ANRS-162-4D: cheaters are exposed

ANRS-162-4D: cheaters are exposed
This paper was originally published here, in French. We provide this translation for your convenience. Some practical aspects may differ where you live.

This what ANRS-4D uncovered

In short:
- J. Leibowitch was right: you can follow the 4/7 schedule, within the rules
- Eviplera ® (Complera ®) is eligible 4/7
- You can go direct to 4/7: bypassing 6/7, 5/7
- There was cheating in this trial
- There was sabotage in this unsponsored trial (see below)
- No intrinsic failure in this trial
- For patients 100% eligible and 100% adherent, regular VL inform us of nothing: they are useless

2 cheaters: revealed by their concentrations!

No doping! Not cheating! No cheaters: dosage reveals who pees blue, and also those who do not take their meds at all!

Le Figaro exposes the cheating:

"Of the 4 patients failing, one quickly abandoned by fear, and two are unlikely to have followed their treatment," says Pierre de Truchis (Hospital Raymond Poincaré), who led the study.

Yes, of Truchis has indeed granted an interview! He leaches out here:
Dr. De Truchis: ... two of the three had low plasma levels of drugs which suggests they did not take quite the expected dose of drugs.

Who are the 2 patients in question? identifying 2 patients 3 on low dosage criterion is easy ... Since 1 of 3 patients always a largely measurable concentration.

Patient number 2 obviously take Atripla ®; he has Efavirenz concentrations, while ON, well above the average (3669 for an average of 2218 among 100 patients) and, while in OFF period, has 1543 (an average of 692 when OFF), which is even a concentration worthy of ON. If de Truchis accounts that patient #2 as one who does not take these meds, he will have clarify. Because, in the published poster, patient # 2 taking his medication properly.

Who are those, then, who do not take the dose as ordered by the trial? Apart from # 1 and # 3? Whose doses are so low that they are not detected. Including in the period in which they were supposed to take meds. So that's quite clear.

You have undetectable concentrations when you are supposed to take medication and that you claim 100% adherence: you are lying!

Dear: Your doctor has prescribed Kivexa + 1 protease inhibitor, to be taken daily, and you miss doses? We understand you ... You are in a vicious circle: you are under PIs, you miss doses, your doctor realizes it, fears resistance, so leaves you under PIs. We understand your interest for the short cycle. We understand ... But you lied to the investigator ... Your lie costs us: redo the trial, delay deployment of the strategy for yet another 3, 4 or 5 years. The millions of patients who are waiting for a reliable strategy or simply treatment (because of shortages), do not say thank you! Here your lies have been damaging and are reprehensible.

Note for future trials: people want to go participate in a trial just to have an excuse to stop their treatment should not be included. This should be the first criteria for non-inclusion in the trial. Exclude anyone who would want to participate just to stop treatment.

We always thank the volunteers ... but not the liars!

Cheating (provisional): it does not count!

Read our complete analysis here!


This paper was originally published here, in French. We provide this translation for your convenience. Some practical aspects may differ where you live.