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.