Trial data

[Ekkiemom]

Hi all....Hope everyone is well!..........I have not been able to find much info on trials for GT1a stage 3-4 fibrosis compensated  Sov/Rib SVR %'s, also for interferon intolerable prior treated.  I've seen a lot of info on treatment naive, cirrhotic, etc.  Can anyone point me to a good website with realistic cure rates......
Be well community

[HectorSF]

There must be some misunderstanding...
Stage 3 fibrosis is bridging fibrosis.
Stage 4, cirrhosis, is beyond bridging fibrosis including collagen completely surrounding the entire expanding nodule.
Stage 3-4 is more advanced fibrosis which includes some cirrhosis
So I am not sure what you mean by "no bridging" when your biopsy result?

Liver fibrosis is the scarring process that is the liver’s response to injury. In the same way as skin and other organs heal wounds by depositing  collagen and other matrix matter so the liver repairs injury through creating  of new collagen. Over time this process can result in cirrhosis of the liver, in which the architectural organization of the functional units of the liver becomes so disrupted that blood flow through the liver and liver function become disrupted.

The main factor in staging fibrosis is the length in expansion of fibrotic areas between portal tracts.

Stage 0 no fibrosis
Stage 1 none or mild peri-portal fibrosis
Stage 2 peri-portal fibrosis with/without extension and portal-portal bridging
Stage 3 multiple portal-central bridges but no nodular formation
Stage 4 cirrhosis, with bands of surrounding tissue around the expanding nodule

Take care.
Hector

[Ekkiemom]

I must of misunderstood the dr. about the bridging. Ok I think I understand a lot more...as always good health to you!
Deb

[HectorSF]

Be well.

Hector

[mac790]

Hello, I am 1a, Stage 5. I have been participating in a clinical trial sponsored by Merck, Phase III. I would expect, with the SVR rates already collated and published for this single pill a day therapy (a direct acting antiviral, and new generation of protease inhibitor), to be fast tracked by the FDA and on the market by the end of next year. If you can hold off on treating, please wait. Merck is not the only big pharma mfr. to have drugs in either Phase II or III trials, all with phenomenal SVR rates. Due to screw ups at the lab Merck uses, I don't know my Week 4 or 6 viral load counts. I can tell you that in 7 days, it dropped from 585,000+ to 396. The published SVR rates, even with cirrhotic persons, is 97%+. No interferon, no ribavirin. One pill a day for 12 weeks. Some in my study got the 16 week treatment arm, but the studies I have quoted are all after just 84 pills. The future is looking extremely bright, if you can hang in there. My trial hospital just bought a brand new "FibroScan" machine, which gives 3D, extremely thorough investigative views the entire liver, not just selected cirrhotic regions of the liver. It is so accurate that it will probably replace needle biopsy as the" gold standard" very, very soon.There may still be some reasons for needle biopsies in the future, I'm not an MD, so I can't definitively state there will be no need for them at all. Please do not lose sleep over your Stage 4 Dx. If your hemoglobin and bilirubin are WNL, and you don't have esophogeal varices, your liver is still doing its' job well. These Stage 3/4... Dxs are very subjective, and can vary significantly between hepatologists. Just realize it is present in some stage or other, and don't do anything to aggravate it. I would love to see you get into a clinical trial of these drugs such as I mentioned. I think the trials may be done on Gilead's next drug, however. Please refer to www.clinicaltrials.gov to see if there is a Phase III trial recruiting near you. If you go to www. healio.com,click through to the GI section, and search for "EASL 2014" or "C-Worthy", you can see for yourself the outstanding, almost unblievable results these new generation meds are having. Regardless if you are a previous null responder to other therapies, or cirrhotic. I failed miserably the "Pegasys" combo therapy in 2009.  Any questions, please feel free to drop me a line or post it. I will finally discover my viral load on 10-3. If that lab Merck insists upon using ( this trial is being run at a world class institution, right up there with Mass General and Johns Hopkins) screws up a third viral load in a row, my Hepatologist's head ( who is running the trial) will explode. Along with mine. Hang in there, the technology is literally improving daily. mac790
P.S. The only downside to these new meds is the cost. The estimated asking price for this drug I am using will be $85,000 for a 12 week course of therapy. We can only hope that the arrival of other, just as good or better meds on the market, plus the pressure from insurance companies and Medicare, will lower the cost of these miracle drugs. Best of luck to you.

[bluemetal]

As Mike716 revealed in his post, and Im in full agreement as a gt1a cirrhotic patient who just ended treatment on Sovaldi/olysio before finishing, its in your best interest to wait a little longer for the sovaldi/ledisprvir combo in Nov-Dec.  To begin with REAL world results on all treatments are not even close to the results being recorded and published by clinic trial people whos primary interest is to market these drugs. Its for this reason that anyone following these "clinical trial " results as a guideline in determining their best course of tx aremisleading themselves. Im only stating an educated  opinion basedon experiance as well. And Im suggesting the Sovaldi/Ledisprvir tx not because of clinical trial data but rather because its really theONLY safe option left for those ofus in this catagory (gt1a F-4). I remain certain that this new Gilead tx will also have liver-brutalizing effects in destroying the virus. And if the Sovaldi/Ledisprvir combo is not added to the third DAA for a tx period of 24 weeks instead of 12 than chances of  permanant SVR are even less for gt1a's.

[hrsepwrguy]

"Gilead tx will also have liver-brutalizing effects in destroying the virus. And if the Sovaldi/Ledisprvir combo is not added to the third DAA for a tx period of 24 weeks instead of 12 than chances of  permanant SVR are even less for gt1a's."

Could you please post some peer reviewed data to support your claim, would love to read it.

Have a great day