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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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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

Tig


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Thanks for the update, RC! The LFT’s look great. We’ll be waiting....



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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 1-4 years!

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Still waiting for HCV RNA LOAD results. CMP test all came back NORMAL.  AST&ALT 15&26.     CBC all fine      Should see HCV results tomorrow afternoon.  Will keep you posted 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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congrats RC. , you should get your lab results soon

what i felt after taking the little pills was like ...wait, don't i need them? , they did their sacred deed , mopped up and left the job site.

a few of us are getting labs early this month. i'll be getting mine next week

 



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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=Waiting for 3mo.VL.July=norm liverpanel.13weeks=UND



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congrats on EOT mak , time to not have to take a pill and trust that the daa's did their sacred duty.



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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=Waiting for 3mo.VL.July=norm liverpanel.13weeks=UND



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Mac, Congrats on your EOT.  Yes it feels funny that first few days after EOT when you usually take your meds, there is some sence of security taking your meds at that precise  time every day for 4 months. With each pill down we feel were one step closer to victory. Vosevi IMO is the best, its a rescue drug and you had it 4 more weeks than usual. You are cured I Promise!

Thanks everyone for the well wishes- I have the blood draw in 1-3/4 hours from now.  I havent realily been sweating it. I really have this calm sence about it. Its like this false pos popped up just to remind me (us all) of what we have gone through, to be thankful for these new DSSs , to stop living in the past - Its a new day and a new year and a new us. Enjoy your SVR everyone- You earned it- Everyone of you- It wasent easy but each one of us did it!!  Thanks for your help!!   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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Oh Dear Robert!!!!! I can only barely c/feel what you and Chris must be feeling!!!!! This just must be a false positive.  (Where I live they have a big thing about false negs or false pos) 52 weeks after all you have been through!!!!.....how can it possibly be back. These things (or  even the remote possibility of them are just unimaginable for all of us)  I just so love your attitude Robert and Chris..  Good Luck Next Week It Can't be back or we are all doomed



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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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I still feel  strange because I should have taken a pill half an hour ago. I hope things will

go good direction, if not I will be always saying oh I had drugs in my drawer - I could take them because it was so easy.  The next treatment would be very aggressive. 

But as far as I red from your posts - it seems that 16 weeks definitely should help and if not adding Epclusa would not help anymore.

just wondering what is the mechanism of a hidden somewhere in liver cells virus and how long it can survive there on drugs.



-- Edited by mcmaklin on Wednesday 2nd of January 2019 04:34:07 AM



-- Edited by mcmaklin on Wednesday 2nd of January 2019 04:35:39 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



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RC,

Like Obs said, oh dear, poor Chris and you for that startle! I too will just sit tight and wait for your next draw results. Will be interesting to hear what your doc(s) have to say about it all. 

I feel strongly that both you (and Mak) and me! are all going to continue to be just fine post-vosevi. : )

 

Mak,

Congrats on getting here! EOT! Yay! I must have been counting wrong and thought your last pill would be tomorrow (Jan 2), but it's kind of nice and appropriate your last pill ended on the first day of the NEW year! I really do think this is going to be a very much better year for you! : )



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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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mcmaklin,

I just pass along knowledge I have learned from my gastroenterologist and reading the literature. The Hep C virus mutates, which is one reason why no successful vaccine has been made yet and companies like Gilead have had to come up with new DAAs which can work when patients relapse after taking one of the first line DAAs like Harvoni.

You tend to ask questions that only a trained gastorenterologist or virologist can answer definitively, and I recommend you address any concerns you have to your treating doctors. One thing I think we all agree on is that it is time for you to stop treatment. You will almost certainly be undetected at 12 weeks after you end treatment. If you are not your doctor will discuss options with you then. Your body has been stressed taking Vosevi for 16 weeks. Take a break, heal up, be good to yourself, and don't over analyze or obsess about relapse. Best wishes for the New Year and SVR12!



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Male, 65, 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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Mak,

Congratulations on finishing!  I'm glad you decided to stop.  Let's wait and see what you experience now.  Everybody is different, so there is no way to say how it will be for you. I do recommend that you continue to drink lots of water.

Please let us know how your test results look in 12 weeks.  In the meantime, don't overthink it.  It's time for you to relax and get on with you life.

