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Post Info TOPIC: New Abbvie drug
Isiscat2011


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RE: New Abbvie drug
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Funny you should mention Gilead stock because I actually considered investing a little in it about a year ago and it has really climbed since then.  Just couldn't bring myself to do it; making an investment game out of people's health just doesn't sit right with me.  My PCP asked me if I thought Gilead would be a good investment and I told him hell yes.   My investment in Gilead is entirely personal, however.   :)



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Diagnosed in 2011, Incivek triple in 2011, tx discontinued, Genotype 1a, CT, VL 7mill, cirrhosis dx in 2012, age 67, waiting for new DAAs.
Isiscat2011


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LC wrote:

I've been a googling and I think if I had bought stock in Harvoni, I'd sale it off before these other meds hit the market. I hope all of you that want it slide in under the wire like Indiana Jones, even those of you who are cats or cat servants. smile

http://seekingalpha.com/instablog/2157011-thinkdifferent/3416735-gild-hcv-opportunity-and-impact-of-competitive-landscape-for-harvoni

http://promarketnews.com/news/gilead-stock-falls-on-sovaldi-sales-miss



-- Edited by LC on Saturday 1st of November 2014 05:13:36 AM

Very interesting, LC.  Harvoni's saving grace in terms of cost will be that the 8 week protocol costs about 63K and I doubt Abbvie will be priced lower than that.  I read that an estimated 45% of patients would be eligible for the 8 week plan.  What that reduced tx duration will do to relapse rates is another question.  Gilead is presently working on its next generation HCV tx.  There may be lots of RAVs to clean up in the future; perhaps Gilead's next combo will have that task.

I am thinking the real party won't get started until there is a 3rd option on the market which should be 3rd or 4th quarter 2015.  And by party I mean substantial market competition and reduced prices.  smile 



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Diagnosed in 2011, Incivek triple in 2011, tx discontinued, Genotype 1a, CT, VL 7mill, cirrhosis dx in 2012, age 67, waiting for new DAAs.
LC


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I've been a googling and I think if I had bought stock in Harvoni, I'd sale it off before these other meds hit the market. I hope all of you that want it slide in under the wire like Indiana Jones, even those of you who are cats or cat servants. smile

http://seekingalpha.com/instablog/2157011-thinkdifferent/3416735-gild-hcv-opportunity-and-impact-of-competitive-landscape-for-harvoni

http://promarketnews.com/news/gilead-stock-falls-on-sovaldi-sales-miss



-- Edited by LC on Saturday 1st of November 2014 05:13:36 AM

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Genotype 1a, VL 1,151,923.  51 years old.  Started treatment on AbbVie TOPAZ II clinical trial Oct 10, 2014!  Undetected at weeks 2 and 4! 
Isiscat2011


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More on Payers vs Prescribers:  PMBs are now compiling their own data to determine tx options for patients irrespective of what doctors prescribe and payers have a long term strategy.  This power play will impact not only Harvoni v Abbvie access but all HCV tx for many years to come.  A quote from PMB Chief Medical Officer, Steve Miller below:

 

....Miller further roiled the waters in an interview about the new generation of hepatitis C drugs. He told Bloomberg that the pricey meds, designed to be used in two- to three-drug ****tails, would have to survive a stringent set of cost-benefit analyses to win coverage from his company. The most expensive products might not win a place on its formulary--even if they're more convenient for patients, such as Gilead Sciences' ($GILD) planned two-in-one pill. ....

We obviously have a long-term strategy," Miller told Pharmalot in October, after the new national formulary hit the news. "This has sent a loud message to the marketplace that we have got to preserve the benefit for patients and plan sponsors and do things to rein in costs. As there are more products in the marketplace that are interchangeable, we'll do more to seek the best value for our members. This is just the beginning of a multistep process over the next several years."

http://www.fiercebiotech.com/special-reports/steve-miller-express-scripts-2014-influentials

 



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Diagnosed in 2011, Incivek triple in 2011, tx discontinued, Genotype 1a, CT, VL 7mill, cirrhosis dx in 2012, age 67, waiting for new DAAs.
Isiscat2011


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mallani wrote:

Hi,

Just my take on AbbVie.

I would be surprised if they get FDA approval by the end of 2014. Their Clinical Trials have been rather slow and cumbersome, and Topaz 11 is not supposed to finish until June 2015. The disparity between the Geno 1a and 1b results suggests that Ribavirin will be required for the Geno 1a's. It seems that cirrhotics will need 24 weeks of Rx, regardless of Rx history.

All three drugs are fairly average in potency. Using a non-nucleoside NS-5B blocker(ABT-333) may be seen as undesirable. This shot-gun approach by AbbVie only works due to the mathematical improbability of developing a RAV to all three drugs.

The risk of drug interactions is greatly increased, particularly with the use of Ritonavir to boost ABT-450. The pill burden is significant, and Prescribers may be reluctant to use Ribavirin.

Relapse on the AbbVie trio may be a disaster. Unlike Sovaldi (which can be re-used), RAV's to ABT-333 may persist for an unknown time period.

Despite all this, the SVR rates are pretty good (but still not finalised). AbbVie will have a market, probably outside the USA, and the price will have to undercut Harvoni significantly. Cheers.

Thank you, Malcolm.  I hope people read your take closely.  

I am wondering if the Abbvie market in the US will be larger than anticipated.  The CEO of Express Scripts, which is the largest PMB in the US, has vowed to remove Harvoni from its formulary if Abbvie gives them a better deal.  I don't think this is just posturing either.   There has been a power struggle between Prescribers and Payers for years and HCV tx may tip the scales in the Payers favor. If that happens what docs prescribe won't matter. PMBs will make the HCV treatment decisions.  A frightening thought in my book.  



