week 26 VL disappointment PLEASE HELP

[geosgirl5656]

my husband is just finishing wk 26 of triple therapy (rib/pegin/vic) he is geno type 1a his VL started at just over 8million, at week 4 of just rib/pegin he was down to less than 3000 at 8 weeks he tested at VL less than 43IU the next three months we undetectable then at week 22 and 24 VL was less than 43IU. Insurance is deniging vic and doctor has gone from telling us we needed to continue to week 48 to saying this is unlikely to work. PLEASE HELP I am not sure what we should do next. He was on two prior experimental treatsments 12 years ago that did not work.

[Advocate1955]

I know you both must be very worried and concerned about the possibility of a viral breakthrough.  My husband, who has failed two previous treatments, is in a similar situation in week 23 with triple tx with Inc., week 4=VL <78, week 8=VL UND, week 12=VL UND, week 18=VL  <12.  We are waiting for the results of PCR from blood draw yesterday and should get the results back next week.  We also fear a viral breakthrough.  Hang in there.  My husband didn't miss any doses.  He was 4 hours late with one dose of Incivek, and then back on schedule.  He also had a two week reduction in Ribavirin (from 1200 to 800) during weeks 12 and 13 due to symptoms of anemia, per doctor's orders.  I find it very upsetting that your pharmacy was two days late with his Vic and your doctor's office was non-responsive about running out of Vic.  In my humble opinion, there is nothing you can do except stay the course for a couple of more weeks and then do another PCR.  Time will tell.  That's what we are doing.  We are trying to stay positive, but I think we have been mentally preparing for the past month for bad news.
Advocate1955

[geosgirl5656]

Thanks for your encouragement we have been seeing the same doctors in Boston for over 11 years and need to trust what they are sharing but the info has been confusing and not great communication during this treatment
Our other two treatments were clinical trials
This time I have done more of research to be sure we are making the most informed decisions but we still need to trust the medical professionals
So hard

[can-do-man]

This is just not typical of a normal breakthrough during treatment, your husband has allot at stake here. This is not the time to let your doctor be wishy washy. Since he makes the big bucks, make him earn it.

[willbb]

I also would add that above is just my opinion and I am not a doctor by any means and the action you decide to take should always be based on a  knowledgeable doctors opinion, however the statement you made :

"but when the insurance company rejected the claim the doctor seemed to change his explaination"        is confusing I know

Again good luck

Will

[willbb]

The futility rules state that if one is DET. at week 24 then the therapy should stop as hrsep has copied above from the Vic dosing  label  as this can lead to possible resistance.however your doctor has  said that unless there is a quantifiable number(,especially on the week 24 test) it was not acting like a typical breakthrough.

It very well could be that he is Det,however it also may be a lab error and that is why cando suggested to see if you doctor can order a re-run of the sample (even if just the one from the week 24 would be best.)

Also he should have another test " now" which would be week 26 or 27 from what you are saying and this will give a better picture.

My advice would be to continue for now ,seeing as you have Vic still and he  has the new test and if UND.. and the week 24 comes back UND. on the re-test then absolutely your doctor should appeal this decision by the insur. co in the loudest voice he can muster..

Good luck

Will

[geosgirl5656]

This is the lab report at week 22

HCV VIRAL LOAD (Final 02/09/12):
      HCV RNA detected, less than 43 IU/mL.
      Performed using the Cobas Ampliprep / Cobas Taqman HCV Test.
      Linear range of quantification: 43 IU/mL - 69 million IU/mL.
      Limit of detection: 18 IU/mL.
      Rare instances of underquantification of HCV genotype 4 samples by
      Roche COBAS  Ampliprep/COBAS TaqMan HCV test method used in our
      laboratory may occur, generally in the range of 10 to 100 fold
      underquantitation. If your patient has HCV genotype 4 virus and if
      clinically appropriate, please contact the molecular diagnostics
      laboratory (617-667-3018) so that results can be confirmed by an
      alternate methodology.

Week 24 lab results
HCV VIRAL LOAD (Final 02/24/12):
      HCV RNA detected, less than 43 IU/mL.
      Performed using the Cobas Ampliprep / Cobas Taqman HCV Test.
      Linear range of quantification: 43 IU/mL - 69 million IU/mL.
      Limit of detection: 18 IU/mL.
      Rare instances of underquantification of HCV genotype 4 samples by
      Roche COBAS  Ampliprep/COBAS TaqMan HCV test method used in our
      laboratory may occur, generally in the range of 10 to 100 fold
      underquantitation. If your patient has HCV genotype 4 virus and if
      clinically appropriate, please contact the molecular diagnostics
      laboratory (617-667-3018) so that results can be confirmed by an
      alternate methodology.

[willbb]

Did you mean both week 22 and week 24 showed <43 ?   Did the lab report state <43 DET?

This is not how typical VL breakthrough  behaves . The VL would be usually much higher ,especially on the week 24 test.

As cando has mentioned.. the best scenario would be if the samples can be re-run.

When is the next VL sceduled  and was one done at week 26?

Will

[jules2551]

He missed six doses due to pharmacy?  Is this ethical?

[geosgirl5656]

the doctor had explained if the labs were viral load detected at less than 43 we were ok as long as it was not a number he did not think it was a breakthrough but when the insurance company rejected the claim the doctor seemed to change his explaination. He did indicate he will appeal the insurance decision

[geosgirl5656]

we have had one follow up test two weeks after the original was detected at less than 43 and that too came back as detected at less than 43

They are having us come in again next week to repeat the labs

[geosgirl5656]

At week 8 of his victrelis the pharmacy was late with his victrelis. The doctors at the hospital were unresponsive and he missed six doses.
His ribo was reduced from 3 am & 2 pm to 3 am after two transfusions at weeks 12 - 16. They increased it again to 2 and 2 at week 25. They are letting us go to week 28 as we still have two more weeks of victrelis. He has been taking procrit which has helped some.  It has been so hard to see him so sick for so long. I don't want him to continue if it is not going to work but I also don't want to make the wrong decision.

[1oftheclub222]

So sorry to hear this news...wishing you the best...

there is one member here who has treated 8 times...there is always hope...if this doesn't work, it's on to the next thing...what ever that will be

[can-do-man]

While this does happen its not real common, is there any way to have the test rerun to make sure? Blips in tx testing have happened... Wishing you the best.

[orphanedhawk]

It's called a breakthrough.
I can't explain it but it's one of the many things this sneaky virus is capable of doing.

[80mecheng]

It seems odd he would go from undetectable to detectable after initial success.  Did he miss any dosages or get way off schedule?

[hrsepwrguy]

Sorry to hear about your husbands situation but the doc and ins co are following victrelis treatment protocol

2.4 Discontinuation of Dosing Based on Treatment Futility
Discontinuation of therapy is recommended in all patients with 1) HCV-RNA levels of greater than or equal to 100 IU/mL at TW12; or 2) confirmed detectable HCV-RNA levels at TW24.

http://www.merck.com/product/usa/pi_circulars/v/victrelis/victrelis_pi.pdf