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Hep C Discussion Forum -> Hep C News -> AbbVie Announces Completion of Phase III Program of All-Oral, Interferon-Free Therapy for the Treatment of HCV Gen. 1
Post Info TOPIC: AbbVie Announces Completion of Phase III Program of All-Oral, Interferon-Free Therapy for the Treatment of HCV Gen. 1
mallani


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RE: AbbVie Announces Completion of Phase III Program of All-Oral, Interferon-Free Therapy for the Treatment of HCV Gen.
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Hi Matt,

I can understand your frustration. Your relapse was obviously due to RAV's. As the AbbVie ****tail blocked 3 viral sites, it is difficult to understand how this can happen. It's unfortunate that all of AbbVie's drugs are not top-drawer. The RAV profile of ABT-450 is not well published, and it needs to be boosted by Ritonavir . ABT-333 is a non-nucleoside NS-5B blocker, not in the same league as Sovaldi. Mathematically, you would still expect this combo to be successful, despite the high pill burden.

AbbVie would be well aware of what RAV's have developed in your case. It doesn't really matter if they won't tell you, as you will win the next round using Sovaldi and hopefully Ledispavir. Be patient, mate.



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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
Matt Chris


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Hello Jill

Thanks for posting that news about Abbvies many phase three trials its very encouraging for the future all orals HCV treatments.  

I was very reluctant to comment on the trial results because I am so personally attached to the Turquoise II trial as a participant who was not one of the 92% fortunate ones who succeeded to SVR 12

The viewpoint that I can expose is from the perspective of the few 8% that did not achieved SVR .

First, its very hard to deal with the pain of failure where so many others have succeeded. You are happy for them and glad they made it but there's a big hole in your heart  every time you hear or read about it.

Anybody who has relapsed can identify with this feeling of failure and the black hole that we can climb into. Hope is the great savior from this condition of despair.  Thankfully there is many new treatments coming down the road which can fill a person hope for a day or a week and we are happy to read about them from our other HepCfriends.

The worst part of failing a phase III HepC trial is that Big Pharma won't and don't reveal the reasons behind your failure. They take 12 vials of blood every visit before, during, and after the trial for an entire year or longer. You gave them permission to do so and to gather baseline resistance, in trial resistance, mutations, and any other anomalies before,during and after the trial ends. They know whats happening, and how it happened but they guard that information and will not disclose it. I have been asking my Study Doctor, the trial monitor, and Abbvie trial director the last 7 months for some insight on my failure so to know how to proceed with future treatment. Not willing and no comment is the answer.

So I wait with all the other 8% and drift in the doldrums of wonderment. There is very little knowledge on how to retreat of DAA triple failure and with this kind of help it will take years.

Figuring out the real reason why a person relapses after EOT though he achieves UND status during the treatment is not a easy thing, but it can be done by a process of elimination of the common reasons, (Ravs, non-compliance, hidden virus, etc,) but without the info its only guessing, maybe someday I will know, for now I wait and keep on keeping on.

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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Cinammon Girl, thanks for clarifying that.

I think it would be great if AbbVie's treatment could be FDA approved this year.



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Tig


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It's reassuring to know that even with these new treatments, Abbvie continues to work with their partners to improve the improvements. One day this disease will go the way of the Polio virus and we'll all be the pioneers of that success! 

http://www.enanta.com/research/hepatitis-c-virus/

Tig



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Tig

67yo 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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Cinnamon Girl


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Hi SusiQ, yes, the results from these new drugs are quite astounding, impossible to imagine just a few years ago.  I don`t know why Merck are being so slow, they need to catch up!

Hi Lauralou, the Sapphire -11 trial was for Gen 1a and 1b, tx experienced and non-cirrhotic, even though it doesn`t say so.  Here`s a a press release from December 2013 announcing the results from that trial...

http://abbvie.mediaroom.com/2013-12-10-AbbVie-Demonstrates-96-percent-SVR-12-in-its-Phase-III-Study-of-Treatment-Experienced-Patients-with-Genotype-1-Hepatitis-C

 



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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.

 

 
lauralou57


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Thank you for posting this.

It is too bad that the did not show any results for genotype 1a, noncirrhotic and treatment-experienced.



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suziq


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Hi Jill,

Thanks!!  Just read this today.  Looks like more and more GREAT drug combos are going to be available this year. Merck (my trial) needs to get moving with their trials.

SuziQ



-- Edited by suziq on Saturday 1st of February 2014 01:33:23 PM

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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
Cinnamon Girl


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AbbVie Announces Completion of Phase III Program of All-Oral, Interferon-Free Therapy for the Treatment of HCV Gen. 1

Jan 31, 2014 NORTH CHICAGO, AbbVie announced the completion of its phase III clinical program and released results of four additional studies designed to assess AbbVie's investigational all-oral, interferon-free therapy with and without ribavirin (RBV) in patients with chronic genotype 1 (GT1) hepatitis C virus (HCV) infection. These results described below confirm previously reported AbbVie data and further demonstrate high sustained virologic response rates 12 weeks post treatment (SVR12) and tolerability in these GT1 patients.

- Ninety-nine percent SVR(12) rates with and without ribavirin in certain patient types

- Even in difficult-to-treat patients (cirrhotic patients) achieved 92-96 percent SVR(12) rates

- AbbVie expects U.S. launch in 2014

Full article and results from Pearl-11, Pearl-111, Pearl-1V, Turquoise-11, Sapphire-1, and Sapphire-11 studies...

http://hcvadvocate.blogspot.ca/2014/01/abbvie-completes-largest-phase-iii.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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