 



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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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Thank you

My definite decision is I stop. I took the last pill today in the mornig. The drugs should help - this was so long. I am not cirrotic, my genotype was 1b not 1a. I had no Y93h. I was not taking Riba though.  I am not going to experiment just to experiment. Nobody was taking the Vosevi for 16 weeks aprt from Robert and me.  And the more I started to feel those drugs in my muscles some strange being tired.

Shall I be careful of anytning now postreatment? Can I expect anyting?

 

About the article, and thank you so much lamassu, this is what you are saying: that taking the drug longer could even cause the resistance while on treatment and the virus to come back? Drugs could also develop under drug selective pressure.

I would like also to understand "This is why Vosevi is never used as a first line DAA but held in reserve for patients who fail to reach SVR12 " 

is the Voxilaprevir responsible (or all this 3 drugs combo) for some more risk on doing RAVs? (for me it is too hard to understand: "HCV RNA polymerase error rate of 10-4substitutions/base/y38 and virion production rate of ~1012 particles/d39 " )   I find it very interesting.

I made my treatment longer because I was a slow responder, but please clarify this, now I am thinking that even one additional Vosevi month could bring a kind of a risk.

 

 



-- Edited by mcmaklin on Tuesday 1st of January 2019 04:52:17 PM



-- Edited by mcmaklin on Tuesday 1st of January 2019 04:55:10 PM



-- Edited by mcmaklin on Tuesday 1st of January 2019 04:57:02 PM

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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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Tig can you lock a thread? This one needs it.

@mcmaklin the excellent paper you referenced (thanks for that) even states that:

In spite of the availability of DAAs, recent clinical data show that approximately 5% to 10% of HCV patients still face treatment failure. The underlying cause is the existence as well as emergence of resistance associated substitutions (RASs) that now poses a formidable challenge in developing higher efficacy DAA regimens. HCV RNA polymerase error rate of 10-4 substitutions/base/y38 and virion production rate of ~1012 particles/d39 suggests that RASs preexist but can also develop during treatment under drug selective pressure.

Emphasis is mine. Please note the concept of drug selective pressure. There is risk associated with continuing to take DAAs longer than your doctor prescribes. The longer you take DAAs the greater the chance your HCV virus (if remaining) could mutate and develop a new resistance associated substitution that Vosevi might no longer be effective against.

This is why Vosevi is never used as a first line DAA but held in reserve for patients who fail to reach SVR12 using other DAAs. The proper thing to do is to follow your doctor's advice and stop Vosevi at 16 weeks. Wait 12 weeks and get a viral load to confirm you are undetectable.



-- Edited by lamassu on Tuesday 1st of January 2019 03:03:40 PM

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Male, 65, 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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Yes, that is true. It needs a scientist. What comes to my mind is that noone knows if those drugs do not" teach" the immune system how it behaves when you stop the drug, or when you half stop this the way I was thinking to do. And where is the virus hiding if people relapse.

 

I was trying to read this https://www.researchgate.net/publication/329368044_Evolution_of_efficacious_pangenotypic_hepatitis_C_virus_therapies

and it is so difficult for me.



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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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Hello Mak,

We don’t have the answer you are seeking. We aren’t scientists or pharmaceutical researchers. We have provided you all the information we have and what is available online and through the resources we are familiar with. This is up to you now. Good luck...



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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 1-4 years!

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Robert, I indeed hope it is a lab error your case. I keep my thumbs.

I reapeat my question here, I have my chance as I am last day on Vosevi, What way continuing the treatment when you know you are UND for 2 more weeks with just removing one drug (not the most important drug going from Vosevi to Epclusa ) could cause RAVs? What way it could do any harm?? Why logically? If not maximise the chance to be cured.

I know you can kick me out from the forum (I hope not) but I am not asking for the advice what  to do but for the mechanism of action and what logically it could do wrong.

The vosevi hits the virus at 3 spots, and the Epclusa hits it at two spots. So I would be continually hitting 2 of the 3 spots for an extra 4 weeks. Could it cause ravs at the two spots I would be hitting with the Epclusa?

