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Post Info TOPIC: New Bristol-Byers Squibb Clinical Trial NCT01979939 With Daclatasvir 30 mg, Asunaprevir 30 mg and BMS-791325 75 mg


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RE: New Bristol-Byers Squibb Clinical Trial NCT01979939 With Daclatasvir 30 mg, Asunaprevir 30 mg and BMS-791325 75 mg
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Hey Andrea

Congrats on your 12 week eot result "Yahoo UND = SVR"

Its the best news that we can hear. 

matt



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"And in the end, the love you take is equal to the love you make"

61 year old Geno type A1, F4 Cirrhotic, started 24 weeks on Harvoni 12-17-14 ,EOT-5 week = UND, 8-31-15 =UND , SVR-24 Baby YES! 



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Paldendrolma, I am here - I sent you a private message!



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Excellent news, Paldendrolma!  The BMS combo of Declatasvir/Asunaprevir is what Japan just got.   smile   

I don't know much about that combo, but have read a bit about the declatasvir, and it sounds like a winner.  



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Diagnosed in 2011, Incivek triple in 2011, tx discontinued, Genotype 1a, CT, VL 7mill, cirrhosis dx in 2012, age 67, waiting for new DAAs.



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I just got the call that my 12 week post-medication test result was UNDETECTABLE. They are calling it a cure!! I am very happy about this. I have had this disease for AT LEAST 25 years. I wonder how Lauralou is doing. Lauralou, are you out there? Anyway, I am so happy for EVERYONE that the days of interferon failure and misery are soon to be over!



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Hi Julia, I`m so sorry the virus came back, how disappointing.  Take some time out to get on with your life now while you`re waiting for the next treatment opportunity to come along, which it will.  Thanks for sharing your journey with us...I wish you all the best of luck next time round.  Take care and do keep in touch.



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Jill 

(70 yo, lives in UK)

Was Gen 3a, 

24wks Peg Ifn/Riba, Sep 2010 - Mch 2011

UND @ Wk.4, UND @ EOT, 

SVR Nov 2011 --> Still UND @ EOT + 4 yrs.

 

 



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lauralou57 wrote:

I just got my 8 week post trial viral load back and I am still undetected! The lab result read "Target not detected"!!!!

In just three more weeks my blood will be drawn for my 12 week post trial viral load.

Andrea and everyone else please let me know how you are doing...

SVR here we come!!!


That`s excellent, Laura, congrats!  I`m really pleased for you, as is everyone here.  Please don`t feel that people don`t care..we do, and we always love to hear good news.  All the best of luck with your 12 week result and SVR!!


 



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Jill 

(70 yo, lives in UK)

Was Gen 3a, 

24wks Peg Ifn/Riba, Sep 2010 - Mch 2011

UND @ Wk.4, UND @ EOT, 

SVR Nov 2011 --> Still UND @ EOT + 4 yrs.

 

 



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Julia:  Thank you so much for keeping us updated.  Everyone is following the clinical trials closely and appreciates your candor.  I'm so sorry it didn't work out this time but your time will come for SVR.  I think of this as a marathon not a sprint and I'm sure my time will come as well.

Lauralou:  Congrats!  I hope you will keep us updated on how you are doing and continue providing support for those who need it.  Your experience and support is invaluable to other hepc sufferers.  We all wish you the best.  



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Diagnosed in 2011, Incivek triple in 2011, tx discontinued, Genotype 1a, CT, VL 7mill, cirrhosis dx in 2012, age 67, waiting for new DAAs.



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Well Laura if that is how you feel than goodbye and again congratulations to you and thank you for sharing your experience.  I was clearly not upset with your accomplishment and am sure most of us feel happy for you.



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Julie Sell


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Good bye.



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J lynch we are both "in the same boat".  However my docs are very excited about all the pharmaceutical companies coming out with HCV drugs. I even see commercials on tv about getting tested for hep c since it is mainly a "silent" disease for most.



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Julie Sell


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Andrea, my trial was a phase 3 and according to my doctor my doctor my liver is still functioning well even though I am stage 3 cihrossis.  I am being treated through a Hep C clinic at a large hospital in my town.  I do not have insurance nor am I financially secure enough to afford treatment.

