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Author Topic: 8 Wk End Of Harvoni Treatment result: Detected  (Read 121518 times)

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Offline dragonslayer

  • Member
  • Posts: 873
8 Wk End Of Harvoni Treatment result: Detected
« on: January 28, 2015, 02:01:17 pm »
Just got my EOT result today.  I dont even know how this could happen.. What am I.. the most unlucky person in the world?  8 wk End Of Treatment result:  Detected  HCV RNA (IU/mL) 29.  Doctor said redo the test in 12 wks and see him after that.  Can it be Detected at EOT and then miraculously disappear in the next 12 wks?   The trials for those with my stats given 8 wks were like 95% successful with SVR 12... I assumed that all of those results also showed Undetected at EOT... Wish I had those numbers... Just totally stunned at this result...
« Last Edit: January 28, 2015, 03:11:26 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 Lukey

  • Member
  • Posts: 319
  • Let Thy Food Be Thy Medicine
Re: 8 Wk End Of Harvoni Treatment result: Detected!
« Reply #1 on: January 28, 2015, 02:43:48 pm »
Sorry to hear this but you could try to see if you can be retested by a different lab to see if you test Und there.

How are your AST and ALT?

Joe
Male -  HCV since 1982 - Born 1951 ~ Geno 1a

Did 8 weeks of Harvoni in 2015. Got normal AST & ALT and undetected VL by week 5, then relapsed 4 weeks post.
-----------------------------------------------------------
July 5, 2018 : began 12 weeks of Vosevi with a VL of 540,000 and AST & ALT of 65 and 105.
2 weeks in : AST 19, ALT 20
5 weeks in : AST 18, ALT 12, VL "<15 detected"
10 weeks in : AST 19, ALT 14, VL "<15 not detected"
4 weeks post : "<15 not detected"

Offline dragonslayer

  • Member
  • Posts: 873
Re: 8 Wk End Of Harvoni Treatment result: Detected!
« Reply #2 on: January 28, 2015, 03:01:50 pm »
Sorry to hear this but you could try to see if you can be retested by a different lab to see if you test Und there.

How are your AST and ALT?

Joe

Both tested normal: ALT 44; AST 25.. Both were slightly above normal prior to treatment.  I have to redo the RNA Quant test again in ~12 wks and Ive got an appt with him after that.  Im really puzzled though.. Statistically, this should be a no brainer, easy test to pass if you go by the trials.   I was exceedingly diligent in taking the pills and living clean, as I do anyway.  I took no supplements that were on a reactive list... So I just dont get it.  My last liver biopsy was in March of 2013 which was scored stage and grade 0-1. My biopsy prior to that was in 2008 which scored stage and grade 0.   With VL at 2.4mil, this 8wk treatment should have been clear sailing.  I just dont get it.
« Last Edit: January 28, 2015, 03:53:58 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 Picnic

  • Member
  • Posts: 110
Re: 8 Wk End Of Harvoni Treatment result: Detected
« Reply #3 on: January 28, 2015, 03:36:47 pm »
Dragonslayer,
As Lucinda says ,"Don't freak out yet!". I had a detected after 8 weeks after I had three undetected. I did one 2 days later and it was undetected and has been since. This could be an abberant lab result, meaning it may not be valid for a number of reasons. The next test will tell the story. I have been undetected since the abberent test. I just finished 24 weeks of S/O. I waiting to do the SVR 4 and 12 and 24. Good luck!
Larry

Offline dragonslayer

  • Member
  • Posts: 873
Re: 8 Wk End Of Harvoni Treatment result: Detected
« Reply #4 on: January 28, 2015, 03:58:27 pm »
Dragonslayer,
As Lucinda says ,"Don't freak out yet!". I had a detected after 8 weeks after I had three undetected. I did one 2 days later and it was undetected and has been since. This could be an abberant lab result, meaning it may not be valid for a number of reasons. The next test will tell the story. I have been undetected since the abberent test. I just finished 24 weeks of S/O. I waiting to do the SVR 4 and 12 and 24. Good luck!

Thanks Larry.. I see a major difference here though... You were slightly detected at 8 wks, but  that was on a 24 wk treatment program, so the 8 wk results, Id imagine, werent nearly as definitive as being detected at End Of Treatment as I was.  Thats what Im freaking out about.  If I got these results at wk 8 of a 12 wk treatment plan, the result would be concerning, sure, but not nearly so concerning as when its the end of treatment result...
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 motor

  • Member
  • Posts: 58
Re: 8 Wk End Of Harvoni Treatment result: Detected
« Reply #5 on: January 28, 2015, 04:43:55 pm »
Bummer dragonslayer.  Your treatment is the first I've read about where they didn't test along the way to measure progress.  Is this common procedure?  Seems negligent to me.  Seems they shouldn't stop at 8wks if you're not undetected.  Can you find a more involved treatment team?
   They want to wait 12wks before testing again and no contact in interim?  Excuse me if I'm out of line with comments, I'm just disappointed for you.
                                                                                             motor   
Age 66male GT 1a/CT  Dx 5/19/14
Likely infected early 70's
VL 3.7mil FibroScan F2 FSure F2
ALT 84(12-78) AST 56(3-36) High
Tx naive
8wks Harvoni start 3/3/15 VA
4wks ALT 25(12-78) AST 22(3-36) Normal 
        VL  <15  NOT DETECTED
8wks ALT 24 AST 19 
EOT  VL   <15  NOT DETECTED
SVR12 VL <15  NOT DETECTED

Offline Bob V

  • Member
  • Posts: 231
Re: 8 Wk End Of Harvoni Treatment result: Detected
« Reply #6 on: January 28, 2015, 04:52:12 pm »
Sorry Paul that sucks.

I know this won't help you but I don't understand why they can't do labs at week 6 and if you're still positive order 4 more weeks.
Male 64
Dx hep non AB 1972, Hep C 1991
GT 1A
VL 3.7m (pre tx)
Liver B 1992, unremarkable
Liver ultrasound 2014, normal
Treatment Interferon 90's x2 failed
Started Harvoni 12/08/2014 (12wks)
Finished Harvoni  3/1/15
5wk lab detected <15
8wk lab UND
EOT lab UND!
12wk post lab UND!
24wk post lab UND!
58wk post lab UND!

Offline Bob V

  • Member
  • Posts: 231
Re: 8 Wk End Of Harvoni Treatment result: Detected
« Reply #7 on: January 28, 2015, 04:57:55 pm »
Bummer dragonslayer.  Your treatment is the first I've read about where they didn't test along the way to measure progress.  Is this common procedure?  Seems negligent to me.  Seems they shouldn't stop at 8wks if you're not undetected.  Can you find a more involved treatment team?
   They want to wait 12wks before testing again and no contact in interim?  Excuse me if I'm out of line with comments, I'm just disappointed for you.
--------
I wasn't scheduled to have labs until EOT and see my doc 3 weeks later. But I was on 12 weeks, my doc said he wouldn't alter the course of treatment anyway. I did get labs at week 5 and I was still detected, less then 12.
Male 64
Dx hep non AB 1972, Hep C 1991
GT 1A
VL 3.7m (pre tx)
Liver B 1992, unremarkable
Liver ultrasound 2014, normal
Treatment Interferon 90's x2 failed
Started Harvoni 12/08/2014 (12wks)
Finished Harvoni  3/1/15
5wk lab detected <15
8wk lab UND
EOT lab UND!
12wk post lab UND!
24wk post lab UND!
58wk post lab UND!

Offline dragonslayer

  • Member
  • Posts: 873
Re: 8 Wk End Of Harvoni Treatment result: Detected
« Reply #8 on: January 28, 2015, 05:00:50 pm »
Sorry Paul that sucks.

I know this won't help you but I don't understand why they can't do labs at week 6 and if you're still positive order 4 more weeks.

Bob, Motor:  You know, I asked him at the beginning if we can do labs before the 8 wks are over so that we can order up another month if needed,  and he simply said NO.  I dont get it either. .I dont know if the numbers dont show any benefit or what. I know some doctors will do that, and others will ask for nothing except a 12 wk test after treatment.   I have a hard time believing that 4 more wks wouldnt have knocked out the 29 lousy remaining virus particles.   Im certainly going to go down that line of questioning with when I see him in April.   Nevertheless, I note in the trials documents, On-Treatment Virologic Failure results were 0/215 in the 8 wk cohort, and 0/216 in the 12 wk cohort as shown in Table 6 from the prescribing document from the Ion-3 trial ***... So with odds like that, how can I still be detected at end of treatment?!  I just dont get it..  If these trial numbers are to be believed and not prettied up for public consumption, then what happened to me should be an impossibility I would think.


***PS.. Called Gilead Medical Info and spoke to a Pharmacist.  I questioned him about the 0/215 (8wk) and 0/216 (12wk) trial stats for On-Treatment virologic failure numbers. One might assume that these represented 100% UND results at end of treatment.. But I found out otherwise.. I was told the criteria for these numbers was not UND but, rather, viral load of 25 or under!   If I were showing a VL of 25 instead of 29, Id have been reported as an on treatment success also... Its things like this which should cause us to look at the trial results with a little more scrutiny, seems to me.
« Last Edit: January 29, 2015, 12:44:14 am 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 Red Hen

  • Member
  • Posts: 187
Re: 8 Wk End Of Harvoni Treatment result: Detected
« Reply #9 on: January 28, 2015, 05:06:15 pm »
Paul, very upsetting! I'm so sorry and wish I knew what you should do next. You will get plenty of advice here. Best to stay calm and maybe re-do labs.
genotype 1a
completed 12 weeks Viekira pak and ribavirin
final results due around the end of April
Undetected 12 weeks post treatment!

Offline Bob V

  • Member
  • Posts: 231
Re: 8 Wk End Of Harvoni Treatment result: Detected
« Reply #10 on: January 28, 2015, 05:08:42 pm »
I hear you Paul, this is gotta suck for you.

My thinking is like yours, it should be set up PRE tx for people on 8 week to have labs at week 4 or 5 and if positive have enough time to ship the meds to you for another 4 weeks.

My doc asked for 12 hoping to get 8. I got approved for 12 so I'm taking 12.
« Last Edit: January 28, 2015, 05:11:30 pm by Bob V »
Male 64
Dx hep non AB 1972, Hep C 1991
GT 1A
VL 3.7m (pre tx)
Liver B 1992, unremarkable
Liver ultrasound 2014, normal
Treatment Interferon 90's x2 failed
Started Harvoni 12/08/2014 (12wks)
Finished Harvoni  3/1/15
5wk lab detected <15
8wk lab UND
EOT lab UND!
12wk post lab UND!
24wk post lab UND!
58wk post lab UND!

Offline Maxlaw

  • Member
  • Posts: 20
Re: 8 Wk End Of Harvoni Treatment result: Detected
« Reply #11 on: January 28, 2015, 08:15:10 pm »
Hi Paul, I don't have any brilliant explanation to offer (maybe Lucinda can provide some medical insight for you), but I just wanted to say how sorry I am that you got this news. It's all of our worst fear. And I really, really hope it was a faulty test and that your next test will be UND!

Wow, I really can't believe your doc wouldn't do any VL tests during your treatment, especially at 4 weeks, if nothing else to see if the treatment was working, and especially given that you requested it! I am currently taking the next generation AbbVie drugs in a clinical trial, and in this trial they test everything (and I mean everything!) every 2 weeks, so I am fortunate to have all the information at every appointment. I can't imagine not knowing anything during treatment!

I know you are flabbergasted by this news, as I know I would be, but from what I have learned from being associated with the trial I am in, there are several more drugs in phase III right now that will be approved soon. So there is something to look forward to if it turns out that the Harvoni didn't work for you.

Wishing you the best,
Max
« Last Edit: January 28, 2015, 08:35:00 pm by Maxlaw »
GT 3a, dx 07/2014, baseline VL <400K, Fibrosis stage F2 prior to treatment; Completed AbbVie trial drugs ABT-493 & ABT-530 03/01/2015; achieved SVR 12 on 5/27/15...CURED!!

Offline bsmith9876

  • Member
  • Posts: 29
Re: 8 Wk End Of Harvoni Treatment result: Detected
« Reply #12 on: January 28, 2015, 09:09:17 pm »
I'm sorry too, paul.  I feel for you.  I'm an eight-weeker myself and just finished my first week....I understand.

Did the doc offer an alternative or say what your next steps would be?

