It was not this time ... yet ... PSI -7977

[liavera]

Hi, there. Today I went to have a first dose of double INTERF / riba but the  doctors convinced me to compete for a place in study group with PSI-7977. Well .. they advised me it would be better option than starting tx now because I have a chance to succeed. Result: the beginning of the tx was in the middle of the year. Does this attitude was good? I can still change my mind and opt for the conventional tx now ...

Lia

[katla]

Hi, I've had my eye on this trial for a while. Do you know where these are being conducted in NYC? According to clinicaltrials they're now recruiting at Bronx VA and not yet recruiting at 10029??? I was hoping it was Mt. Sinai where my doctor is but I don't think it is. Do you know where in the city they'll be??? And if there's no contact number how I'd go about trying to qualify?

Thanks!!!

[curiouslady1]

The best way to find out about this is to go to clinicaltrials.gov and type in NCT 01359644.  The trial that comes up is the original trial.  The one you are looking for is an extension of the original trial.  You will need to call the sites in Florida that are listed there to find out if and when they are recruiting for the BMS/PSI EXTENSION.   The study is for GT 1 either triple failures or naives.  Some are recruiting now.  Some in a month or so.

[linda880]

  Can you share anymore info on the Bms/psi trial set for March?
I am desperately looking to get into an all oral study. Geno 1a F3 so
I do not have alot of time. I live in Florida

[Hopinghepster]

Thanks for the good wishes. The trial I anticipate taking is the Bms/Psi for 1a treatment naives. I'm not anticipating any difficulties with the screening, so it should be all systems go in March!

[gonnabhepcfree]

I definately will.  The trial your talking about is the PSI 7977 and BMS790052 for 1a or triple fails?  My Dr''s office is already screening if so.  Good luck..I feel very grateful to have been able to clear the virus thus far with so lillte discomfort.  Time will tell.. Good luck!!!

[Hopinghepster]

Congratulations on finishing this deeply encouraging trial and thanks for keeping us informed of your progress. Please let us know how the monthly checks play out. I have a very good chance of participating in the next form of this trial - the 12 week version expected to start in March. So my interest in your post treatment progress is very strong and I'm really appreciative of any new information you can communicate. Best wishes!

[gonnabhepcfree]

I am going right now for my last visit of the PS1 7977 and BMS 790052.  Except for some minor fatigue in the beginning I have been side effect free.  I also went undetected at 7 day labs.  ( I will start a 6 month once a month check to make sure I remain und SVR.  

[liavera]

I appreciate that you're having success. Side effects with the PSI are very strong and unpleasant? ? I pray that I may be contemplated by one of the new tx!
my best, Lia

[Alatyr55]

I am currently in week 20 of the Atomic trial (12 weeks of Inf, Riba and PSI, then 12 weeks of PSI only).

All I can say is the 12 weeks I was on Inf and Riba were pretty hard to take. It was getting worse every week.  

The results so far of using PSI-7977 are really good.  I went from 10 million viral load to zero in first week of treatment.

My advice would be to get in the trial if you can.

[liavera]

is right. Here in Brazil it starts after Carnival. I will also have to go to another city, do all the tests again, except the biopsy. Day 26 I'm going to Botucatu city, where the study is going to happen, to bring the proposal / referral from my doctor.hopefully I can...!!!

[curiouslady1]

gonnabhepcfree não mencionou isso, mas eu acredito que ela é GT 3 e só levou uma semana para ser UND se bem me lembro com PSI 7977 e BMS 790052. Ela pode corrigir esta informação, se necessário. By the way, eu tive que sair da cidade no meio da minha seleção para entrar no PSI 7977 ensaios. Não foi um problema. Eles gostam de acomodar seus participantes para experimentos. Todos em seu país sabe que você não pode interferir com o carnaval em 21 de fevereiro !!!!!!

[curiouslady1]

gonnabhepcfree did not mention it but I believe she is GT 3 and it only took her ONE WEEK to be UND as I recall with PSI 7977 and BMS 790052.  She can correct this information if necessary.  

