Viral Load went from UND to <12

My husband is age 59, Hispanic, Genotype 1a, diagnosed in 2007, probably had Hep C for 35 years, liver damage went from f1-2 to f-4 between 2007 and 2010.  Partial responder to 12 weeks of SOC in 2007 and partial responder to 12 weeks of daily Infergen injections and Riba in 2010. Had to discontinue both because he did not have the log drop required to continue. We don't know his phenotype.  Started triple therapy on 9/30/11, with Inc. Some moderate side effects, and completed all 12 weeks of Inc.  Had to reduce Riba from 1200 to 800 for two weeks during week 12 and week 13 due to symptoms of anemia, but then increased back to full dose by week 14.  Wk 4 VL=78, Wk 8 VL=UND, Wk 12 VL=UND, Week 18 VL=<12.  All VL tests were Hep C, RNA, Quant.

I know that in the Telaprevir REALIZE trial, 15% of previous partial responders had virologic failure, which included those who had viral breakthrough.  I also know that if the virus is detected at week 24, he will be required to stop treatment.  I also know that he will not be able to treat again with a protease inhibitor.  I also know that new treatments are 3-5 years, more likely 5 years out.  

His hepatologist is at the University of Washington Medical Center, and she is excellent and experienced.
NP talked to Hepa who said continue treating and do more labs in 4 weeks.

I recall reading in the past 5-6 months on this forum about two people for whom Incivek failed (VL did not drop below 1,000 by week 12).  

Are there people on this forum who have had a viral breakthrough on triple therapy with Inc.?
Is this likely to be a viral breakthrough that will result in having to discontinue treatment at week 24?
If so, what options would be available?

Advocate1955

[can-do-man]

I really don't think at this time you could call it a breaktrough or it would be much higher then that. Not sure about those on Inc but i do know there have been a few that has had this happen on Vic, me included. When this happened to me my doctor had the lab redo the test and it came back und. The ones here that i know about that have had this happen so far they have all become svr. Except beeblessd but she is still treating and her last test she was again und.

I would not let this worry me to much but that is easier said then done. Hang in there, wishing you both the best.

[fretboard]

"NP talked to Hepa who said continue treating and do more labs in 4 weeks."

That's really all he can do.  That >12 could mean anything from a false reading to the end of the fight and he's winning.  That's what I think and that's my hope!  good luck!!

[stormy456]

Oh, I can only imagine what is going on in your mind right now.  I have to agree with can-do that <12 does not constitute a real breakthrough, and that there is a very real likelihood of a false positive.  Please keep us posted, I look forward to the feedback from other members of the forum.

[JasmineT]

Hi advocate, just wanted to throw in some moral support, the fight for svr can be scary.  I agree with the answers above. Stick to the protocols, focus on the next test, and try not to worry.  It's too early and low to be called a breakthrough. My prayers are with you and your husband.

[suezeeque]

I'm not knowledgeable enough to have any answers for you but...  I just wanted to say that my fingers are crossed.  I'm hoping for UND on the next one!

[spectda]

I was und at 10 weeks with vic triple, under 25 at week 12 and und at week 14 , I had to stop tx at week 43 and I am SVR. My doctor believed it was likely a false positive and did not consider it a breakthrough. this was in a trial for vic.
Best of luck to you and your husband,
Dave

[frijole]

I would lean towards a false positive and try to get the test run again with the same sample.  Only I would request a more sensitive test - either the Quest heptimax (to 5)  or the LabCorp QuantaSure (to 2), depending on which lab you use.   Don't give up the ship yet.  Your hubby is one of the really hard to treat patients who has to continue treating in the hopes to achiever SVR and. so far, I think his prognosis is excellent.

bean

[Revalation]

Please keep the faith.
You and your husband have really been very brave.
I respect your support and his courage.
I will keep both of you in my prayers.
Please don't give in or give up.
This to shall pass

Reva

[crigger]

  I donot know the answer

[crigger]

Last message not compleate. The Labs are so different my does not even measure that low. Kind of makes me wonder! I pray that it all works out..

