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Post Info TOPIC: ALL ABOARD THE VOSEVI TRAIN


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RE: ALL ABOARD THE VOSEVI TRAIN
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Hi Mak,

If you are asking me?, no, i really don't have any more new thoughts about your old Ravs history, I have already spoken of them in everything I have ever said about them, in the past, in all our threads. 

But i am awful glad to hear from you, and glad to be able to know a bit more of your news about how you are feeling now (about how it is feeling for you NOT being on the drugs for a while now). Too bad about catching/feeling that cold right now, a cold is just a cold, it will not be affecting your HCV cure. A lot of us seem to have minor afflictions happen to us after EOT, I don't know why, i think it is all the stress we encounter during treatment that certainly does not help us in NOT catching colds during in cold season! Noting your increased thirst and your need for coffee (as you have) is interesting - good you are listening to your body's demands. Keep drinking lots of water then. I made that mistake and found out the hard way that i should have kept up the water drinking after EOT, I slacked off for a while, and did not feel good for it. I also had some funny things with coffee cravings - oddly, i went "off coffee" for some reason!

Are you back in the UK now for the next while, and will be staying there in the UK, or, are you always frequently back and forth between Poland and the UK?

Ah, yes, that's right, thanks for refreshing my memory for me again, over time! You have NOT received your EOT results as of yet -the UK doc is making you wait a long time to receive your Jan 4th VL (EOT) draw results eh?! 

Let us know the EOT VL results when you know please, and when you plan on having your next LFT's/VL done again.

Keep treating yourself as good as you possibly can, you need a bit of recovery time from all this treatment. Get good rest, good food, good sleep, a little exercise and fresh air, and keep drinking lots of good water. I hope your cold is short lived! C.



__________________

HCV/HBV 1973. HBV resolved. HCV undiagnosed to 2015. 63 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)



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Congratulations to Brad and Robert! 

I had the official test the 4th of Jan. They are not telling me anyting they will send mi the results. Only the viral load I did.

The next one - I have forms but there is no time set to do it.

I will do unofficial but have no idea when.

I do need feel much difference after stoping the Vosevi, I do need to drink so much water. this is the ting. And apart from that I cougth a cold, nothing seriouse but I feel unwell. I hope it has no influence on my aim of being cured when you fight with the cold. So now I can say I feel worse than on treatment. And the more I need  a bit more coffee, as durs were dong similar things to coffee I think.

So indeed you do do not have any thoughst on results of my RAS and L31M?

 



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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



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Congrats Brad happy for you!



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Male, 66, Dx 1990, GT 2a/2c. Pre-tx VL 11,500,000, ALT 10, AST 18, F3, 12.4 kPa. Rx: 12 weeks Epclusa, SOT 3/8/18, EOT 5/30/18. Week 2 VL 50, ALT 12, AST 21. Week 10 VL not detected, ALT 12, AST 18. EOT + 12 weeks: VL not detected, ALT 11, AST 19. EOT + 24 weeks VL not detected, ALT 9, AST 24.



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Congratulations, Brad!  So excited for you.  I can't imagine the relief you must be feeling.



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age 65
gender F
genotype 2
fibrosis stage f0
HCV diagnosis date Oct/18
SOT May 10, 2019
HCV medication Epclusa
HCV lab results (viral load 2,950,000, AST unknown, ALT 10
No prior treatment



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Yay.  



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61 y/o, Infected via transfusion Oct'83, GT-1a, F-4 cirrhotic,
tx Holkira pak/moderiba 12 weeks

3 years...post tx... successful dragon slayer 



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Hey Brad,

Congrats on your victory! SVR12 with your Vosevi re-treatment! 

Thank you, so MUCH, for coming back to let us know. i really appreciate it that you let us know (originally), that you were even on Vosevi) and now, how it turned out for you, as there as so few of us (thus far) who have been able to post/share our vosevi experiences here in this website.

I KNOW there ARE a lot of vosevi-takers out there, but it's just that we have just not been fortunate enough to see them all writing their journeys here, so I especially relished hearing from you back with your first post on Oct 9. smile 

You are man of few word, but the words you share ARE GREAT!

I am so glad vosevi cured you after your harvoni failure, we could feel your worry from your Oct posts. What a wonderful outcome now.

If you ever wish to express more, about any sides you might have felt while on the vosevi, or how long ago it was that you failed the harvoni, or, anything at all (from lab results to how you feel now), we would be all ears. 

