all-oral treatments for hep c

[robo229]

does anyone have any experience with the all-oral regimen (inform-1) trial.  side effect?  It sounds too good to be true.  why are they now adding SOC (interferon+ribavirin) to the mix?  

[nygirl7]

I would imagine while they were having success at lowering the viral load it was not eradicating the virus (which is the only realy goal).  

That would be the only thing that makes any sense to me since the goal was originally not to have to use interferon.

[nygirl7]

Honestly that just means I don't know but was taking a wild guess by the way!

[nygirl7]

Robo

Here's the most uptodate info I could find on all the protease inhibitor type trials - I dont keep up much since I'm now SVR but I had time this afternoon at work to google.

http://www.natap.org/2009/HCV/100409_02.htm

[WriteItDown]

These trials (combining a protease inhibitor and a polymerase inhibitor without peg and riba) are still in Phase I.  There have been no trials over a long-term, to see if SVR can be obtained, as far as I know.  So presumably, unless they run into some safety issue, they will keep on testing and see what happens.  You just gotta wait!

http://www.roche.com/investors/ir_update/inv-update-2009-04-27.htm

[robo229]

Thank you all for your insightful responses.  You are a terrific group.  I'm just navigating my way through this.  Your help is much appreciated.
robo

[newleaf09]

It's too early to think about Inform.  Phase 1 trials involve very small numbers of patients and if the drug seems safe enough they move to Phase 2 with more patients and try to fine-tune the appropriate dose for best effectiveness.  It's the Phase 3's that can involve over a thousand patients around the world.  There are literally years between phases and years after they've proved the drug in trials before they can get the drug approved for marketing.  It's wonderful to think of curing HCV without interferon, but it will be with us for quite a while more before there is another option.

I would be surprised if anyone on this forum was among the small numbers who took part in the Phase 1 of Inform.  

[newleaf09]

Just looked the study up at http://www.hivandhepatitis.com/2009icr/easl/docs/042809_a.html.  Small study, only 57 patients, divided into 6 groups, so each group would only have 9 or 10, I guess.  Lots of arms, but in the high dose group with the combination, 25% went UD in the 14 day dosing period.  Incredible.  They are trying the individual drugs with SOC and don't say if they are going to pursue the non-SOC combo course.   I hope we can learn some more at the AASLD meeting coming up. Fascinating.