I believe you will do well because from what I read you have SVR 2+ months after treatment.  My virus came back within the first month after treatment.  I was compliant with the protocol.  I felt like I was getting my energy back.  Then about 2 weeks after I stopped medication I got a bad cold and the fatigue started coming back.  In the back of my mind I had a feeling that the virus had returned.  

I too have had the virus for 27-28 years. So if I have to wait a little longer..... so be it!



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Julie Sell


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I did a BMS study too and failed. 



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John   non-responder  

Undetected at week 2 on solvaldi/rib/interferon:  stayed through week 12 but virus came back as soon as I stopped.  on   Harvoni and ribravirin 24 weeks undetected after two. 8/2/15  12 week EOT  UNDETECTED!  SVR

1991-2015 RIP

 



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Julie, you sound like one of "us"



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Julia, you are right to be careful about which drugs you choose next. I would wait for an approved drug ****tail, or at least a phase 3 clinical trial. It's important to see what your hepatologist thinks. I know that the old drugs can do a job on your liver...i forget, did your enzymes improve on the last trial? I had Hep C for years and kept my head in the sand. There didn't seem to be any hope for me. Now there are options, so read as much about it as you can. I think your Hep C. will be cured soon. Oh yeah, mine too.



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I have a fight or flight reaction I used to flee but have become a fighter and hope not to upset anyone with my results.  If everything was that easy,I wouldn't need the support of my hepcfriends.  I believe it is important to let people learn about the good stories and the not so good stories.  

Let's face it...... this is reality and I am grateful to have people like Laura share their good news.  It gives me hope and I know I will also make it... it will just take time.  This is a way for me to have patience which is a virtue that I am still working on

 



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Julie Sell


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Hi Lauralou, glad to hear you got 8 week results and they were GOOD! I just did my 8 week bloodwork on the 30th. As far as I know, I'm ok. My 4 week bloodwork was OK. I think there were a few relapses at my test site. I wonder if I would even post again if my Hep C came back, I would be afraid of bringing people down. We are here to share and to learn, right? I have to give Julia a hand for being positive. Love to everybody who comes to this site looking for support.



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J lynch I was on the bms clinical trial which is the topic of this thread.  Laura I appreciate your posts and am truly happy that it worked or you.  I know that not everyone will respond the same to these trial drugs.

I also may have been in a different group than you.... I was treatment naive with compensated liver.  I had no adverse side effects to speak of and it was only 3 months of treatment.  There are many people out there who went through months and months of interferon in the past and were non responders.  I consider myself lucky.

 

 



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Julie Sell


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Lauralou57....

Why would you stop posting?  Everyone is happy for your results.  It gives those of us who are untreated hope.  Yes, there are those whose treatment wasn't successful, but no reason for you to leave.  



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Marcy

Long-term HCV, GT1a, IL28B C/T, T/G;  VL 2 mil.  Merck C-Edge Clinical trial  EOT 10/01/14. +24= UND



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I apologize for wanting to share good news. I did not know I was going to upset anyone. I will not post anything anymore here.



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o my goodness....the emotional roller coaster is insane,  after reading all these posts I feel so badly.  I have to also say what an amazing group of people you all are.  I'm almost in tears from the out pouring of knowledge and genuine care.  This is an amazingly strong group of people and I am so lucky to of found this site and proud to be a part of it,

stay stong...get well....((((((hugs to all)))))))



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what treatment were you on that it came back?



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John   non-responder  

Undetected at week 2 on solvaldi/rib/interferon:  stayed through week 12 but virus came back as soon as I stopped.  on   Harvoni and ribravirin 24 weeks undetected after two. 8/2/15  12 week EOT  UNDETECTED!  SVR

1991-2015 RIP

 



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Got my retest results back and it was not a lab mistake, the virus did return.  My viral load was 558,000 and I am getting the fatigue back.  I take 4 hour naps in the afternoon can't seem to stay awake for more than 8 hours at a time.  I feel like a little kid or an elderly person who needs afternoon naps lol.

They asked me if I would be open to trying another clinical trial should one come available in my area.  I said I would consider it but now I am not so sure because I think I can become resistent to the hcv drugs if they don't work.  Don't want to wear out my options.  A better choice I think would be to wait til the new drugs hit the market and they have a better handle on which drugs work for my particular case.