You don't have a sig. line yet, so, for those who had not met you until now, here are some of the prior stats you relayed thus far (but I am just estimating your aprox. start and end dates) ... HCV for 30 years?, GT1b, failed Harvoni in ____. Re-treatment with 12 weeks Vosevi - SOT July 19, 2018 to EOT Oct 11, 2018? VL 3.5 million. UND at week 8 of treatment. SVR12 on Jan. 3, 2019? ... 

Thanks again, so much, for coming back and filling us in - these communications are so appreciated. I am happy for your long-waited and well-deserved SVR12! biggrin C. 



__________________

HCV/HBV 1973. HBV resolved. HCV undiagnosed to 2015. 63 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)



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 I havent met you yet Brad, but I am so happy for you. what a blessed day!



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Gail Tanner

65

Female

Genotype 2

Fibrosis stage: F1-F2 (minimal fibrosis/scarring)

Diagnosis date: 10/30/18

Treatment started: 2/9/19

HCV medication: Epclusa

Viral load: 3,292,271 Iu/ml 

AST: 25 (normal)

ALT: 26 (normal)

ALP: 81

CAP: 226 <10% fat

ANA: 12.8 

No prior HCV treatment.

5/14/19: NO HCV DETECTED!!



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That is fantastic, Brad.  Thanks for bringing that good news into our day.

Now go out and play.  I hope you will mark this occasion with a celebration, anything that does it for you.

Yes enjoy your HepC Free life.  

Let us know how you are feeling as you readjust.

 

 



__________________

GT2a, VL 681,500, Less than F1, Treatment Naive

12 wks Sovaldi/Ribavirin, SOT 2/25/16, EOT 5/17/16

UND at 2,4,8 and 12 wks during treatment but ribavirin crazy.

ALT/AST normal EOT

SVR12 8/13/2016!!!!!!!!!  I WON!!

EOT 6 Months 11/12/2016  CURED

 

Tig


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Excellent! That’s the news I like to hear. Congratulations from me, too. SVR is definitely the way to go! Enjoy your new Hep free life...



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Tig

62 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!

Hep C FAQ   Lab Ref. Ranges  HCV Resistance

Signature Line Set Up/Abbreviations   Payment Assistance

 



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Congrats Brad!!  That VOSEVI is the BOMB!!  Enjoy your Hep C free future.  I like hearing about all the positive vosevi re-treatments. Your in th SVR-12 club now. How are you feeling?  RC



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 M-61(3 Treatments)( SOF-RIBA 2014)(SOF-RIBA-PEG 2016)(HCC 2016) (LIVER TRANSPLANT 8-2017)(VOSEVI-RIBA 2017)   SVR-12. 3-13-18 https://aasldpubs.onlinelibrary.wiley.com/doi/pdf/10.1002/hep4.1280   



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brad!! woohoo, congrats



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Gt:1a-36yrs .Started Intron-A in 96' for 2.5mo-VL still too high.taken off. Labs on 3.6.18:. A1 activity.  f3@60: fibrosur bloodtst. AFP=norm. enz=mostly norm.VL=3.9 million.sot=5.1.18>Harvoni>[8wks]: 4WEEKS=UND. Eot 6/25=L.July=norm liverpanel.*13weeks=UND * 6 months =UND: CLUB ZERO



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Wow Brad, Congratulations to you.  You must be feeling very happy, particularly after a previous failure. Another Vosevi success story. clap.gifclap.gifclap.gif

Enjoy your Hep Free Future. party.gifsun.gif



__________________

66/F Contracted Early 80's First Diagnosed Early 2000's 2017 re diagnosis and referral for treatment Gen 3a Fibroscan 8.7

Epclusa 12 weeks commenced 1 May 2018 ALT 72 AST 67

28 May 2018 4 weeks ALT 16 AST 23 ...... 23 July 2018 EOT ALT 23 AST 30 .....Oct 16 2018 SVR12 UND



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Well just got my 3 months post treatment bloodwork after failing on Harvoni. Vosevi did it for me I am clear.

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Brad


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Hi Mak,

No, I don't have any thoughts about the interesting link you found earlier, other than what I already said about it, that it was interesting and I had not seen that before.

How are you feeling since you have been off the vosevi now (mentally and physically)? You have been off about a week now, do you notice ANY kind of difference?? Maybe you had some subtle sides you ere not really aware of while you were on the vosevi, which you may notice they have gone now?

