Hep C Discussion Forum

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

Isiscat2011 wrote:

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Groupergetter wrote:

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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."   

 

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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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 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.    

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. 

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.

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 

wmlj1960 wrote:

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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?

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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. 

Isiscat2011 wrote:

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 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.
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 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?

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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?

Yes I do have  cirhosis

I have an appointment Monday.  

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.

JLynch30 wrote:

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

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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.

Hi Malcolm:

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