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Hep C Discussion Forum -> Hep C News -> Real World S/O Results
Post Info TOPIC: Real World S/O Results
Isiscat2011


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RE: Real World S/O Results
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It is amazing that anybody ever attains SVR with some of the shenanigans going on in HCV tx practice these days.  Hopefully they will work it out in our lifetimes.  smile

I would definitely call ahead to make sure the Doctor's Order is in place and is correct.  You may want to call the lab directly.  If they have never heard of you (#@$%^&!!) then you will have to call the doctor's office.

It will be a challenge not to commit a homicide.  But, just remember, prison is no place for a young, handsome, fireman to be.  



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Diagnosed in 2011, Incivek triple in 2011, tx discontinued, Genotype 1a, CT, VL 7mill, cirrhosis dx in 2012, age 67, waiting for new DAAs.
Fireman Rob


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Lol- it's a good day to be a human for sure. I just created an account to that link and it does have some very interesting info and is a fairly in depth study. I think what makes me most nervous is my standing order to do blood work at the hospital has been a mess ever since I started Tx. Let's hope they do my CMP and Viral Titer on the 24.

I've had to request and fight to get the 12 week test as my doc doesn't understand SVR 12 with these new DAA's. He also had me on the former post Tx schedule for interferon and RIBA which I had to change. The fact he doesn't even know which Tx I completed worries me. I just hope I don't have to go back to that office... Ha ha

He probably thinks I'm still on Tx!?!

-Rob 

 



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Age 33, Male. GT-1 for ten years. Diagnosed in March, 2014.

Treated with Sovaldi/Olysio: SVR 24 on February 16, 2015!
Isiscat2011


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P.S.   Just remember that ~a week is ~ 2 months in dog years.  Be thankful you are a human.  

In dog time I've been waiting ~ 7 months for my preauthorization.  Fortunately, I am a cat.  lol



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Diagnosed in 2011, Incivek triple in 2011, tx discontinued, Genotype 1a, CT, VL 7mill, cirrhosis dx in 2012, age 67, waiting for new DAAs.
Isiscat2011


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Fireman Rob wrote:

Thanks for posting this,Isis.

I wish there was more research on how this Tx applies to different age groups and health status. My SVR 12 test is coming up on the 24 and I'm really anxious. The thought of trying to obtain a second Tx seems so unlikely after my last experience and seeing what others are going through now with my same insurance. Let's hope the SOC changes soon!

-Rob

 

 Hi Rob:

There are some baseline characteristics if you follow the link but they don't break it down to the degree of specificity you are probably seeking.  The odds are so clearly favorable to you, Rob.  I would be very surprised if you did not SVR.   I don't think anything is going to relieve your anxiety, however, until you see the UND/SVR.   Only ~ a week left for your blood test.  Hang in there!



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Diagnosed in 2011, Incivek triple in 2011, tx discontinued, Genotype 1a, CT, VL 7mill, cirrhosis dx in 2012, age 67, waiting for new DAAs.
Fireman Rob


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Thanks for posting this,Isis.

I wish there was more research on how this Tx applies to different age groups and health status. My SVR 12 test is coming up on the 24 and I'm really anxious. The thought of trying to obtain a second Tx seems so unlikely after my last experience and seeing what others are going through now with my same insurance. Let's hope the SOC changes soon!

-Rob

 



__________________

Age 33, Male. GT-1 for ten years. Diagnosed in March, 2014.

Treated with Sovaldi/Olysio: SVR 24 on February 16, 2015!
Isiscat2011


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RE:UPDATED Real World S/O Results
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Here are some updated results based on 2,063 patients including both non-cirrhotics and cirrhotics (Note that these stats are SV4 ; SV4 results in SVR12 at 94-98%): 

http://www.clinicaloptions.com/Hepatitis/Conference%20Coverage/AASLD%202014/Highlights/Capsules/45.aspx

  • Adjusted analysis of SVR4 with sofosbuvir plus simeprevir with or without RBV across different subgroups of genotype 1 HCVinfected patients showed similar outcomes regardless of whether RBV included

Adjusted* SVR4, %

Genotype 1 Patients Treated With SOF + SMV + RBV

Genotype 1 Patients Treated With SOF + SMV

Overall

87

86

Treatment history

  
  • Naive

87

89

  • Experienced

86

85

Genotype

  
  • 1a

82

84

  • 1b

93

92

Cirrhosis status

  
  • Noncirrhotic

90

89

  • Cirrhotic

83

85

Genotype and cirrhosis status

  
  • Genotype 1a noncirrhotic

87

88

  • Genotype 1a cirrhotic

80

82

  • Genotype 1b noncirrhotic

94

93

  • Genotype 1b cirrhotic

88

87

*Adjusted for cirrhosis status, genotype, previous treatment experience, previous decompensation, and previous triple therapy failure.

