Welcome, Guest. Please login or register.
June 17, 2024, 01:21:15 am

Login with username, password and session length


Members
  • Total Members: 6309
  • Latest: Vicki
Stats
  • Total Posts: 55127
  • Total Topics: 4851
  • Online Today: 102
  • Online Ever: 1314
  • (June 22, 2016, 05:23:42 am)
Users Online
Users: 0
Guests: 88
Total: 88

Welcome

Welcome to the Hep Forums, a round-the-clock discussion area for people who have Fatty Liver Disease, Hepatitis B, C or a co-infection, their friends and family and others with questions about hepatitis and liver health. Check in frequently to read what others have to say, post your comments, and hopefully learn more about how you can reach your own health goals.

Privacy Warning: Please realize that these forums are open to all, and are fully searchable via Google and other search engines. If this concerns you, then do not use a username or avatar that are self-identifying in any way. We do not allow the deletion of anything you post in these forums, so think before you post.
  • The information shared in these forums, by moderators and members, is designed to complement, not replace, the relationship between an individual and his/her own physician.
  • All members of these forums are, by default, not considered to be licensed medical providers. If otherwise, users must clearly define themselves as such.
  • Product advertisement (including links); banners; and clinical trial, study or survey participation—is strictly prohibited by forums members unless permission has been secured from the Hep Forum Moderators.
Finished Reading This? You can collapse this or any other box on this page by clicking the symbol in each box.

Author Topic: Does HCV develope resistance to HARVONI if you relapse.... It appears so.  (Read 66127 times)

0 Members and 1 Guest are viewing this topic.

Offline charly8

  • Member
  • Posts: 113
Reading the NDA filing review for Harvoni, I found something disheartening.  I think there is a risk that if you relapse, you will have bread virus that is more resistant to future treatments.

See the link here (page 80 to 81):

http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/205834Orig1s000MedR.pdf

"""In the HCV GT 1 treatment-experienced, non-cirrhotic subject subset with baseline NS5A resistance associated polymorphisms, no relapse occurs in the LDV/SOF 24 week and LDV/SOF+RBV 12 week arms compared with 21% relapse
rate in the LDV/SOF 12 week arm, suggesting that extending treatment duration or adding RBV may optimize response rates in this subset. Age ≥50 years and IL28B nonC/Cgenotype are additional baseline factors present in all non-cirrhotic subjects with relapse, though not statistically significant. These efficacy data are used in support of LDV/SOF 12 week treatment duration in the HCV GT 1 treatment-experienced, noncirrhoticpopulation, with consideration for 24 week duration in patients with baseline factors associated with a lower response to HCV treatment. Optimizing treatment success with the LDV/SOF regimen, especially for patients with previous PI-failure and minimizing development of NS5A and/or NS5B substitutions which may negatively impact future retreatment options, are factors contributing to this treatment recommendation. As discussed in Section 7.4, no safety concerns are identified precluding use of the LDV/SOF 24 week duration in the non-cirrhotic population."""

Also interesting is Table 37 on page 80, if you are going for 12 weeks and have this NS5A resistance you have a 21% chance of relapse.  If you are going 24 weeks and have this resistance you have a 0% chance of relapse according to theses studies.
« Last Edit: February 18, 2015, 02:59:13 pm by charly8 »
1a, VL  1.05 Mil, ALT 47
Fibrosure F3 December 2014
Fibroscan F0-F1 March 2015
1995 INT & RYB -non-responder
2007 PEGIN & RYB 72 weeks tx - partial responder relapsed
1/23/15 Started Harvoni 12 weeks, EOT 4/17
2 week blood work -  <15 Und. (ALT 25)
4 week blood work - <15 Und. (ALT 29)
2/20/15 added RYB (4 weeks into 12 of tx)
8 week blood work - <15 Und. (ALT 23)
(EOT) 12 week blood work - <15 Und.
4wk POST tx VL - Und. (ALT16, AST 17)

Offline dragonslayer

  • Member
  • Posts: 873
Re: Does HCV develope resistance to HARVONI if you relapse.... It appears so.
« Reply #1 on: February 19, 2015, 09:35:50 am »
This is an interesting find in that, as the FDA filing, the information from the trials is more complete here  than what Gilead provides in their prescribing document, and there's more there than I had time to read.  However, the references to relapse pertain to  treatment experienced patients prior to their exposure to Harvoni, and, as such, I dont know what kind of predictions we can make about future treatments with Harvoni for patients who relapsed on it.   

And really, in the end, just as people now who have relapsed on earlier treatments are being treated with the new drugs albeit with a longer course of treatment, and perhaps the addition of rbv,  wont the same be true for relapsers on Harvoni?     Lastly, this is not new data; its taken directly from the Ion trials, and most of these results are available in the Gliead prescribing document for Harvoni.   The data here may be segmented slightly differently, e.g. in showing results segmented by age departures from 50, etc, but its taken from the same data source.  In other words, taken as a whole, even after the various mutations and resistances are taken into account, the overall success rate in trials has been what Gilead has reported, ie, generally, SVR achieved in over 90%, and this includes prior relapsers.

In addition, if you look at table 40, you see that despite prior treatment failure (many due to NS5A resistance), the SVR  rate with Harvoni is still well over 90%. 

Here's some more information on this subject: 

https://www.informedhorizons.com/resistance2014/pdf/Presentations/DvorySobol%20website2%20HDS%20HCV%20HIV%20resistance%20work%20shop%20presentation%20Final%20Final%206.5.14.pdf

Note this bullet point in the conclusions:

"Pre-Existing baseline NS5A RAVS have a poor predictive value for virologic failure in subjects treated with LDV/SOF"
« Last Edit: February 19, 2015, 02:39:15 pm by dragonslayer »
Paul

DX 2008
Started Harvoni 11/26/14 for 8 wks
Completed 8 wks Harvoni 01/20/15
EOT RNA Quant result:  Detected 29
7.5 wk post tx: Detected < LLOQ(12)
11 wk post tx: UNDETECTED SVR12
24 wk post tx: UNDETECTED SVR24; AST 26; ALT 22; ALP 73
48 wk post tx: UNDETECTED SVR48; AST 18; ALT 18; ALP 70
GT 1a
vl 2.4mil
2008 bpx: Stage&Grade 0
2013 bpx: Stage&Grade: 0-1
IL28B: TT
likely infected early '70s

Offline lporterrn

  • Member
  • Posts: 1,969
  • LucindaPorterRN
    • LucindaPorterRN
Re: Does HCV develope resistance to HARVONI if you relapse.... It appears so.
« Reply #2 on: February 19, 2015, 02:41:34 pm »
Basically, the reason that not everyone responds to Harvoni is they already have a resistant strain. If you take Harvoni as directed, and at most don't miss more than an occasional dose, resistance should not be an issue. Stopping early and restarting is a big no-no. Resistance is a potential problem if you take the medication erratically, or take meds/supplements that interfere with 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 Mr. Bob

  • Member
  • Posts: 37
Re: Does HCV develope resistance to HARVONI if you relapse.... It appears so.
« Reply #3 on: February 19, 2015, 07:41:20 pm »
Hello Lucinda:
What should those of us getting ready to do Harvoni know?
Did you ever get tested for the mutations ?
1..Should we test for these mutations Q30  etc.....
2..should we think of doing Ribavirin  as you did?


Robert


Offline lporterrn

  • Member
  • Posts: 1,969
  • LucindaPorterRN
    • LucindaPorterRN
Re: Does HCV develope resistance to HARVONI if you relapse.... It appears so.
« Reply #4 on: February 19, 2015, 11:56:31 pm »
Mr Bob, I was in a clinical trial, so my situation was different than what most will be offered. I don't think advanced testing is necessary or available at this point. And no ribavirin unless the benefit is clear.
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 JillLynn

  • Member
  • Posts: 205
  • contracted 1973/ peg/rib 1999 & 2004/on harvoni
Re: Does HCV develope resistance to HARVONI if you relapse.... It appears so.
« Reply #5 on: February 20, 2015, 08:45:38 am »
I remember my DR telling my mom and I about this a few years back.
    Never dreamed it was for the Harvoni drug I just finished!!!  He didn't mention again the possibilities of this so I assumed it wasn't possible any longer.   Now I wonder why he didn't put me on the 24 weeks.


deep breath......all we can do is hope for the best.   After my dr forgot to put my viral load test in my last blood draw nothing surprises me.   He mentioned how important post 4 week blood test is AND then FORGOT to put it in my script.    Who does this kind of stuff?   
 And now I have to pay for ANOTHER blood test, drive 45 minutes and well you know ............the worse part is waiting and waiting for the test to show.  Finally I emailed them and said are you sure you put the viral load test in there?  and NOPE they hadn't.
« Last Edit: February 20, 2015, 08:53:48 am by JillLynn »

Offline dragonslayer

  • Member
  • Posts: 873
Re: Does HCV develope resistance to HARVONI if you relapse.... It appears so.
« Reply #6 on: February 20, 2015, 03:35:38 pm »
Ok, so the big question is, if you fail an 8 wk course of Harvoni, for instance, can we be effectively retreated with a 12 wk course possibly with the addition of  ribavirin?
Paul

DX 2008
Started Harvoni 11/26/14 for 8 wks
Completed 8 wks Harvoni 01/20/15
EOT RNA Quant result:  Detected 29
7.5 wk post tx: Detected < LLOQ(12)
11 wk post tx: UNDETECTED SVR12
24 wk post tx: UNDETECTED SVR24; AST 26; ALT 22; ALP 73
48 wk post tx: UNDETECTED SVR48; AST 18; ALT 18; ALP 70
GT 1a
vl 2.4mil
2008 bpx: Stage&Grade 0
2013 bpx: Stage&Grade: 0-1
IL28B: TT
likely infected early '70s

Offline lporterrn

  • Member
  • Posts: 1,969
  • LucindaPorterRN
    • LucindaPorterRN
Re: Does HCV develope resistance to HARVONI if you relapse.... It appears so.
« Reply #7 on: February 21, 2015, 12:45:41 pm »
That is a good question. In April, a lot of data will be released from EASL, then in May at DDW. I think these are going to be pivotal meetings. With shorter treatment durations, data will turn around so much faster than the old days when it seemed to take years to get results.
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 dragonslayer

  • Member
  • Posts: 873
That is a good question. In April, a lot of data will be released from EASL, then in May at DDW. I think these are going to be pivotal meetings. With shorter treatment durations, data will turn around so much faster than the old days when it seemed to take years to get results.