Brenda.
G 1b

Offline dragonslayer

  • Member
  • Posts: 873
Re: 8 Wk End Of Harvoni Treatment result: Detected
« Reply #13 on: January 28, 2015, 09:14:48 pm »
I'm sorry too, paul.  I feel for you.  I'm an eight-weeker myself and just finished my first week....I understand.

Did the doc offer an alternative or say what your next steps would be?

Brenda.

He left notes with the nurses re my result to test again in 3 mos, and make an appt to see him with those results.. Im sure we'll be discussing alternative at that time, ie, maybe Abbvie, or maybe something else as new drugs gain FDA approval.  I called Gilead to find out if I can be retreated with Harvoni for a longer duration or, might there be an immunity/resistance issue with retreating..   They said they had no data on that!   At least none that they could divulge to me.. But if they really have no data, then good luck to the doctors in making a decision on how to proceed.
« Last Edit: January 28, 2015, 09:16:19 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 Bob V

  • Member
  • Posts: 231
Re: 8 Wk End Of Harvoni Treatment result: Detected
« Reply #14 on: January 28, 2015, 09:41:06 pm »
.  I called Gilead to find out if I can be retreated with Harvoni for a longer duration or, might there be an immunity/resistance issue with retreating..   They said they had no data on that!   At least none that they could divulge to me.. But if they really have no data, then good luck to the doctors in making a decision on how to proceed.
----------
I've called Gilead several times with drug related questions, sorry to say they've not been much help. To be honest I don't think they know that much, the drug is too new. They'll know more in the next year as we finish our treatments.
Male 64
Dx hep non AB 1972, Hep C 1991
GT 1A
VL 3.7m (pre tx)
Liver B 1992, unremarkable
Liver ultrasound 2014, normal
Treatment Interferon 90's x2 failed
Started Harvoni 12/08/2014 (12wks)
Finished Harvoni  3/1/15
5wk lab detected <15
8wk lab UND
EOT lab UND!
12wk post lab UND!
24wk post lab UND!
58wk post lab UND!

Offline Bob V

  • Member
  • Posts: 231
Re: 8 Wk End Of Harvoni Treatment result: Detected
« Reply #15 on: January 28, 2015, 09:47:50 pm »
Paul
I see you're a long timer with Hep C going back to the early 70's, me too. I wonder if this plays a roll or should play a roll in the treatment time. It might take longer to clear if you've had this for 40 years.
Male 64
Dx hep non AB 1972, Hep C 1991
GT 1A
VL 3.7m (pre tx)
Liver B 1992, unremarkable
Liver ultrasound 2014, normal
Treatment Interferon 90's x2 failed
Started Harvoni 12/08/2014 (12wks)
Finished Harvoni  3/1/15
5wk lab detected <15
8wk lab UND
EOT lab UND!
12wk post lab UND!
24wk post lab UND!
58wk post lab UND!

Offline dragonslayer

  • Member
  • Posts: 873
Re: 8 Wk End Of Harvoni Treatment result: Detected
« Reply #16 on: January 28, 2015, 10:32:47 pm »
Paul
I see you're a long timer with Hep C going back to the early 70's, me too. I wonder if this plays a roll or should play a roll in the treatment time. It might take longer to clear if you've had this for 40 years.

Who knows?!  I know there are tons of drug interactions they havent studied yet, and I havent read anywhere that they did any data segmenting by length of time infected.. Plus likely a whole lot of other factors.   Id imagine time infected would be a really hard one to study because most patients are only vaguely aware  of when they were infected.  We all have ideas as to when it was most likely, but very few of us can pinpoint the date, etc.   I just think there are so many factors they didnt segment by in the trials that real world results may wind up looking a little different from the trials results and will certainly take time to develop.
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 Bob V

  • Member
  • Posts: 231
Re: 8 Wk End Of Harvoni Treatment result: Detected
« Reply #17 on: January 28, 2015, 11:02:30 pm »
I just think there are so many factors they didnt segment by in the trials that real world results may wind up looking a little different from the trials results and will certainly take time to develop.
------
I agree
Male 64
Dx hep non AB 1972, Hep C 1991
GT 1A
VL 3.7m (pre tx)
Liver B 1992, unremarkable
Liver ultrasound 2014, normal
Treatment Interferon 90's x2 failed
Started Harvoni 12/08/2014 (12wks)
Finished Harvoni  3/1/15
5wk lab detected <15
8wk lab UND
EOT lab UND!
12wk post lab UND!
24wk post lab UND!
58wk post lab UND!

Offline Lynn K

  • Global Moderator
  • Member
  • Posts: 4,545
  • Get tested, get treated, get cured, fight Hep c!
Re: 8 Wk End Of Harvoni Treatment result: Detected
« Reply #18 on: January 29, 2015, 12:45:04 am »
Hi Paul so sorry to hear this my heart goes out to you.

I was looking at the ION 3 results and am seeing 215 tx naive treated for 8 weeks and 202 made SVR12 so 94%. The thing we all need to remember is these were clinical trials and with limited numbers of participants.

Once the meds get out in the real world with larger numbers being treated the stats never remain the same. Could be better could be worse. But none of the number crunching in the world matters if you fall on the short end of the stats.

sending you a big hug Paul

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 ma snart

  • Member
  • Posts: 65
Re: 8 Wk End Of Harvoni Treatment result: Detected
« Reply #19 on: January 29, 2015, 10:03:44 am »
Paul, my wife had her 8 week results and still showed detected 22, but is on the 24 week plan, I too was disappointed with the results as we are allowed to have them every two weeks I could track the progress, 8.5 million, 933, 212, 95, 105, and then 22, Dr told us that when cirrhosis is evident that it takes time to flush them out, I would demand to see your doctor immediately and possibly have a biopsy performed to see if this might have developed, and to try to up treatment time without waiting 12 weeks to see him. I would be livid. Make some more noise.
Good luck
Helen 54 yr old female
Geno 1B since 84 from transfusion
started Harvoni on 11-22-14 with 8.5 million viral
After 8 days 933 viral and normal AST and ALT
Week 10 viral load  UNDETECTED
Week 17    detected 19
Week 18    detected 21
Week 20    UNDETECTED   Doctor did prescribe Ribavirin, but have not taken it yet as we are thinking that weeks 17,18 had to have been mishandled.
All other test have shown normal levels.
Week 21 results  on Tuesday 4-21
Week 4 post Harvoni 24 week plan UNDETECTED!!

Offline dragonslayer

  • Member
  • Posts: 873
Re: 8 Wk End Of Harvoni Treatment result: Detected
« Reply #20 on: January 29, 2015, 10:28:13 am »
Paul, my wife had her 8 week results and still showed detected 22, but is on the 24 week plan, I too was disappointed with the results as we are allowed to have them every two weeks I could track the progress, 8.5 million, 933, 212, 95, 105, and then 22, Dr told us that when cirrhosis is evident that it takes time to flush them out, I would demand to see your doctor immediately and possibly have a biopsy performed to see if this might have developed, and to try to up treatment time without waiting 12 weeks to see him. I would be livid. Make some more noise.
Good luck

My most recent biopsy was  in 2013... I apparently show no evidence of cirrhosis, and I think another biopsy now less than 2 yrs after my last one is not advisable.. Maybe Ill request a fibroscan though.. I think he wants to see the 12wk viral load, and then he will recommend alternatives.    I completed treatment 1/20, so there's no point in thinking I can add a month to that now.. At any rate, I appreciate your suggestions, and after I get over the shock of this, I may take a more proactive approach.  Its not even 24 hrs since I got the result, and my mind is still reeling.  I dont know what can be done immediately anyway; 12 wks is not all that long to wait to develop a new plan.
« Last Edit: January 29, 2015, 10:37:39 am 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 Red Hen

  • Member
  • Posts: 187
Re: 8 Wk End Of Harvoni Treatment result: Detected
« Reply #21 on: January 29, 2015, 10:48:04 am »
I think the idea of a liver scan is a good idea. Non-invasive procedure. Thinking of you and wishing you the best possible treatment in the future.
genotype 1a
completed 12 weeks Viekira pak and ribavirin
final results due around the end of April
Undetected 12 weeks post treatment!

Offline Bob V

  • Member
  • Posts: 231
Re: 8 Wk End Of Harvoni Treatment result: Detected
« Reply #22 on: January 29, 2015, 11:21:37 am »
With all this I think I'm going to get my 8 week labs done VS waiting until EOT. If I'm still detected, maybe see if my doc can add 12 more weeks. Not sure the insurance will go for it. I was under 15 at week five.
Male 64
Dx hep non AB 1972, Hep C 1991
GT 1A
VL 3.7m (pre tx)
Liver B 1992, unremarkable
Liver ultrasound 2014, normal
Treatment Interferon 90's x2 failed
Started Harvoni 12/08/2014 (12wks)
Finished Harvoni  3/1/15
5wk lab detected <15
8wk lab UND
EOT lab UND!
12wk post lab UND!
24wk post lab UND!
58wk post lab UND!

Offline dragonslayer

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  • Posts: 873
Re: 8 Wk End Of Harvoni Treatment result: Detected
« Reply #23 on: January 29, 2015, 11:35:54 am »
With all this I think I'm going to get my 8 week labs done VS waiting until EOT. If I'm still detected, maybe see if my doc can add 12 more weeks. Not sure the insurance will go for it. I was under 15 at week five.

I checked into that at the time with my specialty pharmacy when I asked if the doctor could order a second refill, ie, third bottle during treatment. I was told that the whole process of getting a brand new prescription written and submitted to the pharmacy, who would then have to submit to insurance for approval would have to be followed.. ie, simply adding a refill on to the existing approval, even if the existing approval went far enough out in time to cover it would not suffice.  At that point, i simply capitulated to the existing prescription, assuming, of course, that the trials success numbers would rule.... I was wrong!   Problem is, with my benign biopsy and <6mil viral load, I considered myself so lucky to have gotten approved for even the 8 wks, that I did not want to push it, fearing theyd reevaluate even their original approval......
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 Bob V

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  • Posts: 231
Re: 8 Wk End Of Harvoni Treatment result: Detected
« Reply #24 on: January 29, 2015, 11:55:49 am »
Paul
I'm sure I wouldn't get approval in time to continue tx. Might just get the labs for piece of mind....or not.

I was only going to do 8wks at first, I'll know if I would of been detected at EOT.
« Last Edit: January 29, 2015, 11:57:53 am by Bob V »
Male 64
Dx hep non AB 1972, Hep C 1991
GT 1A
VL 3.7m (pre tx)
Liver B 1992, unremarkable
Liver ultrasound 2014, normal
Treatment Interferon 90's x2 failed
Started Harvoni 12/08/2014 (12wks)
Finished Harvoni  3/1/15
5wk lab detected <15
8wk lab UND
EOT lab UND!
12wk post lab UND!
24wk post lab UND!
58wk post lab UND!

Offline Mike

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  • Posts: 999
Re: 8 Wk End Of Harvoni Treatment result: Detected
« Reply #25 on: January 29, 2015, 12:41:46 pm »
Hi Paul,

Sorry to hear this. The important think to remember that a 100% cure is close at hand and new combinations are coming out this year.

You'll get this dragon for sure!

Best wishes, Mike
Genotype 1a
Treated 2001 with PEG and RIBV
Treated in 2014 SOL+PEG+RIBV
Cured July 2014

Offline BattleTheBeast

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  • Posts: 817
  • Female, 57 - SVR12 as of 7/23/15!!
Re: 8 Wk End Of Harvoni Treatment result: Detected
« Reply #26 on: January 29, 2015, 08:11:00 pm »
Hey Paul,

This totally sucks, not gonna candy coat here. It sucks and I am so so sorry. If it were me I would be looking for a proactive doctor before I began another treatment. I have had multiple blood tests, had one today in fact. I have insurance and I just deal with the co-pay because if it's not doing what it's suppose to do then I want to know ASAP so we can look at options, my doctor supports me but then again I came in pretty sick in the first place so he is watching a bunch of things on me.

Sending you a big hug over the web. It really is possible there was an error. Isn't it worth a re=test just to make sure? I think that would be my step #1 because Labs do make mistakes and anything is possible. Like Mike said there are more new medications coming really soon and hopefully the next path you choose will be the right one to kick that beasts butt!

Mel
~Mel~
Hep C, Type 1, 10/11  viral load 8,238,340, AST-60, ALT-57 Bili .6  Stage 4 cirrhosis,
Week 4 VL <15 AST 20 - ALT 27 Bili .9
Week 9 - switched to Harvoni VL UD!! AST 20 ALT 19

EOT date is 4/30/2015,
SVR 12 is 7/23/15 ACHIEVED!!! 
and SVR 24 ACHIEVED!!

