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Author Topic: Failed 8wks Harvoni  (Read 14194 times)

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Offline easygoing1

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  • Posts: 12
Failed 8wks Harvoni
« on: October 22, 2016, 10:44:54 am »
I've lived with HVC for 43 years.Contracted while in the Army stationed in Germany. 22 years unknown because I had no symptoms. I was diagnosed in 1995 when i donated blood.I put off treatment at that time because of the terrible side effects that went with treatment and I had no symptoms. Dec. 2015 after seeing many Harvoni ads I decided it was time to get treatment.After talking to Gilead about co-pay availability I contacted a gastro dr. and was prescribed 8 wks Harvoni as my viral load was 1.6 million. ALT 62. Fibrosis F2.  My insurance company denied Harvoni and after two months of appeals and denials I was finally approved for Harvoni I was elated.I began taking Harvoni in April 2016. At four weeks HVC RNA undetected.At eight wks HVC RNA undetected ALT 18. Great!! At follow up Sept 28 2016 HCV RNA 1.2 million ALT 36. Relapse and devastated.Now I had resistance testing and show a probable resistance to Simepervir and a Q80K  mutation. I am seeing a Hepatologist in Nov. I am just looking for some insight on my future treatment because I doubt my insurance company will not pay for Harvoni again and would longer treatment work?

Offline FutureThinker

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  • Onward and upward!
Re: Failed 8wks Harvoni
« Reply #1 on: October 22, 2016, 01:34:28 pm »
Hi easygoing1 and welcome to this forum! You will find a lot of good, valid information here in addition to a ton of support.

All of us, I say with confidence, feel your pain w/ that result of relapse.  Some people have these variants and some don't, we just don't know until we go thru treatment.  I do think that will eventually change, as more is learned about treating this disease. I am really looking forward to what info comes out of The Liver Meeting next month, as there have been so many more of us treated to contribute to the body of knowledge that is still growing on HCV.

I had to take my insurance denials to my state insurance board to get my approval for Harvoni, which took close to a year for the whole process.  It was not fun, and since you went thru the denial process yourself, I understand your concern at the prospect of having to go thru that again.  But it appears the denial process is slowing, from what I'm reading on this forum.  Seems more and more people are getting approved more quickly & w/ less liver damage than in the recent past, so that is comforting.  So I think that is in your favor.

There are also several more options now that weren't available when you treated.  I don't know what your genotype is, but these new drugs on the market are also in your favor, as they are a bit less expensive than the Harvoni.  And, there are generics available now that many have been cured w/, so there are options!

Try to keep your chin up and see what you and your doctor can do this time around. This time may be much easier than the last, you just don't know until you try.  Keep us posted and take care --- you will beat this!!!! FT
Treatment naive
Likely contracted mid-70s
Diagnosed 1a, 2011
F1-2
Harvoni X 12 weeks, completed 5/17/16
Pre-treatment: VL 3 mil, AST 64, ALT 84
4 week labs: VL 30, AST 21, ALT 14
8 week labs: VL UD!!!, AST 22, ALT 16
12 week labs: VL UD, AST 23, ALT 14
2 wk EOT: VL UD
12 wk EOT: VL UD, AST 22, ALT 13 =  SVR 12! Yay! 
Last hep appointment: VL UD, AST 19, ALT 12 = SVR 39! I AM DONE!

Offline lporterrn

  • Member
  • Posts: 1,969
  • LucindaPorterRN
    • LucindaPorterRN
Re: Failed 8wks Harvoni
« Reply #2 on: October 22, 2016, 04:18:19 pm »
That's a tough break. It is likely that a different treatment will be prescribed (other than Harvoni or simeprevir. Here is a list of re-treatment options: https://www.hepmag.com/basics/hepatitis-c-basics/hepatitis-c-retreatment-recommendations
The liver meeting is Nov 11-15 - there will be data on retreatment options. HEP has a news feed and I will blog on it.
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 easygoing1

  • Member
  • Posts: 12
Re: Failed 8wks Harvoni
« Reply #3 on: October 22, 2016, 09:14:53 pm »
Thanks Future Thinker for the uplift!!! I forgot to include my genotype which is 1a. I'm staying positive and would like to beat this disease.I ignored it for a long time. Thanks Lucinda for the list of re-treatment options.

Offline Lynn K

  • Global Moderator
  • Member
  • Posts: 4,543
  • Get tested, get treated, get cured, fight Hep c!
Re: Failed 8wks Harvoni
« Reply #4 on: October 23, 2016, 01:26:06 am »
Hi easy
So sorry to read about your relapse.

I treated with sovaldi and olysio for 12 weeks. I started in May 2014 so Harvoni had not been approved yet. Finished treatment in July. At my 12 week post test I had relapsed also viral load 2.4 million.