Hi Lucinda, regarding this point relative to retreating patients who have failed on Harvoni (or rather, patients who have been failed by Harvoni) I spoke to my doctor the other day.  He informed me that Gilead really didnt know the effectiveness or the protocol for retreating Harvoni partial responders or relapsers, and, to that end, they are starting trials to study this.. He suggested that, pending my 4/10 blood test, he could enroll me in one of these trials, the location of which happens to be in the area.. Im not sure this is the best option, but its certainly something to consider. Apparently,  simply prescribing Harvoni again with a longer duration or possibly with ribavirin may not be something he wants to do until there are some study results which would back this up.   I think a lot depends on the condition of one's liver as to whether to switch immediately to another treatment regimen like Viekira Pak which, because of its mandatory inclusion of ribavirin for GT1s might not be preferred, or to wait til Gilead has some data to support retreating methods, or waiting for one of the newer treatments to come on line.
Paul

DX 2008
Started Harvoni 11/26/14 for 8 wks
Completed 8 wks Harvoni 01/20/15
EOT RNA Quant result:  Detected 29
7.5 wk post tx: Detected < LLOQ(12)
11 wk post tx: UNDETECTED SVR12
24 wk post tx: UNDETECTED SVR24; AST 26; ALT 22; ALP 73
48 wk post tx: UNDETECTED SVR48; AST 18; ALT 18; ALP 70
GT 1a
vl 2.4mil
2008 bpx: Stage&Grade 0
2013 bpx: Stage&Grade: 0-1
IL28B: TT
likely infected early '70s

Offline Tpropane

  • Member
  • Posts: 65
  • Heal the past by living in the present.
I believe the key is to have a VERY current picture, biopsy, ultrasound, cat scan, fibroscan AND fibrosure, all within weeks of treatment. The liver can go from 0-60 faster than a Maserati. I think that length of treatment needs to be monitored by YOU! Yes, you are your own best advocate. If you are a non-responder to any other treatment, or cirrhotic. You can entreat your doctor to fight for your approval for a longer length of treatment. If I had not read all 32 pages of the the Gilead Harvoni protocol I would not have been given the 24 weeks. I emailed, called and faxed to make sure that my doctor was submitting for 24 weeks instead of 12. I fit that rule. 100%. I was still denied twice. Harvoni is a miracle. I hope to God there is no relapse for me. I just may choose Oregon or Washington. Which has the better right to die laws?
My concern is, as directly responding to this post, that every person thinks that their liver biopsy from 2010 was fine so 8 or 12 weeks is great as long as they weren't previously treated before. MY PERSONAL OPINION NOT BASED ON ANY SCIENTIFIC FACT WHATSOEVER: Every patient beginning TX on Harvoni needs a liver baseline no less than 30-60 days old. Certainly not 3 years! The, My liver is fine, attitude feels a little like an ostrich sticking its head in the sand, when the one chance for SVR is to have a full and clear picture of WTH is going on with your liver and go from there. Yay! I only have to take this miracle drug with little or no side effects for 8 weeks. God Bless you. I hope you are cured. But I hope you were 100% aware of the full status of the damage HCV did to it right before you start. There is the relapse rate. There is the mistake being made in length of treatment. Don't freak out. 12 weeks works for virgin, undamaged livers. But just make sure that you have it in writing. In my not so humble, smart assed, opinion. Get a VERY current liver baseline to determine length of treatment.
TPROPANE
PS Why aren't they testing for this LL blah blah (brain fog) gene? It seems it may be a major factor as well.
Hep C 1A / TT diagnosed 2009
Non Responder Boceprevir/riba/peg 2011
F-4 Cirrhosis
TX Harvoni 24 weeks started 1/20/15
2 week labs VL 174!
4 week labs UNDETECTED !
8 week labs UNDETECTED !

Offline petra

  • Member
  • Posts: 47
Tpropane,  I think what you are pointing out here is very important.
The status of my liver was not properly assessed. There was lots of blood work, an old ultra sound, and a nurse practitioner palpated my liver. I questioned the situation but was reassured that my liver was fine.
I didn't do enough research. It wasn't until just before I finished my 12 weeks of sovaldi and ribavirin that I found out that there was a 16 week option for patients with cirrhosis.
In one month I will find out if I am 12 weeks SVR or if there was a huge stupid mistake made and I will be stuck with repeating the only option that type 2's have at the moment.

User Name: petra
Gender: female
Height: 5' 7" Weight: 118
Diagnosed: June 2014
Infected: unsure of when
geno type: 2
Biopsy Score:no fibro scan or biopsy
Pre treatment: 3.5 million vl, other blood work normal
TX start date: October 17, 2014
Treatment Protocol: 12 weeks of 400mg of Sovaldi and 800 mg of Ribavirin per day
Side Effects: fatigue, itchiness.

Viral load:
3.5 million at start of treatment
18 at 4 weeks
undetected at 6, 8, and 12 weeks.
SVR at 12 weeks after treatment

Offline Mr. Bob

  • Member
  • Posts: 37
Hello Tpropane,
With your prior treatments and the  DAA's that did not work  why did you not take Ribavirn as well.   Also did you ever have a non detectable viral load with the prior treatments?  Thanks for making us think about getting the  other tests . I think I am going to ask for the Fibroscan  before I finish the  planned treatment in case I have more liver damage than expected.

Robert

Offline Rexray

  • Member
  • Posts: 12
I started an 8 week prescription one week ago.
Contacted my doctor via e-mail and he said t make an appointment to see him in 3 months.
Thinking that was a mis-understanding, I asked him to confirm.
He told me yes, see me one month after I finished taking the medication and they would do the blood test then.
Go figure...

Maybe I'm an easy case, I dunno.
VL 2.3 million, low blood platelets
No cirrhosis
No scarring or anything else
Current Ultrasound/ CATscan/blood test
(biopsy long ago).

But I'll probably go get a VL test done before that thru my family doctor. I want to know what the results are.

Offline Tpropane

  • Member
  • Posts: 65
  • Heal the past by living in the present.
Except for one person here who wasn't responding to Sovaldi which has the same drug in it about half of Harvoni, ribaviron is not prescribed with Harvoni. My doctor says never.
I was undetected at the end of the treatment in 2011 but never had a sustained response.
And I'm advocating very recent (less than 6 months) liver tests (fibroscan, ultrasound, biopsy, cat scan) prior to treatment to help determine length of tx.
Tpropane
Hep C 1A / TT diagnosed 2009
Non Responder Boceprevir/riba/peg 2011
F-4 Cirrhosis
TX Harvoni 24 weeks started 1/20/15
2 week labs VL 174!
4 week labs UNDETECTED !
8 week labs UNDETECTED !

Offline bridget

  • Member
  • Posts: 36
My doctor at recent appointment at the National Institutes of Health agrees with Dragonslayers statement:
 "Pre-Existing baseline NS5A RAVS have a poor predictive value for virologic failure in subjects treated with LDV/SOF"

I asked about NS5A & NS5B. The NIH dr. said testing for these have not predicted treatment failure.  Also, he said if I relapse I CAN be retreated with Harvoni.
And,  he is working on a trial testing a combo of 4 drugs for 4 weeks & they are seeing good results.  He said don't worry, if you relapse, there are many options for pretreatment.

(I have been in an NIH study for 20 years. But I have never qualified for a drug protocol that was a good fit for me. I recently finished 12 weeks of Harvoni paid for by Kaiser Permanente. I am UND now, but my #'s have been up & down.)

Offline karenhoyt

  • Member
  • Posts: 20
    • IHelpC
This is a great thread. Lucinda and all, I'm glad you are keeping up with the new info. I'm voting for updated liver condition before the treatment begins also.

I'm hearing from readers who are UND early with Harvoni and then viral loads going back up. I wonder if the doctors should be extending the treatment time mid-stream?
Karen

Offline dragonslayer

  • Member
  • Posts: 873
This is a great thread. Lucinda and all, I'm glad you are keeping up with the new info. I'm voting for updated liver condition before the treatment begins also.

I'm hearing from readers who are UND early with Harvoni and then viral loads going back up. I wonder if the doctors should be extending the treatment time mid-stream?
Karen

HI Karen... I dont think Ive seen any posts on these forums where patients tested UND early on treatment and then saw viral loads increase..  Maybe Im not reading carefully enough!  In your readings, are these VL  increases found while on treatment or post treatment?

