gs-9190

[denden]

Has any1 heard of this..or trying it?  I when to see a hep-c Dr.for the first time and he ask if I would like to get in a research study.And I don't know what to do. I never had Tx befor and I when to the Dr. to see where I was with the hep-c...I been doing herbs for years now and my numbers was pretty good but the hep-c is still there...so should I try it or wait for new approved drug.

[MissyMouse]

Den,

I've personally never heard of it.   What's your geno type?  Have you had a biopsy or fibroscan blood test to determine the amount of your liver damage?  You can't always assume y ou have minimal damage if your numbers are good.  Mine never went real high and I have advanced damage.

Mouse

[denden]

I'm 1a and no I never had either one of them... but I would have to have a liver biopsy befor I could start the program to see if I had any sign of cirrhosis...

[Pancho and Lefty]

I never heard of it either. I did find this:

http://www.hivandhepatitis.com/2007icr/aasld/docs/121107_a.html

It doesn't look like the silver bullet people seem to be waiting for. . . but none of the other stuff does either.

People who are waiting most often know what shape their liver is in. As Mouse suggests, a biopsy or fibroscan would be very much in order.

As far as trials go. .. . I'd make sure there was no possibility of getting placebo. That generally means phase III.

regards,

Max

PS I just reread the article. .. .I would pass on this stuff even though I don't have insurance to cover tx (again). Sometimes free isn't really worth the risk.

[DougV]

Den,

T'aint none of my business, but low numbers are meaningless.  Mine have always been low, just barely above normal, always.  Was only four years ago they were ever above normal, before that always dead middle normal range, always.  First time ever above normal, ever, October 2004.  I have cirrhosis and never suspected a thing. 

Doug

[denden]

Thanks everone for your input....I wonder how long befor we have new drugs to fight this dragon with? And will someone like me can afford..I have no insurance..

[Pancho and Lefty]

At risk of being offensive, you don't seem to be solution oriented. GET A BIOPSY. Only then can you know how long you can wait.

Reread the above three times.

Unless you're on Medicaid you'll have to have some money to get tx. The drug companies will give you the chemicals. You'll have to pay for at least part of the doc visits, labs, and all the rest.

I paid $240 for the initial consultation. I let them ring up $2800 on my credit card to get a biopsy. When they discovered my finances did have limitations, they did cut some slack. They did expect $230 upfront every time I saw a PA (incredibly obtuse physician's assistant). I started dealing with my GP here in my small town and had my labs done at the local county hospital. They have a patient assistance program that did, indeed, help reduce some of the costs

Unless you do some footwork, you'll never get anywhere. Try to get someone on the inside to advocate for you. Ask for a supervisor until you get something workable.

As for the PI's (protease and polymerase inhibitors) they may be out as early as 2010. . . of course they were fully expected by everyone to be out by 2003. I'm afraid a lot of people waiting for the silver bullet are going to be very disappointed when they do get here. There will be additional sx along with the SOC drugs that are out now. Other developments will most certainly be postponed just the way the PI's have. People could end up waiting. . . in some cases too long.

Mouse posted a 'how to get tx without insurance' or some such, but as far as I know, I'm one of the few here that actually did it without insurance (Jazzdenova put out a lot of pocket cash also. . . I think). I didn't get a thing done until I became committed to doing one hell of a lot of footwork.

It's time to ask yourself. . . how bad do I want it???   Without commitment nothing is going to happen.

Max

[robin]

Ummm...even those of us with insurance are not immune to "crap". My co-pay is $1100 a month...we make too much to qualify for free meds and as of Friday, insurance denied the interferon and ribavirin...AGAIN. I've been fighting with them since 2-5-09. Then, we don't qualify for anything on rescue meds, another $2000-3000 a month, so got that figured out after several weeks...going to get those at the doctor's office which is a two hour drive a couple times a week. Did another call to the pharmacy, filled out appeal paperwork and called the Nurse Practitioner and am hoping for an answer before the end of the month on the Pegasys and Riba.

Like Max said...it can be done but it's not always easy to do so.

[denden]

Thanks again for the replys.....and no I didn't get offened I know you r just trying to help and I tyvm....   I think I will try to get in on the gs-9190 trial  atleast till they do the liver biopsy and see were I'm at.... that much will be payed for and go from there....ty again ........O and one more thing..Pancho and lefty why do you think I should pass on this gs-9190?