Offline Katie

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  • Posts: 784
Re: 8 Wk End Of Harvoni Treatment result: Detected
« Reply #27 on: January 29, 2015, 08:42:18 pm »
Oh Paul....You are going through all of our worst nightmare!  I am so sorry to hear that.  It seems I heard where someone was detected at the end of treatment, but since Harboni is still in your system it continues to work for awhile and they came back cured after 12 weeks.  It was on this forum somewhere and like others have said, labs make mistakes...their calibration could be off or the blood sample was affected by something.

I would also ask for another test sooner than 3 months just to know for sure and to help with the anxiety.  I am so lucky as my viral load was less than 3 million (although in the past it had spiked to 16 million) and they authorized 12 weeks.  That is what my doctor requested and it went through.  I was detected at 4 weeks with 59 so we'll see how that goes.

Hoping you are doing OK.  Thanks for sharing with us as it is important we hear the reality of this treatment and hoping the Harvoni is still kicking butt and clearing your virus!  My thoughts are with you and I send ((((HUGS)))) too!

Katie
1 year post treatment blood work done and I am FREE!
GT 1a (4/1/2016)
Dx 2005
VL 2.6 million (fluctuated from 2-16 million during the 9 years)
Started Tx 12/4/2014 for 12 weeks
4 week blood work  Detected 59 IU/mL
EOT Detected <12 IU/mL
7.5 weeks post  Undetected
16 week post Undetected
24 WEEK POST UNDETECTED (I made it)
Waiting to feel good but feeling blessed!
12 month post treatment.  All blood work absolutely perfect! VL, as expected UNDETECTED!

Offline dragonslayer

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Re: 8 Wk End Of Harvoni Treatment result: Detected
« Reply #28 on: January 30, 2015, 12:52:02 am »
A big thanks to each and every one of you!  I was reluctant to open this thread here because I didnt want to put doubt and fear into anyone else's mind...  I was always fearing reading a thread like mine which kind of takes a small chip out of the Harvoni facade.  But I thought it was important to start contributing to real world results, so here it is.   This wasnt supposed to happen according to trial data.  And yet, it did... Im beyond disappointed in my hepatologist. Hes got mad skills, technically, but he leaves a lot to be desired in his followup and his patient interactions.  I wonder if I would ever have gotten a call from his office re the  status of this blood test had I not made sure the lab sent me a copy so I wouldnt be dependent on him for results.    Its hard to imagine a doctor not making a personal call to his patient upon an apparent treatment failure result... All I got from his nurse, after I called them,  was that he left a small note, either on paper or electronically, to have me retest in 3 mos and make an appt to see him after that.  Its unconscionable to not get a personal call from him .  At the very least, he might have returned the phone msg I left with the receptionist this morning for him to return my call re treatment failure.. Nothing today.  Maybe tomorrow.   

I was thinking of making an appointment right away to speak with him about the situation and options, and my general displeasure with the lack of contact... But then I thought, listen, more blood tests create more anxiety.  Why not just wait for my scheduled April appt and bloodtest then... Hes going to want to see what happens over these 12 wks, anyway, wrt my viral load before we commit to any new treatment plans anyway. And at that time Im going to request he do a fibroscan.  I suppose its not out of the realm of possibilities that the reason the treatment failed is that my liver disease progressed beyond what the most recent biopsy showed.  I know he doesnt think that would be the case, but we dont have to guess; his office has the machine (one of the only ones in the entire area) so we might as well use it.  As for now, Im starting to get over the shock and disappointment of the result. .Its been really rough yesterday and today, trying to keep a positive attitude, but slowly, I feel the veil lifting, and once it does, it will be April before I know it, and Ill be  doing the 12 wk post treatment test, and meeting with him to plan a new course of action.

I'll be sure and report back either here, or in the post treatment forum, with any change of status or any updates.   Everybody, keep hanging in there.
« Last Edit: January 30, 2015, 12:41:27 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 amy1662

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  • Posts: 41
Re: 8 Wk End Of Harvoni Treatment result: Detected
« Reply #29 on: January 30, 2015, 12:55:07 am »
So sorry about your news Paul.  Do not worry you will clear this virus and you still may have a chance with Harvoni. It may still be working in your system since you had that blood work. Do not give up. I don't want to rock the boat but I think that anyone who is on the eight week treatment should have blood work at four weeks and if it comes back detected they should at least allow for a twelve week treatment plan. I feel like a lot of these rules that apply to this treatment are not totally fair. The insurance companies have put too many stipulations (hoops) that one has to cross for this treatment.  I think your doctor should have at least tested you at four weeks knowing that although the cure rate is high it is not one hundred percent. At least that would have given time to get an authorization for the twelve week treatment. I hope when you test again it is undetected. If by chance your not do not worry there are better medications on the horizon so you will beat this that is a guarantee. Try not to think about your last test it is not a definite result. I am going to be praying that you have cleared this virus and show undetected on your next test. Chin up, Amy   

Offline Lynn K

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  • Get tested, get treated, get cured, fight Hep c!
Re: 8 Wk End Of Harvoni Treatment result: Detected
« Reply #30 on: January 30, 2015, 02:55:46 am »
Hi Paul

I did see one post on another web site forum where the person was told he was detected but then retested and was found to be clear and that a lab error had been made. We have all heard stories of people enduring chemo only to find out they never had cancer.

Just on the small chance that the was a lab mix up any chance you could be tested again?

How are you liver function tests? When I relapsed on Sovaldi Olysio I got my LFT results before my viral load and saw my ALT had gone above normal range while it had been normal the whole time I was treating the first time in decades. Seeing the elevated ALT gave me a early warning about my viral load.

Just a thought
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 anniemybaby

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Re: 8 Wk End Of Harvoni Treatment result: Detected
« Reply #31 on: January 30, 2015, 05:49:20 am »
Hi Paul I also am on the 8 wk treatment of harvoni but I need to go for blood work every 2 wks after starting harvoni so they can monitor if its working I was a candidate for the 8 wk treatment because of low viral load n I never had prior treatment I wish you all the best
Annie

Offline kate0b1

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Re: 8 Wk End Of Harvoni Treatment result: Detected
« Reply #32 on: January 30, 2015, 06:01:21 am »
Paul, I am in the don't give up hope just yet group, I don't know what harvioni's half life is, but it may still be there working (might be a question for someone with more knowledge than me). i do know that it took forever (at least that what it felt like) to get the riba out go my system). also does any know yet what the re-treatment options even are yet? if you have to retreat (if you even can), at least you already know the drill and the sides so it will be easy going back.

kate

Offline BattleTheBeast

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  • Posts: 817
  • Female, 57 - SVR12 as of 7/23/15!!
Re: 8 Wk End Of Harvoni Treatment result: Detected
« Reply #33 on: January 30, 2015, 07:57:08 am »
I was awake so I thought I would see if I could find anything on this situation our friend Paul is in today and potentially more of us shortly and so far this is all I came up with:

Details below pulled from http://www.hivandhepatitis.com/hcv-treatment/experimental-hcv-drugs/4627-easl-2014-sofosbuvirledipasvir-cures-more-than-90-of-first-time-and-retreated-genotype-1-patients

ION 1 - 12 vs 24 weeks - 865 Patients

"Among participants who did not achieve SVR12, there was 1 on-treatment viral breakthrough -- in an individual with unmeasurable blood drug levels suggesting lack of adherence -- and 2 post-treatment relapses. The rest were lost to follow-up. All 3 people with virological failure had evidence of NS5A resistance variants"

ION2 - Treatment experienced - 440 Patients

There was a single case of on-treatment viral breakthrough, again in a person with undetectable drug levels. Among the 14% who had resistance-associated variants at baseline, 89% still achieved SVR12.

Out of the 11 participants who relapsed, 7 had cirrhosis. Further evaluation of this group did not reveal any specific clinical factors -- such as platelet count or low albumin -- that predicted who would relapse

ION 3 - Treatment-naive 8 vs 12 Weeks - 647 Patients

No virological breakthroughs occurred during treatment. There were 23 relapses, all but 3 of them in the 8-week treatment arms. Afdhal suggested that people who relapse using a short ribavirin-free regimen could either be retreated with a longer duration or add ribavirin, but there is "no signal about which is better."


The good news is we can retreat after relapse with Harvoni (if the insurance Co will approve), I mean they already just saved themselves a 2.5 million by limiting many of the people on treatment to 8 weeks,

IMHO Penny Wise Dollar Foolish - Basically they approve the minimal number of weeks because in the long run the number of people that will need to be retreated is way less than approving 12 or 24 weeks right out of the gate.

Here's how it breaks down (I am going to round the $ for harvoni just to show my example):

100 people for 8 weeks @ 50K per person and 6,250.00 per week per person. and out of that hundred 5 fail and need to be retreated for 12 and possibly add in RibV.

Total for the 100 initial treatment is    5,000.000.00
Total to retreat 5 for 12 weeks              375,000.00 plus the cost of the RibV
                                    Total of          5,375,000.00
2 pt retreat @ 24 weeks                       300,000.00plus the cost of the RibV
                            Grand Total          5,675,000.00
vs.

100 people for 12 weeks @ 75K per person and 6,250 per week per person

Total cost for the 100 people is     7,500.000.00
Maybe 2 would need to retreat        300,000.0024plus the cost of the RibV
                          Grand Total of   7,800,000.00

It's over a 2 Million dollar savings to the insurance Companies to only approve the 8 weeks instead of the 12 and just retreat the relapsers, Pretty disgusting isn't it? This is the real world and what we are all dealing with it. They save a ton of money by handling it this way. That one little line in the results that some people may only need 8 weeks is what they are running with based on my fancy math above. I do know my numbers are a little low because Harvoni actually costs 1125.00 per pill which is 7875.00 per week not my rounded 6250. 

Believe it or not I have rendered myself speechless and slightly sick to my stomach for now but I am going to hang on to the fact being retreated with Harvoni is an option is we relapse.

Mel
~Mel~
Hep C, Type 1, 10/11  viral load 8,238,340, AST-60, ALT-57 Bili .6  Stage 4 cirrhosis,
Week 4 VL <15 AST 20 - ALT 27 Bili .9
Week 9 - switched to Harvoni VL UD!! AST 20 ALT 19

EOT date is 4/30/2015,
SVR 12 is 7/23/15 ACHIEVED!!! 
and SVR 24 ACHIEVED!!

Offline Picnic

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  • Posts: 110
Re: 8 Wk End Of Harvoni Treatment result: Detected
« Reply #34 on: January 30, 2015, 08:35:54 am »
Wow! Are you an accountant? Great  analysis!
Larry

Offline BattleTheBeast

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  • Posts: 817
  • Female, 57 - SVR12 as of 7/23/15!!
Re: 8 Wk End Of Harvoni Treatment result: Detected
« Reply #35 on: January 30, 2015, 09:12:56 am »
Morning Larry,

Did it make sense? I've barely had any sleep for days and am a bit delirious. It's insane because the more exhausted I am the more my mind continues and I just keep going on and on!

Mel
~Mel~
Hep C, Type 1, 10/11  viral load 8,238,340, AST-60, ALT-57 Bili .6  Stage 4 cirrhosis,
Week 4 VL <15 AST 20 - ALT 27 Bili .9
Week 9 - switched to Harvoni VL UD!! AST 20 ALT 19

EOT date is 4/30/2015,
SVR 12 is 7/23/15 ACHIEVED!!! 
and SVR 24 ACHIEVED!!

Offline Red Hen

  • Member
  • Posts: 187
Re: 8 Wk End Of Harvoni Treatment result: Detected
« Reply #36 on: January 30, 2015, 11:31:32 am »
Wow, Mel! Money talks, doesn't it? Paul, I'm thinking of you and hoping that either the labs are wrong or that you can be re-treated with Harvoni for a longer time in the future, since it has very few side effects. I hate it when anyone has a relapse but also know that it can happen, apparently, with all the various drugs. Asked my doctor at one point what they would do if someone relapsed. Re-treat. Please let us know how you're doing.
genotype 1a
completed 12 weeks Viekira pak and ribavirin
final results due around the end of April
Undetected 12 weeks post treatment!