I know when i was on vosevi I had an increase in my fatigue (I had a lot of fatigue before i started the vosevi mind you). Thank goodness, eventually, the fatigue did slowly improve after I stopped the vosevi - i do think the vosevi added some fatigue to the fatigue i had already been having.

Also, the vosevi seemed to make my stomache roil for hours after a dose, but this was not very disturbing or distressing at all, just something I noticed and put up with.

Brain fog was never thicker for me than when I was on vosevi - but that too soon started to improve and decrease after i stopped vosevi (the brain fog decreased more quickly than the fatigue did).

I am just wondering how it is for you - whether you have noticed any of these things (or perhaps other subtle things) at all. I do recall you have said that you have experienced little as far what you thought might be "sides" while you were on treatment, but now that you are off vosevi, perhaps you will have noticed (in retrospect) that you did feel "something" of a vosevi effect?

You've had a EOT UND right?, so when do you plan on having another set of bloods with VL drawn? - I wonder if you will be able to wait until EOT+12 weeks for your next set of labs??

Let us know how you feel, and what your lab testing plans are - when did your doc want to see you next for an appointment? C.



__________________

HCV/HBV 1973. HBV resolved. HCV undiagnosed to 2015. 63 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)



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Maybe from the attachements I sent earlier you can tell me any thoughts...



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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



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The interesting link was from the place that I found in my RAVs results, there was a link to them. No way to know what to enter there.

Any interpretation, thoughts  of attachments I sent you? For me too wise. Thank you. 



__________________

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



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Hi C   Sorry I dident answer your question. I called Swedish Seattle and spoke with my post transplant coordinator,she said  my Dr was on vacation. She had not seen the test results and said she would pass them on to the Dr on call. She called back that afternoon and asked me to repeat all my blood work on 1-2-19. At this point I told her the test almost had to be false-positive. When the re-test came back UND I called my coordinator again and she said they would probably want me to retest again in four weeks. That was on Friday late afternoon and there was not a Dr around to bounce this information off. So as of Sunday Evening (now)  I don't think My Dr is aware of the first results that showed 20/1.301 log.   Its a good thing Chris and I know a thing or two about all this stuff. Im hoping to get a call from Dr sometime tomorrow (monday)     RC

   



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 M-61(3 Treatments)( SOF-RIBA 2014)(SOF-RIBA-PEG 2016)(HCC 2016) (LIVER TRANSPLANT 8-2017)(VOSEVI-RIBA 2017)   SVR-12. 3-13-18 https://aasldpubs.onlinelibrary.wiley.com/doi/pdf/10.1002/hep4.1280   



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Me too RC, I think the link you posted is one of the best, same one I am sure Mak must have seen in the past as it had been brought to Mak's attention before in these ongoing convo's about Ravs. At least I hope he read it in the past! I really like the AASLD one - one stop shopping, after resist.primer you can go straight over to treatment experienced section next (or whereever one could need to go) to see your choices, or glean the info you are after. I like the way it is all laid out to clickread whatever area you need to. 

Mak brought forward an interesting link today, where you can enter your named RAV's! My, I never saw that one before!

From SVR12 and on (once Mak realizes/accepts he IS indeed cured), he is going to have the rest of his life, all the time in the world, a lifetime, to reflect on and figure out what went wrong with his first treatment, and revel in how the second treatment cured him! SVR12 should bring Mak much comfort!

BTW - I was asking further down - what did your docs have to say to you about your 20iu/ml result - did they have any comment to you, at all, on it? Just wondering. : ) C.

 



__________________

HCV/HBV 1973. HBV resolved. HCV undiagnosed to 2015. 63 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)



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This is the best explanation I have ever seen explaining RAV?s.    Its current and to the point!     RC

https://www.hcvguidelines.org/evaluate/resistance



__________________

 M-61(3 Treatments)( SOF-RIBA 2014)(SOF-RIBA-PEG 2016)(HCC 2016) (LIVER TRANSPLANT 8-2017)(VOSEVI-RIBA 2017)   SVR-12. 3-13-18 https://aasldpubs.onlinelibrary.wiley.com/doi/pdf/10.1002/hep4.1280   



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Well so it seems Viekira/Exviera was not so good treatment at all, if I understand well, for you it would be the worse choice than Harvoni. I am reading it all over again and still am not sure to answer the question I asked, so it happened to me because of drugs or because I was taking them too short? it was not a breakthrough.

Replying to 5-1-18 question yes I was undetected at the EOT.

