Lamidol : Tivicay/Lamivudine

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.

Lamidol : Tivicay/Lamivudine

Retry: Lamidol (Tivicay ® / Lamivudine)

LAMIDOL: Maintenance Dual Therapy Lamivudine (GS) + Tivicay ®

The ANRS has released the launch of the ANRS 167 trial Lamidol, registered under number NCT02527096. Read its description in French here.

Given what I am writing about Tivicay ® monotherapy, dual therapy of Tivicay ® (dolutegravir) + Lamivudine (available generically and under the brand Epivir ®), it makes little player, but he has it reason to rush it. Who can do less, can do more: see the results in attack monotherapy maintenance of combination therapy, this should do it!
There is a similar test: PADDLE, whose results are expected in April 2016.

LAMIDOL dolutegravir Tivicay cure trial Yazdan Yazdanpanah
It is a well bordered test, where the risk is mini-mini, and, above all, that will continue with this dual therapy which leaves the way clear for the monotherapy Tivicay ®, and, in the process, to Hypo- dolu; ie the 5/7, 4/7 and 1/7 with Tivicay ® (dolutegravir).

And that, I can say that it is pure bliss.

Lamivudine (3TC), that everyone knows and that the vast majority are (in its original form or its copy, fluoridated FTC) is known for its safety (see report of the WHO). It is inexpensive and, in itself, very little 'strong'. It potentiates the other NRTIs (eg TDF or ABC AZT and also ...). The intracellular chemistry explains. I have not read anything that suggests a synergistic effect or potentiation with dolutegravir (DTG).

This is more interesting than the Dual Therapy DTG + VPN (Rilpivirine), whose essay, commercial, is underway (SWORD SWORD-1 and-2), which should lead to coformulated maintenance, of course patented, and unnecessarily lengthening, at great cost to the insured, the manufacturer exclusivity period ... So pump Dollar.

DTG + 3TC will be also coformulated one day, but until it is not, it helps to have Tivicay ®, without it being crossed with beads: and that's fine for HYPO-DOLU do!

There are only 110 seats: so manifest now!

The condition of inclusions (see the complete specification for the exclusion or contact the organizers: Véronique Joly at 0140257807, Roland Landman 01 40 25 63 54 or at Yazdan Yazdanpanah 0140257803)
[...]
• Age ≥ 18 years
• nadir CD4> 200 cells / mm3
• Have a genotype prior antiretroviral therapy showing no resistance mutations to reverse transcriptase, protease and, if available, the integrase
• Have a first-line antiretroviral therapy combining two NRTIs and a PI or two NRTIs and one NNRTI or two NRTIs and an INI. A change in treatment for intolerance and / or simplification is allowed. The treatment must not have been changed in the last 6 months
• Having a plasma HIV RNA ≤ 50 copies / mL, this for at least 2 years with at least two viral load measurements per year. The blips (HIV RNA between 50 and 200 copies / mL on a sample but HIV RNA following ≤50 copies / mL) are allowed, except in the last 6 me
• The total number of blips must not exceed 3 during the last two years
• Have a negative HBsAg (*)
• Effective contraception in women of childbearing potential
[...]
(*: 3TC is used for hepatitis B, usually with TDF)

This is a test, so it is more restrictive than the eligibility conditions 4/7
Practical Guide.
I made the turn toward Tivicay ® monotherapy well before the announcement of this trial, and I have kept the virus under control, therefore, I would encourage an interest in this Dual Therapy. No need to be enrolled in the trial, however, to be interested and engage with their regular doctor if one is not a place for you.
For those who try, in the ANRS 167 LAMIDOL or outside, good practice is to make a CV in one month, then 2 months in the month 4, 6, 8, 10, 12. The test provides that month 2, 8 and 12 ... Those who want to ensure, as recommended for the other entries in relief, will make additional CV, at their expense, as explained in the handbook. (Better ... especially in anticipation of the move towards a single agent and, following the entry into the short cycle).

Nothing prevents to test for oneself, if one has no chance to be included. LAMIDOL dolutegravir Tivicay Lamivudine Emtricitabine Truvada Yazdan Yazdanpanah

Should we consider the short cycle with this combination therapy, bypassing monotherapy?

Tivicay ® has an inherent power that allows to consider HYPO-DOLU, and the advantage not to take Lamivudine is not to develop resistance to it from hence to the reserve for ICCARRE 'classic' , if any.

This bi-therapy LAMIDOL, is not relief; Indeed, the combination therapy which it was formed (DTG / AB / 3TC) is, for the vast majority of patients, unnecessary on-on-on-medication by itself. Lamidol ... too! The relief starts with effective therapy such as the monotherapy dolutegravir, not by artificial over-medication, concocted solely for market share and optimization of financial income.
This combination therapy can serve as a stepping stone to HYPO-DOLU (weekly intake). This is probably his only interest.

Emax of dolutegravir: Understand that maximum efficiency, Emax was estimated in an experimental setting where the calculation is illegitimate, imposes the question: what is the true value of Emax? and even: there he has a Emax?
Toxicity or resistance is what may cap efficiency. But with Tivicay ®, alone, there is neither one nor the other. And if there is neither one nor the other, then there is no Emax, no limit to efficiency.

A Dual Therapy, out of the combination therapy for dad, over-medication: YES!
Leave it at that: NO! We must get out of the on-medication!

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


Another new blog will soon have an English edition

Note added 10.22.2015: the first results start to come out at EACS 2015