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Hep C Discussion Forum -> Clinical Trial Participants -> New Study/Treatment (no shots)
Post Info TOPIC: New Study/Treatment (no shots)
mehru


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RE: New Study/Treatment (no shots)
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I feel the same way, it is all a miracle. It has been a long haul for the development of protease inhibitors to finally become an option.  I remember my study doctor at John's Hopkins telling me the next big thing will be the PI's back in 1999 he said it might be another 3 years. I wonder how long scientists around the world have been working on the DAAs?  Does anyone know?



__________________

Geno 1a, Stage 3-4 early cirrhosis (labs, recent biopsy, MRE elastography to confirm), 1999 rebetron trial with inf/riba *non/partial responder at 16 wks.  4/2013 started victrelis triple tx - had to discontinue after 2 weeks due to rash.

 
gsx1250fa


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Hi. I was in a study at the newly named "The Texas Liver Institute " in San Antonio Tx. I believe 8 week Tx (study) is what they are trying to narrow treatment to. On a good drug study it will hopefully work for you. Best of luck :)



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mehru


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I read your post today, were you on a study at NIH? I'm thinking of starting on a study over there and it would help to talk with someone who has participated in their studies.  HOpe all is well with you!



__________________

Geno 1a, Stage 3-4 early cirrhosis (labs, recent biopsy, MRE elastography to confirm), 1999 rebetron trial with inf/riba *non/partial responder at 16 wks.  4/2013 started victrelis triple tx - had to discontinue after 2 weeks due to rash.

 
mehru


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Hi Michael, 

Read your posts today and have to say "good work" staying with tx.  It's a great motivator to do whatever it takes when you have cirrhosis, I have found. Just recently I've been in the process of trying to get in a study that will be starting soon sofosbuvir, ledipasvir & GS9669 for 8 weeks. I don't know if it will be enough but feel like getting started if at all possible and not worry about the results. If I have to keep it going in another program that would be fine too.  It would be nice to lower my VL 5ml, the inflammation gets tiresome. Was your study at NIH? Thanks for your posts it really helps us all!



__________________

Geno 1a, Stage 3-4 early cirrhosis (labs, recent biopsy, MRE elastography to confirm), 1999 rebetron trial with inf/riba *non/partial responder at 16 wks.  4/2013 started victrelis triple tx - had to discontinue after 2 weeks due to rash.

 
Cinnamon Girl


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Many congrats to you, Michael, and very well deserved!  I`m really pleased for you, your determination to beat this disease has finally paid off!  Enjoy your new virus-free life, knowing you`ll never have to do another round of treatment again!  smile



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Jill 

(71 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.

 

 
Matt Chris


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Hello Michael 

Congrats on making it to the six months SVR level. You are a inspiration to all of us that have to build confidence to try re treatment again.

Thanks and please keep us informed.

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! 
gsx1250fa


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Thanks everybody :) I want to stress I am not deterring anybody from what their Dr. recommends right now....but I do think the new drugs will be out more sooner than later. The bottom line for the pharma co is profit and I believe they will get the drugs fast tracked. Thank God for the competitiveness of these companies concerning a Hep C cure  :)



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HR


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That is awesome news. Great job



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ION-3 Trial- Sofosbuvir/Ledipasvir 12 weeks.. UND 4 weeks, relapsed 12 week EOT. 

3-4 on Ischank scale

 

Retreat ION-3 Trial- Sofosbuvir /Ledipasvir 24 weeks

GT-1 (1-31-14) Week 1 VL 62 -Week 4,8,12,16,20 UND EOT 7-18-14
Biggyb


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Great news Michael, like you if i don't beat this i will never do TX with peg again. I just would not be able to handle it ever again. Have a great Hepc free life.

 



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58 yo..Relapsed in 99 and again in 2004. Started triple therapy with Victrelis July 22,2012.  genotype 1a. week 8,12,16,24 VL Undetectable..E.O.T -- 6-22-2013,,,EOT + 24., UND. 

SVR !!!

