Hep C Discussion Forum

Loopy Lisa · Guru

RE: Solvadli and Riba opinions wanted...

Isiscat2011 · Guru

So true, Tig. You have to piece this info together like it was a jigsaw puzzle.

I once stumbled onto all of the Gilead study results included in a single place and I'll see if I can find it again.

Isiscat2011 · Guru

annabanana wrote:
I started Sol/Rib today...now wondering if I should have waited.

You are on a very good combo, annabanana. The overall odds of SVR for GT 3s are 90%+ on the S/R 24 week combo according to the clinical trial data. Even if you had waited you would still need to take the riba because of your genotype.

If your tx works, and it probably will, then you will be glad you did it. If it doesn't you will wish you waited. That is just human nature.

It is quite likely that for the next several years there will continue to be a better tx on the horizon, and by better I mean shorter tx duration, or greater efficacy, or fewer side effects. One day it may be a single injection. In the meantime, those of us who are fortunate enough to have choices will have to make them. The great thing is that the days of it being a choice between the lesser of two evils-- a bad virus or a horrible treatment--are coming to an end.

You will be fine, annabanana. Just take it one day at a time and know that you are already on a good tx combo. :)

Tig · Admin

Yes, there is additional data out there and I invite you to add that if you have it handy, Gilead didn't release it in the same monograph (PDF) format that the last was presented in. This monograph was provided upon release in December. If you have all (most recent) SVR trial data readily available, it would be really helpful if we could get it out there in one comprehensive post, instead of piecemeal. Seems like Gilead releases their research data only when it's financially beneficial. So please if you have time, and all of the SVR trial data, I'd really appreciate you putting it out here for us. Lisa is right, seems like the figures have been adjusted recently and mine is likely incomplete since it is 6 months old. Won't be long and it will all be in need of updating again. That's the thing with studies, alway improving, always changing. Thanks for your your help.

Tig

Isiscat2011 · Guru

annabanana wrote:
Is this TX going to be for GT 3 as well. I see the results of the trials, but can't find anything about it being approved for GT 3.

Yes, the S/L combo with ribavirin has shown 100% efficacy for GT 3s. (See study results summary below.) But, S/L won't be approved until October 10, 2014.

April 10, 2014

Perfect Results for Sovaldi/Ledipasvir, But Only With Ribavirin

Combination therapy with Gilead Sciences fixed-dose combination pill of Sovaldi (sofosbuvir) and the investigational ledipasvir, plus ribavirin, boasted perfect cure rates in treating people with hepatitis C virus (HCV) in a recent trial. This is particularly good news for those with genotype 3 of the virus, who enjoyed halved treatment times compared with current Sovaldi protocol. Results from the ongoing Phase II ELECTRON2 study of 12 weeks of therapy with twice-daily doses of the fixed combination of the polymerase inhibitor Sovaldi and the NS5A inhibitor ledipasvir (LDV/SOF), with and without ribavirin, were presented at the 49th annual meeting of the European Association for the Study of the Liver (EASL) in London.

For treatment-naive study participants with genotype 3, the triple-drug regimen led to a sustained virologic response 12 weeks after completing therapy (SVR12, considered a cure) in 100 percent (26/26) of the cases. For those with genotype 3 who did not take ribavirin, the cure rate was only 64 percent (16/25). Similarly, a group of participants with genotype 1 and decompensated or Child-Turcotte-Pugh Class B cirrhosis who also did not take ribavirin only had a cure rate of 65 percent (13/20). Finally, those with genotype 1 who had failed a previous attempt at therapy with Sovaldi and ribavirin were all cured (19/19) with triple therapy.

Thus, it would appear that, at least for the subgroups treated in this study who fared more poorly without the drug, ribavirin may remain a necessary adjunct to a 12-week course of Sovaldi/ledipasvir therapy.

The ELECTRON2 data suggest that an all-oral regimen of LDV/SOF plus RBV has the potential to provide high cure rates for genotype 3 patients in just 12 weekshalf the duration of current all-oral treatment regimens, Edward Gane, MD, deputy director and hepatologist at the New Zealand Liver Transplant Unit at the Auckland City Hospital in New Zealand, and principal investigator of the ELECTRON2 study, said in a release. These results also suggest that LDV/SOF may be an effective treatment regimen for HCV genotype 1-infected patients who have failed a previous sofosbuvir-based regimen and those with advanced liver disease, including decompensated cirrhosis.

