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R1626

I have just been given the word that at week 12 on the Roche RO4588161 (R1626) Trial my log drop is 1.9.  So close and yet so far.  I will now switch straight over to subsidised SOC for 48 weeks.  I am a little disappointed, however, from the outset it was pretty obvious with this 2b trail that I had drawn one of the short straws in terms of tx arms.  I believe I was receiving 90ug PegINF - 1000mg riba - 1000mg PI but not certaiin.  My chemistry and haematology remained rock solid throughout and currently my WBC, ANC, RBC Lymph, HGB are all comfortably within normal limits.  My viral loads throughout went like bl - 4,480,000, w1 495,000, w2 307,000, w3 465,000, w4 59,000, w6 200,000, w8 133,000, w12 59,000.  From the outset I was concerned with the 90ug PegINF dose that I believe I was on, however as you can see this to me is a riba issue.  I began tx at 74kg and therefore 1kg underweight to receive 1200mg riba and got 1000mg.  At about 4 weeks in I was 76kg and asked for the increase in riba but was advised that I had to stay on 1000 riba as per protocol (which I've been unable to reference).  Anyway next week it is back for baseline bloods and SOC begins, I will be really interested in these blood results because I know for sure that I will have had 3 weeks of 1200 riba and full dose Peg and it will be interesting to see how this has effected my VL. I will not know what tx arm I was in until trial is finihsed at 96 weeks.  So until then I'm not sure if I am a slow/non responder given my suspected dose.  I have no regrets and still believe that R1626 will advance the svr rates.  Some interesting travel stats for my 12 week adventure, 80 hours travel time, 6,000 kms travelled to reach clininc and back.  To my trial buddies here, I wish you every success with the rest of the trial - good luck, I will stay in touch.  Chat soon. Emi
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Avatar universal
I can see the merit of high-dosing the riba .. and I think that's happening.  Are you at 1400mg or will be, Emi?  

As for the interferon, considering it's unknown whether you're going from 90 to 180 or maintaining at 180 (although I think we all kinda think you've been getting 90), I'd be a little wary of doubling to 360 too soon from a potential 90mcg originally, just a thought, particularly when upping the riba also .. even though the goal is to get UND as soon as possible, you also don't want to have to dosage reduce right away because you hit it TOO hard.  Just be careful, Emi. I'm just a little peon here and all I'm saying is be smart.

You mentioned you're getting a baseline, Emi.  How often is your doc going to be testing you once you start into this next 48 week phase?

Trish
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Avatar universal
Hi Emi, great to hear how you are getting on.  This latest result will be crucial for you.  I'd say that if you are right about your previous dosage then 3 weeks of full SOC should whack your virus down to UND from your last reading of 59,000.  If that does not happen then all the alarm bells should be ringing, especially if your hgb is still at 12 or above.  It would then be time to talk to your doc about immediately high-dosing the riba and maybe double dosing the peg too.

Ofcourse you don't want to overdo it and crash out, but your doc will advise you.  In similar circumstances to yours I was advised to high-dose the riba but was scared to do it because I already had quite a bad rash.  

Well goodluck,
dointime    
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Avatar universal
Hi Emi, thanks for posting your results.  I was hoping for an UND for you at 12 weeks and I am sorry that did not happen.  It has been a bit of a ride all around, hasn't it...and certainly for you.  The early withdrawal of the trial drug has certainly made your 12 week decision an easier one, although I would guess you would have gone this route with those results regardless.  

I kinda wonder if you got the 90mcg / 500mg arm because of the sketchy up-and-down results of your viral load....maybe not quite enough of any of the trifecta  Certainly you dropped alot more than me the first week in and then it was the continuing fighting power of the drugs after that.  My own call is that I've had the 90mcg / 1000mg arm, based on a number of factors.  I guess all will be revealed someday.

My own bloods are pretty good for the most part, not entirely where I'd like them .. wouldn't mind the hgb getting out of the 10.* range and the lymphocytes were .5 last check .. wouldn't mind them moving higher either .. though I suspect they will  have moved up with the next blood test this week.  The hgb seems to want to stay there.  Still, it keeps me out of rescue drug and dosage reductions and you get adjusted to whatever is your "normal" don't you. From here on in, I should be able to settle in to a routine of ongoing monitoring and managing it all.

So now it's 48 more weeks of tx on SOC?  I hope no significant change in sides and a very significant change in outcome for you, Emi.  Take care and stay in touch.

Trish
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338734 tn?1377160168
Sounds like a tough break both for the narrow miss on the VL drop and the 1kg weight miss. Sorry to hear it  Wishing you all the  best for future.

Brent
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408795 tn?1324935675
That's a drag, I was keeping up pretty well on yours, Trish etc. on the R1626 trial updates.  Well hopefully things get better for you at some point, it's a real shame that they have to have the trials with the short end of the stick arms at all.  I'm hooked up at a clinical trial site for a telaprevir trial although they really been dragging their feet.  I now have an appt. to see my GI and I think more and more that I will take that route.  I know of one person personally and a number on this forum who have gotten very good tx from those trial sites and ended up with the trial drug, full SOC, UND early etc.  With that said, there have been a couple on this forum who also ended up with the bad arm.  When I think of myself being chosed on a random type situation, I tug away from the trial idea completley.  Actually I'm seeing my HepC doctor to have a ultra-whatever and some bloods just cause it's been since June 2005 since I had a biopsy and I want to stay on top of the numbers so to speak.  I still haven't eliminated the telaprevir trial altogether, I guess you can say it's in somelse's hands.  I will make my decision as I go.  take care of yourself mate and God Bless
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