Offline Bob V

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  • Posts: 231
Re: 8 Wk End Of Harvoni Treatment result: Detected
« Reply #37 on: January 30, 2015, 11:41:28 am »
Excellent Mel. I had this conversation with my wife last night that it all has to do with $$$. Let's be honest it sounds better to say we have a drug that only requires 8 weeks and saves some $$. I'm sorry but "I feel" this is at least a 12wks thing and maybe should be 24. The answer is going to come from us as the true numbers start to come in.

I called my doc office to have them call in some labs for Mon (8wks). I explained about this thread to them and that I was originally only going for 8wks...I want to know if I would of cleared.
Also, if I'm still detected next week I'll have little hope I'll reach SVR 12 even if I'm undetected at EOT.

Paul I think it's great you posted this. And I'd be pissed that the doc didn't call me too. Good luck.
Male 64
Dx hep non AB 1972, Hep C 1991
GT 1A
VL 3.7m (pre tx)
Liver B 1992, unremarkable
Liver ultrasound 2014, normal
Treatment Interferon 90's x2 failed
Started Harvoni 12/08/2014 (12wks)
Finished Harvoni  3/1/15
5wk lab detected <15
8wk lab UND
EOT lab UND!
12wk post lab UND!
24wk post lab UND!
58wk post lab UND!

Offline Katie

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  • Posts: 784
Re: 8 Wk End Of Harvoni Treatment result: Detected
« Reply #38 on: January 30, 2015, 01:52:05 pm »
Hi Guys!  Happy Friday!

When I was first researching Harvoni last spring, to get a grip on it before it came available in October, all I saw for recommended treatment was 12 or 24 weeks.  When I met with my doctor to discuss the new  treatment as he had been following it closely since the beginning (he said 4 years) he never even mentioned an 8 week treatment.  When I heard some of you, who are now my friends, were only being given 8 weeks, my first thought was MONEY!  That is one reason I was making comments about it earlier and it confused me. Then the 8 weeks seemed to be the prescribed treatment for so many I figured I should drop it.  It's always about money instead of the good of the patient with the insurance companies.  It is sick!

They don't consider the mental anguish it puts someone through to get the news of relapse, let alone the physical setback and how that affects the overall health.

I am hoping the Harvoni still in the system is still working and searching out those few alien monsters and squashing them for the parasites they are so the SVR12 is still achieved.  It sounds like that may be a good possibility and the percentages of a cure are still high so I am sure most will be OK.

We all need the reality of the situation so we can stand up for ourselves and for each other.

Thanks for you post Mel.  It is an eye opener and when you almost double the profits you list it is obvious what they are doing.  It's just typical of corporations in this day and age and it is wrong.  And thank you Paul for sharing your situation with us.  We are all with you! 

Katie
1 year post treatment blood work done and I am FREE!
GT 1a (4/1/2016)
Dx 2005
VL 2.6 million (fluctuated from 2-16 million during the 9 years)
Started Tx 12/4/2014 for 12 weeks
4 week blood work  Detected 59 IU/mL
EOT Detected <12 IU/mL
7.5 weeks post  Undetected
16 week post Undetected
24 WEEK POST UNDETECTED (I made it)
Waiting to feel good but feeling blessed!
12 month post treatment.  All blood work absolutely perfect! VL, as expected UNDETECTED!

Offline anniemybaby

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Re: 8 Wk End Of Harvoni Treatment result: Detected
« Reply #39 on: January 30, 2015, 02:41:55 pm »
Hi Katie I know with my 8 week treatment the reason being is a low viral load and no cirrhosis 
Annie

Offline Bob V

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  • Posts: 231
Re: 8 Wk End Of Harvoni Treatment result: Detected
« Reply #40 on: January 30, 2015, 02:51:49 pm »
My .02
If they wanted to improve patient outcomes with Harvoni: all patients on 12wks and  patients should have VL test at 8wks if undetected complete 12wks. If positive test every 2wks until undetectable then add 28 more doses. Yes this is a PIA and labs cost money but long term it would save $$$ and a better SVR rate.

For patients with cirrhosis they might need the full 24wks regardless.

I know, I'm dreaming.



 

 
« Last Edit: January 30, 2015, 03:05:00 pm by Bob V »
Male 64
Dx hep non AB 1972, Hep C 1991
GT 1A
VL 3.7m (pre tx)
Liver B 1992, unremarkable
Liver ultrasound 2014, normal
Treatment Interferon 90's x2 failed
Started Harvoni 12/08/2014 (12wks)
Finished Harvoni  3/1/15
5wk lab detected <15
8wk lab UND
EOT lab UND!
12wk post lab UND!
24wk post lab UND!
58wk post lab UND!

Offline Katie

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  • Posts: 784
Re: 8 Wk End Of Harvoni Treatment result: Detected
« Reply #41 on: January 30, 2015, 03:04:15 pm »
We also need to remember that even if you are UD during treatment doesn't mean you've cleared the virus as there are limits to the sensitivity and the post tx test at 12 weeks is the one that shows if they are replicating and if you are clear.

I feel they are just using the low VL and no cirrhosis as an excuse to save money and gamble with our health, but then I don't have much faith in their intentions.  Just my opinion.

I just hope I am wrong and everyone clears this disease without relapse, but Paul is a disturbing example  and the way his doctor treats him is not how it should be.

I don't want to be a downer for anyone as I have faith in this new drug and in the end I know we will all be OK.  It is just getting through it, so I'm going back to my positive energy and am grateful to be able to speak freely on this forum.

Thanks to all of you for being here.  You make this journey so much better.

Katie
1 year post treatment blood work done and I am FREE!
GT 1a (4/1/2016)
Dx 2005
VL 2.6 million (fluctuated from 2-16 million during the 9 years)
Started Tx 12/4/2014 for 12 weeks
4 week blood work  Detected 59 IU/mL
EOT Detected <12 IU/mL
7.5 weeks post  Undetected
16 week post Undetected
24 WEEK POST UNDETECTED (I made it)
Waiting to feel good but feeling blessed!
12 month post treatment.  All blood work absolutely perfect! VL, as expected UNDETECTED!

Offline Bob V

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  • Posts: 231
Re: 8 Wk End Of Harvoni Treatment result: Detected
« Reply #42 on: January 30, 2015, 03:12:53 pm »
Katie
I agree with you and some, I hope I'm wrong too. If my Monday lab comes back detected that means I would of had a failed treatment too. 
Male 64
Dx hep non AB 1972, Hep C 1991
GT 1A
VL 3.7m (pre tx)
Liver B 1992, unremarkable
Liver ultrasound 2014, normal
Treatment Interferon 90's x2 failed
Started Harvoni 12/08/2014 (12wks)
Finished Harvoni  3/1/15
5wk lab detected <15
8wk lab UND
EOT lab UND!
12wk post lab UND!
24wk post lab UND!
58wk post lab UND!

Offline Lynn K

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  • Get tested, get treated, get cured, fight Hep c!
Re: 8 Wk End Of Harvoni Treatment result: Detected
« Reply #43 on: January 30, 2015, 03:43:26 pm »
Great analysis Mel

All I can say is it's all about the Benjamin's
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 kate0b1

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  • Posts: 293
Re: 8 Wk End Of Harvoni Treatment result: Detected
« Reply #44 on: January 30, 2015, 05:32:08 pm »
@mel, wow thats a great post. lots to think about there, thanks for the hard work

kate

Offline Mike

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  • Posts: 999
Re: 8 Wk End Of Harvoni Treatment result: Detected
« Reply #45 on: January 30, 2015, 06:13:24 pm »
I know I'll get some boos and hisses for writing this. Regardless:

The reason why some folks are on 8 week course of Harvoni is because that is all that is needed to achieve an SVR12 for 95% of this qualified population.

In fact, this is supported by empirical research that demonstrates that the  efficacy for those who qualify for an 8 week course of treatment is commensurate with the efficacy of those requiring a 12 or 24 week course.

In medical science, the least invasive treatment which is shown to be effective is always the first choice.

There is also an ethical issue: Would it be appropriate to prescribe a cancer patient  a 20 week course of chemotherapy when the research indicates that, for this particular patient's clinical picture, all that is needed is a 10 week course? Absolutely not.

The same is true here.

Having said this, the unfortunate fact is that 90-95% efficacy is not a 100% and some will fail to clear the virus (I failed my first treatment).

The good news is that this population can be retreated and it doesn't appear that the body develops a resistance to the antivirals.

Best wishes, Mike

Genotype 1a
Treated 2001 with PEG and RIBV
Treated in 2014 SOL+PEG+RIBV
Cured July 2014

Offline anniemybaby

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Re: 8 Wk End Of Harvoni Treatment result: Detected
« Reply #46 on: January 30, 2015, 06:24:14 pm »
OK I'm totally starting to freak out I read these posts everyone that was on the 8 wk treatment couldn't rid the virus so I'm 2 wks into treatment n I'm probably gonna still have the virus at end of 8 wks then what do I do will they prescribe me more medication what will happen omg I'm freaking
Annie

Offline anniemybaby

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Re: 8 Wk End Of Harvoni Treatment result: Detected
« Reply #47 on: January 30, 2015, 06:32:51 pm »
I'm calling my GI Dr Monday I want a back up plan if I'm still infected in 8 wks this &#%# has me scared well my insurance company gave me no problems for the prescription so hopefully if I need 4 more wks I can receive it is there no end to this madness
Annie

Offline kate0b1

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Re: 8 Wk End Of Harvoni Treatment result: Detected
« Reply #48 on: January 30, 2015, 06:38:40 pm »
@annie, don't freak, as mike said you are on 8 weeks for a reason. I do utilization review for a "for profit" hospital and yep there is a crap ton of money/insurance woes out there, but the bottom line is that you are on 8 weeks for a reason.
1) most if not all us on 12 weeks with or without other meds is because we have failed treatment before.
2) you should be having labs at 4 weeks to see where you are with your VL, if your not cleared, that is the time to have a discussion about weather or not to add more time.
Are you having labs @ 4 weeks? if not thats the question you need answered.
this is scary for all of us but your on the right path for you. ;)
kate

Offline Red Hen

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Re: 8 Wk End Of Harvoni Treatment result: Detected
« Reply #49 on: January 30, 2015, 06:40:29 pm »
Annie, I think most people who have the 8 week treatment prescribed for them do clear the virus. That's what Mike is saying. What I wonder about is if all doctors are educated enough about HCV to make an informed decision about length of treatment. I guess the drug company or insurance company recommends what they have determined is sufficient. I am, naturally, skeptical about that. However, it doesn't mean that the 8 week course doesn't work. It usually does. Don't freak out.
genotype 1a
completed 12 weeks Viekira pak and ribavirin
final results due around the end of April
Undetected 12 weeks post treatment!

Offline Katie

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Re: 8 Wk End Of Harvoni Treatment result: Detected
« Reply #50 on: January 30, 2015, 06:44:12 pm »
Annie you need to read Mike's comments again.  Not everyone on 8 weeks is going to fail to clear the virus.  The cure rate is still high it just isn't what was originally recommended from the initial trial tests, which were on very small groups.

I think it would be good to discuss this with your doctor for a back up plan, in case you are in that small percentage which is somewhere between 5-10 %, according to what Mike posted.  None of us know and won't know until we are tested at least 12 weeks after we stop the medication.  This drug is really new and the data isn't all in.

My comments were that I don't always trust the intentions of insurance companies, but I am hoping the doctor stands up for their patients and does the very best for them.

I didn't want to cause you any distress as I was worried some of these comments would upset you.  You are being regularly tested so you should see the results.  Many of us are only tested at 4 weeks and then 8 weeks later and then again at 12 weeks.  That leaves a big gap in knowing what is going on, which other than peace of mind, doesn't really change anything.

Hope this helps in putting your mind at ease.

Katie
1 year post treatment blood work done and I am FREE!
GT 1a (4/1/2016)
Dx 2005
VL 2.6 million (fluctuated from 2-16 million during the 9 years)
Started Tx 12/4/2014 for 12 weeks
4 week blood work  Detected 59 IU/mL
EOT Detected <12 IU/mL
7.5 weeks post  Undetected
16 week post Undetected
24 WEEK POST UNDETECTED (I made it)
Waiting to feel good but feeling blessed!
12 month post treatment.  All blood work absolutely perfect! VL, as expected UNDETECTED!

