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Hep C Discussion Forum -> On Treatment -> Trial for people who failed DAA treatment
Post Info TOPIC: Trial for people who failed DAA treatment
mcmaklin


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RE: Trial for people who failed DAA treatment
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And another question which is imporant to me: can the virus MUTATE because of treatment the way that it can be something new unable to be cleared by any drgus?

 



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2nd Vosevi12wks- SOT Sept 12,2018 to EOTDec 5, 2018. Pre-trtmnt - VL 1.4 mil, ALT 45, AST __, ALP 69, GGT 90. 2 week - VL 49, ALT 26, AST __, GGT 53. 4 week-VL <15, GGT42 other normal, 5week: ALT 17,AST 27, Bili 11.8, ALP 68,GGT 36,15X VL12., 6week ALT 19,AST 26,Bili 16,20,GGT35, VL<12,8W UND
mcmaklin


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Just to remind you - I have probably no NS3 RAVs - I have NS5A RAVs L31M and Q54h and genotype 1b.

My consultant believes the best available regimen here will be ABT-530 and ABT-493 which works probably the best for L31M. I trust my consultant although this is interesting what I can get to know here. ABC-530 is probably much better than Velpatasvir here

So if you want to help me just let us discuss this

Do you know anyone with genotype 1b who failed Viekira Exviera?



__________________

2nd Vosevi12wks- SOT Sept 12,2018 to EOTDec 5, 2018. Pre-trtmnt - VL 1.4 mil, ALT 45, AST __, ALP 69, GGT 90. 2 week - VL 49, ALT 26, AST __, GGT 53. 4 week-VL <15, GGT42 other normal, 5week: ALT 17,AST 27, Bili 11.8, ALP 68,GGT 36,15X VL12., 6week ALT 19,AST 26,Bili 16,20,GGT35, VL<12,8W UND
Canuck


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Pablo,

Yes, not only does this article (kind of) touch on mcmaklin's query, but so do other studies/articles stuffed inside and throughout that GT3's and sof/vel trials thread. As well, there are other articles regarding IL28b CC, CT and TT, and other articles related to RAV's (in one way or another) scattered in different threads all over this site, that are of general subject matter interest, none that outright answer what is the best regime for mcmaklin.

In quest of thee "specific" best "rescue regime" for mcmaklin, it is hard to know with any authority, the subject is so complex. Maybe Tig or malcolm can wing it with some thinking on this.

The article we have here, unfortunately, is absent of and does not highlight NS3/4A VOX (used in conjunction with sof/vel as Gilead's rescue regime) - there are other articles (mostly pro-Gilead) that speak further on this triplet rescue regime that we have yet to see to come to market.

Generally, VEL is proving itself very pan/effective regardless of GT's, CT's/TT's, RAVs, cirrhosis, etc., boasting a host of qualities that allows it to help many people better.

The next good question is (getting ahead of ourselves), if you fail sof/vel, then where do you go? But all the while you have to note that most are NOT failing sof/vel as a treatment-naïve or as a rescue regime, nor are they failing sof/vel/vox as a rescue regime.



__________________

HCV/HBV 1973. HBV resolved. HCV undiagnosed to 2015. 64 y.o. F. Canada.

GT3a, Fibroscan F3/12 kPa - F4/12.6 kPa, VL log 7.01 (10,182,417), steatosis, high iron load.

SOF/VEL with/without GS-9857 trial - NCT02639338.

SOT March 10 - EOT May 5, 2016 - SOF/VEL/VOX 8 week trial.

 

(SEE UPDATES IN BIO)
Pablito


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I attach a paper on RAVs.  I think I may have got it from Canuck.



Attachments
RAVs.pdf (595.1 kb)
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44 y.o. male, HCV G4 since 1996, F-scan score 9, F2, Failed prior I/R, finished sof/vel/vox 8 weeks 5/16, pre-treatment VL 2 million, EOT UND, EOT+4 UND, EOT+12 UND.
mcmaklin


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Hello I am waiting for trials for those who relapsed with ABt-530

Please let me know about RAVS - I know I have L31M - what do you say sometimes "to test RAVs" in "position" 1, 2, 3. What does it mean? I know I can test for specific RAVs in Region Ns5A like L31M or Y93h. Can I test more somewhere?

do you know anyone else who relapsed after  Viekira/Exviera with genotype 1b?



-- Edited by mcmaklin on Wednesday 14th of September 2016 02:01:15 PM

__________________

2nd Vosevi12wks- SOT Sept 12,2018 to EOTDec 5, 2018. Pre-trtmnt - VL 1.4 mil, ALT 45, AST __, ALP 69, GGT 90. 2 week - VL 49, ALT 26, AST __, GGT 53. 4 week-VL <15, GGT42 other normal, 5week: ALT 17,AST 27, Bili 11.8, ALP 68,GGT 36,15X VL12., 6week ALT 19,AST 26,Bili 16,20,GGT35, VL<12,8W UND
mcmaklin


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Hello - I am waiting for trials for those who relapsed - trials with

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2nd Vosevi12wks- SOT Sept 12,2018 to EOTDec 5, 2018. Pre-trtmnt - VL 1.4 mil, ALT 45, AST __, ALP 69, GGT 90. 2 week - VL 49, ALT 26, AST __, GGT 53. 4 week-VL <15, GGT42 other normal, 5week: ALT 17,AST 27, Bili 11.8, ALP 68,GGT 36,15X VL12., 6week ALT 19,AST 26,Bili 16,20,GGT35, VL<12,8W UND
Canuck


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Canuck wrote:

Hi mcmaklin,

Don't know what country you are in. Here in Canada, Epclusa seems to have finished trials, but the sof/vel (perhaps with the VOX) I just did, would seem to fit your bill, as far as TT, RAVS.

