4 week blood test results. And the rest!

[asle]

Firstly, I have been a little overwhelmed at my body's inability to handle triple tx with Incivo. Very disappointed, body. And as I have a rather foggy, spongy half a brain happening, I have found it hard to post. But today I got back some results and need some feedback.

Firstly, I was waiting on the results of the 4 week VL (started with 17mil) and HCV PCR results. These blood tests taken 18/3/13 were used to check 4 week results, and I added  Iron, Thyroid, B12, Folate to the request.  Today is 25/3 and this is what the lab sent to my doctor.
HCVL RNA                         Detected
HCV Viral Load                   15
HCV Log Viral Load             1.2 IU/mL

HCV RNA has been detected, however the calculated quantification is below the linear range and the numeric value should be interpreted with caution.
Early viral treatment response (EVR) is defined by at least a 2-log reduction in viral titre following 12 weeks of therapy.

I thought that I would have a more definite result of where the virus was at in an HCV PCR result. Why have I got an RNA and not a PCR? What's the difference?

Also, my hemoglobin levels dropped from the start of Tx level of 146, to 2nd week 110, third week 89, then 75. Went in last wed for a couple of bags of blood. Felt almost human again. Give me more blood. Had more blood tests today to check hemoglobin level. Get results tomorrow. Australia doesn't use Procrit in HCV Tx, so it's straight to transfusions.
BUT, Iron levels are high at 45 (Bloods taken BEFORE blood transfusion), so GP a bit concerned. B12 439,  Ferratin 791. Folate 1020. Except for the high Iron, are the others OK that high?

OK. Next concern. My thyroid. Was diagnosed finally with Hypothyroidism in about 2001, and have managed it on 100mg Oroxine and 100mg DHEA. I had adrenal exhaustion and my body stopped making Progesterone etc, so I took DHEA. It worked with the Oroxine, and I was managing physically very well for the past 12 years. Everytime I tried to stop the DHEA coz I would rather not be taking a steroid hormone, my body would crash, and my thyroid would go haywire, so it was easier to stay on it. Like I said, I was functioning well. Then I was told I can't take DHEA with Incivo, so I have been aware that, along with all the Sx of Riba, Interferon and Incivo, how would I notice if my DHEA levels plummeted and my thyroid began to misbehave. But I DID notice, and so I asked for TSH and T3 T4 tests on 18/3. T3 and T4 fine, TSH 14.3. Not good.
What does that mean?
My GP said to up the Oroxine to 200mg, and do a test again in 3 weeks.

I have made an appointment with Head nurse of Liver Clinic  for this Thursday, as my doctor didn't seem to think she needed to see me for another month.
And I am now very concerned about this new doctor at Liver Clinic. I had been seeing the head of Gastrology at the hospital for the past 2 years leading up to TX. We communicate very well, have both been honest and upfront with each other. But this new doctor came to see me after transfusion, and I tried to talk about what was going on, and when I asked whether we could nurse me through the next 7 weeks, she said it looks more like we have to look at terminating Tx. NO discussion. NO what options have we got. NO desire to communicate further. It was a bit of a belly blow. First time I really faced the reality of not being able to finish Tx.
Anyway, I thought I had better speak to head nurse in Liver Clinic ASAP, to sound out what this doctor is really like, and if I might just deal with Head of Liver Clinic like I used to.
Bit of a **** really.

[asle]

Firstly, thanks again for still being there, Pooh.

Will have my old spunky specialist back. Not the very Scottish Christine.. Smiles all round. He was away.

Thyroid: Upping Oroxine from 100mg to 200mg, with a TSH test in 3 weeks. if there is still a problem, then endocrinologist time. My thyroid reading the day I started Tx,  TSH was 1.7,(19/2) so a big jump to 14.3 (18/3).

As my viral load dropped from 17 million (19/2) to just 15 (18/3), which I understand is about a 5 log drop (don't understand the log measure!), everyone seems pleased.

Even though high Iron and Ferratin readings, if I stop trying to take in as much iron from other sources, if I need more transfusions that will be OK.

I am aware that I will be treating for 48 weeks. We have to get me through the Incidious, then try to up my Ribavirin from just 2 a day, slowly til back to 1200mg, or thereabouts.