[neptune235]

I don't think you can say this is a false positive without more info.  I agree it's best to stay on track with treatment, and continue viral load testing.

Here is my addition to the anecdotal mix:  A few years back I was treating with Infergen and Riba, became undectable, and then had test results of <43.  In my case (and I assume the same is true with your test), this result means detectable virus but below the limit of the quantitative test.  

After several months of repeated <43 viral load results, we stopped treatment (it was about at week 66), and within a month my viral load was up over a million, heading north.

It will be interesting to see what your result is in 4 weeks.  Good luck for a return to UND status!

[Advocate1955]

Thanks very much to everyone for your encouraging words and support.  

We understand that it's too early to know what VL=<12 means and that there are more sensitive tests.  It would have been much nicer to hear UND though!  :)  

I will ask his NP if they could run the same sample through with a more sensitive test.  We will stay the course with treatment, do another VL on Feb. 28th, wait for the results, and see what the hepatologist recommends depending on the results.  My husband will be in week 22 about that time, so I'm assuming that unless there is a 1 log increase with that VL, his hepatologist would do another VL about two weeks later at the end of week 24, to check again, although we didn't talk about that when she called yesterday.  Does that sound right?

From what I've read, if a patient on a PI has a Viral Breakthrough (defined as HCV RNA detectable at anytime during treatment after being UND  http://www.clinicaloptions.com/Hepatitis/Treatment%20Updates/HCV%20New%20Agents/Module/Practical_Guide/Pages/Page%202.aspx) of more than 1 log increase, the PI must be discontinued. I read this in:  “An update on treatment of genotype 1 chronic hepatitis C virus infection: 2011 practice guideline by the American Association for the Study of Liver Diseases”, By: Marc G. Ghany, David R. Nelson, Doris B. Strader, David L. Thomas, Leonard B. Seeff  

Does anyone on the forum know what a 1 log increase from UND would be?  Just wondering.

Also, from what I've read, Hep C, g 1a, can have a "wild type" mutation, which demonstrates more resistance.  I read this in the following article:  http://www.journalofclinicalvirology.com/article/S1386-6532%2811%2900342-8/abstract.  

Is this "wild type virus" a mutation on the NS3 protease gene?  

And, if so, would the percentage of people who had Virological Breakthrough on the REALIZE trials be largely made up of people who have this mutation?  

Thanks for all your help.  I know that I'm probably stressing over something that will turn out to be a glitch (hope and pray), but after two previous failed therapies, I'd rather study and be prepared with my questions ahead of time.

Advocate1955

[jules2551]

You are Waaayyyy  over my head in all of these questions.  You look like you have studied and prepared very well for your Hepa Dr.

As for the one log increase?  I believe you would just add a zero to the previous VL?  so if it was VL=<12 then one log increase would be VL=<120.  Which of course would not be UND.

You better wait for the pros to chime in here.  They definitely know more than I do on the subject.

Best of luck to you and your hubby...hang in there

jules

[willbb]

I would agree with cando and frijole on this ,if possible the best case scenario would be if they could re-test the same sample  again.
A "breakthrough " is technically a >1 log (factor of 10)( above Und). in this case so  it would be 100 IU/ml.
So no, technically there has been no breakthrough,however the re -do if possible hopfully sheds more light on this and if that is not possible obviously the next PCR should tell the story.

Yes ..1a can show more mutation sites than say 1b,however I don't know the stats on whether or not there was more breakthoughs in trials with 1a vs. 1b,

Att this point  maybe not stresiing (easier said than done I know) about the  sceintific aspect of it.. and just carrying on till the re-test or next PCR and hopfully  it was just a blip in the test.

Good luck

Will..

[Advocate1955]

That's what we're hoping for:  just a blip.
Advocate1955

[HippyHal]

Praying for success, and that it was just an anomaly.