Hi Bridget... Since your doctor is affiliated with NIH (lucky you!), if you get the chance to ask him, maybe you can find out from him if he could name some studies that support the idea of retreating Harvoni failures with Harvoni.  My doctor told me  Gilead is or will be soon running trials in order to make this determination.  I suppose the question that needs answering is how resistant the virus becomes after being treated with Harvoni. Also what needs to be determined is what is the preferred Harvoni protocol for retreatment.. .ie, do 4 more wks need to be given?  8 wks?  Does it need to be combined with any other drugs?   I dont think they know the answers to these questions yet, so please, post any trial results or studies that have data answering these questions. Thanks!
Paul

DX 2008
Started Harvoni 11/26/14 for 8 wks
Completed 8 wks Harvoni 01/20/15
EOT RNA Quant result:  Detected 29
7.5 wk post tx: Detected < LLOQ(12)
11 wk post tx: UNDETECTED SVR12
24 wk post tx: UNDETECTED SVR24; AST 26; ALT 22; ALP 73
48 wk post tx: UNDETECTED SVR48; AST 18; ALT 18; ALP 70
GT 1a
vl 2.4mil
2008 bpx: Stage&Grade 0
2013 bpx: Stage&Grade: 0-1
IL28B: TT
likely infected early '70s

Offline Lynn K

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

I am a 3 time null responder to interferon based tx. First was interferon mono-therapy 3 shots a week for 6 months then 2 times with each brand of interferon plus ribavirin. The last treatment not only did my viral load not decrease it actually increased while on treatment.

I was diagnosed with F4 cirrhosis Jan 2008 on my 4th biopsy over many years of being followed. I was not permitted to even try Telaprevir as my odds of success were about 14% and treating could cause me to decompensate so I had no treatment available to be basically since 2004.

I treated last year with Sovaldi / Olysio for 12 weeks as that was the protocol at the time. Six months after I finished tx the protocol was changed to 12 months for cirrhotics like myself.

I was virus not detected at 4 weeks on tx and at EOT but was found to have relapsed when tested 12 weeks post tx.

II started on Harvoni Nov 18 for 24 weeks and after discussion with my doctor she agreed to add Ribavirin which after waiting for approvals finally started 9 weeks into tx with Harvoni. She said she wished she had started me with both in hindsight based on my treatment history.

Also 12 weeks Harvoni with Riba is an alternative treatment vs 24 weeks of Harvoni alone for some patients.

So I disagree on a couple of points. I for one did respond to Sovaldi just most likely treatment was stopped too early. Also I have seen several others treating with Harvoni plus Ribavirin not just me.

For example per the AASLD Recommendations for Testing, Managing, and Treating Hepatitis C

UNIQUE PATIENT POPULATIONS: PATIENTS WITH DECOMPENSATED CIRRHOSIS

http://www.hcvguidelines.org/full-report/unique-patient-populations-patients-decompensated-cirrhosis

the recommendation is:

Recommended regimen for patients with decompensated cirrhosis (moderate or severe hepatic impairment; CTP class B or C) who may or may not be candidates for liver transplantation, including those with hepatocellular carcinoma. This regimen should be used only by highly experienced HCV practitioners.

Daily fixed-dose combination ledipasvir (90 mg)/sofosbuvir (400 mg) and RBV (initial dose of 600 mg, increased as tolerated) for 12 weeks is recommended for patients with decompensated cirrhosis.

also:
For patients with decompensated cirrhosis in whom prior sofosbuvir-based treatment has failed, daily fixed-dose combination ledipasvir (90 mg)/sofosbuvir (400 mg) and RBV (initial dose of 600 mg, increased as tolerated) for 24 weeks is an alternative regimen.

Also:

Retreatment Box. Summary of Recommendations for Patients in Whom Previous Treatment Has Failed

http://www.hcvguidelines.org/full-report/retreatment-box-summary-recommendations-patients-whom-previous-treatment-has-failed

Two options with similar efficacy in general are recommended for patients with cirrhosis who have HCV genotype 1 infection, regardless of subtype, in whom a prior PEG-IFN, RBV, and an HCV protease inhibitor regimen has failed.

Daily fixed-dose combination ledipasvir (90 mg)/sofosbuvir (400 mg) for 24 weeks is recommended for retreatment of patients with cirrhosis who have HCV genotype 1 infection, regardless of subtype, in whom a prior PEG-IFN, RBV, and HCV protease inhibitor regimen has failed.

Rating: Class I, Level A

Daily fixed-dose combination ledipasvir (90 mg)/sofosbuvir (400 mg) plus weight-based RBV (1000 mg [<75 kg] to 1200 mg [>75 kg]) for 12 weeks is recommended for retreatment of patients with cirrhosis who have HCV genotype 1 infection, regardless of subtype, in whom a prior PEG-IFN, RBV, and HCV protease inhibitor regimen has failed


Recommended regimen for patients who have advanced fibrosis, in whom a previous sofosbuvir-containing regimen has failed.

Daily fixed-dose combination of ledipasvir (90 mg)/sofosbuvir (400 mg) with or without weight-based RBV (1000 mg [<75 kg] to 1200 mg [>75 kg]) for 24 weeks is recommended for patients who have cirrhosis, in whom a previous sofosbuvir-containing regimen has failed.
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 HHburme

  • Member
  • Posts: 117
  • Harvoni start 12/13/14 12wks UD/24wk DET
I relapsed on Harvoni after being UD at 4,8,12 wk tx tests and then tested 12 wk eot with 3 million vl. Is there another option for me ? GI Doc was surprised as I was and didn't have any answers. Not ready to throw in the towel, if anyone has any suggestions I would really appreciate it. Maybe a study or something ?

John
infected age 19, blood transfusion 1977, detected 2003  GT 1a, Harvoni relapse 06/15, Clinical Trial Study for SOF/VEL GS-9857 start 02/16. SVR12 Cured 08/16

Offline KimInTheForest

  • Member
  • Posts: 1,972
  • Believe in yourself
I relapsed on Harvoni after being UD at 4,8,12 wk tx tests and then tested 12 wk eot with 3 million vl. Is there another option for me ? GI Doc was surprised as I was and didn't have any answers. Not ready to throw in the towel, if anyone has any suggestions I would really appreciate it. Maybe a study or something ?

John

So very sorry to hear about your relapse, John. I have no specific advice about what to do next. But it is true that more drugs - and better refinements on the existing drugs - are coming out all the time. And one thing that means is: Lots of clinical trials.

I am currently getting my 12 weeks of Harvoni+Riba through a clinical trial in Canada. I think a clinical trial is a great way to get treated, if you get the right type of trial - an Open Label trial where you know exactly what you will be taking and for what duration (i.e., no possibility of placebo or sub-optimal duration). You tend to be more closely monitored on a trial, with more frequent labs and more extensive follow-up after EOT. My lab results each time blood is drawn fill 29 pages! (I just ask for copies of 3 of those pages each time - the 3 I care about.)

I am reading a lot of exciting things about GS-5816, currently in testing. I think it is usually combined with Sofosbuvir or possibly Harvoni. Effective for all  genotypes. I was looking for a GS-5816 trial before the one I am on came up and I jumped at it.

I know it is a huge set-back, and I am sure very depressing, to learn you did not achieve SVR12. But just remember that the cure actually is here now - in various different forms. If one drug doesn't work for you, the next will,. You will get cured. Just a few years ago, none of us could say that with any certainty.

Best to you,
kim

« Last Edit: June 12, 2015, 03:21:51 pm by KimInTheForest »
Kim Goldberg (Nanaimo, BC)
1970s: Contracted HCV (genotype 3a)
2015: Cured with Harvoni + ribavirin (12 weeks)
MY STORY: https://pigsquash.wordpress.com/2016/01/28/undetectable-my-hep-c-story/

Offline dragonslayer

  • Member
  • Posts: 873
Kim, since youre in a trial, maybe you can answer this.. Even if youre assigned to one of the placebo or short duration groups, and dont hit svr, doesnt the trial generally offer the more effective protocol to you in the end?
Paul

DX 2008
Started Harvoni 11/26/14 for 8 wks
Completed 8 wks Harvoni 01/20/15
EOT RNA Quant result:  Detected 29
7.5 wk post tx: Detected < LLOQ(12)
11 wk post tx: UNDETECTED SVR12
24 wk post tx: UNDETECTED SVR24; AST 26; ALT 22; ALP 73
48 wk post tx: UNDETECTED SVR48; AST 18; ALT 18; ALP 70
GT 1a
vl 2.4mil
2008 bpx: Stage&Grade 0
2013 bpx: Stage&Grade: 0-1
IL28B: TT
likely infected early '70s

Offline KimInTheForest

  • Member
  • Posts: 1,972
  • Believe in yourself
Kim, since youre in a trial, maybe you can answer this.. Even if youre assigned to one of the placebo or short duration groups, and dont hit svr, doesnt the trial generally offer the more effective protocol to you in the end?

Hi Paul. Yes, that is what I have been told by various doctors & nurses here in Canada re: trials - that if you are in a blind trial and end up with a placebo or shorter treatment duration and don't get cured, you will at end of study be given a chance to take the full course of the real drugs. I am not sure I would have signed on for that where ribavirin is involved. Would just want to do that once.

kim
Kim Goldberg (Nanaimo, BC)
1970s: Contracted HCV (genotype 3a)
2015: Cured with Harvoni + ribavirin (12 weeks)
MY STORY: https://pigsquash.wordpress.com/2016/01/28/undetectable-my-hep-c-story/

Offline KimInTheForest

  • Member
  • Posts: 1,972
  • Believe in yourself
I relapsed on Harvoni after being UD at 4,8,12 wk tx tests and then tested 12 wk eot with 3 million vl. Is there another option for me ? GI Doc was surprised as I was and didn't have any answers. Not ready to throw in the towel, if anyone has any suggestions I would really appreciate it. Maybe a study or something ?

