Keep Your fingers crossed!

Success for this trial would be the ultimate good news!

www.hepatitis-central.com/mt/archives/2008/11/new_hcv_trial_c.html

[Rockerforlife]

YES.....THIS LOOKS LIKE WHAT WE WANT TO SEE....EXCELLENT NEWS

[zazza]

This is very interesting, but who dares to be a lab rat for this kind of trial with both a protease inhibitor and a polymerase inhibitor but no interferon? I wouldn't. Well, maybe if I knew I did not respond at all to interferon.

[can-do-man]

interferon-free would be nice, but what about the riba??? The new P I's have already shown to be worthless without the riba. I sure wouldn't want to try this, might end up like susan400 and be screwed

[Rockerforlife]

Some people have no choice but to to do this trial

[zazza]

Yeah, I was wondering about the riba too. Wonder if they are getting that?

Rocker, can you elaborate on that?

[zazza]

I am thinking that some people might not understand the consequences of getting enrolled in a trial like this. How much information about this do they get?

[can-do-man]

Thats what sad about some of these new trials, most of us are so naive when we first hear about HCV and just don't know to question some of this... Being a lab-rat is one thing but at what cost... Scares me

[Marcia2202]

So... if you don't SVR, you develop immunity and are left with SOC, or how does that work. Sounds risky to me, 'cause if that doesn't work either, you cannot do SOC + PI. Scares me, too.

[Rockerforlife]

Some people have done a lot of other trials and are not allowed in anymore because they eiter didnt respond to the certian types of drugs...Susan 400 is one who has used up most of her optins i believe.....ya?

[Rockerforlife]

Bocecperir and Telepriver  trials will not accept Susan now...and she has done 5 SOC tx`s....what options does she have left>.......????.....NEW DRUGS

[Marcia2202]

They are going to try this on treatment naive ppl.

[can-do-man]

BTW, thanks BelB64 for bringing this out, first i had heard of it. Hope all is well with ya.

[zazza]

Did it say treatment naive? Scary. As I said, I would only contemplate it if I knew for sure I had no response at all ever to interferon.

[Rockerforlife]

ohhhhhh....a little detail i missed....OUCH.....be careful of this trial then...i thought it was a last resort thing....scary is right

[Marcia2202]

yes, here it is again... paragraph 2


Hepatitis C Information Central
Research & Treatment News
The latest research & treatment news about Hepatitis C infection, diagnosis, symptoms and treatments.


Three companies unite to begin an innovative Hepatitis C trial, where two oral antiviral drugs will be combined in the absence of interferon.

Pharmasset Announces Initiation of Hepatitis Antiviral Combination Study

Tuesday, 11 November 2008

Pharmasset, a clinical-stage pharmaceutical company, Roche and InterMune, a biotechnology company, have announced that the first patients have been dosed in an innovative clinical trial in patients chronically infected with the hepatitis C virus.

The trial is said to be the first to investigate the combination of two oral antiviral molecules in the absence of interferon. The initial study will evaluate the safety and combined antiviral activity of R7227 (ITMN-191), a protease inhibitor, and R7128, a polymerase inhibitor, in 14 days of combination therapy in treatment-naive patients infected with hepatitis C virus (HCV) genotype 1.

This direct antiviral combination study represents an important first step in evaluating the therapeutic potential of an all-oral, interferon-free combination treatment for HCV, the three companies said.

Dan Welch, chairman, CEO and president of InterMune, said: "The goal is to develop a treatment regimen that is better tolerated, shorter in duration and delivers higher sustained viral response rates. We are pleased to participate in the first clinical exploration of an all-oral, direct antiviral regimen towards that goal."

[Rockerforlife]

Who in their right mind would choose this over the PI`S

[Rockerforlife]

AND soc drugs that is

[Marcia2202]

I really hope they will prove our scepticism wrong!

[merryBe]

maybe they know something we don't know??

who will try it?? who in their right mind?  well those without many choices might.

and prison populations probably. States are now mandated to treat, and the cost is enormous.......so they probably are going to mine the prisons for guinea pigs and probably get lots of takers.

Most clinical trials do not offer a truly informed consent...they cannot, in the sense that these are NEW drugs, they really can't say definitely this will give you x, y and z symptoms and side effects, in fact, even if they knew....that information could throw the whole study off...

so how likely is it that they are going to explain carefully the risk of trial vs SOC to treatment naive and ergo the least informed patient populace??????......
not likely,
not likely at all.

mb

[Kristina538]

Am I right in reading that this would only be a 14 day trial?