  • Predictors of SVR4 with sofosbuvir/simeprevir with or without RBV identified for patients with genotype 1 HCV infection
    • Positive predictor
      • Baseline albumin odds ratio (OR): 2.3 (95% CI: 1.3-3.9)
    • Negative predictors
      • Genotype 1a infection OR: 0.3 (95% CI: 0.1-0.9)
      • Previous decompensation OR: 0.2 (95% CI: 0.1-0.3)
      • Failure of previous telaprevir plus pegIFN/RBV or boceprevir plus pegIFN/RBV therapy OR: 0.4 (95% CI: 0.2-0.9)
  • Safety outcomes with sofosbuvir regimens appear favorable to date
    • 5.7% incidence of serious adverse events
    • 12 deaths: 9 in cirrhotic patients and 3 in noncirrhotic patients
      • Sofosbuvir plus pegIFN/RBV: sepsis (n = 1)
      • Sofosbuvir plus RBV: cardiac arrest (n = 2), multiorgan failure (n = 1)
      • Sofosbuvir plus simeprevir: hepatic failure (n = 2), ischemic stroke (n = 1), renal and hepatic failure (n = 1), aspiration pneumonia (n = 1), vascular shock (n = 1)
      • Sofosbuvir + simeprevir + RBV: suicide (n = 1), unknown cause (n = 1)

Safety Outcome

SOF + PegIFN/RBV
(n = 384)

SOF + RBV
(n = 667)

SOF + SMV
(n = 784)

SOF + SMV + RBV
(n = 228)

Total
(N = 2063)

Serious adverse
event, %

2.9

7.9

4.6

7.5

5.7

Death, n

1

3

6

2

12

 



__________________

Diagnosed in 2011, Incivek triple in 2011, tx discontinued, Genotype 1a, CT, VL 7mill, cirrhosis dx in 2012, age 67, waiting for new DAAs.
OldenSlow


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RE: Real World S/O Results
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OldenSlow wrote:
Robertsamx did the 16 and relapsed! No complaints, here. Well... it did kinda suck. For those caring to send money in lieu of sympathy, checks are accepted.  wink

In re-reading this earlier post of mine, it dawned on me that someone more literal than myself might interpret it as an actual plea for money and/or sympathy for Robertsamx or myself.  That was not my intent.  The intent was humor, at which I fail often enough (sorry bout that, but it will happen again).  Just needed to clarify.  Thanks.



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66 y/o male - Geno 1b - F4 cirrhotic dx 2001 - 16 wk treatment w/ Sovaldi/Olysio/Riba - Und @ EOT+24 SVR

 
robertsamx


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I did see  the web cast Sunday, I saw about 70% of it.  Imformative.    I think my Retreatment may be Sofosbuvir-Daclatasvir.  Now let me say that if RIBA needs to be added that I would gladly do RIBA again.  As bad as the RIBA  S/X  are, thay don't compare to the S/X the  virus itself can cause. For hard to treat and retreatment I think RIBA will be  useful.  RC



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 M-68, 3 Treatments)( SOF-RIBA 2014)(SOF-RIBA-PEG 2016)(HCC 2016) (LIVER TRANSPLANT 8-2017)(VOSEVI-RIBA 2017)   SVR-12. 3-13-18   
OldenSlow


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Isiscat2011 wrote:
Hahaha......Did you happen to catch the AASLD Webinar, Wayne?  

I wasn't able to watch it, Isis.  Been in the process of moving and can't seem to find the time to do much of anything else.  Amazing the time/energy it takes to relocate.  

I know RC will hit on the right stuff before too long.  Pulling for the guy.  He's had a terrible time of it.  Whenever I got to feeling sorry for myself about the friggin riba, I'd read one of his posts and start to feel better by comparison.  He hates that crap even worse than I, which is saying something.



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66 y/o male - Geno 1b - F4 cirrhotic dx 2001 - 16 wk treatment w/ Sovaldi/Olysio/Riba - Und @ EOT+24 SVR

 
Gator Man


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Isiscat2011 wrote:
RudiRoo wrote:

The link also had a helpful article about brain fog. Can't recall most of what it said 

 LOL   This is becoming the story of my life.  

 I'm looking, looking ... oh, there it is, underneath my hair and above my mouth. What were we talking about?



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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.
Isiscat2011


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RudiRoo wrote:

The link also had a helpful article about brain fog. Can't recall most of what it said 

 LOL   This is becoming the story of my life.  