They are starting to dole it out, spotty, "approved and on the market" (here and there) in U.S. One customer on site hails from Alabama, another in Ohio.

In Canada they have "technically approved" Epclusa, doing GT 1-6, 12 weeks, cirrhotics add riba. (But this does not mean anyone, anytime soon, in Canada is going to get it!)  C.

I tried to edit this old post, I thought I already done so?, but it didn't work, too old I guess  - this was in regard to mcmaklin (about sof/vel, etc.) - to his query about Abby drugs. I've corrected my post now (shown above) -  it was OHIO not Ontario.

 

 



__________________

HCV/HBV 1973. HBV resolved. HCV undiagnosed to 2015. 64 y.o. F. Canada.

GT3a, Fibroscan F3/12 kPa - F4/12.6 kPa, VL log 7.01 (10,182,417), steatosis, high iron load.

SOF/VEL with/without GS-9857 trial - NCT02639338.

SOT March 10 - EOT May 5, 2016 - SOF/VEL/VOX 8 week trial.

 

(SEE UPDATES IN BIO)
mcmaklin


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HR, How are you doing on the newest Abbvie trial? I failed Viekira+Exviera and maybe will be taking part in the 3rd phase of Abbvie Trial that you are taking? How are you? Which group are you in and how do you feel?



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2nd Vosevi12wks- SOT Sept 12,2018 to EOTDec 5, 2018. Pre-trtmnt - VL 1.4 mil, ALT 45, AST __, ALP 69, GGT 90. 2 week - VL 49, ALT 26, AST __, GGT 53. 4 week-VL <15, GGT42 other normal, 5week: ALT 17,AST 27, Bili 11.8, ALP 68,GGT 36,15X VL12., 6week ALT 19,AST 26,Bili 16,20,GGT35, VL<12,8W UND
Canuck


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Hi,

Don't know what country you are in. Here in Canada, Epclusa seems to have finished trials, but the sof/vel (perhaps with the VOX) I just did, would seem to fit your bill, as far as TT, RAVS.

They are starting to dole it out, spotty, technically it is "approved and on the market" (here and there) U.S. and Canada. One customer on site hails from Alabama, another in Ohio. Canada they have "approved" doing GT 1-6, 12 weeks, cirrhotics add riba. C.

Corrected!



-- Edited by Tig56 on Saturday 27th of August 2016 03:26:17 PM

__________________

HCV/HBV 1973. HBV resolved. HCV undiagnosed to 2015. 64 y.o. F. Canada.

GT3a, Fibroscan F3/12 kPa - F4/12.6 kPa, VL log 7.01 (10,182,417), steatosis, high iron load.

SOF/VEL with/without GS-9857 trial - NCT02639338.

SOT March 10 - EOT May 5, 2016 - SOF/VEL/VOX 8 week trial.

 

(SEE UPDATES IN BIO)
Loopy Lisa


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Hey folk,

Sorry to hear about the RAV's. I think these trials look promising and it gives more options for people. A choice between pills for 12 weeks and a single injection, I'd take the latter any day of the week. 

I hope this time you get a cure, nothing worse than disappointment when everyone else seems to be curing...

Good luck!!!!



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Genotype: 3b

VL.�over 15, 000 000

Failed TX 2014: Interferon/Riba.

Cured using Sof/Dak combination.

I can eat cake again! <3 
mcmaklin


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I replased a month after EOT.

What are options for me now? My consultant says that we know we are waiting for, that the most promising option among patients with NS5A mutations seems to be ABT-530 and ABT-493. That the results of researches show that they work better then other drugs against mutations. 

Have you Heard about trials for those who relapsed? 

Do you know other who relapsed after Viekira+Exviera?

Genotype 1b, TT, now F1,  Relapsed a month after EOT after Viekira+Exviera no Riba 12 weeks in December 2015

As now is 6 months after EOT I know I have RAVs: In Region NS5A I HAVE L31M and Q54h,  I do not have Y93H. I have no RAVS in regions NS3. 



-- Edited by mcmaklin on Thursday 18th of August 2016 11:42:56 PM

__________________

2nd Vosevi12wks- SOT Sept 12,2018 to EOTDec 5, 2018. Pre-trtmnt - VL 1.4 mil, ALT 45, AST __, ALP 69, GGT 90. 2 week - VL 49, ALT 26, AST __, GGT 53. 4 week-VL <15, GGT42 other normal, 5week: ALT 17,AST 27, Bili 11.8, ALP 68,GGT 36,15X VL12., 6week ALT 19,AST 26,Bili 16,20,GGT35, VL<12,8W UND
HR


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JLynch30 wrote:

you failed harvoni 2 times?  With or without Ribavirin?  I have not heard of this - are there others in the same boat?

