, we'll do the counting! ANRS-4D: trial 600.000 Euros, annual savings 400.000 Euros: the best investment for our government!
By spending less, wisely, on can fill the deficit, maintained, of our Socialed Health and save it, without putting France on its knees, as proposed by F. Fillon.
The icing on the cake
Goodbye, sad clown! ... We won? Not sure! What a loss of time! A five-year period of which he only has one regret (keep well seated...): the false debate on citizenship. In the meantime, the 1.5 million additional unemployed will appreciate and will vote. Not so simple when you read the Fillon program for social security (kindly published by the Canard), and of which the Senate Channel has broadcasted the implementation project.
It's sure game! Finally, we have put behind us a casting error: the casting method is a real catastrophy: the primary is used to eliminate: remains the most idiot ... We have been fooled! Pffff ...
C'est la vie! Champagne!!!
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This paper was originally published here, in French. We provide this translation for your convenience. Some practical aspects may differ where you live.
Sunday, December 11, 2016
testimonies
testimonies
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.
Here we read the testimony by patient ZERO: video
Short-cycle (6/7, 5/7; / 4/7) has been explored since 2000 (approximately), in parallel (one could say competition), with other ideas (e.g. long cycles, Controlled long-term interruption, monotherapy, etc.). This strategy was explored by 2-3 doctors (Dr. Cal Cohen in the USA, Dr. Leibowitch in France).
There are many veterans of the Short-cycle ... And they are people of flesh and bones.
They have left us their testimony in the trials, which are as many certified testimonies, published under hospital control: eg. ANRS-4D: So it's not anecdotal.
They also testified (thank you!) ... The publisher offers a free excerpt:
http://www.pictorus.info/pdf/00_ExtraitICCARRE.pdf
And also: Alexandre Bergamini: who wrote Forsaken: An AIDS Memoir.
Among other testimonies, palmsprings describes:
Impose your luck! (*)
From our great friend, Myriam:
Hold on to your happiness! (*)
And from a pusillanimous Hugo...
... and goes to your risk. (*)
Dr. Jacques Leibowitch wrote:
66 patients at 2 days per week, out of 94, it is 2/3 of those who lighten, or 1 in 2 patients of this APHP hospital; And says here: I have fifteen patients to 1 day a week
To look at you, they will get accustomed
The film to be seen ... In his hospital in Brest, a pulmonologist discovers a direct link between suspicious deaths and the taking of a medicine marketed for 30 years, the Pick. From the isolation of the beginnings to the media explosion of the affair, the story inspired by the life of Irene Frachon is a battle of David against Goliath to finally see the truth triumph.
To see again: from the lie to the confessions return on the scandal Cahuzac
To follow in the news: ANRS launched a comparative trial, in the second line, (monotherapy-IP alone vs with Lamivudine), hence its name MOBIDIP (Mono or Bitherapy of Protease Inhibitor) Premature termination of IP Monotherapy (presentation in Glasgow, last month).
(*): This is a poetic emphasis, not a medical advice; It comes from ...
Impose your luck, shake your happiness and go to your risk. To look at you, they will become accustomed (René Char, 1950)
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.
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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.
Some testimonials ...
By Charles Edouard!Here we read the testimony by patient ZERO: video
ICCARRE ZERO ... [...] In 1990, Keith Haring dies, I have 7 T4 left and I do not get much hope. [...] In 1997, I meet Jacques Leibowitch who struggles to convince me to try the first tritherapies. My health improves, my T4 go up slowly. In 2005, I meet my love and my T4 soar so that when we make children, we will take, with the doctor's approval, the decision to try naturally. Neva is born in 2010, Ari in 2011; They are seronegative, my wife too. I am the patient zero of ICCARRE protocol, I have even taken only once a week and the virus was, two months later, always, under the rug, [...] and I am again at two days a week without any particular problems.
Short-cycle (6/7, 5/7; / 4/7) has been explored since 2000 (approximately), in parallel (one could say competition), with other ideas (e.g. long cycles, Controlled long-term interruption, monotherapy, etc.). This strategy was explored by 2-3 doctors (Dr. Cal Cohen in the USA, Dr. Leibowitch in France).
There are many veterans of the Short-cycle ... And they are people of flesh and bones.
They have left us their testimony in the trials, which are as many certified testimonies, published under hospital control: eg. ANRS-4D: So it's not anecdotal.
They also testified (thank you!) ... The publisher offers a free excerpt:
http://www.pictorus.info/pdf/00_ExtraitICCARRE.pdf
And also: Alexandre Bergamini: who wrote Forsaken: An AIDS Memoir.
Among other testimonies, palmsprings describes:
As a Result... my desire to go to 5/7... has been somewhat showered... It's a pain, they scare us ... Whereas we would need so much to be reassured and supported. I am lost and in doubt... And a little disappointed by my infectiologist.
[Then a year later:]
Since June I went on to 5/7 (under Eviplera®). In May, I had 461 CD4 (38%). Now, on 20th September (after 3 months of 5/7, ) my CD4 rose to 769 (43%). So everything is fine! And I remain undetectable. CD4 / CD8 ratio: in May = 0.86, now = 1.08 My infectiologist is aware of my Short Cycle, I'll visit her mid-December.
[Then a year later:]
Since June I went on to 5/7 (under Eviplera®). In May, I had 461 CD4 (38%). Now, on 20th September (after 3 months of 5/7, ) my CD4 rose to 769 (43%). So everything is fine! And I remain undetectable. CD4 / CD8 ratio: in May = 0.86, now = 1.08 My infectiologist is aware of my Short Cycle, I'll visit her mid-December.
Impose your luck! (*)
From our great friend, Myriam:
I asked for so many times... [...] All is now settled down: the neurological pains, although I still have a damaged sciatic nerve, the muscular pains. And then the belly has deflated with normal transit and no more nausea (or very little) either[...] loss of autonomy, 6 months without being able to walk... I turned in circles for 5 YEARS...
Hold on to your happiness! (*)
And from a pusillanimous Hugo...
The 6/7 with Eviplera® seems to work 100% for everyone. [...] It is true that for the 5/7, I do not have much feedback... [...] in short... I'll wait to see the news and if I move forward...
[Then a year later:]
Good! More than one year at 5/7 with Eviplera®: always undetectable. The 4/7 is tempting...
[Then a year later:]
Good! More than one year at 5/7 with Eviplera®: always undetectable. The 4/7 is tempting...
