Hep C Discussion Forum

zavr · Veteran Member

RE: Some thoughts on Viekira

Tig · Admin

Found some additional Info on the Viekira Pak. Haven't seen much attention being paid to it since Harvoni started the rounds. I haven't seen this one before, thought since I was up, I'd post it for your reading pleasure! Enjoy!

http://www.viekirahcp.com/?cid=ppc_ppd_viekirad7_ggl_bv_3436

http://abbvie.mediaroom.com/2014-12-19-AbbVie-Receives-U-S-FDA-Approval-of-VIEKIRA-PAK-Ombitasvir-Paritaprevir-Ritonavir-Tablets-Dasabuvir-Tablets-for-the-Treatment-of-Chronic-Genotype-1-Hepatitis-C

Tig

lilbit · Senior Member

I am absolutely rooting for you Matt and what you are doing is so important for all of us on or that have completed the Viekira Pak. I'm sure you recall in the hand book the notation that said enough study had not been completed on resistance and re-treatment. I was thrilled when you were approved for Harvoni. Am keeping you in my prayers.

Matt Chris · Guru

ABBvies new Viekira pack has a valuable place in the arsenal agains't HCV. The available ways to treat HCV are expanding and will get better in the coming years for all the Geno types. With the addition of a competitor to Gilead for patients it will in the long run bring down the cost and make meds available for more people, not to mention Merck products and other several other drugs entering the market.

The strong suit with the ABBvies new drugs is in treating Geno Type 1b all the SVR percentage for the GT1b are higher, up 18% points than the GT1a in the 12 week cirrhotic study. I can provide some insight into the ABBvie quad protocol since I was on the trial for cirrhotics and now am on the Gilead's Harvoni. The pill burden on the ABBVie drugs for me was no more trouble than the current Harvoni & Ribavirin and the sides effects are almost the same. If I was treatment naive and was a GT1a I would make a case for Harvoni, but if I was a GT1b I would feel very happy to select the Viekira pack. Even the SVR rates are not that bad for GT1a compared to just last year. One of the important factors in patients looking for re-treatment or cirrhotics is the duration factor, in my case I believe 12 weeks was not long enough for me a GT1a cirrhotic. I felt this near the end of my trial but ABBVie rejected my request to extend into the 24 week arm. The statistics for 12 week GT1a cirrhotics arm was near only 80% SVR and thats why the FDA dosing guidelines is 24 weeks for many hep-C patients scenarios. One of the bigger advantages of Gilead's Harvoni over ABBvies is its non used of Ribavirin, that can be another arrow in the quiver if you can somehow prove you can't handle its side effects, but with Ribavirin so called come back into doctors used maybe not.

In the future we will know the real numbers on a lot of these questions about prescriptions filled, SVR rates ,relapse protocol and the Rav's that appear on these different drugs regimens.

I myself am a test for re-treatment of a ABBVie Quad drugs regimen relapse with Harvoni, wish me welll because again I have entered undiscovered country.

matt

suziq · Senior Member

My oh My. The thing I don't like is having a pharmacy decide what treatment I should get. I, also, realize that clinical trials are not real world usage. Their trials are skewed to get FDA approval.

My Merck phase 2 trial was very open. They took old people (me) with cirrhosis (me)--pre-treated (not me), and those with HIV in their phase 2 trial. Everyone at my center reached SVR. Hopefully, they will get FDA approval by summer. They tried some 4 week trials that didn't work out so well this last year. The 12 week trials did best. I did 18 weeks with ribavirin. No other pharma tried 4 week trials. I admire Merck for trying to have a real world approach during their trials. And, of course, I am grateful to them for my SVR.

As for Mallani--I love his calm, well thought out, sharing of information. I, personally, do not feel that information should scare anyone. The more information, the better decision one can make. Well, maybe I need to back track on that a little--the scary part. The information I received on interferon over the years did scare me some. I chose not to take it.

Only time will tell how well each of the new drugs will work. We will have more info as time goes by and more drugs get FDA approval--like my drug from Merck. As Mallani pointed out, the drug companies now need to get busy for Geno 2 and 3's and, of course, on pricing.