 

~Bob~
mallani


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Hi Michael,

Congrats on your SVR!! You have shown great persistence and deserve your result. This will be great encouragement to those who have failed triple. Being on the arm that contained Riba. with Sofosbuvir/Ledispavir was probably a godsend.  However we'll have to wait for the Trial results. Go out and relax- 4 lots of Rx is very impressive, so enjoy your HCV free life. I know how you're feeling, having just had the same result myself. 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
Tig


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Congratulations on your SVR!!! It will be a blessing when the all oral meds become available, but who really knows when that will be? I believe there will continue to be extensive utilization of INT assisted therapies well into the future. So I encourage everyone to seek out the advice of a hepatologist before deciding on your own to postpone treatment. Delay can be the wrong choice. Get diagnosed, then decide. I understand the negative side of INT therapy, it's not much fun. I hope your liver and your body recover quickly and hopefully completely! Best of luck and continued SVR

 



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Tig

67yo GT1A - 5 Mil - A2/F3 - (1996) Intron A - Non Responder, (2013) Peg/Riba/Vic SOT:05/23/13 EOT:12/04/13 SVR 9+ years!

Hep C FAQ   Lab Ref. Ranges  HCV Resistance

Signature Line Set Up/Abbreviations   Payment Assistance

 
Loopy Lisa


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I am really happy your nightmare has ended. I have read other people have a similar situation. I decided I would wait for all oral, I can hardly stand taking a normal pain killer let alone injecting. I hope you recover fast and at last can look forward to a wonderful future Hep C free x



__________________

Genotype: 3b

VL.�over 15, 000 000

Failed TX 2014: Interferon/Riba.

Cured using Sof/Dak combination.

I can eat cake again! <3 
gsx1250fa


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Just an update. 6 mos post was und...so I have formally achieved SVR. It's been a long 4 yrs. Knowing what I know now... I would have waited for the all oral (no interferon) drugs...which has cured me. Not to deter anybody, but the prior 3 yrs 3 Tx attempt/failures with interferon ...IMHO...advanced my liver damage. Some have been cured with the trip tx...some haven't. I'm not a doctor, but I went from a stage 2 (of 6) to a stage 5 in those 3 yrs. Hopefully my liver damage will somewhat reverse itself over time now. The new all oral regimes will be a blessing for those afflicted in the future. Thanks for all the support and best of luck to all :)



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gsx1250fa


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Thanks ya'll. Next blood draw is 6 mos post. 



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Cinnamon Girl


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Fantastic news, Michael!  biggrin  Your perseverance certainly is inspirational but this is also a personal triumph without a doubt, and very well deserved after so many attempts at treatment!   Very well done, and all the best of luck for your 6 month result. 

Keep us posted!  ~ Jill



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Jill 

(71 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.

 

 
Matt Chris


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Hey Michael

Thats fantastic news, I am so happy that you made it to 12 weeks UND with all the ups and downs that you have been through. 

It also gives many others hope that have failed previous treatments.

It gives me hope personally, because I am in the Abbotts trial Meds. for cirrhotics and was wondering if only 12 weeks would be long enough for treatment.

I await my 4 weeks EOT/post treatment labs with greater hope now that I've read your posts again.

Thanks again and again and keep us informed

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! 
gsx1250fa


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Just a quick update. 12 week draw und :) Considered "clinical cure", but I know 6 mos post is the grand finale. Sigh of relief none the less. Been a long 4 yrs. I am not posting this for a personal victory tribute....but for those still struggling like I was. It took 4 years and 4 Tx attempts to get here. Don't give up no matter what. You can beat this thing...and with the new drugs coming out...quicker and easier :) Hopes and prayers for all :)



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Biggyb


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Great news Jim, you gonna kill that friggin dragon one way or another. I like your determination. Keep us posted.



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58 yo..Relapsed in 99 and again in 2004. Started triple therapy with Victrelis July 22,2012.  genotype 1a. week 8,12,16,24 VL Undetectable..E.O.T -- 6-22-2013,,,EOT + 24., UND. 

SVR !!!