Offline anniemybaby

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Re: 8 Wk End Of Harvoni Treatment result: Detected
« Reply #51 on: January 30, 2015, 07:01:56 pm »
I'm sorry I'm just really scared
Annie

Offline Bob V

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Re: 8 Wk End Of Harvoni Treatment result: Detected
« Reply #52 on: January 30, 2015, 07:24:34 pm »
There is also an ethical issue: Would it be appropriate to prescribe a cancer patient  a 20 week course of chemotherapy when the research indicates that, for this particular patient's clinical picture, all that is needed is a 10 week course? Absolutely not.
----
 Mike
Read my post, that's why I say do labs and treat accordingly.
Male 64
Dx hep non AB 1972, Hep C 1991
GT 1A
VL 3.7m (pre tx)
Liver B 1992, unremarkable
Liver ultrasound 2014, normal
Treatment Interferon 90's x2 failed
Started Harvoni 12/08/2014 (12wks)
Finished Harvoni  3/1/15
5wk lab detected <15
8wk lab UND
EOT lab UND!
12wk post lab UND!
24wk post lab UND!
58wk post lab UND!

Offline Bob V

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Re: 8 Wk End Of Harvoni Treatment result: Detected
« Reply #53 on: January 30, 2015, 07:30:58 pm »
Annie
Don't freak out, like Katie said talk with your doc. Remember 90-95% will be undetected.
Male 64
Dx hep non AB 1972, Hep C 1991
GT 1A
VL 3.7m (pre tx)
Liver B 1992, unremarkable
Liver ultrasound 2014, normal
Treatment Interferon 90's x2 failed
Started Harvoni 12/08/2014 (12wks)
Finished Harvoni  3/1/15
5wk lab detected <15
8wk lab UND
EOT lab UND!
12wk post lab UND!
24wk post lab UND!
58wk post lab UND!

Offline Katie

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Re: 8 Wk End Of Harvoni Treatment result: Detected
« Reply #54 on: January 30, 2015, 08:02:38 pm »
I'm sorry I'm just really scared

You don't need to be sorry.  This is frightening for everyone and we all understand.  Most of us have been on this forum for several months so we are used to going back and forth and discussing the different options and remember, we are not doctors or medical research scientists, we are just infected same as you.  That's why our support of each other is so important as we totally understand the ups   :) and downs  :-[  and round and rounds!    :o  Just hang in there and keep being proactive!

Katie
1 year post treatment blood work done and I am FREE!
GT 1a (4/1/2016)
Dx 2005
VL 2.6 million (fluctuated from 2-16 million during the 9 years)
Started Tx 12/4/2014 for 12 weeks
4 week blood work  Detected 59 IU/mL
EOT Detected <12 IU/mL
7.5 weeks post  Undetected
16 week post Undetected
24 WEEK POST UNDETECTED (I made it)
Waiting to feel good but feeling blessed!
12 month post treatment.  All blood work absolutely perfect! VL, as expected UNDETECTED!

Offline Lynn K

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Re: 8 Wk End Of Harvoni Treatment result: Detected
« Reply #55 on: January 30, 2015, 10:21:54 pm »
Annie

95% cure you will be fine don't worry. Take a deep breath and exhale slowly.

We are all nervous, I am nervous just remember

“It’s OKAY to be scared. Being scared means you’re about to do something really, really brave.” -Mandy Hale
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 Katie

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Re: 8 Wk End Of Harvoni Treatment result: Detected
« Reply #56 on: January 30, 2015, 10:45:29 pm »

“It’s OKAY to be scared. Being scared means you’re about to do something really, really brave.” -Mandy Hale
[/quote]

Great quote Lynn!

How are you feeling these days with your new treatment?  Hoping all is going well for you.  Your common sense posts help keep us grounded.  Thank you.

Katie
1 year post treatment blood work done and I am FREE!
GT 1a (4/1/2016)
Dx 2005
VL 2.6 million (fluctuated from 2-16 million during the 9 years)
Started Tx 12/4/2014 for 12 weeks
4 week blood work  Detected 59 IU/mL
EOT Detected <12 IU/mL
7.5 weeks post  Undetected
16 week post Undetected
24 WEEK POST UNDETECTED (I made it)
Waiting to feel good but feeling blessed!
12 month post treatment.  All blood work absolutely perfect! VL, as expected UNDETECTED!

Offline Lynn K

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Re: 8 Wk End Of Harvoni Treatment result: Detected
« Reply #57 on: January 30, 2015, 10:47:47 pm »
Just got my 1 week on Ribavirin results looking for changes in hemoglobin:

1/13/15 before Riba
HGB   11.1 - 15.9 g/dL   13.7

1/27/15 after 1 week
HGB   11.1 - 15.9 g/dL   11.9

So still in normal range steady as she goes
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 Katie

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Re: 8 Wk End Of Harvoni Treatment result: Detected
« Reply #58 on: January 30, 2015, 10:56:50 pm »
Glad to hear it.

Keep the faith!

Katie
1 year post treatment blood work done and I am FREE!
GT 1a (4/1/2016)
Dx 2005
VL 2.6 million (fluctuated from 2-16 million during the 9 years)
Started Tx 12/4/2014 for 12 weeks
4 week blood work  Detected 59 IU/mL
EOT Detected <12 IU/mL
7.5 weeks post  Undetected
16 week post Undetected
24 WEEK POST UNDETECTED (I made it)
Waiting to feel good but feeling blessed!
12 month post treatment.  All blood work absolutely perfect! VL, as expected UNDETECTED!

Offline Bob V

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Re: 8 Wk End Of Harvoni Treatment result: Detected
« Reply #59 on: January 30, 2015, 11:00:58 pm »
Lynn
Good news. When do you get your next HgB?
Male 64
Dx hep non AB 1972, Hep C 1991
GT 1A
VL 3.7m (pre tx)
Liver B 1992, unremarkable
Liver ultrasound 2014, normal
Treatment Interferon 90's x2 failed
Started Harvoni 12/08/2014 (12wks)
Finished Harvoni  3/1/15
5wk lab detected <15
8wk lab UND
EOT lab UND!
12wk post lab UND!
24wk post lab UND!
58wk post lab UND!

Offline Lynn K

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Re: 8 Wk End Of Harvoni Treatment result: Detected
« Reply #60 on: January 30, 2015, 11:02:06 pm »
Hi Bob

next Tuesday 2/3 so end of week 2
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 Bob V

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Re: 8 Wk End Of Harvoni Treatment result: Detected
« Reply #61 on: January 30, 2015, 11:55:58 pm »
Lynn
Hoping for a stable HgB for you.
Male 64
Dx hep non AB 1972, Hep C 1991
GT 1A
VL 3.7m (pre tx)
Liver B 1992, unremarkable
Liver ultrasound 2014, normal
Treatment Interferon 90's x2 failed
Started Harvoni 12/08/2014 (12wks)
Finished Harvoni  3/1/15
5wk lab detected <15
8wk lab UND
EOT lab UND!
12wk post lab UND!
24wk post lab UND!
58wk post lab UND!

Offline JoeK9999

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Re: 8 Wk End Of Harvoni Treatment result: Detected
« Reply #62 on: January 31, 2015, 08:26:04 am »
Bob, Motor:  You know, I asked him at the beginning if we can do labs before the 8 wks are over so that we can order up another month if needed,  and he simply said NO.  I dont get it either. .I dont know if the numbers dont show any benefit or what. I know some doctors will do that, and others will ask for nothing except a 12 wk test after treatment.   I have a hard time believing that 4 more wks wouldnt have knocked out the 29 lousy remaining virus particles.   Im certainly going to go down that line of questioning with when I see him in April.   Nevertheless, I note in the trials documents, On-Treatment Virologic Failure results were 0/215 in the 8 wk cohort, and 0/216 in the 12 wk cohort as shown in Table 6 from the prescribing document from the Ion-3 trial ***... So with odds like that, how can I still be detected at end of treatment?!  I just dont get it..  If these trial numbers are to be believed and not prettied up for public consumption, then what happened to me should be an impossibility I would think.


***PS.. Called Gilead Medical Info and spoke to a Pharmacist.  I questioned him about the 0/215 (8wk) and 0/216 (12wk) trial stats for On-Treatment virologic failure numbers. One might assume that these represented 100% UND results at end of treatment.. But I found out otherwise.. I was told the criteria for these numbers was not UND but, rather, viral load of 25 or under!   If I were showing a VL of 25 instead of 29, Id have been reported as an on treatment success also... Its things like this which should cause us to look at the trial results with a little more scrutiny, seems to me.

Paul - Just keep in mind with these low numbers the majority still reached SVR12.
I read a post on another forum of a detected at EOT and then the woman reached SVR12 and SVR24. Evidently the immune system was able to eradicate the rest. So keep your spirits up. We are all in the unknown boat.
Diagnosed July 1995 - Genotype 1a
Think I have I had since the early 70's
Prior to Harvoni treatment:
VL 3.8 million AST/ALT 40/56
Mild inflammation, no fibrosis
Treatment naive
 
Started Harvoni 10/23/2014 for 12 weeks
11/20/2014  HCV RNA Qual - Detected
Last Day of Harvoni 01/15/2015
04/08/15 - 12 week post harvoni VL test - Not Detected
07/05/15 - 24 week post harvoni VL test - Not Detected
01/19/16 - 1 Year  post harvoni VL test - Not Detected
AST/ALT 22/22
CURED!!

Offline dragonslayer

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Re: 8 Wk End Of Harvoni Treatment result: Detected
« Reply #63 on: January 31, 2015, 10:35:30 am »
Paul - Just keep in mind with these low numbers the majority still reached SVR12.
I read a post on another forum of a detected at EOT and then the woman reached SVR12 and SVR24. Evidently the immune system was able to eradicate the rest. So keep your spirits up. We are all in the unknown boat.

Thank you guys for giving hope.  It surely will make the 12 wks til my next bloodtest and followup appt with hepatologist easier to take.  Ive read that even one lowly viral particle is enough to replicate and send the viral load back into the millions, which is often used as an explanation for relapse, ie, the rna quant test shows undetected when below 12 or 15, but it may not be zero, hence, in 12 wks, when svr12 is tested for, it appears as a relapse, when in all likelihood, it never really went away...  I mean, this is certainly a possible scenario.  So at first glance, its difficult for me to buy into the concept that a vl of 29 on last day of harvoni can go to und at  the svr12 test.

A more positive interpretation might be that of those testing UND at end of treatment, probably only a very small number really have a viral load count of zero; seems more likely to me that the real number might be somewhere between 1 and the lowest bound of the test, whether 12 or 15, or whatever it is...  If that is a valid interpretation, then that can give people like me more hope also.

Continuing along this line of thought,  I mentioned earlier that although the total number of participants in the Ion-3 groups  of both 8 and 12 wk recipients showed 0/451 on-treatment viral breakthrough making it appear as though I really am a total outlier, the fact remains, according to the Gilead Medical Info pharmacist I spoke to, the criteria for making it into this group was not UND,  but a quant rna value of <=25!  In other words, Im close enough to those results that its not inconceivable that, on any given day, I would have tested with that 'no viral breakthrough on treatment' result as well.. So that gives me a little hope too.. Not much, but enough to help me past the next 12 wks.

Thanks all for your continuing comments and well wishes.
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 Islandgirl

  • Member
  • Posts: 295
  • Started Harvoni 12/3/14 - EOT 2/25/15
Re: 8 Wk End Of Harvoni Treatment result: Detected
« Reply #64 on: January 31, 2015, 10:54:32 am »
First, Paul, I'm so sorry you are going through this! 

I remind myself from time to time that just because I was UD at 4 & 6 wks, doesn't mean it will be the same at next test, although I'm hoping/praying it will.  I confess it's my attempt to keep from being too overwhelmed if it happens, since I've seen it happen with others in our Forum Family. 

Originally, I naively thought if UD it would remain UD, your experience is a BIG reminder to keep hopeful but to keep open to changing direction if the final test turns out to not be what we're all hoping for. 

There's a wealth of great information and reassurance in these posts and I hope more people get a chance to read them.  Thanks everyone!  I'm holding all of us in positive thought - along with a group hug (we never get enough hugs :))  ...Islandgirl 
1b, treatment naive, positive for Hep C since 1994; thought to be transmitted via blood transfusions in 1976
Started Harvoni 12/3/14, EOT 2/25/15
12/31/14 labs - Virus Undetected, ALT/18, AST/34
3/25/15 labs - 1 mo post 12 wk Harvoni TX Virus Undetected!!  :) ....Islandgirl

Offline Lynn K

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Re: 8 Wk End Of Harvoni Treatment result: Detected
« Reply #65 on: January 31, 2015, 01:46:54 pm »
My thinkng is that with the 95% SVR rate that 95% truly were virus free at EOT which was confirmed 12 weeks later and the other 5% had a few below detectable levels.