As your knowledge is indeed great and I have so many data I am sending there my test for predictions. Can you comment this please? I do not understand what is this Substition on scored position. And now I am trying to help you to reply the question I have asked about my relapsing and about my chances now. I believe all data I have here  can bring anything new.

I am also attachin here NOT MINE, I HAVE GOT IT TO COMPARE FROM SOMEONE ELSE I know, who also failed Viekira/Exviera  (as far as I know the worse way, having viremia just after the EOT back, and having F3-F4 and 1b genotype as well). The person now is having retreatment with Maviret+Sofosbuvir+Riba. After finish the first month is <12 still detected. - I would like to understand those predictions of mine, and I know it could be an important document for you. I do not know what is a substitution on scored position and what is resistant here, and what they tested (It was done by me second wise doctor, not at the place where is my official treatment, although I gave it to them)

Additionally I am sending you another paper that I have  after my bad treatment, another mutation test from May 2016 - It seems they were not able to do it that  well  as later, but the test says only (translation): we made a sequencing of the fragment coding material  to the NS5A in the area of mutation L31M and Y93H in the HCV Genome. In the material we DID NOT FIND presence of mutation Y93 relative to the ref sequence AY045702 for subtype 1b. WE FOUND MUTATION L31M,  APART FROM THAT  ADDITIONALY WE FOUND MUTATION Q54H. {IS IT ANYTHING IMPORTANT??}

And at the same time in May 2016 they were also testing me for the NS3 - document says: we made a sequencing fragment coding region NS2 among mutation D168A/F/H/N/Y/V in the HCV genome. W have  not confirmed in the material  mutation D168A/F/H/N/Y/V relative to the ref sequence AY045702 for subtype 1b.

We were not able to estimate mutation for Y56H in the material - the reason could be: low Viral Load, different than 1b HCV genotype, mutation in the place of the attaching (connecting) starters or current treatment.

It seems in my second test later, they mentioned the Q54H but has it disappeared or what happened?  By the way I think I found anything interesting https://hcv.geno2pheno.org

 And what means this NONE near the Velpatasvir...

 


-- Edited by mcmaklin on Sunday 6th of January 2019 11:36:12 AM



-- Edited by mcmaklin on Sunday 6th of January 2019 11:36:59 AM



-- Edited by mcmaklin on Sunday 6th of January 2019 11:39:16 AM



-- Edited by mcmaklin on Sunday 6th of January 2019 11:48:26 AM



-- Edited by mcmaklin on Sunday 6th of January 2019 11:50:04 AM



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-- Edited by mcmaklin on Sunday 6th of January 2019 12:05:27 PM



-- Edited by mcmaklin on Sunday 6th of January 2019 12:08:30 PM



-- Edited by mcmaklin on Sunday 6th of January 2019 12:11:22 PM



-- Edited by mcmaklin on Sunday 6th of January 2019 12:14:13 PM

Attachments
__________________

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



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Mak,
I was hoping to avoid this topic...it gives me a headache!
I was happy to be finished researching this area when deciding my re treatment approach.
It was a frustrating experience.
I was approved for Vikiera Pak but was naturally concerned about the
cross resistance with the failed NS3/4 PI simeprevir and the NS3/4 PI
component parataprevir included in Vikiera Pak. Why I was the only
one concerned about it among everyone involved in my treatment remains a mystery.
I was ultimately able to convince my hepatologist that this was the wrong
regimen to use, as it clearly states in the AASLD guidelines.
Some Doctors are willing to re-treat using different PI's but HCV patients...not so much.
There is an issue with Resistant substitutions with how long it takes for them to
disappear and I was not willing to chance using another PI in my re treatment.

Genetic Barrier to Direct Acting Antivirals in HCV Sequences Deposited in the European Databank
https://www.gastrojournal.org/article/S0016-5085(16)30055-5/pdf

Resistance of HCV to DAAs is determined by 3 major
factors.
One is the genetic barrier to resistance, related to
the number and type of
nucleotide substitutions required
for emergence of RASs during replication and to the number
and type of RASs required for a viral
variant to acquire full
resistance to the drug.
The genetic barrier to resistance
varies with drug class, specific drug, and HCV genotype or
subtype.
It determines the likelihood that resistant viruses
are generated during replication.
Resistance is also determined by the fitness of resistant virus populations, which is
independent of the level of resistance conferred by the RASs
(the most resistant variants are not necessarily the fittest
and vice versa).
Fitness determines the likelihood that
generated resistant viruses persist in minor or major populations.
Resistance is finally determined by level of drug
exposure compared with the drugs 50% and 90% inhibitory concentrations in vitro.
In vivo exposure affects the
ability of a drug to inhibit replication of resistant variants.