John

Hi again John. Here is the website for the list of all clinical trials: https://clinicaltrials.gov

I don't know what Genotype you are, but if you are Geno 1, you can type "Genotype 1" into the search box and that will show you all clinical trials for new HCV drugs for Genotype 1 people. Some are already completed. Some only want treatment-naive. But it gives you all of that info.

I see several AbbVie trials currently "Recruiting" or "Not Yet Recruiting" for trials of new drugs, which means they won't be Harvoni (since that is a Gilead product). Maybe that would be a good route for you to go…?

So trials are a possibility. It takes a bit of research. But if you find a trial you qualify for, and if it lists a trial location near enough to you that you could travel to it for your labs and monitoring, then you could ask your doctor to refer you to it.

best,
kim
Kim Goldberg (Nanaimo, BC)
1970s: Contracted HCV (genotype 3a)
2015: Cured with Harvoni + ribavirin (12 weeks)
MY STORY: https://pigsquash.wordpress.com/2016/01/28/undetectable-my-hep-c-story/

Offline Lynn K

  • Global Moderator
  • Member
  • Posts: 4,544
  • Get tested, get treated, get cured, fight Hep c!
If you can find out where clinical trials are usually done in your area you could try to contact the group running the trial directly.

I know here in the Seattle area many are through the UW hepatology department, as well as Virginia Mason and Swedish Hospital. I was in a couple of trials that were besed in our other large city Tacoma.

I believe the phase 3 trials may not use placebos just different treatment durations or combinations of meds and a variety of different patient scenarios naive vs experienced etc.

The goal of the phase 3 trials from what I have seen is efficacy phase 1 is safety and not sure about phase 2.

Best of 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 HHburme

  • Member
  • Posts: 117
  • Harvoni start 12/13/14 12wks UD/24wk DET
Kim, Lynn and everyone
Thanks for the info and support. I will do some research on trials and hopefully something will come down the pike for me. Thanks to this board, as I do not feel so alone and helpless. Been extremely difficult to try and wrap my brain around the fact that I was UD for all tests until final 12 wk eot. Took every pill at exact time everyday, hydrated, changed razors, toothbrushes, etc. I guess in the end, it's the bitter end for me, I'm one of the 5% that did not make it. All I can do is get back up and start fighting ! And that has always been my strong suit. So If I have to be one of the failures maybe it's better me than someone weaker. I pray for everybody's health and happiness. I will win in the end.....I always have and will continue to. John
infected age 19, blood transfusion 1977, detected 2003  GT 1a, Harvoni relapse 06/15, Clinical Trial Study for SOF/VEL GS-9857 start 02/16. SVR12 Cured 08/16

Offline KimInTheForest

  • Member
  • Posts: 1,972
  • Believe in yourself
That's a tremendous fighting spirit you have John. It will see you through this ordeal. Good luck to you. Stay strong.

kim
Kim Goldberg (Nanaimo, BC)
1970s: Contracted HCV (genotype 3a)
2015: Cured with Harvoni + ribavirin (12 weeks)
MY STORY: https://pigsquash.wordpress.com/2016/01/28/undetectable-my-hep-c-story/

Offline badbradley

  • Member
  • Posts: 294
I relapsed on Harvoni after being UD at 4,8,12 wk tx tests and then tested 12 wk eot with 3 million vl. Is there another option for me ? GI Doc was surprised as I was and didn't have any answers. Not ready to throw in the towel, if anyone has any suggestions I would really appreciate it. Maybe a study or something ?

John
Hi John,  Sorry for the crummy news. Same for me with S/O 12wks. Here is some info on re-treatment.  http://www.natap.org/2015/EASL/EASL_26.htm
Hope it is useful.  Take care.
Brad

   
Geno 1a
Sov/Oly 12wks - relapse
Har/Riba 12wks
Alt-16  Ast-17 SVR - 12
Alt-15  Ast-14 SVR - 24

Offline terih

  • Member
  • Posts: 74
Hi John, I'm sorry for your relapse! I can totally relate to exactly how you feel right now! Just read some of your last posts and did all of the things you did, to try and insure success. I too had all undetected viral loads , right up to the relapse. So I guess we are now part of the next generation of treatment! Not a place you or I wanted to be! But here we are and it seems you are getting your fighting spirit back, so that's good news!  :)

I agree with all of the above comments about trying for a trial, I'm hoping to be in one at the end of August! My new Doc, who is a heptologist at the Texas Liver Institute, says the new drugs on the way are going to be even better than Harvoni!  There are some DAA relapse trials starting soon, so please try and find one. Maybe try calling the above mentioned Institute and they can put you in touch with one close to you! Just an idea, since they are high up on the research chain.

Again, I'm sorry for your relapse, but know that you are not alone! All my best to you!  Teri
64 yrs. on this fine planet!
diagnosed 1993
Stage 1 cirrhosis
Genotype 1a
12 wks. Harvoni  Relapse late Feb. 2015
Currently treating with Solvaldi/Olysio
The light at the end of the tunnel, is often not a train!

Offline HHburme

  • Member
  • Posts: 117
  • Harvoni start 12/13/14 12wks UD/24wk DET
Re: Does HCV develope resistance to HARVONI if you relapse.... It appears so.
« Reply #28 on: January 25, 2016, 10:26:37 am »
Got into a study for Harvoni relapsers !!!!!

Fight the Good Fight

John
infected age 19, blood transfusion 1977, detected 2003  GT 1a, Harvoni relapse 06/15, Clinical Trial Study for SOF/VEL GS-9857 start 02/16. SVR12 Cured 08/16

Offline Lynn K

  • Global Moderator
  • Member
  • Posts: 4,544
  • Get tested, get treated, get cured, fight Hep c!
Re: Does HCV develope resistance to HARVONI if you relapse.... It appears so.
« Reply #29 on: January 25, 2016, 12:58:21 pm »
Alright! Fantastic news John!

Any details about the trial that you can share?

Congrats :)
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 Murray

  • Member
  • Posts: 11
Re: Does HCV develope resistance to HARVONI if you relapse.... It appears so.
« Reply #30 on: January 26, 2016, 03:56:06 pm »
Hey John, do share your trial you just got into.

I am a Harvoni relapser. The real problem though is the awful side effects. I am now about 6 weeks post tx and not only is my viral load above 4M, but I am now anemic. Never in my life did I have this problem. Fatigue is bad, I slept all day yesterday and can barely get out of bed. I called the Gilead assistance program, but as expected it was a total joke. The guy not only criticized forums like this on, but when I mentioned AA he spewed statistics that proved it unsuccessful. I guess my 22 years C&S is a fluke. Very frustrated and very sick. Due to my experience I am really reluctant to do any new tx. First I have to get healed from the Harvoni.

Offline lporterrn

  • Member
  • Posts: 1,969
  • LucindaPorterRN
    • LucindaPorterRN
Re: Does HCV develope resistance to HARVONI if you relapse.... It appears so.
« Reply #31 on: January 26, 2016, 04:24:00 pm »
Murray,
Thanks for your post and sorry this is happening. Do you mind if I ask you 2 questions - do you have cirrhosis and were you on ribavirin with your Harvoni?
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 Murray

  • Member
  • Posts: 11
Re: Does HCV develope resistance to HARVONI if you relapse.... It appears so.
« Reply #32 on: January 26, 2016, 04:33:25 pm »
It was Harvoni only for 12 weeks.
I just had a CAT scan prior to tx and was told there was minimal scarring and cirrhosis, though I was never clear what that meant. I've never done a fibroscan. I contracted sometime in the 70's and have never been treated. 1a genotype.

Offline lporterrn

  • Member
  • Posts: 1,969
  • LucindaPorterRN
    • LucindaPorterRN
Re: Does HCV develope resistance to HARVONI if you relapse.... It appears so.
« Reply #33 on: January 26, 2016, 05:21:53 pm »
There is a huge difference between minimal scarring and cirrhosis - do you have the actual report? (I think it is important for us to keep a copy of or have access to our records) Did anyone use the term F1, F2, F3, or F4? If you have cirrhosis, then the anemia makes sense and is not a result of the Harvoni. However, if you have minimal scarring, then the anemia does not make sense.

For instance (and I am just speculating here), what if you had a little reflux while you were on Harvoni, and that lead to a little GI bleed, then that would explain your anemia. Anemia always has a cause, and after we hit 60, its often from a GI bleed. In this mythical case, then a doc would suggest medication and an iron supplement (maybe an endoscopy too), and that might fix your problem and in a few weeks you'd be a happy camper.
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 Murray

  • Member
  • Posts: 11
Re: Does HCV develope resistance to HARVONI if you relapse.... It appears so.
« Reply #34 on: January 26, 2016, 05:48:13 pm »
Yes, she told me to start taking Iron supplements. My anemia was first notice from 12/29 lab which was 2 weeks post tx. The lab from 1/20/16 still positive for anemia, in addition to very low iron.

