Hep C Discussion Forum

JimmyK · Guru

RE: RELAPSE AFTER VIEKIRA PACK?? PLEASE HELP

mcmaklin · Senior Member

Hello, do you have any more news for retreating people after Viekira Pack relapse? I know only that I have no NS5A ravs, and still waiting for NS3 tests. Is there a chance I will be treated with f.ex Veltapasvir no Riba? My doctor asks me to wait because she believes newer drugs are less resistant

mallani · Guru

Thanks Mike.

I don't know how to do that.

Discussions like this (by Feld) are bringing the latest options to the table.

Note that Ribavirin is to be considered for some patients.

Note that Sovaldi is active against ALL known RAVs, but can develop it's own. Thankfully, the Sovaldi RAVs are short-lived, meaning Sovaldi can be re-used after a period.

-- Edited by mallani on Tuesday 9th of February 2016 11:55:34 AM

wmlj1960 · Moderator

mallani wrote:
Jordan Feld knows what he's talking about.
http://www.clinicaloptions.com/Hepatitis/Treatment

Viewing this link requires you to register with the CCO site. If anyone has a problem registering or are unable to view the linked document then the text can be viewed via the attachment below, however registering to view the linked page also provides links to additional information not included in the attached text document.

Malcolm, I shortened your url to fit the forum display for all devices. I have the full url available if needed. smile

mallani · Guru

Jordan Feld knows what he's talking about.

http://www.clinicaloptions.com/Hepatitis/Treatment

[url shortened to fit screen]

-- Edited by wmlj1960 on Tuesday 9th of February 2016 07:34:46 AM

Tig · Admin

Hi Mak,

Good to hear that you're clear of those RAV's. I would wait for the next new Gilead treatment that will soon be released, Sovaldi and Velpatasvir. You shouldn't need to use Ribavirin and the trial data has been excellent. Good luck, let us know what you hear.

mcmaklin · Senior Member

Hello, please help me what options now. The RAVs I was testingL in Region NS3 I have no Y56h and no D168V and in region NS5A no Y93H RAVS.

I would not like to take Ribavirn to retreat. What are options for me now? Do I need to test for other RAVs?

JimmyK · Guru

https://www.youtube.com/watch?v=V2f-MZ2HRHQ

Tig · Admin

Hey McMaklin,

Here's some additional information the good doctor has provided the forum.

http://hepcfriends.activeboard.com/t56863437/understanding-ravs-effect-on-treatment-and-re-treatment-sele/

mcmaklin · Senior Member

Thank you for the info about Veltapasvir.

1. Why it sounds promising for genotype 1b if you have NS5A or B RAVs? One of the worse would probably be Y93H variant.

Is it possible to treat it with Veltapasvir? I am waiting for my RAVs tests caused by Viekira+Exviera?

2@mallani wrote that "you will have RAV's at the NS-3-4, NS-5A and non-nucleoside NS-5B sites. Sovaldi is effective against ALL of these".

I am really not sure if Sofosbuvir is really effective against ALL of this (NS3-4, NS5A)

JimmyK · Guru

Good Morning,

I have been reading the Press Release on SOF/VEL and it looks quite promising. I will be discussing this one next Tuesday when I speak with my Doctor. Wish I new more about release timeline but clearly it is eminent.

When I think about just the prospect of one pill a day compared to the ten I was taking that STILL has me a bit messed up I get pretty encouraged about future outlook.

2016 looks to be a great year for us.

(Press Release attached.)

Regards

JimmyK

mallani · Guru

Hi mcmaklin,

A belated response to Tig's comment.

At our recent meeting, V-Pak was barely mentioned, as AbbVie are not trying to get it approved in Australia. It's a bit odd, as they funded many Trials, and made it available for compassionate use. Now that Harvoni, Sovaldi and Daclatasvir will be available to all patients from March 1st., I guess they have given up.

RAV testing in treatment failures WAS discussed. It was not thought to be necessary or cost-effective, now that Sovaldi will be available. You will have RAV's at the NS-3-4, NS-5A and non-nucleoside NS-5B sites. Sovaldi is effective against ALL of these, as I've mentioned before.

