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Hep C Discussion Forum -> General Discussion -> DAA Combos: FDA Approval Status
Post Info TOPIC: DAA Combos: FDA Approval Status
Isiscat2011


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RE: DAA Combos: FDA Approval Status
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UPDATE:  The FDA review date for the BMS combo daclatasvir/asunaprevir has been moved up to November 30, 2014 (from December 7, 2014). 

The Daclatasvir/Asunaprevir combo will likely be FDA approved only for use together.  That means in order for docs to prescribe Daclatasvir with Sovaldi in the US they would have to prescribe off-label.  Off label prescriptions are not favored by insurance companies where FDA approved combos are available.  Gilead continues to resist the use of Sovaldi with Daclatasvir in the US. 

The European Commission approved Daclatasvir on August 27, 2014.  Daclatasvir will, therefore,  be paired with Sovaldi for European use (as cost permits).  

http://phx.corporate-ir.net/phoenix.zhtml?c=106664&p=irol-newsarticle_print&id=1961265&highlight= 

 



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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.
Tig


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The AASLD treatment guidelines and their collaborative partners, are constantly updating their information. From what we've seen, the treatment guidelines and recommendations change weekly, if not daily! I think that we, as a group, are probably one of the better informed groups available. I'm thankful that there are the number of involved members here, willing to help provide the updated information. It's a valuable resource and I appreciate the interest and the help in maintaining access to the most current data.

http://www.hcvguidelines.org/full-report-view

http://www.iasusa.org/

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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Isiscat2011


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Just wanted to add that the AASLD guidelines are still being updated.  

I suppose it isn't fair to crucify the authors yet but what they have done so far isn't giving me the warm fuzzies. 



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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.
Tig


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Hey John,

Saying what is better is a difficult process at best! It's going to to require exposure to the virus under multiple different circumstances and as Isiscat mentioned, doctors will likely begin customizing treatment plans based on previous treatments, RAV's, and individual genetic screening. The options today are vastly different and dare I say vastly improved (because that data has yet to be presented by the manufacturers). I believe we're going to see great improvements as well as available options in the next 1-2 years. Your question will be answered in the next few years, but not until these trials have completed and the data studied. 

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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Isiscat2011


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John:

I seem to recall you were on Interferon more than once.  I don't see that in your sig line anymore.  It is also interesting that you were RVR this time (undetectable at 2 weeks and throughout tx).  Did you actually see the viral load results?



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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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The only one that isn't for 1as is the BMS combo: daclatasvir/asunprevir.   Hard to say which combo will be best for each person.  

I like the sovaldi/ledipasvir combo, but honestly I would have some concerns about taking sovaldi a second time, despite what the drug manufacturer says. The available information is just so limited.  Those concerns would be lessened if the tx duration was extended or the second tx included different second or third DAAs. 

It seems pretty clear that you are not Interferon sensitive so combining Sovaldi with a different drug may have more success for you.  I would recommend that everyone who hasn't done so yet get a current liver assessment and their IL28b typed.  At some point docs will begin individualizing tx and these factors should play a role in selecting the best tx.

The Abbvie combo, which will be approved December 21st is also an option for 1as.  We don't have much to go on except for the clinical trial results which obviously look very promising.  

For now I don't think most people will have much control over the tx combo used or the duration of tx.  Insurance will ultimately decide although having a good and supportive doc will certainly help.  The new AASLD guidelines are not as helpful as they should have been.   Could be because almost every doc who participated in writing the guidelines has a conflict of interest (receives pharma money) but that is a whole other ball of wax.

 



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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.
JLynch30


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Is any of them better for 1a's?

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John   non-responder  

Undetected at week 2 on solvaldi/rib/interferon:  stayed through week 12 but virus came back as soon as I stopped.  on   Harvoni and ribravirin 24 weeks undetected after two. 8/2/15  12 week EOT  UNDETECTED!  SVR

1991-2015 RIP

 
Isiscat2011


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Here is a list of the 5 DAA combos that are coming soon.  The drug manufacturer, genotypes each will treat, and the expected FDA approval dates are noted:

 

ledipasvir / sofosbuvir

Gilead

NS5a inhibitor/nucleotide analog polymerase inhibitor 

Genotype 1 CHC

10/10/2014

___________________________________________________

daclatasvir / asunaprevir

Bristol-Myers Squibb

NS5a inhibitor/protease inhibitor

Genotype 1b CHC

12/07/2014

____________________________________________________

ABT-450 /ritonavir/ombitasvir/dasabuvir

AbbVie / Enanta

ritonavir-boosted proteaseinhibitor/NS5a inhibitor/non-nucleoside polymerase inhibitor

Genotype 1 CHC

12/21/2014

__________________________________________________

MK-5172/MK-8742

Merck

protease inhibitor / NS5a inhibitor

Genotype 1 CHC

2H:2015

_____________________________________________________

daclatasvir / asunaprevir / BMS-791325

Bristol-Myers Squibb

NS5a inhibitor/protease inhibitor/ non-nucleoside polymerase inhibitor

Genotype 1 CHC

2H:2015



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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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