-- Edited by mcmaklin on Tuesday 1st of January 2019 07:14:13 AM



-- Edited by mcmaklin on Tuesday 1st of January 2019 07:17:59 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



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Ahhh Robert, what a fright/shock for you and your lovely Chris.

Like all of your friends/fans here, I will be watching for the redraw results with fingers crossed.

happy new year

 



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61 y/o, Infected via transfusion Oct'83, GT-1a, F-4 cirrhotic,
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3 years...post tx... successful dragon slayer 



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Hi Tig My alt&ast. Were 12&25 last week.  Im not sweating this one!   RC

Wednesday we do all the blood work.   I will keep you all posted.  It almost has to be Falts Positive .   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   

Tig


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Not only that, but your ALT would be elevating in most instances. Did they draw new enzymes?



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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 1-4 years!

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Has to be a false positive.  its only 5 points over the detectable level of 15

Im really not to worried about it.  After 3 treatments and a liver transplant I have seen and heard it all.   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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Oh yeah, no way. Must be false.  Wow.  Let us know right away what you find on the next draw.

You must be absolutely blind sided.  My mouth has dropped. 

 

I just did an out of the blue liver panel and all looks well. Now I want a more info.



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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

 

Tig


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Let’s hope you’re right and that 20 IU was a fluke. Relapses don’t typically come back with such a low viral count. Relapses in general, the ones I’ve seen anyway, are much higher. I’m going to hold out for that retest. I know that won’t relieve the anxiety, but if it is back, you’re stronger than you have been for years and another round of Vosevi would be the ticket.



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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 1-4 years!

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Hi all.   2018 is going out kicking and fighting!!   I thought  it would be nice to do a SVR52 so on Dec 27 I had a blood draw , the usual stuff, CBC-CMP- TAC level-and HCV RNA LOAD. To my surprise the HCV RNA came back Positive, load 20 with a log of 1.301    Chris started crying when she opened up the results on line.  I turned white and about fell out of my chair.

There is just NO WAY , It has to be a false positive!  I will re-test Wed 1-2-19

Happy new year !!!!     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 did not ask endless question- I only asked how would resistance while on treatment look like. Furthermore in my last post I asked a few other questions after reading more of Sleestak. Especially if there were patients who did not respond to Vosevi 

thank you and my last email I believe was quite wise and not asking all over the same questions. The more - I wrote I managed to talk to my doctor and I wrote you that my choise is to stop. It is easier to say when it is not your lifetime decision. The forum and you all are indeed helpful and thank you for your knowledge.



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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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Mak,

I have asked politely to put a stop to the endless questions. We cannot answer them in a manner that you seem satisfied with. Any further questions must be directed to your doctor. Thank you.



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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 1-4 years!

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My doctor that I have a good contact told me that the treatment was longer anyway and there were no resistance for the drug so to finish it. What would mean resinstance here? 



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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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asking the same question over and over is not going to change the answer.

take them or dont take them, whatever you decide.

most of us non-doctors here think its unnecessary.

 

 



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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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The strange thing that "there is no accurate answer" if taking Epclusa after Vosevi could  destroy the treatment of Vosevi. I have no knowledge of substiotiusions and RAVs, although I am reading it carefuly, many times  I do not understand this L31M I had, I do not understand substitutions. . So maybe someone is more wise here, what could happen, for instance, that Epclusa after Vosevi could cause me not to go SVR? I thought that it could be just opposite, or it does not do anything if there is no virus. Why it is so difficult to say? And why do your rother encourage me to stop?



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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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Vosevi trials: 8 and 12 weeks, only. No 16 or 20 week data points, and no added Epclusa. We can’t tell you to take any off label medication, or encourage you to do so. Please don’t ask us to make your mind up for you. We can’t do that.

Make a decision Mak. We can’t tell you anything that hasn’t been said. Please decide what you want to do and let’s finish this up. Thank you.



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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 1-4 years!

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I am reading. I do not know still, my conclusion is that nobody was even trying Vosevi for 16 weeks. It should be more than enough. I also have a feeling that I feel a bit tired of those drugs. Like weaker muscles or something like that at some time of a day (some tiredness but not of my head!)  but generally I feel well.

That nobody knows if generally taking drugs so long (or longer than necessary is generally safe). The very interesting for me was that Sleestak pointed on the strategy of adding one more drug to the combo and that this is so powerful.

