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Saturday, November 21, 2015

DOLULAM and EACS-2015


This paper was originally published here, in French. We provide the google translation for your convenience. Proper translation will come soon. Some practical aspects may differ where you live.

DOLULAM and EACS-2015

DOLULAM and other mono-bi therapies: EACS-2015

One of our readers asks:
If dolutegravir does not change why not take one?
Very good question ... Which leads to another:
If dolutegravir does not change why take in life, the initial dose of horse?
Indeed, 50 mg is a useless overdose.
The 2 questions and 2 answers are linked: my discussion of the extraordinary efficiency of DTG, which is independent of dose, monotherapy, leads to its logical consequence:
-1 Monotherapy Tivicay ® (DOMONO): possible
-2 Dose reduction (HYPO-DOLU): possible

Everything flows efficiency, independent of dose, the DTG. And as one does not go without the other, the same clinicians who understand that monotherapy is possible, understand, sooner or later, that dose reduction in practice: in short cycle is possible. This will be necessary ... Only fools never change their opinion: Even Dr. Molina has become the PreP: that says it all!

And in retrospect, the converts include ICCARRE. And even if they do not understand ... What's important is that the patient, she has everything to gain from this competition between clinicians.

For clinicians, independent, even, indeed, their only and last chance to exist: with injectables, more issues to experiment, regardless of firms. How to experience the Cabotegravir injection in monotherapy if the manufacturer does not provide you? You will buy an injectable combination therapy and separate the nanoparticles encapsulated with your little fingers ???

And that is the triumph of ICCARRE: the short cycle, with a super efficient therapy: the 4-T (quadruple) generic or dolutegravir (and perhaps Bictégravir - GS-9883) ... Whatever ...

Me too, I turned my cuti several attempts to pass the 1/7: if we do not change its software is becoming obsolete.

The downside is that it takes dolutegravir be fully effective ... So there is no mutation (INI due to first generation: RAL and EVG): This is why we must avoid taking Stribild Genvoya ® or ®. For those who have not taken them: Tivicay ® walk alone ... That's Christine Katlama who will give the coup de grace, as we shall see in the coming months ... Evolve or disappear ...

EACS (and / or mono-bi DTG): how much of study: 1, 2 ... No: 7 (not least ...)

PADDLE, DOMONO, Rojas (Barcelona), Katlama (Salpêtrière) Hoqueloux (Orléans), Lamidol, Dolulam (excluding Sword Sword-1 and-2). Translations are available here.

PADDLE test

Presented by Dr. Pedro Cahn (here in discussion with Dr. Cal Cohen, inventor of 5/7) HYPO-DOLU EACS 2015 monotherapy Tivicay dolutegravir cohen Pedro Cahn Paddle Summary: 1066: dolutegravir-Lamivudine as initial therapy in naive patients infected with HIV: first results of the trial PADDLE

Objectives: Based on the results of the test Gardel, we designed a test, proof of concept, which is to assess antiviral efficacy, safety and tolerability of combination therapy of lamivudine (3TC) and dolutegravir (DTG ) in initial therapy.

Methods: A pilot study of 20 HIV-1 infected adult ARV naive. Eligible participants had no resistance INI and CV <100,000 and negative hepatitis B. Viral load was measured at first, then the days 2,4,7,10,14,21,28 then every two weeks until week 12. later, the CV was measured every 12 weeks. The primary endpoint was SVR, defined as the proportion of patients with VL <50 copies / mL at 48 weeks. (Algorithm FDA-snapshot). The interim analysis (S 24) is presented ici.Les patients will be followed for up to 96 weeks.

Results: Participants received 50 mg + DTG LMV 300 mg once daily. Baseline characteristics were: the median CV 24.128 copies / mL (IQR: from 11.686 to 36.794). Four patients = 100,000 copies / mL at the base. Median CD4 count of 407 cells / mm3 (IQR 296-517). Rapid antiviral response was observed. (Median decrease in CV, at week 12 was 2.74 Logs). All subjects achieved a viral load <400 copies and 50 copies / mL. at week 3 and 12, respectively. The observed viral decay rate is similar to that reported in SINGLE-1. Fifteen patients completed their 24 weeks maintaining viral suppression <50 copies. No tolerance / toxicity problems were observed.

Conclusion: During the first 12 weeks of the study PADDLE, dual therapy with lamivudine plus DTG enabled rapid virologic suppression with a safety profile / tolerability favorably in individuals infected with HIV-1, naive treatment. This is the first report of a successful Lamivudine + INI [NdT DTG], combination therapy, in treatment-naïve patients.

DOLULAM Study: DTG + 3TC combination therapy in maintenance

HYPO-DOLU EACS 2015 Dolulam dolutegravir Dr Jacques Reynes Montpellier

Presented by Dr. J. Reynes, this pilot study evaluates a switch to a combination therapy DTG 50mg / 3TC 300 mg, taken once a day for maintenance.

Interim results (S24) were presented at EACS (27 patients). Patients mostly older, heavily pretreated.

No virologic failure were observed, 3 patients discontinued therapy (2 for adverse events) and 1 due to intensified following a blip [NdCh-E yet a blip is not a good reason to change strategy, but ...].

CD4 remained unchanged.

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

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