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Author Topic: Anyone non responsive to Harvoni only treatment then try Harvoni and ribavirin  (Read 10791 times)

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Offline Mugzy

  • Member
  • Posts: 12
It's been almost a year since I finished a 12 week Harvoni treatment clearing after 2 weeks follow up and relapsing after 6 months. My Dr suggested waiting for other treatments that are in the Horizon. And we touched on maybe trying Ribavirin with Harvoni. Has anyone relapsed after Harvoni only treatment then tried Harvoni and Ribo for positive results?
Genotype 1A
1985 diagnosed non A non B
1997 Peg Ribavirin interferon no response
fibrosis L3
viral load 10,87596
Alt 74
Ast 39
5/16/15 started 12 week Harvoni
5/30/15 Viral load <15 UD
Alt-25
Ast-21

Offline AussieRosa

  • Member
  • Posts: 226
Hi Mugzy. Sorry to hear about your treatment failure. I don't have any info or knowledge on your treatment options, but as you said, there are a number of new drugs in the pipeline for those who failed on Harvoni and other DAA's. Has your doc mentioned resistance testing? If it were me in your position I'd wait a little while for one of those new drugs, rather than try the same med plus Ribavirin. That's just me, I have no factual basis for that opinion other than having recently treated with Ribavirin. Hopefully someone else will be along soon with something more concrete to add. Wishing you all the best for your future retreatment.
Gt 1a
contracted 1983
Fibroscan 6.1
Treatment naive
VL 2.97M
ALT 38
AST 47
Started Viekira Pak + Ribavirin Tues 19th Jan 2016
Week 4: VL Undetected!
March 5th Ribavirin dose reduction to 800mg from 1000mg
EOT April 11th 2016. VL Not Detected
12 Weeks post EOT: SVR12. Cured with a capital C!!
6 months post EOT: Undetected :-)

Offline brie41

  • Member
  • Posts: 191
Hi Mugzy,

  I wish no one here ever had to experience a relapse.  It is so crazy that it can hide for that many months before rearing its ugly head again.  But sadly it does so I am in total agreement with AussieRosa and testing for resistance and seeing what other options are available for you.  I can't imagine how shocking it must have been to get that last result.  Hang in there and I bet you will beat it next time!!!  Brie
Diagnosed  HCV, 1A 2006
Viral load 6 million
Ast/Alt always in the 20's
F0-F1, never changed
Treatment naive, started 8 week Harvoni 3/15/16
4 and 8 week labs undetected
6 week eot labs undetected
13 week eot UNDETECTED!

Offline Lynn K

  • Global Moderator
  • Member
  • Posts: 4,544
  • Get tested, get treated, get cured, fight Hep c!
Hi Mugzy

Were you tested at 12 weeks post treatment and SVR at that time?

I relapsed after treating with Sovaldi and Olysio for 12 weeks (AASLD later determined for someone like me 24 weeks is recommended)

I treated for 24 weeks with Harvoni and after I had started I asked my doctor about adding Ribavirin so I was on Riba for 15 of those 24 weeks.

From what I have read you should undergo resistance testing to determine the best course of action for you at this point. For those who do not have an urgent need to treat the recimnendation is to wait for newer treatments. But for those with urgent need they should do the resistance testing and go from there based on those results

See http://www.hcvguidelines.org/full-report/retreatment-persons-whom-prior-therapy-has-failed


"Recommended for Genotype 1 HCV NS5A inhibitor Treatment-experienced Patients"