[Pancho and Lefty]

The headline for the GS-9190 included a warning for risk of cardiac side effects. Also, from what I've read, they've only used it for 8 to 12 wks by itself. . . got some undies and then stopped the trial. That's also been done with Alinia and, I think, fluvastatin. Several of these things may work, but none have proved to get rid of the virus permanently when used alone.

The study I found was also a Phase 1.  You can't be sure not to receive a placebo unless the study is at Phase III. Again, at this point, almost everything is being used in conjunction with IF/riba.

Can you post a link to the study you're considering? Perhaps you could put together a list of questions to ask the people doing the study.

Will you be offered rescue drugs?  (mostly never on trials)
Will they be using IF/riba along with GS?
How long will the trial last?
Will there be a cutoff for non-response? (will they remove you if you don't respond in a predetermined time frame)

My expertise is limited, to say the very least, but I would try to get on a boceprevir or teleprevir trial since they have been shown to be effective.

I think my bottom line would be if I absolutely couldn't get treatment any other way, I would go with a trial after doing my best to choose carefully.

I hope Willy sees this. He's been looking at different studies for years.

sincere best wishes,

Max

PS, I copied this excerpt from the Phase I results:

quote>QT Elongation

However, the preliminary results from Part B suggested that GS 9190 may be associated with QT elongation, a type of heart rhythm disturbance. Based on routine electrocardiograms (a standard test for cardiac safety in drug trials), the researchers observed “a possible but not confirmed” QT elongation in the second multiple-dose cohort.

Gilead Sciences, the company developing the drug, has initiated a specific QT study to look at the potential cardiac risk of GS 9190 among healthy volunteers without hepatitis C. This study is expected to be concluded by the end of the year.

“These Phase I data support continued evaluation of GS 9190 as a potential therapeutic option for hepatitis C virus,” presenter Ira Jacobson, MD, of Cornell’s Weill Medical College said in a Gilead press release. “New, more convenient and better tolerated medicines for HCV are urgently needed, and we look forward to continuing our assessment of GS 9190 in this clinical program.”<unquote

[denden]

This IS a Phase 2b Randomized, Double-Blind,Placebo-Controlled Trial Comparing 24 or48 Weeks of GS-9190, in Combination with Peginterferon Alfa 2a and Ribavirin, to 48 Weeks of Peginterferon Alfa 2a and Ribavirin for the Treatment of Genotype-1 Chronic Hepatitis C Virus infection.

  Treatement Group A (50 subjects) : PEG+RIBA+Placebo for 48 weeks followed by 24 weeks of follow up
  Treatement Group B (100subjects) : PEG+RIBA+GS-9190 for 48 weeks followed by 24 weeks of follow up
  Treatement Group C (50 subjects): PEG+RIBA+GS-9190 for 48 weeks followed by 24 weeks of follow up;however there is the possibility to stop all study drugs after 24 weeksif your HCV RNA levels are undetectable at Week 4 and remain undetectable through Week 24. If you stop all study drugs after 24 weeks of treatement you will be followed for 48 weeks off study drugs.

    Hope this will clear things up some......thanks again

[denden]

One more thing it's only for people that has not had any TX befor

[Pancho and Lefty]

Wow,

This is a no-brainer. At the very least you'll get 48 wks SOC tx. If I needed it and qualified, I'd definitely go for it..

I hope you keep posting to let us know how things go for you.

Max

[Hank's mom]

denden - sorry for hopping on board late - I wonder since you didn't mention it - at what point you can get helper drugs, such as something for depression, nausea, aches, etc. May be I missed this being mentioned, so just humor me, I'm getting younger.

As far as the original wonder drug you found - if it was such a wonder wouldn't we all know about it? I don't mean to be glib or rude in any way, but my Nurse Practitioner, who I think the world of, explained to me long ago, that if something like this existed, wouldn't we all be better off - we're not. It also makes me wonder that puter smart people like Pancho had trouble finding it.

I certainly wish you the best - among our ranks, every conceivable story, trip, other issues have been visited upon our membership - and together we have made the road a little less rocky.

Susie

[denden]

   Thanks Pancho and Lefty  for your help and advice


  Momxfive yes they will give me helper drugs to cope with the sides......it was the Dr. that told me of this trial.... I went to see what he could do for me cause I didn't think I was doing to good with the herbs that I been on for years.( altho I think they do help to a point) but I  been slowly getting worse and worse so I hope I havn't waited to late...

  I go wednesday to sign the paper work and set up appointement for biopsy  and more blood work if all good then i'm in and start TX