Hep C Discussion Forum

Zlikster · Guru

RE: Bristol Meyers is back in the race ALL genotypes

Cinnamon Girl · Guru

Hi Malcolm, that is strange, I hadn`t noticed that! As far as I`m aware < (the LLOQ) (TD) still means just that, Target (virus) Detected, and that`s what we always advise our members if they ask.

I don`t understand, how that can qualify as SVR12? It says the same thing in the notes for Ally 1 and 2 as well.

mallani · Guru

Hi SuziQ and Z.,

Can someone answer a question? In the Ally 3 Trial notes, there is a statement under Primary Outcome Measures.

'......SVR12 defined as hepatitis C virus (HCV) ribonucleic acid (RNA) < lower limit of quantification (LLOQ) target detected (TD) or target not detected (TND) at followup week 12...............'

A VL test with a result of <15 (TD) at my Lab., is regarded as Detected, so no SVR. ( my Lab. uses a LLOQ of 15). Has something changed?

Z.- this will be the first Phase 3 Trials with Daclat/ Sofos. Is Fibroscan now available in Bosnia, or do you have to go back to Split? Good luck, anyway-the reading won't have changed. Cheers.

suziq · Senior Member

Hi Zlister,

Cheryl is the trial coordinator and screens all the applicants. She is responsible for getting applicants for trials and overseeing all the trials and data. You can double check the info with her. Don't think she has info on where other trials are held. She has no idea what is coming to that center until a drug company notifies her. She was notified of my trial mid-August--we screened Aug 27 and trial started Sept 8. She said she got the info yesterday and the trial would probably start in Feb.

SuziQ

Zlikster · Guru

Thanks Suzi,

if it really starts in 3 week time, i have no chance to get my visa sorted that quick :( if there will be some location in Europe tho, i do not need any visa (for up to 6months stay)...

I don't wanna bug your doc (Cheryl) with something unrealistic for me (3weeks deadline), she seems really nice tho :)

hahah, from your posts you seem like 30something lady :) it's all in the (foggy lol) mind!

cheers!

suziq · Senior Member

Hi Zlikster,

Yes, I am almost sure. I keep saying that trials are often full or done before the clinicaltrials page gets the info. Email Cheryl and double check if you want to. I told her that I would be notifying you as soon as I got home yesterday. So an email won't be a surprise to her.

BUT, please remember I am an old lady just coming off 18 weeks of ribavirin and could possibly have gotten it wrong. LOL

Cheers, SuziQ

Zlikster · Guru

@SuziQ, you will recover pretty fast. I remember 2 weeks after my last shot/pill, my blood pic was almost back to normal. Pretty fast recovery. I only got really bad sunburns (i swear i was only 10min on the sun) from Riba leftovers :)

Are you sure that BMS trial (Dac+Sof 12w) is the one your hepa is mentioning to be happening soon @ your hospital? Since there are still no locations and recruitment on the clinical trial page? If you take into account dates published, i doubt they will start before June 2014 with that BMS trial and recruitment should be finished until then. Are we talking about the same trial?

@Malcolm, I am getting FibroScan via insurance, on other hand i am paying for FibroTest (50EUR). My hepa wants to check has my FibroScan score changed, it's not my request, yet hers...last FibroScan i did was 6 months before tx. FibroTest is (i guess) just to double confirm FibroScan score . As for Dacla+Sof...that clinical trial says Phase III? Have you checked ct link: http://clinicaltrials.gov/ct2/show/NCT02032901?term=Daclatasvir+%2B+Sofosbuvir&rank=2

yeah, i am worried about 12w thing too, but i think it's worth a shot? i wish there was an arm with Riba included (obviously Riba is important to GT3s), but i can't be picky with only 2 GT3s trial options at the table atm (Gilead's 3 arm and BMS 1 arm in my case). You think i should wait more for some other trials? not much happening for GT3s lately :( this BMS trial sounds too good to be skipped...

suziq · Senior Member

Hi Matt,

The coordinator said they got the trial for Geno3 only at this time.

This is my first day with NO meds. Had AM meds yesterday but no riba at night. I expect to feel better quickly. Either the meds or the iron has done a number on my stomach for the past several weeks. Stopped the iron on Sunday.

