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Hep C Discussion Forum -> Knowledge/Info Section -> A Guide to the Phase 3 clinical trials of Sovaldi/Ledipasvir for Gen 1
Post Info TOPIC: A Guide to the Phase 3 clinical trials of Sovaldi/Ledipasvir for Gen 1
HR


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RE: A Guide to the Phase 3 clinical trials of Sovaldi/Ledipasvir for Gen 1
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annabanana wrote:

Just wondering if there is any new info on GT 2 or 3.   Won't change my TX but if Sol/rib doesn't work first time are there other options.

 Sure. Gilead is coming out with the GS-5816 with Sofosbuvir  that is pan genotype. Suppose to be good results. I don't think we hear much about it because they are trying to get Sof/Led FDA approved right now.

there are other companies besides Gilead working on this too. Idenix has one and Merck just bought them or is in the process. Good luck



__________________

ION-3 Trial- Sofosbuvir/Ledipasvir 12 weeks.. UND 4 weeks, relapsed 12 week EOT. 

3-4 on Ischank scale

 

Retreat ION-3 Trial- Sofosbuvir /Ledipasvir 24 weeks

GT-1 (1-31-14) Week 1 VL 62 -Week 4,8,12,16,20 UND EOT 7-18-14
annabanana


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Just wondering if there is any new info on GT 2 or 3.   Won't change my TX but if Sol/rib doesn't work first time are there other options.



__________________

GT3A            DX 2002              VL 400,000           AST/ALT normal         Started Sol/RIBA June 9 2014 for 24 weeks
HR


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Fireman Rob wrote:

Wow- those are incredible cure rates! I wish there were more numbers like this for Sovaldi/Olyiso as I hope to not enter the "treatment experienced" population when I finish this combo. I'm sure there will be soon enough...

Have any of you seen anything besides the 92-94% success rate with S/O? It would probably help if I knew whether I'm 1a or 1b. Too bad doctors around my location don't care about that.

Thanks for posting that link Jill. Very informative.

-Rob

 Hey Rob

  Mine was the exact same thing. 1a-1b. Later when I got to the trial place I was asking them about it and they told me I was 1a. Good luck sir.



__________________

ION-3 Trial- Sofosbuvir/Ledipasvir 12 weeks.. UND 4 weeks, relapsed 12 week EOT. 

3-4 on Ischank scale

 

Retreat ION-3 Trial- Sofosbuvir /Ledipasvir 24 weeks

GT-1 (1-31-14) Week 1 VL 62 -Week 4,8,12,16,20 UND EOT 7-18-14
Cinnamon Girl


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That is strange, Rob, and Isiscat is right that it should be included in your genotype test result.  As you say though, you`re already on tx so it doesn`t make much difference at this stage, and you stand a very high chance of success on the S/O combo whichever it is.

This new era of treatment drugs and combos is just incredible and it`s getting even better.

 

 



__________________

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.

 

 
Fireman Rob


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Thanks for the reassurance Isiscat. When I first got tested, my doctor didn't provide me with a sub type. When I looked it up on my online records it says "Genotype 1a or 1b. My medical assistant can't find a sub type anywhere. At this point, it's probably irrelevant but if relaspe occurs I'll definitely be testing. Lol

Have a good one!



__________________

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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Hi Rob:

Your geno 1 sub-type is probably already known because it is usually established with the initial genotype testing.  If you call your doctor's office they should have this information in your lab work.  The treatment naive, non cirrhotic, SVR rates are exceptionally high for both gt1 sub-types on the S/O combo.  Most likely you will never need a second tx.  No cause to worry at this point.  You are well on your way to SVR already.



__________________

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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Wow- those are incredible cure rates! I wish there were more numbers like this for Sovaldi/Olyiso as I hope to not enter the "treatment experienced" population when I finish this combo. I'm sure there will be soon enough...

Have any of you seen anything besides the 92-94% success rate with S/O? It would probably help if I knew whether I'm 1a or 1b. Too bad doctors around my location don't care about that.

Thanks for posting that link Jill. Very informative.

-Rob



__________________

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

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


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Thanks Jill! That's a very helpful guide. Looking at the SVR rates gives me chills up my spine! How incredible are those results? Can you imagine what might be available in another two years? It staggers the mind!

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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A very informative guide to Gilead`s fixed dose combo Sovaldi/Ledipasvir with or without ribavirin, for genotype 1, which includes the results from the Phase 3 clinical trials.

This treatment is expected to receive approval from the U.S F.D.A. in October this year.

I thought it would be useful to post this here for reference purposes.  Pdf format...

http://www.hcvadvocate.org/hepatitis/factsheets_pdf/Phase_3_Genotype_1_SOF-LDV.pdf



__________________

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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