   4 - 11 1000/UL   5.7
RBC   3.97 - 5.65 MILL/UL           4.25
Hemoglobin   13 - 17 G/DL   10.0
Hematocrit   37.5 - 49.9 %   34.8
MCV   80 - 100 FL                   81.9
MCH   27 - 33 PG   23.5
MCHC   32 - 36 %                   28.7
Total Iron   50 - 180 mcg/dL   31
TIBC   250 - 425 mcg/dL           589
% Saturation 15 - 60 % (calc)   5

Hepatitis C RNA PCR, IU/mL   <15 IU/mL          2556841
Hepatitis C RNA PCR, log 10   <1.18 Log IU/mL      6.41   



Offline KimInTheForest

  • Member
  • Posts: 1,972
  • Believe in yourself
Re: Does HCV develope resistance to HARVONI if you relapse.... It appears so.
« Reply #35 on: January 26, 2016, 06:38:26 pm »
For instance (and I am just speculating here), what if you had a little reflux while you were on Harvoni, and that lead to a little GI bleed, then that would explain your anemia. Anemia always has a cause, and after we hit 60, its often from a GI bleed. In this mythical case, then a doc would suggest medication and an iron supplement (maybe an endoscopy too), and that might fix your problem and in a few weeks you'd be a happy camper.

Hi Lucinda. How would I know if I have a GI bleed? Would it cause black stools for example from dried blood coming from higher up the tract?

My serum ferritin has been super low since EOT 6 months ago. And that made it extra hard for me to rebound from the hemolytic anemia caused by the ribavirin in my case (12 weeks Harvoni/riba for geno 3a). My hemoglobin and red blood cells are now back in normal range (but near bottom of reference range). However, I cannot get my serum ferritin to climb above 20 ug/L (reference range 5-247, with 15-50 being "Probable Iron Deficiency"). I have been taking daily iron supplements since Sept 1, and resumed eating red meat daily at same time. I am also separating my tea consumption from iron consumption because of the chelating effect the tea tannins have on iron. And I am consuming Vit C-rich foods or supplements with my iron.  I am also taking sublingual B12, although I wasn't alarmingly low on that at 225 pmol/L (ref range 150-650). After 5 months of this daily iron consumption and supplementation, I would expect to see some increase. But nothing. :(

I was probably iron deficient before starting treatment. I was vegetarian for many years and made no effort to separate tea-drinking from iron consumption.

I had some instances of acid reflux during treatment, and occasionally still have it post-tx in bed at night. Had not experienced that prior to treatment. So your comment about a GI bleed caused by onset of acid reflux possibly being responsible for iron deficiency got me thinking... Is there any way for me to find out without having a camera put down my throat?

Thanks! :)
kim
Kim Goldberg (Nanaimo, BC)
1970s: Contracted HCV (genotype 3a)
2015: Cured with Harvoni + ribavirin (12 weeks)
MY STORY: https://pigsquash.wordpress.com/2016/01/28/undetectable-my-hep-c-story/

Offline coastal girl

  • Member
  • Posts: 36
Re: Does HCV develope resistance to HARVONI if you relapse.... It appears so.
« Reply #36 on: January 27, 2016, 07:08:51 pm »
OK, I really wished I didn't read this board.  My treatment was 12 weeks.  I have read that this is the suggested treatment for treatment naive with/without cirrhosis.
Was i mislead by Gilead...I was so looking forward to a 12 week post undetected result, now I'm really worried!!!
At 4weeks I dropped from 12 million to 64 than at EOT undetected..relapse would be bad...I'm child pugh A with meld score of 2 which is good...I had an endoscopy which showed fundul varies...which is not good
8/6/15
1a, shear wave elastography F4
ast-114 alt-80,
viral load 5,941,282

Start Harvoni 9/3/15
ast-131 ast-97, viral load 12,997,415

9/29/15 4 week labs VL 64
ast 34 alt 17
11/25/15  12 wk EOT Undetected!
AST 29 ALT 17  Albumin 3.8 Bil .06

12 week PostTX UNDETECTED!!!
AST 33 ALT 20  Bil. 0.9 Albumin 3.9

25 week Post Tx  UNDETECTED

Offline gnatcatcher

  • Member
  • Posts: 1,372
Re: Does HCV develope resistance to HARVONI if you relapse.... It appears so.
« Reply #37 on: January 27, 2016, 08:22:37 pm »
coastal girl, yes, the protocol is 12 weeks for Tx naive 1a with/without cirrhosis. Your pre-Tx numbers are a lot like mine, and FibroScan is shear wave elastography, so we're both F4 by the technology my hepatologist trusts, and we're both Child Pugh A. Your EOT numbers look great. I've already passed SVR12. The chances that either you or I will relapse are very, very small. Yes, a small percentage of people on these forums have relapsed, in which case resistance testing is the next step so they know whether the relapse was due to resistance to one of the medicines in Harvoni or whether some HCV managed to hide out until treatment was over. This way, their hepatologists know what to prescribe next, so they can get cured. AFAIK, your having fundal varices doesn't affect whether or not the Harvoni treatment will cure you of Hep C, so your odds of being cured should be as good as any other GT 1a F4 Child Pugh A person, which is to say, very high.

Gnatty
9/29/71 transfusions
HCV genotype 1a
7/09/15-9/30/15 Harvoni

Before treatment:
Viral Load 9,490,582
FibroScan 19.5 kPa [F4]
ALT 262
AST 217
ALP 183

Most recent:
VL still UNDETECTED (SVR 102)
FibroScan 7.6 kPa [F1-2]
ALT 15
AST 20
ALP 85

Offline coastal girl

  • Member
  • Posts: 36
Re: Does HCV develope resistance to HARVONI if you relapse.... It appears so.
« Reply #38 on: January 27, 2016, 08:43:25 pm »
thank you for your reply Gnatcatcher :)
I was not referring to the varices as a predictor of relapse only that it could progress into more of a health risk if I were to relapse and the liver came under attack again causing the portal pressure to elevate.  I have done extensive research and the belief seems to be that reaching SVR stops damage to the liver and with HCV related cirrhosis, may lessen portal pressure, fingers crossed!  I really do believe that I will reach SVR but there is always that nagging thought...but what if.  I usually just tell it to "go away, I don't need that negative energy, leave me alone, I will be cured"!!
3 weeks until my 12 week post tx test!  Can't wait to receive "undetected"!!!
8/6/15
1a, shear wave elastography F4
ast-114 alt-80,
viral load 5,941,282

Start Harvoni 9/3/15
ast-131 ast-97, viral load 12,997,415

9/29/15 4 week labs VL 64
ast 34 alt 17
11/25/15  12 wk EOT Undetected!
AST 29 ALT 17  Albumin 3.8 Bil .06

12 week PostTX UNDETECTED!!!
AST 33 ALT 20  Bil. 0.9 Albumin 3.9

25 week Post Tx  UNDETECTED

Offline Lynn K

  • Global Moderator
  • Member
  • Posts: 4,544
  • Get tested, get treated, get cured, fight Hep c!
Re: Does HCV develope resistance to HARVONI if you relapse.... It appears so.
« Reply #39 on: January 28, 2016, 04:18:20 am »
Hi Coastal girl

I have had cirrhosis for 8 years now and was diagnosed with grade 3 esophageal varicies that required banding in 2012.

I treated 3 times with interferon based tx (null responder), once with Sovaldi / Olysio for 12 weeks (relapse) then this last go with Harvoni for 24 weeks and ribavirin for 15 weeks.

I am doing fine with the liver I still have. Of course I would be ecstatic if I had improvement but am not counting on it. All I do know is my clock is reset and I will likely live a normal life span and die from something other than liver disease. Although even with cure those of us will still need to be monitored every 6 months probably for life with abdominal ultra sounds and AFP blood testing to monitor for HCC as we are at increased risk of liver cancer. However even that risk is decreased significantly with cure.

I can live with that scenario and apparently I can live for a whole lot longer than I thought I would.

Curious about your comment that you have a MELD score of 2? As far as I know the lowest number is 6 the scale is 6 to 40 and even a healthy person would score a 6.

My MELD score currently is 7, it was 8. I am also a child Pugh score "A" and considered to have compensated cirrhosis.

https://www.unos.org/wp-content/uploads/unos/MELD_PELD.pdf

The Model for End-Stage Liver Disease (MELD) is a numerical scale, ranging
from 6 (less ill) to 40 (gravely ill), used for liver transplant candidates age 12
and older. It gives each person a ‘score’ (number) based on how urgently he
or she needs a liver transplant within the next three months. The number is
calculated by a formula using three routine lab test results:

*bilirubin, which measures how effectively the liver excretes bile;

*INR (prothrombin time), which measures the liver’s ability to make blood clotting factors; and

*creatinine, which measures kidney function. (Impaired kidney function is
often associated with severe liver disease.)

https://optn.transplant.hrsa.gov/resources/allocation-calculators/meld-calculator/

Best to you on your way to SVR :)
« Last Edit: February 06, 2016, 11:53:07 pm by Lynn K »
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 coastal girl