Isiscat2011 · Guru

Tig56 wrote:
Hi Lisa,
Here's Gileads data on the SVR rates: http://www.gilead.ca/pdf/ca/sovaldi_pm_english.pdf
__________________________________________________________________________________________________________
I'm sure you know this, Tig, but that report is based on Gilead's clinical trial studies up to Dec. 2013. Gilead released additional trial study data subsequently including the VALENCE and PHOTON-1 studies.

TazKat · Senior Member

I am doing the sovaldi interferon & riba for 12 weeks. haven't we seen pretty good results from that? my doc says 90%. I am right at stage 4 with mild cirrohis. am I confused again?? wah. see I wish they would do the viral test next week.. hmm

Loopy Lisa · Guru

Tig56 wrote:
Hi Lisa,
Here's Gileads data on the SVR rates: http://www.gilead.ca/pdf/ca/sovaldi_pm_english.pdf

Tig

Thanks Tig,

I tried to read it but I'm too tired to concentrate. Will read it through in the morning - well actually its already morning but I haven't slept - damn hot weather and a pesky mosquito grrrr!

Tig · Admin

Hi Lisa,

Here's Gileads data on the SVR rates: http://www.gilead.ca/pdf/ca/sovaldi_pm_english.pdf

Tig

Loopy Lisa · Guru

Isiscat2011 wrote:
Hi Ro:
1a, cirrhotics, who are treatment experienced with protease inhibitors, have not been sufficiently tested to predict outcomes with the S/R combo.
S/R is the recommended tx for genotypes 2 & 3. It can be used for 1s for 24 weeks. I would not expect to see particularly high SVR rates with this combo and your "negative" factors. Here are some overall stats, but again, this does not factor in cirrhosis or prior tx experience.
Response Rates in Study PHOTON-1a

HCV genotype 1
HCV genotype 2
HCV genotype 3

SOVALDI + RBV
24 weeks
TN (N=114)
SOVALDI + RBV
12 weeks
TN (N=26)
SOVALDI + RBV
24 weeks
TE (N=13)
Overall
76% (87/114)
88% (23/26)
92% (12/13)
Outcome for subjects without SVR12
On-treatment virologic failure
1% (1/114)
4% (1/26)
0/13
Relapseb
22% (25/113)
0/25
8% (1/13)
Otherc
1% (1/114)
8% (2/26)
0/13

TN = Treatment-naïve; TE = Treatment-experienced

You would have a better shot at SVR by adding Olysio. You can appeal again and see what happens, but you will need a doctor that is actually fighting for you, and even that might not do it. Eventually insurance companies will have to pay for all oral treatments but we aren't there yet.

Taking S/R on a "test" basis for 4 weeks won't necessarily help because you could become undetected only to relapse.

Personally, I'd wait for the S/L combo but this is a very personal choice.

That's strange, I have read so many results stating this treatment was perfect against G2 in the 90s and G3s remained around 78%. This seems a little off to me?

Huey · Guru

annabanana wrote:
I started Sol/Rib today...now wondering if I should have waited. Is this TX going to be for GT 3 as well. I see the results of the trials, but can't find anything about it being approved for GT 3.

Thanks!

If your in the USA Sovaldi and Riba for 24 weeks is approved by the FDA but you have to get your insurance Co. to pay for it. and it seems it is getting harder and harder.

annabanana · Member

I started Sol/Rib today...now wondering if I should have waited. Is this TX going to be for GT 3 as well. I see the results of the trials, but can't find anything about it being approved for GT 3.

Thanks!

Tig · Admin

I haven't seen this website listed here, so I thought I'd post it just in case it was missed. I had heard several times that Sov/Led was slated for Oct or Nov 2014 and now Bill mentioned Oct. 10th, so I went looking for confirmation and this is what I found. Looks like Oct. 10th is your day, providing the FDA does their part. The eyes are upon them... A new day is dawning

Final FDA Decision Anticipated by October 10, 2014~Gilead

Tig

Isiscat2011 · Guru

Bills wrote:
OCT 10th is going to be very busy day for doctors LOL
_________________________________________________________________________________________________________
Bills: It really is. My hepatologist is already booked up 2 months in advance. When I asked the receptionist why she said it was because of the anticipation over the new HCV drugs that will soon be available.
I am seeing him this month and am planning to get started on anything I can to prepare. Good luck to all of us!