It's not relevant, but the SVR rate for Simeprevir (olysio)/Peg/Riba was ~60% which is worse than boceprevir (Victrelis). I'm guessing Simeprevir will be dropped from our PBS.

It is also interesting that GP's will be trained to prescribe the new drugs, particularly in country areas. Hepatologists tend to be found in our larger cities, and this should ease the workload and make for easier access. As always, I worry about getting fibrosis staging done before treatment starts.

In your case, forget about RAV's and wait for Velpatasvir to be approved. Sovaldi/Velpatasvir should not need Ribavirin. Cheers.

JimmyK · Guru

Hi MC,

Yup Breakthrough and RAV's are going to be an issue. But they are not going to be a thing to sweat. Just something to deal with and overcome.

If you apply that strategy to self you will do fine.

You like to read so please read this.. http://hcvadvocate.org/hepatitis/factsheets_pdf/stress_liver.pdf

Take control of self and only THEN can you tackle a Dragon. You are in a fight dear friend, if you want to win you must first take fear and make no room for it. Take control, seize life and let no Dragon Ever bring you down.

An enemy senses fear and upon it pounces. That same enemy senses strength and from it flees.

James 4:7English Standard Version (ESV)

^"Submit yourselves therefore to God. Resist the devil, and he will flee from you."

The devil is in fact the Dragon. Look~~>

Revelation 20:2English Standard Version (ESV)

²And he seized the dragon, that ancient serpent, who is the devil and Satan, and bound him for a thousand years,

OK I know I know Hep C is not in context but I also know that same principle applies.

Trust God and fear NONE.

JimmyK

wmlj1960 · Moderator

mcmaklin wrote:
What does SOT mean

Hi mcmaklin.

SOT stands for 'Start Of Treatment'. Malcolm posted a list of all the forum abbreviations in the thread linked below.

As Jill said, "don't worry", there is a solution that will work just fine for you to achieve SVR. smile

Forum abbreviations

mcmaklin · Senior Member

Hi JImmyK and all , thank you.

Breakthrough on Viekira + Ribavirin?

Are you doing any RAVs tests? Please please update me all you know and I will update you. As soon as you can.

My doctor is doing tests for RAVs and we are waiting

Thank you for emailing me

-- Edited by mcmaklin on Monday 25th of January 2016 10:58:49 PM

-- Edited by mcmaklin on Monday 25th of January 2016 11:01:08 PM

JimmyK · Guru

Hello Mac.

You are not alone. I am seeing my Doc next Tuesday and will let you know what he says.

No worries, it will all be fine.

JimmyK

Cinnamon Girl · Guru

Ok, I understand where you are with this, and I`ve read the information you posted which was taken from the AASLD guidelines for people who have failed the Vik Pak treatment combo.

Yes, it does look as though the most appropriate option for you if you`re impatient to retreat would be Harvoni with the addition of ribavirin. I do understand why you would want to avoid ribavirin though, and if you`re prepared to wait for a year or so that situation may well have changed.

I`ll do some more searching as well and see if I can find any more information.

Let us know when you get those results and when you`ve spoken with your doctor about them.

Try not to worry, you have plenty of time.. smile

mcmaklin · Senior Member

Dear Cinnamon Girl,

I Am still waiting for RAVs results... I could only find one person who relapsed and no person with 1b non cirrotic...

Cinnamon Girl · Guru

Hi mcmaklin,

I`m very sorry you relapsed after your Vik Pak treatment, it has happened to others as well, you are not alone. Try not to get too stressed about this, you`ll be able to do another treatment after a while and there`s no reason to think you won`t be successful next time. You aren`t cirrhotic and so have time to wait for whichever will be the most suitable drug combo for you.

I suppose you have discussed your options with your doctor, and if so, what does he recommend?

Tig · Admin

Will have to do some investigating on your questions, all very good. Malcolm just attended a meeting on future considerations. Perhaps he will be able to provide the most current recommendations on that. There are some very good options in final trials, so the future looks good. I'll do some looking....

Here's a starter: http://www.medicalnewstoday.com/releases/304990.php

http://www.aasld.org/events-professional-development/liver-meeting%C2%AE-2016

mcmaklin · Senior Member

Hello, I am still waiting for RAVs tests results.