Being a 3 time prior treatment failure with cirrhosis for 6 years at that time I was devastated as well. It was announced by the AASLD in October that for those like me prior non responders with cirrhosis I should have treated for 24 weeks with those meds.

I had the same fear that my insurance would not cover a second expensive treatment since I failed sovaldi olysio and I had to fight to get those medicines. I was initially denied by my insurance but after I personally appealed plus some information from my doctor I was approved for Harvoni.

Harvoni was approved in late October 2014 and I started a new treatment in November of 24 weeks of Harvoni to which we later added ribavirin just in case I needed the extra help so I took ribavirin for 15 of that 24 week treatment. I did not have resistance testing done they were not recommending that yet but it sure makes sense to have it done.

I finished treatment in May 2015. I tested not detected at 4,12, 24 and 44 weeks post so I can say I am finally cured.

I am sure your doctors are working hard to find the best treatment for you. New information is coming out all the time. Hang in there and stay strong they will find a cure for you.

It will happen for you!
Genotype 1a
1978 contracted, 1990 Dx
1995 Intron A failed
2001 Interferon Riba null response
2003 Pegintron Riba trial med null response
2008 F4 Cirrhosis Bx
2014 12 week Sov/Oly relapse
10/14 fibroscan 27 PLT 96
2014 24 weeks Harvoni 15 weeks Riba
5/4/15 EOT not detected, ALT 21, AST 20
4 week post not detected, ALT 26, AST 28
12 week post NOT DETECTED (07/27/15)
ALT 29, AST 27 PLT 92
24 week post NOT DETECTED! (10/19/15)
44 weeks (3/11/16)  fibroscan 33, PLT 111, HCV NOT DETECTED!
I AM FREE!

Offline easygoing1

  • Member
  • Posts: 12
Re: Failed 8wks Harvoni
« Reply #5 on: November 10, 2016, 08:10:29 am »
I had my appointment with a Hepatologist yesterday. This was my first visit with this doctor and he seemed to be well informed on the treatment of HCV. I have failed 8 weeks treatment with Harvoni. My viral load is back to pre-treatment levels. 1.2 mil.My fibrosure was at F2.He suggested not prescribing a different DAA at this time as an immunity to DAA may result. He wants to retest in six months. Basically he said the patients who have failed DAA's is still a gray area that is strongly being studied. Gilead is presenting a new triple drug combination but it is not yet approved.You can Google the Gilead Polaris DAA study and find information on it. It will probably be discussed at the Liver meeting this weekend.So for now I'm just waiting and keeping my head up and hoping for better luck next time.

Offline Pete

  • Member
  • Posts: 110
Re: Failed 8wks Harvoni
« Reply #6 on: November 14, 2016, 01:58:08 am »
Hello Easy - I too failed 12 weeks of Harvoni.  It is a huge disappoint for sure.  I also had the resistance testing.  My doctor recommended  Viekira/Ribavirin 24weeks.  I have one month to go.  If your Fibrosure is accurate, then you likely have time to wait  as your Doctor has suggested.  Good luck and carry on. 

Pete

Offline easygoing1

  • Member
  • Posts: 12
Re: Failed 8wks Harvoni
« Reply #7 on: November 14, 2016, 07:48:05 am »
Hey Pete  Thanks for the reply. I hope the treatment with Viekira/Ribavirin is going well Any side affects? I initially was prescribed Viekira Pac because Express Scripts would only pay for Viekira. I battled for Harvoni and after three appeals was prescribed eight weeks Harvoni and failed. I had no side affects with Harvoni. I really didn't want to take Ribavarin. Let me know how you are doing.

Offline Pete

  • Member
  • Posts: 110
Re: Failed 8wks Harvoni
« Reply #8 on: November 19, 2016, 02:32:58 am »
Hello Easy - I've had really no side effects to report with VP/Riba.  Slight drop in hmg  initially, but it came back up.   I don't think there's anyway to know before hand if ribavirin will be a challenge or not.  If you should be approved for new meds in the future, I wouldn't be overly concerned about the ribavirin if that's part of the treatment.  Eat right, exercise some, drink sufficient amounts of water and you'll likely be fine.

My doctor recommended I not retreat with Harvoni due to the results of my resistance testing, and also mentioned that patients who failed Harvoni, and then retreated with Harvoni/Riba for 24 weeks, had SVR rates only in the 70% range.

This stuff is changing all the time, and new meds are on the way.  Have you asked about getting into a clinical trial?  Might be an option. 

Regards,
Pete

Offline easygoing1

  • Member
  • Posts: 12
Re: Failed 8wks Harvoni
« Reply #9 on: November 20, 2016, 09:59:27 pm »
Hello Pete.. good to hear no side effects with your treatment. I am being treated by a doctor who is affiliated with Loyola University medicine and they do have clinical trials but none at this time. Thanks and hang in there.

 


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