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.

[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