A Guide to the Phase 3 clinical trials of Sovaldi/Ledipasvir for Gen 1
HR said
Jun 27, 2014
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
annabanana said
Jun 27, 2014
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.
HR said
Jun 27, 2014
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.
Cinnamon Girl said
Jun 27, 2014
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.
Fireman Rob said
Jun 27, 2014
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!
Isiscat2011 said
Jun 27, 2014
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.
Fireman Rob said
Jun 27, 2014
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
Tig said
Jun 27, 2014
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
Cinnamon Girl said
Jun 27, 2014
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...
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
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.
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.
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.
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!
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.
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
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
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