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Post Info TOPIC: History of Sovaldi
Isiscat2011


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RE: History of Sovaldi
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Huey:

How about this as a solution:  We tax the crap out of the top 1% (how many houses do Oprah and Brangelina need anyway?).  Then we nationalize the pharmaceutical industry, hire the best MDs/Phds available and pay them well to continue the work they are already doing, and re-invest profits from the drug sales for future innovations.  

The free market R&D costs are presently grossly inflated because the big pharma companies do not share information and must continue reinventing the wheel. Moreover, the big pharma marketing costs exceed R&D expenses by 19 to 1.  Both R&D and marketing costs would be greatly reduced by taking drug development and sales out of the competitive free market system.

That's what I'd do if I was King of the World.  Unfortunately, that is unlikely to happen without an endorsement from Oprah.  biggrin

 

P.S. Gilead will recoup that 11 billion in the first year of S/L sales.  They already broke pharma sales records with 2.3 billion in the first quarter of Sovaldi's release and the S/L combo hasn't even hit the shelves yet!  



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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.
Tig


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Hey Huey,

Nice thought, but it's 11 Billion, not million! 

Tig



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Tig

68yo GT1A - 5 Mil - A2/F3 - (1996) Intron A - Non Responder, (2013) Peg/Riba/Vic SOT:05/23/13 EOT:12/04/13 SVR 9+ years!

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Huey


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Why couldn't Express scripts make a deal with Gilead , " ok you need to recover 11 million, we will buy 11 million dollars worth all at once, but for half the price.  " That would at least end the argument about needing to recover initial cost and once they are operating in the margins the stock holders would get plenty!



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  HCV Genotype 3a , now Psot-Tx was on S/riba. First VL was 5.8 mil on 7-5-13 then "und" at 3.8 weeks. 06/13/14 still und. off meds 3 days back on 7/29 Last pill 08/10/14 SVR+4

 
Isiscat2011


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mallani wrote:

 Sovaldi could have easily gone the way of PSI-938. 

And, therein lies one of the many problems with placing the future of life saving drugs in the free market system.   It can delay and even prevent innovation where it is most needed.   



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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.
Jaded


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It's a great drug. Unfortunately the greed of the company that owns it has caused this drug to do more harm than good to the people who need it today...in terms of stress and anxiety. The drug does not work if you can't get it.

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mallani


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Hi guys,

The outrage at the cost of Sovaldi was predictable, but it came as no surprise. Gilead's offer of $11 billion was said to be 2 or 3 times higher than what Pharmasset would have accepted.

In any case, it was a brave move by Gilead. Sovaldi could have easily gone the way of PSI-938. Revenue to date would indicate it will take about 3 more years before Gilead covers it's costs. By then, who knows what will happen. We may have a vaccine, an cytoplasmic blocker or cell-entry blocker, and the anti-replication drugs may be superseded. I can live with Gilead's price structure.

I can't live with Janssen's ridiculous price of $66k (for 12 weeks) of Olysio. That really stinks.

If I was a Merck shareholder I'd be pulling my hair out. They had the first DAA to be approved (Victrelis) then sat and watched while Vertex cleaned them up with Incivek. They have sat on MK-5172 for 2 years. This is the only antiprotease that is potent, with an excellent resistance profile. Clinical Trials have been sparse. If you believe in a drug, you have to throw money at it, do countless Trials and get it approved. That's what Gilead did, and they are starting to see the rewards. By the time MK-5172 hits the pharmacies, there will only be crumbs to pick up.

As Matt said, everyone wants to do Trials with Sovaldi.  It's too late- Sovaldi/Ledipasvir will pick up 75% of the market share if it is cleverly priced. Cheers.



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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
jimbob


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Isiscat2011 wrote:
Matt Chris wrote:

One of the goals is to find the mix/combo of drugs that can reduce treatment time to as little as 4 weeks.

Stay tuned, HCV is getting checked into a corner and will be check mated sometime in the next five years.