Ro: Good call. It really does come down to the benefits vs the risks of waiting and the numbers say wait. We will discover levels of patience we didn't even know we possessed.
Mugsy: Gilead will become a money printing machine before this is over! The financial pundits say Gilead will rake in 80-90% of the market profits for HCV tx and I wouldn't be surprised.

Mugsy · Senior Member

I was all ready to start INF/Sovaldi/RIBA in March/April had the go ahead from my insurance but after reading info here I am waiting, too. Sure hope Gilead is making a sh&%load of this new S/L medicine for all us waiters! biggrin

Bills · Guru

Hi Ro

Thanks for starting this one, I'm also waiting for Oct for me I just can't take another failed TX

The answers here are just about the best I've seen all in one place ( as related to me waiting and Why )

My neighbor just told me yesterday He was Pos HVC just found out 3 weeks ago. He was being directed to treat now. by a gastro Dr

He went to Dr today with a handful of data on this subject and pose it to his Dr. I cant wait to give Him all this

Thanks Ro for posting this just in time to give this guy some options he didn't know about

And as always the biggest thanks to all of you who find this info OCT 10th is going to be very busy day for doctors LOL

BillS

Ro · Senior Member

Issiscat,

Going to stir the pot and try to fight, but will be ok if I fail and have to wait... You are right the whole situation sucks!

thanks for the info.. I will " keep swimming"

Ro

Just got a call from the assist head of Drexel Liver Center in Philly. He believes it would be worth the wait (as long as things stay stable) for the new meds to come out in October... So I will ..

Thank you all for your opinions. I will still bug the insurance company as I fell it is a worthwhile fight for someone....

Ro

-- Edited by Ro on Friday 23rd of May 2014 09:13:52 PM

Isiscat2011 · Guru

Hi Ro:

It isn't about what is "fair." It is about what meets the insurance company's criteria. The good news is insurance companies' criteria are established by the medical SOC, which is established by the AASLD guidelines for HepC tx, and you appear to meet those. That doesn't mean the insurance companies will make it easy, however. The bad news is that SOC for HepC tx is in a transitional state so it is all kind of a mess right now.

Trying to get your insurance company to pay without having a doctor who is willing to jump through the hoops will be next to impossible so do try to get your doctor on board (and be nice about it). smile In a nutshell, your insurance company will require you to show that the off-label tx is medically necessary. This information might help (created by the folks who sell Olysio) :

http://www.janssenaccessone.com/pages/olysio/office-resources/eap_information.jsp

Scroll down and click on the name of your insurance company.

Or, you can conserve your energy, make the best of a beautiful summer, and wait a bit longer for an even better tx. biggrin Okay, I get it. Waiting sucks.

Ro · Senior Member

Wayne and Isiscat,

I plan to still seek fair treatment from the insurance company. If all else fails, I will not do the treatment without the olysio, therfore I will wait..

Hitting the computer now to wage "war" on blue cross.

I have been on hold on my phone for the greater part of today while people kept transferring me to anyone who could speak... ... we will see how effective I can be on the computer with emails etc. Also sending letters to every name I come across in Blue Cross management....

thank you both for you input

Ro

Isiscat2011 · Guru

After a bad experience (or two or three) with HepC tx one tends to view the data with skepticism. Still, it is hard not to be very favorably impressed with the S/L data. If it is as good as it looks this really is a tremendous breakthrough in HepC tx and I think it might just be that good (or pretty darn close to that good).

Only time will tell but I am certainly willing to wait a while longer to find out.

OldenSlow · Senior Member

With regards to the SOF/LDV combo expected to be approved in the fall, here's a link to the Phase 3 study results for Geno 1 treatment-experienced patients:

EASL ION-2 Report

The math supports waiting it out. Best of luck to you.

wayne

Ro · Senior Member

Thank you all for your responses.. I have been definitely leaning towards waiting...I will be speaking with MD tomorrow and will have my decisioin made by then.. IF I am not in any acute danger right now, I believe waiting for new meds is best...AS a 1A, failed responder, with stage 2 cirrhosis I think the odds are still in my favor to wait..