About half way down

"Ledipasvir/sofosbuvir failures

Data on the retreatment of patients for whom prior treatment with ledipasvir/sofosbuvir has failed are very limited. In a pilot study, 41 patients with and without cirrhosis who did not achieve an SVR with 8 weeks or 12 weeks of ledipasvir/sofosbuvir were retreated with 24 weeks of ledipasvir/sofosbuvir. (Lawitz, 2015b) SVR12 rates varied according to the presence or absence of NS5A inhibitor RAVs. Among 11 patients for whom NS5A inhibitor RAVs were not detected, SVR occurred in 11 of 11 (100%); in contrast, among 30 patients for whom NS5A inhibitor RAVs were detected, SVR occurred in 18 of 30 (60%). Importantly, NS5B inhibitor RAVs (eg, S282T) known to confer decreased activity of sofosbuvir were observed in 3 of 12 (25%) patients for whom the retreatment regimen was not successful. (Lawitz, 2015b) Similarly, in the OPTIMIST-2 study in which patients with cirrhosis were treated with simeprevir and sofosbuvir, the presence of NS3 RAVs, namely the Q80K polymorphism, led to a decreased SVR rate in patients with HCV genotype 1a infection. SVR occurred in 25 of 34 (74%) patients with HCV genotype 1a and the Q80K RAV and in 35 of 38 (92%) patients with HCV genotype 1a without the Q80K RAV. (Lawitz, 2015) Based on these data, retreatment for patients for whom an NS5A inhibitor-containing regimen has failed should be considered in the context of retreatment urgency and the presence or absence of RAVs to inhibitors of NS3 and NS5A. Further, based on limited data, RBV is recommended as part of all retreatment regimens for patients in whom prior treatment with NS5A inhibitors has failed. Although no data exist, consideration may also be given to the addition of PEG-IFN to the retreatment regimen in patients who are eligible for this agent; PEG-IFN will have antiviral activity regardless of the RAVs present."
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 Mugzy

  • Member
  • Posts: 12
Thanks for your feedback Lynn, I was away from my residence post treatment and it was actually  a nephrologist I was seeng for having high protein in my urine who did my blood work which included a full liver profile which was more like 5 months post treatment. So as for the SVR which I just looked up what that was probably was not done. The one thing that I have a hard time understanding is why some people get 12 week treatment and some get 24 on Harvoni. I know my doctor was asking for 24 but the insurance only covered 12 it makes me wonder if a longer treatment would have made a difference. I was at L3 Fibrosis at the time with a very high viral load. I thought I had read somewhere the makers of Harvoni will provide you with a 2nd treatment at no charge if you don't clear??
Genotype 1A
1985 diagnosed non A non B
1997 Peg Ribavirin interferon no response
fibrosis L3
viral load 10,87596
Alt 74
Ast 39
5/16/15 started 12 week Harvoni
5/30/15 Viral load <15 UD
Alt-25
Ast-21

Offline Lynn K

  • Global Moderator
  • Member
  • Posts: 4,544
  • Get tested, get treated, get cured, fight Hep c!
Really the only people who would be prescribed Harvoni for 24 weeks per the Harvoni prescribing information

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

are GT 1 patients "Treatment-experienced with compensated cirrhosis (Child-Pugh A)"

So for example I treated 3 times with interferon based treatment and was a null responder in that I had no decrease in viral load.  I was diagnosed with cirrhosis in Jan 2008 F4 on liver biopsy and confirmed in Oct 2014 with a fibroscan score of 27. So with all that I was prescribed 24 weeks of Harvoni.

For treatment naive without cirrhosis the recommendation is 12 weeks. I really have not seem many that were on Harvoni for 24 weeks and the ones I have seen were prior treatment failures with cirrhosis like myself.

I have not seen anything about Gilead giving away a second shot at treatment and with out the resistance testing that could be a waste of effort to treat with Harvoni again


Anyway bottom line you need to have the resistance testing done to determine where you should go from here

These are the recommendations of the AASLD for people who have failed a treatment with Harvoni or other NS5A inhibitors

Retreatment approach and potential regimens (including other NS5A regimen containing failures)

For patients with cirrhosis or other patients who require retreatment urgently, testing for RAVs that confer decreased susceptibility to NS3 protease inhibitors (eg, Q80K) and to NS5A inhibitors should be performed using commercially available assays prior to selecting the next HCV treatment regimen.

For patients with no NS5A inhibitor RAVs detected, retreatment with ledipasvir/sofosbuvir and RBV for 24 weeks is recommended.

