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Post Info TOPIC: Harvoni- full Prescribing Information


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Hi everyone...

I`m bringing the link up to the top of the thread again, so that people don`t have to scroll down to the end to find it. 

Harvoni - Full Prescribing Information...

http://www.gilead.com/~/media/Files/pdfs/medicines/liver-disease/harvoni/harvoni_pi.pdf



__________________

Jill 

(68 yo, lives in UK)

Was Gen 3a, 

24wks Peg/Riba, Sep 2010 - Mch 2011

UND @ Wk.4, UND @ EOT, 

SVR Nov 2011 --> Still UND @ EOT + 4 yrs.

 

 

Tig


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States developing Sov/Harv Medicaid hurdles that are sure to impact treatment. More reason to fight these prices.

 

http://www.forbes.com/sites/brucejapsen/2014/10/10/as-hepatitis-pill-harvoni-joins-sovaldi-states-erect-medicaid-hurdles/

Tig



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Tig

61 yo GT1A - 5 Mil - A2/F3 - (1996) Intron A - Non Responder, (2013) Peg/Riba/Vic SOT:05/23/13 EOT:12/04/13 SVR 1-4 years!

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Hi Greg,

Considering your concern. have you looked into the possibility of trials??  Or called Gilead patient (or should I say patience) assistance program to see what they might offer monetarily for re-treatment if you fail on their treatment??  Or might Gilead have any trials for those who have relapsed??  And, of course, Sovaldi/Olysio is not an FDA approved combo.

Without a signature line on your posts, it is hard for me to remember the details of your treatment. If I have the details, I can email my coordinator to see if she has any suggestions. 

Wish I could be of more help, but the drugs are so new that maybe the companies don't have their act together yet.

Looks like JLynch30 is looking for the same info that you are in his post Keiser California. Looks like he did the approved combo with Sovaldi.

 Have the same suggestion as I made earlier-- to start a post on "Failed Sovaldi  What now?"  so the info is in one place.

 SuziQ



-- Edited by suziq on Sunday 12th of October 2014 11:05:02 PM



-- Edited by suziq on Sunday 12th of October 2014 11:07:57 PM

__________________

Geno 1A  Age 82 Treatment naive Cirrhotic Told I had liver disease in 1966. Diagnosed as Hep C 1999.Started Merck clinical trial with Riba on 9/9/2013 Week 1 and 2 <25  Weeks 4, 8, 12,16,18 UND.  EOT Jan 14,2014  EOT +12 UND   JULY 1 2014 EOT+24= SVR



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Thanks for clarifying, Grouper.  I'm happy to see people are really thinking hard about these choices.

Regarding insurance or medicaid/medicare denial of all tx after a certain number of attempts, as an attorney, it is my opinion that such action would absolutely be prohibited by law where tx is considered necessary.  Payers will get away with paying for whatever is cheapest, assuming it is comparable in terms of efficacy, but denying HCV tx to those in need would not fly with the courts.  They may even get away with rationing to the sickest patients but this will be temporary.

The only way denial of all future tx would be possible is if it could be proved that further tx attempts would always be futile. That could only happen if nothing worked and scientists gave up.  With an infectious disease that just won't happen.  I don't think denial of ALL future tx is something we need concern ourselves with AS LONG AS WE HAVE PRIVATE INSURANCE OR MEDICAID COVERAGE OR MEDICARE WITH RX COVERAGE.  

If your insurance won't cover the Harvoni they will cover the Abbvie.



-- Edited by Isiscat2011 on Sunday 12th of October 2014 09:24:50 PM

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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.



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Isiscat2011 wrote:
Groupergetter wrote:

For those that have relapsed on Sovaldi. the concerns related to Harvoni are greatly magnified. IF we are fortunate enough to get our insurance to pay for the second S/L tx, it will likely be our "last best hope."   

 


With all due respect I disagree completely.  Harvoni is the best thing we have for HCV tx, but it is far from our "last best hope". Gilead is in the process of improving its Sovaldi combo now.  I wouldn't count other pharmas out either.  Abbvie is a fine combo.  It will have a riba requirement for some but that shouldn't deter someone who needs tx now from trying it.  Merck has kept a lower profile but they have some promising drugs in clinical trial and in future development as well.  

IMO, we have to recognize that some people in the harder to tx populations--particularly tx experienced cirrhotics--are going to go through multiple txs but that doesn't mean Harvoni is our last best hope.  Most cirrhotics will last many years without decompensation or HCC, but we are at risk and the risk increases with time, absent SVR. 