... and goes to your risk. (*)
Dr. Jacques Leibowitch wrote:
[...] Of the 115 patients attending our clinic [...] 94 patients volunteered for treatment, 5 and 4 days a week, or reduced in stages to 4, 3, 2 and 1 day per week In 94, 84, 66, and 12 patients respectively
66 patients at 2 days per week, out of 94, it is 2/3 of those who lighten, or 1 in 2 patients of this APHP hospital; And says here: I have fifteen patients to 1 day a week
To look at you, they will get accustomed
The film to be seen ... In his hospital in Brest, a pulmonologist discovers a direct link between suspicious deaths and the taking of a medicine marketed for 30 years, the Pick. From the isolation of the beginnings to the media explosion of the affair, the story inspired by the life of Irene Frachon is a battle of David against Goliath to finally see the truth triumph.
To see again: from the lie to the confessions return on the scandal Cahuzac
To follow in the news: ANRS launched a comparative trial, in the second line, (monotherapy-IP alone vs with Lamivudine), hence its name MOBIDIP (Mono or Bitherapy of Protease Inhibitor) Premature termination of IP Monotherapy (presentation in Glasgow, last month).
(*): This is a poetic emphasis, not a medical advice; It comes from ...
Impose your luck, shake your happiness and go to your risk. To look at you, they will become accustomed (René Char, 1950)
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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.
Sunday, November 27, 2016
Quatuor, Premium and Eclipse
Quatuor et Stratégie #2
By Charles-Edouard!|
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Testimonies |
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 ...
Hello from Thailand,
I started on 6/7, a month ago (Truvada + Edurant).
My Thai doctor [...] disagrees with Short Cycle ... and tells me that even if you take your medication every day, sooner or later, you will have resistance, and will have to change for more expensive drugs [note: he has to pay ...] so my question is:
Do you really think that Short Cycle can produce resistance to treatment?
Is it true that if a person takes his medicine every day, [...], he will have resistance to his treatment sooner or later?
I'm at 6/7 days, and what he said really frightened me, I do not know if I will ever try in 5/7, or quickly return to 7/7, So as not to risk resistance.
I started on 6/7, a month ago (Truvada + Edurant).
My Thai doctor [...] disagrees with Short Cycle ... and tells me that even if you take your medication every day, sooner or later, you will have resistance, and will have to change for more expensive drugs [note: he has to pay ...] so my question is:
Do you really think that Short Cycle can produce resistance to treatment?
Is it true that if a person takes his medicine every day, [...], he will have resistance to his treatment sooner or later?
I'm at 6/7 days, and what he said really frightened me, I do not know if I will ever try in 5/7, or quickly return to 7/7, So as not to risk resistance.
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
Do you know people who have been Short Cycling their treatment for a long time, 5 years or more, without being resistant to treatment?
Charles-Edouard Dec 5 2016
The answer to this question is simple: YES
Short-cycle (6/7, 5/7; / 4/7) has been explored since 2000 (approximately), in parallel (we can say competition), with other ideas (eg long cycles, Controlled long-term interruption, monotherapy, etc.). This strategy was not the one favored by medical researchers as a whole. But it was explored, pursued, by 2-3 doctors (eg Cal Cohen in the USA, Dr Leibowitch in France); It is also very interesting, because premonitory, to re-read the arguments developed by these, at the very beginning.
So there are indeed veterans of the Cycle Court ... Not thousands ... They exist and they are people of flesh and bone.
They have left us their testimony in a number of ways, including the trial reports, which are all certified testimonials published under hospital supervision: the last one has been made public by the ANRS. they are not anecdotal.
They also testified in books:
The publisher of one of these works has put an extract on line :
http://www.pictorus.info/pdf/00_ExtraitICCARRE.pdf
Short-cycle (6/7, 5/7; / 4/7) has been explored since 2000 (approximately), in parallel (we can say competition), with other ideas (eg long cycles, Controlled long-term interruption, monotherapy, etc.). This strategy was not the one favored by medical researchers as a whole. But it was explored, pursued, by 2-3 doctors (eg Cal Cohen in the USA, Dr Leibowitch in France); It is also very interesting, because premonitory, to re-read the arguments developed by these, at the very beginning.
So there are indeed veterans of the Cycle Court ... Not thousands ... They exist and they are people of flesh and bone.
They have left us their testimony in a number of ways, including the trial reports, which are all certified testimonials published under hospital supervision: the last one has been made public by the ANRS. they are not anecdotal.
They also testified in books:
The publisher of one of these works has put an extract on line :
http://www.pictorus.info/pdf/00_ExtraitICCARRE.pdf
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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:
By Charles Edouard!
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?
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 ...
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.
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ANRS-4D on prime time state TV:
a commented transcript
By Charles Edouard!
ICCARRE goes mainstream TV: this strategy exposes itself to the general public, in a prime time: Le Journal de la Santé (Health Magazine)(France-TV5); To review it, just follow this link to replay. This transcription allows us to heil this extraordinary work, to make the content accessible to all, without risk of unavailability or restriction, and, above all, translate for our non-french speaking audience.
Source: http://tinyurl.com/ICCARRE-TV
Source: http://tinyurl.com/ICCARRE-TV
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.
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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.
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:
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.
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
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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:
Hill has suggested that reservoir reductions on the order of 5-6 logs (100,000-1 million fold) would be necessary to delay viral load rebound for 30 years [...], while a yearlong delay would likely require a drop of at least 3 logs (1,000 fold). [...] a new model was published that argues that significant delays in viral load rebound might be achieved with far more modest declines in HIV reservoir size.
[...] produces a result of one successful reactivation of latent HIV every six days, considerably less frequent than a previous estimate [...]
The researchers extrapolate that a yearlong delay in viral load rebound might therefore be achievable with a reduction in the HIV reservoir of 60-70 fold, a more optimistic scenario [...]
significantly lowered HIV reservoir levels would also allow for a more direct assessment of the impact on time to viral load rebound.
[...] produces a result of one successful reactivation of latent HIV every six days, considerably less frequent than a previous estimate [...]
The researchers extrapolate that a yearlong delay in viral load rebound might therefore be achievable with a reduction in the HIV reservoir of 60-70 fold, a more optimistic scenario [...]
significantly lowered HIV reservoir levels would also allow for a more direct assessment of the impact on time to viral load rebound.
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 | Titre | Lien |
| R. Davey / A. Faucy | 1999 | HIV and T-Cell dynamics after | read... |
| Marek Fischer | 2003 | HIV RNA in plasma rebounds within days | read... |
| Mark T. Bloc | 2006 | The Role of Hydroxyurea ... | read... |
| Rothenberger | 2012 | Abstract_Brief_Interruption | read... |
| Rasmussen | 2014 | Panobinostat_latentvirus | read... |
| Kroon & Ananworanich | 2016 | 160717 Ananworanich Abstract 10535 | read... |
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?