Happy Holidays to Everyone--whatever your choice of spiritual beliefs or treatment.

SuziQ

-- Edited by suziq on Sunday 28th of December 2014 01:31:28 PM

-- Edited by suziq on Sunday 28th of December 2014 01:41:38 PM

LC · Senior Member

lilbit wrote:
My only purpose for throwing a hissy is that I do not want someone scared away from Viekira if that is all they can get. If they can wait on Harvoni that is awesome. I believe I was told that a good attitude going in to treatment was very important for compliance and also to get you through rough spots. If you go in scared of what could happen seems that would be counter productive. Just my opinion.

I am done fighting this cause. It is apparent I am not changing any opinions and basically just pissing folks off.

No doubt, and the sad thing is - it's pretty good stuff from were I'm sitting. I opened my last packet this morning. I know it's heck of a lot better than the old Interferon treatments that some of you signed up for fairly recently too, but I understand that you gotta take what you can get when you're sick and that's all there is.

All I am really trying to say is much the same as lilbit's saying - if you make people feel Viekira is sub-par when it's all they can get, especially if they don't have the luxury of waiting or they really want treatment asap, well I don't think you're doing them a favor.

Best of luck to you all! May everyone on here still dealing with HCV achieve SVR in 2015! smile

Miss B · Senior Member

Mallani,

Thank you for clarifying the comment about sanitized rates, that is what I guessed you had meant. Please continue with the musings - you raise questions/concerns that should be explored; but that we might not see ourselves. Don't be concerned that you are steering people to or from any particular treatment. By raising those questions, you help us to be better informed when meeting with our doctors so that we can ask them to answer those questions in the context of our own medical situations.

Cheers, & Happy New Year!

lilbit · Senior Member

lol Malcomb I love your musings and count on you a lot for information. Thank you for the correction on how many people tested, like I said I wasn't positive. Even with 2300, if 80% of them were SVR that 1840 that are free of Hep C. I so agree with you on the fact that everybody should get treatment. And I do not mean just in the US but everybody. I absolutely have no clue when it comes to RAVs and what drugs could or would or whatever causes them. The handbook that came with our study explained that it could happen and you either accepted that fact or dropped out of the study. They also stated that not enough research had been completed to determine how long it would take to be able to be treated with something else. I decided years ago that I would never treat my hep C. I watched my husband fail two horrible treatments and lose his health completely. But when friends started dying or getting very sick I decided to give it a try. I jumped on the Abbvie study and so far so good. No promises that I won't relapse but I haven't seen a treatment yet that doesn't have relapses.

My only purpose for throwing a hissy is that I do not want someone scared away from Viekira if that is all they can get. If they can wait on Harvoni that is awesome. I believe I was told that a good attitude going in to treatment was very important for compliance and also to get you through rough spots. If you go in scared of what could happen seems that would be counter productive. Just my opinion.

I am done fighting this cause. It is apparent I am not changing any opinions and basically just pissing folks off. If anyone decides to join the dark side and takes on Viekira I will definitely be here to support them. Been there, done that is always good to have around. That is one luxury I did not have when I started my study.

mallani · Guru

Hi guys,

Oh dear, I'll stop musing. I did not mean to imply that the AbbVie combo is not an effective treatment option.

Miss B: 'sanitized' SVR rates was only meant to mean some Trial results were not included. The Turquoise-I trial came out with a 90.6% SVR rate. Also, no previous PI treatment failures were included, and no patients with moderate hepatic impairment were included. The results are great- anything over 90% SVR is. Experience has shown that you can usually drop about 10% when it comes to the real world.

Libit: The actual number of patients in the AbbVie Trials was 2,300 (not 6,000). This is pretty low and way below the numbers in the Victrelis Trials.

The RAV details in the Viekira Prescribing Information is vague,was written by AbbVie, and there must be some independent information. I'll wait until I stumble across it.

The different treatments for Geno 1a is interesting, and not explained. In the viral structure, only the NS-3 site is quite different between the Geno 1a's and 1b's. In the 1a's, it only takes a single simple aminoacid substitution to produce a RAV, compared to the 1b's, where two more complex substitutions are required. This is why the 1b's did better on the early antiproteases. This makes me think Paritaprevir is the weak link in the chain. Abbott's new ABT-493 should resolve this, if they ever get around to getting it approved.