 

        ___________________________________________________________________________________________appointment _________

Won't that be something to see.  One day it will be like taking a cycle of antibiotics and people will be vaccinated against ever contracting it in the first place. Great topic, indeed!

 

 Isis, Chris--

If this "TT-034" should get approval, it may just be a matter of making a single appointment with the doctor. That will truly be amazing. Until then, a single pill for a few weeks sure won't hurt anyone's feelings. 

 



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jimbob: 64 y/o, GT 1A, F1-F2, diagnosed 1996. Since 1970. SOT 3.5 mil VL on 3/10/14 with Sov/Rib/Peg for 12 weeks. Tx naive. UND @ week 4,8,12. EOT 6/2/14.
CharlieC


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I have been 10 days on Solvadi (400mg) and Daclatasvir (60mg).    I am on 24 week course of treatment.  I did receive the Daclatasvir for "compassionate" use and the Solvadi was at first rejected by my Insurance but Doctor appealed and was finally approved.  Promising trials in the past few years so looking forward to my first follow up in June.   Liver enzymes have fallen quite a bit in the last week. I have not been able to touch base with anyone that has been on this treatment.  Anyone out there that did this as a Clinical Trial.  Great info in this forum thanks for all the info.



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Charlie 58 Female: Diagnosed 1990s Genotype 1a, w/ITP: 2009 for Eltrobopag and Interferon for HepC/ITP, 2012 Incivek/Interferon/Riba. 24 weeks began 5/2014 Solvadi 400mg/Daclatasvir 60 mg Completed 10/27/14 still Undetected
Isiscat2011


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Matt Chris wrote:

One of the goals is to find the mix/combo of drugs that can reduce treatment time to as little as 4 weeks.

Stay tuned, HCV is getting checked into a corner and will be check mated sometime in the next five years.

 

        ___________________________________________________________________________________________________________

Won't that be something to see.  One day it will be like taking a cycle of antibiotics and people will be vaccinated against ever contracting it in the first place. Great topic, indeed!

 



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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.
Tig


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Thanks Malcolm for the continuing education! We all know what happens as a result of the use of these drugs, but the why and how often evades discussion. I've posted this monograph link before but think now is a good time to bump it back into the discussion. Lots of good info in it.

Tig

Sovaldi Monograph



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Tig

68yo GT1A - 5 Mil - A2/F3 - (1996) Intron A - Non Responder, (2013) Peg/Riba/Vic SOT:05/23/13 EOT:12/04/13 SVR 9+ years!

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patiently_waiting


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Interesting info. I'm curious if the issues being discussed re: Sovaldi/Int/Riba also apply to Sovaldi/Olysio/Riba? 



-- Edited by patiently_waiting on Friday 23rd of May 2014 04:43:40 PM

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42 yrs old: geno 1b, 23mil VL, ALT/AST 269/94 as of Apr '14.  Got HCV when I was 16.  Relapsed from Peg/Riba twice, last time in '08.  Completed Sol/Oly on 9/2/14, UND as of 10/7/14
Matt Chris


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Hey Malcolm 

Great topic, we see that Sovaldi has to be combined with another DAA to be highly effective and in the future we will see many combinations tried. Actually right now its being tested with BMS NS5A Daclatasvir and the most intriguing is the Merck combo trial with Sovaldi, here is the trials description. 

This is a study of MK-5172A & Mk-8742 and sofosbuvir (SOF) in treatment-naive participants with chronic hepatitis C (HCV) genotype 1 (GT1) or genotype 3 (GT3). 

The Mercks NS3/4a protease inhibitor (MK-5172a) and the NS5A inhibitor (MK-8742) are regarding as some of the best new 2nd generation DAA on the market with high barrier to RAV's , also Abbvie's ABT-530 NS5A has great possibilities as well to be combine with Sovaldi.