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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
Hello,
My name is Joey and I don't really know how to contact the author of this blog, so I'll try it here :)
I'm HIV positive for 3 years now, probably. I'm treatment-naive. My last CD4 count was 380, VL 280 000. I feel generally unwell for almost a year. I don't know if it's for HIV, but I have A LOT of symptoms. For example: daily sweating, itching all over my body, tight chest, occasional dry cough, vision problems, digestive issues, weight loss...
I'm thinking about finally going on ARVs. Would you say I'm a good candidate for Tivicay monotherapy? My doc is of course against this (I'm in Eastern Europe). He would recommend it just with Edurant. Do you think it would be better to start dual therapy (Tivicay + Edurant) and then to stay just on Tivicay? Or could I benefit just from Tivicay? I haven't had any gene testing done.
Thanks so much in advance!
My name is Joey and I don't really know how to contact the author of this blog, so I'll try it here :)
I'm HIV positive for 3 years now, probably. I'm treatment-naive. My last CD4 count was 380, VL 280 000. I feel generally unwell for almost a year. I don't know if it's for HIV, but I have A LOT of symptoms. For example: daily sweating, itching all over my body, tight chest, occasional dry cough, vision problems, digestive issues, weight loss...
I'm thinking about finally going on ARVs. Would you say I'm a good candidate for Tivicay monotherapy? My doc is of course against this (I'm in Eastern Europe). He would recommend it just with Edurant. Do you think it would be better to start dual therapy (Tivicay + Edurant) and then to stay just on Tivicay? Or could I benefit just from Tivicay? I haven't had any gene testing done.
Thanks so much in advance!
Charles-Edouard 14 nov. 2016
Hi,
Trials on Tivicay monotherapy, or bitherarapy with Tivicay, are promissing. They have been done with patients whose VL was lower than 100.000; So yours is a bit high compared to published trials.
It is a bit higher than the generally advocated limit for Edurant+ truvada (aka Eviplera or Complera).
This is relatively unimportant since your initial treatment does not have to be your maintenance treatment.
Therefore you may start on about anything as long as you can gradually move forward to a maintenance regimen that suits your lifestyle.
if 7/7 suits you here is a sample course:
- start with Triumeq (DTG/ABC/3TC) for 6 months
- drop the ABC , therefore Tivicay + Lamivudine (DTG/3TC): this dual therapy is considered very safe (for 6 months or more)
- maybe drop the 3TC for a Tivicay monotherapy : trials results are satisfactory but there has been a few failure, so frequent VL should be available to avoid uptake and resistance
If you would prefer a 1/7 route
- start with Atripla (EFV/TDF/F-3TC) for 6 months (maybe a bit tough at start)
- switch to Eviplera (RPV/TDF/F-3TC), 7/7 for 6 months
- move to short cycle 4/7 (skip Friday, Saturday, Sunday) for 1 year
- move to 3/7 with frequent VL monitoring at first
Those are exemples.
if you would want alternatives and/or discuss with doctors who have expertize in maintenance strategies please see our page:
https://charles-edouard-ma-liberte.blogspot.fr/p/medecins-allegeurs.html
Dr Lanzafame is may be not too far from you and masters these Tivicay Monotherapies
Do not hesitate to post comments if you need further assistance
Trials on Tivicay monotherapy, or bitherarapy with Tivicay, are promissing. They have been done with patients whose VL was lower than 100.000; So yours is a bit high compared to published trials.
It is a bit higher than the generally advocated limit for Edurant+ truvada (aka Eviplera or Complera).
This is relatively unimportant since your initial treatment does not have to be your maintenance treatment.
Therefore you may start on about anything as long as you can gradually move forward to a maintenance regimen that suits your lifestyle.
if 7/7 suits you here is a sample course:
- start with Triumeq (DTG/ABC/3TC) for 6 months
- drop the ABC , therefore Tivicay + Lamivudine (DTG/3TC): this dual therapy is considered very safe (for 6 months or more)
- maybe drop the 3TC for a Tivicay monotherapy : trials results are satisfactory but there has been a few failure, so frequent VL should be available to avoid uptake and resistance
If you would prefer a 1/7 route
- start with Atripla (EFV/TDF/F-3TC) for 6 months (maybe a bit tough at start)
- switch to Eviplera (RPV/TDF/F-3TC), 7/7 for 6 months
- move to short cycle 4/7 (skip Friday, Saturday, Sunday) for 1 year
- move to 3/7 with frequent VL monitoring at first
Those are exemples.
if you would want alternatives and/or discuss with doctors who have expertize in maintenance strategies please see our page:
https://charles-edouard-ma-liberte.blogspot.fr/p/medecins-allegeurs.html
Dr Lanzafame is may be not too far from you and masters these Tivicay Monotherapies
Do not hesitate to post comments if you need further assistance
Joey 20 Nov. 2016
Hello Charles,
thank you for your reply!
I have a question regarding Triumeq. Do you think it would be possible to have it prescribed in 3 separate tablets (DTG/ABC/3TC)? Hopefully this is not going to be a problem in my country.
Regarding 1/7 route, I would prefer it to 7/7, of course. But I've heard a lot of information about NRTI and NNRTI (in Atripla or Eviplera) being quite damaging to human body. I'd rather avoid those and hopefully manage to get to just using Tivicay as a monotherapy. What do you think? Are NRTI and NNRTI actually that harmful?
Thanks in advance for response.
thank you for your reply!
I have a question regarding Triumeq. Do you think it would be possible to have it prescribed in 3 separate tablets (DTG/ABC/3TC)? Hopefully this is not going to be a problem in my country.
Regarding 1/7 route, I would prefer it to 7/7, of course. But I've heard a lot of information about NRTI and NNRTI (in Atripla or Eviplera) being quite damaging to human body. I'd rather avoid those and hopefully manage to get to just using Tivicay as a monotherapy. What do you think? Are NRTI and NNRTI actually that harmful?
Thanks in advance for response.
Charles-Edouard 20 Nov. 2016
Hi Joey,
Your question is 2 fold and is about strategies that are still in experimental stage. Whatever experimental you intend to do, you should have a strict policy of more frequent VL, typically every 2 months, at the begining only. You may want to keep us posted, so that we may share your experience with others.