Correct me if I'm wrong, but I have not read anything about Express Scripts making access to treatment any easier. ALL patients should have access to treatment, irrespective of Fibrosis stage.

Getting away from Geno 1's for a moment, let's think about all those Geno 3's who are being ignored. At least Gilead is well on the way with it's pan-genomic GS-5816(in combination with Sovaldi), which showed 96% SVR in Phase 2 Trials. Let's get it approved so the Geno 3's will have cause for celebration as well.

As has rightly been said, most people don't worry about this stuff so the musing has stopped( in public). Cheers.

maddie · Senior Member

OK.....Merry Christmas all. We are all so fortunate to have very viable treatments with minimal sides now available. Truly a wonderful Christmas gift! smile

I do believe Mallani is just trying to bring some more scientific understanding into the picture here. For most on the forum with no medical or scientific background, he gives a better understanding of these very complex medications, his input is extremely valuable. I also, believe that the majority of us on this forum are not going to make decisions based on one persons opinion. For the most part we are not intellectually challenged individuals. If the Abbvie protocol is the one covered by one's insurance and there are no reasons to contradict taking that protocol...then go for it! I think what Mallani is trying to say is that there may be some instances where it may not be best, for example if svr was not attained on another protease inhibitor not that long ago. Since protease inhibitors form ravs that may decrease one's chances of svr, a better option might be Harvoni because no protease inhibitors are used in that protocol. That is where a discussion with your physician is vital.

LC thanks for posting the link to Viekiera pack. It is appreciated. And so is your advice in your post.... "Also, there are some things in life I honestly feel like you might be best served by consulting with your own personal doctor first and foremost on, as they should be the most up to speed on your unique situation and locale. Consider doing a bit of your own research too, and take everything in and weigh what you feel are your best options, and make up your mind accordingly. Every situation is different." I agree that we need to remember that we are our own best advocates.

Miss B, I believe that the phrase, "The sanitized 95-100% SVR rates" posted by Mallani refers to the fact that those numbers were the ones reflected in the trials. When drugs are approved and used by the general population, the results are sometimes not as impressive.

pl1952 · Senior Member

Thanks for posting that link LC...I'm interested and haven't found much on the Viekira pack. On to my reading now...

LC · Senior Member

Hmm, I don't know if you could quite call me a lay person, as I have had a bit of nurses training. Nursing wasn't for me however, and I turned to computer science. I work in a hospital now in an IT role, helping doctors and nurses with their computer issues.

I hope I didn't come off like I didn't value Malcolm's opinion, because I certainly do. He is a tremendous asset to this forum. I find his observations extremely interesting and insightful. However, he is someone I don't know at all in real life and this is his own personal opinion, which every doctor I've ever met (and I know a lot of them) tends to have.

Heck, for all I know, he could have a lot of stock in Gilead and isn't a doctor at all. blankstare Please forgive me for saying that Malcolm, but honestly some people are a little too trusting of someone they only know through the internet.

Also, there are some things in life I honestly feel like you might be best served by consulting with your own personal doctor first and foremost on, as they should be the most up to speed on your unique situation and locale. Consider doing a bit of your own research too, and take everything in and weigh what you feel are your best options, and make up your mind accordingly. Every situation is different.

I am thankful as can be I didn't listen to my doctors advice and delayed treatment when Peg Interferon was offered me 2 years ago. Don't be sheep people, make up your own minds - unless you truly don't have that sort of intellectual capacity. hmm

Here are 49 pages of additional information about AbbVie's Viekira pack if anyone is interested or up for the challenge of doing a bit of their own research. http://www.rxabbvie.com/pdf/viekirapak_pi.pdf

Miss B · Senior Member

Mallani,

Thank you for your insight regarding AbbVie's V-Pak. It's not easy for lay people to compare apples to oranges.

What do you mean when you said,

The sanitized 95-100% SVR rates.