 Without Ribavirin both times. I would say there are others but I don't know the number. It cures most folks the first go around so I wouldn't worry too much about my situation. 



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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
JLynch30


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you failed harvoni 2 times?  With or without Ribavirin?  I have not heard of this - are there others in the same boat?



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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

 
HR


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Hey Matt,

Yes. TLI is the site that called me. I have not got any info on my RAV profile since last treatment. Ive been feeling good so I haven't been really concerned about it but I think I will start to pursue that info again. They just don't like to give out that info for some reason. I asked about getting my Il28B genotype and they said Gilead has that and they ( TLI) didn't have that info. Also said that that didn't matter on these new DAA's . Well the sign up sheet for this ABBVIE trial wants you to have the IL28b test done which makes me think it might be more important than they let on.  

So at any rate this ABBVIE trial is a Phase II so I'm not going to participate. I will wait for Phase 3 or something down the road a bit. 

Cochrystal Pharma has some interesting things coming up. The guy from Pharmasett is there. Check out their website.

Good luck with treatment and I want to see a SVR 12 from you. Take care Buddy.



__________________

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
Matt Chris


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Hey HR

Nice to hear from you again, thanks for posting this info. I assume that TLI is one of the sites for this study. I had been watching these ABBvie DAA's for quite a while, reading data from NATAP it said that in vitro they had a very high barrier to HCV resistance / RAV's so it might be a good fit for either a NS5A or NS3/4 failure. BTW, HR did you get any data on your RAV's profile since your last treatment, it can be very important in choosing your next DAA selection.

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! 
Tig


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Hi,

I had not seen the newest info on that, TT033 was the older article I read. After you pointed it out, I found this short article on TT034. It's an interesting protocol we're definitely going to watch! Thanks for all your info.

http://www.news-medical.net/news/20150429/Fifth-patient-dosed-in-Benitecs-TT-034-Phase-IIIa-clinical-trial-for-prevention-of-HCV-infection.aspx



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Tig

68yo 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!

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HR


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Tig 

Its TT034 and it is an IV infusion. Single shot and you're done. As I said the 6 th patient is going to be dosed in about 6 weeks( fingers crossed no more delays) and this is where efficacy will start to show if it works. There are 5 cohorts and the 6th patient is the first in cohort 3. It's a frustrating trial to watch because of the delays but Lawitz's team has been added to the trial sites so that may help speed things up.

Yes, our friend Ribavirin is still in the mix. The lady I talked to about this Abbvie trial was saying these are second generation drugs? Anyway I just don't want to do 3 trials and it not work. I guess we will see.



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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
Tig


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Hello,

I haven't heard much on this, but it does appear to be an effective pan genotypic combination. I don't see much discussion on treatment lengths though. I see that our old friend and enemy, Ribavirin is still in the mix. The clinical trial information states that Abbvie is sponsoring the studies on it.

Another thing I found while searching was Benitec's work with TT 033. It's a single dose regimen administered IV. I'm going to look for more current information on that.

 http://www.natap.org/2014/AASLD/AASLD_51.htm  ABT 493/530

http://www.natap.org/2014/CROI/croi_14.htm   ABT 493

http://www.natap.org/2014/CROI/croi_11.htm.  ABT 530

Clinical trials: 

https://clinicaltrials.gov/ct2/show/NCT02243280?term=Abbvie+%26+Hepatitis+C&recr=Open&no_unk=Y&rank=10



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Tig

68yo 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!

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HR


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Hey guys,

i haven't posted in a while but was contacted by my study place about a trial for people who failed DAA treatment so I thought I would run this by you. As some of you know I failed Harvoni twice. The first was 12 weeks and the second was 24 weeks. 

Anyway, has anyone had any experience with the drugs below? 

I have been keeping a very close eye on Benitec/Tacere and here in about 6 weeks they will be getting into therapeutic level dosing. 

Thanks

 

 

 

 

Dosing Period

You will be assigned to one of three study Arms (Arm A, B, or C) in a 1:1:1 ratio based on your HCV genotype 1 subtype (1b or non-1b) and the type of DAA treatment that you previously received.

If you are an eligible to participate in the study, you will be enrolled into one of the following arms:

  • Arm A: ABT-493 200 mg (two 100 mg tablets) + ABT-530 80 mg (two 40 mg tablets) once daily for 12 weeks

  • Arm B: ABT-493 300 mg (three 100 mg tablets) + ABT-530 120 mg (three 40 mg tablets) once daily + RBV 800 mg (four 200 mg tablets) once daily for 12 weeks

  • Arm C: ABT-493 300 mg (three 100 mg tablets) + ABT-530 120 mg (three 40 mg tablets) once daily for 12 weeks 



__________________

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
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