Hep C Discussion Forum

Isiscat2011 · Guru

RE: More News from AASLD Meeting

Isiscat2011 · Guru

Matt Chris wrote:
Hey Isiscat
Did you notice Dr. Poordads take on treatment term "Big Guns" view versus the other Docs.
I think these leaders will do what they think is best the the patient, they may talk big picture in front of the camera but I would say 85% would still go the longer safe route than short until its proven beyond a reasonable doubt.
matt

He was one of your docs, right? Yes, it sounds like he would not be shy about using the big guns. biggrin

Btw, cute bow-tie. Sort of a Pee-Wee Herman thing going on with his attire.

JLynch30 · Senior Member

That is what sold my doctor I think. "Big Guns" for me after 6 interferon regiments

Matt Chris · Guru

Hey Isiscat

Did you notice Dr. Poordads take on treatment term "Big Guns" view versus the other Docs.

I think these leaders will do what they think is best the the patient, they may talk big picture in front of the camera but I would say 85% would still go the longer safe route than short until its proven beyond a reasonable doubt.

matt

Isiscat2011 · Guru

Matt Chris wrote:
I wonder how Ribavirin will play in the new guidelines, after seeing the round table video its seems that Ribavirin has been resurrected.
We will see if these Doctors are the pulse of HCV treatment or just a splinter group.
matt

Good question. Just guessing but I think Riba is being resurrected in order to shorten the Harvoni tx time; the cost of tx for cirrhotics is simply too high at 24 weeks.

So, now they have a new study to point to and say "You only need 12 weeks if you add riba." Voila, they have just saved ~100K which can be used to treat another person or almost two more people at 8 weeks. Most cirrhotics will SVR with 12 anyway so it is easily justifiable. And, there is at least a medical argument to be made that 24 weeks will result in over-treatment of most.

It will be interesting to see what individual clinicians do because, if the AASLD adopts 12+riba, it will be in direct conflict with the FDA approved duration. Will the FDA update the duration to 12 weeks? If not, will clinicians go with the AASLD guidelines over the FDA's recommendations? It is anybody's guess. You've studied this stuff long and hard. I'd love to hear your take. I'd love to hear Malcolm's too but he is on a well deserved holiday.

Matt Chris · Guru

I wonder how Ribavirin will play in the new guidelines, after seeing the round table video its seems that Ribavirin has been resurrected.

We will see if these Doctors are the pulse of HCV treatment or just a splinter group.

matt

shadow10cats · Senior Member

I have corresponded with the AASLD and Audry Davis-Owino, who is the Director of Gov & Practice Guidelines told me they are re-doing the guidelines and they should be available in early December. Until then this link is to the most current.

http://www.hcvguidelines.org/

Isiscat2011 · Guru

Hi John:

Yes, a protease inhibitor, like Tig said. My understanding is that you treated with Incivek which is in the same drug class as Simeprevir; both are PIs. So you have treated with both a PI and Sovaldi.

I interpreted the docs comments in a broader context. They were saying if you have a hard to treat, cirrhotic, patient who has prior tx history with both a PI and Sovaldi, then give the patient 24 weeks. If you don't qualify as a hard to tx patient then I don't know who does (several Interferon/Riba treatments, a clinical trial, Incivek, and Sovaldi).

Another thing to keep in mind is that the medical profession tends to think not only of the individual-- but also of societal interests--the greater good. The greater good can be served by treating more patients for a shorter duration, and let the chips fall where they may. 12 weeks of Harvoni with riba is a cost saving measure--no doubt about that-- and it is contrary to the FDA recommended tx duration for tx experienced, cirrhotics.

After all you have been through, if it was me, it would be showdown time with this nasty virus. I would insist on 24 weeks with S/L. Sure, the odds are in your favor with 12 weeks, but they have been in your favor before. This time the odds need to be overwhelmingly against the virus, and I would not believe they are based on this small study, which is contradicted by larger studies as well as by the FDA recommendation. But that's just me.

Beacon · Senior Member

These doctors also seem to feel that the AASLD is going to update

their treatment guidelines next month.

This is an excellent presentation and you can quickly skip anything

your not interested in.

-- Edited by Beacon on Tuesday 18th of November 2014 02:50:21 AM

Tig · Admin

I believe the PI in this instance means "Protease Inhibitor", like Incivek, Victrelis or Olysio.

Tig

JLynch30 · Senior Member

PI is peg interferon? - yes.

if you mean sovaldi yes - with peg/rib for 12 - relapse.

Are they not saying sof/sim treatments together?