Also, I don't think the RAV concerns are anything to sneeze at.  RAVs are what will cause relapses and the science behind them needs to be understood and disseminated to physicians and patients. 

If Harvoni isn't available I would try the Abbvie combo, or the Merck, or the BMS Decltasvir/Sovaldi combo when FDA approved, or even sooner if you desire and are accepted for a clinical trial.  Any of them could work.  We just don't have the specific information yet on what it will take to kick RAVS butt but one day all RAVs will be defeatable. 


 Isis, what I'm saying is for those who have relaspsed on Sovaldi once, IF insurance pays for a second round, it becomes very questionable they would pay for a third of any high dollar tx.  Clearly the science in meds will continue to improve, but as you said the risk of hepatic symptoms and HCC increases absent SVR.  Perhaps I should have stated this more clearly....sorry bout that.  

Hopefully I will know more after my  doc's appointment.  I may be worrying about nothing, it's possible my insurance won't cover the Harvoni?  Then it becomes a matter of what trial I could get into.  I appreciate all your great input and sharing of knowledge.  I just want to make the best informed decision possible.  smile  



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1b  Int/Riba relapse @ 48 weeks.  Stop tx Peg Int/Riba 12 weeks ill. Relapse S/O 6/23/14 :(   Started Harvoni 11/12/14  EOT 4/28/15.  EOT+4 UND :)  SVR! 8/4/15  :)     Thankful for every morning.

Tig


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Thanks Grouper (Greg)! I appreciate your point of view and the link. It helps to see the new data being released from multiple sources as well. Everyone's input is appreciated! Good luck with your appointment this week. I'll be anxious to hear what your next course of action will be.

Tig



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Tig

61 yo GT1A - 5 Mil - A2/F3 - (1996) Intron A - Non Responder, (2013) Peg/Riba/Vic SOT:05/23/13 EOT:12/04/13 SVR 1-4 years!

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Thanks Greg, great link.

I'm praying that all of you about to treat with this new med will finally reach SVR. Sure looks like one great concoction.  smile



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Dx. 2005-liver bx.: stg 2/gr 1. at that time  - GT 1a multiple transfusions in 1981.  Started Sovaldi and Olysio 1/16/14  (No prior treatments) Q80K present.  UND week 4,8 and at EOT.   UND at wk 4EOT, Und at wk 8EOT  SVR 12!!!..SVR 24 :-)



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Groupergetter wrote:

For those that have relapsed on Sovaldi. the concerns related to Harvoni are greatly magnified. IF we are fortunate enough to get our insurance to pay for the second S/L tx, it will likely be our "last best hope."   

 


With all due respect I disagree completely.  Harvoni is the best thing we have for HCV tx, but it is far from our "last best hope". Gilead is in the process of improving its Sovaldi combo now.  I wouldn't count other pharmas out either.  Abbvie is a fine combo.  It will have a riba requirement for some but that shouldn't deter someone who needs tx now from trying it.  Merck has kept a lower profile but they have some promising drugs in clinical trial and in future development as well.  

IMO, we have to recognize that some people in the harder to tx populations--particularly tx experienced cirrhotics--are going to go through multiple txs but that doesn't mean Harvoni is our last best hope.  Most cirrhotics will last many years without decompensation or HCC, but we are at risk and the risk increases with time, absent SVR. 

Also, I don't think the RAV concerns are anything to sneeze at.  RAVs are what will cause relapses and the science behind them needs to be understood and disseminated to physicians and patients. 

If Harvoni isn't available I would try the Abbvie combo, or the Merck, or the BMS Decltasvir/Sovaldi combo when FDA approved, or even sooner if you desire and are accepted for a clinical trial.  Any of them could work.  We just don't have the specific information yet on what it will take to kick RAVS butt but one day all RAVs will be defeatable. 



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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.



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For those that have relapsed on Sovaldi. the concerns related to Harvoni are greatly magnified. IF we are fortunate enough to get our insurance to pay for the second S/L tx, it will likely be our "last best hope."   

Here is a link with prescribing information and the Harvonu clinical trial results in a format that may be easier to interpret: http://www.hepatitisc.uw.edu/page/treatment/drugs/ledipasvir-sofosbuvir 

If anyone has additional insight, thoughts, or other information/sources, related to options it would be greatly appreciated. I have an appointment with my doc this week.  I can't afford to make the wrong decisions.  Thanks in advance.