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Diagnosed in 2011, Incivek triple in 2011, tx discontinued, Genotype 1a, CT, VL 7mill, cirrhosis dx in 2012, age 67, waiting for new DAAs.
RudiRoo


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Thanks for that, Isis. The link also had a helpful article about brain fog. Can't recall most of what it said but the take away is there is some hope that with successful treatment, in a few months my brain will be returned to it's rightful owner. I really miss it.



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Hep C since 1982, GT IL28b CC, tx naive, VL 2.5M, normal liver panel, Hepascore F-0, A-1. Sjogren's, Hashimoto's, Raynaud's, etc. SOT S/O 12 wk tx on 10.28.14. EOT 1.19.15. HEP C FREE AT LAST! 4.29.15
Isiscat2011


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OldenSlow wrote:

Robertsamx did the 16 and relapsed! No complaints, here. Well... it did kinda suck. For those caring to send money in lieu of sympathy, checks are accepted.  wink

Hahaha......Did you happen to catch the AASLD Webinar, Wayne?  I thought it was really good and thanks so much for introducing me to that website.

DAA retreatment wasn't discussed in detail--they seemed to think the jury is still out on the best approach for that--but I got the impression that the panel's opinion was that Sovaldi retreatment looks promising but changing the 2nd DAA would be advisable.  Robertsmx should be able to successfully retreat with a different combo or even just a different 2nd.

The attending hepatologists sure had a strong preference for Harvoni (as demonstrated by the polling responses).  Did Gilead's stock just increase?  lol



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Diagnosed in 2011, Incivek triple in 2011, tx discontinued, Genotype 1a, CT, VL 7mill, cirrhosis dx in 2012, age 67, waiting for new DAAs.
OldenSlow


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Isiscat2011 wrote:

Turns out the riba wasn't really necessary.  Poor Wayne endured 16 weeks of that.  

Robertsamx did the 16 and relapsed! No complaints, here. Well... it did kinda suck. For those caring to send money in lieu of sympathy, checks are accepted.  wink



__________________

66 y/o male - Geno 1b - F4 cirrhotic dx 2001 - 16 wk treatment w/ Sovaldi/Olysio/Riba - Und @ EOT+24 SVR

 
Fireman Rob


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Great Article,

This patient population were all patients that required a non-interferon Tx and appeared to be in the "hard to treat" population. Considering the small samples of the initial clinical trials, the reality for many INT Eligible patients is still probably closer to the 90% for SVR 12.

This is a great article to show how patients facing transplant or received LT shortly after Tx responded to S/O. Pretty impressive! Thanks for posting this, Isis. 

My fingers are crossed for everyone who is on or has experienced the S/O combo. I'm getting more nervous every day for my Nov. 24 blood work.

Good luck everyone!

-Rob



__________________

Age 33, Male. GT-1 for ten years. Diagnosed in March, 2014.

Treated with Sovaldi/Olysio: SVR 24 on February 16, 2015!
Isiscat2011


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smile  Gator Man.  84% is nothing to sneeze at.  That is about what Harvoni is expected to do in the same amount of time (12 weeks) for tx experienced cirrhotics.  Not bad at all.   Like you say, compared to the previous tx, it is phenomenal.

Turns out the riba wasn't really necessary.  Poor Wayne endured 16 weeks of that.    



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Diagnosed in 2011, Incivek triple in 2011, tx discontinued, Genotype 1a, CT, VL 7mill, cirrhosis dx in 2012, age 67, waiting for new DAAs.
Gator Man


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Isiscat2011 wrote:

For anyone who is interested in some real world results on the S/O combo:

 

http://www.ajmc.com/conferences/AASLD2014/The-Real-World-Experience-With-Simprevir-and-Sofosbuvir-Based-Regimens-in-Hep-C-Treatment

I'm glad I was one of the 84%in the real world at SVR 12 who were successfully treated on the S/O combo. As Greg, Bob and others can attest, 84% is a significant improvement on older IFN therapies, but not good enough if you are in the 16% who relapsed. I hope the real world data on Harvoni gets much closer to the 100% mark. 

Thanks Isiscat for staying on top of the 2014 AASLD meeting.



__________________

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.
Isiscat2011


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For anyone who is interested in some real world results on the S/O combo:

 

http://www.ajmc.com/conferences/AASLD2014/The-Real-World-Experience-With-Simprevir-and-Sofosbuvir-Based-Regimens-in-Hep-C-Treatment



__________________

Diagnosed in 2011, Incivek triple in 2011, tx discontinued, Genotype 1a, CT, VL 7mill, cirrhosis dx in 2012, age 67, waiting for new DAAs.
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