-- Edited by JLynch30 on Tuesday 18th of November 2014 01:24:13 AM

Isiscat2011 · Guru

Hi John:

Haven't you previously treated with a PI?

JLynch30 · Senior Member

Sorry I mean slide 31 and 27

JLynch30 · Senior Member

Thank you so much for your feedback. Unless i am listening to this wrong - the big gun therapy would be for those who failed sim/sof together.

The interfon/rib/sov failures were 100% svr when retreated with sov/rib/led for 12.

I directed my situation to slide 27 and 32.

Isiscat2011 · Guru

Matt Chris wrote:

Simply FANTASTIC

You are right, Matt. Fantastic. I know I have officially lost my mind because I would now rather watch 4 Hepatologists belaboring the minutiae and nuances of HCV tx than watch Russell Crowe giving the Ancient Romans what for in "Gladiator." I just might have to view that again. hahaha

Isiscat2011 · Guru

Hi John:

You are a man of few words, and your sig line doesn't fully describe your situation, but my understanding is that you are a 1a, cirrhotic, tx experienced with both a PI and Sovaldi. You have had multiple txs and based on your sig line have been a non-responder. I don't believe your IL28B has ever been determined but based on your lack of sensitivity to Interferon it isn't the ideal CC. These are all still relevant factors.

I would strongly encourage you to watch the presentation Matt posted; the 4 panel members would unanimously treat for 24 weeks in your situation and they would consider throwing in some Riba. These are world class Hepatologists who have vast knowledge and experience in HCV tx. As they would say it is time to throw the "big guns" at it. That's all I'm going to say. Your call.

Isiscat2011 · Guru

Excellent find, Matt. I am only 30 minutes into the presentation and I had a vision of the future. The vision showed AASLD recommending Harvoni + Riba 12 weeks for tx exp cirrhotics unless the patient is RIBA INTOLERANT. Then, I saw a flash of light and the words COST SAVINGS were scrawled across the sky. Yes, this is the future.

Now, I'm hoping the AASLD guidelines are delayed until my script for 24 is approved and filled. lol Man, things are changing fast.

Ok, back to the film. More later. :)

JLynch30 · Senior Member

I have been waiting to hear all day whether to start tomorrow on 12 harvoni and ribravirin.

I know these doctors and they are some of the best ones around - all three said they would treat 12 weeks with rabri for someone like me.

This is probably the most important post I have read on here over the years - thank you my friend!

Matt Chris · Guru

Hey All

I just watched the best video round table discussion on HCV about oral treatment regimens that I have ever seen.

Title : Advances in Chronic Hepatitis C Management and Treatment

This is a discussion on all the latest treatment regimens by the top clinicians in the USA

Here is the link http://s318638489.onlinehome.us/files/aasld2014/

Simply FANTASTIC

matt

PS This is a slow load from the internet so be patient.

Isiscat2011 · Guru

RudiRoo wrote:

____________________________________________________________________________________________________

This is an FDA approved drug. It seems like results should be posted prior to approval, or at least since then?

Hi RudiRoo:

The FDA allows Pharma to continue to submit clinical trial results, as well as other important information, up to a year after approval and that time can be extended even longer. The idea is to get the drugs to the public asap--which hopefully is a good thing--but it isn't always.

Isiscat2011 · Guru

Matt Chris wrote:
One of the problems with smaller trial studies is it can be skewed my several variables. For example the mixed of GT1a and GT1b can make a differance in the overall SVR rates, during Abbvies Turquoise II trial the overall SVR was 94% but drilling down into the variables the GT1a SVR rate was 91.6% but the GT1b were 99.2% and yet further if you look at the IL28b 12 week sub group the SVR % was only 80.50%
The point is we have learned how variable in patients can effect the SVR % but not learned to overcome this differences yet, but it is coming with additional improved DAA's
matt

These variables occur in larger studies as well. That problem is lack of transparency because they know the differences but often do not make the data accessible to the public. And that still doesn't explain the wide disparity between 82% and 96% for the same patient population.

Matt Chris · Guru

One of the problems with smaller trial studies is it can be skewed my several variables. For example the mixed of GT1a and GT1b can make a differance in the overall SVR rates, during Abbvies Turquoise II trial the overall SVR was 94% but drilling down into the variables the GT1a SVR rate was 91.6% but the GT1b were 99.2% and yet further if you look at the IL28b 12 week sub group the SVR % was only 80.50%

The point is we have learned how variable in patients can effect the SVR % but not learned to overcome this differences yet, but it is coming with additional improved DAA's

matt

RudiRoo · Senior Member

Isiscat2011 wrote:
My question is why does one study result in an 82% SVR rate and the other a 96% SVR rate for the exact same tx population and protocol? It is as if the results are being intentionally manipulated. hmmmmm..........