Also bear in mind say it was 3 IU/mL so 3 units of virus per mL of blood. If memory serves the body has about 4 liters of blood so really that is a lot of virus left over that survived treatment.
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 dragonslayer

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Re: 8 Wk End Of Harvoni Treatment result: Detected
« Reply #66 on: January 31, 2015, 02:47:39 pm »
My thinkng is that with the 95% SVR rate that 95% truly were virus free at EOT which was confirmed 12 weeks later and the other 5% had a few below detectable levels.

Also bear in mind say it was 3 IU/mL so 3 units of virus per mL of blood. If memory serves the body has about 4 liters of blood so really that is a lot of virus left over that survived treatment.

Lynn, Is this in response to my statement regarding what the Gilead pharmacist told me regarding the criteria used in the trials to establish on-treatment-virologic-failure being a viral load <=25 and not UND or 0? 
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 Katie

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Re: 8 Wk End Of Harvoni Treatment result: Detected
« Reply #67 on: January 31, 2015, 03:17:43 pm »
[Also bear in mind say it was 3 IU/mL so 3 units of virus per mL of blood. If memory serves the body has about 4 liters of blood so really that is a lot of virus left over that survived treatment.
[/quote]


Oh Dear Lynn,  Now you have my head swimming with questions on that statement.  I had thought of this when I was first diagnosed but haven't pondered it lately.

Just think how many were in the total blood volume when we were in the millions!!!

So are they uniform throughout the circulatory system?

Are these the ones who escaped the liver, if so how many are left there doing damage?

If blood was tested every day for a week what would the readings be? Would they fluctuate?

How do they get that count?  Is it an average or an indication, a sensitivity test or and actual count?  They are SO tiny, we can't even comprehend.

I knew they were other worldly parasites!

All I know, is that 59, in my case at 4 weeks, is a heck of a lot better than 3 million, and my body is an incredible machine that fights hard to keep running so I will put these questions aside and just be grateful I am improving and know I will be cured, soon, as we all will.

I believe the drug stays in our system working after the last pill and has diminished them to the point of extinction and the monster will the be defeated.  Remember, many people infected with Hep C take care of the virus on their own and never go to the chronic state so when we get to a very low viral load, even after the treatment and even after the medication has flushed out, our immune system is still working and killing the virus.   If this doesn't make sense, please let me know.

Good.  I talked myself out of the panic mode!  HA!  It's going to be a good day.  Breathe, Relax, Enjoy and Celebrate the day. We are warriors in this battle and our victory is coming!

Katie
« Last Edit: January 31, 2015, 03:19:31 pm by Katie »
1 year post treatment blood work done and I am FREE!
GT 1a (4/1/2016)
Dx 2005
VL 2.6 million (fluctuated from 2-16 million during the 9 years)
Started Tx 12/4/2014 for 12 weeks
4 week blood work  Detected 59 IU/mL
EOT Detected <12 IU/mL
7.5 weeks post  Undetected
16 week post Undetected
24 WEEK POST UNDETECTED (I made it)
Waiting to feel good but feeling blessed!
12 month post treatment.  All blood work absolutely perfect! VL, as expected UNDETECTED!

Offline bridget

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Re: 8 Wk End Of Harvoni Treatment result: Detected
« Reply #68 on: January 31, 2015, 10:04:48 pm »
Paul,
I am so sorry that this happened to you! It makes me very angry that your dr. didn't follow up with you directly. Treatment failure definitely merits a phone call! I agree that you deserve a re-test of those labs. 12 weeks is too long to wait.  Email your dr. and express your frustration/anxiety & ask for a re-test.  It's a reasonable request.  It would also be a good test to see how your dr. responds to your request. If you don't like the way you are being cared for, find a better dr.
Best of luck

Offline dragonslayer

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  • Posts: 873
Re: 8 Wk End Of Harvoni Treatment result: Detected
« Reply #69 on: January 31, 2015, 10:22:46 pm »
Email the doctor?  Lolz... wish I could.. The only way I can communicate at all with the doctor aside from an office vist is through his nurse via phone.  Hes one of 3 or 4 doctors in a local Comprehensive liver center. These doctors to their own biopsies and transplants...  That leaves patient contact aside from office visits to the their nurses.. I have requisitions for blood work from him which his nurse sent me which I can basically do anytime I want.  Im gong to follow the orders he left with the nurse for a 12 wk wait and a retest followed by an office visit..   If I want this doctor to go to bat for me regarding retreatment Im going to have to follow his advice.. When I see him in april, Ill let my feelings be known.  I dont see what retesting now will do. Ill still have to be retested in 12 wks at which time we'll know either that Im SVR12 or that I need to be retreated.. .Before that, nothing can be determined.. Even if I tested UND now, Id Still have to be retested at 12 wks, so I really dont think this plan is a bad one..More testing, for me, just adds to the anxiety, and accomplishes nothing since the 12 wk retest is mandatory anyway. The only thing I heartily object to is the lack of any ability to speak with him outside the office visit and his failure to contact me personally after the eot bloodtest result.  I also would have preferred if I got 12 wks of treatment, but the data, so far,  just really doesnt support it for someone with my stats..
« Last Edit: January 31, 2015, 10:24:17 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 Lynn K

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Re: 8 Wk End Of Harvoni Treatment result: Detected
« Reply #70 on: February 01, 2015, 01:55:30 am »
Hi Paul

I was thinking about this comment you wrote:

"A more positive interpretation might be that of those testing UND at end of treatment, probably only a very small number really have a viral load count of zero;"

When I wrote:
" My thinkng is that with the 95% SVR rate that 95% truly were virus free at EOT which was confirmed 12 weeks later and the other 5% had a few below detectable levels."

That is only my personal opinion and I am not at all a medical professional. Just in my thinking it seems that once off the meds the therapeutic effect has ended so they would have to be zero at that point for those that eventually make SVR  or the virus would come back since it was still there just below detectable.

But again it is only my lay persons opinion trying to make sense of the science.

Wishing you only the best
« Last Edit: February 01, 2015, 02:30:01 am 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 Lynn K

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Re: 8 Wk End Of Harvoni Treatment result: Detected
« Reply #71 on: February 01, 2015, 02:25:27 am »
Hi Katie

Ok so I am not a scientist so this is all only my opinion ok?:

Just think how many were in the total blood volume when we were in the millions!!!

Yes that is correct like my viral load 2 million /mL lots of them but remember they are very, very small.

So are they uniform throughout the circulatory system?

I would think so that is where we test for them.

Are these the ones who escaped the liver, if so how many are left there doing damage?

I don't think they stay in the liver in a higher quantity but I am very much outside my knowledge here on this. So there is no escape they are freely flowing throughout the circulatory system. Again I am not a scientist.

If blood was tested every day for a week what would the readings be? Would they fluctuate?

When we are not being treated yes there is variation from what I have been told basically sampling variation. So yeah just like all your other blood tests when you are being tested frequently if you compare your liver enzyme tests they change all the time as do others. What they look for is trend.

How do they get that count?  Is it an average or an indication, a sensitivity test or and actual count?  They are SO tiny, we can't even comprehend. Way out if my league on this one. I think the test is done by a machine and as they draw more than a mL I think it is sample average.

All I know, is that 59, in my case at 4 weeks, is a heck of a lot better than 3 million, and my body is an incredible machine that fights hard to keep running so I will put these questions aside and just be grateful I am improving and know I will be cured, soon, as we all will.

Absolutely I trust the science if they had not been shown to be effective in trials and not dangerous the meds would not have been approved.

I believe the drug stays in our system working after the last pill and has diminished them to the point of extinction and the monster will the be defeated.  Remember, many people infected with Hep C take care of the virus on their own and never go to the chronic state so when we get to a very low viral load, even after the treatment and even after the medication has flushed out, our immune system is still working and killing the virus.   If this doesn't make sense, please let me know.

Interesting theory never thought about that I did check the hat life of Sovaldi Ledipasvir but I don't recall off hand but I think it is only a day or 2 and the meds are no longer in our systems they have been excreted in our urine and poop.

I just don't see any value in worrying about the end result at this point. Sure it is natural to be concerned as we all want to be rid of this virus or we wouldn't be here, but excess worry or freaking out will not change the final result it only makes today stressful when it does not need to be.

Best to you you will be fine
« Last Edit: February 01, 2015, 02:27:05 am 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 BattleTheBeast

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Re: 8 Wk End Of Harvoni Treatment result: Detected
« Reply #72 on: February 01, 2015, 02:44:55 am »
Interesting Lynn,

I wonder if this medication help to build up whatever it is that helps our ability to fight the virus off ourselves when we have completed the course. So the medication kills off what it can find but does it also help us to fight it on our own after that magic Undetected so we would be more like the group who's own bodies fight it off naturally.  I mean after TX it will always show HepC yet we no longer have the active virus once we reach SVR24 (I know some people think 12 is the new 24).

Just curious, no matter how much I read or try to understand it's still really confusing to me and I am tying to make some sense out of it.

Mel
~Mel~
Hep C, Type 1, 10/11  viral load 8,238,340, AST-60, ALT-57 Bili .6  Stage 4 cirrhosis,
Week 4 VL <15 AST 20 - ALT 27 Bili .9
Week 9 - switched to Harvoni VL UD!! AST 20 ALT 19

EOT date is 4/30/2015,
SVR 12 is 7/23/15 ACHIEVED!!! 
and SVR 24 ACHIEVED!!

Offline Lynn K

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Re: 8 Wk End Of Harvoni Treatment result: Detected
« Reply #73 on: February 01, 2015, 02:54:57 am »
Yeah me too Mel lol

Yes we will always test positive to antibodies but hopefully never again for the virus.

Just like if you have either been immunized against or had the measles you will have measles antibodies same thing with hep c except hep c antibodies don't protect us from reinfection.

I don't think my system can beat hep c on its own that is why I became chronic like 75% of those exposed do and why even though I was UND after 12 weeks of Sovaldi Olysio I relapsed after treatment stopped.

Who knows maybe that is why some clear and some relapse that your body still needs to get rid of the last few which if that is the case doesn't sound like good news for me. I think I need the meds to take care of the virus 100%
« Last Edit: February 01, 2015, 03:05:21 am 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 JoeK9999

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Re: 8 Wk End Of Harvoni Treatment result: Detected
« Reply #74 on: February 01, 2015, 08:04:17 am »
I agree with Paul that more testing just adds to the anxiety.
When I called Gilead after my 1 month on treatment still detected test,
they told me just finish the medicine and and get the 12 week post treatment test.
I never got another HVC RNA test, just CBC and Liver panel tests. And my doctor was only interested in a post 24 week test, period. He didn't care about any other HCV RNA testing.

After more reading I am not even sure about test results. I am confused because
I have read some of the virus can be stuck in you for a long time, but without the capability of replicating. So does that mean the tests finds those, but they have been cleaved and thus not a problem for us?

We've seen enough on treatment results going
both ways in this forum with Harvoni. The only tests that count are many months post treatment as we have seen in past treatment protocols results. We can only pray for a good outcome for ourselves. We cannot predict it and we certainly don't need anymore stress and anxiety.  I am wishing and praying for the final outcome we all want.
Diagnosed July 1995 - Genotype 1a
Think I have I had since the early 70's
Prior to Harvoni treatment:
VL 3.8 million AST/ALT 40/56
Mild inflammation, no fibrosis
Treatment naive
 
Started Harvoni 10/23/2014 for 12 weeks
11/20/2014  HCV RNA Qual - Detected
Last Day of Harvoni 01/15/2015
04/08/15 - 12 week post harvoni VL test - Not Detected
07/05/15 - 24 week post harvoni VL test - Not Detected
01/19/16 - 1 Year  post harvoni VL test - Not Detected
AST/ALT 22/22
CURED!!

Offline bridget

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Re: 8 Wk End Of Harvoni Treatment result: Detected
« Reply #75 on: February 01, 2015, 09:53:23 am »
Paul,
Sorry to hear that you cannot email your dr.   The only way I was approved for treatment and later approved for the correct length of treatment was to write to my dr. with facts from Gilead, AASLD & the ION-3 Trial.  It's easier to reference those sources in writing. 

If no email, I would write via snail mail & would want to know why you were not tested at 4 or 6 weeks when there would have been time to lengthen treatment to 12 weeks? And, if you are still at 29 at 12 weeks EOT, what is the treatment recommendation? I would also like a re-test now, just to confirm the accuracy.

