Gilead study GS-US-248-0131 - phase 2 all oral

[OC]

I was screened today for the Gilead Protocol Number: GS-US-248-0131, Clinical Trials Identifier: NCT01435226

http://www.clinicaltrials.gov/ct2/show/NCT01435226?term=gilead&state1=NA%3AUS%3ACA&rank=13

“A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study of GS-5885, GS-9451, Tegobuvir and Ribavirin (RBV) Compared with GS-5885, GS-9451 with Tegobuvir or RBV in Treatment-
Experienced Subjects with Chronic Genotype 1a or 1b Hepatitis C Virus (HCV) Infection”

This study also has a sub study (rescue therapy) that involves:

If the study doctor determines that you are not responding to the study drugs, you will be offered additional medications to treat HCV. If you decide to participate and receive the rescue therapy, you will receive GS-5885, GS-9451, PEG and RBV for up to 24 weeks, followed by up to 24 weeks with just PEG and RBV depending on your response to study drugs.

I will know shortly if I will be participating in this study.

What are your thoughts on this trial since this is a randomized, double blind, placebo-controlled study?

peace

[OC]

with all of the clinical trials, is it best to let your hepatologist recommend what they think is the best one?

[researchmonkey326]

Good luck!  I just finsihed a Gilead trial with good results (hopefully SVR) and my clinic is starting the trial that you are talking about.  I can tell you that I received very good care throughout and the trial protocol involved excellent monitoring and frequent bloodwork.  I hope it works for you.

[OC]

I will talk to the study doctor before actually starting the trial.

With so many clinical trials, it's not easy to try and figure out which one is the best for you.

peace

[OC]

Good luck with SVR...that would be amazing!!!

peace

[OC]

i go back on thursday 10-27-11, if all goes well, i should be given the meds then, to start shortly thereafter.

[curiouslady1]

Whoa.  Awesome.  Did they pass your screening guy?  This was the toughest part for me waiting to see if they would have me.  The trial passed my screening before I passed theirs.  I thought Mary4now also did Gilead and got great results.  You go get em.  Let us know when you start.  

[nowhine]

Please keep us posted on your treatment. The thought of meds that will cure with, at least, no interf. are encouraging for many of us on this board. You did not give us some information ie g-type, liver biopsy stage, first timer, etc. Your doc. will know what's best for you. I would not rush into treatment if you can wait as there are many new trials going on. I have just started the Gilead trail with the option meds you described in your post. Good luck and please keep us posted.

[OC]

thanks, this will be my second try, will update this thread.

contracted in 77' or 78'
genotype 1a, CT, grade 2-3, stage 2-3
2002-2003 null responder (SOC)

peace

[OC]

started today 10-27-11, rock and roll the place!!!

peace

[OC]

first couple of days headache at night and that's it, but i have continuous mild nausea...i think i'm getting the ribavirin and not placebo because my temper is certainly shorter.

this is nothing compared to the SOC, that i did in 2002-2003. i haven't taken anything for the side effects yet.

i go back this thursday, that will be one week.

peace

[OC]

after 7 days, my viral load went from 11,100,000 to 290, i'm responding and that is great news...i had my 14 day blood test today and have to wait one week for the results and i need to be undetected or i'm out of the study...

1) if not undetected, then i have the choice of doing the sub study which is GS-5885 (ns5a inhibitor), GS-9451 (ns3 protease inhibitor), & SOC

2) i did the SOC for 46 weeks (null responder) in 2002/2003 and it wasn't fun at all...my concern is whether i will have built up a resistance in the 3 weeks on this study (even though the first threshold is at 2 weeks)...and should continue with the 2 DAA's and SOC or wait for another interferon free trial...

peace

[nowhine]

Hi. As I posted earlier I am doing the same meds but with the interf/riba. I got my week 1 results today as well, 336 from baseline of 17,000,000. There are 4 other victims at my doc office and 2 are und. at week 2, and the other 2 are still waiting for week 2 results. It looks like a strict protocol with und. at week 2 for your traiI. We are all null responders. I asked the question today about resistance and my doc said they stop tx if you don't get results and no worry about resistance. The biggest predictor is RVR and you have that. So you are still in the game (I know it's no game). Your doc will know whats best. If offered the interf/riba I think you will find it not as bad as you know what to expect. That is my experience although I just did shot #3 tonight. Best of luck and I pray you get und. results. You will get SVR stay the course.

[OC]

thank you so much, i really appreciate the kind words and prayers...i expect the same for you and will pray for you to stay SVR...

peace

[OC]

UPDATE:

after 14 days my viral load went from 11,100,000 to 290 (first week), then from 290 to 65 (second week), so i can't continue with the study because i'm not undetected.

i jumped on the sub study which is the 2 DAA's (GS-5885 - NS5A inhibitor) and (GS-9451 - NS3 protease inhibitor) with SOC (interferon and ribavirin), took the first shot today.

need to be undetected by week 4 of sub study.

peace

[Susan_1a_CC]

Best of luck on the sub study.  Nice that there was another avenue for those in your situation to take.  Keeping my fingers crossed for you hitting SVR.

[sandysf]

Glad to hear they offered you sub study.  Are you guaranteed all four drugs?  If so, that is amazing.  

[nowhine]

OC good luck with the additional meds. As I mentioned I am in this study. I got my week 2 results yesterday 166 IU/ml from baseline of 17million. I started week 4 yesterday and thus did shot #4 last night. My doc office is getting 100% und. so far at week 4 for all participants. We are all null responders. Although I am not und. yet I am getting good results thus far and my doc seems confident I will succeed. I am cautiously optimistic to say the least until I get that UND. I am in the wait and see mode.

Check out this BMS study involving the same meds we are on. 100% SVR.
I know its another pharma co. but my doc says its the same stuff.
http://www.natap.org/2011/EASL/EASL_28.htm

Good luck my prayers are with you.

[OC]

thanks, i appreciate it!

peace

[OC]

yes, i'm guaranteed all 4 drigs.

peace

[OC]

keep it going your almost there!!!

peace

[OC]

i don't have week 3 blood test results yet, after 2 weeks, i have some changes in blood besides viral load.

ALT - 74 to 27
AST - 61 to 28
HGB - 14.7 to 12.3
HCT - 42 to 36
RBC - 4.8 to 4.0
Platelets - 105 114
total bilirubin - .4 to 1.4

not sure what the significance of these changes are.

peace

[belle19]

i am in a gilead right now.  i was UND at 8 weeks and now it's the 22nd week and i'm still UND.  i find out 12/9 which study group i'm in and if i can stop.  i am on peg, riba and gs-9451 (possibly a placebo).  good luck to you.  belle

[belle19]

meant gilead study.

[OC]

that's great!!!...sounds like you're going to make it...

peace