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Hep C Discussion Forum -> On Treatment -> Sofosbuvir plus simeprevir undetectable!
Post Info TOPIC: Sofosbuvir plus simeprevir undetectable!
Mark Y


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RE: Sofosbuvir plus simeprevir undetectable!
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Bills wrote:

Who Can't be impressed with that, That's what we need to hear. Thanks so much for posting that.

I have question 

Is that combo released and available now? I may have missed that announcement.

In any case that's great news keep up the good work may your TX finnish quickly and SVR be following fast

BillS  

Hi BillS, I'm a new member here and just started reading this forum. Yes, this combo is released and available now, In California anyways. I received my approval last week and am waiting on my prescriptions to arrive now, should start RX next week. 

 



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55 yr old male. GT 1a. Diagnosed in 1985. Stopped pega/riba in 2005 due to side effects. Started Solvaldi/Olysio 2/14/14. VL 3,700,000. 2/21/14 VL 244. 3/07/14 VL Undetected.
Michaele


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Tig56, Thanks a million  . Michaele

 



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aprileee


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Great news!!! :))



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33 years old Genotype 3a NO luck with Peg & Riba in 2013 but am undetected after 2 weeks of Sovaldi with Riba 2014 :)
Tig


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Hi Michaele,

First of all, don't be ashamed of anything. What's important is that you're catching back up! 

I mentioned the portal htn, because of the comment you left in your bio on your profile page. The lipoprotein test is a test they run to check your cholesterol level. I'll include a link that better describes it at the end. If you don't have any extenuating circumstances, including no portal htn, I would continue to confirm the need for the extra 3 months of Tx. The metavir score is the inflammation and fibrosis score (level) resulting from your biopsy.

http://www.merriam-webster.com/dictionary/lipoprotein

http://hepatitis.about.com/od/diagnosis/a/Metavir.htm

Best, Tig



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Tig

68yo GT1A - 5 Mil - A2/F3 - (1996) Intron A - Non Responder, (2013) Peg/Riba/Vic SOT:05/23/13 EOT:12/04/13 SVR 9+ years!

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Michaele


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Hi Tig56,   Dont know about the Metavir score, isnt stage score the same or based on it? Mine was (2-3)  2 yrs ago . Didnt have  signs of portal Htn with endo 2 yrs in a row. Did blood work for genotype which we know, viral load which hasnt been done in 10 yrs and ( lipoprotien?)

My lipid are always wonderful, why pretest? As you can see I havent kept up with any of this for a long time and am ashamed to admit it.



-- Edited by Michaele on Thursday 6th of February 2014 06:09:27 PM



-- Edited by Michaele on Thursday 6th of February 2014 06:20:25 PM



-- Edited by Michaele on Thursday 6th of February 2014 06:25:23 PM

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Tig


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Hi Michaele,

That is strange that Medicare would require such a course of Tx. My experience is just the opposite, if they can reduce costs, they will. I have to agree that too much of a good thing can be wasteful. With your history, I wonder why your doc insists on the 6 month Tx schedule? The only thing I remember was your mention of portal htn. With your biopsy score, it doesn't seem likely that you have any severe fibrosis. Has the consideration been made to confirm the Metavir score with another biopsy or fibroscan? Of course the cost of another biopsy would about equal the cost of another 3 months of medication. But the physical and mental price you would pay certainly needs to be considered. Whatever the decision, the drug combo you'll be on is a sure winner IMO and I wish you the best of luck!

Tig



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Tig

68yo GT1A - 5 Mil - A2/F3 - (1996) Intron A - Non Responder, (2013) Peg/Riba/Vic SOT:05/23/13 EOT:12/04/13 SVR 9+ years!

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Michaele


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Great news for you, WOW.   My Dr. said I have to do sofosbuvir, simeprevir and riba for 6mo. not 12 weeks. I showed her copy of med societies guidelines published Jan 30 2013. she assured me I have to do 6mo and riba, too. She said she would let me know if she was wrong.  I think it has to do with Medicare part D requirements, but I could be wrong. Why would medicare want to pay for more Rx than required. But 6 mo of no interferon sounds good to me .Would be nice not to do Riba . We did blood work today and she is sending Rx request ASAP. Keep up the good fight. Michaele



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Tig


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Hi John,

Your news just continues to get better and better all the time! It's such a joy to read between the lines and feel your excitement. We're all very happy for you and thrilled that you seem to be almost skating through Tx. The news that we may be seeing the beginning of the end to Interferon use is stellar all by itself!