__________________

1b  Int/Riba relapse @ 48 weeks.  Stop tx Peg Int/Riba 12 weeks ill. Relapse S/O 6/23/14 :(   Started Harvoni 11/12/14  EOT 4/28/15.  EOT+4 UND :)  SVR! 8/4/15  :)     Thankful for every morning.

LC


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I am glad you are still posting on here mallani! You and Cinnamon girl are the only names I recognize after 2 years of waiting for better drugs.

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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! 



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Sorry about the double post--couldn't figure out how to delete it.

 

I don't really know much about this topic, but I think I would call some other drug companies such as Merck or Abbvie and see if they are doing (or planning to do or accepting patients on) any trials for those who have not achieved SVR on the present drugs available.  Of course I had a wonderful trial coordinator who said she would find a trial for me after Gilead rejected me for a trial that did not accept cirrhotics. I was accepted into a Merck trial.

  As a trial coordinator for several different drug companies, she had knowledge of results that most doctors do not have--and requirements for who can or cannot get into each trial.  I did a phase 2 trial that had limited info from their phase 1 trial.  Fortunately, I was successful.  Of course she can not give me ANY info on her experience with any trial that has not published results.  So my trust was in her ability to assist me.  I do know that they did a trial on reversal of cirrhosis in participants with fatty liver disease.  For any further info about that trial, I will have to wait until results are published. 

Malcolm has so much more knowledge in this area-but I thought I'd just throw the idea out for discussion.  The wait for other new drugs to be FDA approved will probably be less than a year.  Merck is accepting participants with HIV and on methadone on their trials now.  Got that info from this forum.  You might start a topic for those who were not successful with Sovaldi like" No SVR with Sovaldi, What Now?"and see if others have information or experience in that area.  You also might call some trial centers to see what they are doing or have coming up.  PR me if you want the number to my trial center.

SuziQ 

 



-- Edited by suziq on Sunday 12th of October 2014 05:03:46 PM

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Geno 1A  Age 82 Treatment naive Cirrhotic Told I had liver disease in 1966. Diagnosed as Hep C 1999.Started Merck clinical trial with Riba on 9/9/2013 Week 1 and 2 <25  Weeks 4, 8, 12,16,18 UND.  EOT Jan 14,2014  EOT +12 UND   JULY 1 2014 EOT+24= SVR



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I don't really know much about this topic, but I think I would call some other drug companies such as Merck or Abbvie and see if they are doing (or planning to do or accepting patients on) any trials for those who have not achieved SVR on the present drugs available.  Of course I had a wonderful trial coordinator who said she would find a trial for me after Gilead rejected me for a trial that did not accept cirrhotics. I was accepted into a Merck trial.

  As a trial coordinator for several different drug companies, she had knowledge of results that most doctors do not have--and requirements for who can or cannot get into each trial.  I did a phase 2 trial that had limited info from their phase 1 trial.  Fortunately, I was successful.  Of course she can not give me ANY info on her experience with any trial that had not published results.  So my trust was in her ability to assist me.  I do know that they did a trial on reversal of cirrhosis in participants with fatty liver disease.  For any further info about that trial, I will have to wait until results are published. 

Malcolm has so much more knowledge in this area-but I thought I'd just throw the idea out for discussion.  The wait for other new drugs to be FDA approved will probably be less than a year.  Merck is accepting participants with HIV and on methadone on their trials now.  Got that info from this forum.  You might start a topic for those who were not successful with Sovaldi like" No SVR with Sovaldi, What Now?"and see if others have information or experience in that area.

SuziQ 

 



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Geno 1A  Age 82 Treatment naive Cirrhotic Told I had liver disease in 1966. Diagnosed as Hep C 1999.Started Merck clinical trial with Riba on 9/9/2013 Week 1 and 2 <25  Weeks 4, 8, 12,16,18 UND.  EOT Jan 14,2014  EOT +12 UND   JULY 1 2014 EOT+24= SVR



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wmlj1960 wrote:
__________________________________________________________________________________________

Can you explain further for this dummie Icat? I would think a relapse @ 12 wks would trigger a Tx discontinuation but I suppose they may continue although I was under the impression that once UND is achieved during Tx, you should remain UND for the entire remainder of the Tx's scheduled time frame. If not, Tx is considered a failure. If this member did indeed do a fresh restart Tx with a 24 wk time frame, then my question is, "How long has Harvoni been available for trials etc? 