One might think that why would these other drug companies bother with Sovaldi since they have there own combos. But the FDA suggested / requested in there Guidelines document that big Pharma cross collaborate with the other companies in the HCV trials to address the need for the patients that happen to fail or relapsed on DAA's. One of the goals is to find the mix/combo of drugs that can reduce treatment time to as little as 4 weeks.

Stay tuned, HCV is getting checked into a corner and will be check mated sometime in the next five years.

matt          

 

  



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61 year old Geno type A1, F4 Cirrhotic, started 24 weeks on Harvoni 12-17-14 ,EOT-5 week = UND, 8-31-15 =UND , SVR-24 Baby YES! 
Isiscat2011


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JLynch30 wrote:

yes, the gamble with me is whether they will pay again if needed.

 

I think they will but first they will make you stand on your head, repeat the alphabet backwards 6 times, and then do a few back-flips for them.  

Seriously though, they seem to be taking a look-see approach with the 12 week tx approvals.  If 12 weeks work, great.  If not then they pay for another 12 weeks later--the incremental approach--hoping to save some money that way.   In the meantime tx costs will get lower as the market heats up.

This will change as the AASLD guidelines are updated and the SOC for tx lengths is firmed up.   If 24 weeks becomes SOC then the insurance companies will pay for 24.  Change takes time.



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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.
JLynch30


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yes, the gamble with me is whether they will pay again if needed.

 



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John   non-responder  

Undetected at week 2 on solvaldi/rib/interferon:  stayed through week 12 but virus came back as soon as I stopped.  on   Harvoni and ribravirin 24 weeks undetected after two. 8/2/15  12 week EOT  UNDETECTED!  SVR

1991-2015 RIP

 
Isiscat2011


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mallani wrote:

Hi John,

Until Ledipasvir is approved, SVR rates are a bit of a lottery.

 

   _____________________________________________________________________________________________________________

 

So true, and this is another reason insurance companies are being a pain in the butt for so many people.  They want less risk and the highest possible success rates.  

Well, actually, they would probably rather not pay at all, but if they have to then they want tx to be successful.  That makes sense. 



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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.
mallani


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Hi John,

Until Ledipasvir is approved, SVR rates are a bit of a lottery.

For Sovaldi/ Peg and Riba, we still have a problem with non-CC allele at IL28B, cirrhotics (or F3's) and high starting VL. These patients have only a quoted 71% SVR rate with the 12 week course. They really should have 24 weeks. Cheers.



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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
Isiscat2011


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I won't forget them.  



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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.
JLynch30


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any data on relapse with solvaldi, interferon and rib?



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John   non-responder  

Undetected at week 2 on solvaldi/rib/interferon:  stayed through week 12 but virus came back as soon as I stopped.  on   Harvoni and ribravirin 24 weeks undetected after two. 8/2/15  12 week EOT  UNDETECTED!  SVR

1991-2015 RIP

 
mallani


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Hi all,

We talk about Sovaldi as if it's an old friend. It really had a turbulent beginning. It was developed by Pharmasset in 2010 as a second-string NS-5B nucleoside inhibitor, to go with it's PSI-938, the first nucleoside inhibitor. For a company with no drug products and only 80 employees, the share price went beserk after the first Trials. However, worries about liver toxicity led to suspension of PSI-938 in 2011. Nevertheless, Gilead Sciences went ahead and purchased the company for the well-published $11 billion, in November 2011. This was an incredible risk.

The first Trials of PSI-7977 were interesting. Virtually all patients became Undetected by 3 weeks, even with monotherapy, and irrespective of the initial VL. This is by far the most potent DAA. However, after 6, 8 and 12 weeks of monotherapy, all patients relapsed. No explanation of this was ever given apart from 'no resistant variants were found'. I take this to mean that any RAV's could not be identified or were transient.

As the aim was to be Interferon free, Ribavirin was added and the SVR rates skyrocketed. Other drugs were added and it took 2 years of trial and error to come up with the combos we have today. It's been an intense, fascinating 2 years of research and we will soon forget the thousands of patients that put their lives on the line to get to today's easy treatment. Thanks be to them!



__________________

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
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