I'm OK (Explanation of mood)

[annieCinMD]

I thought I'd explain my mood update. I am on a study for SCH 900518 with Ritonavir. I crossed over at week 16 from straight SOC. My week 16 result, the new baseline for the study drug was 14,000 and week 12 was 25,000. I just don't think I am responding well to SOC. I had a huge drop at week at week 2 (2.2 million to 97,000), then it went back up to 324,000 at week 4. It has been trending downwards, but appears to be slowing down. I am actually hopeful for the PI. This one is a second generation from Teleprevir and Boceprevir, so I think the hope is it is even better than the other 2. I am hoping to see UND at my next visit on the 16th. The good news is I think I will either have good news meanwhile or go off at 28 weeks at most total. I am actually pretty hopeful for the PI to do it's magic.

[annieCinMD]

I totally agree with you! If I have to treat again, it won't happen for a long time, unless of course, I get sick and have to. I think if crossing over was not offered, I'd have considered stopping. I can endure another 12 weeks (only 10 now).  I was very sorry to hear of your relapse. It is folks like you that may get the biggest gains from these new drugs. Of course, shorter TX duration is a nice plus for anyone! Yes, the trials are a bit picky about who gets admitted. This one wants treatment naive, genotype 1 with no evidence of bridging or fibrosis, age 18-55, so on and so forth. Basically, I think they want the participants to be somewhat healthy to begin with. Best wishes to you as well,  Anne

[IAmTheWalrus]

Crossing over now is WAY better than finishing and then trying again! I certainly would have done that but I was told that these trials did not accept TP patients.

Like Rocker, I am very optimistic about the results shown on the new PI drugs. I had read that they both Vertex and Schering-Plough were working on 2nd and even 3rd generations of the current PI drugs Telaprevir and Bocepravir.

My best wishes to you!
Brent

[annieCinMD]

No 518 trial in Canada as far as I can tell from Google. There are 20 locations in the US, if memory serves me (It doesn't always serve me too well here lately).

[lapis]

Yes, glad to hear what's going on with you, I was a little concerned when I read your mood.  It will be exciting to hear how you do with the PI added.  Thanks for keeping us posted.

Lapis

[Rockerforlife]

Do you know if the 518 trial is coming to canada?...i know someone wants in   im seeing my nurse tommorrow and i will ask her...i look forward to seeing my nurse...i like her alot...she looks like Mary Hartman from that ET show...to me anyway...and she s so caring...without over doing it...very professional

[annieCinMD]

Thanks, hon!  And Happy (early) Birthday!

[annieCinMD]

This study is not a blinded one. Once I got in the first arm, the SOC one, I knew I was getting the real thing. I was given the option to cross over, which I took. I know I'm getting the study drugs, and not placebos. I don't think there would be much point in giving an option to cross over and giving sugar pills. I know you got UND real early on with the Boceprevir. That's why I feel optimistic that I will be, too, after 2 weeks of the SCH 900518.

[Rain6866]

We will get our UND back together!!! I know we will because its my birthday wish on the the 21st.

What more could a girl want on her 41st?

[annieCinMD]

Yes, there is a 48 week arm. Actually, it has 7 or 8 arms total. I'm sure I won't get a 24 week, I'll probably go 48 if I respond. I need to re-read the paperwork. Yes, the PI gets taken around the same time every day. I take it and the Ritonavir once a day. They both need to be refrigerated, so I keep them in my little fridgy that I have in my bedroom with my Black Cherry Fresca in it. Since I have a Black Cherry Fresca every night, I see my meds and remember to take them. Glad to hear you and your daughter have the good stats. The younger the better, she can wait. I was starting to get a little to close to menopause to want to hold out too much longer. I had heard there was a correlation with women and menopause and the disease taking off. Not sure if I'd want to go through menopause and TX at the same time anyway. That could be brutal for my poor family!

[Rockerforlife]

If you are going to get the real BOC and not the plebco...you VL will be UD hours after takin the BOC...the new BOC 158 trial kicks A.ss all the way to the curb.

[Isobella]

Thanks.  And yes, her vl <400,000 and geno 1a, 1/1.   My vl was low-ish at 900,000and no damage, so we are both very fortunate, too.  

I didn't know that was your trial. My doc was very excited about it.  Good for you for getting in it. Do you have to take the pills like clockwork every 8 hours like the telaprevir? Is there a 48 week arm?

Hope to hear your good news on the 16th =)

[annieCinMD]

Thanks, everyone. I am actually glad to know it might not be working now rather than having a relapse occur after doing an entire course of tx. One of you had mentioned Brent, and that is just devastating. Some of these other people don't have the benefit of being Stage 1, Grade 1 after 20 plus years. I have time on my side if the PI doesn't work this time around. Izzy, I didn't know you have a child with hep C. I'm sorry to hear that. I'm fortunate that my one kid tested negative. I hope his/her numbers are like mine. I did the watch and wait thing for several years myself. If you aren't sick, probably a good route to take. Maybe this new PI is the breakthrough that we're all waiting for.

[newleaf09]

Oh, you're in THAT trial.  The boceprevir and teleprevir showed very encouraging results.  The 'new generation' PI in your trial is supposed to be absolutely amazing.  Since you're not responding perfectly to the interferon, I think you will be especially pleased with the addition of the new drug.   Good luck in waiting for the results...that's the hardest part.

[Isobella]

So glad to hear you are starting the PI.  I'm pullling for you....bettin on UND next time.  

And Annie, I want to thank you for being in the trial.  As the mother of a "watch and wait" hepper....we appreciate your help in getting these new drugs out =)  The sooner the better!

Good luck.  Can't wait to hear your good news next PCR!!

Isobella

[portann]

Thank you so much for explaining your profile mood and also for sending me a note about it earlier.

Your optimism is amazing and I take my hat off to you at this trying time.

My very best wishes and hope for good news at your next visit on the 16th. It may well be a further example of the difference the trial drug can make when added to SOC.

Fingers crossed,
Port