Sleesstak also writes "Another approach in patients with prior non-response to NS5A-containing therapy has been studied in genoptype 1, 2, and 3 patients who did not respond to velpatasvir-containing regimens including sofobuvir/velpatasvir and sofosbuvir/velpatasvir/GS-9857. (Gane, 2016)"

Does this above mean that there were already failures of Sof/Vel and GS-9857(Vox)??? 

 

The strange thing that "there is no accurate answer" if taking Epclusa after Vosevi could  destroy the treatment of Vosevi. I have no knowledge of substiotiusions and RAVs, although I am reading it carefuly, many times  I do not understand this L31M I had, I do not understand substitutions. . So maybe someone is more wise here, what could happen, for instance, that Epclusa after Vosevi could cause me not to go SVR? I thought that it could be just opposite, or it does not do anything if there is no virus. Why it is so difficult to say? And why do your rother encourage me to stop?

There is also one person telling me, that in the previous era on interferon you had to take drugs something like 3 months when you were UND to maintain  the SVR. He is asking what do you risk to take even 3 months longer, why not do do it if you have drugs in your drawer. (I would feel that maybe one month more and no more)

-- Edited by mcmaklin on Sunday 30th of December 2018 05:37:21 PM



-- Edited by mcmaklin on Sunday 30th of December 2018 05:38:14 PM



-- Edited by mcmaklin on Sunday 30th of December 2018 05:44:02 PM



-- Edited by mcmaklin on Sunday 30th of December 2018 06:07:29 PM

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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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Poor Mak! My goodness, after all this time and reading you have done! ... what does low or high barrier to resistance mean?? ... well, I could generally say, low is not ideal, and high is good/better/best? 

You are asking sleestak the same impossible-to-answer questions you have been asking for a while now (what will happen if i take epclusa now) the same question we and your docs have not been able to provide a firm answer to. There is no accurate and exact example of information found on which to base a correct answer to your question. The info you search for will not be found if it does not exist.  Sleestak has very kindly given you "input" examples, but your situ is unique, therefore not applicable/similar to any other scenario we or your docs can find. 

Sleestak, yes I agree!, that article Feld wrote at that time was a really good one. I was re-reading what you had posted here again last night, and was trying hard to recall the author you drew upon, as i was sure I had remembered reading this before! As Feld outlined there back then, for the longest time it WAS wise to default to adding riba (they still do!) as for some people it's use is still on the books! But I agree whole-heartedly with your sentiments about riba use, about not having to use it! (blech), and about reviewing the best things we have in our arsenal and choosing the best carefully (as intimated by Lawitz here ...  Healio/HCV Updates ). I admire Feld's writings in general, in "Clinical Comments" and elsewhere, and I have posted a couple good different ones here in this site.  I especially liked one of the more recent ones Feld worked on where they were comparing the potencies of the double NS3/4A and 5A Mav to the triple NS3/4A, 5A and 5B Vosevi, both containing 5A's and 3/4A's but where the triple was trouncing the double (comparative superiority being shown in the triples 3/4A and the 5A). All good reading. Until I see further data to counter my reading thus far, I remain to side on the value of a triple and of our Vosevi triple over anything else. Nice to be able to chat about these readings and choices. 

Mak, are you any closer to feeling like you know what you want to do?? Have you asked your family what they think?? 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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What does it exactly mean? sof/led is low barrier to resistance ? And Velpatasvir is high? 



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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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mcmaklin wrote:

  May less potent drugs after Vosevi cause that I will not be UND? 



-- Edited by mcmaklin on Sunday 30th of December 2018 07:33:08 AM


 My only input on this question is I know of a patient that treated with 8wks of Sofosbuvir/Simeprevir (NS3/4A inhibitor, low barrier to resistance) and switched to Sofusbuvir/Ledipasvir (NS5A inhibitor, low barrier to resistance) for an additional 20wks and was cured.  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. What the results will be...who knows? Ya rolls the dice ya takes yer chances!



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To understand it with your great knowledge that I do not have. May less potent drugs after Vosevi cause that I will not be UND? Is there ANY logical possibility of this to happen when I take Epclusa now? Thank you for your patience -  this is the basic question. If this is possible to happen  I will stop the treatment  definitely.