Which ever route you choose, your first leg will be a 6 months course of tritherapy (because your VL commands this). And Eviplera (RPV/TDF/F-3TC) should normally not be that choice. Tivicay+Truvada (DTG + TDF/F-3TC) is one combo that suit you request for a 'split' combo. After the 6 months course, you can then decide to go towards Tivicay Monotherapy (ideally with a Bitherapy stepstone) or towards 4/7 (with possible extension to 1/7): so your choice will be around mid-2017, at the earliest. By that time a good number of trials will be published and may guide you.
So T&T is way to postpone the choice, while leaving all options open.
Through this English version of the blog, you get a window to what is going on in France, without the need to participate in French discussion: let me wrap in a few words:
- Eviplera is higly praised and safely used in 4/7 (see ANRS-4D trial). It is also experimentaly used in 2/7. Tolerability is very good for a high proportion of patients. Toxicity gets reduced by the short cycle.
- Tivicay monotherapy is highly praised, but there has been a few failures (rare, but still) in trials. Experimental extension to 4/7 is undergoing and doing well; considering that 3TC is not toxic, it may be a good addition to ensure success.
- Tivicay with either Truvada (DTG + TDF/F-3TC) or in the Triumeq form (DTG/ABC/3TC) is being experimented all the way to 1/7 (very limited number of volunteers)
Strangely enough the best tolerated a combo is, the higher the success rates in short cycle. I guess this is because short cycle candidates, with toxic combos, are more prone to skip more than the short cycle schedule allows for, and, thus fail...
My gut feeling is that all these strategies are succesfull when handled in a step wise progression with at least 6 months (12 better) validation periods. So, whichever your target is, you have plenty of time.
Keep us posted
Your question is 2 fold and is about strategies that are still in experimental stage. Whatever experimental you intend to do, you should have a strict policy of more frequent VL, typically every 2 months, at the begining only. You may want to keep us posted, so that we may share your experience with others.
Which ever route you choose, your first leg will be a 6 months course of tritherapy (because your VL commands this). And Eviplera (RPV/TDF/F-3TC) should normally not be that choice. Tivicay+Truvada (DTG + TDF/F-3TC) is one combo that suit you request for a 'split' combo. After the 6 months course, you can then decide to go towards Tivicay Monotherapy (ideally with a Bitherapy stepstone) or towards 4/7 (with possible extension to 1/7): so your choice will be around mid-2017, at the earliest. By that time a good number of trials will be published and may guide you.
So T&T is way to postpone the choice, while leaving all options open.
Through this English version of the blog, you get a window to what is going on in France, without the need to participate in French discussion: let me wrap in a few words:
- Eviplera is higly praised and safely used in 4/7 (see ANRS-4D trial). It is also experimentaly used in 2/7. Tolerability is very good for a high proportion of patients. Toxicity gets reduced by the short cycle.
- Tivicay monotherapy is highly praised, but there has been a few failures (rare, but still) in trials. Experimental extension to 4/7 is undergoing and doing well; considering that 3TC is not toxic, it may be a good addition to ensure success.
- Tivicay with either Truvada (DTG + TDF/F-3TC) or in the Triumeq form (DTG/ABC/3TC) is being experimented all the way to 1/7 (very limited number of volunteers)
Strangely enough the best tolerated a combo is, the higher the success rates in short cycle. I guess this is because short cycle candidates, with toxic combos, are more prone to skip more than the short cycle schedule allows for, and, thus fail...
My gut feeling is that all these strategies are succesfull when handled in a step wise progression with at least 6 months (12 better) validation periods. So, whichever your target is, you have plenty of time.
Keep us posted
Joey 21 nov. 2016 à 05:39
Hi Charles,
thanks for all the info, it's really appreciated! I was asking about a split combo because Triumeq is 3in1-pill regimen and after 6 months I would drop the ABC, as you suggested. So I would then need to have my prescription changed to just dolutegravir+3TC, or even start with three separate pills from the beginning, and do this "incognito" :) But I'll see what my doctor says, he seems quite open-minded and maybe he would approve.
The thing is, I don't really know how does it work with my insurance company. Is it more expensive for them to pay for 3 pills vs. one-pill med Triumeq? It wouldn't even make sense for them - someone wanting 3 pills instead of 1. An ideal scenario for me would really be Triumeq first 1/2 year and then bi-theraphy - still not sure if my doctor would approve. But I think I can talk him into that :)
I think though, insurance co. would be probably happy to change from Triumeq to just dolutegravir+3TC as that would be cheaper, wouldn't it?
Regarding Truvada, I would rather not take it. I've heard it can cause significant bone density loss... More so than other ARV drugs. I might be wrong, but that is what I've learned from various sources.
Thanks again!
thanks for all the info, it's really appreciated! I was asking about a split combo because Triumeq is 3in1-pill regimen and after 6 months I would drop the ABC, as you suggested. So I would then need to have my prescription changed to just dolutegravir+3TC, or even start with three separate pills from the beginning, and do this "incognito" :) But I'll see what my doctor says, he seems quite open-minded and maybe he would approve.
The thing is, I don't really know how does it work with my insurance company. Is it more expensive for them to pay for 3 pills vs. one-pill med Triumeq? It wouldn't even make sense for them - someone wanting 3 pills instead of 1. An ideal scenario for me would really be Triumeq first 1/2 year and then bi-theraphy - still not sure if my doctor would approve. But I think I can talk him into that :)
I think though, insurance co. would be probably happy to change from Triumeq to just dolutegravir+3TC as that would be cheaper, wouldn't it?
Regarding Truvada, I would rather not take it. I've heard it can cause significant bone density loss... More so than other ARV drugs. I might be wrong, but that is what I've learned from various sources.
Thanks again!
Sunday, October 23, 2016
Quatuor: what for ?
Quatuor: what for ?
This paper was originally published here, in French. We provide this translation for your convenience. Some practical aspects may differ where you live.
Following our suggestion: he goes to de Truchis; was disappointed ...
Excellent move! Finally, we have doctors who know about lighter treatments (most are in France):
http://once-weekly-hiv-therapies.blogspot.fr/p/experienced-doctors.html
7/7 triple therapy followed by 4/7, triple therapy has advantages: it is perfectly mastered at Garches Hospital (by de Truchis) and is based on solid science: 0 intrinsic failures in 190 patients! It opens to 1/7: weekly dosing, which is great, psychologically speaking.
The Mono Tivicay ®, practiced by some in 4/7, is an attractive compromise.
De Truchis offers a strategy where he excels: There is no reason for disappointment ... If you want to be disappointed, for sure, then, you go to Molina! There, you'll be served!
