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Week 22 results: VL stayed at <12 IU/mL (HCV Quant PCR)
We just got results of week 22 PCR back for my husband, who is 59 yo, Hep C, G 1a, f-4, 2 times previous failed treatments, and is now treating with triple therapy with Incivek, is starting week 24 today.
VLs as follows:
week 4: Det at <78 IU/mL
week 8: UND
week 12: UND
week 18: Det at <12 IU/mL
week 22: Det at <12 IU/mL
His NP called Vertex with the <12 IU/mL results, who told her that it is fine for him to continue treating as long as the VL does not go above 25 IU/mL.
So, he continues with treatment (finished Inc. on 12/24/11, now on Riba and Interferon) and we see NP again on 3/30/12 and re-do PCR same day. The VL has been checked with the same test and the same lab each time. It is the HCV Quant PCR Abbot Real Time assay and according to the results "the quantity of virus is below the limit of detection - the minimum virus level that gives a positive result in 95% of replicates - is 12 IU/mL".
Thanks to all for your well wishes this past month, and we will keep you posted.
We are relieved that he gets to continue treatment and hoping for UND at the end of this month.
Advocate1955
VLs as follows:
week 4: Det at <78 IU/mL
week 8: UND
week 12: UND
week 18: Det at <12 IU/mL
week 22: Det at <12 IU/mL
His NP called Vertex with the <12 IU/mL results, who told her that it is fine for him to continue treating as long as the VL does not go above 25 IU/mL.
So, he continues with treatment (finished Inc. on 12/24/11, now on Riba and Interferon) and we see NP again on 3/30/12 and re-do PCR same day. The VL has been checked with the same test and the same lab each time. It is the HCV Quant PCR Abbot Real Time assay and according to the results "the quantity of virus is below the limit of detection - the minimum virus level that gives a positive result in 95% of replicates - is 12 IU/mL".
Thanks to all for your well wishes this past month, and we will keep you posted.
We are relieved that he gets to continue treatment and hoping for UND at the end of this month.
Advocate1955
I am praying soo strong for you that the next test comes back UND for your husband. Reading the last post, my history is very much like his. (Partial Responder in first tx and then 2nd tx, it returned as soon as I stopped tx) I get my 24 week in another wk and anxious to know how it will turn out.
Keeping you always in my prayers, Anita
Keeping you always in my prayers, Anita
We don't know yet what exactly is going on with my husband.
We met with his NP last week, and she talked to his hepatologist, called Abbott, and called Vertex to discuss his last two PCR results. This is his third time treating 1) SOC-2007, 2) daily Infergen injections & 1400 mg Riba-2010, and 3) triple tx w/Inc-current. He was a partial responder to the first two treatments (i.e. he had the two log drop by the required time, but then did not have a significant drop after that and had to discontinue both treatments at 12 weeks).
We asked his NP if my husband's DET < 12 IU/mL results at week 16 and week 22 mean that he had a low level of virus that was not detected by the PCR test at weeks 8 and 12 that may be replicating and causing a viral breakthrough due to 1) his body's poor response to Interferon after finishing Incivek (because he was UND at week 8 and week 12) or if it means that 2) his specific "strain" of Hep C virus mutated after week 12 after completing Incivek and is more resistant. She said they're not really sure, and that it could be 1) or 2) (or both?). When she called Vertex, they said to continue treating him and re-check the VL at the end of this month, which will be the end of week 26 of his treatment. If it's working he will be treating for 48 weeks. If it's not working he will have to stop treatment.
Microbiologists, virologists, and researchers are learning so much about HCV every day. We are hoping that triple tx is working for him, but we are aware that it may not be.
His liver is still compensated, so his NP feels that he is benefiting from treating when there are treatment options and he has taken advantage of every opportunity to treat.
Advocate1955
We met with his NP last week, and she talked to his hepatologist, called Abbott, and called Vertex to discuss his last two PCR results. This is his third time treating 1) SOC-2007, 2) daily Infergen injections & 1400 mg Riba-2010, and 3) triple tx w/Inc-current. He was a partial responder to the first two treatments (i.e. he had the two log drop by the required time, but then did not have a significant drop after that and had to discontinue both treatments at 12 weeks).
We asked his NP if my husband's DET < 12 IU/mL results at week 16 and week 22 mean that he had a low level of virus that was not detected by the PCR test at weeks 8 and 12 that may be replicating and causing a viral breakthrough due to 1) his body's poor response to Interferon after finishing Incivek (because he was UND at week 8 and week 12) or if it means that 2) his specific "strain" of Hep C virus mutated after week 12 after completing Incivek and is more resistant. She said they're not really sure, and that it could be 1) or 2) (or both?). When she called Vertex, they said to continue treating him and re-check the VL at the end of this month, which will be the end of week 26 of his treatment. If it's working he will be treating for 48 weeks. If it's not working he will have to stop treatment.
