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Author Topic: New orals for previous Incivek/telaprivir relapsers, gen 1a  (Read 8176 times)

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Offline CB

  • Newbie
  • Posts: 2
New orals for previous Incivek/telaprivir relapsers, gen 1a
« on: February 13, 2014, 09:59:57 pm »
Hello there!

Great forum folks, fab info, thanks to all our courageous and compassionate posters! My question is for Lucinda - I've read some of your posts, and your story, and it seems you are the ideal person to answer my queries, having been thru treatment yourself, as well as having your finger on the pulse with recent developments.....we are very lucky that you take the time and energy to be involved here!

I can't recall where I found your post, but it suggested that recent guidelines (USA?) recommend HCV 1a prior Telaprivir treated (protease inhibitor) will not be offered the new only oral regimes, but will need Interferon / RIBA ?

I know that the Gilead Sofosbuvir / Ledipasvir clinical trials on relapsers have been very successful, but the numbers seemed small (around 40?). I wonder if you've had any first hand experience with the new oral combos (interferon and RIBA free) working on patients who have relapsed after Telaprivir? I understand that this protease inhibitor can cause resistance, but it seems that both the Sofosbuvir and the Ledipasvir (or Daclatasvir?) attack through a different pathway, and may prove in any case effective, little miracles that they are!

I wonder if you are aware of any upcoming clinical trials on such subjects, or whether you've seen such subjects treated successfully? Also, what time lapse between treatments is necessary - between ending the interferon / RIBA with Telaprivir and starting eg Sofosbuvir / Ledipasvir? Or Daclatasvir.....

I am in Australia, and I ask these questions because I'm 8 months into the Telaprivir treatment (VL 2588228 at week 0, 593 / 2.77 at week 4, 0 at weeks 12 and 24) but am utterly at the end of my tether and looking at my options. I'm 45 lady, Geno 1a, for 20-25 years, and have resisted interferon treatment for years bc I fear the well documented and lasting side effects. Two years ago my fibroscan was 7.8, then within one year it went to 9.8. For the second scan, my LFT were very inflamed, ALT 250 AST 171, but I was unaware that this can cause an artificially inflated and inaccurate scan. So I very reluctantly followed advice of docs and began treatment, again unaware that new orals were so close (the docs had predicted 5-6 years wait, so I felt that my hands were tied, and I wasn't aware of the trials option)

Treatment has been very difficult, with minimal support and single parenting my small daughter, so that our life has been turned upside down and i am in bed 90% of the time, but my MAIN concern is the lasting toxicity of the interferon / riba. Since I've been madly researching since SOT, have educated myself (rather too late!!) I asked for a new fibroscan 2 weeks ago - since my LFT's are now normal, no inflammation, the result is likely to be more accurate. It is now 7.4 - LESS than it was 2 years ago. The professor scanning said this was not due to the meds, they do not impact a scan so quickly, rather the previous scan was inaccurate re inflammation.

On the basis of such a scan I would NEVER have chosen to treat - had in fact refused treatment 2 years prior, with higher scan.

My inclination is to stop treatment now - 8 months 'wasted' is no solid reason for 4 more months of toxicity and it's heavy impact on health and family (it is a massive upheaval for an 8 year old to have her sole parent incapacitated for 12-24 months), AND the newer interferon free treats seem so promising, even for relapse after a protease inhibitor. If I were alone, and assured I'd bounce back totally, and lasting impacts, like this awful brain fog, were nill, I'd walk over hot coals to treat, but here that simply is not the case - it has to be a risk / benefit analysis in the end.