For mono Tivicay®: Katlama (Salpêtrière, Paris), Hocqueloux (Orléans), Lafeuillade (Toulon)
The ANRS feeds Big Pharma and this is no good for patients. Leibowitch is an outspoken opponent of the ANRS since its creation: why would you want the ANRS make him a bed of roses? These squabbles Parisian are at the expense of patients! Please, stop!
The enemy, defeated by ICCARRE, comes back through the window: ANRS, wants to limit the bombastic effect and deprive ICCARRE its atomic class victory atomic class.
A trial is a test of hypothesis: always keep an eye on terms and conditions for inclusion. The hypothesis tested in ANRS-4D: Leibowitch he lied? The answer is no! So ICCARRE-2 results (94 patients) and ANRS-4D (96 legitimate patients) can be aggregated: 190 patients!
What is then the hypothesis tested in the Quatuor?
When the ANRS publicized Quatuor, it sees in ANRS-4D 4 failures. These failures were lies, as it has been found out later. 4 failures that can not teach us anything about any inclusion criteria (always the harmful influence of Rouzioux-of-Criterias), especially as they are 'failures' without any other cause than cowardice and toxicity (the reduction of which is the target ...). 4 pseudo-failures, how to analyze them? We need more ... How Many more? Well ... 25 ... 25 divided by 4% falls on 625.
Did not you find the size of this trial: 640 patients, a bit unusual? 640? Why not 600 or 800, no... 640 ...
640 So ... That is rounding 25 divided by the failure rate (which were pseudo-failures, remember)
If there had been only three failures (ie if virologist-saboteur had been excluded), the trial would have been set at 840 ... The size of the test depends on the presumed failure rate (by ANRS, here misguided by anti-ICCARRE lobby). This failure rate (which was revised lower) made them very upset: the anti-ICCARRE lobby anticipated 5 or 10.
They have been screwed ... So they screw us ...
The intrinsic failure rate was 0 in the 96 'real' ANRS-4D participants, therefore, the 94 patients at Garches are valid: 190 patients, 0 failure: 0 among 190. Quatuor is only 3 times ICCARRE + ANRS-4D. ZERO was the observed rate, perhaps a bit lucky ... A bit of favorable luck.
In the test of hypothesis, we test the negation of which would be favorable (null hypothesis), hence the inversion in the expression: we invalidate the negation (I know ... It's not easy ...)
The main hypothesis tested is: the low rate of failure in ANRS-4D was due to chance. A secondary hypothesis is tested: INIS are not suitable for 4/7.
We want to ensure the true rate (1 or 2%?) Or ... But, then, we should look at the REAL rate of intrinsic failures, and put an end to cheating and sabotage. Especially as test of two hypotheses is tricky.
One of the stated objectives is to open the process to as many patients as possible. Of course, we do not believe a word: the avowed purpose is to delay, limit the impact of ICCARRE.
Compare, differential conditions for inclusion ICCARRE, ANRS-4D and Quatuor
In a future post, we will discuss other aspects:
- Avoid cheating
- Include as many therapies as possible
- Avoid changing the key criteria
- Dare to be transparent
- The problem of Premium eligibility: observation of Eclipse
Until then: be compassionate ! Millions of patients in need suffering overmedication, when millions do not have access, the cost of a million death each year!
This paper was originally published here, in French. We provide this translation for your convenience. Some practical aspects may differ where you live.
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This paper was originally published here, in French. We provide this translation for your convenience. Some practical aspects may differ where you live.
Quatuor and Strategy # 1
Following our suggestion: he goes to de Truchis; was disappointed ...
I am HIV positive since 2007, treatment naïve; I went to see Dr. DE TRUCHIS recently; he offered HAART for one year and then Short Cycle Therapy; I admit I was disappointed.
I would like Tivicay® first line monotherapy; Do you know a doctor offering induction monotherapy in treatment naive people ?
I would like Tivicay® first line monotherapy; Do you know a doctor offering induction monotherapy in treatment naive people ?
Excellent move! Finally, we have doctors who know about lighter treatments (most are in France):
http://once-weekly-hiv-therapies.blogspot.fr/p/experienced-doctors.html
7/7 triple therapy followed by 4/7, triple therapy has advantages: it is perfectly mastered at Garches Hospital (by de Truchis) and is based on solid science: 0 intrinsic failures in 190 patients! It opens to 1/7: weekly dosing, which is great, psychologically speaking.
The Mono Tivicay ®, practiced by some in 4/7, is an attractive compromise.
De Truchis offers a strategy where he excels: There is no reason for disappointment ... If you want to be disappointed, for sure, then, you go to Molina! There, you'll be served!
For mono Tivicay®: Katlama (Salpêtrière, Paris), Hocqueloux (Orléans), Lafeuillade (Toulon)
Quatuor? Why is that?
The ANRS feeds Big Pharma and this is no good for patients. Leibowitch is an outspoken opponent of the ANRS since its creation: why would you want the ANRS make him a bed of roses? These squabbles Parisian are at the expense of patients! Please, stop!
The enemy, defeated by ICCARRE, comes back through the window: ANRS, wants to limit the bombastic effect and deprive ICCARRE its atomic class victory atomic class.
A trial is a test of hypothesis: always keep an eye on terms and conditions for inclusion. The hypothesis tested in ANRS-4D: Leibowitch he lied? The answer is no! So ICCARRE-2 results (94 patients) and ANRS-4D (96 legitimate patients) can be aggregated: 190 patients!
What is then the hypothesis tested in the Quatuor?
When the ANRS publicized Quatuor, it sees in ANRS-4D 4 failures. These failures were lies, as it has been found out later. 4 failures that can not teach us anything about any inclusion criteria (always the harmful influence of Rouzioux-of-Criterias), especially as they are 'failures' without any other cause than cowardice and toxicity (the reduction of which is the target ...). 4 pseudo-failures, how to analyze them? We need more ... How Many more? Well ... 25 ... 25 divided by 4% falls on 625.
Did not you find the size of this trial: 640 patients, a bit unusual? 640? Why not 600 or 800, no... 640 ...
640 So ... That is rounding 25 divided by the failure rate (which were pseudo-failures, remember)
If there had been only three failures (ie if virologist-saboteur had been excluded), the trial would have been set at 840 ... The size of the test depends on the presumed failure rate (by ANRS, here misguided by anti-ICCARRE lobby). This failure rate (which was revised lower) made them very upset: the anti-ICCARRE lobby anticipated 5 or 10.
They have been screwed ... So they screw us ...
The intrinsic failure rate was 0 in the 96 'real' ANRS-4D participants, therefore, the 94 patients at Garches are valid: 190 patients, 0 failure: 0 among 190. Quatuor is only 3 times ICCARRE + ANRS-4D. ZERO was the observed rate, perhaps a bit lucky ... A bit of favorable luck.