We don't have the Heptimax or Quantasure measures here in Nth Qld. Not sure about rest of Australia.

So, haemoglobin levels are back up this week from 75 before transfusion to 97. Having another test Monday.

It looks to me that my body just went into oops, what the hell is going on, and reacted rather violently to Tx. Now it's had a big hug, a good talking to, and as I learn more and can recognise Sx etc, and I can hear my body again through these poisons, I believe in the process.
Just one day at a time.
Don't put off bathing and creaming the merest hint of a rash.
Eat more than 20 grams of fat if you can. Try to wait only 20 minutes before pills. I no longer have heartburn/acid, though if I don't eat enough at 7pm Riba, even though its such a reduced dose, I get stomach pain.

[asle]

I've asked for an 8 week test to see where everything is at, especially for the PCR results. They've agreed.

[asle]

Thanks for your kind words. I hope you are being supported there over the ditch, in the land of the wrong white crowd. Spent a few years there over time.

[asle]

Thanks for your advice and interpretations of tests and your wealth of experience.
Have called a bit of a meet at the hospital for tomorrow, to discuss my concerns with new doctor etc.
Hopefully, all will become clearer. Will stay in touch, of course. You are all my lifeline.
In the meantime, trying to remain sane with the landlords deciding that my flat needed a makeover. They know I'm on treatment, and how 'under the weather' I am. Especially pre transfusion,. But THAT didn't stop Cat, oh no. I was finally banished to the bedroom whilst a new roof went into the bathroom, and the lounge got emptied and painted etc. This is AFTER painting the bedroom, where I had to go and sleep at a friend's house where she talked all night. THEN the plumber came to fix downstair's bathroom, which is under my bedroom, So I had drilling, banging and swearing from under the bed, swearing and falling ceiling in bathroom, teams of helpers to paint and strip lounge, and everyone taking smokos on the front porch, where I used to lay in the afternoons.
Team that with all the old bay windows being taken off to be stripped, and the urgent influx of hungry mosquitoes, and I didn't know what was what for 2 weeks. Between rashes and hungry mozzies, and heat rash and stateless in my pretty little hideaway, the lounge got finished yesterday. Now I have to clean up the mess, and put everything back. I had a balance going here before Invasion day. Make little mess, then clean little mess.
These things are sent to test us.

[hrsepwrguy]

Protocol states you have to be under 1000 IU/ml at wks 4 and 12 to continue treatment

[hepcat1954]

thanks!  so you have to be  1000 IU/mL.

[hrsepwrguy]

2.7.1 Duration of Treatment in Treatment-Naive Subjects

In subjects who have had no previous treatment for HCV (treatment-naive), treatment with telaprevir must be initiated in combination with Peg-IFN and RBV and administered for 12 weeks.

• Subjects with undetectable HCV RNA at Weeks 4 and 12 receive an additional 12 weeks of Peg-IFN and RBV alone for a total treatment duration of 24 weeks

• Subjects with detectable HCV RNA at either Weeks 4 or 12 receive an additional 36 weeks of Peg-IFN and RBV alone for a total treatment duration of 48 weeks

HCV-RNA levels should be monitored at Weeks 4 and 12 to determine treatment duration.

Treatment with telaprevir should be discontinued in subjects who do not have an adequate viral response during treatment.

http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/AntiviralDrugsAdvisoryCommittee/UCM252562.pdf

Treatment Futility Rules: All Patients
HCV-RNA  Week 4 or Week 12: Greater than 1000 IU/mL Discontinue INCIVEK and peginterferon alfa and ribavirin (INCIVEK treatment complete at 12 weeks)
Week 24: Detectable Discontinue peginterferon alfa and ribavirin

Laboratory Tests
HCV-RNA levels should be monitored at weeks 4 and 12 and as clinically indicated. Use of a sensitive real-time RT-PCR assay for monitoring HCV-RNA levels during treatment is recommended. The assay should have a lower limit of HCV-RNA quantification equal to or less than 25 IU/mL and a limit of HCV-RNA detection of approximately 10-15 IU/mL. For the purpose of assessing response-guided therapy eligibility, an “undetectable” HCV-RNA result is required; a confirmed “detectable but below limit of quantification” HCV-RNA result should not be considered equivalent to an “undetectable” HCVRNA result.


http://pi.vrtx.com/files/uspi_telaprevir.pdf .