Greg D · Senior Member

Thank you Malcolm for looking out for the group. Even though I am through treatment (hopefully) I really, really appreciate you and all that you do for those of us who need to know the information you provide. Please keep being the light that leads the way!

Cheers!

Tig · Admin

"Health plans and PBMs were largely forced to cover the costs of Gilead's hepatitis C drugs because they were the most effective and only treatments available. That changed Friday when the Food and Drug Administration approved Abbvie's Viekira Pak. The company set the sticker price of Viekira Pak at $83,300 for 12 weeks of treatment, a small discount to Harvoni which suggested a reluctance to compete solely on price.

But then AbbVie negotiated for exclusive formulary access to with Express Scripts. The negotiated price for Viekira Pak was not disclosed, but Express Scripts said it was a "significant discount" to the drug's sticker price."

http://www.thestreet.com/story/12992524/1/express-scripts-and-abbvie-drug-pricing-deal-might-devastate-biotech-bull-market.html

Tig

LC · Senior Member

mallani wrote:
Hi libit,
I hope my musings about Viekira don't cause any anguish. As you say, for most patients, the pill burden will be manageable.
I would not be musing at all if AbbVie had put a price of $50k on their combo. As it is, Viekira and Riba will cost as much as Harvoni.
AbbVie have had their new drugs, ABT-493 (antiprotease) and ABT-530 (NS-5A blocker) for some time now. Both drugs are far more potent than Paritaprevir and Ombitasvir, with much higher barriers to resistance. We haven't heard much about them.
Matt certainly was retreated with Harvoni. Some time had elapsed after his AbbVie relapse, and I'm not sure he ever got a full explanation for his relapse. He can answer this.
My only gripe is that we don't get the full story. Cheers.

AbbVie probably does actually have a price close to $50k, to Express Scripts, and on the condition of being the exclusive provider. I wouldn't be surprised if they don't pull the same stunt with the government for the Medicaid market. That's Chicago lawyers for you. I do wish I had had the funds to have bought stock in AbbVie, as the writing has certainly been on the wall as far as what to expect.

Most people aren't going to care as much as you will about all the drug details Malcolm, or if the drugs approach is similar to a shotgun or scalpel. The questions I would be asking myself if I was still waiting for treatment would be - how effective is this treatment, how tolerable, will this be covered by my insurance, if this treatment fails - can I be retreated with other drugs, and will this treatment cause me any long term side effects? I think it's pretty comparable to Harvoni in the important issues. Whether we are swallowing 1 pill or 9 isn't even important to me. The AbbVie drugs show results fast, are extremely effective, and speaking from my own experience only - the side effects of these drugs has been very minor.

I know one member on here who was approved for the Topaz 2 trial, and after listening to all the hoopla about Harvoni, along with some other life factors, she decided to decline the trial. Now, she will probably have to max out her insurance deductible to get the same drugs she would have originally been paid to take.

I wasn't going to post here anymore after seeing how a very valuable forum member (a licensed attorney who helped forum members with their appeals, including a member of the admin team who voted her off the island here) was treated after her responses to what I felt as well were some negative posts by another member, but I am concerned with the negative posts about what is likely to be the only available treatment for many in the near future.

mallani · Guru

Hi libit,

I hope my musings about Viekira don't cause any anguish. As you say, for most patients, the pill burden will be manageable.

I would not be musing at all if AbbVie had put a price of $50k on their combo. As it is, Viekira and Riba will cost as much as Harvoni.

AbbVie have had their new drugs, ABT-493 (antiprotease) and ABT-530 (NS-5A blocker) for some time now. Both drugs are far more potent than Paritaprevir and Ombitasvir, with much higher barriers to resistance. We haven't heard much about them.

Matt certainly was retreated with Harvoni. Some time had elapsed after his AbbVie relapse, and I'm not sure he ever got a full explanation for his relapse. He can answer this.

My only gripe is that we don't get the full story. Cheers.

lilbit · Senior Member

Malcomb I do not even begin to know much about any of the drugs you are talking about other than just completing the treatment. Every article I read talks about the significant pill burden. How hard is it to take pills twice a day approximately 12 hours apart. The only problem I had with that was the morning dose because it wasn't supposed to be taken on an empty stomach. I don't like breakfast but once I realized coffee worked just as well for me, no problem.

