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1554289 tn?1297130104

Patient Week 9 Vertex Quad arm trial

Was randomized to quad arm clinical trial of Telepavir, Vetex-222, Interferon and Ribavarin 9 weeks ago and learned yeserday virus went undetectable by week 2 and has continued undetectable until my last bloodwork @ week 8. The trial has been fairly uneventful although I was pulled from work right away due to fatigue an moderate irritibility. I dose a total of 16 pills twice daily onl the 3 oral drugs and once weekly on the Interferon. The amount of bloodwork conducted has been outrageous sometimes spending 8-10 hours with the phlebotomist. Feel free to ask any questions and I will make every attempt to answer honestly.
29 Responses
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Avatar universal
We are all pulling for you here!  Too bad it doesn't help with your freight...  Good luck on your return to work.
Helpful - 0
179856 tn?1333547362
And the Train Kept a Rolling with the good news......keep  it up Steve it will be worth it once you hear SVR!
Helpful - 0
374652 tn?1494811435
rooting for a 12 wk SVR.  congratulations
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Avatar universal
Glad to hear things are improving for you. Thanks for keeping us posted. A 12 week svr would really be something. Good luck with the continuing results- Dave
Helpful - 0
1554289 tn?1297130104
SX continue clearing more and more each day and for the most part feel like my old self. At one point during Tx I was uncertain I would ever be normal again so I am grateful the Sx are disapearing. Eyesight thing a bit slower but also a bit better each day as well and I see the eye Dr this Friday. My pending return to work on the 14th is causing a little anxiety due to the grueling nature of my work in the freight business but will manage I think..
Helpful - 0
1554289 tn?1297130104
Last injection on 1/16 and now 2 days of orals left. Vision was getting a bit blurry so saw an eye doctor today also who thought interferon related upon photos/scans and an exam and thinks it will improve, Very happy it's nearly over as I am bot certain I could have made 48 weeks or even 24 even though I thought I was a very strong individual which apparently isn't the case... Now just wait for followups and pray a lot.Will post further study notes as I get them
Helpful - 0
Avatar universal
Hey Steve, when I started the trial, the sed VL's wud b blinded until the end. Mayb Doc didn't wanna tell u that. I too am geno 1A and female 46. When I started I was over 2 mill. When they pulled me off after 4 wks to start SOC only, I was  down to 318 thous.Which was unblinded when I stopped Vertex. I was the guinea chosen just to try the 222 and 950. I felt like crap only on those 2 drugs and muddled to work for 2 months. I cudnt focus, I was pale, walked around like a zombie. After it took 2 hrs to get ready for wk everyday, I was wore out. I have been off for a month on SOC only. These docs want u to work to have a normal routine. Shoot when u look in the mirror, is it really healthy for people to c us stoned all day and trippy dreams at nite? I don't even wanna leave the house, I'm much more comfortable home. People having to work on treatment I do admire, but we are not productive, face it people and I was feeling like people at work looked at me weird and avoided me like the plague. I was more depressed at work and had to get outa there cuz of my feelings of lil things irritating the crap out a me. Lol. So point was... Oh yeah, the numbers. Unblinded til the end. At least u know the crap is working. Ps- b careful when u punch those tellies out of the pack. If I break them and still have to swallow them, they are worse than getting stuck sideways! I feel your pain Buddy. I thought I cud b a trooper too. My guy just came back from Afghanistan to help me. Yeah rite, push me to run around like a soldier. Hmmm, even been agitated at him and he's only been home a week. RIBA is ramblin on- sorry...
Helpful - 0
1554289 tn?1297130104
They may have told me the exact PCR done but my retention ***** lately - however I will find out ASAP for you guys. I know they told me the test administered had ability to detect even a single unit of measurement as is by far the most sensitive available. I am keeping my fingers crossed for the best outcome and will attempt to find any technical type questions you guys may have ok...
Helpful - 0
233616 tn?1312787196
Sounds very promising Steve, I'm thrilled for you, and grateful you could do the trial and forge new ground for the rest of us!

Obviously they were interested in clearance rates and how stressed out this combo was on the heart, hence the timed draws and EKGs
.
I'm assuming that if your PCR is zero at 2, 8 and 12 weeks then they are pretty confident they got all the virus.
Speaking for most of us, we'd gladly trade 12 weeks of whooped for the 1 or 2 years all we 1a's endured, even in it was a bit hairier, 12 weeks sounds like heaven to a former treater! I hope to God it all pans out for you.