[hepcat1954]

It's been awhile for me but if you're under 25 week 4 and week 12, you discontinue incivek and do 12 weeks of SOC for a total of 24 weeks.  RVR's on victrelis do a minimum of 28 weeks.

If you're not RVR, then you do a total of 48 weeks...

[jules2551]

As for your thyroid TSH elevated and T3 and T4 are normal, you should have a thryroid antibody test run.  It's called Antithyroglobulin Antibody.  This will confirm or deny Hashimoto's Autoimmune Disease.  You are definitely "hypo" and probably feel like $^&*!  Do you find that your throat is tight in the morning and it's difficult to swallow?  Along with chills in the afternoon?  I agree with Pooh that you should see an endocrinologist to get this under control as soon as possible.  

As for your Iron levels- You are from Australia so some of your numbers don't make any sense to me because you probably have different reference ranges than we do here in the US.  In order to diagnose iron overload you need to have a Serum Iron (SI), Transferritin Iron Saturation % (TS%), Total Iron Binding Capacity (TIBC), Unbound Iron-binding Capacity (UIBC), and Ferritin.  According to my lab reference ranges your Ferritin is definitely out of range.  On average it should be between 50-150.  

If they above iron tests come back elevated you may have Hemochromatosis.  It's a genetic disease in which your body produces too much iron and stores the excess in the liver.  The iron will also damage your liver along with the Hep C.  The only way to reduce your iron levels is to have a phlebotomy.  They will continue this until your TS% is an acceptable level and monitor you further.

But since you are having HGB issues right now there is no way they would address the iron levels.  If I were you I would have the test runs just to know one way or another.  Who knows the labs could have been a fluke.  

Definitely have the thyroid taken care of ASAP.  You don't want this to be a game changer for your future treatment.

Best of luck and keep us updated!
Jules

[pooh55811]

I just wanted to expand on my comment about your thyroid and adrenal problems. As I previously stated, as far as your thyroid is concerned, you seem to have a very complicated problem with the thyroid and the adrenal glands. Because your thyroid and adrenal problems are intertwined, there is not a simple answer to your question. You already had a complicated situation before treatment and it appears that treatment is compounding your thyroid and adrenal problems. This is why I suggested that you get an urgent appointment with an endocrinologist who can accurately determine your current medical situation and manage your treatment for both your thyroid condition and your adrenal condition. Hopefully, a knowledgeable and experienced endocrinologist will be able to treat and stabilize your thyroid and adrenal problems and allow you to continue treatment. So it is urgent that you see an endocrinologist ASAP before your liver treating team makes any decisions on terminating your Hep C treatment.  Hopefully, the endocrinologist will be able to tailor a treatment for you that will allow you to stay on Tx. Best of luck.

[willbb]

TSH 14.3. Not good.
What does that mean?
------------
-that you are "hypothyroid" (underactive thyroid) .
Normal ref. range is .5  -5,however most good endo's would like to keep this in the .5 to 3 range.

Synthroid is the medication used to treat this with excellent results and very few, if any SX for most.

The thyroid could be "hypo" as a direct result of the therapy doing INF.. (very common) or could also be just normal age related(as this is also very common)

An appoint with your doctor or possibly and Endo to gauge and tx. this problem would be advised  best..
Will

[Idyllic]

I am thinking along the lines of detected.

1) HCV-RNA in plasma was measured using a COBAS® TaqMan® assay with a lower limit of quantification of 25 IU/mL and a limit of detection of 10 IU/mL.

So that was UND based on that particular assay. You were detected based on the limits of detection for the assay of the test you used.

It goes on to say:
"    For the purpose of assessing response-guided therapy eligibility at weeks 4 and 12 (see Table 1), an “undetectable” HCV-RNA result is required; a confirmed “detectable but below limit of quantification” HCV-RNA result should not be considered equivalent to an “undetectable” HCV-RNA result."

To me this is a good example of why so many of us who were UND based on the Taqman eventually wanted to have a PCR with the Heptimax or the Quantasure.
_________________________

As far as your thyroid what was your baseline TSH and what is it now? Interferon can induce, exacerbate or worsen Hypo in some people so based on what little you have mentioned in this post it would not be unusual for your TSH to hike.

