Starting Sofosbuvir GS 5885

[Renee543]

Hi, I tried Teleprevir last year and failed. The Institute called me last week to see if I wanted to be in this new study for Sofosbuvir GS 5885. I have not been able to get much info on the net except from the Drug Co.
They have one slot open and I need to be there tomorrow for my bloodwork and EKG. Is there anyone on Med Help that is in this trial or anyone with any info that would help me make this decision. I was so dis-hearted when I could not stay in the Teleprevir study. It is Phase 3, either 12 or 24 weeks and either with or w/o Riba.  It starts next week. Thanks for any info. Reen

[matt2200]

you said " I sometimes think they seem to think we cannot understand or figure out things, so they give us over simplified answers to very complex questions."

i see this from time to time in my work and my own interactions with my doctors...some doctors want to keep it simple, thinking they are going over most lay peoples heads, using the terms found in their medical books.

for example, i recently saw an orthopedic surgeon who has helped me with my right shoulder, injured in a skydiving incident and 2 motorcycle accidents.

he would point to the bone on the X-ray and just call it a bone or "this area here"..through my work, i knew he was pointing at the acromion, glenoid and supraspinatus tendon and the groove it rides in on the humerus...when i used hose terms, he smiles and then continued to use the medical terms they learn in school because he saw that i understood what he was talking about.

i see a lot of doctors (again, through my work, i am exposed to surgeons and specialists of all kinds) and i think they are actually taught in school to keep it simple for us lay people

[matt2200]

when i discussed the blind results of the EOT week 12  (is that right? we are not told the results of EOT12, we either are set up with our EOT24 visit or receive the SUX-2-B-U letter?)

the trail nurse and i speculated it may have something to do with the psychology that is behind the "placebo effect"...(those treated with a placebo sometime recover simply because they feel they are receiving treatment)..

they may not want people knowing at different stages of the study for some reason or another, as it may affect the results?

sounds far fetched, i know.... pure speculation but it is odd that they do not tell us.

[Renee543]

I kind of agree with you from my experiences with two trials now. I sometimes think they seem to think we cannot understand or figure out things, so they give us over simplified answers to very complex questions. Maybe it's because they themselves do not know. I know I have been told a couple of bogus answers. One taking iron supplements help with the drop in hemglobin. Not true. Two because I started with a high enzymes, I should not expect them to be low after txt. Not true.
In searching to find correlations between ALT/AST and VL, you are right even the studies are contradictory.
I think we are just part of the means to the end. Maybe we will get lucky. I hope so.

[Renee543]

Will, I found that study interesting. I have been reading about the correlations between ALT, AST, RNA and PCR. There seems to be no direct correlations. What lead me on this search is the fact (as I have already posted several times) that at the end of EOT +4 I am UND but my ALT/AST are still in the 40's. My trial nurse's explanation does not satisfy me. But it is hard to find any info about the correlation between liver enzymes and VL. Your study said lab findings cannot take the place of histopathlogical exam (biopsy). And I have read that a biopsy should be done before and after txt. This seems to be the predictive indicator of liver injury.
AST/ALT used to detect liver injury and help determine which form of liver disease and of course used to monitor txt.
From what I have read there seems to be a drop in enzymes at the end of triple therapy, but does not indicate a correlation with VL.
But this is what they use to indicate if we are still UND at EOT 4 until EOT =12, since we don't have privy to our PCR.
I don't understand this.
Here's an intersting short study:

http://www.ncbi.nlm.nih.gov/pubmed/23097965

[gsx1250fa]

Thanks. I was on the 12 week arm of Sofosvuvir/ledipasvir/Riba. I am Geno 1A and I had 3 prior Tx attempts/failures (with interferon) over the last 4 years. I am  cirrhotic stage 5 of 6 ishak scale....so this last Tx was crucial. Hopefully my liver will heal over time to the best of it's ability. I do not post to "claim personal victory"...but to give hope to the rest who are struggling through treatment with and without failures. If these new meds can work for me (a hard case no doubt)...I believe they can work for all. Hopefully Ledipasvir will get on the fast track for FDA approval. In combo with the Sofosbuvir it seems to be the "wonder drug combo" for 1A's. Hopes and prayers for us all :)

[gerard11]

Congrats on your wonderful news!!!!!!! Each and every victory is a tremendous victory for all who are in treatment for this disease. This is a wonderful, life changing day!!!!!
Thank you for updates, and once again congratulations on SVR!!!!