1. Please let me know when there is a new liver congress?

2. Please let me know if you know somebody with 1b TT who relapsed after Viekira+Exviera no Riba. AM I THE ONLY ONE? Please.

3. And the more important - for now Harvoni with Riba gives me more chances to be cured, am i right?

4.Is it possible if I wait a year the knowledge will be much better to be able to avoid Ribavirin.

5. What is the next drug in clinical trials if I have (I do not know yet) NS5A RAVs?

mcmaklin · Senior Member

Hello, today my doctor did tests and am waiting for results:

In region NS3 mutation Y56H and mutation D168V

In region NS5A mutation Y93H

To remind I relapsed after Viekira+Exviera in week 4 after EOT

mcmaklin · Senior Member

Thank you so much for your help
First of all I go to my consultant next week and she will try to assign RAVs.

1.Maybe I was simply taking it too short time? 12 weeks. Is it possible that there is no drug resistance at all after taking Abbie? That it is all the same as it was before the treatment

2. The most important thing - when the virus came back how big amount it was after half a year? Isn't it like that it will be now duplicating more than it was?

3. Do you know some more people who relapsed after Abbvie? I need to contact them

dharmabum · Senior Member

Hi Mcmaklin,

Please do not be upset. Your liver is in good shape, so you can wait a few months or more to consider Harvoni or other new meds filtering in through the FDA.

I guess you could say that this is a good time to have Hepatitis C. Lots of options out there...

Take care of yourself; hang tough and enjoy the holidays

Jo

mcmaklin · Senior Member

It says that:

HCV replicons expressing the sofosbuvir-associated resistance substitution S282T were susceptible to NS5A inhibitors and ribavirin. HCV replicons expressing the ribavirin- associated substitutions T390I and F415Y were susceptible to sofosbuvir. Sofosbuvir was active against HCV replicons with NS3/4A protease inhibitor, NS5B non-nucleoside inhibitor and NS5A inhibitor resistant variants.

But another guide

I read here http://www.uptodate.com/contents/treatment-regimens-for-chronic-hepatitis-c-virus-genotype-1

Prior failure with an NS5A-inhibitor regimen Data on patients who have failed treatment with ledipasvir-sofosbuvir or ombitasvir-paritaprevir-ritonavir plus dasabuvir are extremely limited. For most patients, we defer retreatment until additional data are available. For patients with cirrhosis who warrant more imminent treatment, we agree with the AASLD/IDSA guideline recommendations to test for resistance-associated variants (RAVs) and select a regimen based on those results [2]. For those who have no NS5A RAVs, retreatment with ledipasvir-sofosbuvir plus ribavirin for 24 weeks is recommended. For those who have NS5A RAVs but have no NS3 RAVs (eg, Q80K), simeprevir plus sofosbuvir plus ribavirin for 24 weeks is recommended. For those who can tolerate interferon, the addition of peginterferon may further enhance efficacy of these regimens, although there are no direct data to confirm this. Those with both NS5A and NS3 RAVs should be retreated through a clinical trial.

mcmaklin · Senior Member

Please help me I am really upset about the situation I relapsed after Viekira pack. It was unexpected, I am not cirrhotic.

Apart from that I do not want to be treated with Ribavirin when my liver condition is now almost healthy after treatment.

How can we now what happened. Can I retreat with let's say Harvoni for 24 weeks but with no Ribavirin?

Or if this fails it will be even more difficult later? I will not agree for Riba, I need to create music, and be active. Is there a possibility and how big that I can be treated with Harvoni and that it will cure me? Anyway I have to wait probably half a year until virus multiplies and maybe it variants go back to position before treatment.

-- Edited by mcmaklin on Thursday 24th of December 2015 09:54:12 PM

mallani · Guru

There are plenty of references.

This link is easiest to understand. Look at Para 12.4 under 'Cross Resistance'.

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

mcmaklin · Senior Member

There is a chance to be retreated with Harvoni. The only thing I would like to not to take Riba? Is Riba really necessary here?

mcmaklin · Senior Member

Thank you Mallani. How do you know that " Sovaldi is effective against all known V-Pak RAVs."