In the test of hypothesis, we test the negation of which would be favorable (null hypothesis), hence the inversion in the expression: we invalidate the negation (I know ... It's not easy ...)
The main hypothesis tested is: the low rate of failure in ANRS-4D was due to chance. A secondary hypothesis is tested: INIS are not suitable for 4/7.
We want to ensure the true rate (1 or 2%?) Or ... But, then, we should look at the REAL rate of intrinsic failures, and put an end to cheating and sabotage. Especially as test of two hypotheses is tricky.
One of the stated objectives is to open the process to as many patients as possible. Of course, we do not believe a word: the avowed purpose is to delay, limit the impact of ICCARRE.
Let's compare inclusion criteria
Compare, differential conditions for inclusion ICCARRE, ANRS-4D and Quatuor
| Conditions | ICCARRE | ANRS-4D | Quatuor |
| CD4 at baseline | > 200 | > 250 | > x (CD4-Quatuor) |
| perfect adherence | prerequisite | requested (controlled by dosage) | Quatuor ? |
| reservoir (proviral DNA) | Not required | Not required | ? |
| Nadir (CD4) | Not required | Not required | ? |
| CD4/CD8 Ratio | Not required | Not required | ? |
| pregnancy | ? | to be avoided | ? |
| duration under current molecules | > 6 months | 4 months | ? |
| Is Nevirapine eligible ? | Yes | No | ? |
| Is Issentress eligible ? | Yes | No | ? |
| Is Stribild® eligible ? | non avail. | No | ? |
| Is Triumeq (ou T&T) eligible ? | non avail. | non avail. | ? |
| is Tivicay® Bithérapie eligible ? | non avail. | non avail. | ? |
| Is Tivicay® Monothérapie eligible ? | non avail. | non avail. | ? |
| Eclipse (Time to rebound) | not published | no | ? |
In a future post, we will discuss other aspects:
- Avoid cheating
- Include as many therapies as possible
- Avoid changing the key criteria
- Dare to be transparent
- The problem of Premium eligibility: observation of Eclipse
Until then: be compassionate ! Millions of patients in need suffering overmedication, when millions do not have access, the cost of a million death each year!
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< Previous The Montreal patient |
Home
French (original) This blog is not a medical advise
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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.
Saturday, October 15, 2016
The Montreal patient
The Montreal patient
This paper was originally published here, in French. We provide this translation for your convenience. Some practical aspects may differ where you live.
A patient at Clinique l'Actuel, screwed by Stribild ®
A case reported by the so lovely Dr. Réjean Thomas:
Development of a G118R mutation in HIV-1 integrase Following a switch to monotherapy dolutegravir ...
Poor patient ... HLA * 5701 positive ... This may have helped him be asymptomatic for so long. Why enter the treatment on the basis of a single reading of CD4 < 350? Ah ... Yes ... The new US recommendations, with, as first choice, Stribild ®. Why start so early with the Tivicay® mono-therapy, whereas a Dual Therapy Tivicay® + Lamivudine could have made a reasonable step? See how the Doctor (Dr Thomas?), puts the blame on the patient? He would have learned about the mono Tivicay ®? Where so? On the internet probably. Oh ... Naughty boy! ... And he is pushing, despite admonitions by his doctor ... Yes ... But without prescription, the patient can do nothing ...
In the discussion, the authors note:
Science, showing theAchilles Heel Trojan Horse, only took place in Oct. 2015, and, rare, very rare, too rare are those who relayed the discovery, made in Paris. The damage is done, and the pill is bitter to swallow ... And also for the prescribing doctor ... Stribild ®, once again, challenged ... Poor Quebec ... Its First-in-class biologists were the first to pinpoint the mono Tivicay® ...
Bad luck, the marketing teams from their Southern neighbors had already managed to position theTrojan Horse Stribild® as best choice, without the faintest history. Finally, this patients ends up with PIs. Holy shit ...
You read, here, and nowhere else, about the Achilles heel, the Mono Tivicay as first Line, the extraordinary success of ANRS-4D, the negative recommendation by the HAS for Genvoya ®, the Montreal patient (another exclusive ...), then you begin to see the broad picture. That's it, you think you have it all!
Not so fast! You do not know yet the Munich patient, DoluMono, Domono (later, this October!), how the snowman melts, suicides during the START trial ... I have more! And the best!
TheAchille's Heel Trojan Horse has been widely discussed here. It was presented by C. Katlama at EACS-2015 and published in June 2016. Our regular readers had a head start ...
Hop! (as Achille Talon would say) Good weekend and good fuck!
This paper was originally published here, in French. We provide this translation for your convenience. Some practical aspects may differ where you live.
Stribild® as Achille's Heel
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This paper was originally published here, in French. We provide this translation for your convenience. Some practical aspects may differ where you live.
A patient at Clinique l'Actuel, screwed by Stribild ®
A case reported by the so lovely Dr. Réjean Thomas:
Development of a G118R mutation in HIV-1 integrase Following a switch to monotherapy dolutegravir ...
Montreal: another victim of Achille's Heel:
A 42-year-old Quebec man having sex with men was diagnosed with HIV-1 infection in 1999. He remained asymptomatic and ART-naive until 2013 with viral loads ,6000 copies/mL and CD4 cell counts > 500 cells/mL. Initiation of ART was considered in August 2014, when he presented with a CD4 cell count < 350 cells/mL and a viral load of 4000 copies/mL. Genotypic analysis revealed a subtype B infection and CXCR4 tropism. He tested
HLA-*5701 positive, contraindicative for abacavir.
In September 2014, he initiated a once-daily Stribild® regimen of elvitegravir/cobicistat/tenofovir disoproxil fumarate/emtricitabine and was virally suppressed for 5 months. In February 2015, the patient’s viral load was undetectable (< 40 copies/mL) and his CD4 cell count had increased to > 500 cells/mm3. The patient,
aware of the existence of so-called ‘light’ therapy prescribed elsewhere, requested a switch to dolutegravir monotherapy to minimize side effects. After discussion with the physician about potential problems involving monotherapy [Ch-E: so the doctor says ...], the patient was switched from Stribild® to dolutegravir monotherapy (Tivicay®) at that time.[Ch-E: Who writes the Rx ? The Doc, No ? ...]