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Age 54,  G1a,   F1,  12wks S/O 2014 - rlps ,  12wks Har/Rib 2016 - SVR 12 ,



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mak, at what week eot did they discover the detection?



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Gt:1a-36yrs .Started Intron-A in 96' for 2.5mo-VL still too high.taken off. Labs on 3.6.18:. A1 activity.  f3@60: fibrosur bloodtst. AFP=norm. enz=mostly norm.VL=3.9 million.sot=5.1.18>Harvoni>[8wks]: 4WEEKS=UND. Eot 6/25=L.July=norm liverpanel.*13weeks=UND * 6 months =UND: CLUB ZERO



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Thank you for the very interesting information again.

 

I am just curious how a relapse is connected to the barrier of resistance on treatment. It is relapse not a breakthrough- when I was taking Viekira I relapsed and I was UND so is it not the thing that simply I was not taking drugs long enough? The treatment was working well while on drugs.



__________________

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



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RC,

None of us can be happier for you. Oh how we want to see these und's!

So, I am sure you must have had a "consult" (a verbal exchange/query) with your doc over your recent labs ... what "words" did your doc have to say to you about your first VL of 20 iu/ml? - what "explanation" did he offer you for your first lab showing up as a VL of 20 iu/ml?

C.



__________________

HCV/HBV 1973. HBV resolved. HCV undiagnosed to 2015. 63 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)



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Hey sleestak,

I am happy and more comfortable with how you have retracted your (prior) comment about the importance of the third component the NS3/4A  VOX in the triple vosevi, I was having a bit of trouble with that statement (as was worded at the time). I am glad you have been over reading in the sof/vel and sof/vel/vox thread. Not to detract from the importance of a good powerful NS5A anyday, but good thing, vosevi has that too!

Tig and RC and i and others have had many, very similar and repeated discussions with Mak over various different threads, over time (some threads which Mak started and many other threads where he brought up questions and was having conversations with us, on this very subject). As you can see in the more recent threads (Maks or Angelseven), we had been (not that long ago) comparing the potency of the double MAV (5A and 3/4A only) as compared to the triple Vosevi (5A, 5B and 3/4A), and where we were studying what the best re-treatment drug choices were when it comes to doubles or triples. Angelseven you may recall did an off-label addition of sof to make her Mav a triple.

Those studies (over in the sof/vel and sof/vel/vox thread) were very convincing to me on the power held in 3/4A's (like VOX) and in a triple like vosevi. Especially convincing was how pre-existing RAV's were no obstacle for vosevi.

We are right to reinforce to Mak that he has indeed received and done the best 16 weeks possible! smile C.



__________________

HCV/HBV 1973. HBV resolved. HCV undiagnosed to 2015. 63 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)



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Hi Mak,
Earlier in the thread I stated this
Logically it would seem better to drop the protease inhibitor rather than the NS5A inhibitor. As you stated, it is the NS5A that is the more important one.
After further evaluation, I am retracting my statement.
While it is true that concerning resistance, treatment regimens are particularly concerned with the NS5A target, the NS5A inhibitor is not necessarily the most important component of the treatment regimen where re-treatment is concerned.
As Tig Stated prior to your retreament; With the new DAAs, they typically have a combination of drugs that break the chain of replication at several points, NS5a, NS5b and NS3/4. As long as the virus is effectively blocked at one point in the chain and long enough to render the virus undetectable, your immune system then takes over and maintains or sustains the viral response (SVR).

https://hepcfriends.activeboard.com/t61807677/sofvel-and-sofvelvox/

In your case, with the L31M substitution, albeit susceptible, the Voxilaprevir is as much an important part of the regimen as the others.
When I was retreating, the strategies available for retreating were 1) switching to a different DAA class or classes, 2) treating for longer, and 3) adding ribavirin.
Because the "second generation" DAA's were not approved yet, my only options were to switch the target site from NS3/4A(simeprivir) which was in the regimen I failed, to NS5A(ledipasvir) which is in Harvoni. Then I also added Ribavirin just because it was the only other available drug to throw at it at that time.