Could you try to find out which TYPE of PCR test they are administering?
They shouldn't have any problem with telling you what test they are using.
Many of us try to follow what the technology and would be interested in the exact type test they are administering to check your VL, because we try to gauge the reliability of the various methods.
Thanks,
and may you be rewarded for your efforts with SVR forever.

mb
Helpful - 0
Avatar universal
Hi Steve-
Great news on your results. What a huge step it will be if and when people are able to attain svr after such a short time of tx. I hope we hear that you did svr in a few months.
Good luck,
Dave
Helpful - 0
1554289 tn?1297130104
Didn't discover many details at my week 10 visit this morning. Was shown a letter stating I qualified to end trial and SOC treatment @ week 12 based upon the most sensitive of lab tests available indicated zero virus @ week 2 as well as week 8. This trial had provision for continuation of SOC for up to 48 weeks if detectable virus is less than 25 but above 0. Nurse informed she had not yet recieved the data revealing exact day to day values but it would be forthcoming. As I mentioned the amount of bloodwork conducted, especially the first 2 weeks, was staggering so they should eventually provide me with much more accurrate data.  
Helpful - 0
1554289 tn?1297130104
Yes we were all informed of that in November and December that certain arms and been deleted from trial due to breakthrough of those on the dual therapy only.
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Avatar universal
Vertex said it was ceasing the study arm that examined telaprevir with its lead investigational hepatitis-C virus polymerase inhibitor, known as VX-222. The decision stemmed from the study meeting a predefined stopping rule related to viral breakthrough.

This is a recent news release, I pasted it.  Easy to find on google
Helpful - 0
1554289 tn?1297130104
Both are different Vertrex trial drugs and each is a PI- one polymearse and one protease, yes now i am happy I wasn't randomized otherwise even though it's been a bit grueling.
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Avatar universal
is VX-222 Telaprevir or something different.  The 12 week course of tx has me thinking this is not Telaprevir.  Please clarify.
Helpful - 0
476246 tn?1418870914
I think you should be happy you were not randomized into the dual arm with 222 and Tela.

If I'm not mistaken I read somewhere that they discontinued those arms, as people experienced break throughs.
Helpful - 0
1554289 tn?1297130104
Anxious for my week 10 visit tomorrow... should be chalk-full of details to post here tomorrow sometime. Just did my injection and feeling really positive for some reason, will do my orals around 2000hrs and hope to eat something substantial. They actually promoted eating greasy type foods to assist the effectiveness of the meds...
Helpful - 0
Avatar universal
Yes, that is the proper trial, but he could either be in arm C or arm D.  they were both the same but the VX dose was 100 in arm C and 400mg in D arm.  (I'm going from memory)

Arm A and B were both discontinued.  Those involved the PI's exclusively, with no IFN or RBV with the same VX-222 dosing differences (either 100 or 400mg)

They just started a 5th arm with Riba and the 2 PI's and i would guess that Vertex had the choice of which VX-222 dosing to use, and I'd guess that it would be the 400 due to the earlier 2 failures........unless there have also be a lot of discontinuations at the higher dose. If Steve has had a 25 pound weight loss it doesn't sound like a pleasure cruise.  
OTOH...stopping at 12 weeks sounds like a dream.

willy
Helpful - 0
1554289 tn?1297130104
Yes that sounds like it however I am cetain there was a provision for 48 weeks in certain instances. There was an elimination of a couple of arms early on however I can't recall them exactly. I do get some confusion with the TX and don't often feel tack sharp if you know what I mean. Initially I was hoping to be randomized into the dual arm with 222 and Telapavir but when randomized into the quad arm I asked a lot of questions aand soon knew this seemed like a more aggressive approach perhaps with a better shot @ RVR and hopefully eventual SVR
Helpful - 0
96938 tn?1189799858
This might be it, or similar:

Treatment Arm D: Experimental
Subjects who meet pre-specified viral response criteria will stop their assigned treatment at 12 weeks.
Subjects who do not meet the pre-specified viral response criteria will receive peginterferon alfa-2a and ribavirin for an additional 12 weeks for a total treatment duration of 24 weeks.
Interventions:
Drug: telaprevir
Drug: ribavirin
Biological: peginterferon-alfa-2a
Drug: VX-222

Drug: telaprevir
tablet, 1125-mg, twice daily
Drug: ribavirin
tablet, 1000-mg for subjects weighing <75-kg or 1200-mg for subjects weighing ≥75-kg, twice daily
Biological: peginterferon-alfa-2a
subcutaneous injection, 180-mcg, once weekly
Drug: VX-222
capsule, 400-mg, twice daily
Helpful - 0
1554289 tn?1297130104
Yes treatment naive prior, don't know recent VL as my docotor was never so concerned during pre-trial screening stating he thought not as relevant as other factors. I recall it jumping around all over the place quite a bit in the past several years. Early stage 2 fibrosis as shown on biopsy last September
Helpful - 0
Avatar universal
Go for it dude, you'll have alot of folks rooting for you here. How about some details other than geno type. First time tx? VL? liver stage? etc. jm
Helpful - 0
1554289 tn?1297130104
Yes I believe that to be the case however I am a bit unclear myself to be honest. I will have all the details at my week 10 visit on Moday the 10th. I am a bit anxious now and keep getting a little ahead of myself sometimes.
Helpful - 0
Avatar universal
Are they stopping your meds because they think that you're done?  Great result and fast too, and keeping my fingers crossed for you staying SVR.  
Helpful - 0
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