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Post Info TOPIC: Simeprevir and Sofosbuvir Likely Approved by 2014 - Clinical/Ethical/Pharmacoeconomic Dilemmas Loom


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RE: Simeprevir and Sofosbuvir Likely Approved by 2014 - Clinical/Ethical/Pharmacoeconomic Dilemmas Loom
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Hi Tonib,

The present triple therapy WORKS! Look at me, and old cirrhotic who has had HCV for 40+ years. It appears I have cleared the virus. It's no picnic, but it's better than dying of liver cancer. Don't be scared, most people on the Forum have had great success and we're here to help and support. The new DAA's may work better with fewer side effects, but why wait for years when you can get successful treatment now.



__________________

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

Tig


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Hey tonib, I just started 3x therapy on May 23 and have been told ill be on the 48 week treatment. I understand what concern and second guessing are all about and can tell you that the negatives can over-power the positives if you allow it, don't let that happen. There are plenty of success stories here and there will be more to come. Yours and mine for starters! We can do this together, okay? I say okay! Hang in theresmile



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Tig

66 yo GT1A - 5 Mil - A2/F3 - (1996) Intron A - Non Responder, (2013) Peg/Riba/Vic SOT:05/23/13 EOT:12/04/13 SVR 8+ years!

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Thanks for your feedback, I do feel better now.  The info about the insurance in right on!  I am currently employed with health benefits, but in this economy things could change quickly.  

And thanks for the nice words about my daughter, she's my hero a true warrior!  Love her so much!

12 days and I start......breath in....breath out....



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 geno 1, started peg and riba 7/5/13, now 29th day is vicrellis ***tonib VL started 6 million, after 5 weeks 374,000, after 8 weeks 150,000....the big test for VL is 9/27 at 12 weeks  TAKEN OFF THERAPY JUST NOT WORKING FOR ME...12 WEEKS STILL HAVE 9000 VL



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Hi Tonib, No doubt it's weighing on you heavily now.

I can share my experience with you.

I decided to do the triple treatment now (started 4/16/13), instead of waiting. One reason for starting is the insurance issue. I may not have as good insurance as I do now in 1 or 2 years. I would have wanted nothing more than to wait for the easier softer treatment. Less side effects, less time.....oh well - I'm actually jealous of the ION3 folks right now.biggrin

The second reason to Carpe Diem is my current state of health. Healthier folks have a better chance of clearing the virus and their bodies can take the chemical ****tail without a lot of post effects for the most part.

There is no guarantee I would be as healthy in 1 1/2 years as I am now. I am 50 and I've had the virus 33+ years. JoAnneh you are so correct.

Not sure of the forum you are getting the "hurting more than helping" info on the triple. You know everybody has an opinion like everyone has an &*&*^^.  Seems a bit harsh. I had to promise my doc I would stay off the computer looking at people's experiences and opinions about treatment. I was scaring myself to death.

I had to follow my heart and gut about starting this now. So my heart & gut said do it.

So going into 10 weeks of a 24 week treatment - how's it been for me??? Well, it's a tough one, I will not sugarcoat it. I knew exactly what i was in store for. But I am doing it.

And the biggest prize I keep my eye on, is this October of 2013, I will be done with treatment and 6 months after that I will have a blood test to detect vl. I will be SVR and I'll never have to think of myself as HCV+ again.

Peace to you tonib- don't let the fear paralyze you. K



__________________

HCV 1A 1980. Dual tx 2003 -UND at wk 11-discontinued due to severe depression

Started Triple 4/16/13 for 24 weeks

UND wk 4,6,8,12,17 & 24

E.O.T. 9/29/13

EOT + 12 weeks=SVR, and EOT +26 weeks=Cured!



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Tobin,
No sense waiting for new drugs.
Try not to get wrapped up in negative talk.
Triple tx has worked for MANY people on
This forum. At your age and having had Hep C
For 25-30 years you are wise to start tx ASAP.
I have a neighbor at age 53 has liver cancer from
Hep C.
Wonderful news that ur daughter is in remission!

__________________

JoAnne

Genotype 1a, Triple therapy w/Invicek started May 19, 2012

DET 4 wk. UND 2,6,12,24 48 treatment. Achieved SVR 2013!



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All this info is making me crazy, here I sit with the decision made to begin my 3X therapy on July 5 and now I am reading all this stuff about the sofosbuvir. Its so confusing, on another forum someone told me the that the 3X is gonna hurt me more than it will help and that there is really no true cure for this virus.
My daughter was dx with ms about 10 years ago and since then they have been promising a non injectable med, well just recently they approved it. My thought is that if she had waited for this drug she would have gone without therapy for 10 years. Right now she is in remission (THANK YOU GOD!!) If she waited she most likely would have become really sick.
So now here I am facing the same dilema that my daughter had to face......to start or to wait....they say the sofosbuvir will be good to go in 1st quarter 2014....but what happens if it isn't...its all so confusing

__________________

 geno 1, started peg and riba 7/5/13, now 29th day is vicrellis ***tonib VL started 6 million, after 5 weeks 374,000, after 8 weeks 150,000....the big test for VL is 9/27 at 12 weeks  TAKEN OFF THERAPY JUST NOT WORKING FOR ME...12 WEEKS STILL HAVE 9000 VL



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Hi Jill,

Dilemma is hardly the word.  Nightmare is more appropriate.

Why on earth can't Ledispavir be given 'priority review'. Sofosbuvir works best with a NS5A Blocker, not an antiprotease like Simeprevir.

The Rx failures with Victrelis and Incivek will be excluded. These patients are probably Interferon resistant, so will have to sit around for at least another year or more.

There is no significant improvement for the Geno 3's, although they may be spared Interferon.

As the article says, Insurance Companies will not be prepared to pay for the Sofosbuvir- Simeprevir combo. Gilead will make the price of it's own combo ( Sofosbuvir and Ledispavir) very attractive, to stop mixing and matching.

The wait continues for another couple of years...............



__________________

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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Both Simeprevir and Sofosbuvir Likely Approved by 2014 - Clinical/Ethical/Pharmacoeconomic Dilemmas Loom

As expected, simeprevir, and now also sofosbuvir, are being given "priority review" by the FDA.  With the 6-month rule under the Prescription Drug User Fee Act...that means there`s a good chance we`ll have both of these anti-HCV drugs some time in late 2013.

Which also means HCV treaters will soon face a major dilemma regarding management of HCV genotype 1.

Full article...

http://hepatitiscnewdrugs.blogspot.co.uk/2013/06/both-simeprevir-and-sofosbuvir-likely.html

 



__________________

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.

 

 

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