GSI-7985 Trial 2nd week UND

Question

Like others reporting in on this trial of combo Sofosbivir/GS-5885 my 2nd week labs are undetectable VL. Back in 2006-2007 I was in Vertex Prove1 trial but I got placebo instead of the telapivir. So for 48 Weeks on Vertex's dime I got SOC. I had so many side effects I was seeing an audiologist and dermatologist besides the trail doctor. Vertex offer roll over with the telapivir but DR's would not let me do it. Said they were afraid the interferon would make me deaf. My 3rd shot my ears started screaming. I had to wear ear plugs to go out because loud sounds were painful. I relapsed and have been doing HR liver lovers supplements the past 5 years waiting for non-interferon trial. I listed my self at two clinical labs in San Francisco and it turned out both called me for this non interferon study. Anyone waiting for treatment should be actively on anti-fibrotic regiment if possible. My biopsy in 1999 was stage 0., then in 2005 Stage 2. That's when I was offered the Vertex study starting in 2006. My 2008 biopsy was stage 2 grade 1. I had to have biopsy for this new study and it came back stage 2 grade 2. So in 5 years I was able to keep progression of fibrosis down to only 1 grade higher but same stage. I credit HR supplements.Now that we know about IL28B I'm CT, interferon combo TX odds are less and even less for TT. For those of you waiting for these new NS5A and NS5B hibitors because interferon is your enemy my advice is keep to an anti-fibrotic regiment and wait. For those with more advance cirrhotic stage find a trial, even if you have to commute to major city. Praying for a cure for everyone.

BoceprevirGal · Accepted Answer

Congrats on your 2 week Undie result!  I am worried about my friends/family participating in the clinical research trials, because I am afraid they may build up a resistancy to the new meds, if say, a genotype 1 was given the sofosbuvir, but not the riba, and not clear. Then,. later on, when the sofosbuvir is approved, they may have built up a tolerance, ya know?
    Was your clinical trial a "blind" one, or did you know exactly what they were giving you? I am in the S.F. area as well~

rk2761 · Answer

Thanks for looking up that profile. I wonder why he or she stopped posting. 

It will take a lot of reading to get up to date on this!

Good luck with your treatment.

rk

purplecat · Answer

http://www.medhelp.org/doctor_profiles/show/165565
Found HR's profile for you

purplecat · Answer

http://www.medhelp.org/user_journals/show/4497/HRs-Liver-Lover-Supplement-List-

HepatitisReseacher used to post until about 2010.  I know a few went to his lab in southern california for fibroscan.  SFbaygirl was one of them.  you can read up on his threads by scanning HepatitisReseacher find his profile and click post and read on.  I buy most of my supplements from Lef.org.  you can google discounted membership lifeextension and get membership discount coupon to only pay 49.00 per year for discount purchasing throughout the year.  This list is old so smartbomb I think is no longer in biz. Also later posts for HR talked about using R-lipoic acid instead of Alpha lipoic acid better and Super ubiquinol CoQ10 an reg CoQ10  HR talks about diet and leaky gut syndrome and important use of probiotics..  Right now while on treatment for trial I'm allowed to take Vit D, salmon oil, flaxseed oil, CoQ10 and R-lopioc acid.  Gilead doesn't want me to take the others because of unknown effect on the 7985 drug.  All I know is my stages jumped when I did nothing and did not jump and stayed steady for the 5 years after failed treatment.

rk2761 · Answer

What are HR liver lovers supplements and where can I learn more about an anti fibrotic regime 

Thanks

purplecat · Answer

it was unblinded and at the last minute they changed all the 12 week just 7985 and no Riba to 24weeks unless they get the data on naive trial that 12 weeks was successful without the ribavirin compared to the 24 weeks no Riba before I reach 12 weeks. I got the 12 week with no riba so my clinical nurse said I will probably go 24weeks unless Gilead has results with near full clearence. She doesn't think the results will be in by the time I reach 12 weeks. Once I go over 12 weeks they will not pull me off 24weeks regime.  Starting at almost 20 million to UND in 2 weeks is pretty impressive. I think Renee explained this 12week to 24week change in her post better.  Anyway 12week 24 week, I don't care, just want SVR.  Maybe I can have a glass of wine before I die!  The non-alcholic wines are terrible!

HappyByChoice · Answer

I just want to extend my gratitude to all who participate in these trials and studies... thank you for your willingness to pave the way for others!!

Great to hear of your UND!!!

rivll · Answer

Bocepgal:
http://www.medscape.com/viewarticle/777475_5

In general, the nucleoside/nucleotide analogs have a high barrier to resistance[35] and are very potent. In the ELECTRON study of sofosbuvir, no differential was observed between genotypes 1a and 1b, and no resistance was seen despite 89% of subjects being the unfavorable genotype 1a population in the study.[20]

Purplecat: I am very happy you got into that study. I was in the 7977/Riba study and it appears to have been successful.

rivll · Answer

I asked my trial Dr. about resistance factors and he said for these type of drugs (sofosbuvir) resistance is not a concern. I didn't ask for an explanation because he was already out of the door. Now that you brought it up, I will see if I can find some info. on that question.

GSI-7985 Trial 2nd week UND

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