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SYNERGY Trial Results - SOF/LED

As some have been posting recently that they have relapsed after their Sovaldi based treatment, I decided to do some research on the new drug combo pill Sofosbuvir/Ledipasvir expected to be approved in early October.  I found this
presentation given at the Croi 2014 Conference which shows very impressive results. Please note that the trials included only small numbers of patients.

http://www.croiwebcasts.org/console/player/22048?mediaType=slideVideo&

If nothing else this should give us all hope that  HCV will be globally eradicated sometime in the near future.

Nan


12 Responses
Avatar universal
Yes, that's an excellent reference. The Synergy study you're referring to was sponsored and conducted by NIAID on a small group of 60 trial participants that were considered underserved and marginalized. Most of the participants were African-Americans. This trial was designed to study difficult to treat populations because of genotype (1a), non-CC polymorphism, poor treatment response, poor med compliance, barriers to accessing treatment and several other factors that translated in poor hcv tx access and tx outcomes. Synergy included several treatments arms. All were inf and riba free. The tx with sofosbuvir and ledipasvir is the treatment arm you've alluded to.

There are more trial study data which includes SOF and LDV which are sponsored by Gilead Sciences Inc makers of SOF and LDV.  LONESTAR, ION 1, ION 2 and ION 3 clinical trails. The ION study includes a larger study population of HCV mono infected, HIV/HCV co-infected, cirrhotics and non-cirrhotic individuals.

There's hope and optimism now that newer class of DAAs are coming to fruition. When SOF/LDV is finally approved this fall by the FDA it's going to make a huge difference in terms of hcv treatment options. Peace.

683231 tn?1467323017
tHi Nan

When I spoke with my doctor about what if I don't clear the virus with Sovaldi Olysio she had concerns if my insurance would cover a second treatment with a Sovaldi based medicine. So I am hoping like heck I don't have to find out the answer to that question. That would be amazingly bad if I tried and failed and they wouldn't let me try the next best because they are too similar.

Has anyone heard anything about that possibility or have any thoughts?

Lynn
Avatar universal
My doc said I could easily do the next Sovaldi treatment if I don't clear with Olysio. And that if Sovaldi doesn't get the results they had expected (although she says of her patient base, which is fairly big, 10% are relapsing, which is what they were expecting, a bit worse) Sovaldi prices are going to go down because the govt is now doing an investigation as to their pricing, it's kind of a scandal that in Egypt it's as cheap as antibiotics because that's all they can pay, Europe is cutting deals with Gilead, etc. She told me she doesn't expect that Sovaldi will stay as expensive as it is, more shall be revealed. Also, that perhaps it's not the Sovaldi that's at fault here but the Olysio, there are all kinds of things to consider. Just my views.
9662954 tn?1405606159
Lynn, I spoke to Acaria and they said they will be interested in both categories of patients, those like us and those new to treatment.  I asked the same question too! Let's just hope we stay on track.

I thought about transplants, and if I ever got that sick, I would not do a transplant.  I am okay with new drugs that do not destroy me--like interferon did, but that's where I personally draw the line.  Because of my size, a liver for me would fit a kid! I could not take that opportunity away from a child with their life yet to be lived.  Seeing people die while waiting, and working with donor families has def given me a different perspective.

So, we keep doing fab, and if we have to consider the new drugs, I believe they are opting for our group S&O to do the new sovaldi pill for 24 weeks.  

Thanks for info!  Best, dbz  
Avatar universal
Hi Nan,
I’m new on this site.  Just completed 4weeks Synergy trial conducted by NIAID Sofosbuvir+Ledispasvir+ GS-9451+GS-9669 (first treatment). I’m 1b chronic hepatitis with inflammation, no fibrosis, no cirrhosis, baseline viral load 500,000. Diagnosed 17 years ago. Undetectable 1,2,3,4 week during the treatment and first week after the treatment. The adverse events are very mild, mostly fatigue. My 1 month follow-up visit on the next Tuesday.  Little bit nervous.
Avatar universal
Wow - only four weeks! You can bet we are all rooting for you to reach SVR.
It's amazing that you have no fibrosis after 17 years with this virus. It would be even more amazing if you actually clear this virus with such a short treatment.

You have my best wishes for a successful outcome.

Nan

Avatar universal
Thank you for adding more specific information about the trial. I will look over those other trial results again.  

I think its important for everyone to know that should they relapse there will be alternative treatment in just a few short months.  I know it must be devastating to hear the virus is back after hearing you are UND throughout the treatment.
My husband will be finishing up his treatment in 2 weeks (Sovaldi + Ribavirin 24 weeks).  I think its important to be prepared for any news and maintain hope that one day this virus will be gone.

Nan

Avatar universal
I thought about the same thing.  Will my husband have a problem getting approval for this next Sovaldi based treatment should this one fail?

I decided that he will, given the cure rates associated with it.  It is just more cost effective for the insurance company if he gets rid of this virus. The alternative would be more hospitalizations and maybe even the need for another transplant. At least that is what I'm hoping they will conclude if faced with this decision.  God willing he will reach SVR and there will be no need for another treatment.  I wish the same for you!

Nan

Avatar universal
Thank you so much, Nan. I really, really hope
Avatar universal
http://video.healio.com/video/Paul-Y.-Kwo-MD-on-the-current-an;Hepatology

Found this video of Dr Kwo speaking about the new therapies coming soon.

What came to my mind after watching it was: "Don't worry, be happy."

Nan
Avatar universal
http://video.healio.com/video/New-treatment-regimens-for-cirrh;Hepatology

Another video which gives us hope Hep C will be eradicated someday soon.

Nan
Avatar universal
I understand completely where you are coming from on the transplant statement.  But, I also can see where someone might come from another viewpoint and go with a transplant.  I don't want to judge them because I haven't walked in there shoes.  Who knows what I'd really do if I was at death's door.  With that being said, I would not take a piece of a liver (living donor) from any family member, ever.  Because I don't feel like I've been such a 'great and wonderful family member' that would be worthy of them sacrificing their live for me.  And people donating a living donor piece of liver do so at a great risk to themselves.  I wouldn't want to take a liver from a child either.  I, too, have a very small upper body mass and even have to purchase petite sizes in blouses due to shoulder/ribs/chest, etc.  But, if a donor was another piece of a deceased liver and it was shared with another person who was suffering from Hep C, like each Hep C person got half of the deceased person's liver, in an instance like that, I might be convinced to do it.  But, I'm no where near ever having to consider that and I'm blessed that I haven't reached that point after 30 yrs of having this.  I am approximately a Stage 2.   Susan400
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