Laura congrats to you!!!!!!

 

 



-- Edited by julia1065 on Wednesday 4th of June 2014 11:53:27 PM



-- Edited by julia1065 on Wednesday 4th of June 2014 11:55:14 PM

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Julie Sell


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I just got my 8 week post trial viral load back and I am still undetected! The lab result read "Target not detected"!!!!

In just three more weeks my blood will be drawn for my 12 week post trial viral load.

Andrea and everyone else please let me know how you are doing...

SVR here we come!!!



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Yes paldendrolma I am anxiously awaiting my retest results which should be soon. I unfortunately didn't ask enough questions whole I was being tested through the 12 weeks so I am not sure about the hemoglobin. My trial consisted of 200 participants (120 in USA and 80 in other countries). There were 4 groups-- 2 groups treatment naive & 2 "treatment experienced". Some had Riba some placebo. It is interesting you said about rashes I did get a strange rash but only on 1 hand. I was very tired but felt like energy was coming back 2 months into my trial. I can't stand waiting to find out if I had Riba I am not a very patient person but working on that character defect lol. 

I have my fingers crossed for you that your treatment was a success.  I feel no news is good news so if they didn't contact you I would also wait til my next visit.  

 



-- Edited by julia1065 on Thursday 29th of May 2014 06:27:00 PM

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Hi Julie, Sorry to hear about your results, but let's wait for the retest. I didn't even know they were giving these drugs with Ribavirin. I am not a fan of Ribavirin, having suffered through treatment with that and Interferon in the past. I just did the triple therapy. finished the treatment on April 4 and I don't even know the 1 month results yet. They said they'd call me if there was a problem. I decided not to call them, I'll find out my one month results when I take my 2 month blood tests. BTW, if you had Ribavirin, I think you would have felt tired, possibly had a rash, and other symptoms. Your hemoglobin would have dropped a little as well I think. Anyway, I think they are truly going to find a cure. Keep your chin up. I'll post results when I get them. I have a stage3 biopsy and I worry too, so I'm thinking of you.



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I will post results as soon as I know. They said it could take a week.

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Julie Sell


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Thanks, Julie. I know the riba wildcard, especially for cirrhotics, is a key question in some of these trials. We're a trickier treatment group and I'm ever curious. Best of luck with the retest and do let us know. Don't be a stranger. wink

wayne



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66 y/o male - Geno 1b - F4 cirrhotic dx 2001 - 16 wk treatment w/ Sovaldi/Olysio/Riba - Und @ EOT+24 SVR

 



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Thank you my friends for all your support my prayers are that all of us can an one day be cured. Wayne, I am not sure yet if I had Rib or placebo. My best guess is that I had Rib only because I had some side effects when I first started which included headaches, sore throat and swollen glands. After I started with these side effects I researched the Rib online and it seems that those are some side effects of Ribavirin. I won't know for sure until they do the unblinding. BMS still wants me to continue my followup appointments. I have I believe about five more months until the end of the study. My doc says that by then the new drugs should be on the market. I will keep you posted. Btw since I came up positive they needed a retest which I did today. Maybe there was a mistake at the lab, I would be elated if that was the case. At the 4 week post blood test my viral load was 500,000.

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Julie Sell


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Sorry, Julia.  That is a tough one, but it won't be long before you can try again, and next time with great results.  There should be a whole bunch of people starting near the same time frame.  Hopefully, me too.  We can all keep each other company.  smile



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So sorry to hear this, Julie. Thank you for letting us know what's going on. Your hopes must have been sky high, especially with such a rapid response to the drugs. Stay strong and know that you'll be able to come back in the near future and do permanent damage to the bug.

Would you happen to know if you were in the Ribavirin or Riba placebo arm? Or is that information they won't divulge?

Be well..

wayne



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66 y/o male - Geno 1b - F4 cirrhotic dx 2001 - 16 wk treatment w/ Sovaldi/Olysio/Riba - Und @ EOT+24 SVR

 



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Hi Tig,

Thank you for your support.  I am grateful to have found this site and find comfort in reading about others who have or are in "my shoes".  I am also grateful that we have come a long way in the treatment of HCV.  I have waited a long time to even find doctors who can help me (being uninsured) and will just have to wait a little longer.  I feel the best thing I can do at this time is to keep a positive attitude.  Sometimes it is hard but I have a great support system in my family, friends and doctors.  I now also have all my new hepcfriends who share their experience, strength and hope.