The patient had detectable viral escape (< 50 copies/mL) in August 2015. Drug resistance testing on his plasma viral RNA on two occasions in August (300–800 copies/mL) revealed the acquisition of the G118R in viral integrase Analysis of the patient’s proviral cDNA revealed an absence of G118R in archived virus. Sequencing of RT and protease revealed an absence of any acquired resistance mutations or polymorphisms. The integrase, RT and protease genes were all of subtype B origin. In August 2015, the patient’s ART regimen was changed to darunavir/cobicistat/tenofovir/emtricitabine and his viral load returned to undetectable by September 2015. The patient has remained virally suppressed to date, indicative of treatment adherence.
The patient had detectable viral escape (< 50 copies/mL) in August 2015. Drug resistance testing on his plasma viral RNA on two occasions in August (300–800 copies/mL) revealed the acquisition of the G118R in viral integrase Analysis of the patient’s proviral cDNA revealed an absence of G118R in archived virus. Sequencing of RT and protease revealed an absence of any acquired resistance mutations or polymorphisms. The integrase, RT and protease genes were all of subtype B origin. In August 2015, the patient’s ART regimen was changed to darunavir/cobicistat/tenofovir/emtricitabine and his viral load returned to undetectable by September 2015. The patient has remained virally suppressed to date, indicative of treatment adherence.
Poor patient ... HLA * 5701 positive ... This may have helped him be asymptomatic for so long. Why enter the treatment on the basis of a single reading of CD4 < 350? Ah ... Yes ... The new US recommendations, with, as first choice, Stribild ®. Why start so early with the Tivicay® mono-therapy, whereas a Dual Therapy Tivicay® + Lamivudine could have made a reasonable step? See how the Doctor (Dr Thomas?), puts the blame on the patient? He would have learned about the mono Tivicay ®? Where so? On the internet probably. Oh ... Naughty boy! ... And he is pushing, despite admonitions by his doctor ... Yes ... But without prescription, the patient can do nothing ...
In the discussion, the authors note:
[This is] perhaps due to previous use of raltegravir or elvitegravir [...] [NdT: i.e. the Achilles heel Trojan Horse], and that this substitution was then amplified by dolutegravir mono-therapy.
Science, showing the
Bad luck, the marketing teams from their Southern neighbors had already managed to position the
You read, here, and nowhere else, about the Achilles heel, the Mono Tivicay as first Line, the extraordinary success of ANRS-4D, the negative recommendation by the HAS for Genvoya ®, the Montreal patient (another exclusive ...), then you begin to see the broad picture. That's it, you think you have it all!
Not so fast! You do not know yet the Munich patient, DoluMono, Domono (later, this October!), how the snowman melts, suicides during the START trial ... I have more! And the best!
The
Hop! (as Achille Talon would say) Good weekend and good fuck!
|
< Previous Gvt Health body torpedoes Genvoya(tm) |
Home
French (original) This blog is not a medical advise
|
Next >
Quatuor: what for ? |
This paper was originally published here, in French. We provide this translation for your convenience. Some practical aspects may differ where you live.
Saturday, October 1, 2016
Gvt Health body torpedoes Genvoya(tm)
Gvt Health body torpedoes Genvoya(tm)
This paper was originally published here, in French. We provide the google translation for your convenience. Proper translation will come soon. Some practical aspects may differ where you live.
From a patient who has poorly maneuvered:
What a journey! You toasted almost all your treatment options simply because of toxicity that you, and you alone, allowed to break in... Bravo!
Apart from the initial phase, your new combo has a very low dropout rate. This one remains widely used, to the chagrin of merchands. The Genvoya ® proposal will then have no interest.
If the patient has a proactive doctor: the 'promise' for relief that was made to encourage the patient to enter early in treatment, will be held. If the doctor is of the reactive type (relief only if under duress) the promise of yesterday will quickly retracted.
Remember to ask about what happens next before running to the slippery slope
In the first few years of its release, no one had seen the toxicity caused by TDF (which is in Truvada®). No one. No one; neither phase 3 trials or systematic monitoring done by D: A: D: S. And this, everyone has forgotten.
Toast an option due to resistance or due to toxicity, it is the same shit!
If the doctor is seasoned and proactive; the 'promise' of a lower medication burden that entices the patient to early treatment, will be fulfilled. If the doctor is of reactive type (lesser medication load only if under pressure) the promise of yesterday will quickly be retracted.
You want to take a second opinion (in a perspective a lower burden): you are proactive.
And, if you go to a reactive doctor, same as your current doctor, you are fooled again. And you can not know in advance: doctors not to put their 'profile' under their name
Translation Note: the HAS (Haute Autorité de Santé) is a French gvt body, established in the wake of the Vioxx and mediator scandals; An equivalent to Britain's NICE. It aims at protecting patients and doctors again falatious claims.
The HAS ruling concerning Stribild® was already severe: it had positioned Stribild® in second line.
It points: [...] the low genetic barrier to resistance to elvitegravir and the lack of demonstration superiority in terms of effectiveness compared to other available INI (Dolutegravir, Raltegravir), and the need for a pharmacokinetic enhancer, Cobicistat, [...]
Genvoya® is nothing but Stribild® where TDF was substituted by TAF. Here is piece in Pharmaceutical that introduces the trick: This is an incremental innovation, which the Transparency Commission of the HAS has also denounced no improvement in actual benefit (although benefit is important)
The 2 reference documents are:
TRANSPARENCY COMMITTEE, Avis and March 2, 2016 and SUMMARY OF OPINION OF THE TRANSPARENCY COMMITTEE; General access is here.
About Genvoya®, it says: When a treatment strategy with integrase inhibitor is considered, Genvoya ® is a second-line treatment option.
In short: Say, you are under Atripla ®, and your doctor offers Genvoya®. If you want to follow the opinion of the HAS (or simply if you want to avoid Genvoya® food obligation): simply show this ruling to the doctor. Does s/he considers a treatment strategy with integrase inhibitor? Obviously, yes. Can s/he suggest Genvoya®? Well no ! It should first try the alternatives: Raltegravir (Isentress ®) or Dolutegravir (in Triumeq® or Tivicay ® ®)
If we follow the HAS (May 2016), Genvoya ® should only be considered as a replacement to Stribild® or Isentress ® . HAS denies the use of Genvoya® outside this context of historical continuity.
If you go by the HAS, Genvoya ® should never be your first treatment, or even, in the vast majority of cases, your second. At the earliest, this will be your third ...
For a relegation, that is a relegation! ...
And that nobody talks about ...
Having thus torpedoed Genvoya®, HAS will engage in an exercise of unprecedented baseness.