Also was Peg Int or Riba included in either of this members Tx?

____________________________________________________________________________

 

Also, some insurance providers and government agencies are limiting Sovaldi tx to one time per life. 


 Does this include Medicare? Do you have a link to more information on this?

 


 

Hi Mike:

He may pop in to share his story again himself but my recollection is that he was in a clinical trial for 12 weeks on the S/L combo (Harvoni), relapsed after completing tx, then later was placed on the S/L combo again for 24 weeks with the same results.  No peg or riba. 

I don't know exact dates but Sovaldi was being tested with Declatasvir (a BMS protease inhibitor) at least as far back as late 2011/early 2012 and probably years before that with animal studies (covering Isis' ears).  Gilead decided to create its own 2nd DAA (Ledipasvir) because it did not want to share the profits with BMS. Given the length of time testing takes I would guess Gilead began testing Harvoni on humans in 2012.

I don't know about Medicare but the states (Medicaid) will have their own rules and some are in the process of working them up now.  You would have to research the specific state. 



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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.



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JLynch30 wrote:

SO WILL THEY OFFER IT TO ME?  would you take the offer?


Whether you can get Harvoni or not probably depends more on your insurance coverage than anything else.  Some insurance companies are placing restrictions on receiving Sovaldi more than once.  Some have time restrictions (such as 2 years) ; others actually have "once in a lifetime" clauses.  Others have no such restrictions.

Your doctor may also have a DAA tx preference but, as you can see from Malcolm's comments, nobody knows with certainty how effective Harvoni will be at treating Sovaldi relapsers, because Gilead has not disclosed the relevant information.  Either Gilead doesn't know or they aren't saying.  It seems likely to me that Gilead would have some data by now and the FDA also has more than they are disclosing.

In answer to your question, yes, I would take it but I would want 24 weeks.  The reasons I would take it, in your shoes, are: (1) you have cirrhosis and need to treat asap, (2) notwithstanding the RAVS question, Harvoni will be the best combo available for the next couple of years, IMO, (3) there is no way to know that the next combo approved (which will be Abbvie) would be any better for your particular situation, and (4) I tend to believe that, although Gilead has not been forthcoming, they would be somewhat unlikely to intentionally deceive the FDA and the public if they had conclusive evidence that retreatment with Harvoni should not be recommended with previous Sovaldi users.  Stalling is one thing but intentional misrepresentations could subject Gilead to serious civil and even criminal liability.  Hard to imagine they would risk that much but anything is possible where billions of dollars are at stake. 

I don't know if this helps, John.  I am very disappointed that Gilead has not been more forthcoming with such important information.  I also know how long you have been trying to SVR and this just isn't right.  

 



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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.



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Isiscat2011 wrote:
 I haven't seen any studies with Sovaldi retreatments.  I have only seen the one member here who relapsed at 12 and then again at 24 weeks of retreatment, although he treated with Harvoni both times.
_____________________________________________________________________

 Can you explain further for this dummie Icat? I would think a relapse @ 12 wks would trigger a Tx discontinuation but I suppose they may continue although I was under the impression that once UND is achieved during Tx, you should remain UND for the entire remainder of the Tx's scheduled time frame. If not, Tx is considered a failure. If this member did indeed do a fresh restart Tx with a 24 wk time frame, then my question is, "How long has Harvoni been available for trials etc? 

Also was Peg Int or Riba included in either of this members Tx?

____________________________________________________________________________

Isiscat2011 wrote:
Also, some insurance providers and government agencies are limiting Sovaldi tx to one time per life. 

 Does this include Medicare? Do you have a link to more information on this?

 



__________________

57 yo, geno 1a, Dx 1994 HCV-HIV co-inf, Dx 2013 decompensated cirrhosis
Tx #1 - 24wks Sov+Riba /SOT 7-24-2014/UND@EOT/DETECTED@EOT+16 wks
Tx #2 - 24wks Harvoni /SOT 7-25-2015/UND@EOT,+12,+24,+52,+115wks = SVR-115

Mike

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Hi John,

Gilead haven't addressed this issue. The 24 week recommendation for previous treatment failures (with cirrhosis) only mentions previous Peg/Riba, +/- a protease inhibitor.

I would try for 24 weeks.

For any members who don't know their liver status, this would be a good time to request a biopsy or Fibroscan. Cheers.