  • Member
  • Posts: 36
Re: Does HCV develope resistance to HARVONI if you relapse.... It appears so.
« Reply #40 on: January 28, 2016, 02:39:09 pm »
Hi Lynne,  about the Meld score, every time I did a calculation it came up 6.  My Doc gave me the number 2 for which I was surprised but not to much....I am constantly correcting her...she told me my platelets were 84, wrong, I always go to the doctors with lab results in hand and I pointed out it was 98 which has been increasing over the past few months.  I need to change Doctors.  I asked her if my varices were  considered large or small for which she responded that the Doctor who did the endoscopy didn't seem to think it was significant...I have read that the size can be an indicator of the portal pressure.  This Doctor is good at reciting the standard of care and thats about it.
I asked her about regression of fibrosis/cirrhosis and she responded there is no regression of cirrhosis.  I said what if the scan number was due to inflammation, she responded that with the varices and low platelets and the liver scan, diagnosis of cirrhosis was correct...(probably so but I won't give up hope for improvement).  I asked what if I do another scan in a year and it comes back a F2 (doesn't hurt to think positively) she responded that those test aren't always accurate...exactly my point!!!  She said nothing else on the matter.  I told her of course I'm going to follow the prescribed testing, ultrasound, blood test and endoscopic test keeping an eye on stools and skin and eye color.  Obviously I am concerned about my health and will do all possible to keep myself healthy that is why I am so informed!!!  But I will not follow the mindset of some Doctors, which in my experience is to focus on the worst case scenario, I stay focused on the most hopeful...You bring to your life what you think about!!!!
Time to change Doctors!!!!
8/6/15
1a, shear wave elastography F4
ast-114 alt-80,
viral load 5,941,282

Start Harvoni 9/3/15
ast-131 ast-97, viral load 12,997,415

9/29/15 4 week labs VL 64
ast 34 alt 17
11/25/15  12 wk EOT Undetected!
AST 29 ALT 17  Albumin 3.8 Bil .06

12 week PostTX UNDETECTED!!!
AST 33 ALT 20  Bil. 0.9 Albumin 3.9

25 week Post Tx  UNDETECTED

Offline Lynn K

  • Global Moderator
  • Member
  • Posts: 4,544
  • Get tested, get treated, get cured, fight Hep c!
Re: Does HCV develope resistance to HARVONI if you relapse.... It appears so.
« Reply #41 on: January 28, 2016, 02:45:08 pm »
Wow yeah see a new doc indeed!

I see a hepatologist associated with a liver transplant center. For us with cirrhosis they are the best equipped knowledge wise to care for us. Also we will be in their system in the event we need their full range of services.

Yeah always great when we have to educate our doctors

Good luck :)
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 gnatcatcher

  • Member
  • Posts: 1,372
Re: Does HCV develope resistance to HARVONI if you relapse.... It appears so.
« Reply #42 on: January 28, 2016, 03:04:01 pm »
. . . I asked her about regression of fibrosis/cirrhosis and she responded there is no regression of cirrhosis. . . .

Very few doctors are aware that there is mounting evidence that cirrhosis can regress, because such evidence is quite recent.

But I will not follow the mindset of some Doctors, which in my experience is to focus on the worst case scenario, I stay focused on the most hopeful...You bring to your life what you think about!!!!
Time to change Doctors!!!!

Good for you!  There is abundant evidence that mindset affects bodily processes. BTW, I've "fired" doctors (by going elsewhere instead) when it was in my body's physical and/or emotional best interest to do so. Lynn is right on -- having an up-to-date hepatologist is very useful.

There is an excellent recent book by Leslie D. Michelson called The Patient's Playbook: How to Save Your Life and  the Lives of Those You Love that has great, well-organized advice on how to choose PCPs and specialists, etc. It's got terrific summaries at the end of each chapter called Quick Guides, so you don't need to spend a lot of time with it. My library system has many copies, so anyone reading this who is interested should easily be able to get your hands on a library copy.
9/29/71 transfusions
HCV genotype 1a
7/09/15-9/30/15 Harvoni

Before treatment:
Viral Load 9,490,582
FibroScan 19.5 kPa [F4]
ALT 262
AST 217
ALP 183

Most recent:
VL still UNDETECTED (SVR 102)
FibroScan 7.6 kPa [F1-2]
ALT 15
AST 20
ALP 85

Offline FutureThinker

  • Member
  • Posts: 711
  • Onward and upward!
Re: Does HCV develope resistance to HARVONI if you relapse.... It appears so.
« Reply #43 on: February 01, 2016, 12:08:04 pm »
Going back to the original question on this topic, Merck's new drug, Zepatier, approved last week, is recommending in their info that RAVs be tested for prior to starting treatment in order to determine length of treatment and if RBA is needed.

This is the first pharm co to recommend this for HCV treatment and a question I've had for some time now.  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 northfork

  • Member
  • Posts: 57
Re: Does HCV develope resistance to HARVONI if you relapse.... It appears so.
« Reply #44 on: February 06, 2016, 04:57:07 pm »
I relapsed at week 20 of Daclatasvir / Asunaprevir in a 2013 clinical trial.

After 24 weeks of Harvoni And being undetected at weeks 4 and 12 during treatment, my viral load is 1.3 million at 12 weeks end of treatment. I became very sick with strep during my last 3 weeks of treatment and something similar happened before I relapsed on Daclatasvir.

Is there anything coming up for people like me?
Probably infected 1969. Diagnosed 2006. Genotype 1b.
Daclatasvir/ Asunaprevir 2013:relapse
Harvoni 24 weeks 2015:relapse
sofosbuvir, velpatisvir, voxillaprevir  trial started on drug 7/16. Viral load 890,000 approx. F2. Undetected after week 1.
12 week SVR achieved Jan 2017.
SVR 24 achieved April 2017 !

60 weeks post treatment...UNDETECTED!

Offline lporterrn

  • Member
  • Posts: 1,969
  • LucindaPorterRN
    • LucindaPorterRN
Re: Does HCV develope resistance to HARVONI if you relapse.... It appears so.
« Reply #45 on: February 06, 2016, 08:26:29 pm »
Kim - I lost track of this thread and to answer your question:
Quote
How would I know if I have a GI bleed?
It depends on where it is but usually the first test is an inhome fecal test. Easy, cheap, and other than the icky factor, painless.

Future - my Monday blog will be on the very subject

Northfork - velpatasivir/sofosbuvir is probably the next option for you (due out June 28)- what does your doc suggest?
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 northfork

  • Member
  • Posts: 57
Re: Does HCV develope resistance to HARVONI if you relapse.... It appears so.
« Reply #46 on: February 06, 2016, 09:35:43 pm »
I have an appointment with him 2/16. He is the Hep C guru, they say, but he's 0 for 2 with me. I must have some superbug that has set up shop in my body since 1969. Probably has a flat screen tv and a barka-lounger set up somewhere. i hope the next medicine is the charm and the property manager that kicks the bug out for good.
Probably infected 1969. Diagnosed 2006. Genotype 1b.
Daclatasvir/ Asunaprevir 2013:relapse
Harvoni 24 weeks 2015:relapse
sofosbuvir, velpatisvir, voxillaprevir  trial started on drug 7/16. Viral load 890,000 approx. F2. Undetected after week 1.
12 week SVR achieved Jan 2017.
SVR 24 achieved April 2017 !

60 weeks post treatment...UNDETECTED!

Offline lporterrn

  • Member
  • Posts: 1,969
  • LucindaPorterRN
    • LucindaPorterRN
Re: Does HCV develope resistance to HARVONI if you relapse.... It appears so.
« Reply #47 on: February 07, 2016, 04:02:45 pm »
Well Northfork, don't give that superbug a beer or he'll just settle in forever. Time to give him the boot
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 KimInTheForest

  • Member
  • Posts: 1,972
  • Believe in yourself
Re: Does HCV develope resistance to HARVONI if you relapse.... It appears so.
« Reply #48 on: February 07, 2016, 11:21:27 pm »
Kim - I lost track of this thread and to answer your question [re: how do I know if I have GI bleed]:  It depends on where it is but usually the first test is an inhome fecal test. Easy, cheap, and other than the icky factor, painless.

Thanks Lucinda. I think I will do that.

kim
Kim Goldberg (Nanaimo, BC)
1970s: Contracted HCV (genotype 3a)
2015: Cured with Harvoni + ribavirin (12 weeks)
MY STORY: https://pigsquash.wordpress.com/2016/01/28/undetectable-my-hep-c-story/

Offline Lynn K

  • Global Moderator
  • Member
  • Posts: 4,544
  • Get tested, get treated, get cured, fight Hep c!
Re: Does HCV develope resistance to HARVONI if you relapse.... It appears so.
« Reply #49 on: February 07, 2016, 11:43:44 pm »
A little more info on GI bleeding

http://www.healthline.com/symptom/gastrointestinal-bleeding

What Are the Signs of Gastrointestinal Bleeding?
There are a few things that you can look out for if you suspect that you might have GI or rectal bleeding. Your stool might become darker, like coal tar, if the bleeding is coming from the stomach or upper GI tract. You may pass blood from your rectum during bowel movements, which could cause you to see some blood in your toilet or on your toilet tissue. This blood is usually bright red in color. Vomiting blood is another sign that there is bleeding somewhere in your GI tract.