Also as was mentioned earlier regarding resistance. The NS5A inhibitor Ledipasvir is considered to have a low barrier to resistance. As well, the NS3/4A protease inhibitor Simeprevir is a low barrier to resistance drug, which was a component of my first treatment Sofosbuvir/Simeprevir.
All the drugs in Vikiera pak are low barrier to resistance also.
VOSEVI - (Sofosbuvir, Velpatasvir, Voxilaprevir) all of these drugs have a high barrier to resistance. In effect this means higher potency basically.
Regarding your L31M substitution; You've re-treated with an NS5Ainhibitor with a higher barrier to resistance. You also have the NS3/4A target covered in the chain- also with a higher barrier to resistance drug.
So you've treated on the best of the best with the bonus of an additional 4wks tacked on to your original 12 wk script.
You couldnt be in a better position for SVR!

I'll just add this here from Robertsamx experience;

Response-guided treatment in
the DAA era may still be an important tool in difficult-to-treat persons. Because this was a single case,
it is important to state that we cannot infer safety
and efficacy when applying to a wider population.
Specifically, we cannot conclude from our experience if SOF/VEL/VOX alone for 12 weeks would
have proved effective without RBV intensification
or duration extension to 16 weeks.

https://aasldpubs.onlinelibrary.wiley.com/doi/pdf/10.1002/hep4.1280 


While you are not a liver transplant recipient, you are the only other person we know of thus far to receive 16wks of Vosevi. No one can predict your outcome. But we all have a good hunch what will be!!



-- Edited by sleestak on Saturday 5th of January 2019 09:55:44 PM

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Thank you all, If we learn anything through the course of treatment the #1 thing is patience.The second thing is not to jump to any conclusions before you have all the facts. With the knowledge gained from this forum and sharing all our treatment experiences, things come into a clearer focus. We all hear about false positives but may think in the back of our minds- no way it doesnt happen- or we think it only happens to others so I must have relapsed, but false positives do happen and now that we have experienced it amongst us it should give others hope. 2018 ended on such a low note- just a little residual twitch from a Long Dead Dragon, reminding me of what I have been through and the hard battle won. And 2019 starting out with Victory renewed and confidence restored. Never Give Up!!  RC



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ROBERT!! Such a long journey, you are an inspiration. Enjoy Enjoy Enjoy!

And CONGRATULATIONS ,!!!!! 

 



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60 years on planet, Female, diagnosed 1978 as non-a non-b, VL 8mill+, Fibro f-1f-2, Genotype 1a, treatment naïve....UNTIL 7-01-18  !!!! started Harvoni 12 weeks. :)

4 weeks=UND, 8 weeks=UND, 12 weeks=UND (EOT= 09-23-2018)



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So fine , Robert.  Congratulations.  I know you knew it was a false positive reading, but getting the results on paper, officially ... must feel  like putting the load down.  Whew.



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70 YO M, Dx 1999, 1a, cirrhosis; Pegasys/Riba Neupogen Aranesp in 2001, partial responder; PegIntron Riba 2002, partial; Phase 2 Clinical Trial Pegasys/Valopocitabine 2004, relapse at EOT; Sovaldi/Olysio 2014, SVR; HCC 2015, TACE 2016, Transplant 2016

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Nothing means you should take the Epclusa. The literature provided proves the efficacy of Vosevi. You will not gain a single advantage by taking additional DAA’s. Let’s concentrate on your week +12 viral load test. It will prove what you have completed was effective.



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Tig

62 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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does it mean I could take the Epclusa longer or the risk was anyway too high because of lack of the Vox? Is this Vox generally important?



-- Edited by mcmaklin on Saturday 5th of January 2019 11:12:16 AM

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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

Tig


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Outstanding news, RC! I had my fingers crossed so hard, they started cramping. I can’t figure out why these situations arise. Perhaps to test our will and patience level. You Sir, have proven your strength more than once. SVR is yours, cherish it...



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Tig

62 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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yay Robert 



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61 y/o, Infected via transfusion Oct'83, GT-1a, F-4 cirrhotic,
tx Holkira pak/moderiba 12 weeks

3 years...post tx... successful dragon slayer 



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sleestak,

That was a good report on vosevi you posted here. I had mean to post it too, but hesitated, and then did not get back to posting it, so thanks very much for getting it posted. It continues to speak to the prowess of vosevi and the lack of problematic issues with it's use, and with interesting mention of specific Ravs. I took the liberty of copying this vosevi info (your link) and pasting it to be over in the Sof/Vel/Vox thread as well. You and lamassu are finding some good reading. The link Mak posted was quite up to date and encompassing as well. smile C.



