7985 Gilead trail stopping at 12 weeks no riba ION-2

[purplecat]

I was first in the ARM for 12 weeks of Sofosbuvir/5885 NO Riba.  When I started treatment I was told that Gilead modified the study to be 12 weeks with Riba and 24 weeks with and without Riba.  My group was rescheduled for 24 weeks unless response from the 12 week from ION-1 came back over 75% before my 12th week ends.  Well I just got the call my last pill is Wednesday 24April the end of my 12th. I am being put back into 12 week no riba arm.  This means that 75% or greater without riba cleared virus in 12 weeks from ION-1.  I don't know if I should be happy or am disappointed.  I was hoping results weren't back by next week and I would stay for the duration. This drug only has a little GI problem and sometimes headache, that's it.  I know stay positive, I have 75% chance, I was UND the second week when viral load started at over 19 million.  I'm stage 2 not cirrhotic, etc, etc, I have a 75% chance. Good Luck and my god bless everyone no matter what treatment you are doing or going to start.

[rivll]

This is very exciting.
I understand your apprehension but they do have a rollover plan for those who relapse don't they?
My understanding is that with sofosbuvir  resistance is not an issue...

[purplecat]

No rollover plan and I asked in the very beginning. It is exciting that 1 pill for 12 weeks can do so much with little side effects. The percentage can actually be higher.  I was not told actual percentage, just that the 75% protocol was met so they have decided to bring back the 12 week arm originally planned in ION-2. Could the percentage be actually higher?  Wouldn't that be fantastic! We shall all know soon.  

[rivll]

Very exciting. Thanks for posting.

[hepcat1954]

I'm on the same arm and have the same apprehension as you.  I go to clinic this a.m. and will ask the nurse for more info...

[purplecat]

You originally were the 12 week no riba group.  The ION-2 clinical trials link has not been updated yet.  It still shows the three 24 week ARM's and the one 12 week with Riba.  No press release with the change or anything yet.  But those of us from ION-2 that pulled the 12 week and then told it probably will be 24 and had to sign another consent form with this change, will be moved back to 12 weeks only.  

The Vertex telaprevir trial I pulled the SOC straw and when CPMC SF mixed me up with another participant who got the Vertex but virus went wild, I couldn't get CPMC to straighten this out with Vertex and get me into the rollover after I relapsed.

I'm praying 12 weeks is enough, wanted to be able to stay in the 24 weeks but that is not meant to be.  12 weeks might be all we need.  I hope so, good luck.  

[hepcat1954]

The next study Gilead is doing at my clinic is 7977 + 5885 for 8 or 12 weeks +/- Riba.  I think they must have pretty good data for the 12 week arm with no Riba to test 8 weeks.  I have to believe that we're going to be OK.

Good luck to you!

[purplecat]

*This is what they told you at your trial center today?    Thank you for this good news, I've been a little worried after my phone call from my NP yesterday.  Best Wishes

[hepcat1954]

yes, my nurse said they're approved to study 30 people in the new trial.

[hepcat1954]

P.S. the paper said >= 75%.  It's the minimum they're required to show the FDA to continue.  She believes the numbers are higher but they've decide to announce the minimum.  The EASL conference this month may have the exact data.

[purplecat]

I just got back from the clinic.  It's seems the results they were waiting for were actually from the LONESTAR trial.  This 12week ARM without Rib is from previously treated people that did not respond or relapsed.  It was not the ION-1 naive. Now it makes more sense.  I totally misunderstood over the phone what the NP was telling me.  So results from Lonestar were at least 75% or better in just the 12 week no riba, this is why they dropped my group back to the original 12 week. I was not familiar with Lonestar so my NP said she would send me more data by email.  I just looked it up on the internet and got this info as follows: "LONESTAR is a study to evaluate a once daily fixed-dose combination tablet containing sofosbuvir and GS-5885 with and without RBV among a range of genotype 1 HCV patient populations There are 8 and 12 week arms.. This study, which will enroll 100 patients, is the first trial to evaluate the combination of sofosbuvir and GS-5885 for only eight weeks of treatment".  Any one know about LONESTAR Trial?
All this info will probably be coming out from Amsterdam  during the EASL/International Liver Conference 24April-28April 2013.  

[hepcat1954]

Lonestar is only at the Alamo Research Center in San Antonio.  It had 2 arms: 8 weeks and 12 weeks.

Here it is:

http://clinicaltrials.gov/ct2/show/NCT01726517?term=gilead+hcv+5885&recr=Open&no_unk=Y&type=Intr&rank=2

[purplecat]

This must be the 8 and 12 week you were talking about.  Anyway this is the protocol results that they used to put us back to 12 weeks on our ION-2 trial. Only 100 total in this trial with 5 ARMS, this about 20 only were probably in the 12 week no riba previously treated with PI ARM.

I feel like I've been on a bucking horse(12wk, 24wk,12wk) but hoping to hold on for good outcome.  Thanks and Good Luck.  