I have waited years to do a treatment without interferon. I was diagnosed at 64. I was (and still am) single and was caring for my mother who was in a wheelchair and had severe dementia at the time. Interferon was simply not an option. I've used alternative supplements over the years and had few side effects from my Hep C and my health remained good but the damage to my liver continued.

I switched my interest to clinical trials the last 2 years or so. I was getting pretty old and felt it was 'now or never" Once the trials have ended (probably by 2015) I am hopeful there will be easier treatments available for everyone. I feel extremely fortunate to have gotten a trial and try to share what I hear about in case someone else wants/needs the info.

By the way, the doctor at my test center has had luck with the insurance companies for the Sovaldi/Olysio combo since the FDA approval.

It is such an exciting time for us.

This forum has been the best I have found over the years. Thanks to everyone for all the information and support. So glad I found it--guess I'm just lucky.

SuziQ

Matt Chris · Guru

Hey Suziq

Congrats on your EOT, you will be getting your engery back soon and floating with that great feeling of being off treatment.

Suziq you have been a great encouragement for all who are considering trials as a option for treatment. BTY will your trial center be offering the new BMS Sofosbuvir and Daclatasvir trial to your people?

We are all pulling mightly for your good results in your future and the good will you will provide. Best of luck

matt

suziq · Senior Member

Zlikster,

Listen to Mallani. I cautioned that this combo is in very early stage for Geno 3 and it actually starts in about three weeks. It is unfortunate that you have to travel. Bunny had been waiting for a trial in Canada and when she finally got a contact number from Gilead--the trial was filled with those on the center waiting list. She has cirrhosis. If the company wants updated info, they will do it for free at screening. My last biopsy was free--paid for by Gilead. I was rejected for that trial due to cirrhosis, but was on the center waiting list for next appropriate trial. If you have a possibility for the one in UK--go for it.

I just posted two more companies doing trials this year. Did not read carefully as I am not looking for a trial.

I am sure that what is right for you will show up at just the right time--just as mine did.

Hugs SuziQ

Bills · Guru

I can't believe it,

Thank you all for putting this up. This topic is going to get a lot of response.

Zlikster,

We're in it to win it this time, I'm thinking the same thing is 12 weeks enough? I said it before after doing the triples I'd do 24 wks just to be safe.

I'm not crazy about being a Lab Rat again and so scared about another relapse But I am applying Faster than you can say ASAP. I'll think it over while I wait we can always back out if the waters don't look good. I got my money on Daclatasvir+Sofosbuvir combo. I didn't expect to see it out so soon. Just wish it was 24 weeks. So SVR to all we're on our way. I'm so excited I'd drink to that if my liver wasn't shot. I love saying that

Bill S

mallani · Guru

Hi SuziQ,

Congrats on getting to the end! Hope you rapidly recover and set a new SVR age record. You've been an inspiration and deserve a great result.

Zlikster- save your money, man. Your Fibroscan won't have changed! I wouldn't say Daclat. is better than Ledip.- Sofos./Daclat. only reached the Phase 2 level, and the numbers weren't large, and there was a lot of preselection. I agree about the 12 week v. 24 week duration, particularly for relapsers. Good luck.

Zlikster · Guru

thanks Suzi! Last batch of pills!!! July and SVR celebration will come soon. Indeed you have a great and caring doc ;)

i am waiting for my hepa to get back from vaca (after 20th of January) to check with her (and do FibroTest and FibroScan), maybe she has some BMS connections/hints too.

UK would be definetly my first pick for a location, since my visa (work permit) for USA has expired (few days ago! yay), but if there will be only trials in USA, i will get on getting new one (tho getting new one can take 1-3months)

Daclatasvir+Sofosbuvir is the best possible trial there is i think. Ledipasvir seems to be a bit less effective as NS5A inhibitor than Daclatasvir, so it seems to be best combo NS5A and NS5B inhibition. I wish only there was a 24w arm too. Hope i will be one of 150 lucky persons accepted to that trial...

best!

Tig · Admin

Hi Susan,

Thanks for the BMS update! I know Zlikster is so happy that you provided that information here on the forum. It's about time the hope for all the GT 3's was given a boost. I'm so hopeful that this will be the answer they've been seeking.