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HCV/HBV 1973. HBV resolved. HCV undiagnosed to 2015. 63 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.

 

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ah, good and correct outcomes! What we want and expect for everyone on vosevi!

Very nice to see your labs RC. We will wait to see Maks next. biggrin C.



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HCV/HBV 1973. HBV resolved. HCV undiagnosed to 2015. 63 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)



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@ robertsamx, Great news!
@ mcmaklin, Welcome to EOT and were all anticipating that big fat UNDETECTED!


Not recent news but I thought this would be a good spot to drop this link 
DECEMBER 2018 (Journal Of Hepatology)
Herein, we show that the presence of pretreatment drug resistance did not affect treatment outcome in these patients who had previously received direct-acting antivirals. We also showed that new drug resistance was rare in patients who failed treatment with SOF/VEL/VOX for 12weeks. This has important implications for the selection of best retreatment strategies for these patients.

https://www.journal-of-hepatology.eu/article/S0168-8278(18)32279-7/fulltext
No impact of resistance-associated substitutions on the efficacy of sofosbuvir, velpatasvir, and voxilaprevir for 12weeks in HCV DAA-experienced patients




-- Edited by sleestak on Friday 4th of January 2019 10:06:15 PM



-- Edited by sleestak on Friday 4th of January 2019 10:34:38 PM

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rc



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Gt:1a-36yrs .Started Intron-A in 96' for 2.5mo-VL still too high.taken off. Labs on 3.6.18:. A1 activity.  f3@60: fibrosur bloodtst. AFP=norm. enz=mostly norm.VL=3.9 million.sot=5.1.18>Harvoni>[8wks]: 4WEEKS=UND. Eot 6/25=L.July=norm liverpanel.*13weeks=UND * 6 months =UND: CLUB ZERO



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What fantastic news Robert. clap.gifclap.gif You coped so well, so positively and you were right! sun.gifThe sun shines on you.



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66/F Contracted Early 80's First Diagnosed Early 2000's 2017 re diagnosis and referral for treatment Gen 3a Fibroscan 8.7

Epclusa 12 weeks commenced 1 May 2018 ALT 72 AST 67

28 May 2018 4 weeks ALT 16 AST 23 ...... 23 July 2018 EOT ALT 23 AST 30 .....Oct 16 2018 SVR12 UND



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mcmaklin wrote:

Robert!!! I am so happy for you almost have tears in my eyes! So what could it be???


 @MAC.  Its like we all have been telling you, some things just happen and we cant explain them or why they happen.  My false positive test on 12-27-18 just happened. No one can explain it . Im thankful im cured with 16 weeks of vosevi.  You are cured too!!   RC



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 M-61(3 Treatments)( SOF-RIBA 2014)(SOF-RIBA-PEG 2016)(HCC 2016) (LIVER TRANSPLANT 8-2017)(VOSEVI-RIBA 2017)   SVR-12. 3-13-18 https://aasldpubs.onlinelibrary.wiley.com/doi/pdf/10.1002/hep4.1280   



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I had the official UK blood test today .



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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



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Robert!!! I am so happy for you almost have tears in my eyes! So what could it be???



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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



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THE RESULTS OF THIS WEEKS HCV LOAD TEST ARE BACK 

HCV NOT DETECTED

RC

 



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Good work team.  I think that answers everything.

Mak, please take your mind off of this.  Stop wondering and predicting doom.  Try to have a positive attitude.  You are not in the past, where your treatment failed.  You need a new focus.  It will make you better faster.  Do something you feel really good about,  and celebrate the end of a very powerful treatment.

Really.



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GT2a, VL 681,500, Less than F1, Treatment Naive

12 wks Sovaldi/Ribavirin, SOT 2/25/16, EOT 5/17/16

UND at 2,4,8 and 12 wks during treatment but ribavirin crazy.

ALT/AST normal EOT

SVR12 8/13/2016!!!!!!!!!  I WON!!

EOT 6 Months 11/12/2016  CURED

 



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Well said Tig. Thank you for explaining treatment emergent ravs. 