[Advocate1955]

Yes, as I recall you are f3 Lia, so you and your docs do need to take that into consideration as you research the the PSI-7977 trial, the number of months before it starts, and all of the details of the trial (what are the chances of you being on a placebo, how long will the trial last, will you be able to take rescue meds to stay on the Hep C drugs if you become anemic or neutropenic, if it turns out you are on a placebo would you then get the PSI-7977 drug afterward, etc.).
Advocate1955

[liavera]

I hope by then my not increase the degree of fibrosis and I don't get cirrhotic  ... but the doctors know what they do ... I think ...btw, I'll try and wait ... meanwhile enjoying the carnival in Brazil ... no alcohol ...
hugs, my best to all
Lia

[curiouslady1]

I know.  So they are at least going to do the BMS/PSI extension at your site and my site.  There are 4 arms.  Two for naives and two for failures to the triple.  I don't know if all the original sites will be doing the extension.
http://www.dailymarkets.com/stock/2011/11/04/new-12-week-interferon-free-treatment-arms-added-to-all-oral-combination-study-of-psi-7977-and-daclatasvir-bms-790052-for-hcv-genotype-1/

My understanding is that they may be screening now but they won't be starting until March or so because they dont have the drugs out yet.  Ran out I guess.  

[gonnabhepcfree]

My coordinatior told me yesterday that they are going to be starting a new study with our study drugs for geno 1a naive and people who failed triple.  I believe she said another for just four weeks but not 100 percent on that one.  

[curiouslady1]

Can you tell us the name or number of the trial?  Some are listed at clinicaltrials.gov.  

[curiouslady1]

Ah.  I see you found the page.  The trial must be available in your country to participate.  Not all trials have placebos.  Even the ones who have placebos with Hepatitis C, they are given a chance to have treatment after a period of time.

[liavera]

Gen 03...Incivek/Victrelis aren't available in Brazil... Hi, curiouslady. Tried to join the clinical trial? why it did not work? I will have little chance to participate ... not want to get in the placebo group!  still do not know the protocol, all I know at the end of January

hugs

[curiouslady1]

There is some information of excellent results with PSI 7977 that might be helpful to know about for Genotype 2 and 3.

http://www.hepmag.com/articles/psi7977_svr_hcv_2501_21405.shtml

[Advocate1955]

Hi nygirl7, I don't think Lia meant that she was going to be taking a double dose of Interferon.  I think she meant she was doing SOC ("double drug treatment") of Interferon and Ribavirin.  Maybe Incivek and Victrelis aren't available in Brazil?
Advocate1955

[flcyclist]

FYI, I believe Lia is Geno-3.

[OdinLovesLife]

Sounds like good advice from your doctors. Go for it! I definitely would. People have behailersing very promising results with PSI 7977. In fact I would fly to the other side of the world to do such a trial if I could.

Obviously as others have said, check the trial details. In particular, what is the protocol if you get the placebo.

[curiouslady1]

If your docs think this would help you, why not?  I do have a lot of info on my Med help page under "journals" because this is the drug I am on.  Some of it is personal opinion as I go through my journey but also I have a lot of links to research etc.  that have come up related to the PSI 7977 drug.  I think some are still available.  I am not sure which trial you are interested in but this drug is being combined with other drugs in trials so you might want to find out more about them too.   Also,  finding out about clinical trials in general (wikipedia is a good source) and  HepC trials in particular (I don't know about this link but I am sure it is in the archives) would be good.

Even if you went for SOC + 7977 it would probably be an easier go but the all orals are a nice option and you probably wouldn't have much down time from them if at all (maybe a little fatigue and stomach distress/heartburn).  The people on this forum and those that gonnab and myself have come into contact with in our trials have not had breakthroughs.  Too early to tell about relapse but it looks good so far with early Undetectable status for many if not most of us.  HTH

Anyway, if it didn't work, because of the unusually high resistance profile, you could probably turn around and do the current triple.  

Since your docs use the word "compete" you may want to get on the list now.  There are a number of preliminaries and you don't want toget left behind if this is what you want to do.  I just got in and could feel the wind at my back as they shut the door behind me.  Someone just after me in screening didn't make it in time.  There were 6 accepted at my site.