For patients who have NS5A inhibitor RAVs detected and who do not have NS3 inhibitor RAVs detected, treatment with simeprevir, sofosbuvir, and RBV for 24 weeks is recommended.

For patients who have both NS3 and NS5A inhibitor RAVs detected, limited data suggest a retreatment approach based on sofosbuvir combined with either elbasvir/grazoprevir or PrOD may be efficacious. (Lawitz, 2015e); (Poordad, 2015a) In a retreatment arm of the C-SWIFT study, 23 patients who had failed shorter courses of elbasvir/grazoprevir plus sofosbuvir were retreated with 12 weeks of this combination plus weight-based RBV. In a per protocol analysis a 100% SVR12 rate was achieved (23/23), including SVR in 9/9 patients with dual NS3 and NS5A RAVs. (Lawitz, 2015e) A second phase II study of 22 patients, including 14 PrOD failures, evaluated retreatment with 12-24 weeks of PrOD plus sofosbuvir. Treatment duration and RBV usage were determined by cirrhosis status, HCV RNA response on therapy, and genotype subtype. SVR12 data was available on 15 patients with 14/15 (93%) attaining SVR12. Based on these limited data, patients with dual NS3 and NS5A class RAVs may be retreated with elbasvir/grazoprevir plus sofosbuvir with weight-based RBV for 12 weeks or PrOD plus sofosbuvir for 12 weeks in genotype 1b and 24 weeks with weight-based RBV in those with genotype 1a.

If these regimens are unavailable, retreatment should be conducted in a clinical trial setting, as an appropriate treatment regimen cannot be recommended at this time.

Sorry to hear you are in this situation. Maybe you can find a clinical trial for the newest treatments before they are released

https://clinicaltrials.gov/

good luck
Lynn
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 BillT

  • Member
  • Posts: 573
Patience Grasshopper.The FDA just approved the new treatment.  :)
Contracted 1973 Military
Diagnosed 1980
Pegintron treatment 2004 unsucessful
Genotype 1b
FibroScan 10 (F2)
Start Viekira 10.17.2015

AST 40 ALT 69
VL 440k
10.31.2015/Week 2 Labs : AST 14/ALT 17
No VL done
10.14.2015/Week 4 labs : AST 14/ALT 14
VL UNDETECTED!!!
12.11.2015/Week 8 Labs : AST 12/ALT 13
No VL done
01.05.2016/EOT labs : AST 15/ALT 13
VL UNDETECTED!!!

12 WEEK SRV:UN-BLOODY DETECTABLE !!!!!!!!

24 WEEK SVR:UNDETECTABLE!!!! Thank You God.

Fibroscan 6Mo. Post Treatment 7.15.2016-5.3(F1)

Offline Lynn K

  • Global Moderator
  • Member
  • Posts: 4,544
  • Get tested, get treated, get cured, fight Hep c!
Hey BillT what is this new treatment of which you speak?

Thankie
Lynn
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 Karen1124

  • Member
  • Posts: 76
Hey Mugzy, I also relapsed on harvoni, My doctor just prescribed 24 weeks of Harvoni and Riba He says I do have cirrhosis! I am scared of this riba!  I had the resistance test. I am not resistant! He says that is good. Waiting for approval from insurance.

Geno 1a
VL 2 million
DX May 1 2014
Bio June 5 2014
moderate fibrosis
Start Harvoni 2/5/2015
EOT 4/1/2015
 7/22/2014 alt 186 12/30  64  3/5/15  39
7/22/14  ast 114    12/30.  41  3/5/15  27
Don't know how I got hep C in my 20s I did snort coke a few times.
3/5/15 undetected
4/2/15 less than 15 VL ferrin levels normal
4/9/15 undetected!!
6/24/15 relapse VL 424,000
7/26/16 Started treatment today Harvoni and Ribavirin 24 weeks