@MAC- I have relapsed twice just 4 weeks post, on both R/X I was UND at EOT. My Drs could not tell me why the virus Survived.They speculated it was my chirross and virus hiding out in scarred tissue In my liver. Tig has answered you questions about why you relapsed- Its difficult to know why- The medical community doesnt have a diffinative answer for any of us relapsers . Its just one of those things that we accept, retreat and move on. You have re-treated with the best of the best (VOSEVI) that is used as a rescue treatment for treatment failures. Thats it-period-  You have done everything possible, above and beyond standard re-treatment- Time to wait and see like the rest of us have had to do.   RC



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 M-61(3 Treatments)( SOF-RIBA 2014)(SOF-RIBA-PEG 2016)(HCC 2016) (LIVER TRANSPLANT 8-2017)(VOSEVI-RIBA 2017)   SVR-12. 3-13-18 https://aasldpubs.onlinelibrary.wiley.com/doi/pdf/10.1002/hep4.1280   

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The L31M RAS (substitution) was found when you were tested. Since the substitution was found after you relapsed, it’s considered treatment emergent, or developed while you were on treatment. A NS5A RAS can be long lasting and if retreated with the same drug, it must be determined how resistant the substitution is to the drug in question, namely Ombitasvir. If you were to try treatment again with the same drugs, and it was decided the risk was worth taking, the length of treatment would have to be extended and the addition of Ribavirin in the case of Viekira and Exviera, would have been required. Since you retreated for 16 weeks with Vosevi, the possibility of RAS interference was mitigated, if not eliminated.

People relapse for any number of reasons and sometimes it’s difficult to determine exactly why, if ever. This has been a difficult virus to eradicate for many decades and they’re just now getting a handle on it. Still, approximately 1 in 10 will relapse, but they’re getting it down to half that now with the newest DAA’s, like Epclusa, Vosevi and Mavyret. 

 



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Tig

62 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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Well, so why I am not cirrotic and was UND at the end of treatment with Viekira:Exviera and then relapsed within a month...?



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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



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MAC, The medical community believes one area the virus can hold/hide is in scar tissue of a cirrhotic liver. Blood carrying the DAAs is not able to penetrate the hard nodules of a cirrhotic liver and therefore the virus possibly can escape detection and re-emerge after treatment when  DAA therapy has stoped.  If I remember correctly you are F0 to F1 so this should not apply to you.  As for the post office question,IMO they are talking about mutations that escape detection which I beleave are a common natural occurrence . RC



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 M-61(3 Treatments)( SOF-RIBA 2014)(SOF-RIBA-PEG 2016)(HCC 2016) (LIVER TRANSPLANT 8-2017)(VOSEVI-RIBA 2017)   SVR-12. 3-13-18 https://aasldpubs.onlinelibrary.wiley.com/doi/pdf/10.1002/hep4.1280   



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mcmaklin,

The article you referenced discusses HCV viral replication in patients with active HCV, not patients who have achieved SVR12. According to "Long-term follow-up of successful hepatitis C virus therapy..." by M. Hedenstierna et al. in the article discussion the authors note that:

In conclusion, residual HCV RNA can be detected up to 9 years after SVR in a minority of the patients. This low-level HCV RNA may sustain HCV-specific immune responses but does not cause detectable liver disease. Taken together, our data indicate that a treatment-induced SVR corresponds to a cure and that the clinical significance of any residual trace amounts of HCV RNA seems limited.

Please, enjoy life, relax and wait for SVR12.

 

 



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Male, 66, Dx 1990, GT 2a/2c. Pre-tx VL 11,500,000, ALT 10, AST 18, F3, 12.4 kPa. Rx: 12 weeks Epclusa, SOT 3/8/18, EOT 5/30/18. Week 2 VL 50, ALT 12, AST 21. Week 10 VL not detected, ALT 12, AST 18. EOT + 12 weeks: VL not detected, ALT 11, AST 19. EOT + 24 weeks VL not detected, ALT 9, AST 24.



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Robert I indeed hope it is the lab error

 

Can you Please help me understand virus hiding in the Liver based on the article I sent before or if not it is here: https://www.google.co.uk/amp/s/medicalxpress.com/news/2017-10-hepatitis-body.amp

 

 

How long can those post offices with the virus survive while on treatment? This is probably why the treatment must be 3 months long. How long they can exist unseen?



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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



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Well that's good news for sure Robert. You feel fine, your LFT's are great. headbang.gif



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66/F Contracted Early 80's First Diagnosed Early 2000's 2017 re diagnosis and referral for treatment Gen 3a Fibroscan 8.7

Epclusa 12 weeks commenced 1 May 2018 ALT 72 AST 67

28 May 2018 4 weeks ALT 16 AST 23 ...... 23 July 2018 EOT ALT 23 AST 30 .....Oct 16 2018 SVR12 UND

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