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Julie Sell
Tig


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Hi Julie,

Welcome to the forum, I'm glad you're here. I'm sorry to hear that you failed treatment, but your doctor is right, there are several current and new treatments soon to be approved that will take care of that pesky virus once and for all. The time invested is certainly difficult to get past, but your positive attitude will see you through. I would take some time and clear this current round of drugs and ready for the final assault! Your day is just around the bend. 

I look forward to following your recovery and if you have any questions or advice, please let us know! Good luck...

Tig



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Tig

63 yo GT1A - 5 Mil - A2/F3 - (1996) Intron A - Non Responder, (2013) Peg/Riba/Vic SOT:05/23/13 EOT:12/04/13 SVR 5+ years!

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I forgot to add that I was in study group NCT01973049 which is the group with compensated cirhossis

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Julie Sell


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Hello I am new to this forum. Congrats to anyone who had success with this BMS trial. I enrolled as one of 120 USA participants. I was in the treatment naive group. My viral load also dropped to undetected by week 2. Didn't have any major side effects to speak of and my energy level was definitely improved. I completed the trial at the end of April and went back for my one month followup on May 19th. I got a call from my doctor on Friday May 23rd and was given the bad news that my virus has returned. The treatment was unsuccessful for me. After crying my eyes out all weekend and feeling sorry for myself, I now have accepted it.
I was told by my doc that new treatments are in the pipeline for FDA approval and hopes to get me another regimen before the end of the year.

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Congratulations Mag on completing tx and being UND. You were very fortunate to have found a trial with little or no sx - good for you! It's great news to hear you have been feeling better since wk 2 as well. What relief that must be!

Best wishes Mag on a new beginning. 

 



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jimbob: 64 y/o, GT 1A, F1-F2, diagnosed 1996. Since 1970. SOT 3.5 mil VL on 3/10/14 with Sov/Rib/Peg for 12 weeks. Tx naive. UND @ week 4,8,12. EOT 6/2/14.

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Hi Mag,

Congrats on your very good news! I wish we could bottle a pill that provides the burst of renewed energy we all seem to feel following treatment. Even on different protocols, I think the renewed energy is similar across all regimens. Whatever it was, I enjoyed it, and hope it lasts a while! I wish you continued good luck and hope a lasting SVR is in your future! Keep in touch smile

Tig



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63 yo GT1A - 5 Mil - A2/F3 - (1996) Intron A - Non Responder, (2013) Peg/Riba/Vic SOT:05/23/13 EOT:12/04/13 SVR 5+ years!

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Hope everyone is doing well after finishing meds last month. I've been feeling fantastic lately, very energized, clear headed and can really tell the difference between having the virus and no longer having it, it's like a night and day experience. Since there weren't any side effects from this med combo, I was able to experience a very doable tx this time around and actually started feeling great around week 2 while on tx and continued to stay that way through the end of 12 weeks.  I'm hoping anyone else that participated in this trial also had a similar experience and felt like this tx was very doable for them.

I got the news I was really waiting to hear and my 4 week EOT VL came back undetected !

It's so great hearing this after after a failed grueling 48 wk tx and relapsing in 2007, one month post EOT.

if anyone is looking for a great med combo and can wait, with docs advise, for this combo to be FDA approved, I would go for it. That's just basing my opinion on my own experience, and there are a lot more great tx's still in phase 3 trials or getting their FDA approval very soon, it's all just right around the corner! 

Mag

 



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GT 1a, previously treated with peg and riba for 48 wks., relapsed 4 wks post tx. Finished 12 wks in the BMS trial on April 18. 



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Oh, thank goodness!  What relief you must feel.  Maybe you even feel happier than if they had gotten it right the first time, huh?  Okay, maybe not.   biggrin

I'm so happy for you.