Microbiologists, virologists, and researchers are learning so much about HCV every day. We are hoping that triple tx is working for him, but we are aware that it may not be.
His liver is still compensated, so his NP feels that he is benefiting from treating when there are treatment options and he has taken advantage of every opportunity to treat.
Advocate1955
Advocate: Thank you for taking the time to educate us. Do you think the virus went into hiding and the test is picking up the residual virus that is leaking into the bloodstream? GB
My husband's result said Very Low Positive, HCV RNA detected < 12. So the Abbot test detected the virus but couldn't quantify it because it was under it's quantification limit, which is 12. Rexx, if you could post exactly what is written on your lab results, I could try to help you interpret it. If yours says "negative" or "undetected" < 12, then your Abbot test did not detect any virus under it's limit of 12. My husband's was UND at weeks 8 and 12, and then DET < 12 at weeks 16 and 22.
Advocate1955
Advocate1955
I agree with Rexx. The detectable less than 12 part is confusing. Isn't 12 both the lower detection threshold and also the lower quantification limit for this test? Can this test really detect the virus below 12?
how can he be dtectable when he is under 12.i thought that the det. limit of this test is 12 and when he is under 12 should that not be UND?
i have the same test i think and the said under 12 and negative.iam very confused about this
i have the same test i think and the said under 12 and negative.iam very confused about this
I'm pulling for him. And for you. Bless you for standing by him and all your efforts to assist him in ridding himself of this terrible virus. I wish you both only the best. <3
OOPS! I meant to refer to the HALT-C trial (not the Ideal Study).
A conclusion of the HALT-C trial was, "Long-term therapy with peginterferon did not reduce the rate of disease progression” and “These findings do not support maintenance therapy with peginterferon in patients with chronic hepatitis C and advanced hepatic fibrosis who are non-responders to a course of peginterferon/ribavirin therapy.”
I'm not a doctor, nor am I a researcher, but I believe pegylated interferon helps in the long run.
Best Wishes, GB
A conclusion of the HALT-C trial was, "Long-term therapy with peginterferon did not reduce the rate of disease progression” and “These findings do not support maintenance therapy with peginterferon in patients with chronic hepatitis C and advanced hepatic fibrosis who are non-responders to a course of peginterferon/ribavirin therapy.”
I'm not a doctor, nor am I a researcher, but I believe pegylated interferon helps in the long run.
Best Wishes, GB
I concur with Bean -- regardless of what happens, his liver is getting a break while he is on treatment.
Some people (like me) believe pegylated interferon reverses liver damage (S1/S2/S3 -- but maybe not S4) and also delays the onset of tumors. I know, the Ideal Study did not prove that, and the medical field generally does not support interferon maintenance therapy, but I believe it makes a difference.
My posting is not directly related to your concern and I see from your many postings that you are exceptionally knowledgable of HCV & the treatment. I just wanted to reinforce the good that is likely being done even if the virus is not (currently) UND.
Some people (like me) believe pegylated interferon reverses liver damage (S1/S2/S3 -- but maybe not S4) and also delays the onset of tumors. I know, the Ideal Study did not prove that, and the medical field generally does not support interferon maintenance therapy, but I believe it makes a difference.
My posting is not directly related to your concern and I see from your many postings that you are exceptionally knowledgable of HCV & the treatment. I just wanted to reinforce the good that is likely being done even if the virus is not (currently) UND.
I am very relieved he can continue tx. I'm dissapointed there was any detection but everything you said above makes sense. This is incredibly low...don't lose hope. Continuing thoughts and prayers for you over here. Hang in there!
frijole: We knew that he would be going for 48 weeks from the beginning of treatment (if it worked) because of his Cirrhosis. His Hepatologist told us that right from the start. What we didn't know is whether he would have to stop now or be able to continue.
willbb: The NP called Vertex and discussed the Det <12 IU/mL results from week 18 and week 22, and they said for him to continue as long as he doesn't go above 25 IU/mL. I know that it's confusing because it's different than their futility rules, which say stop if detected at week 24. He started week 24 yesterday afternoon (3/9/12). So yesterday was the end of week 23/beginning of week 24. The next appt with the NP and the next PCR is scheduled for 3/30/12, which would be the end of week 26/beginning of week 27, since does his injection on Friday afternoons. So, they will do the blood draw just prior to the week 27 injection. The reason he is "off schedule" for the PCRs is due to the severe ice storm that we had around week 16.
candoman: He will not have a week 24 PCR, but will instead have a week 26 PCR. I know that Detected below the limit of quantification is not equivalent to an Undetected result. His Lab tests say "<12 IU/ML, very low positive, HCV detected by the Abbott Real Time HCV PCR assay using perimeters specific for the 5'UTR, the quantity of virus is below the limit of detection (the minimum virus level that gives a positive result in 95% of replicates is 12 IU/mL, the clinical significance of very low HCV level is uncertain and should be individualized."