Since you are Hypo I am guessing you know the symptoms. Not knowing more of the facts I agree about not taking the DHEA.  But seriously I encourage you to seen an Endo about this especially if your adrenal or cortisol levels are involved.

I like to post a study or less biased info but in this case I think this guy gives a good explanation
http://www.drdebe.com/dhea-the-real-story.html

[pooh55811]

First, I am sorry to see that you are having all of these problems with treatment. I know that is very discouraging.

I agree with hrsepwrguy  concerning the testing method and the terminology used (RNA, PCR). I also agree that you are still Detectable, even though at a very low detection level, and that the test used is a very sensitive and accurate test.

With your test result of    HCVL RNA   Detected;   HCV Viral Load    15,
the protocol would call for you to do 12 weeks of Incivek, Interferon, and Ribavirin, and then an additional 36 weeks of Interferon and Ribaviron, for a total treatment time of 48 weeks. You were Detectable at week 4 so you would need to do the 48 weeks, not the 24 weeks.

I know being DET at week 4 is discouraging but several of us (myself and hrsepwrguy included) were DET at week 4, did 48 weeks of treatment, and have attained SVR. It is true that the SVR percentage rate is lower (than someone with eRVR), but you are responding to treatment (17,000,000 down to 15) and your VL is now low. You still have a very good chance at attaining SVR just like hrsepwrguy and I did (and many others).

The main problems you face, as you know,  are the other medical conditions you have and your other lab values.

Your Hemoglobin dropped dramatically from 146 to 75 in 4 weeks. That is a rapid drop. Ideally you would be able to use Procrit as well as transfusions. But since that is not the case, hopefully they will continue to transfuse you. I know there was another woman on the forum who did have multiple frequent transfusions while on treatment just so she could stay on treatment. I believe she had since attained SVR.

Your blood levels of Iron at 45, B12 439,  Ferratin 791, and Folate 1020 ..... I am not positive what those levels would correlate to in the US. Here is some information you could look at. You need to find out the normal range for the tests in Australia. Then the info below may be of use.

http://labtestsonline.org/understanding/analytes/serum-iron/tab/test

http://labtestsonline.org/understanding/analytes/ferritin/tab/test

http://labtestsonline.org/understanding/analytes/vitamin-b12/tab/test

http://www.nlm.nih.gov/medlineplus/ency/article/003488.htm

http://www.nlm.nih.gov/medlineplus/ency/article/003490.htm

http://www.nlm.nih.gov/medlineplus/ency/article/003686.htm

As far as your thyroid is concerned, you seem to have a very complicated problem with the thyroid and the adrenal glands. I cannot answer exactly what your tests mean. My suggestion would be to get an urgent appointment with an endocrinologist who can determine your current situation and manage your treatment for your thyroid condition. I don't think a general practitioner has the expertise to handle your thyroid and adrenal problems, especially while you are on treatment.

If you are comfortable dealing with the head of the liver clinic, then it would probably be best to continue seeing that doctor. Why would you change now if the head of the liver clinic has been seeing you and if you are comfortable with that doctor and trust that doctor. Plus that doctor knows your history. If it was me, I would try to stay with the doctor I knew and trusted. Hopefully you will be able to talk with the doctor you trust and see what your options are.

Your situation and your medical problems are complicated so you need a team of knowledgeable, experienced,  and competent doctors to manage your care. Hopefully you will be able to stay on treatment, but you need a competent team to be able to figure out your medical problems and manage them well.

I surely hope you can get the expert care you need so that you can finish treatment if at all medically possible.

I wish you the very best of luck.

[ceanothus]

Your stuff is complicated with a number of issues I don't fully understand, but I can at least chime in on the HCV RNA PCR results. You didn't achieve EVR but you are responding well. In terms of viral load there is no reason at all for you to discontinue tx. I was also still DET at 4 weeks, but was UND by the time I got to 8 weeks. I completed 48 weeks of tx 6 months ago and am now SVR (hooray!). This is the same path you would normally follow unless there are other reasons for stopping tx early. I don't know a lot about the thyroid problems you are facing, and I hope someone with more knowledge of that will come on and help out. It's also a real shame that you can't get procrit, but in your shoes I would take as many transfusions as are needed. Good luck!