Do you have any source please?

thank you!!!

mallani · Guru

Relax buddy. You're not the only one to relapse after Viekira-Pak.

Technivie is actually for Genotype 4.

You will have RAVs to the AbbVie drugs. RAVs are drug specific and Sovaldi is effective against all known V-Pak ones.

Retreatment with Harvoni is your best option but there's no hurry for that. Wait 6-12 months and there may be something better eg from Merck. Cheers.

wmlj1960 · Moderator

Sorry to hear that your treatment failed Mac. But like I said previously, "You are F1 and there is no urgency to get cured today. There will be a tomorrow". There are many better options in your future so don't give up. SVR will happen for you. smile

Tig · Admin

Hi Mac,

I'm sorry to hear that they confirmed a relapse. I wouldn't worry about the RAV's at this point. There are other options available that will do the job. There are several new protocols in final trials that are proving very effective. Is there a chance that you could get approved for Harvoni? As Malcolm mentioned, it would benefit you to include Ribavirin as part of a 12 week protocol. If you have any questions, don't hesitate to ask.

mcmaklin · Senior Member

Sorry but Tehchnivie is for Genotype 3 only, it is not for genotyope 1 as you suggested beceause other did not work

mcmaklin · Senior Member

Unfortunatelly I can confirm I have relasped 3 weeks after EOF. I did a retest and now is 140000. Virus replicates. I am really worried about mutations. And how can I be cured now.

mcmaklin · Senior Member

Well, I contracted hepc geno 1b by blood transfusion when I was born. I am aware about this for 3 years. 3 years ago when I got to know it was 5mln, a year later 2400000 and when I was starting Viekira+Exviera 1400000.

In 2 weeks of treatment 260, after one month below the level of measuring, after next 2 months of treatment 0. And 3 weeks after EOT HCV RNA 0. Then not confirmed yet next week 27000.

Fibroscan shows that my liver is healthy now - before it was almost F2.

I hope if really virus comes back that it cannot do more damage to my liver and that the immune system will work the same.

Unfortunatelly I did not know that Dasabuvir is worse then the one from Harvoni. Have you got any source of it?

Groupergetter · Guru

Hi Mac, apparently the virus does replicate quickly after relapse. When I relapsed on the Sovaldi and Olysio If I recall correctly my viral load was around 56,000 4 weeks post tx. Having cirrhosis I did 24 weeks of Harvoni, and remain clear. I asked my doc to consider riba in addition to Harvoni but she said no. Harvoni is the real deal. Wishing the best for you.

mallani · Guru

Sorry, that probably isn't easy to understand.

What I meant was that Dasabuvir is not a very powerful drug. Abbvie have dropped it from their new drug, Technivie and it is not included in the Trials of their new drugs, ABT-493 and ABT-530.

Retreatment with Harvoni is possible, as it is effective against all the resistant variants that can occur after Viekira-Pak failure.

Viral numbers can fluctuate enormously from day to day. The survival time of each viral particle is a matter of hours. It has been estimated that a VL of 1 million ME/ml can mean up to 2 trillion replications per day. That's an awful lot of liver cell cytoplasm being used up.

Why are you so keen to avoid Ribavirin? If I had relapsed, I'd want all the help I can get. However, 12 weeks of Harvoni will work for you, although I'd want Ribavirin as well.

Best of luck.

mcmaklin · Senior Member

1.thank you. While waiting for the retest results just curious if it is possible that virus replicates at one week from very little to 27000. Saying that it was 0 I meant they told me I was undetected. That HCV Rna 0

2.So does it mean that Dasabuvir is much worse than Sovaldi?

3. does it mean that retreatment with harvoni is possible?

4.Please explain the last sentence - What does it mean that RAVs quickly develop to Dasabuvir (my native language is not English) - and that Sovaldi is active against all of them?

5. As non cirrotoc can I avoid Ribavirin?

-- Edited by mcmaklin on Saturday 19th of December 2015 08:17:10 AM

-- Edited by mcmaklin on Saturday 19th of December 2015 08:20:29 AM

-- Edited by mcmaklin on Saturday 19th of December 2015 09:38:14 AM

mallani · Guru

It is not possible to have a reported VL of 0.