 

~Bob~
Rockyfeller


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Hi, I'm back.  Last year I did a 12 week clinical trial (July-October)with sofosbuvir (GS-7977), ribavirin and pegasys.  At the end of the trial my tests came back negative, but that only lasted about 6 weeks.  I keep going back for regular blood tests, and although the AST and ALT numbers have risen slightly, to 73 and 57 respectively, the viral load bounces around from 3,000,000 to 7,000,000 or so. 

I got a call today and they want me to come back and try the sofosbuvir plus ledipasvir (where do they get these names from?  How about something we can pronounce, like "Hep killer 1 and 2").  I've been researching the results and they look promising, but the no riba or pegasys makes it sound very tolerable.

I am fortunate to live in a town with a teaching/research hospital, so I only have to drive about 10 minutes for my appointments.  I am looking forward to starting this trial, and hopefully getting rid of this thing once and for all.



__________________

genotype 1a, viral count 7 M

7/12/12 started triple with GS-7977(400 mg 1/day), Peginterferon and Ribavirin  12 wk  trial

11/2012 no svr

12/10/13 new trial with sofosbuvir/ledispavir combo and riba12 wks

3/10/14 UND

3/16/15 still UND, and feeling great
gsx1250fa


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Thanks ya'll and congrats malcolm on your 12 week EOT result :) I haven'y been on the forum too much lately. Hopefully interferon will be a thing of the past. After the 1st 3 Tx attempt rounds with it...I swore never to go on it again. I believe the upcoming generation of hep c Tx patients...are going to have it much easier THANK GOD!



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mallani


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Hi Michael,

Great to see persistence pays off! Excellent result. I think the 12w VL will be just be a formality. Congratz.



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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
Cinnamon Girl


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Another great result, Michael, it`s continuing to look very promising for you!  Congrats!  smile  You must be so relieved!  Almost there, at last.



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Jill 

(71 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.

 

 
Biggyb


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Great news and good luck on next one.



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58 yo..Relapsed in 99 and again in 2004. Started triple therapy with Victrelis July 22,2012.  genotype 1a. week 8,12,16,24 VL Undetectable..E.O.T -- 6-22-2013,,,EOT + 24., UND. 

SVR !!!

 

~Bob~
gsx1250fa


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Welp...8 wk post Tx draw was UND. I was a bit nervous on this one. Doc said I now have a 98% chance of final SVR and if UND at 12 weeks post they consider it a "clinical cure" with 6 mos UND being the final chapter. The clouds are finally parting and the sun is shining through :) These last 4 years (4 Tx attempts) have been a PITA!

 



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Matt Chris


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Hey Michael

That's great news, that many UND in a row is a recipe the SVR.

It also give great hope for the many other members the have failed treatments before.

We all are pulling for you because, you leading the way to our new hope and vision.

Please keep us in the loop.

Matt



__________________

"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! 
gsx1250fa


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Hi and thanks Malcolm. GLAD you are doing well :) This was definetely a cakewalk compared to the last 3 Tx attempts with interferon...the 3rd attempt being the worst. Virtually no side effects on the 12 week study. I believe my body handles the riba better than most....or maybe has acclimated to it. They did my 4 week draw (5 days early) and still UND :) My next draw at 8 weeks will be another hurdle. Doc says most relapses occur within 6 weeks and my chances of reaching SVR go up considerably if I pass this point. Hopes and prayers for everybody! OH...I am 47 yo.



-- Edited by gsx1250fa on Tuesday 16th of April 2013 05:52:05 AM

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mallani


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Hi Michael,

Sounds like the Trial was a piece of cake compared to your previous experiences. Good luck for the SVR. I've forgotten your age? 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
gsx1250fa


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Thanks! At this point ...stage 5 (cirrhotic) of 6 ishak scale...I'm at a crucial point with my liver. Doc seems to think if the virus stays clear...my liver will heal itself over time. My disease seems to progress rapidly going from stage 2, three years ago, to stage 5 just before this Tx. The other FDA approved drugs aren't an option anymore as I have failed 3 tx attempts over the last 3 yrs...last one being Trip Tx with vict. REALLY need SVR this time :)



