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Hep C Discussion Forum -> Post Treatment -> My doctor isn't asking for followup Viral Load test after Harvoni???
Post Info TOPIC: My doctor isn't asking for followup Viral Load test after Harvoni???
RonH


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RE: My doctor isn't asking for followup Viral Load test after Harvoni???
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Congrats on the UND news! It is your body and life, demand your tests to know what is going on!



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Genotype 2, VL 10,000,000

Sovaldi 400milligram 1x daily Ribavirin 400 milligram 2x daily. Started treatment 8-19-14, UND 9-30-14 UND 11-12-14!
Tess


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Thanks Taz & Jill! I hope the dragon is dead and gone!  I'll be bugging the doctor for monthly VL tests.  He's already irritated that I didn't agree with him on the length of treatment.  Oh well, this ain't no popularity contest wink

- Tess



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HCV Gen 1a diagnosed 2001; Labs 11/13/14: VL 1.2 million IU/mL, ast 88, alt 111. Harvoni TX 12 weeks.  EOT - 2/18/15, VL UND & normal ast/alt.

4 wks after EOT, VL = UND; normal AST/ALT at 4, 8 and 14 weeks after EOT.  15 weeks after EOT = Undetectable!
TazKat


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Hooray!!! Slaying then dragons I say!!!!

 

Taz



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TazKat Genotype 1A null responder x 3 riba & iterferon twice, relapsed from Incivek 2012 with only 12 weeks left to do. stage 4 mild cirrhosis 4/25/2014/ started sovaldi riba & interferon.. finished treatment 7/17/14  results 7/25  cleared..

 

 
Cinnamon Girl


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Hi Tess,

Great to hear your EOT results still show you are UND...congrats!!

I agree that you should be getting more viral load testing post treatment, and I would expect you to be getting them at 4 and 12 weeks at least.  Especially considering that an UND result at 12 weeks is now considered as SVR with the new drugs, including Harvoni.

I`m sure you`ll be fine after responding so well but it`s a huge boost to get those results to confirm it! 



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Jill 

(71 yo, lives in UK)

Was Gen 3a, 

24wks Peg Ifn/Riba, Sep 2010 - Mch 2011

UND @ Wk.4, UND @ EOT, 

SVR Nov 2011 --> Still UND @ EOT + 4 yrs.

 

 
Tig


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Tess,

The data listed on the ION trial charts you referenced does indicate zero EOT failures. The listed relapse information are the results of VL testing at EOT +12 and 24 weeks according to the report. Far higher than the old SOC's!

Tig



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Tig

67yo GT1A - 5 Mil - A2/F3 - (1996) Intron A - Non Responder, (2013) Peg/Riba/Vic SOT:05/23/13 EOT:12/04/13 SVR 9+ years!

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Tess


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Thanks Tig,

In the charts for the three ION trials, tables 6, 8 and 10, all say zero for On-treatment Virologic Failure.  Does that mean everyone in the studies were UND at EOT (and then some relapses occurred later)? 

Matt, I'm thinking the same. VL tests at 4, 8, 12 and 24 weeks after tx are the way to go if possible!



__________________

HCV Gen 1a diagnosed 2001; Labs 11/13/14: VL 1.2 million IU/mL, ast 88, alt 111. Harvoni TX 12 weeks.  EOT - 2/18/15, VL UND & normal ast/alt.

4 wks after EOT, VL = UND; normal AST/ALT at 4, 8 and 14 weeks after EOT.  15 weeks after EOT = Undetectable!
Tig


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Hey Tess,

The easiest way to direct you to the trial results is to have you review sections 14.2 and 14.3. There are charts describing each of the three ION trials. You will find the rates of success and failures there. The rates are in the high 90 percentile, with the longer courses of Tx generally having higher rates by a few points. HTH!

Tig



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Tig

67yo GT1A - 5 Mil - A2/F3 - (1996) Intron A - Non Responder, (2013) Peg/Riba/Vic SOT:05/23/13 EOT:12/04/13 SVR 9+ years!

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Matt Chris


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Hey Tess

Congrats on your EOT UND result, its always a happy day to get that news.

The four weeks after EOT to me is the biggest and hardest hurdle to make. I will absolutely be requesting 4, 8, 12 weeks and 24. I happen to totally agree with knowing ASAP if I relapsed so I can determine the cause, RAV's or not. Most clinical trials test even more that this.

matt      



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"And in the end, the love you take is equal to the love you make"

61 year old Geno type A1, F4 Cirrhotic, started 24 weeks on Harvoni 12-17-14 ,EOT-5 week = UND, 8-31-15 =UND , SVR-24 Baby YES! 
Tess


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Thanks Tig.  The result I received today was from the EOT, and it is a great emotional boost!

If I'm reading the info in your link right, it says all 3 trials had no virologic failures while on treatment.  Does that mean everyone was UND at EOT and any failures happened during the weeks after treatment? 

Knowing the VL at 12 weeks after treatment is so important.  I think my nurse is being way too casual about the post tx VL tests!  I mean, can they really be making people wait 6 months or more after treatment to find out if they relapsed or not? disbelief   I will definitely ask for viral loads at 4 and 12 weeks.



__________________

HCV Gen 1a diagnosed 2001; Labs 11/13/14: VL 1.2 million IU/mL, ast 88, alt 111. Harvoni TX 12 weeks.  EOT - 2/18/15, VL UND & normal ast/alt.

4 wks after EOT, VL = UND; normal AST/ALT at 4, 8 and 14 weeks after EOT.  15 weeks after EOT = Undetectable!
Tig


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Hi Tess,

I'm unable to find my information on this. My bookmark library is so large now, I can't keep it organized, poo...  Anyway, you will note in the following paragraph from the Gilead Harvoni pdf, Section 14.1 Overview of Clinical Trials, the routine post treatment viral load testing was done at EOT + 12 weeks. Aside from this bit of info, it has been almost routine to do a VL test at the EOT as well. While not specifically called for, the EOT test provides a great morale boost to the patient. Ask your doctor to do the test and they very often will order it for you. Your insurance company may say no, but you never know til you try. Good luck...

 

Tig

 

  1. "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." 

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


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Tig

67yo GT1A - 5 Mil - A2/F3 - (1996) Intron A - Non Responder, (2013) Peg/Riba/Vic SOT:05/23/13 EOT:12/04/13 SVR 9+ years!

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Tess


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Hi all,

I finished 12 weeks on Harvoni last week (2/17), and today the nurse practitioner said my Viral Load test on 2/18 came back UND.  Woohoo!!!

But then this has me confused: confuse When I started treatment in November she gave me a standing lab order for blood work for 6 months.  The first three months' orders included HCV viral load tests.  The last three, for March, April & May don't call for VL; only CBC, liver functions and creatinine.  I asked her about that today and she said "right....you can see the doctor in 6 months if you want and talk about it then".  What???

Shouldn't there at least be a VL test at 12 weeks after TX, and usually at 4 weeks after?  It seems like that from what I've been reading.  If there's a relapse I would want to know ASAP.  Thanks for any input!

- Tess



__________________

HCV Gen 1a diagnosed 2001; Labs 11/13/14: VL 1.2 million IU/mL, ast 88, alt 111. Harvoni TX 12 weeks.  EOT - 2/18/15, VL UND & normal ast/alt.

4 wks after EOT, VL = UND; normal AST/ALT at 4, 8 and 14 weeks after EOT.  15 weeks after EOT = Undetectable!
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