Patient Week 9 Vertex Quad arm trial

[SteveOC]

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.

[SteveOC]

Should add I am Geno type 1 male 48 y/o dosing at highest randomised doses in trial,  Lots of chills fatigue and about a 25# weight loss thus far which truth be told i could easily afford to lose...

[Susan_1a_CC]

The 8-10 hr. stint with the phlebotomist - is that basically draw blood, take some meds, and then 8 hrs. later draw more blood?  If so, is that voluntary or mandatory?  Glad to hear that you went und. so fast - looks promising.  Wishing you continued good results,
Susan

[nygirl7]

8 - 10 hours with the hemotologist that seems utterly impossible i mean how much blood can they take out of one person at a time?

Congrats on the und at week 2 that is absolutely excellent!

[Marcia2202]

UND at week 2 bein a geno 1!!! That is super good news. Lots of pills to swallow, but it seems well worth it, having RVR'ed so early.

I was on SOC only and was also debilitated during treatment. That is obviously the price some of us have to pay. It's not easy...

May I ask how long you will be on treatment?

Wishing you all the best with tx!!!

[SteveOC]

Mandatory per this particular protocol- Lab draws 22 tubes of blood once weekly over an 8 hour period at two 1 hour intervals (1 pre-dose), than one 2 hour interval, one 4 hour interval than an EKG and finally an 8 hour interval. This often turned into 10 hours depending on how busy lab was that day. I was informed yesterday I will be stopping ALL meds @ week 12 although there were provisions to continue up to either 24 weeks or 48 weeks on the dual arm (standard of care meds Peg and Ribavarin) Felt absolutely horrible all last week but this week almost symptom free which has been the story all along the trial so far.

[Susan_1a_CC]

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.  

[SteveOC]

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.

[orleans]

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

[SteveOC]

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

[FlGuy]

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

[SteveOC]

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

[Willy50]

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

[SteveOC]

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...

[Marcia2202]

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.

[pcds]

is VX-222 Telaprevir or something different.  The 12 week course of tx has me thinking this is not Telaprevir.  Please clarify.

[SteveOC]

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.

[pcds]

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

[SteveOC]

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.

[SteveOC]

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.  

[spectda]

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

[merryBe]

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

[SteveOC]

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...

[curehepc]

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...

[SteveOC]

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