My interpretation of all of this is that Incivek did it's job in weeks 1-12 because he became UND, but after finishing Incivek and being only on Interferon and Ribavirin he now has a very low detection, under the limit of detection, in the case of this particular test <12 IU/mL. I don't know if this means that his particular virus is a particularly resistant virus, since this is his 3rd time treating, or if this means that he doesn't respond as well as others to Interferon, or both.
Since there is a family history of HCC (brother had HCC/transplant), I know that his Hepatologist will follow him closely if he does have to stop treatment due to futility. Well, actually I imagine that she will follow him closely either way.
For now, he continues treatment, and we re-check PCR at the end of the month, and depending upon results find out if he continues or stops.
Thanks for all the well wishes everybody.
Advocate1955
willbb: The NP called Vertex and discussed the Det <12 IU/mL results from week 18 and week 22, and they said for him to continue as long as he doesn't go above 25 IU/mL. I know that it's confusing because it's different than their futility rules, which say stop if detected at week 24. He started week 24 yesterday afternoon (3/9/12). So yesterday was the end of week 23/beginning of week 24. The next appt with the NP and the next PCR is scheduled for 3/30/12, which would be the end of week 26/beginning of week 27, since does his injection on Friday afternoons. So, they will do the blood draw just prior to the week 27 injection. The reason he is "off schedule" for the PCRs is due to the severe ice storm that we had around week 16.
candoman: He will not have a week 24 PCR, but will instead have a week 26 PCR. I know that Detected below the limit of quantification is not equivalent to an Undetected result. His Lab tests say "<12 IU/ML, very low positive, HCV detected by the Abbott Real Time HCV PCR assay using perimeters specific for the 5'UTR, the quantity of virus is below the limit of detection (the minimum virus level that gives a positive result in 95% of replicates is 12 IU/mL, the clinical significance of very low HCV level is uncertain and should be individualized."
My interpretation of all of this is that Incivek did it's job in weeks 1-12 because he became UND, but after finishing Incivek and being only on Interferon and Ribavirin he now has a very low detection, under the limit of detection, in the case of this particular test <12 IU/mL. I don't know if this means that his particular virus is a particularly resistant virus, since this is his 3rd time treating, or if this means that he doesn't respond as well as others to Interferon, or both.
Since there is a family history of HCC (brother had HCC/transplant), I know that his Hepatologist will follow him closely if he does have to stop treatment due to futility. Well, actually I imagine that she will follow him closely either way.
For now, he continues treatment, and we re-check PCR at the end of the month, and depending upon results find out if he continues or stops.
Thanks for all the well wishes everybody.
Advocate1955
For the purposes of assessing response-guided therapy eligibility, an "Undetected" result is required; a "Detected" result below the limit of quantification should not be considered equivalent to an "Undetected" result.
http://www.mayomedicallaboratories.com/test-catalog/Clinical+and+Interpretive/83142
http://www.mayomedicallaboratories.com/test-catalog/Clinical+and+Interpretive/83142
I'm with will, why not a 24 week pcr?.... Confusing when they just make up the guidelines as they go. Not encouraging from them.
Sorry to hear your husband still has Det. virus.
Hopefully on the next PCR he shows UND.,however I am a bit confused.
You say Vertex said to continue on with therapy,however in their prescribing label it says that if there is Det. virus at Wk.24 all therapy should cease.
Also you say he is currently starting week 24 and they will not do another PCR till Mar. 30 which will be 27 weeks completed.
Just a bit confusing on the different protocol they are advising..
Good luck to you and hubby and hoping for the best for him..
Will
Hopefully on the next PCR he shows UND.,however I am a bit confused.
You say Vertex said to continue on with therapy,however in their prescribing label it says that if there is Det. virus at Wk.24 all therapy should cease.
Also you say he is currently starting week 24 and they will not do another PCR till Mar. 30 which will be 27 weeks completed.
Just a bit confusing on the different protocol they are advising..
Good luck to you and hubby and hoping for the best for him..
Will
Not good, but I certainly would do the 48 too. I wish there was some kind of a power boost that could be used when there is detectable virus -- maybe another round of a PI -- but that would not work, I know.
THere has got to be some answer out there somewhere, advocate. His liver is getting a break right now and that is a good thing.
my very best thoughts
bean
THere has got to be some answer out there somewhere, advocate. His liver is getting a break right now and that is a good thing.
my very best thoughts
bean
Whew. Sad it wasn't a false positive on the last test, but it is pretty darn good news that the small amount of virus still present allows him to continue tx. Could have been much, much worse. Very happy for you both
While I know the most recent VL results are not what you had hoped for, at least he can continue treatment and hopefully reach UND next time.
I am hoping for the best outcome for your husband.
I am hoping for the best outcome for your husband.
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