Not sure if this is normal, but is it weird that the study results are still not posted at : http://www.clinicaltrials.gov/ct2/show?term=Ion+2&rank=1 ? This is an FDA approved drug. It seems like results should be posted prior to approval, or at least since then?

Isiscat2011 · Guru

Matt Chris wrote:
Reading the Gilead site article shows than your better off including Ribavirin with Harvoni if your only doing 12 weeks.

But this data seriously contradicts the ION-2 study where the same tx population did worse with riba and the riba arm only had an 82% SVR rate (as opposed to a 96% rate). The 24 arm results are different as well, but not dramatically.

So, the question is, why the glaring contradictions in study results? The easy answer is that none of this has much impact on 24 weekers anyway but it may be more complicated than that. If riba doesn't help and can actually reduce SVR rates, as the ION-2 results indicate, then we should see a 96% SVR rate @ 12 weeks without it, in which case 24 weeks would be entirely unnecessary. Something fishy here.

Matt Chris · Guru

Reading the Gilead site article shows than your better off including Ribavirin with Harvoni if your only doing 12 weeks. The other things I see is Sofosbuvir with a 2nd DAA is a much better combo than Interferon ever was.

And the biggest to me is the second study (Oral #235),

51 genotype 1 patients who previously failed SOF/PegIFN/RBV, SOF/RBV or a SOF placebo/PegIFN/RBV treatment regimen received Harvoni plus RBV for 12 weeks. Twenty-nine percent of study patients (n=15/51) had cirrhosis. Ninety-eight percent (n=50/51) achieved SVR12 following 12 weeks of treatment with Harvoni plus RBV. - See more at: http://www.gilead.com/news/press-releases/2014/11/gilead-announces-harvoni-study-results-in-chronic-hepatitis-c-patients-with-advanced-liver-disease-and-those-who-failed-prior-treatment.

This confirms the justification of re-treating relapsers of other DAA's, Especially those that have been previously exposed to Sofosbuvir, they can be treated within a short time after being exposed to Sofosbuvir as long as they add a good 2 gen. additional DAA with it.

Yahoo !

matt

Isiscat2011 · Guru

Guys:

What do you think of these new study results? (see details below) Harvoni + Riba for only 12 weeks = 96% SVR vs Harvoni alone for 24 weeks = 97% SVR.

This is JLynch's situation --doc wants him on H/R for 12 weeks--and we will probably be seeing more of this protocol in the future.

Isiscat2011 · Guru

Some ION 2- results for comparison:

94% with sofosbuvir/ledipasvir for 12 weeks;
96% with sofosbuvir/ledipasvir plus ribavirin for 12 weeks;
99% with sofosbuvir/ledipasvir for 24 weeks;
99% with sofosbuvir/ledipasvir plus ribavirin for 24 weeks.

In the 12-week arms, cure rates were a bit lower for people with cirrhosis: 86% with sofosbuvir/ledipasvir alone and 82% with sofosbuvir/ledipasvir plus ribavirin. However, all cirrhotic patients treated for 24 weeks with either regimen achieved SVR.

My question is why does one study result in an 82% SVR rate and the other a 96% SVR rate for the exact same tx population and protocol? It is as if the results are being intentionally manipulated. hmmmmm..........

Isiscat2011 · Guru

Here is some recent news on HCV tx from the AASLD meeting:

http://www.fiercepharma.com/story/winners-and-losers-aasld-check-out-merck-abbvie-gilead-and-jj-data/2014-11-12

Of special interest (Harvoni of course) is the GS-US-337-0121 Study. (Sorry, JLynch, I didn't read that closely enough when you posted about it.) The results are quite interesting. Here is the highlight for tx experienced, compensated cirrhotics:: Harvoni + Riba for 12 weeks results= 96% SVR Harvoni alone for 24 weeks= 97% SVR

This appears to conflict with prior study results that indicate adding Riba doesn't make any difference. Having said that, assuming the accuracy of these results, cutting the tx time in half does sound attractive for those who can tolerate Riba. After seeing some of the post-tx Sovaldi complaints (of those who were on Sovaldi for 12 weeks) I can't help but wonder how the post-tx issues will be when Sovaldi duration is doubled to 24 weeks. Comments?

http://www.gilead.com/news/press-releases/2014/11/gilead-announces-harvoni-study-results-in-chronic-hepatitis-c-patients-with-advanced-liver-disease-and-those-who-failed-prior-treatment

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