We're all being skeptical here, but given the often long-term sx's of interferon and the dangers associated with riba,  I'm sincerely hoping they're on the right track...  I know my local specialists are pretty excited about what this trial may bring to the table.  

I wouldn't personally want to be a lab rat for new trials...... but even on SOC,  I feel a little lab-ratish anyway!!!    I was disappointed to be 'advised' in 1994 to tx without knowing the chances of SVR and after relapsing, was no longer 'tx naieve'.    It's easy to know in hindsight, but it certainly highlights how much research we have to do to determine our health care.

[mike716]

Dan Welch (off the record): "Dese guys makin Interferon just don't wanna play fair, dey won't split the take fifty-fifty, so we're gonna go widout 'em. Who needs 'em? If it don't work, so what? We're making enough offa dese trials. Funding up da gazoo...people dyin like flies...de gov's goin nuts. They'll try anything. 'N I got all the anythings you could ask for. I got pro...pro...uh... (what was it, Louey?) oh, yeah...protease inhibitor...I got polimerasa inhibitor... You name it, I'm gonna inhibiit it. For a price, natch. When they get sick from de inhinbitors, I'm gonna sell 'em an inhibitor inhibitor. Whaaaa. Da loot's gonna be rollin in."

[fretboard]

Oh, I must have missed something?lol   As far as this trial goes, nobody in their right mind would get into a study like the one above unless.  They were so bipolar, they couldn't get tx otherwise.  They are in a third world country or even in the US and don't know much, in other words they are ignorant about HepC.  And the last group is ppl who think they are really smart and don't like needles.lol   Besides that, it's such a far fetch, I don't know anyone who would just jump into this trial.  Of course some of these studies pay, so you never know, I think some ppl would do anything for money.  You do have to keep in mind that they used to only tx ppl with interferon without Riba in the old days, so there are some ppl who are SVR today and never had to use Riba.  I don't know what the future holds, I just hope we all clear.  

[zazza]

Yeah, 14 days, what is that about? Nobody is going to get cured in that time, just resistant. Do they want to see how big a virus decline they can induce in that time or what?

[burned74]

Maybe someone in stage 3 or early 4 that is scared to death of SOC would want to try this.
I think many new drug trials are begun like this. I remember reading about the first "Vertex 950" trials  and they had a relatively small number of people in a relatively short time frame. I guess they have to start by seeing whether there are serious side effects.

BTW I think that the purpose of the riba is to magnify the effects of interferon, and w/o IFN,riba is useless anyway.

[zazza]

You probably are right about that. So these patients really can be considered guinea pigs then. Sad.

[BelB64]

I don't have Hep C but a loved one of mine does. I do as much reading on the subject as I can and sharing any new information I find that is promising is the least I can do for this fabulous forum.

Good luck to all!

[nygirl7]

Maybe this would be a trial for someone like our great great old friend Mr. Beagle Bailey who can't take riba cause of his Thalessemia?

Please don't make me think too long about what they did to Susan. Now I know that trials are supposed to be 'random' but they SHOULD look at someones history and see how many times they have already desperately tried and then nudge someone like that into the strongest med arm dont you think? She responded SO WELL - if she had just had that riba I know she would have made it that time. It makes me so mad honestly it makes my head hurt.

She COULD have developed on immunity but how do they KNOW unless they let her try again (and of course now they wont).  *****'ing **********#!s

[merryBe]

on the other hand, 14 days is pretty short...what if the dang thing works....

of course both protease inhibitor and  polymerase inhibitors have some serious sides...

but IF and thats a big IF they combo does not exascerbate those sides, or compound them...and seeeing as how the short duration might keep some of the more serious sides from ensuing....it might be worth a shot. Wouldn't those patients be laughing all the way to the bank.....hee hee...you did 2 years, I did 2 weeks...
stranger things have happened...

If they could get all types 1's to go UND in 1 or 2 weeks, then the extended tx's would become a thing of the past....so even if this is only to show what the drugs alone might do in 99 % of the virus...the next logical step would be...and what if SOC follows...how much better are the outcomes then given early response and can tx duration be shortened without reducing outcomes then.

They gotta start somewhere .

It seems that the current thinking is that the stronger drugs that wipe out completely quickly have the best shot because theres no time for a wild strain...whereas the longer duration tx allows ample time for adaption.
Now I've read that retroviruses can mutate in as little aa 20 minutes...so I don't quite get why the 14 day window was chosen...I think the eventual goal will be big guns and a 24-48 hour window. Brave new world.

Peraonally, I would take 10 pills if it would get me there sooner and with more liklihood than the current extended tx and percentages have offered.