Congratulations on finishing all the pills. It's a wonderful feeling to know you've completed the treatment phase of the therapy. Now you have to keep your eye on the SVR prize and I know with your positive attitude, that's the plan. You've really done well from the start and I've been very impressed with your ability to stay strong and positive throughout Tx. I'm also very appreciative of your continued support to everyone here, thank you! Good luck with your future tests and the SVR you deserve. You know we're pulling for you!!

Best, Tig

suziq · Senior Member

Attention Genotype 3's and Zlikster

My study center will be doing this BMS study in early February for genotype 3's only. HOWEVER, it is the first study on Geno 3 so it will be like a phase 1 study. There is no data on Geno 3 .It was 100% on geno 1's. So, if anyone is interested. let me know. I will send you the contact number. It is in Arlington Texas. She just got the info this morning. It is not listed as recruiting yet.

Took my last pills this am at the study center. I was the only one there on 18 weeks. The rest did 8 or 12 weeks. I have 3 monthly checks and then PT final appt in July. So, hopefully I will be SVR before my 80th birthday in August. Cheryl said if I don't reach SVR, she will find me another trial. I really like her.

Beautiful sunny day here--about 70 degrees.

Have a Happy Day. I will post my lab results from today when I get it.

SuziQ

Zlikster · Guru

thanks Tig!

only thing that worries me a bit, it's duration - 12w. As i recall Phase I (or was that II) of Dac+Sof was 24w and for GT2/3 it was 80-100% SVR rate. Will 12w be too short for same SVR chance? who knows, but i will press to get in this trial hard ;)

Wondering whats BMS agenda here...maybe they expect that 12w of Sof+Dac be more effective for GT3s than 24w of Sof only and maybe cheaper for insurances to give approval (i doubt Daclatasvir will be 1k $ per pill)?

Clinical study completion date is March 2015, so if u calculate duration 12w + post checkup (4w, 24w) that means trial has to start latest in June 2014. Great thing is that there are only 2 post study PCR tests, 4w and 24w. Means i can stay 3+1months whereever it will be and get back for EOT+24w checkup.

@Jill, THIS IS THE ONE! I know it! ;)))

best

-- Edited by Zlikster on Sunday 12th of January 2014 10:31:15 PM

Cinnamon Girl · Guru

Thanks for posting this, SusiQ, very helpful of you.

Best of luck, Zlikster, this could be just what you`ve been waiting for!! smile

Tig · Admin

I'm really happy for you Zlik! I will continue to send out positive vibes and wishes for the outcome you have earned and well deserve!! Good luck my friend...

Zlikster · Guru

Thanks Tig n Suzi! i can only say WOW wotta NEWS!

Daclatasvir+Sofosbuvir is dream (clinical trial) come true (back again) :D Can't wait for "ALLY"!!! Seems BMS didn't forget us GT3s :D

now what to do, wait for this amazing clinical trial with or gamble with Gilead's 3 arm Sof/Rbv+Peg thing...hmmm. I will wait for my hepa to get back from vaca and consult with her. BMS is pretty present with it's products in Bosnia, maybe my hepa knows a thing or two :)

@SuziQ, already EOT time for you? hope all is well

CHEERS!!!!!

-- Edited by Zlikster on Sunday 12th of January 2014 09:24:31 PM

Tig · Admin

I'm so happy to hear that tomorrow will be your EOT day!! I know what a welcome day that is. You've done an excellent job and followed the protocol to the letter. You've done your part and now the wait begins. This is when a positive attitude helps greatly and you've always had that. Good luck and enjoy the end of those pills tomorrow!

Tig

suziq · Senior Member

Hi Tig,

I was thinking of Zlikster too. He is so worried that there will be no more trials for Geno 3. But this is great news for everyone--all genotypes. And it looks like the trials will not be confined to the USA. The early BMS/Gilead trial had great results until Gilead backed out. And my trial, Merck, is just being silent despite great reviews for Phase 2 trials. Tomorrow is my last day of meds--EOT labs Tuesday morning. Even without interferon I am so ready to stop treatment. My memory and focus have been out of synch. Just can't concentrate as well.