-- Edited by mcmaklin on Sunday 30th of December 2018 07:33:08 AM

__________________

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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Canuck wrote:

   Interesting the comment within the 2016 writing you quote from sleestak - where the motivation to go with harvoni+riba treatment was urgency to be treated and to avoid a possible 2 year wait for the more effective Vosevi! A testimonial for Vosevi in itself! ; )

I still say you have already done the best with your 16 weeks of Vosevi Mak! C.


 These strategies were what was available at that point in time 2015/2016/2017


A snippet from an excellent article by Dr Jordan Feld;

The data on retreatment are just starting to emerge. Whereas these studies cannot address every situation, a few general approaches are supported both by good logic and at least some empirical evidence: 1) switching to a different DAA class or classes, 2) treating for longer, and 3) adding ribavirin.

Although the mechanism(s) of action of ribavirin remain elusive, almost all studies using ribavirin with DAAs have shown that it delays or prevents the emergence of resistance, particularly in difficult-to-cure populations. Because ribavirin seems to raise the barrier to resistance, particularly for low-barrier DAAs including NS5A and protease inhibitors, it makes sense to add ribavirin to DAAs when retreating patients with presumed or known resistance.

Combining Strategies

All of the small retreatment studies Ive mentioned successfully combined at least 2 of 3 approaches: switching to a different DAA class, treating for longer, or adding ribavirin. However, most of these retreatment studies were in patients without cirrhosis, a relatively easy-to-cure population. In clinical practice, many of the patients whose first treatment fails are those with advanced cirrhosis. For these tougher-to-treat patients, a combination of all 3 approaches would likely be worthwhile.
...........................................................................................

So essentially it is thought that ribavirin in effect raised the barrier of resistance in a low barrier resistant drug. We no longer need ribavirin with the high barrier to resistance drug regimens available today (thank Christ) and the extension of treatment with Vosevi beyond 12 wks is by and large unnecessary.

As Canuck has stated....you have already done the best with your 16wks of Vosevi

Not sure of a salvage regimen for Vosevi. I believe the current strategy would be to try a different regimen with some add-ons but it would be experimental at this point and probably pretty tough to get insurance to cover it.

 



-- Edited by sleestak on Sunday 30th of December 2018 06:14:59 AM

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Thank you again. I read it all. We all know that Epclusa is less potent. The result we want is 0 HCVRNA forever.

 But if the virus is hidden  somewhere -  may Epclusa kill it finally or it is so unlikely that it would kill but instead make another treatment impossible? What am I risking if I take it? If there is no virus there is no virus, so if I take the Epclusa may I do anything wrong? to cause the virus to come back by taking Epclusa when I stop it lets say after 2 weeks?



-- Edited by mcmaklin on Sunday 30th of December 2018 05:57:10 AM



-- Edited by mcmaklin on Sunday 30th of December 2018 06:01:29 AM

__________________

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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Not to be unfriendly, but are you kidding? We've been over this again and again.  Give yourself a chance and get the definitive SVR12 behind you.



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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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Mak,

Sleestak has very kindly done some very good in-depth sleuthing for you about "longer courses" (pertaining to epclusa), and of other regiments, but the bottom line (to me) is that you have had the benefit of doing 16 weeks of a triple (Vosevi) that contains a NS5A, a 5B and a 3/4A ... NOT a 5A/5B double (Epclusa) with riba added (or some other triple made-up by adding riba to a double) - there is quite a bit of difference in efficacy when you compare Vosevi to Epclusa period for use in the treatment-experienced (even if you were to add riba to epclusa to make it a triple of sorts), and even if you were to extend the epclusa/riba course (IMO). The NS3/4A VOX is a very good, potent and important component of the Vosevi triple. Just saying. You are a good reader sleestak! Interesting the comment within the 2016 writing you quote from sleestak - where the motivation to go with harvoni+riba treatment was urgency to be treated and to avoid a possible 2 year wait for the more effective Vosevi! A testimonial for Vosevi in itself! ; )

I still say you have already done the best with your 16 weeks of Vosevi Mak! 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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Yes, i remember that, that your sister got her cure - but ... interesting (for both of you, and us) to know she was a CC, and, that she was even able to find out she was a CC. I was only able to find out I was CC by happenstance. But regardless of ones Il28b status, whether CC/CT/TT etc., Vosevi has maintained it's high cure rate for us despite many of our "come withs", including RAV's.