If you see any of these symptoms or if you have vomit that looks like coffee grounds, call your doctor immediately. GI bleeding could signal a potentially life-threatening condition, and prompt medical treatment is essential. Seek treatment immediately if you experience paleness, weakness, or shortness of breath. These could be signs of severe bleeding.
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 KimInTheForest

  • Member
  • Posts: 1,972
  • Believe in yourself
Re: Does HCV develope resistance to HARVONI if you relapse.... It appears so.
« Reply #50 on: February 07, 2016, 11:48:52 pm »
Thanks for that additional info, Lynn. I must admit I don't have any of those signs and symptoms of GI bleed (thank goodness!). But I would like to pin down why I cannot build up my blood iron levels to a normal level no matter how much iron and red meat I consume. I'll do the (icky) fecal test. But maybe I am not absorbing for some reason.

kim
Kim Goldberg (Nanaimo, BC)
1970s: Contracted HCV (genotype 3a)
2015: Cured with Harvoni + ribavirin (12 weeks)
MY STORY: https://pigsquash.wordpress.com/2016/01/28/undetectable-my-hep-c-story/

Offline Lynn K

  • Global Moderator
  • Member
  • Posts: 4,544
  • Get tested, get treated, get cured, fight Hep c!
Re: Does HCV develope resistance to HARVONI if you relapse.... It appears so.
« Reply #51 on: February 07, 2016, 11:53:15 pm »
The link was about more significant bleeding but as Lucinda said smaller amounts you won't see and have to do stool sample testing for trace amounts from a slow bleed
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 KimInTheForest

  • Member
  • Posts: 1,972
  • Believe in yourself
Re: Does HCV develope resistance to HARVONI if you relapse.... It appears so.
« Reply #52 on: February 08, 2016, 12:10:47 am »
The link was about more significant bleeding but as Lucinda said smaller amounts you won't see and have to do stool sample testing for trace amounts from a slow bleed

Good point. I'm going to do that test.

kim
Kim Goldberg (Nanaimo, BC)
1970s: Contracted HCV (genotype 3a)
2015: Cured with Harvoni + ribavirin (12 weeks)
MY STORY: https://pigsquash.wordpress.com/2016/01/28/undetectable-my-hep-c-story/

Offline northfork

  • Member
  • Posts: 57
Re: Does HCV develope resistance to HARVONI if you relapse.... It appears so.
« Reply #53 on: February 08, 2016, 07:43:08 pm »
I relapsed after 24 weeks of Harvoni. The doctor called and said I need to hold out for a potent triple therapy. Anything out there? :'(
Probably infected 1969. Diagnosed 2006. Genotype 1b.
Daclatasvir/ Asunaprevir 2013:relapse
Harvoni 24 weeks 2015:relapse
sofosbuvir, velpatisvir, voxillaprevir  trial started on drug 7/16. Viral load 890,000 approx. F2. Undetected after week 1.
12 week SVR achieved Jan 2017.
SVR 24 achieved April 2017 !

60 weeks post treatment...UNDETECTED!

Offline gnatcatcher

  • Member
  • Posts: 1,372
Re: Does HCV develope resistance to HARVONI if you relapse.... It appears so.
« Reply #54 on: February 08, 2016, 08:07:54 pm »
northfork, I'm hoping Lucinda and/or Lynn will be able to answer your question. Lynn finally got cured via her fifth treatment, in which ribavirin was added to the 2 drugs that make up Harvoni in order to make it a potent triple therapy. Perhaps ribavirin can be added to Lucinda's suggestion of velpatasivir/sofosbuvir? -- Lucinda and Lynn, is that a possibility?
9/29/71 transfusions
HCV genotype 1a
7/09/15-9/30/15 Harvoni

Before treatment:
Viral Load 9,490,582
FibroScan 19.5 kPa [F4]
ALT 262
AST 217
ALP 183

Most recent:
VL still UNDETECTED (SVR 102)
FibroScan 7.6 kPa [F1-2]
ALT 15
AST 20
ALP 85

Offline HHburme

  • Member
  • Posts: 117
  • Harvoni start 12/13/14 12wks UD/24wk DET
Re: Does HCV develope resistance to HARVONI if you relapse.... It appears so.
« Reply #55 on: February 09, 2016, 12:00:30 am »
Northfork, sorry to hear about your relapse. I also relapsed after Harvoni treatment. I can tell you that there are new drugs in the pipeline for us . One of the future meds will have three drugs and hopefully will cure even the toughest, most resistant viruses like I have. Very,very few patients have relapsed on Harvoni so data is limited. But I can tell you that research continues and the future is very bright for curing hcv for everyone. The last 15 months have been one hell of a roller coaster ride.

Fight the Good Fight
infected age 19, blood transfusion 1977, detected 2003  GT 1a, Harvoni relapse 06/15, Clinical Trial Study for SOF/VEL GS-9857 start 02/16. SVR12 Cured 08/16

Offline Lynn K

  • Global Moderator
  • Member
  • Posts: 4,544
  • Get tested, get treated, get cured, fight Hep c!
Re: Does HCV develope resistance to HARVONI if you relapse.... It appears so.
« Reply #56 on: February 09, 2016, 01:02:39 am »
About all I know is you should do resistance testing and then see what clinical trials may come available or see what the other relapsers are doing like HHburme

Good luck guys you are not forgotten
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 northfork

  • Member
  • Posts: 57
Re: Does HCV develope resistance to HARVONI if you relapse.... It appears so.
« Reply #57 on: February 09, 2016, 08:48:22 am »
Thanks to HHburme. I now have hope.
Probably infected 1969. Diagnosed 2006. Genotype 1b.
Daclatasvir/ Asunaprevir 2013:relapse
Harvoni 24 weeks 2015:relapse
sofosbuvir, velpatisvir, voxillaprevir  trial started on drug 7/16. Viral load 890,000 approx. F2. Undetected after week 1.
12 week SVR achieved Jan 2017.
SVR 24 achieved April 2017 !

60 weeks post treatment...UNDETECTED!

Offline HHburme

  • Member
  • Posts: 117
  • Harvoni start 12/13/14 12wks UD/24wk DET
Re: Does HCV develope resistance to HARVONI if you relapse.... It appears so.
« Reply #58 on: February 17, 2016, 11:41:37 am »
Nortfork, Yesterday I took my first pill(dose) of Gileads latest HCV drug that is clinical trial stage. This medicine has 3 drugs, one pill, SOF/VEL and their newest drug which has not been named yet. I will take this one pill everyday for 84 days and hopefully this will cure me. If all goes well this drug should be approved at the beginning of next year.This pill is designed for Harvoni relapsers like us, but will cure any HCV, any genotype, whether resistant or not, cirrhotic or not, treatment naïve or not, etc. A lot of Great Hope for a  Hep C Free life !!!!!
Fight the Good Fight

John
infected age 19, blood transfusion 1977, detected 2003  GT 1a, Harvoni relapse 06/15, Clinical Trial Study for SOF/VEL GS-9857 start 02/16. SVR12 Cured 08/16

Offline KimInTheForest

  • Member
  • Posts: 1,972
  • Believe in yourself
Re: Does HCV develope resistance to HARVONI if you relapse.... It appears so.
« Reply #59 on: February 17, 2016, 03:14:42 pm »
Nortfork, Yesterday I took my first pill(dose) of Gileads latest HCV drug that is clinical trial stage. This medicine has 3 drugs, one pill, SOF/VEL and their newest drug which has not been named yet. I will take this one pill everyday for 84 days and hopefully this will cure me. If all goes well this drug should be approved at the beginning of next year.This pill is designed for Harvoni relapsers like us, but will cure any HCV, any genotype, whether resistant or not, cirrhotic or not, treatment naïve or not, etc. A lot of Great Hope for a  Hep C Free life !!!!!
Fight the Good Fight

John

Good luck with this new treatment, John! :)

kim
Kim Goldberg (Nanaimo, BC)
1970s: Contracted HCV (genotype 3a)
2015: Cured with Harvoni + ribavirin (12 weeks)
MY STORY: https://pigsquash.wordpress.com/2016/01/28/undetectable-my-hep-c-story/

Offline Lynn K

  • Global Moderator
  • Member
  • Posts: 4,544
  • Get tested, get treated, get cured, fight Hep c!
Re: Does HCV develope resistance to HARVONI if you relapse.... It appears so.
« Reply #60 on: February 17, 2016, 04:10:45 pm »
Just to add if the treatment is in the context of a clinical trial you have to go with what they are using as the treatment regimen but if through your doctor never hurts to ask what they think about adding Ribavirin especially in the context of being a relapser
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 AussieRosa

  • Member
  • Posts: 226
Re: Does HCV develope resistance to HARVONI if you relapse.... It appears so.
« Reply #61 on: February 19, 2016, 12:05:05 am »
Good luck this time around, John. I hope this one is the charm!
Rosa
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 Pete

  • Member
  • Posts: 110
Re: Does HCV develope resistance to HARVONI if you relapse.... It appears so.
« Reply #62 on: February 19, 2016, 12:50:33 am »
Quote
Nortfork, Yesterday I took my first pill(dose) of Gileads latest HCV drug that is clinical trial stage. This medicine has 3 drugs, one pill, SOF/VEL and their newest drug which has not been named yet. I will take this one pill everyday for 84 days and hopefully this will cure me. If all goes well this drug should be approved at the beginning of next year.This pill is designed for Harvoni relapsers like us, but will cure any HCV, any genotype, whether resistant or not, cirrhotic or not, treatment naïve or not, etc. A lot of Great Hope for a  Hep C Free life !!!!!
Fight the Good Fight

Yes good luck for sure John!  I was informed today that I've been officially rejected for the Abbvie trial (mentioned in another post) due to my tumor status.  More on that later.

In any event, if you could provide additional info on the 3rd "unnamed drug" you mentioned in the Gilead trial, (or the trial number), please give us a head up.  I'll be meeting next week with medical staff to discuss tumor options, and also next step treatment options after failing 12 weeks of Harvoni.  I'll be sure mention the Gilead trial you have referenced here. 