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Lauralou, I am so relieved for you. I haven't gotten my 4 week post trial results yet. I think they were drawn on may 4. If I call, they may be available. I probably won't call. I'm waiting for my 8 week appointment. I am hoping we will all be cured, I think it will happen. Best of Luck on your next test....and keep taking care of yourself (better than luck!)  Andrea



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Yay! Woooohoo Laura!!!  Fantastic to hear this, these meds are the bomb! You're on your way to SVR. 

I just knew this had to be a lab error, fingers are uncrossed now, as I read the good news. You must be so relieved ))))

I had my EOT PCR done early by the GI doc and results are undetectable at week 2.  Going back to the trial clinic at the end of this week for the week 4 labs to be drawn. I'll post my results.... 

Good luck everyone, wishing everyone the same great news!

Mag



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GT 1a, previously treated with peg and riba for 48 wks., relapsed 4 wks post tx. Finished 12 wks in the BMS trial on April 18. 



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Wow, Laura, what excellent news!!  You must be so relieved and I`m very pleased for you, congrats!

It was an unusual looking result and it really needed to be retested, and how good to hear this!

Onwards and upwards to SVR!  biggrin



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Jill 

(70 yo, lives in UK)

Was Gen 3a, 

24wks Peg Ifn/Riba, Sep 2010 - Mch 2011

UND @ Wk.4, UND @ EOT, 

SVR Nov 2011 --> Still UND @ EOT + 4 yrs.

 

 



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I have great news!

The results of my second blood test came back UNDETECTED!

The hep C doc said the first one was a false positive and that he had seen false positives many times.

SVR Here I come!

Thanks to everyone for their kind support!



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Thanks so much for all of the support!

It does my heart good!

MagTX, I have that link and I will find it and post it.

I am also doing some research on the relapse and I will post that when I get it also.

My hep C doc is also very puzzled about this and wanted me retested.

As soon as I get the results of the retesting I will post that.

-



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Hi Lauralou57,

Very sorry you had to get this bad news! no  But, I am glad to hear that you're doing ok otherwise, low liver fibrosis, feeling strong and looking forward to moving on to another better med combo for your situation, in the near future. You've gotten some great advise here already from other members, so hang on and there will be a better combo for us 1a's that didn't treat successfully with the current protocols.

Your 4 week post tx VL seems a bit odd to me, it's so low and am curious if that isn't a lab error. Cross contamination does happen on occasion and people can have a false reading. I'm still holding out a little hope for you that this may have been an error. It's most likely that when someone relapses it happens in the first four weeks after meds are finished up, and the VL comes back much higher than what was reported to you. VL's during a relapse are most times as high as they were at baseline prior to beginning tx. However, it may be that your VL was just at the beginning of rising or replicating, but the next PCR should tell the story of what is really going on. My fingers are crossed for you till we hear more......

I should have my VL results hopefully by the end of this week and will post them. I'm a bit nerve wrecked after hearing about relapses with this phase 3 BMS trial. I'm completely aware that it happens but it's much harder hearing it when I know it's someone that participated in the same trial as me.  Do you have the link or info to the phase 2 BMS trial that showed the percentage of 1a's that relapsed with Daclatasvir, asunaprevir and 791325, if you have this could you please post it?

Stay strong and be well.

Mag



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GT 1a, previously treated with peg and riba for 48 wks., relapsed 4 wks post tx. Finished 12 wks in the BMS trial on April 18. 



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Hello Laura

I was sad after reading your news as I can fully understand the frustration of possible relapse. With all that it takes to be in a clinical trial, the before, during and afterward  when it does not goes well as we had hoped it can leave a hole and a person can tend to blame themselves and wonder where they went wrong. If we had a high compliance on the meds and completed all the meds then we cannot blame ourselves because some drugs work better on some than others. We know GT1a can be harder to cure than GT1b patients but with all the combos coming out within a year or so they will figure out which drugs are better suited for all the Geno types. Hang a there there has never been a better time to be treated in the next year. Gilead's new combo, Merck and Abbvie has some great products coming out and will nail this virus once and for all time.

Waiting with you.

matt        



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"And in the end, the love you take is equal to the love you make"

61 year old Geno type A1, F4 Cirrhotic, started 24 weeks on Harvoni 12-17-14 ,EOT-5 week = UND, 8-31-15 =UND , SVR-24 Baby YES! 



