Achilles heel

Achilles heel
This paper was originally published here, in French. We provide this translation for your convenience.

Breaking news: I will soon publish the first results obtained with Tivicay ®, alone, in first line ... Bingo!... Bingo!

Certainly, there were rare failures, in some patients, but not just any patient! This is not 20%! Let's stick to data ... The risk is anything but random: it is limited to well discernible patients: those with a predictable weakness: the Achilles heel!

The Achilles heel

Catie discussed in the same issue and Genvoya® and Mono Tivicay ®:
http://www.catie.ca/sites/default/files/tu212b.pdf

Pr. Christine Katlama has drawn attention to the risk to undertake Tivicay monotherapy for patients who already made use of RAL or EVG, i.e. Isentress®, Stribild® or Genvoya®.

Catie presents, verbatim, in English and French, all known cases of failure in this strategy: they are few and well described.

I have presented in previous posts: 1 , 2, 3, and, the original slides are here.

Prof. Christine Katlama divides her 28 patients into 2 subgroups: those who have never taken nor Isentress® nor Stribild® (/ Genvoya®) (Group # 1) and others who have already taken one and / either (group # 2). Thanks to Catie's issue dedicated to Genvoya®, we can do some basic accounting:

In Paris (Katlama) :
Group # 1 Group # 2 + = 28; Group # 1 = 15 and group # 2 = 13
Failures in the group # 1: 0 (15)
Failures in group # 2: 3 (out of 13)
In Barcelona :
Group # 1 Group # 2 + = 33; Group # 1 = and # 2 = group? (But> 2)
Failures in the group # 1: 0 (over ?)
Failures in group # 2: 1 (of at least 2?)

Reading Catie allows us this simple accounting. Just read and count ...

When one is already in group # 2, knowing that there is an identified risk, circumscribed, albeit poorly quantified, and what to do is important.
When one is in group # 1, we can consider to stay there. At least for now.
I am in the group # 1, which appears to date, nice and interesting to preserve.

If you are in the group # 1, stay there ... So avoid Stribild® / Genvoya® at all costs.
The genotype does not help much. These tests were done in patients by Pr. Katlama (of course ...). None had had a previous failure with Integrase inhibitors. This is not an earlier failure that puts you in the group # 2 ... So none of these patients had no detectable, anticipated risk.

Only the patient's history is offered as explanation for the risk..

In group 2, there are three failures, but also 10 success. You can either see the glass 3/4 full or 1/4 empty ... In group 1, no failure ...

Understanding the Achilles Heel is important for all!

There are only two questions to ask oneself:

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

For those who have the Achilles heel, consider your options with care: 4 out of 5 patients are successfull; not bad!
For those who have not (yet) the Achilles heel: avoid it at all costs!
For those who don't have it and will safely move towards the mono Tivicay®, read this carefully: because the risk of failure was the consequence of mutations that you have been able to avoid, then, understand this: it is not because of the dose: the dose (50 mg) was revised upward for all (including those who have the Achilles heel), wheras you were not at risk! QED.

Upcoming posts: Tivicay® Monotherapy in first line, why avoid TruLight trial, how to wean antidepressants ...

Breaking news: I will soon publish the first results obtained with Tivicay ®, alone, in first line ... Bingo!... Bingo!

Have a good week and enjoy sex



This paper was originally published here, in French. We provide this translation for your convenience.

First line monotherapy

This paper was originally published here, in French. We provide this translation for your convenience.

Tivicay ® monotherapy in First Line

By Charles Edouard!

This is thanks to the Internet: we can seek, search, recheck, express ourselves (without censorship ...), identify sock puppets, and disseminate real practical information. Our ultimate judgment is more guided by to the conviction of a doctor, who sometimes earns more in 'consulting fees' than patients visits.

Dolutegravir Monotherapy in First Line (Induction)

In our post: The brilliant Dr Cahn, I had predicted: This quasi monotherapy in treatment as first line opens, obviously, the door to new results in induction monotherapy. This will eventually come out, probably as early as 2016 ...

Well, here we are

I have the results: they are great!

First, let's see what is at stake: the Phase II trial clinical had demonstrated the feasibility of first line monotherapy with Tivicay ®.

For maintenance, there are only two questions to ask, to collectively and individually:

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

For those who start treatment in 2016, or have a virus whithout the Achille's heel (Achille's heel = previous usage of Isentress® or Stribild® / Genvoya®), validation of monotherapy as first line answers positively, obviously, the first question.

Use of Tivicay ® to its true potential means:

- Consider maintenance with less than 50 mg (i.e. 10 mg)
- Use Dolutegravir for PrEP
- Treat better, everywhere: and eradicate

Maintenance requires less than the initial treatment.

What means less than 50 mg (for abatting the initial VL)? What do you think?

Starting in 2016, we will start counting treatment-naïve patients, who become undetectable with Tivicay® monotherapy . They will add to the already 9 known patients (8 in the ING 111521 trial in 2008, 1 at Dr Lafeuillade in 2015. This will add up and reinforce what I have been saying here for some time: monotherapy Tivicay® is a First line treatment, and its logical continuation, for maintenance, is open to an ICCARRian scheme: Hypodolu.

This will also position Tivicay ® Monotherapy against Protease Inhibitors monotherapy, which is already approved by the ANRS (French HIV R&D Authority) for maintenance, but not for first line treatment, where it had failed.

This is expected because the 'power' of Dolutegravir is not only similar to that of Darunavir (approx. 2.5 Log) but probably much more, as I've shown here.

Do not confuse these first line monotherapy results with maintenance monotherapy (clinical trial: DOMONO) whose results are expected in late 2016, due to delays in recruitment.

I will publish, here, soon, the first results of Tivicay ® monotherapy as First Line.

This is a small trial. To begin with...

Generalizing this approach has many merits, especially to make it a more affordable and more attractive treatment.

For us, what matters is that this will allow more patients to enter this therapy for maintenance, and understand, too, that Tivicay ® monotherapy is not a dosage reduction. The dosage adjustment (reduction) is when one cuts into the firstline treatment dosing!

PreP: this will allow to understand that mono Tivicay ® is also a very good candidate for Prep. PrEP is not limited, thankfully, the sole Truvada ®. There is nothing magical about Truvada ® which makes the only technique for PreP! ... And as Aurobindo anounces dolutegravir at $ 66 / patient / year (sic!), well, we can use it also for PreP.

Before considering DOMONO for all, however, one needs to understand the Achille's heel: There is no risk for patients who have never taken nor Isentress® nor Stribild® / Genvoya®: for those took one of these two drugs, there is a small risk: the Achilles heel, which we will explore in the upcoming post, before we publish the full results of the monotherapy Tivicay® , as first line ...

Upcoming topics: the Achille's heel; Why avoid TruLight trail ...

Let us take a pause, and enjoy the taste of this announced victory!


This paper was originally published here, in French. We provide this translation for your convenience.