Anyway Lucinda, and any other interested peeps, my questions to you are whether

1. You have seen the new interferon / RIBA free regimes effective in gaining SVR for those retreating after relapse from a protease inhibitor?
2. What time span must lapse between treatments?
3. Do you predict that docs will in the near future recommend such regimes for relapsers, or will they more likely involve longer treatment than the 8-12 weeks, and with interferon / riba because of any resistances created by prior treatment? My Dr. believes that as I have been shown to respond to Interferon, AND because of potential resistances re protease inhibitor, AND because these new fancy orals will be rolled out slowly and selectively to save on costs, that I will in any event be forced to take interferon and / or riba in any re treatment.
4. Do you know of any trials on the horizon for relapsers (Australia, Italy or India - my partner is Italian, in Italy, we lived in India more than a decade)
5. If the Sofosbuvir / Ledipasvir combo pill were manufactured generically in India (with or without the blessings of Gilead), what is there to stop patients accessing the treatment over there?
6. What is 'off label' treatment,, and how would one access this?
6. No doubt as a HCV nurse, you've encountered clients ending Telaprivir treatment early (ie, at 32 weeks rather than recommended 48 weeks!) Have you seen any achieve SVR even so?!
7. Even though my access to new orals may be a couple of years away, the progression of this disease is after all slow, and with a fibrosis of 2, scan 7.4, conscientious lifestyle, I can perhaps afford the wait without dire consequences?

Thanks so much for having the patience to listen, and sorry for being a bit lengthy! I would really appreciate ANY feedback on these questions, as I'm finding reliable and unbiased advice extremely difficult to access at the moment, and am a wee bit confused!

Thanks again
CB x

Offline lporterrn

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  • LucindaPorterRN
    • LucindaPorterRN
Re: New orals for previous Incivek/telaprivir relapsers, gen 1a
« Reply #1 on: February 17, 2014, 12:23:40 am »
Hi CB x,
I apologize, I can’t give your amazingly well-thought out post an equally well-thought out response, but will do the best I can. I am a bit tied up, with less time than usual.
Let’s start with the retreatment data. First, there just isn’t much out there, mainly because telaprevir (and boceprevir) haven’t been out very long, and with high response rates, there aren’t a lot of retreatment candidates.

Here are the guidelines to read for yourself: http://www.hcvguidelines.org/full-report/retreatment-persons-whom-prior-therapy-has-failed

However, keep in mind that in the U.S., we are within 6 yo 9 months of one, probably two even better HCV treatments, which will change these guidelines. Although I don’t know what the specific data is re telaprevir nonreponders, sofosbuvir /ledipasvir have low-resistance profiles, so I expect response rates will be high. Ditto on some of the other drug combos in the pipeline. Here is some data that includes non-responders with prior ifn/rbv/protease: http://www.gilead.com/news/press-releases/2013/12/gilead-announces-svr12-rates-from-three-phase-3-studies-evaluating-a-oncedaily-fixeddose-combination-of-sofosbuvir-and-ledipasvir-for-genotype-1-hepatitis-c-patients

Not aware of any upcoming clinical trials on such subjects. Don’t know what the wash-out period for clinical trials would be, but in real life, doubt there would be a required time lapse between treatments.

As for your personal situation, you have my complete sympathy. All your points for considering stopping are well-reasoned, I just can’t render an opinion. I think you can’t make a wrong decision, assuming you are making it with medical advice.