Offline yag1064

  • Member
  • Posts: 58
  • Enjoy the life you have.
Hi Karen1124,
     There are many people who share there bad experiences, making others worry. That is sad to me. Worry and stress are things you should reduce. Everyone is different. If you are going to think about how your treatment will go, why not think it will be a breeze. It's just as true as the other. Why waste the energy on the negative. You need your energy for your treatment.
    I had the Harvoni/Ribivarian. Didn't suffer one bit. Slept well. Ate well. Got cured. You can do the same. I am not special. You are.
Rick
Tested positive 2007
Non respond-er to treatment 16wk of 48wk
Started I/R/Sol May 2014
Hep C returned as of Jan 2015
Started Harvoni Sep 16, 2015
1st Test V/L:20
2nd Test V/L: undetectable
Dec 2015 EOT V/L undetectable
12 wk SVR :undetectable  Mar 25,2016
24 wk SVR: undetectable  Jun 24,2016
52 wk SVR undetectable   Dec 16,2016   -- I,m past it!!!
Shambhala

Offline Karen1124

  • Member
  • Posts: 76
Hi yag1064,

 I am so glad to hear you had no side effects! I have read a lot of horrible side effects
from people on riba! I am hoping for smooth sailing like you! Thank you for your response I need to hear that! Life is Good!! Karen
Geno 1a
VL 2 million
DX May 1 2014
Bio June 5 2014
moderate fibrosis
Start Harvoni 2/5/2015
EOT 4/1/2015
 7/22/2014 alt 186 12/30  64  3/5/15  39
7/22/14  ast 114    12/30.  41  3/5/15  27
Don't know how I got hep C in my 20s I did snort coke a few times.
3/5/15 undetected
4/2/15 less than 15 VL ferrin levels normal
4/9/15 undetected!!
6/24/15 relapse VL 424,000
7/26/16 Started treatment today Harvoni and Ribavirin 24 weeks

Offline Mugzy

  • Member
  • Posts: 12
So I saw my doc today and they are looking into putting me on Epclusa I wonder if that was what BillT was referring to?
Genotype 1A
1985 diagnosed non A non B
1997 Peg Ribavirin interferon no response
fibrosis L3
viral load 10,87596
Alt 74
Ast 39
5/16/15 started 12 week Harvoni
5/30/15 Viral load <15 UD
Alt-25
Ast-21

Offline BillT

  • Member
  • Posts: 573
That's the one Mugzy.I missed that message but I posted a separate post in the On Treatment.I know Lynn saw it so I just never looked again.Sorry about that.Let us know when you start and how you're doing.I know a lot of us are curious.
Contracted 1973 Military
Diagnosed 1980
Pegintron treatment 2004 unsucessful
Genotype 1b
FibroScan 10 (F2)
Start Viekira 10.17.2015

AST 40 ALT 69
VL 440k
10.31.2015/Week 2 Labs : AST 14/ALT 17
No VL done
10.14.2015/Week 4 labs : AST 14/ALT 14
VL UNDETECTED!!!
12.11.2015/Week 8 Labs : AST 12/ALT 13
No VL done
01.05.2016/EOT labs : AST 15/ALT 13
VL UNDETECTED!!!

12 WEEK SRV:UN-BLOODY DETECTABLE !!!!!!!!

24 WEEK SVR:UNDETECTABLE!!!! Thank You God.

Fibroscan 6Mo. Post Treatment 7.15.2016-5.3(F1)

Offline Lynn K

  • Global Moderator
  • Member
  • Posts: 4,544
  • Get tested, get treated, get cured, fight Hep c!
Good luck Mugzy!

Are they adding Ribavirin to give things a kick?
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 Mugzy

  • Member
  • Posts: 12
i doubt riba will included nothing is definite we are just starting the process of looking into it hope I get approved ill keep everyone informed
Genotype 1A
1985 diagnosed non A non B
1997 Peg Ribavirin interferon no response
fibrosis L3
viral load 10,87596
Alt 74
Ast 39
5/16/15 started 12 week Harvoni
5/30/15 Viral load <15 UD
Alt-25
Ast-21

 


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