Sounds like you are getting close to the finish line!  Be well,

Pete




Offline HHburme

  • Member
  • Posts: 117
  • Harvoni start 12/13/14 12wks UD/24wk DET
Re: Does HCV develope resistance to HARVONI if you relapse.... It appears so.
« Reply #63 on: February 19, 2016, 01:10:22 am »
Pete, the clinical trial is GS-US-367-1171  http://www.clinicaltrials.gov. There are 3 drugs in the one pill Sofusbuvir//Velpatasvir and GS-9857, one tablet daily with food for 84 days. Gilead also has Sof/Vel to be approved around June. Hopefully this 3 drug version will do the trick. 3 days and no SE at all.
Fight the Good Fight
John
infected age 19, blood transfusion 1977, detected 2003  GT 1a, Harvoni relapse 06/15, Clinical Trial Study for SOF/VEL GS-9857 start 02/16. SVR12 Cured 08/16

Offline HHburme

  • Member
  • Posts: 117
  • Harvoni start 12/13/14 12wks UD/24wk DET
Re: Does HCV develope resistance to HARVONI if you relapse.... It appears so.
« Reply #64 on: February 19, 2016, 01:14:58 am »
Thanks Rosa, The research team believes this will be the one. Let's hope it works,

Fight the Good Fight

John
infected age 19, blood transfusion 1977, detected 2003  GT 1a, Harvoni relapse 06/15, Clinical Trial Study for SOF/VEL GS-9857 start 02/16. SVR12 Cured 08/16

Offline jakas

  • Member
  • Posts: 265
Re: Does HCV develope resistance to HARVONI if you relapse.... It appears so.
« Reply #65 on: February 19, 2016, 04:37:10 am »
Best of luck for this new one. Finishing Harvoni in 2 weeks so will be good to know how you get along incase I dont clear it
M/57 yrs.
Contracted (Unknown) 10-20-30 yrs back ??
Treatment Naive
Geno 1a&1b
VL  17+ million
ALT 200+, AST 170+
Fibroscan F4 ( 26+ kpa ) on 8th Dec. 2105
Started Tx 11th Dec.2015 ( 12 wks. Gilead Harvoni)
7/1/2016 :Viral Load|<25 UND.
23/1/2016: ALT 34 , AST 35, ALP 143
8 week NO labs done
EOT:03.03.2016 ( 84 pills eaten )
ALT 26, ALP 124, BIL .54
V/L <25 UND E.O.T.
4 weeks E.O.T. V/L UND::: SVR 4
SVR 12 and  SVR 24 on 16/8/16
Fibro 24.5kpa 23/05/16
SVR 63 05/17
Fibro 17.03.2020 kpa 6.3

Offline northfork

  • Member
  • Posts: 57
Re: Does HCV develope resistance to HARVONI if you relapse.... It appears so.
« Reply #66 on: February 19, 2016, 09:14:27 am »
Lynn,

When I was 2 months away from EOT(24weeks) I asked the Dr. if I should add RIBA for last 8 weeks. He said there was no data on that. After relapse I asked if RIBA would have prevented it. He said maybe. Recommending triple therapy he said he would not do RIBA with these since they are potent. I may get in a trial with these 3. (Filed) I am waiting for my screening results. But I am wondering if I should wait and pay and see another Dr to ask about RIBA again.

FailedDaclatasvir, failed Harvoni. Gen 1b. Age 66---might have some cardiac issues, high calcium score in 2 heart scans and sometimes get PVCs. Probably why RIBA is contraindicated. Good platelets and good LFTs.
Probably infected 1969. Diagnosed 2006. Genotype 1b.
Daclatasvir/ Asunaprevir 2013:relapse
Harvoni 24 weeks 2015:relapse
sofosbuvir, velpatisvir, voxillaprevir  trial started on drug 7/16. Viral load 890,000 approx. F2. Undetected after week 1.
12 week SVR achieved Jan 2017.
SVR 24 achieved April 2017 !

60 weeks post treatment...UNDETECTED!

Offline Pete

  • Member
  • Posts: 110
Re: Does HCV develope resistance to HARVONI if you relapse.... It appears so.
« Reply #67 on: February 19, 2016, 10:16:45 pm »
Northfork - You failed 24 weeks of Harvoni?  I didn't think that was possible, at least according to the stats I've read.  I can't speak to your RIBA question, but you should ask our doctor about RAV testing before starting another round of treatment. 

Patients who failed treatment with an NS5A inhibitor (e.g., ombitasvir) are likely to have RAVs against NS5A-acting drugs (e.g., ledipasvir, daclatasvir); thus, resistance testing should be performed before retreatment.

More on  hepatitis C resistance associated variants (RAVs) on pg 17 of this report:

http://www.hepatitis.va.gov/pdf/treatment-considerations-2015-02.pdf

There are a few trials that are specifically looking for patients who have failed DAA's.  Perhaps you can find something along those lines. 

Regards,
Pete




Offline jakas

  • Member
  • Posts: 265
Re: Does HCV develope resistance to HARVONI if you relapse.... It appears so.
« Reply #68 on: February 20, 2016, 02:55:16 am »
this is a good read very informative, thanks
M/57 yrs.
Contracted (Unknown) 10-20-30 yrs back ??
Treatment Naive
Geno 1a&1b
VL  17+ million
ALT 200+, AST 170+
Fibroscan F4 ( 26+ kpa ) on 8th Dec. 2105
Started Tx 11th Dec.2015 ( 12 wks. Gilead Harvoni)
7/1/2016 :Viral Load|<25 UND.
23/1/2016: ALT 34 , AST 35, ALP 143
8 week NO labs done
EOT:03.03.2016 ( 84 pills eaten )
ALT 26, ALP 124, BIL .54
V/L <25 UND E.O.T.
4 weeks E.O.T. V/L UND::: SVR 4
SVR 12 and  SVR 24 on 16/8/16
Fibro 24.5kpa 23/05/16
SVR 63 05/17
Fibro 17.03.2020 kpa 6.3

Offline andoson72

  • Newbie
  • Posts: 2
Re: Does HCV develope resistance to HARVONI if you relapse.... It appears so.
« Reply #69 on: February 26, 2016, 03:05:59 am »
Hi Guys, I am a 43 year old male who has recently completed a Merck trial using the once per day pill containing Grazoprevir and elbasvir. About 4 weeks after starting treatment, i felt really good, i was exersizing, my fatigue had all but gone. My Rash that i have had for years dissapeared and everything looked good.

I was SVR4, then at week 8 post treatment the bloody virus came back. I am hoping that Merck can come up with another treatment that adds another component to combat my resistence, they are testing the resistance now, so hopefully within a couple of months i will be on a new trial.

Since the virus has come back, my fatigue has come back with a vengence, my rash is back, my eyesight has got worse and i have been sick for about 3 weeks out of 6 since the virus returned.

Apart from my short story, my question is this. After i received my SVR4 Not detected results and the fact that my ALt and AST levels were the lowest they have ever been, i decided to start taking Dandelion tea again. I am wondering if this could of contributed to me re-lapsing??? What does everyone think?

Offline Pete

  • Member
  • Posts: 110
Re: Does HCV develope resistance to HARVONI if you relapse.... It appears so.
« Reply #70 on: February 28, 2016, 01:12:34 am »
Sorry to hear the Merck trial failed you and that you are not feeling well.  Is this Merck's new (for all genotypes) drug? Please share a bit of your histology...genotype, how long you've had the virus, fibrosis staging.  Is this your first treatment?  You didn't mention how long your treatment was.  Not trying to get into your business, but by everyone sharing info here, it may be of help for others.   

My thoughts on the dandelion tea?  I wouldn't be concerned about it.  It only takes a few copies of the virus (to few to be detected) that were not destroyed to start replicating.  The tea did not resurrect the dragon.  It happens, so don't blame yourself. 

I didn't achieve SVR following 12 weeks of Harvoni, and I also felt pretty crummy for a couple months afterwards. My V/L spiked as well as my enzymes.  Things have settled back into my historical range now. I know how disappointed you are. But don't despair, you are still young and their seems to be plenty of reports regarding new drugs in the pipeline.   

Regards
Pete




Offline andoson72

  • Newbie
  • Posts: 2
Re: Does HCV develope resistance to HARVONI if you relapse.... It appears so.
« Reply #71 on: February 28, 2016, 01:28:37 am »
Hi Pete,

Thanks for your kind words. The Merck trial went for 12 weeks, 1 tablet per day, really easy and my body tolerated really well.

I am Genotype 1a, and this is my first treatment.

I have had Hep C for about 20 years. Stage 3 fibrosis. For some reason the hep c makes me struggle with a number of other area's of my life such as eyesight, diabetes, erectile dysfunction, blood pressure, fatigue, brainfog etc, etc, however i have always worked full-time and pushed through the tiredness, however it is now getting harder to continue due the symptoms that come and go.

I am confident Merck will come back with another trial on a drug that can fight my resistance, i just have to wait i guess.

I am glad that the Dandelion tea was not the cause, it just was the only thing i started to take again after i was SVR4.

Anyway, all good Pete, i will hang in there. I am sorry to hear that your treatment did not work. I will let you know when the next Merck treatment is offered to me, or you might want to approach the company.

Good luck, hopefully this answered some of your questions.

Cheers,

Jason

 


© 2024 Smart + Strong. All Rights Reserved.   terms of use and your privacy
Smart + Strong® is a registered trademark of CDM Publishing, LLC.