Re your questions, I've provided some responses:
1. You have seen the new interferon / RIBA free regimes effective in gaining SVR for those retreating after relapse from a protease inhibitor? – see above
2. What time span must lapse between treatments? – see above
3. Do you predict that docs will in the near future recommend such regimes for relapsers, or will they more likely involve longer treatment than the 8-12 weeks, and with interferon / riba because of any resistances created by prior treatment? My Dr. believes that as I have been shown to respond to Interferon, AND because of potential resistances re protease inhibitor, AND because these new fancy orals will be rolled out slowly and selectively to save on costs, that I will in any event be forced to take interferon and / or riba in any re treatment. – I don’t know anything about healthcare in Australia, but in the U.S., likely nearly everyone will get sofosbuvir /ledipasvir or he AbbVie combo.
4. Do you know of any trials on the horizon for relapsers (Australia, Italy or India - my partner is Italian, in Italy, we lived in India more than a decade) No
5. If the Sofosbuvir / Ledipasvir combo pill were manufactured generically in India (with or without the blessings of Gilead), what is there to stop patients accessing the treatment over there? Don’t know enough about this.
6. What is 'off label' treatment,, and how would one access this? – This means that docs can write an Rx using any drugs that are FDA approved (in the U.S), even if they haven’t be specifically approved for that combo or application.
6. No doubt as a HCV nurse, you've encountered clients ending Telaprivir treatment early (ie, at 32 weeks rather than recommended 48 weeks!) Have you seen any achieve SVR even so?! – Yes, but can’t tell you the #s or what the data reveal.
7. Even though my access to new orals may be a couple of years away, the progression of this disease is after all slow, and with a fibrosis of 2, scan 7.4, conscientious lifestyle, I can perhaps afford the wait without dire consequences? Based solely on what you told me, most experts in the U.S. would say you can wait.

Hope you are able to make a decision that is right for you.
Peace,
Lucinda
Lucinda Porter, RN
1988 Contracted HCV
1997 Interferon nonresponder
2003 PEG + ribavirin responder-relapser
2013 Cured (Harvoni + ribavirin clinical trial)
https://www.hepmag.com/blogger/lucindakporter

Offline CB

  • Newbie
  • Posts: 2
Re: New orals for previous Incivek/telaprivir relapsers, gen 1a
« Reply #2 on: February 23, 2014, 12:44:07 am »
Dear Lucinda,

SINCERE THANKS for taking the time from your busy life to so thoughtfully contemplate all of the questions I posed (on revisiting my post I can see I was in a right old state!!) In any case, you've clarified much for me, and given me the courage to know that whatever decision I make it will be ok - we are all so very lucky to be dealing with this virus at this particular time with all the brilliant med advancements. I haven't stopped tx as yet, am due to take the shot on Monday, Im giving myself a week to just sit with the decision, away from frantic research and thinking, and hopefully the right path will reveal itself to me.....meanwhile, I've been trying to get outside at least once a day, which seems to be helping!

But I do have a new sx that's surfaced in the last 2 weeks, and it's rather terrifying me - from one day to the next my body has started twitching and jerking, can be day or night, but more obvious at night, and any part of the body (fingers, whole hand, back, bottom, thigh, foot, leg) sometimes it's just a twitch, other times my whole foot jerks 20 cm or so.....I'm hoping its not connected with some kind of nerve imbalance? I mentioned it to the specialist, he said probably RLS, but I thought that was more a need to MOVE the legs than a jerking? Anyway, let me know if you've encountered this type of sx before!

Again Lucinda, thanks so much for your time and attention, your input to this forum is wonderfully valuable to us all.....and by the way, well done you for conquering this dragon in the end!! Yaaaay!!, CB x

Offline lporterrn

  • Member
  • Posts: 1,969
  • LucindaPorterRN
    • LucindaPorterRN
Re: New orals for previous Incivek/telaprivir relapsers, gen 1a
« Reply #3 on: February 23, 2014, 11:30:15 am »
You are welcome. One more thought, although it smacks of self-promotion - since you are this far into treatment, if you decide to stick it out, perhaps it is a matter of fortifying yourself with some new tools. I've written 2 books that are geared towards treatment, the second one is exclusively focused on treatment - Hepatitis C Treatment One Step at a Time. You can read quite a bit for free on Amazon. Another free resource that has great info is http://www.hcvadvocate.org/hepatitis/factsheets.asp Scroll down to the side effect management fact sheets and then scroll further down to the guides. Perhaps this will help.
Lucinda Porter, RN
1988 Contracted HCV
1997 Interferon nonresponder
2003 PEG + ribavirin responder-relapser
2013 Cured (Harvoni + ribavirin clinical trial)
https://www.hepmag.com/blogger/lucindakporter

 


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