My reason for writing would be to create a paper trail to document your concern that by not testing you mid-treatment, an opportunity was missed to cure you.  This may help your case if you are denied re-treatment.  If I was not comfortable with the way the dr. responded, I would rather shop for a new dr. now vs. waiting 12 weeks to start looking. What if he told you after waiting for your 12 week appointment that he does not recommend treating you anytime soon?  Why wait 12 weeks for that news?

I'm still puzzled about your finding that Gilead claimed success for anyone <25!
I had never read that!
Good luck, hang in there, you WILL be cured eventually. 

Offline bridget

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Re: 8 Wk End Of Harvoni Treatment result: Detected
« Reply #76 on: February 01, 2015, 09:55:55 am »
Paul,
Who made the decision not to test you mid-treatment?  Doctor or Insurance company?
Just curious.

Offline dragonslayer

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Re: 8 Wk End Of Harvoni Treatment result: Detected
« Reply #77 on: February 01, 2015, 10:13:28 am »
Bridget,

I already knew how he worked prior to receiving my prescription.. In my pre-treatment meeting with him, I learned that the only number he's interested in is the 12 wk post treatment number.  I had asked him if hed do a a test prior to end of treatment and he said no.  It had nothing to do with insurance so far as I could tell.  Doctors have different approaches to how to work with this disease.. He is a transplant hepatologist and far from a novice in the field.  At some point, either you trust your doctor or you dont.. The on treatment bloodtests, for instance, while commonplace on trials and with earlier forms of treatment due to the relatively large numbers of null responders, assumes a lesser roll with the new DAAs to some doctors. At the end of the day, the only  number that matters is the 12 wk post treatment number.  All the rest is a bit of noise in the system. 

> What if he told you after waiting for your 12 week appointment that he does not recommend treating you anytime soon?  Why wait 12 weeks for that news?<<

Because I presume it takes time for viral loads to return to a more stable value after having been so diminished during treatment.. That and the fact that there is still a chance that svr12 might be achieved. 

>>I'm still puzzled about your finding that Gilead claimed success for anyone <25!<<

As I wrote in my post, this was the number Gilead used in the trials to ascertain whether or not there had been any 'on treatment Virologic failure' as reported in the trial tables in the prescribing document (as can be seen in table 6 relative to the Ion-3 trial, for instance) .  This  was conveyed to me by a Gilead pharmacist who I reached through Gilead Medical Info.   He seemed extremely well versed on the data and the result, although was only allowed by FDA guidelines to convey certain info to patients.. He couldnt, for instance, advise me as to whether Harvoni may be retreated and whether there was any resistance or immunity involved.. He did say, however, that they were permitted to divulge this and other info to doctors. 
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 apache

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Re: 8 Wk End Of Harvoni Treatment result: Detected
« Reply #78 on: February 01, 2015, 02:50:42 pm »
Executive summary: having one EOT result which is > 25 IU/mL is not necessarily an indication of treatment failure. :)   See the appended for more on this.  In particular, look at the bold highlighted section.

---- cut here for more details ----


Quote
>>I'm still puzzled about your finding that Gilead claimed success for anyone <25!<<

As I wrote in my post, this was the number Gilead used in the trials to ascertain whether or not there had been any 'on treatment Virologic failure' as reported in the trial tables in the prescribing document (as can be seen in table 6 relative to the Ion-3 trial, for instance) .  This  was conveyed to me by a Gilead pharmacist who I reached through Gilead Medical Info.   

This "25" threshold (IU/mL) is actually mentioned in the detailed Harvoni product insert:
    http://www.gilead.com/~/media/Files/pdfs/medicines/liver-disease/harvoni/harvoni_pi.pdf

If you search for "25" (in the .pdf viewer), it'll eventually take you to:

Section 14.1: Overview of Clinical Trials

which contains this info:

Quote
All three Phase 3 trials evaluated efficacy of HARVONI (one fixed-dose tablet of 90 mg of ledipasvir and 400 mg of sofosbuvir administered once daily) with or without ribavirin. Treatment duration was fixed in each trial. Serum HCV RNA values were measured during the clinical trials using the COBAS TaqMan HCV test (version 2.0), for use with the High Pure System. The assay had a lower limit of quantification (LLOQ) of 25 IU/mL.

Sustained virologic response (SVR) was the primary endpoint and was defined as HCV RNA less than LLOQ at 12 weeks after the cessation of treatment. Relapse was a secondary endpoint, which was defined as HCV RNA greater than or equal to LLOQ with 2 consecutive values or last available post-treatment measurement during the post-treatment period after achieving HCV RNA less than LLOQ at end of treatment
.

The hopeful part is the last sentence (where I've added the bold):
Quote

Relapse was a secondary endpoint, which was defined as HCV RNA greater than or equal to LLOQ with 2 consecutive values or last available post-treatment measurement during the post-treatment period after achieving HCV RNA less than LLOQ at end of treatment.

The fact that they mentioned 2 consecutive values... implies that the RNA measurement test is not 100% accurate.  In other words, having one test with a value that is not UND is not necessarily an authoritative determination of treatment failure.

The difference between LLOD (Lower Limit of Detection) and LLOQ (Lower Limit of Quantification) is a bit confusing, but there is a Medscape article which gives a pretty good explanation.  Note that the Medscape article is not about Harvoni, but about a different Rx.  However their explanations of LLOD, LLOQ are well-done, and will help clarify how things are measured in clinical trials:

Quote
http://www.medscape.com/viewarticle/756591_3
Lower Limit of Detection (LLOD) Versus Lower Limit of Quantification (LLOQ)

The LLOD is the HCV RNA concentration at which less than 5% of the samples that contain a known amount of an RNA standard yield a signal that can be detected. The LLOQ refers to the lowest HCV RNA concentration that is within the validated quantitative range of an assay. An undetectable result indicates that HCV RNA was not detected in the sample. The limit of detection and the limit of quantification vary according to the assay used. Both the boceprevir and telaprevir phase III studies used the COBAS TaqMan HCV RNA assay, version 2.0 (Roche), with a LLOD of 10 IU/mL and a LLOQ of 25 IU/mL. Eligibility for RGT was based on the lower limit of detection (<10 IU/mL) of the assay. There is thus a range in which HCV RNA can be detectable, but falls below the level of quantification. This situation is not uncommon during HCV treatment and is associated with lower SVR rates.



Offline BattleTheBeast

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Re: 8 Wk End Of Harvoni Treatment result: Detected
« Reply #79 on: February 01, 2015, 02:57:23 pm »
Hi Apache,

Thanks for sharing that but I have to admit I am still lost with this whole thing. Perhaps a bulb with go off in my head for this one but right now it's just not making too much sense to me.

I bet in 2 months I look at this post I made and laugh that I didn't understand it :)

Mel
~Mel~
Hep C, Type 1, 10/11  viral load 8,238,340, AST-60, ALT-57 Bili .6  Stage 4 cirrhosis,
Week 4 VL <15 AST 20 - ALT 27 Bili .9
Week 9 - switched to Harvoni VL UD!! AST 20 ALT 19

EOT date is 4/30/2015,
SVR 12 is 7/23/15 ACHIEVED!!! 
and SVR 24 ACHIEVED!!

Offline dragonslayer

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Re: 8 Wk End Of Harvoni Treatment result: Detected
« Reply #80 on: February 01, 2015, 02:58:11 pm »
Wow, Apache.. Great Find!!!!  That is  bound to make those of us with lower limit type detectable amounts during or at End Of Treatment feel considerably Better.. . I think many of us have been focusing on UND as the only measure of on-treatment or EOT success. Perhaps we can now expand this a little to encompass values near the lower bound.. Really good find, corroborating what the Gilead Pharmacist told me.. Thanks much.
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 Red Hen

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Re: 8 Wk End Of Harvoni Treatment result: Detected
« Reply #81 on: February 01, 2015, 03:13:16 pm »
I'm like Mel and really don't understand all of this. It does seem like the drugs would continue to work in the body after the last pill and that the 12 week after treatment time frame might have some relationship to that. I'm not a doctor and never wanted to be one. Just hope that all paths lead to successfully getting rid of the virus!
genotype 1a
completed 12 weeks Viekira pak and ribavirin
final results due around the end of April
Undetected 12 weeks post treatment!

Offline Katie

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Re: 8 Wk End Of Harvoni Treatment result: Detected
« Reply #82 on: February 01, 2015, 03:40:01 pm »
Thanks Apache.  Appreciate you taking the time to share that.

The thing I know about viruses is they are Sci Fi...They aren't alive but these non living parasites are very specific, looking for the right cell to penetrate and use those cells to inject their DNA or RNA which allows them to replicate.  Ever since my micro biology class many years ago they have given me the creeps and they cause so much disease and are the most difficult to treat.  What is even worse is that there are viruses out there we haven't even discovered yet and may very well be causing other chronic and terminal conditions where the cause is yet unknown.  Hep C was only discovered in 1989, and then it took a couple years to perfect the blood screening tests for safe transfusions or other blood products.

This site gives a good history of Hep C up to the pre release of Harvoni and the language is in layman's terms.  It doesn't go into the test trials but is a fact sheet on the history and is quite interesting.

http://hcvadvocate.org/hepatitis/factsheets_pdf/Brief_History_HCV.pdf

Enjoy your Sunday, and if you are a football fan, Have a good All American Super Bowl Sunday.  I do admit to watching the commercials and half time, but that's about it.  Many in Alaska are excited as the Sea Hawks are considered "Our Team". HA!

Katie
1 year post treatment blood work done and I am FREE!
GT 1a (4/1/2016)
Dx 2005
VL 2.6 million (fluctuated from 2-16 million during the 9 years)
Started Tx 12/4/2014 for 12 weeks
4 week blood work  Detected 59 IU/mL
EOT Detected <12 IU/mL
7.5 weeks post  Undetected
16 week post Undetected
24 WEEK POST UNDETECTED (I made it)
Waiting to feel good but feeling blessed!
12 month post treatment.  All blood work absolutely perfect! VL, as expected UNDETECTED!

Offline Lynn K

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Re: 8 Wk End Of Harvoni Treatment result: Detected
« Reply #83 on: February 01, 2015, 04:39:06 pm »
I have run across something about virus fragments being in the blood that are not able to replicate.

My testing for the virus is at week 4 on treatment, EOT and 12 weeks post but I am thinking about asking my doctor to skip the EOT and do a 4 week post tx test. To me the EOT virus test means little and since I relapsed on Sovaldi Olysio seeing a 4 week post tx test I think would be more informative.
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 Bob V

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Re: 8 Wk End Of Harvoni Treatment result: Detected
« Reply #84 on: February 01, 2015, 04:39:59 pm »
Apache
Great post. Pre tx I really studied that drug info, still do.

Paul,
 I think I posted this before but my doc wasn't going to do labs until EOT too. His reasoning was that he's not going to change the treatment so what's the point. I asked and he did order 5 week VL, I was under 15. I'm doing a 8 week tomorrow. Am a nurse and I always had to follow labs so to do it for myself just seems normal. I want to know where I'm at at what point I'm UND or not. Also, I'm want to see if I would of been detected after 8 weeks.
 
I'm hoping in light of this new info today things turns out well for you, fingers crossed.
« Last Edit: February 01, 2015, 04:41:39 pm by Bob V »
Male 64
Dx hep non AB 1972, Hep C 1991
GT 1A
VL 3.7m (pre tx)
Liver B 1992, unremarkable
Liver ultrasound 2014, normal
Treatment Interferon 90's x2 failed
Started Harvoni 12/08/2014 (12wks)
Finished Harvoni  3/1/15
5wk lab detected <15
8wk lab UND
EOT lab UND!
12wk post lab UND!
24wk post lab UND!
58wk post lab UND!