I think you should consider yourself very blessed to have the help of a physician that is not only so involved and considerate in your personal care, but is obviously a doctor that is genuinely involved in the continuing education to battle this disease. I believe it's the effort of people like him/her that get the insurance boards to change the use of combinations like yours from off label to standard of care status. Good luck with your results!

Tig



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Tig

68yo GT1A - 5 Mil - A2/F3 - (1996) Intron A - Non Responder, (2013) Peg/Riba/Vic SOT:05/23/13 EOT:12/04/13 SVR 9+ years!

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Gator Man


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Great news Darkstar! I had my blood work done yesterday at 28 days and will get my results next week. I hope the 40 at two weeks will go to UND as well. As a side note, my ALT is at 67 which is as low as it has been in 20 years.

The Dr. told me that he has 31 patients (including me) enrolled in this latest Sovaldi/Olysio  trial and everyone had at least a 4 log reduction in VLs. There were a couple UND at two weeks and several between 100 to 350. Side effects in this group have not been severe enough for anyone to discontinue TX.

He was at a conference of HIV/HCV doctors last week and the growing consensus is that interferon doesn't need to be a part of TX, particularly for prior null responders. Overall, insurance carriers have gone along with off label TX plans with these doctors.

Will post my personal VL news next week.








-- Edited by Gator Man on Thursday 6th of February 2014 03:11:50 PM

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Geno 1b, compensated cirrhotic, 54 yo, prior null responder. Pre tx VL approx 595,000, tx with Sovaldi/Olysio (no Riba) started 1/8/14. VL 40 @ 2 weeks, UND @ 4 weeks. Still UND @ EOT + 1 year.

Gator Man SVR12, Dragon 0, Final Score.
Matt Chris


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Hey Darkstar

Great news, and a great attitude. Yes its a new world of treatment and you my friend have hit the mother load.

matt



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

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


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Just had VL checked after 4 weeks, still undetectable!  LFTs almost completely normal.  There have been a lot of discussions about whether ribavirin should be added. The COSMOS numbers were small so although no additional benefit, it is hard to know.  The bottom line is that sofosbuvir plus simeprevir and many of the new combinations that will follow are likely to dramatically change the management of hepatitis C.  



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Gator Man


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Thanks Dragon Slayer, Matt and Tig. The next VL blood work is February 5th and hoping for UND. Given the COSMOS results, I didn't press my Dr. about adding Riba to the mix;certainly more than encouraged at this stage of TX that the plan is working well.



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Geno 1b, compensated cirrhotic, 54 yo, prior null responder. Pre tx VL approx 595,000, tx with Sovaldi/Olysio (no Riba) started 1/8/14. VL 40 @ 2 weeks, UND @ 4 weeks. Still UND @ EOT + 1 year.

Gator Man SVR12, Dragon 0, Final Score.
Hep-C Dragon Slayer


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Congrats Gator Man,   Soon to be UND. 

 

I agree with Tig, I had a day 18 versus day 14 VL lab test and the results were less then 15.

 

Stay strong.



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GT 1A:  VL: 4,695,000, started treatment 1/6/13 with off label Sovaldi/Olysio/Riba     No Interferon due to Sarcoid  in liver and lungs.  Recent biopsy shows Cirrhosis level 5/6.  EOT 3/30/14. SVR 8 on 5/30/14
Matt Chris


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Hi John

Good to read your latest labs, your on track like Tig said

So keep up the compliance on Meds and away the HCV flys

Matt



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

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


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Hey John,

That's great news! That's a very significant drop, "almost" undetectable. With that rapid a reduction, I'm sure if you had another VL done today, it would be UND. That's what it's all about my friend. Keep fighting and keep believing! Good luck...

Tig



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Tig

68yo GT1A - 5 Mil - A2/F3 - (1996) Intron A - Non Responder, (2013) Peg/Riba/Vic SOT:05/23/13 EOT:12/04/13 SVR 9+ years!

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Gator Man


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I just received my two week lab results; v.l. went from 595,090 to 40! Also no side effects in the interim.

