Gilead Trial

[MFK53]

About to start trial with GS-5885, GS-9451 and tegobuvir and RBV or the first two and a combination of either tegobuvir and a placebo of RBV or the opposite. No interferon....Would appreciate any thoughts from others that have been on this trial as to their experiences and any helpful suggestions....Thanks in advance.

[MFK53]

why are you so against this one?

[UKgirl55]

I screened for this trial and backed out. I'm screening for another one soon...There will be no problem screening for another trial. Don't do this one!

[OC]

treatment experienced with SOC and my VL never went under 70K.

started the all oral trial, VL 11,100,000, 2 weeks down to 290, third week 3770...

taken off the oral trial and put on rescue therapy, 2 DAA's & SOC, VL from 3770 to 33 in 8 weeks, just took my 10 week blood test today.

peace

[adamben101]

I think if it was me I would want to try everything I could get my hands on.  That means look for a study with PEG and RIBA and whatever other orals you could add in there, preferably a few.  If you can get into the 7977 great.  If not, there are others.  Hope this helps.  I don't want anyone to feel the anxiety and fear I did after relapsing from 4 meds and thinking I would be resistant for the next 5-10 years at least, and maybe forever.

[adamben101]

Whoa!  Hang on a sec!  You already treated?  I missed that part.  In that case, I absolutely disagree with an all-oral trial.  As far as I know, and I'm not a doctor, this is a HUGE NO NO!  I think it's generally accepted that if anyone has gone through treatment once with PEG and failed, any following treatment MUST include PEG.  I really want you to get some more posts on this subject before you have to make a decision.  I recommend starting a new thread specifically on that topic...treating a second time all oral when the first treatment with PEG failed.

[MFK53]

Wow, that is a lot to digest and just as I about to start the trial. Everybody has individual medical backgrounds and because of mine this is the first trial that I qualified for. If I back off not sure how that would affect my getting into future trials. I will bring up your concerns with my doctor and very much appreciate your response. Having been on interferon once and getting a zero response but all the unpleasant side effects my doctor is very hesitant to put me on that again but I will address it. Thanks and best of luck to you....

[adamben101]

I'm on this trial.  Like others, I started out on RIBA, 9451, 5885, and 9190.  UND in first week and relapsed after 2 months.  I'm now on rescue week 17 including PEG and minus 9190.  I'm UND again thankfully.  I cannot recommend this trial you mention.  It's slightly different than the one I entered in that you are taking a chance of NOT having RIBA.  A lot of us had the RIBA and it failed so why would you take the chance without it?  I would never have gone into my trial if it didn't have 4 HepC killers without the PEG.  Looking back on experience and what's going on in the market now, I would recommend strongly you hold off from this trial and wait for one with the Pharmasset (now Gilead) 7977 and RIBA.  And even moreso, I would recommend looking for one that uses the new drugs with PEG.  Yes, WITH PEG.  The timeframes are shorter typically, like 12-24 weeks.  Trust me, it sounds long but personally I'm now looking at 56 weeks of treatment bc I took the same chance, and it was a better chance than what you're looking to get into.  When my doc told me about the relapse, it scared me so bad all I could think about was being resistant to the oral drugs and treatment.  You do not want to be in that position.  I would gladly trade off and take a trial with PEG, RIBA, and some new trial meds.  I think it's your best chance.  Sorry, don't mean to scare you but I don't wantto see you get into the position I was in.  Good luck!

[MFK53]

Thanks. That is very helpful. I've got a very positive attitude so I am going into this with open eyes but confident. These trials cost Gilead alot of money and they have a vested interest in having each patient succeed so I believe that those that are screened and enter the trials have a good chance of knocking this thing out. They are not going to put anyone in any trial unless they and the doctor's believe they will succeed. There is too much money at stake.

[OC]

RVR (Rapid virological response)= No virus detected at week 4.
eRVR(Extended rapid virological response) = No virus detected at week 4 and week 12.
EVR (Early Virological Response) = 2 log drop of HCV RNA after 12 weeks.
cEVR = Complete Early Virological Response — No virus detected after 12 Weeks.
SVR12 (Sustained virological response)12 = No virus detected at 12 weeks after completion of treatment.
SVR24 = No virus detected at 24 weeks after completion of treatment

Null response - Failure to reduce HCV RNA by at least 2 logs10 (100 times) after 12 weeks of prior treatment, which is the currently recommended Food and Drug Administration (FDA) definition for clinical trials of investigational hepatitis C treatments.

Partial response - At least a 2-log10 (100-times) drop in HCV RNA, but inability to fully remove the virus from the blood by week 24.

Breakthrough - After dropping to undetectable levels, HCV RNA is detected again in blood during treatment.

Relapse - After dropping to undetectable levels, HCV RNA is detected again in blood after treatment ends.

[MFK53]

Read your thread which is very interesting and helpful. I start the trial on Friday morning and the subject of "rescue" programs have never been brought up or the introduction interferon. I did look up and see that I am on GS-US-248-0132. I hate to ask a dumb question but I'm assuming UND means undetected but what is SVR? Thanks

[OC]

I'm on that trial, but the all oral failed, now I'm on the rescue trial.

Since Gilead bought Pharmasset, for their PSI-7977, that maybe the one to get on

I'm genotype 1A, CT
grade 2-3, stage 2-3
failed SOC in 2002/2003

Here is a link to my thread, http://www.medhelp.org/posts/Hepatitis-C/Gilead-study-GS-US-248-0131---phase-2-all-oral/show/1610899?personal_page_id=82286

good luck!

peace

[MFK53]

sorry to hear, thanks for good wishes and advice

[MFK53]

stage 2-3, done two weeks ago, don't have anything more specific

[jsf52]

Hi, If this is the all oral trial then there are others who have participated on this site.  You can get the trial number from the informed consent and maybe send out a message to see who is in the same trial. I was in a trial with IFN, RBV, GS9451 and GS5885.  Had to drop after 12 weeks due to viral load going back up as a result of resistance.  This was my second attempt at tx - was a non responder the first time.  Good luck and hope that you get UND and SVR.

[1oftheclub222]

have you had a biopsy lately?  What is your liver at?

[MFK53]

Genotype 1A. Was treated with Interferon and RBV in 2003 which was unsuccessful and stopped after three months. DK Trial ID#. Sorry.

[nowhine]

Perhaps you could offer some more information. gt 1a or b. Have you treated before and the outcome. Also what is the trail ID#. Best of luck.