__________________

Geno 1b, IL28B CT,  x3 prior relapser,  ex-cirrhotic, 74 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 +4 years

Malcolm



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Yes I do have  cirhosis

I have an appointment Monday.  



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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

 



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SO WILL THEY OFFER IT TO ME?  would you take the offer?



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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

 



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Hi all,

As usual, Gilead has been allowed to avoid the hard questions.

Remember, when Sovaldi was used as monotherapy, all patients became Undetected within 4 weeks, but ALL relapsed between weeks 8 and 12. Why? Gilead mumble that the S282T polymorphism was only found in one patient. There are obviously multiple polymorphisms that interfere with Sovaldi's action. Some of these have been now admitted, including the L159 and V321 RAV's.

What we need to know is how long these RAV's persist. This is vital for retreatment options. On Page 19, under 'Persistence', we get the cryptic comment the ' No data are available....'. Not good enough!

We get the expected long list of RAV's associated with the NS5A site. This is to be expected, as this is an unstable site. Ledipasvir (and Daclatasvir) are limited by this instability. At least Gilead say 'All Ledipasvir resistence-associated substitutions in NS5A were fully susceptible to Sofosbuvir....'.

We also get a list of NS5B substitutions. The comment 'The clinical significance of these substitutions is unknown.....'. Again, not good enough. We get the comment that Ledipasvir is effective against the S282T RAV but, there is no comment that Ledipasvir is effective against the NS5B RAV's listed. This is vital information!

I am confused about the reference to baseline polymorphisms at both NS5A and NS5B.  Given that Rx-experienced patients with baseline NS5A polymorphisms showed a 22% relapse rate after 12 weeks of treatment, but 0% after 24 weeks of treatment, surely there should be a recommendation that all Rx-experienced patients should be tested for baseline polymorphisms.

Finally, I was amused to see that Olysio has appeared on the list of drugs not to take with Harvoni. Gilead must be pissed off that Olysio has been used with Sovaldi for the last 6 months!

So, great drug combo, the end of the 'beginning of the end' for HCV treatment. With >90% chance of SVR, this is the end of the race. As ~90% of the world's HCV patients remain undiagnosed, this is the next challenge.



__________________

Geno 1b, IL28B CT,  x3 prior relapser,  ex-cirrhotic, 74 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 +4 years

Malcolm



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JLynch30 wrote:

If they try to get me 12 weeks should I demand 24?

 


The difference between 12 and 24 weeks SVR rates is 86% and 100%, JLynch.   That is for tx experienced cirrhotics.  Your sig line doesn't indicate but I seem to recall you do have cirrhosis.  Note this was a very small study group and real world SVR rates are typically lower.



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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.



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JLynch30 wrote:

______________________________________________________________________________________________________________

I called Gilead and spoke to a nurse - she said despite my failure I  would be eligible or 24 weeks.


I haven't seen any studies with Sovaldi retreatments.  I have only seen the one member here who relapsed at 12 and then again at 24 weeks of retreatment, although he treated with Harvoni both times.  In theory, the Ledipasvir should be able to control the Sovaldi RAVS, but unless there are some studies done, the best patients will be able to get is an educated guess.  

No offense to the Gilead nurse, but I doubt she has a sophisticated understanding of RAVs and, naturally Gilead doesn't mind people retreating-good for study purposes-- and and good for the bottom line. I would trust Malcolm's opinion over hers.  

It is an important question because cirrhotics especially can't afford to continue retreating indefinitely.  If there is a better option--perhaps different DAAs-- patients should be so advised.

Also, some insurance providers and government agencies are limiting Sovaldi tx to one time per life.  Aside from the question of the legality of such a provision, it makes me wonder if they have information patients don't about retreatment efficacy.



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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.



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If they try to get me 12 weeks should I demand 24?

 

I called Gilead and spoke to a nurse - she said despite my failure I  would be eligible or 24 weeks.



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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

 



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Hi Malcolm:

What are your thoughts on retreating with Harvoni for those who relapsed on Sovaldi?   



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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.



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Hi all,

Harvoni is the best DAA combo approved so far, and deserves to be a 'Sticky'. Cheers.

http://www.gilead.com/~/media/Files/pdfs/medicines/liver-disease/harvoni/harvoni_pi.pdf

 



__________________

Geno 1b, IL28B CT,  x3 prior relapser,  ex-cirrhotic, 74 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 +4 years

Malcolm

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