I'll post any trials I read about.

SuziQ

Tig · Admin

Thanks for posting SuziQ! I love seeing these opportunities available for everyone, but particularly the EU. Access to these drugs is tough and these trials often provide a lot of needed hope to many that would normally have to wait extended periods to get them. I thought of Zlikster and hope he's able to get into something like this.

suziq · Senior Member

Found This article today. There will be more clinical trials in the coming year.

SuziQ

2014-Daclatasvir Accelerated Review By European RegulatorsSubmission includes EUs first all-oral and ribavirin-free investigational regimen for use in treatment naïve genotype 1, 2, 3 patients and protease inhibitor treatment failures. I'm sure by now you've come across Bristol-Myers recent announcement that daclatasvir will get an accelerated review by European regulators. In addition the company said "The application seeks the approval of daclatasvir for use in combination with other agents, including sofosbuvir, for the treatment of chronic hepatitis C." Ahhhh Yes. As noted in the press release: The EU submission follows the recent Bristol-Myers Squibb regulatory filing in Japan seeking approval of a Daclatasvir-based regimen for the treatment of patients infected with HCV genotype 1b. 2013-Off The Cuff **September 2013 at the University of Michigan Hospital, a "Doctor was granted FDA emergency approval to use sofosbuvir/daclatasvir in a hepatitis C transplant patient" 2014-Daclatasvir Plus Sofosbuvir-Three HCV Clinical Trials Sponsored By Bristol-Myers Squibb Yesterday on the blog I posted three Phase III clinical trials sponsored by Bristol-Myers using daclatasvir + sofosbuvir, unfortunately recruiting has not started, nor have the trial locations been made available. Click on the links for additional trial information.Phase III Daclatasvir + Sofosbuvir in Cirrhotic Subjects and Subjects Post-liver Transplant (ALLY 1) Criteria

Inclusion Criteria:

Subjects chronically infected with HCV Genotype 1, 2, 3, 4, 5, or 6 with HCV RNA viral load of 10,000 IU/mL at screening
Subjects may be treatment-naïve or treatment-experienced
Cirrhotic subjects must have cirrhosis confirmed by biopsy, Fibroscan or fibrotest and Aspartate aminotransferase platelet ratio index (APRI) criteria as outlined in the protocol
Post-transplant subjects must be at least 3 months post-transplant with no evidence of moderate or severe rejection

Purpose This trial is open to patients with cirrhosis due to chronic HCV, and to patients who have already received a liver transplant for chronic HCV. All subjects will be treated with Daclatasvir and Sofosbuvir for 12 weeks. Under certain conditions, the treatment duration may be extended for cirrhotic subjects. The study will test how well this combination of investigational drugs works to treat chronic HCV.Phase III Daclatasvir and Sofosbuvir for Genotype 3 Chronic HCV (ALLY 3)

Inclusion Criteria:

Subjects chronically infected with HCV genotype 3
Subjects who are HCV-Treatment-naive - Subjects who are HCV-treatment-experienced
Previous exposure to non-structural 5A (NS5A) inhibitors is prohibited
HCV RNA 10,000 IU/mL at Screening

Purpose

To study the combination of Daclatasvir and Sofosbuvir for the treatment of HCV Genotype 3 infectionPhase III HIV/HCV Co-Infection Daclatasvir (DCV)+ Sofosbuvir (SOF) (ALLY 2) Criteria

Inclusion Criteria:

Subjects chronically infected with HCV genotype 1, 2, 3, 4, 5 or 6, as documented by positive HCV RNA at screening
HCV-Treatment-naive subjects
HCV treatment-experienced subjects are eligible.
All permitted prior anti-HCV therapies must be discontinued or completed at least 12 weeks prior to screening
Subjects must have an HCV RNA 10,000 IU/mL at Screening
Subjects must have HIV-1 infection

Purpose To study the combination of Daclatasvir and Sofosbuvir for the treatment of HCV/ HIV Coinfection Enjoy your weekend, see you all soon Tina Photo Credit - http://www.idse.net/ViewArticle.aspx?d=Hepatitis&d_id=213&i=February2012&i_id=813&a_id=20132

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