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Hi Laura, really sorry to hear this!  You are so right though...better drugs are coming and you have time to wait.

Unfortunately none of the current viral load tests are sensitive enough to measure down to zero so an `undetected` result is based on the those limitations... the test can only detect the virus above a certain quantity according to which test is being used and doesn`t mean there is no virus left circulating in our blood streams.  Once the medications have stopped then it does sometimes happen that the remaining virus can start replicating again.  This is why we have a waiting time of 24 weeks, and now more usually 12 weeks post tx, for SVR (`Sustained Virologic Response`) to be determined.

Many thanks for sharing your trial journey with us, we really appreciate everyone who takes part in clinical trials, you are paving the way for others coming along. 

Stay strong, and take care of yourself, the next treatment will be the one! 

 

 

 

 



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Jill 

(70 yo, lives in UK)

Was Gen 3a, 

24wks Peg Ifn/Riba, Sep 2010 - Mch 2011

UND @ Wk.4, UND @ EOT, 

SVR Nov 2011 --> Still UND @ EOT + 4 yrs.

 

 



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Hi Laura,

Sorry to hear about the relapse. As your biopsies all showed little liver damage, it's possible the virus remained in your blood. Remember Undetected means just that- it doesn't mean the virus is absent. Blood monocytes often contain virus, so this can be missed.

Your time will come- you don't need to rush. Wait for Sovaldi/Ledipasvir, and you'll be fine. Cheers.



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Geno 1b, IL28B CT,  x3 prior relapser,  ex-cirrhotic, 75 yo, did 48 weeks with Victrelis/Peg./Riba.  VL 1.28m at start, UNDET. at 8 ,12 ,16 ,24 ,30  and 48 weeks.  EOT 15 Feb 2013 , UNDET. at EOT + 28 weeks. SVR!  Still Undet. at EOT +5 years

Malcolm



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Stay as strong as you are, Laura.  You will be fine.  Your SVR is only delayed but still in your near future.   Take care. 



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Diagnosed in 2011, Incivek triple in 2011, tx discontinued, Genotype 1a, CT, VL 7mill, cirrhosis dx in 2012, age 67, waiting for new DAAs.

Tig


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Hi Laura,

Sorry to hear you came back detected, bummer. There are a number of factors involved in all of these trials and treatments and the drugs and/or treatment duration are part of it. As you know already, the newest protocols with Sovaldi with just about anything are very effective. From your story, it's apparent that you're a fighter and after that accident and the recovery you had to go through, you obviously learned a lot about staying involved in the battle. This is no different, just stick to it and you will beat this! 

It's hard to say where your virus was hiding but your treatment was obviously effective against it and possibly had you taken the treatment for another 4, 6 or 12 weeks, it would've been enough to kill all of the remnants hiding behind an imagined wall or corner in your liver somewhere! This is one of the things some will experience on a trial. A trial is a fancy name for practice, some succeed, and unfortunately some don't. But you know that there are already some excellent options available now and in 6 months, Gilead will roll out Ledispavir and Sovaldi together in a single pill, once daily blockbuster treatment that has the highest rates of success ever achieved. SVR is on the horizon, keep your spirits up and hold onto that great attitude you have!! Your day is coming and coming soon, good luck...

Tig



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Tig

63 yo GT1A - 5 Mil - A2/F3 - (1996) Intron A - Non Responder, (2013) Peg/Riba/Vic SOT:05/23/13 EOT:12/04/13 SVR 5+ years!

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It's really amazing to think about the new drugs coming up. And several options to choose from. And relapsers have the best odds of anybody, 100% on some studies. Getting rid of this virus is now a question of when, and not if. Great attitude Laura. I had a hissy fit myself, but I was on the RIBA (rage) so blame it on that! Soon hep c will be an outpatient treatment with a prescription. Sending some good karma your way fellow warrior!



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  1. Gracie

1A. Previously treated non responder Rebetron in 2000 And Incevik in 2014 with a breakthrough at week 12. Fibroscan 15.5. VL 6,000,000. Finished 24 weeks harvoni on Dec. 19, 2015. SVR. Latest Fibroscan 8.8.

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