VL tests don't work that way. They have a LLOQ which is usually 15 ME/ml (or 12 ,10, or even 5, depending on the particular test).

By the way, Dasabuvir is a fairly weak non-nucleoside blocker of NS-5B. It can't be compared with Sovaldi, which blocks the active component of NS-5B.

RAVs quickly develop to Dasabuvir- Sovaldi is effective against all of them. Cheers.

mcmaklin · Senior Member

Is IT possible that a week before was HCV rna 0 and during one week it is 27000?

mcmaklin · Senior Member

Dasabuvir, Omnibuvir, Paritaprevir, Ritonavir. The standard approved doses. 3 months.

Matt Chris · Guru

'Hey Mac

My viral load at 4 weeks EOT (relapse) was 51,300

I decided to add Ribavirin for the 24 weeks because of the previous trials data showed that adding Ribavirin increase SVR rates by 5 to 3 percent for cirrhotic patients. The ION trials showed 100% SVR for Harvoni & Ribavirin for 24 weeks for previously treated patients.

Harvoni is a very easy protocol for most men, but harder on females. One of the most critical / important factor on relapsers is compliance during treatment, Harvoni makes this very easy as its one daily pill, either in the morning or night.

BTW what Abbvie drugs were you on?

matt

-- Edited by Matt Chris on Friday 18th of December 2015 04:46:37 AM

mcmaklin · Senior Member

Hey Matt,

I red it all! Thank you, really many thanks!

I am waiting for retesting. I red nowhere (you did not write about it) what was your viral load at week 4 after EOT? (when you relapsed)

Why you had to take Harvoni both with Riba?

The interesting part was about "nucleotide analogue NS-5B blockers (eg Sofosbuvir) compared with the non-nucleotide blockers (eg ABT-333). Both do the same job, but essentially block different sites on the RNA polymerase."

How did you feel on Harvoni?

Matt Chris · Guru

Hey Mac

I relapsed at the 4 week EOT (End of Treatment) June of 2013.

Follow this Hyperlink on the forum to read the thread about me and others that were on the ABBVIE Turquoise II trial in 2013

http://hepcfriends.activeboard.com/t52696291/abbott-labs-turquoise-ii-open-label-clinical-trial/

Also read the link Harvoni treatment train to understand how re treatment via Harvoni was undertaken

http://hepcfriends.activeboard.com/t58762824/all-aboard-for-the-harvoni-treatment-train-enjoy-the-ride-fo/

Hope this help answers most of your questions.

matt

mcmaklin · Senior Member

*liver condition- sorry for the dictionary. In which arm you were on trials- where you taking full doses of medicines?

mcmaklin · Senior Member

Hi Matt, when did you relapse? What was your initial viral load and genotype? What was your lover condition? I still hope it is an error.

Matt Chris · Guru

Hello Mac

I can totally understand your where your at, but I have been there. Don't despair if you have relapsed there is a way back to gain SVR.

I also relapsed on a 12 Abbvie clinical trial in 2013 , but 1 year 5 months later I started 24 weeks of Harvoni & Ribavirin and now 1 year later I am SVR-24 and feeling much better. You have a better odds than I did, with not being cirrhotic and by the time you will retreat Gilead's 2nd generation NS5B will be available, which will be even better. So take heart all will turn out well for you in the long run.

matt

mallani · Guru

No problem.

Just a temporary setback.

Wait a while, then try Harvoni. You can afford to wait.

Many of us relapsed, and had no options. Cheers.

mcmaklin · Senior Member

Yes, I was even undetected EOT+3 and ALAT ASPAT AND GGTP NORMAL.

EOT +4 ASPAT was 50. All other normal. Fibroscan much better then it was, it all reverted almost to F0. I had the virus from 1975 when I was born (blood transfusion).

Tig · Admin

The test that showed 27000 is your viral load. You said you were undetected during treatment but detected at EOT+4. Your liver enzymes are still in good shape, which often elevate if relapse has occurred. The only way to confirm it is to repeat it. Laboratory errors happen, that's why having a bad or questionable test repeated is a good idea. Machines break, improper sequencing, human error, etc., are things that happen unfortunately, but retesting minimizes those errors.

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