Offline Tess1971

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  • G2b, 12wk Sov/Riba, End 11/15/14 UD, SVR-5,14 & 32-UD
Re: 8 Wk End Of Harvoni Treatment result: Detected
« Reply #85 on: February 02, 2015, 12:59:58 pm »
My gastro did not do any VL checks until EOT either.  He only checked platelets, LFT, etc due to using ribavirin.  He insisted that it was meaningless until treatment is over as he would continue treatment no matter what the results were.  Not sure if it was a $$ thing with insurance or truly in his experience.  I still have not seen him and will not until after my 12 week blood work.  I only communicated with his nurse during treatment.
I agree with many here that it is a question of $$ with the insurance companies as when I read studies they all had 12 and 24 week originally for Harvoni. 
I feel fortunate to have been UND so far, but, ribavirin has taken its toll on me.  I am still recovering from it.  And since I am Geno 2 there are no other options for me at this time.
In my research I have found that all these drugs remain in the system after treatment so b between that and your immune system you can still clear that small amount of virus left especially since the drugs interfere with replication.  Be positive that your body will prevail ! :)

Offline anniemybaby

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Re: 8 Wk End Of Harvoni Treatment result: Detected
« Reply #86 on: February 03, 2015, 04:27:14 pm »
I've been reading this thread Im also on harvoni for 8 wks I go for blood work every 2 wks till finished with treatment but my GI Dr told me she doesn't say I'm cured till a 6 month blood work after treatment I guess all drs are different
Annie

Offline Bob V

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Re: 8 Wk End Of Harvoni Treatment result: Detected
« Reply #87 on: February 03, 2015, 04:35:29 pm »
Annie
I think for people who took Harvoni SVR 12 was almost 99% at 24 weeks. I'll have both for piece of mind.
Male 64
Dx hep non AB 1972, Hep C 1991
GT 1A
VL 3.7m (pre tx)
Liver B 1992, unremarkable
Liver ultrasound 2014, normal
Treatment Interferon 90's x2 failed
Started Harvoni 12/08/2014 (12wks)
Finished Harvoni  3/1/15
5wk lab detected <15
8wk lab UND
EOT lab UND!
12wk post lab UND!
24wk post lab UND!
58wk post lab UND!

Offline dragonslayer

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Re: 8 Wk End Of Harvoni Treatment result: Detected
« Reply #88 on: February 03, 2015, 04:38:21 pm »
I've been reading this thread Im also on harvoni for 8 wks I go for blood work every 2 wks till finished with treatment but my GI Dr told me she doesn't say I'm cured till a 6 month blood work after treatment I guess all drs are different

I think some of the Drs are still using the older Interferon related protocols, where, if Im not mistaken, SVR24 was the name of the game (although, never having been treated with that drug, I could be completely wrong on this one)... The new DAAs which dont include interferon are more likely to include SVR12 as the end measure of success.  But as we can see, these measure will likely undergo a period of adjustment as the newer regimens roll out. .. And, at the end of the day, there still will be individual differences among the Drs and how they work....  If SVR4 is something like 99% predictive of SVR12, Im not sure it must go much beyond that even.  But one likes to be 100% sure in this arena, if that is even possible.
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 anniemybaby

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Re: 8 Wk End Of Harvoni Treatment result: Detected
« Reply #89 on: February 03, 2015, 04:46:24 pm »
Thanks Bob n dragonslayer I just can't wait to b hep c free I guess I'm going to try n lay down I've basically been up 24hrs n I feel like I've been up for days hubby says I look like a zombie he's lucky I love him hahaha
Annie

Offline dragonslayer

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Re: 8 Wk End Of Harvoni Treatment result: Detected
« Reply #90 on: March 18, 2015, 08:58:22 am »
Just heard from my doctor regarding the test I did at 7.5 wks post treatment.. As you may recall, at EOT on 1/20/15 I was singing songs of woe because I tested Detected with a VL of 29... The test I just did 7.5 wks post treatment came back still Detected, but with a level below the LLOQ limit of 12..  Doctor tells me if I were relapsing, or if I still had active virus, at 7.5 wks post treatment, the VL would have gone back into the millions where it was before... He thinks that this is a good indicator toward SVR. Ill test again at 12wks, 24wks, and 48wks.  But the fact that over a month after stopping Harvoni, the viral load was still decreasing into the range below Lower Level of Quantification is certainly a very good sign, and that  Im most likely in the SVR camp ...
« Last Edit: March 18, 2015, 09:06:48 am 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 Long_Haul

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  • Slayed the Dragon
Re: 8 Wk End Of Harvoni Treatment result: Detected
« Reply #91 on: March 18, 2015, 09:05:31 am »
Awesome news Paul! I hope you continue to progress to SVR. I wonder if they need to send the blood test to a different lab to see if the result is the same?  At any rate this looks promising and a lot better than dealing with a relapse. Best wishes and keep driving the number down. Be healthy and happy.


AL
Genotype 1A

Diagnosed 1989
Biopsy-cirrhosis stage 4 2000, no starting VL this round

3 rounds of Int+Rib
(Combo/48wks,Peg/26 Wks,Triple with Incivek/16wks)
UND with Incivek, Relapsed
Started 12 weeks Harvoni and Rib Jan 2nd,2015
4 weeks Undetected
8 weeks Undetected!
EOT at 12 weeks Undetected
EOT at 24 weeks STILL UNDETECTED
Completed TX Mar 26th,2015

EOT plus 4 weeks UNDETECTED
EOT plus 12 weeks UNDETECTED !!!!!!!!!!! I am DONE!

NO LONGER a member of the "WAITING GANG"

Offline JoeK9999

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Re: 8 Wk End Of Harvoni Treatment result: Detected
« Reply #92 on: March 18, 2015, 09:34:05 am »
Paul - What a load of great news!
Very encouraging for the rest of us that are playing the waiting game.
Diagnosed July 1995 - Genotype 1a
Think I have I had since the early 70's
Prior to Harvoni treatment:
VL 3.8 million AST/ALT 40/56
Mild inflammation, no fibrosis
Treatment naive
 
Started Harvoni 10/23/2014 for 12 weeks
11/20/2014  HCV RNA Qual - Detected
Last Day of Harvoni 01/15/2015
04/08/15 - 12 week post harvoni VL test - Not Detected
07/05/15 - 24 week post harvoni VL test - Not Detected
01/19/16 - 1 Year  post harvoni VL test - Not Detected
AST/ALT 22/22
CURED!!

Offline apache

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Re: 8 Wk End Of Harvoni Treatment result: Detected
« Reply #93 on: March 18, 2015, 09:37:08 am »
Quote
He thinks that, this is a good indicator toward SVR. Ill test again at 12wks, 24wks, and 48wks.  But the fact that over a month after stopping Harvoni, the viral load was still decreasing into the range below Lower Level of Quantification, Im most likely in the SVR camp is certainly a very good sign...

Congrats Dragonslayer, it sounds like you are definitely headed towards SVR. :)

Now that you're no longer actively taking Harvoni, perhaps it would be beneficial to try taking some of the non-Rx "liver healthy" supplements (milk thistle, dandelion root, etc) that many of us were taking before Harvoni?   Of course the evidence for these is mixed, but there is significant positive anecdotal evidence for these types of supplements.

The big concern with taking supplements while actively taking Harvoni is that the interaction (if any) has not been well studied.  Commingled with Harvoni, they could be detrimental.  Then again, it seems more likely that it would be beneficial.  However given the extreme cost of Harvoni, everyone leans towards the "lets just eliminate all supplements" argument.  And that makes sense.

But now that you're no longer on Harvoni, perhaps it might be worthwhile to add these (or other similar) supplements, to improve your chances of SVR? 

I'm no MD, but when I asked my MD about how long a Rx remained in one's system after the last dose, he said that it varies (no kidding), but it can actually be accurately calculated by looking up the "half-life" of the particular Rx.   The rule they use is that after 5 (five) half-lives, the Rx is effectively no longer active.    The reason for 5 half-lives is:
          5 half-lives = (0.5 * 0.5 * 0.5* 0.5 * 0.5)
                           = 0.0313
                           = 3%

In other words, after 5 half-lives, the effective amount of the Rx still remaining in the body is 3%, which is essentially equal to 0.

For Harvoni, the half-life is actually specified in the 31 page detailed product insert:
         http://www.gilead.com/~/media/Files/pdfs/medicines/liver-disease/harvoni/harvoni_pi.pdf

in section 12.3 Pharmacokinetics, under the "Elimination" subsection. 
They analyze the half-live in terms of the components of Harvoni:
           Harvoni = sofosbuvir + ledipsavir

and the half-lives of those two are:
            ledisavir = 47 hours
            sofosburir = 0.5 hours

which implies the half-life of Harvoni is the max of those two:  47 hrs.
Rounding that up to an even 48 hrs (ie, 2 days).
and then multiplying by 5 to get 5 half-lives:
     ==>  5 half-lives of Harvoni = 10 days.

Thus, after 10 days the amount of Harvoni still present in one's body is essentially zero.   

So if one were to start taking supplements after finishing a course of Harvoni, it would seem wise to wait 10 days.  Which you have.

Again, I'm no MD, but this is a possible strategy you might want to run by your MD. He'll either say:
   a) "Excellent idea, go for it."
   b) "Horrible idea, because... <some wise insightful observation>."
   c) "I have no idea.  It's up to you to decide."

Best wishes for a SVR!   8) 

Offline charly8

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Re: 8 Wk End Of Harvoni Treatment result: Detected
« Reply #94 on: March 18, 2015, 09:57:57 am »

and the half-lives of those two are:
            ledisavir = 47 hours
            sofosburir = 0.5 hours
 

Great Post Apache.  Just one clarification.  Sofosbuvir quickly breaks down into GS-331007 (the primary active ingredient) which has a half life of 27 hours.  This is why we are able to take one pill a day.  If it was .5 hours we would be popping almost 12 pills a day.
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

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Re: 8 Wk End Of Harvoni Treatment result: Detected
« Reply #95 on: March 18, 2015, 10:07:18 am »
Apache.. Great find there in those stats.. Both prior and Post treatment, I take Maximum Milk Thistle from Natural Wellness every day.  Ive been doing so ever since I was diagnosed in '08.   I have no idea if it works, but I do know that IVe had this disease for over 40 yrs, and Im still F 0-1 on the biopsies, so no reason to stop doing what Ive been doing.
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 motor

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  • Posts: 58
Re: 8 Wk End Of Harvoni Treatment result: Detected
« Reply #96 on: March 18, 2015, 10:29:52 am »
Great news DragonSlayer, thanks for posting and to other recent posters for useful info. 
   The VA had me scheduled for 12wks treatment, but changed it to 8.
Age 66male GT 1a/CT  Dx 5/19/14
Likely infected early 70's
VL 3.7mil FibroScan F2 FSure F2
ALT 84(12-78) AST 56(3-36) High
Tx naive
8wks Harvoni start 3/3/15 VA
4wks ALT 25(12-78) AST 22(3-36) Normal 
        VL  <15  NOT DETECTED
8wks ALT 24 AST 19 
EOT  VL   <15  NOT DETECTED
SVR12 VL <15  NOT DETECTED

Offline apache

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Re: 8 Wk End Of Harvoni Treatment result: Detected
« Reply #97 on: March 18, 2015, 11:16:59 am »
Quote
Just one clarification.  Sofosbuvir quickly breaks down into GS-331007 (the primary active ingredient) which has a half life of 27 hours.  This is why we are able to take one pill a day.  If it was .5 hours we would be popping almost 12 pills a day.

Thanks for the clarification charly8!  Your explanation makes perfect sense.   

Offline Picnic

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Re: 8 Wk End Of Harvoni Treatment result: Detected
« Reply #98 on: March 18, 2015, 02:23:19 pm »
I told you not to freak out!
Larry

Offline chino1969

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Re: 8 Wk End Of Harvoni Treatment result: Detected
« Reply #99 on: March 18, 2015, 02:52:23 pm »

Lynn,
I had exactly the same experience you did with Solvadi/Olysio.  I was SVR at 4 & 12 weeks with ALT & AST in the normal range.  I was on it for 12 weeks.  Two months after treatment I had the tests repeated and noticed my LFTs were elevated with the SVR coming in later which showed the Hep C to be back.  I am now doing 24 weeks of Harvoni with my 4 weel blood work coming up.

I sought another opinion/doctor at The Univ. of PA Hospital; a renowned hepatologist who is handling my treatment as well as my Gastro..  He told me that had I done a 24 week course of Solvadi/Olysio, there is a good chance I would have remained virus free.



Hi Paul

I did see one post on another web site forum where the person was told he was detected but then retested and was found to be clear and that a lab error had been made. We have all heard stories of people enduring chemo only to find out they never had cancer.

Just on the small chance that the was a lab mix up any chance you could be tested again?

How are you liver function tests? When I relapsed on Sovaldi Olysio I got my LFT results before my viral load and saw my ALT had gone above normal range while it had been normal the whole time I was treating the first time in decades. Seeing the elevated ALT gave me a early warning about my viral load.

Just a thought

 


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