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Diagnosed in 2011, Incivek triple in 2011, tx discontinued, Genotype 1a, CT, VL 7mill, cirrhosis dx in 2012, age 67, waiting for new DAAs.
Dzdayscomin


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darkstar wrote:

Just received and took my first dose of Harvoni.  That link really only addresses price and not efficacy.

 That is just great DS ! You have been thru a lot and hope and pray this is the o he that gets er done !

Best wishes and prayers your way!

Duane



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53yr M 1a acq 12/83 cirr pre tx MELD 17  tx nv diag 1/29/12  tx S/O 3/5/14  trans list.

EOT 5/28/14 UND 6/12/14 SVR 8/29/14 MELD 14 dx HCC 9/5/2014 tumor ablation 9/24/14

In the 10K lakes State It's not about us but those around us.
LC


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Don't worry lilbit, all Abbvie has to do is undercut Gilead (which shouldn't be too hard) and Express Scripts already announced that Abbvie will have their business. So I imagine the Abbvie combo will be around for your husband.

__________________

Genotype 1a, VL 1,151,923.  51 years old.  Started treatment on AbbVie TOPAZ II clinical trial Oct 10, 2014!  Undetected at weeks 2 and 4! 
lilbit


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Malcomb,

Topaz II is the long term phase three that will continue to test you for 260 weeks. What they are doing in this one is treating you then tracking your quality of life. I think all the other tests for 1a have been completed and reported and the results are excellent. Yes the drug burden is more extensive but you only do meds twice a day. No big deal on that. Only problem with meds is getting the things out of the packaging the first couple times. Once you get it, it is a breeze. LC posted and excellent article about it. I am in week 9 now, undetected and side effects have been minimal so far. Yes I got Riba so can feel it sometimes but once I got used to it didn't scare me any more. I understand that some folks can't or won't take riba so this might not work for them. And I know most everyone wants to get on Harvoni. Can't blame them but it might not happen right away unless they are very sick. Seems it would be nice to have something to fall back on.

You are right about drug interaction and they are very careful to screen your current meds and to make sure you notify them if your meds are changed. Was not a problem with me as I do not take anything. They also talk about if you quit mid stream that there is not enough information about when you could be treated again or with what. I would imagine that this applies to relapse also. There are other Abbvie studies out there going on that are using the same combo but for other geno types.

I hope they approve this sooner rather than later. I would love to get my husband on it. He has been through treatment twice and it damn near killed him. He could handle this I am sure. He is 70 yo and can not handle any more hardcore treatments. I will be disappointed if this ends up overseas. I would be happy for them, of course, but I want my hubby cured also.

__________________

64 yo Diagnosed in 1991 with Hep C, Genotype 1a, VL close to 16,000,000, Tx Abbvie Topaz II 9/5/14, Wk 2 and 4 und. End of treatment 11/27/14 undetected.  EOT+4 und  EOT+12 und.  EOT+24 und CURED, EOT +52 now I feel really cured.
mallani


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Hi,

Just my take on AbbVie.

I would be surprised if they get FDA approval by the end of 2014. Their Clinical Trials have been rather slow and cumbersome, and Topaz 11 is not supposed to finish until June 2015. The disparity between the Geno 1a and 1b results suggests that Ribavirin will be required for the Geno 1a's. It seems that cirrhotics will need 24 weeks of Rx, regardless of Rx history.

All three drugs are fairly average in potency. Using a non-nucleoside NS-5B blocker(ABT-333) may be seen as undesirable. This shot-gun approach by AbbVie only works due to the mathematical improbability of developing a RAV to all three drugs.

The risk of drug interactions is greatly increased, particularly with the use of Ritonavir to boost ABT-450. The pill burden is significant, and Prescribers may be reluctant to use Ribavirin.

Relapse on the AbbVie trio may be a disaster. Unlike Sovaldi (which can be re-used), RAV's to ABT-333 may persist for an unknown time period.

Despite all this, the SVR rates are pretty good (but still not finalised). AbbVie will have a market, probably outside the USA, and the price will have to undercut Harvoni significantly. Cheers.



__________________

Geno 1b, IL28B CT,  x3 prior relapser,  ex-cirrhotic, 75 yo, did 48 weeks with Victrelis/Peg./Riba.  VL 1.28m at start, UNDET. at 8 ,12 ,16 ,24 ,30  and 48 weeks.  EOT 15 Feb 2013 , UNDET. at EOT + 28 weeks. SVR!  Still Undet. at EOT +5 years

Malcolm
LC


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Do you not see the linked chart from Harvoni?

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Genotype 1a, VL 1,151,923.  51 years old.  Started treatment on AbbVie TOPAZ II clinical trial Oct 10, 2014!  Undetected at weeks 2 and 4! 
darkstar


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Just received and took my first dose of Harvoni.  That link really only addresses price and not efficacy.



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LC


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There is a link in this article to Harvoni presentation slides rating Harvoni, AbbVie, Merck, and I think another one.

http://www.marketwired.com/press-release/move-over-gilead-abbvie-could-bring-serious-competition-to-hcv-market-1956910.htm

I am on the combo in a clinical trial right now, so is lilbit and hippiechick.  My side effects have been very mild.



__________________

Genotype 1a, VL 1,151,923.  51 years old.  Started treatment on AbbVie TOPAZ II clinical trial Oct 10, 2014!  Undetected at weeks 2 and 4! 
darkstar


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Abbvie is going to be presenting data on their three drug combo in early November.  They filed at the same time that Gilead filed Harvoni for approval.  Does anyone have an opinion on the relative efficacy of the two combos.  Abbvie's coho is three instead of two drugs!



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