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Zlikster


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great news Michael! thanks for sharing! really interesting to hear stories with brave people like you who decide to go on clinical trials.

best



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GT 3 dg. 08-2012 / FibroScan: 5 kPa F1 / FibroTest: F0-1 A1 / SoC TX: PegInt 120mcg+Riba 1000mg UND from w8 relapse EOT+4w
01-2016 Sof+Dac+Riba UND from w8, SVR24!
gsx1250fa


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Thanks folks. Doc said only 1 person (Tx Naive) relapsed on the initial  8 week arm, but went UND immediately on the rescue part for naive Tx participants only. Pretty good stats so far :)



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Cinnamon Girl


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Hi Michael, this is great news, so pleased for you!  You`ve done so well on this trial and it`s looking very promising for you!   Thanks for sharing your latest result with us, this gives so much encouragement.  Have a happy Easter!  smile



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Jill 

(71 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.

 

 
Matt Chris


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Michael 

Thanks; very encouraging news indeed, keep them coming. 

Remmember also, you now have to heal your rest of your body and spirit so eat healthy and feed your spirituals needs.

Matt



__________________

"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! 
gsx1250fa


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2 week post Tx blood draw was UND. My Tx/trial was the 12 week gilead combined pill sofosbuvir/gs-5885 (ledipasvir) with riba. I went UND at week 4....then 8 and 12....and now 2 week post Tx. Some (refresher) background on me. I am a 3 Tx attempt null responder over the last 3 yrs. I went into this study stage 5 (cirrhotic) of 6 ishak scale. So far so good. 



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Cinnamon Girl


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shorty213 wrote:

good evening everyone.I am out of Los Angeles and am having trouble finding interferon free TX study in my area.any leads? How do I find one?

Hi again Shorty, how are things going for you now?   Your doctor will probably be able to advise you on suitable trials in your area.  Here`s a site you could try as well, you can search by location and trial type...

http://www.clinicaltrials.gov/

Best of luck!  ~ Jill

 



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Jill 

(71 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.

 

 
shorty213


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good evening everyone.I am out of Los Angeles and am having trouble finding interferon free TX study in my area.any leads? How do I find one?

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Geno1a vL12 million
gsx1250fa


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Thanks :) I'll keep ya'll updated when I do my blood draws.... good or bad. Hopes and prayers for us all! Thanks :)



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Cinnamon Girl


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Great, well done Michael!  Fingers crossed for you...it`s gone well for you so far!  smile  ~ Jill



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Jill 

(71 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.

 

 
gsx1250fa


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Welp...Took my final dose (ledipasvir/sofosbuvir/riba) this morning and gave my 12 week blood draw. We shall see. Doc gave me a realistic 80's % chance of svr given my prior Tx's and the fact I am cirrhotic. I have a better chance than ever before. Hopes and prayers for all of us :)



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gsx1250fa


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Thanks :) I could actually put myself on self concocted Quad therapy..lol...think I'll wait :)



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Cinnamon Girl


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Great results so far, Michael, good going.  smile  I can understand you feeling tempted to dig out your stash of old tx drugs...but don`t do it!!!

Keep going..best of luck!  ~ Jill

p s. - I`ve joined your 2 threads together so that your updates and replies are all in one place.



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Jill 

(71 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.

 

 
gsx1250fa


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Well...week 8 came back UND also. Alt (74) and AST (54) were a slight drop. I just hope 12 weeks is enough Tx time. That is the length of the study. I have half a mind to continue (personal Tx) with the excess of  drugs I have been storing for the last 3 yrs of Tx. I could probably extend another couple of months with the riba, vic and interferon I have left over from the prior Tx attempts. probably won't though. just a thought..... 



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gsx1250fa


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Thanks. Hopefully this treatment sticks for me and all others in my study group. We are all null responders to prior treatments. If so...maybe a more "pleasant" way to treat/cure will be available soon. Fingers crossed and prayers repeated :)



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Mary Jane


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thumbsup.gif Michael... hoping this one sticks, thanks for sharing, glad no side effects how awesome... all the best MJ



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Do not go where the path may lead, go instead where there is no path and leave a trail.Ralph Waldo Emerson

1a - VL 22 million  F2- IL28B- CT / Inck-Riba- Peg triple therapy 9/15/12 UND 4/8/14  8 wks BT ..3/1/2013 done! 3wks Post UND
gsx1250fa


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Thanks. Hope it sticks. Hopefully a new era in treatment (interferon free all oral) without the extreme side effects is around the corner. 