I ended up getting riba, so yes I had a few side effects. I was irritated at times, an occasional mild headache, at the beginning a little out of breath and lack of energy, and yes I did get an irritating rash the last three weeks. But I never missed a beat the whole time on treatment and did not change my lifestyle in any way. Nothing like the two times my husband was treated that have completely ruined his health. At EOT I was still undetected and am certainly hopeful that it stays that way. I realize I am not out of the woods yet.

I think what I am trying to say is that there may be people that this comment will scare out of treatment. If Express Scripts sticks to their guns and will only cover the Viekira Pak for certain people aren't they going to be hesitant going in because of all the possibilities you have stated here. As far as what is available if you relapse it seems to me that Matt Kris relapsed on this and is either on or going on Havoni soon. Abbvie has tested a lot of people (I heard 6000 but may not be correct) on this combo and produced the results to the FDA. Whether sanitized or not a lot of lives have been saved and a lot more will be.

It seems to me that Abbvie has done exactly what we all wanted them to do. By dropping prices it seems that Gilead will be forced to do something about the pricing and
make some deals of their own to cover more folks. Then maybe everyone that wants Harvoni will be able to get it.

Please do not take this comment as trying to start trouble or arguing with you. I most definitely am not. I am just saying if I was just going in to or trying to get treatment this would most certainly make me less confident. If I had waited on Harvoni I would have had to wait a very long time. I do not have the qualifying factors with my Hep C and was definitely not sick enough to get it. Maybe this treatment can clear people up before they get bad.

Rubye · Senior Member

I don't even understand half of what you said :) but I know that if I should relapse I want Harvoni. Evidently, having done Sovaldi/Olysio would exclude me from the Viekira pak and I am actually grateful for that. I think. Thank you for sharing this information.

mallani · Guru

Hi all,

I don't scour the Medical literature the way I used to, but I must be missing something. There are many unanswered questions about the Viekira Pak from AbbVie.

Usually the FDA gives a detailed profile of drugs it has approved. I can't find any new information about the AbbVie drugs.

AbbVie has stuck by it's shotgun approach to HCV treatment, using 3 DAA's (none of them remarkable) in the hope that mathematically they will work as a whole. They have ignored the other Genotypes, and only concentrated on Geno 1's.

The resistance profiles of it's drugs remain a mystery. Early reports showed the ABT-450 (now Paritaprevir) needed to be boosted by Ritonavir for adequate blood levels. RAV's quickly developed at NS-3 sites 155, 156 and 168. The familiar R155K RAV soon appeared in Geno 1a's, and various 168 substitutions appeared in Geno 1b's. One report said the D168Y variant caused marked decreased efficiency of Paritaprevir in both 1a and 1b's. Suddenly, there is silence about this. What about the NS-5A blocker, Ombitasvir (formerly ABT-267)? It surely has resistant variants, but none have been published.

Finally, I'm not sure how the name Dasabuvir (I thought -buvir was reserved for nucleoside NS-5B blockers) was allowed for ABT-333. It makes it sound as good as Sofosbuvir, but it is a completely different type of drug, being a non-nucleoside NS-5B blocker! Again, this is a resistance prone type of drug, but nothing has been published about this.

The RAV issue used to be a big deal. I'm not sure why it no longer is.

The sanitized 95-100% SVR rates will not translate into real life. I presume that previous PI treatment failures will be excluded from Viekira treatment (because of potential RAVs).

If Ribavirin needs to be used as well, that's 5 drugs in the combo. 5 possible drug interactions and side effects. This is a significant pill burden, but nothing like the 18 pills/day I had to swallow. Patients on Clinical Trials tend to be more compliant with drug dosages- this may not happen in the real world. This will be a big factor in Harvoni's dominance.

AbbVie will do deals, and maybe Insurance companies and Governments can use this to negotiate a better price for Harvoni.

If I was prescribed Viekira, I'd ask 'What are my options if I relapse?'. You won't get an answer.

Competition is great, but I'd want Harvoni. Cheers.

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