So, it had just disqualified for lack of improvement (TAF weak evidence of toxicity reduction), but, in the same document, it pleads the manufacturer to promptly substitute TDF by TAF, in other products . It has nothing to do with Genvoya®, but they write it there, in the ruling on Genvoya ®: message well received or a shot in the dark?
France, now a pharmaceutical dwarf, forced to supplication.
As if the US were to return a favor as they just sunk their flagship to the sea floor!
HAS saw it coming: in a future post, I 'll report how a Quebec doctor screwed a patient. For him, the pill is bitter: if he had read us, he would have thought twice.
This case illustrates a scandal being put in place: it is the same order of magnitude as the tainted blood scandal: the problem is known, but the alarm is not sounded.
By definition, the trap is concealed: it is enough to reveal the mechanism for curdling terror. To be continued...
Seronegative explain life to poz, as read on the Web, and worth reflecting upon:
Have a good week-end and good fuck!
This paper was originally published here, in French. We provide the google translation for your convenience. Proper translation will come soon. Some practical aspects may differ where you live.
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Home
French (original) This blog is not a medical advise
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The Montreal patient |
This paper was originally published here, in French. We provide the google translation for your convenience. Proper translation will come soon. Some practical aspects may differ where you live.
From a patient who has poorly maneuvered:
After a blip (23 copies) with Isentress® in August and kidney failure under boosted combination therapy (PREZISTA®-NORVIR®): Return to TRItherapy in September (Kivexa®-Viramune®).
I can not take Truvada® precisely because of these kidney and bone disorders. Truvada® is great but replacing it is not obvious.
My infectious disease specialist says Genvoya® is expected later this year.
What do you think?
I can not take Truvada® precisely because of these kidney and bone disorders. Truvada® is great but replacing it is not obvious.
My infectious disease specialist says Genvoya® is expected later this year.
What do you think?
What a journey! You toasted almost all your treatment options simply because of toxicity that you, and you alone, allowed to break in... Bravo!
Apart from the initial phase, your new combo has a very low dropout rate. This one remains widely used, to the chagrin of merchands. The Genvoya ® proposal will then have no interest.
If the patient has a proactive doctor: the 'promise' for relief that was made to encourage the patient to enter early in treatment, will be held. If the doctor is of the reactive type (relief only if under duress) the promise of yesterday will quickly retracted.
Remember to ask about what happens next before running to the slippery slope
In the first few years of its release, no one had seen the toxicity caused by TDF (which is in Truvada®). No one. No one; neither phase 3 trials or systematic monitoring done by D: A: D: S. And this, everyone has forgotten.
Toast an option due to resistance or due to toxicity, it is the same shit!
If the doctor is seasoned and proactive; the 'promise' of a lower medication burden that entices the patient to early treatment, will be fulfilled. If the doctor is of reactive type (lesser medication load only if under pressure) the promise of yesterday will quickly be retracted.
You want to take a second opinion (in a perspective a lower burden): you are proactive.
And, if you go to a reactive doctor, same as your current doctor, you are fooled again. And you can not know in advance: doctors not to put their 'profile' under their name
HAS torpedoes Genvoya®
Translation Note: the HAS (Haute Autorité de Santé) is a French gvt body, established in the wake of the Vioxx and mediator scandals; An equivalent to Britain's NICE. It aims at protecting patients and doctors again falatious claims.
The HAS ruling concerning Stribild® was already severe: it had positioned Stribild® in second line.
It points: [...] the low genetic barrier to resistance to elvitegravir and the lack of demonstration superiority in terms of effectiveness compared to other available INI (Dolutegravir, Raltegravir), and the need for a pharmacokinetic enhancer, Cobicistat, [...]
Genvoya® is nothing but Stribild® where TDF was substituted by TAF. Here is piece in Pharmaceutical that introduces the trick: This is an incremental innovation, which the Transparency Commission of the HAS has also denounced no improvement in actual benefit (although benefit is important)
The 2 reference documents are:
TRANSPARENCY COMMITTEE, Avis and March 2, 2016 and SUMMARY OF OPINION OF THE TRANSPARENCY COMMITTEE; General access is here.
About Genvoya®, it says: When a treatment strategy with integrase inhibitor is considered, Genvoya ® is a second-line treatment option.
In short: Say, you are under Atripla ®, and your doctor offers Genvoya®. If you want to follow the opinion of the HAS (or simply if you want to avoid Genvoya® food obligation): simply show this ruling to the doctor. Does s/he considers a treatment strategy with integrase inhibitor? Obviously, yes. Can s/he suggest Genvoya®? Well no ! It should first try the alternatives: Raltegravir (Isentress ®) or Dolutegravir (in Triumeq® or Tivicay ® ®)
If we follow the HAS (May 2016), Genvoya ® should only be considered as a replacement to Stribild® or Isentress ® . HAS denies the use of Genvoya® outside this context of historical continuity.
If you go by the HAS, Genvoya ® should never be your first treatment, or even, in the vast majority of cases, your second. At the earliest, this will be your third ...
For a relegation, that is a relegation! ...
And that nobody talks about ...
HAS: schizophrenic and obsequious
Having thus torpedoed Genvoya®, HAS will engage in an exercise of unprecedented baseness.
So, it had just disqualified for lack of improvement (TAF weak evidence of toxicity reduction), but, in the same document, it pleads the manufacturer to promptly substitute TDF by TAF, in other products . It has nothing to do with Genvoya®, but they write it there, in the ruling on Genvoya ®: message well received or a shot in the dark?
France, now a pharmaceutical dwarf, forced to supplication.
As if the US were to return a favor as they just sunk their flagship to the sea floor!
Genvoya ® HAS got it right: the trap is set for you
HAS saw it coming: in a future post, I 'll report how a Quebec doctor screwed a patient. For him, the pill is bitter: if he had read us, he would have thought twice.
This case illustrates a scandal being put in place: it is the same order of magnitude as the tainted blood scandal: the problem is known, but the alarm is not sounded.
By definition, the trap is concealed: it is enough to reveal the mechanism for curdling terror. To be continued...
Comical: the Seroneg's coming-out
Seronegative explain life to poz, as read on the Web, and worth reflecting upon:
| Weird story about the 'AIDS' organizations: An official at a local 'conference' (AIDES) talks to about twenty HIVers on how to approach life ... I ask him if he is HIV positive, to what he replied that he preferred to keep the answer for himself! ... I left the room, protesting that announcing one's HIV status could be a problem that adds to the one of announcing one's HIV negative status! |
Have a good week-end and good fuck!
|
< Previous Pr. Delfraissy's surrender |
Home
French (original) This blog is not a medical advise
|
Next >
The Montreal patient |
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.
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