Six other patients at my Hep C clinic currently treating with Sovaldi/Olysio (no Riba.) have v.l.s from 20 to 80 after two weeks. So far the COSMOS trial results are holding up in the real world.



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Geno 1b, compensated cirrhotic, 54 yo, prior null responder. Pre tx VL approx 595,000, tx with Sovaldi/Olysio (no Riba) started 1/8/14. VL 40 @ 2 weeks, UND @ 4 weeks. Still UND @ EOT + 1 year.

Gator Man SVR12, Dragon 0, Final Score.
darkstar


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Matt,

Very confusing, of course because of insufficient data.  For those of us with long standing virus and compensated cirrhosis, time is not always an ally.  Hopefully, sofosbuvir has a different resistance profile but of course I am worried.  What is remarkable is how rapidly signs of inflammation go away when virus is killed!  Hopefully, the rapidity of response will predict for a sustained viral response.

 

 



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Matt Chris


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Hey Darkstar

Its very interesting about how well you are responding, what Malcolm is eluding to is its generally acknowledged that those that had previously had been exposed to a protease inhibitors may not respond to another treatment with the same type of DAA.

But the treatment with all these new DAA's is undiscovered country especially when put in combination with Sofosbuvir. There is a lot more learning in the coming years about how we will be looking at being retreated with those who have been exposed to previous DAA's.

The truth is we can't be for sure when it comes to the 2nd and 3rd generation DAA's how they will react because there is no data and hardly any or no experiences with patients that fit into that group yet. This is going to be a super educational year about HCV, especially for me because I was exposed to a trio of DAA's and relapsed.

matt  



-- Edited by Matt Chris on Tuesday 21st of January 2014 04:02:37 PM

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

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


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Hi darkstar,

It's interesting that you're on Simeprevir after a treatment failure with Incivek. It's great that you're Undet. using this combo. I was going on the Simeprevir Prescibing Information, where they say Simeprevir has not been trialled with previous antiprotease failures.( last para. in Item 1, page 3)

http://www.janssentherapeutics.com/shared/product/olysio/prescribing-information.pdf

Obviously Simeprevir is less effective when the Q80K mutation is present. I had assumed the Incivek and Victrelis RAV's were also included, but am obviously wrong. Perhaps in combination with Sovaldi, the mutations are less important. You actually stopped the Incivek triple due to Sx, rather than relapse, so this may make a difference. Anyway, keep on truckin' and we'll be keen to follow your progress. Cheers.



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

Malcolm
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Congrats Darkstar,

Positive news on the new tx.

I am day 15 non interferon and hope to achieve same results soon.

 

 

 



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GT 1A:  VL: 4,695,000, started treatment 1/6/13 with off label Sovaldi/Olysio/Riba     No Interferon due to Sarcoid  in liver and lungs.  Recent biopsy shows Cirrhosis level 5/6.  EOT 3/30/14. SVR 8 on 5/30/14
darkstar


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mallani wrote:

Hi all,

It seems that nobody is using Sovaldi with Peg and Riba for Geno 1. This is understandable. Any other DAA with Sovaldi will be a winner +/- Riba. Obviously previous Rx failures with Victrelis or Incivek should avoid the protease inhibitors, apart from Merck-5172. It's good to see these off-label combos being approved by the InsuranceCos. I'm waiting for a Sovaldi/Victrelis patient! Cheers.

 Not certain what you mean by, "obviously previous Rx failures with Victrelis or Incivek should avoid the protease inhibitors, apart from Merck-5172."  I took both, now undetectable on simeprevir and sofosbuvir.



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mallani


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Hi all,

It seems that nobody is using Sovaldi with Peg and Riba for Geno 1. This is understandable. Any other DAA with Sovaldi will be a winner +/- Riba. Obviously previous Rx failures with Victrelis or Incivek should avoid the protease inhibitors, apart from Merck-5172. It's good to see these off-label combos being approved by the InsuranceCos. I'm waiting for a Sovaldi/Victrelis patient! Cheers.



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

Malcolm
Bills


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Thanks for letting me know 

That sound as good as the  Daclatasvir + Sofosbuvir which is still a trial. Either way somethings gonna give

Thanks Bill S 

 



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Bills

Harvoni started 12-12-14 for 24 wks PrevTX Geno 1 stage 3 cirrhosis - non resp Int/ ribv. Started Trial  in Aug 2011 -July 2012 into Incivek relapsed  Feb 2013 Had 72 weeks on interferon & Riba.