[hepcat1954]

No, the Lonestar trial is what caused them to maintain the 12 week no riba arm in the ION-2.

There will be a new trial for an 8 to 12 week 7977+5885 coming up.  It will be nationwide.

[Geshmit]

Here in the UK we're doing the ION-1 trial for the first time - I'm starting Tuesday - four arms with and without Riba. I'm worried about side effects cos I've got to work - sole breadwinner. Can anyone allay my fears? I'm geno 1b, non-cirrhotic, treatment naive, 30 years Hep C.
thanks for any info

[hepcat1954]

The new trial is the ION-3; 8 to 12 weeks, w & w/o riba.

[purplecat]

I only took the 7985 no riba.  In the beginning I had GI problems and headache.  Gas, bloating and stomach pains with nausea and sometimes woke up with headache.  You can read my journal.  My bookeeper at work has colitis.  She said theseGI symptons is similar to what she gets with colitis.  She suggested I go on colitis type diet.  I did this and bingo, all systems went away and I sailed through the last 6 weeks with no sides.My NP said another female subject was having similar sides and went on non dairy diet and also sides went away.I believe at my clinic 2 of use had the more severe GI out of 9 and diet change worked.
All symptoms posted on the contract are for those who get Riba ARM. Ribavirin sides are known, but since there is no interferon, I haven't heard of anyone that had to lower dose or discontinue, or not be able to work. I know of one person who was on 24 week with no riba and had to discontinue at week 13 due to extreme nausea.  I don't think this person adjusted diet to compensate.  It's interesting how the current "Vic" and Inc" PI's need fat and meal.  I took my pill early on empty stomach and went a couple of hours before I ate.  I'm sure this info is being gathered from these trials,
This was a breeze compared to SOC.  You'll will be able to work and be just fine.  Let us know what ARM you get, with or without the Riba.  Good luck and best wishes.  

[rivll]

I am so glad you are posting about your trials. This is really important information and you are breaking ground for the multitudes that will be following you with these news drugs.
I feel very hopeful for the HCV community.

[Geshmit]

Thanks Hepcat. Well I started on Tuesday - 12 weeks with Riba. First day a bit rubbish - black cloud etc; then ok for a couple of days but today I had extreme nausea and GI stuff - a bit shivery and flu-ish in the evening too. I usually keep a healthy diet, with not much dairy, but find when I eat carbs like pasta, bread and rice, it's easier. Now I'm not so sure so any help on diet  would be great. Also is there any way with diet to make sure my hemoglobin doesn't go right down?

Taking 1000g riba - three in the morning and two in the evening with the FDC drug.

I'd appreciate diet tips cos my usual diet (which is healthy) makes me feel very sick. Today was tough but then again it's only day 4.

thank you and best to all

[rivll]

I am not sure about diet. I found less dairy and bread to help a bit.
What did help me was ginger. I ate a lot of ginger daily.

I am sure hep and purple cats ill come along with some good diet advice.

Good luck!

[Geshmit]

Yes, I also eat ginger but yesterday it didn't help. It was a bit like having extreme morning sickness all day.Let's see what the day brings. Just going to take my morning dose now, so gonna try with quinoa cooked with fruit and ginger.

Tips welcome.
thanks all

[purplecat]

As I posted to you earlier, I tried non dairy, low fact with no bread at first.  Then I added back some bread after two weeks and did OK.  It was a guessing game really.  Consider using a food diary that you keep every day.Write down all "suspect" foods and beverages that seem to aggravate your condition that day.  Then eliminate them the next day and see how you feel.  Mine was cheese! Then raw vegetables.  I switch to cooked and then sailed through. Also I took 7985 on empty stomach and didn't eat for a couple of hours.   If I did the pill with food I would get gas., so I waited to eat.

As I posted above, it was my bookeeper who suffers from colitis that suggested this stradegy.  It worked for me. hope it works for you.    

[Willy50]

I've been on this for 3.5 weeks. I'm on the riba arm. So far for me no discernible gastro events.

My hemoglobing IS dropping but no food issues I can tell.

[nobodyone]

How long will you be on this?  I am on the Gilead with RBV  Friday it will be 4 weeks, supposed to do 24 weeks.

[Geshmit]

Hi all

Well it's been 4 weeks; ups and downs with sides.
I am a  bit disappointed as I expected to be UND in week 2, but VL was down to 27. I was 43 the first week down from 5 million and I don't feel as if it's going down fast enough. I'm genotype 1b and doing the 12 week arm of 7985 w riba.

Thanks for your diet tips, purplecat. I'm taking the 7985 with food so I'll try it without to see if it helps gas. Digestive issues better but not perfect - still, it's doable. Had a few bouts of breathlessness, but haemoglobin is ok still.

I'm just concerned that my VL is not moving quickly enough and I only have 12 weeks...

hope you're all doing well