You are doing the near impossible here (trying to compare apples to oranges), trying to compare yourself into the old Astral Epclusa studies when you have been on Vosevi - there are just waaaaay too many differences and variables within you and within these old Epclusa studies to be able to predict what effect taking epclusa now will have on you, but of course if it makes you feel better or you think it helps (about reaching your Epclusa decision) then of course spend time studying epclusa if you wish to. You do not fit the Epclusa Astral 4 study variables, such as ... doing riba and you are not decompensated - the Astral 4 Epclusa trial you have been reviewing does not really apply well to your circumstance thus why your Vosevi experience is like comparing a Vosevi apple to an Epclusa orange.

For your review, re-iteration and comfort you should actually be re-reading all of the Vosevi trial data, all 4 - (the Polaris 1, 2, 3, and 4 trial data we have given to you many times before) - don't overlook the Polaris trial data - simply for (big) little things, such as ... the large proportion of trial participants who were NOT CC's, (just like you), the treatment-experienced/with RAV's and cirrhosis who were easily cured at very high rates with Vosevi courses at 12 weeks (or less!). You should be getting a lot of solace and comfort knowing you have done very well to complete 16 weeks of Vosevi. 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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mcmaklin wrote:

It seems for the genotype 1 there were much better results with 24 weeks of Epcusa than 12...


 Sofusbuvir/velpatasvir+ribavirin 12wks GT1    96% svr12  

 Sofosbuvir/velpatasvir 24wks  GT1    92% svr12

Keep in mind these patients had decompensated cirrhosis

So it would seem that the booster of ribavirin had more of an affect than extending treatment. That is the reason for Vosevi treatment of 12wks only.

      Also I found some info from early 2016 that might be of interest.

A second phase II study of 22 patients, including 14 PrOD failures, evaluated retreatment with 12-24 weeks of PrOD plus sofosbuvir. Treatment duration and ribavirin usage were determined by cirrhosis status, HCV RNA response on therapy, and genotype subtype. SVR12 data was available on 15 patients with 14/15 (93%) attaining SVR12. Based on these limited data, patients with dual NS3 and NS5A class RAVs may be retreated with elbasvir/grazoprevir plus sofosbuvir with weight-based ribavirin for 12 weeks or PrOD plus sofosbuvir for 12 weeks in genotype 1b and 24 weeks with weight-based ribavirin in those with genotype 1a. If these regimens are unavailable, retreatment should be conducted in a clinical trial setting, as an appropriate treatment regimen cannot be recommended at this time. Another approach in patients with prior non-response to NS5A-containing therapy has been studied in genoptype 1, 2, and 3 patients who did not respond to velpatasvir-containing regimens including sofobuvir/velpatasvir and sofosbuvir/velpatasvir/GS-9857. (Gane, 2016) Retreatment with sofosbuvir/velpatasvir with ribavirin for 24 weeks yielded high overall response rates (91% or 59/65). Among genotype 1 patients, 97% (33/34) achieved SVR. Baseline NS5A RAVs did not appear to effect SVR rates. In 34 genotype 1 patients, 6 patients had NS5A RAVs prior to retreatment, all of whom achieved SVR. Although data is extremely limited, retreatment with sofosbuvir/velpatasvir + ribavirin for 24 weeks should be considered in genotype 1 patients who have not responded to prior NS5A-based therapy, especially if there is urgency for treatment.

(Based on these limited data, patients with dual NS3 and NS5A class RAVs may be retreated with PrOD plus sofosbuvir for 12 weeks in genotype 1b)

Just by adding sofosbuvir to PROD and retreating for 12 wks with the very same regimen was effectively curing PROD failures. Numbers were small but again showing that adding another drug to the mix is a very effective strategy. That theory is what I based my decision on to retreat with Harvoni/Riba rather than wait an additional 2yrs for Vosevi or Mavyret.

 

 

 



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Canuck wrote:

Hey Mak,

I forgot to ask you this ... not long ago, you mentioned speaking with your Mom about your hepc treatment progress, and a long time ago you had also  mentioned a sister (who had been cured of her hepc ), I was just wondering ... what advice does your family give you on this matter? - what do they think? - what are they saying to you on this? Just curious. C.