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Cinnamon Girl


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Hi Michael, that is such great news, you must be thrilled!  Congrats to you!!  biggrin  Good to hear it`s going so well with hardly any sx, keep going and best of luck!   ~ Jill

ps - I don`t know why your post repeated so many times but I`ve removed the duplicate ones for you.  We`ll check it out.



__________________

Jill 

(71 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.

 

 
gsx1250fa


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Week 4 results came back Undetected :) First time UND for me in 4 treatment attempts over the last 3 years. I feel I'm half way home. Now I just have to stay UND. Haven't had any real side effects even with the riba...which leads me to believe...most of the prior side effects were due to the interferon. It's a good day! Thank you God :)



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Cinnamon Girl


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Hi Michael, thanks for sharing the details of the study you are on, looks like you`re heading in the right direction so far at only 2 weeks in.  Best of luck with your 4 week blood results!  smile

I`m moving this thread to the `Clinical Trials` section and making it a `sticky` like the other trial threads we have going on.  Looking forward to following your progress.  Keep us posted!  ~ Jill



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Jill 

(71 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.

 

 
gsx1250fa


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Thanks for the support and just an update. 

Pretreatment viral load 3.6 mil

alt-270

ast-213

Week 1 bloodwork Viral Load <25

alt-137

ast-81

Week 2 bloodwork Viral Load still <25

alt-86

ast-56

A few of the participants (that I was able to talk to)  with lower pretreatment viral loads have gone UND at week 2. They (as all in my study) are prior null responders.

Next bloodwork will be at 4 weeks. I have a glimmer of hope nonetheless. All participants will do the full 12 weeks regardless of VL. here is an article by gilead that came out yesterday. Shows hope for the prior null responders:)....and PLENTY of hope for treatment naive genotype 1a people. thanks

 



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mallani


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Hi Michael, welcome back. I remember your previous posts in July 2012 when you were discussing your Victrelis regime. Sorry to hear that didn't work. I presume when you say Geno 1a-5, the 5 is your Knodell Score from the liver biopsy. Glad to hear you're on a good trial- we will follow your progress with interest. If I was on that trial, I would prefer to be on the arm you are on (with Riba). Best of luck and please let us know how you go. Cheers.



__________________

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
TazKat


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yes please keep us informed. i too am going to see a new doc. this one is a real heptologist that moved to the umc in jackson ms. i was going to g&I clinic. but she got pissed at me because i had to leave treatment at 3.2 weeks because i broke a tooth halfway in my head that hurt like hell.. well i have a whole new smile (dentures) now. lol  i had done treat of interferon & riba twice for 3 months each to no avail. trhe 2nd nurse practionier (sp) should have know better to even let me try again. i was on a study trial of something (i forget the he name) & had a small rash within 3 weeks into & they immediately took me off. well will never show crap again.. .  it was a double blind study that we found out after i was on incevik last oct that in fact the other was working on me in that small ength of time. i was undetected with the incivek, but i think the the prob with my hard headed geno type 1a self is that when it is just the interferon & riba & a small cell (must have been hiding) just does NOT work for me. at least i was undetectable for about 6 months or more. i really want to keep up with this new thing. so please keep the info coiming. i was stage 3 almost 3 yrsago. i am kinda scared now. i  know that my viral load jumped from 0 to 500,000 in two weeks. ??? does it do that, that fast?   :)  Taz

 



__________________

TazKat Genotype 1A null responder x 3 riba & iterferon twice, relapsed from Incivek 2012 with only 12 weeks left to do. stage 4 mild cirrhosis 4/25/2014/ started sovaldi riba & interferon.. finished treatment 7/17/14  results 7/25  cleared..

 

 
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