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Post Info TOPIC: Abbvie Combo: December 21


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RE: Abbvie Combo: December 21
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Isiscat2011 wrote:

So, now you are probably asking yourself: "Well, what can this Abbvie combo do for me?"  (Who wouldn't?)  Unfortunately, nobody can answer that question definitively but here is what it did for a couple of different HCV populations in clinical trials:  

Treatment Experienced:

http://www.hivandhepatitis.com/hcv-treatment/experimental-hcv-drugs/4620-easl-2014-abbvie-oral-regimen-cures-96-of-treatment-experienced-genotype-1-patients

 

People with cirrhosis:

http://www.hivandhepatitis.com/hcv-treatment/experimental-hcv-drugs/4633-easl-2014-2abbvie-3-drug-combination-cures-up-to-96-of-hepatitis-c-patients-with-cirrhosis

 

P.S.  The above applies to Genotype 1s.   I don't know if the other GTs will be able to use this combo.  They seem to get left behind sometimes, don't they.  Sorry, GT 2 + 3.  :(



-- Edited by Isiscat2011 on Wednesday 13th of August 2014 04:48:08 AM


 I am on week 4 of the clinical trial for this combo and was undetectable at 2 weeks (yay for me!). It's a lot of different pills to take but Abbvie has a perfect opportunity to steal the market away from Gilead if they offer anything close to a reasonable price. (Meaning less than $84k.) Exciting times!



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I pushed that LIKE button Aegeanhmm



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  HCV Genotype 3a , now Psot-Tx was on S/riba. First VL was 5.8 mil on 7-5-13 then "und" at 3.8 weeks. 06/13/14 still und. off meds 3 days back on 7/29 Last pill 08/10/14 SVR+4

 



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Great new...thx for the update. The only question I have is how affordable will or won't this be?

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64 year old EOT 10-28-15,SVR24 April 21 2016  ALT-12/AST-23 June '19 - fibroscan 6.9 F-0 July '19



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So, now you are probably asking yourself: "Well, what can this Abbvie combo do for me?"  (Who wouldn't?)  Unfortunately, nobody can answer that question definitively but here is what it did for a couple of different HCV populations in clinical trials:  

Treatment Experienced:

http://www.hivandhepatitis.com/hcv-treatment/experimental-hcv-drugs/4620-easl-2014-abbvie-oral-regimen-cures-96-of-treatment-experienced-genotype-1-patients

 

People with cirrhosis:

http://www.hivandhepatitis.com/hcv-treatment/experimental-hcv-drugs/4633-easl-2014-2abbvie-3-drug-combination-cures-up-to-96-of-hepatitis-c-patients-with-cirrhosis

 

P.S.  The above applies to Genotype 1s.   I don't know if the other GTs will be able to use this combo.  They seem to get left behind sometimes, don't they.  Sorry, GT 2 + 3.  :(



-- Edited by Isiscat2011 on Wednesday 13th of August 2014 04:48:08 AM

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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.



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So, I was just checking on how thing are progressing for the Abbvie combo, and it appears this combo will be approved on December 21st.  

Abbvie submitted its New Drug Application (NDA) to the FDA on April 21, 2014 and it was granted breakthrough status in May.  On June 13,2014 the FDA granted it priority review. The timeline for NDAs that are granted priority review is 6 months.  The 6 month calendar begins 60 days after the NDA is submitted which in Abbvie's case means June 21, 2014.    June 21 + 6 months = December 21.   

Anybody who has a burning desire to know about the FDA approval process can click here:

http://www.fda.gov/forconsumers/byaudience/forpatientadvocates/speedingaccesstoimportantnewtherapies/ucm128291.htm

 

The Abbvie combo will include the following:  the HCV protease inhibitor ABT-450 boosted with ritonavir, the NS5A inhibitor ombitasvir (ABT-267), and the non-nucleoside HCV polymerase dasabuvir (ABT-333).

You can read all about this combo here:  

http://www.hivandhepatitis.com/hcv-treatment/experimental-hcv-drugs/4715-abbvies-3d-hepatitis-c-combo-gets-priority-review-in-us-and-europe



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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.

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