Cinnamon Girl


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Bills wrote:

 

I have question 

Is that combo released and available now? I may have missed that announcement.


 Hi Bill, this is what`s known as an `off label` treatment which hasn`t actually been approved by the FDA.  Both drugs have been given individual FDA approval which means that doctors are now able to prescribe them in combination.  The protocols for their use are based on previous clinical trials (`Cosmos` trials). 

And yes, it`s great news!  smile

 



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Jill 

(71 yo, lives in UK)

Was Gen 3a, 

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

UND @ Wk.4, UND @ EOT, 

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

 

 
Bills


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Who Can't be impressed with that, That's what we need to hear. Thanks so much for posting that.

I have question 

Is that combo released and available now? I may have missed that announcement.

In any case that's great news keep up the good work may your TX finnish quickly and SVR be following fast

BillS  



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Bills

Harvoni started 12-12-14 for 24 wks PrevTX Geno 1 stage 3 cirrhosis - non resp Int/ ribv. Started Trial  in Aug 2011 -July 2012 into Incivek relapsed  Feb 2013 Had 72 weeks on interferon & Riba.

newmex


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congrats Darkstar, sounds like you have found a winner. Good Luck and keep us informed.

So is this drug combo effective after boceprevir of teleprevir?



-- Edited by newmex on Monday 20th of January 2014 02:08:30 PM

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John
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Fantastic news!   I pray I am as fortunate when I get my 2 wk bloods. 



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Dx. 2005-liver bx.: stg 2/gr 1. at that time  - GT 1a multiple transfusions in 1981.  Started Sovaldi and Olysio 1/16/14  (No prior treatments) Q80K present.  UND week 4,8 and at EOT.   UND at wk 4EOT, Und at wk 8EOT  SVR 12!!!..SVR 24 :-)
Shep


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All I can say is WOW! That is fantastic--Congratulations!!

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Diagnosed 1996 genotype 1b VL alot tx starting 12/23/11 Victrelis UND week 8!!! 28 weeks of tx

Completed tx 7/6/12--still UND!!!!
ucbgal


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early responder & und, congratualations!!!!!

with such wonderful news so early on dealing w/ the sx makes it easier.

stay strong & be well.

sandy,ucbgal



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Zlikster


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thats really some great news Bob! :)

stay UND 4 EVER!



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


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Hi Bob,

Sounds better than your experience with the Incivek triple. Great news about the Undet. and you should be on a winner. Keep us informed. Cheers.



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

Malcolm
Cinnamon Girl


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Great news, Bob, how fantastic, and very encouraging for you! 

Thanks for the update, and best of luck for continuing UND this time around!  It`s looking very promising!  smile



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Jill 

(71 yo, lives in UK)

Was Gen 3a, 

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

UND @ Wk.4, UND @ EOT, 

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

 

 
Tig


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That's great news Darkstar! It looks like you found a real winner this time and you certainly earned that! I wish you continued good luck biggrin

Tig



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Tig

68yo GT1A - 5 Mil - A2/F3 - (1996) Intron A - Non Responder, (2013) Peg/Riba/Vic SOT:05/23/13 EOT:12/04/13 SVR 9+ years!

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suziq


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That is really great!!!  I didn't reach UND until my week 4 labs. Sounds like your body is really responding well. 

SuziQ



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Geno 1A  Age 82 Treatment naive Cirrhotic Told I had liver disease in 1966. Diagnosed as Hep C 1999.Started Merck clinical trial with Riba on 9/9/2013 Week 1 and 2 <25  Weeks 4, 8, 12,16,18 UND.  EOT Jan 14,2014  EOT +12 UND   JULY 1 2014 EOT+24= SVR
Matt Chris


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Wow that is fantastic, very fast viral elimination.

Do you know what your baseline starting Viral count was?

That is some powerful combination.

Keep up the great results.

matt 



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

61 year old Geno type A1, F4 Cirrhotic, started 24 weeks on Harvoni 12-17-14 ,EOT-5 week = UND, 8-31-15 =UND , SVR-24 Baby YES! 
lauralou57


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Congragulations



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darkstar


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G1a with Q80K, prior null responder (IFN + Riba) intolerant of triple Rx.  Undetectable after two weeks, no side effects!!



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