 They do not recommend me anything. BTW my sistes who is CC has been cured by 8 weeks of Harvoni.



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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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It seems for the genotype 1 there were much better results with 24 weeks of Epcusa than 12...



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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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mcmaklin wrote:

Thank you again. 

How the drugs can affect organs if you take After 4 months of Vosevi tHe Epclusa (Velpanat from Natco)? What they do if there is no virus? Where there trials when people were taking Epclusa for more than 4 months? Was it safe? 


 ASTRAL-4 Trial

Design: Randomized, phase 3 trial to examine the safety and efficacy of a
fixed-dose combination of sofosbuvir-velpatasvir for 12 weeks +/- ribavirin
or for 24 weeks in patients with GT 1-6 chronic HCV with decompensated
cirrhosis
§ Setting: 47 sites in United States
§ Entry Criteria
- Chronic HCV GT 1, 2, 3, 4, 6
- Child-Pugh-Turcotte class B
- Prior treatment failure (except for prior NS5A or NS5B) allowed
§ Exclusion Criteria
- Prior or impending (within 12 weeks of study entry) liver transplantation
- Platelet count <30,000 or CrCl <50 ml/min
§ Primary End-Point: SVR12

 

https://slides.hcvonline.org/uploads/193/astral4.pdf



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Hey Mak,

I forgot to ask you this ... not long ago, you mentioned speaking with your Mom about your hepc treatment progress, and a long time ago you had also  mentioned a sister (who had been cured of her hepc ), I was just wondering ... what advice does your family give you on this matter? - what do they think? - what are they saying to you on this? Just curious. 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)

Tig


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Hi Mak,

We can’t answer these questions. We have gone over every possible scenario with you and it seems we are no closer to answering your questions now, than we were in the beginning. It’s time to make this decision on your own. We can’t tell you what to do.

Your doctors have all weighed in and they also believe it’s time to end your treatment. You need to finish and wait the 12 weeks for the results. We can’t keep hashing and rehashing the what if’s. Please understand, it serves no purpose to keep repeating ourselves and that seems to be what is happening here.

You need to finish and get this behind you. Your relapse was a totally different protocol and Vosevi was designed to cure those failing other DAA’s. Trust the new DAA rescue protocol (Vosevi) and be done. Thanks for your understanding...



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I do not want to get you tired. Sorry but the trauma after first treatment when you were in 1% is big. 

When the virus is hidden somewhere - Logically could  downgrading the protocol (without Vox) help virus to survive? Can the immune system if the virus would be still somewhere to destroy it without drugs? Logically. If adding Epclusa gives me a bit more percent to be cured I would take it one month more. It is the NS5 inhibitor that is the most important here 



-- Edited by mcmaklin on Saturday 29th of December 2018 01:12:29 PM

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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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I don't know of any trial for that.  Most people stop at the end of their prescribed treatment plan.  

The protocols are designed get to Sustained Undetected AND/OR <12.  That's the finish line. So finish, already.biggrin



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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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Thank you again. 

How the drugs can affect organs if you take After 4 months of Vosevi tHe Epclusa (Velpanat from Natco)? What they do if there is no virus? Where there trials when people were taking Epclusa for more than 4 months? Was it safe? 



__________________

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 Mak and (hello again sleestak!),

Nice to hear from you again sleestak - and very nice you have added some of your past hx here for Mak's benefit and perspective, but I am still curious as to where all your OLD posts and hx live sleestak, your "on-treatment" threads, etc., (that I have inquired after before), but it is nice to at least find out more about you today by your post to Mak. 

BTW sleestak - of the few and varied posts you have made, the comments or the material you bring up is often of very good interest - you should post more! smile I like your new avatar as well, some dif from the old fighter one!

So Mak, being that you said your extra 4 weeks of Vosevi is coming to an end about Jan 2nd, please let us know what your decision is ... will you or won't you be taking the additional 4 weeks of Epclusa starting Jan 3? You have a lot of people here on the site interested to find out what your decision is going to end up being. Let us know as soon as you will please. Whatever you have decided Mak, I hope it IS the start of some peace for you. 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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