Any other opinions, data etc greatly appreciated.. I think I have exhausted the internet for research.. now trying to figure out what it all means

Again thank you for all your responses, as I have been told: "Keep swimming"

Ro

patiently_waiting · Senior Member

It doesn't make much sense that your insurance company would deny a highly successful combo in favor of one with a much worse success rate, but then again they don't always do things that make sense. As others have said if I were in your shoes I'd wait.

mallani · Guru

Hi Ro,

I forgot to add a link to a small Trial of cirrhotics, using 24 weeks of Sovaldi and Riba. As you see, the weight-based Riba patients achieved an SVR rate of 68%. Cheers.

http://www.ncbi.nlm.nih.gov/pubmed/23982366

mallani · Guru

Hi Ro,

There is no data available for Tx-failure Geno 1 cirrhotics, using this combo. Personally, I'd wait for Sovaldi/Ledipasvir. Cheers.

Isiscat2011 · Guru

Hi Ro:

1a, cirrhotics, who are treatment experienced with protease inhibitors, have not been sufficiently tested to predict outcomes with the S/R combo.

S/R is the recommended tx for genotypes 2 & 3. It can be used for 1s for 24 weeks. I would not expect to see particularly high SVR rates with this combo and your "negative" factors. Here are some overall stats, but again, this does not factor in cirrhosis or prior tx experience.

Response Rates in Study PHOTON-1a

	HCV genotype 1	HCV genotype 2	HCV genotype 3
	SOVALDI + RBV 24 weeks TN (N=114)	SOVALDI + RBV 12 weeks TN (N=26)	SOVALDI + RBV 24 weeks TE (N=13)
Overall	76% (87/114)	88% (23/26)	92% (12/13)
Outcome for subjects without SVR12
On-treatment virologic failure	1% (1/114)	4% (1/26)	0/13
Relapseb	22% (25/113)	0/25	8% (1/13)
Otherc	1% (1/114)	8% (2/26)	0/13

TN = Treatment-naïve; TE = Treatment-experienced

You would have a better shot at SVR by adding Olysio. You can appeal again and see what happens, but you will need a doctor that is actually fighting for you, and even that might not do it. Eventually insurance companies will have to pay for all oral treatments but we aren't there yet.

Taking S/R on a "test" basis for 4 weeks won't necessarily help because you could become undetected only to relapse.

Personally, I'd wait for the S/L combo but this is a very personal choice.

TazKat · Senior Member

I am on it. won't be tested until I finish treatment to know anything.. that is bcbs for ya. I am hanging tough, it is hard but u just have to set ur mindto it. I have hard time on weekends after shot, that is when I want to give up. but then I have made it to shot #5 will be Friday. so heck I am almost 1/2 done. no giving up.. keep the faith!!!

beingsassy · Senior Member

I have genotype 2 and am taking ribavirin and sovaldi. I had detectable v.l. u til my 8 week labs. I don't have any liver disease so I can't really answer ur question but I think it's worth a shot. My side effects have been minimal but I've had some. One suggestion I have is to call the solvaldi help line and talk to the nurses there. They had answers to all my questions and seemed to be knowledgable. Number is 1- 855-769-7284. Wishing u the best.

gigi

Huey · Guru

Hi,, I cannot say I am Exactly the person to compare with , but , I am a Geno Type 3a.. I get Sovaldi and Ribavirin for 24 weeks and I have about a 80% chance givin all the negitive indicators I have. Generally what they do is test you after 4 weeks then if you don't have either a RVR or an Extended RVR. then they pretty much know you will be a non responder. so try it for four weeks and go from there.

Ro · Senior Member

I cannot get medical approval for solvaldi and olysio from Blue Cross :( (Horizon PA)

The doctor is recommending that I do just the solvaldi and riba. Having failed prior treatments of peg interferon and riba; infergen and riba; and also incivik, peg and riba..I am wondering how successful that would be....Is there anyone out there that has been successful in achieving SVR on just solvaldi and riba after failing other treatments?

I am stage 2 cirrhosis, bilirubin 1.64, liver enzymes all elevated, and have mild esophageal varicies for which I was placed on cardivilol

I need to make up my mind and feel I do not have all the facts.

Knowing olysio will be on label with solvaldi soon, and/or ledivispor will be approved October 5.. not sure if I should wait.. or take the "soft treatment" as the doctor referred to it.

would appreciate your experiences..

thank you

-- Edited by Ro on Wednesday 21st of May 2014 09:19:44 PM

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