Clinical Trial - New Tenofovir ( GS 7340 )

[Bob0620]

Link :

http://www.anzctr.org.au/trial_view.aspx?ID=347732

[ikepono]

my kidney function results came back abnormal so my dr. told me to split the Viread "tablet". this is difficult because the pill will not break evenly and the dosing is now uneven. I have not been feeling well and wonder If I developed resistance. I will have new blood work done in a week to confirm.

[veteranB]

Good news yes.

[Bob0620]

This is a randomized, open-label, active-controlled study whose primary objective is to evaluate the safety and efficacy of several doses of GS-7340. This study will evaluate the safety, viral kinetics, and antiviral activity of 4 different doses of GS-7340 over 28 days of therapy. In addition, the study will evaluate the antiviral activity of an optimal dose of GS-7340 versus 300mg Tenofovir disoproxil fumarate (TDF) over 28 days of therapy

[Bob0620]

Latest trial

Link - http://clinicaltrials.gov/ct2/show/NCT01671787

Conducted in Ausralia, New Zealand & Canada.

[Bob0620]

I just post a new thread about data on tenofovir released by Gilead.

http://www.medhelp.org/posts/Hepatitis-B/Report--New-Tenofovir--GS-7340-/show/1696000

[4est]

some news on this topic ?

[stef2011]

i was notice that the other nuc's used also in hiv (including the fail one), have a bigger dose in hiv then in hbv but thnofovir has the same dose and I was wandering why.

sorry can you explain this in detail

what about the Italian study that you mentioned regarding half dose of Tenofovir

difficut to find, i will try.it has been done a long time ago.the big problem is split viread pills by half, they are made so you cannot split.generics from cipla and other drug makers can be split.
but this is not good because we dont know if tenofovir resistance can happen, that trial was only 1 or 2 years.split pills is good only in case of kidneys toxicity instead of taking pills every other day

[4est]

http://www.medhelp.org/posts/Hepatitis-B/New-Tenofovir/show/1636140

[4est]

what about the Italian study that you mentioned regarding half dose of Tenofovir ?

i was notice that the other nuc's used also in hiv (including the fail one), have a bigger dose in hiv then in hbv but thnofovir has the same dose and I was wandering why.

[Bob0620]

I keep track and try to get more info

[StephenCastlecrag]

Good news. It is just starting and will last for 1 month. Hopefully, Phase 2 can start soon after. Thanks.

[stef2011]

please keep an eye on it, 28days short trial will make data available soon

[stef2011]

i dont like the fact they use lower quantity to compare, it doesn t make sense because there are italian trials with tdf half dose being safe and active even on lam mutants with no toxicity......

i think they must compare same tdf doses even if GS 7340 could reach higher plasma levels, the point is improve potency of tdf without kidneys toxicity but at same doses or plasma levels

we will see results and look carefully for comparison in plasma levels