[willbb]

hepcat & asle:


Incivek's treatment protocol is if you're < 25 IU/mL @ week 4 & week 12 you should continue Tx for 24 weeks
------------------------------
Opps..Not necessarily.

If virus is detected (as is the case of the original poster the protcol is to do Inci. for the 12 weeks and then continue on the combo if INF/Riba for another 36 weeks...Total of 48Wks

As HPG  metntioned above ,,if the Virus is still DET. (as the lab report reads that it is )  ,and with this particular test the limit of Detection(LOD) is between 10 and 20 (below)

http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2168538/


When serial dilutions of genotype-specific clinical HCV specimens were tested, the assay showed a limit of detection between 10 and 20 IU/ml and a linear range of 25 IU/ml to 3.91 × 108 IU/ml.

To the OP:  There is no reason to stop therapy ..with this result .

Good luck on your next PCR. Hopfully it wil lbe UND.

Will

[hepcat1954]

Incivek's treatment protocol is if you're < 25 IU/mL @ week 4 & week 12 you should continue Tx for 24 weeks.  So you're responding properly.  Why do they want to take you off Tx?  Talk to your main liver doctor as this does not sound correct.

[asle]

I guess what I am looking at, and someone please correct or enlighten me, is that as I am still detectable at wk4, and having such a tricky time with the Incivo, that there is a very real possibility that there is nowhere to go here, and they'll pull me off all tx.
Alternatively, if I had've been UND wk4, and they decided to pull the Incivo, they might have kept me on riba and Interfering for the 48 weeks, with some chance of SVR.
My real concern here is that they pull me of Tx completely. I already waited 15 months to go on Tx while my husband- at-the-time went on, then as he left me the day he finished Tx, my specialist wanted to wait another 3 months for me to pull my head in re; vodka therapy for broken heart, and to see if I was in a good frame of mind to go on Tx. So, I'm concerned that damage to my liver continued during this time, and I may not be able to keep further deterioration at bay whilst I wait for new tx/trials to come to Australia. Even if I never touch alcohol again, the damage is done.

[asle]

The lower limit of detection is 15 HCV RNA.
The linear range is 15 (log 1.2) to 100,000,000 (log 8.0) HCV RNA IU/mL.
The test used the COBAS Ampliprep/COBAS TaqMan HCV assay, version 2.0.

Can you explain further if this is the definitive test you would want at the first 4 week vL test? I'm sure it is NOT the result I would want at this stage!

[hrsepwrguy]

"I thought that I would have a more definite result of where the virus was at in an HCV PCR result. Why have I got an RNA and not a PCR? What's the difference?"

There is no difference, they are the same test.

RNA = ribonucleic acid = This is what they look for to detect the virus

PCR = polymerase chain reaction = This is the method they use to detect the RNA

Definition: PCR, which stands for polymerase chain reaction, is a biochemical technique performed in laboratories. There are many medical, legal and research uses for PCR, including virus and bacteria identification, forensic matching and diagnosing disease (such as genetic disorders).
----------------------------------------------------------------------------------------
Now to address your result.

HCVL RNA                         Detected
HCV Viral Load                   15
HCV Log Viral Load             1.2 IU/mL

HCV RNA has been detected, however the calculated quantification is below the linear range and the numeric value should be interpreted with caution.

It clearly states that you are still detectable for the virus and really that is what is important at your wk 4 viral load test.

However it appears that you are detectable below the limit of quantification (15 IU/ml) but I am not sure of that because I don't know the LLOQ or LLOD of the test you took

[nzkiwilife]

Hi asle,
I'm in nz and procit isn't funded here either.
Someone more knowledgeable than me will be sure to post tomorrow am.
I don't know about all the stuff in your post but I can empathise.  
All the best to you!

[jpv1]

wow sounds like a lot going on there. I have the same issues here in Brisbane no straight talk. Being american it seems they dont likeme getting free health care either. They have post phoned my TX treatments for almost 2 years Im even thinking about a lwayer at this point. There telling me I have to see a denist even though my dental work in my opinion is fine. I go to the dentist he sends me back to the hospital and now they tell me its 5 more weeks for an appointment geesh some so call free health care they should call it " no care" Keep us posted on your findings ASLE least we got some sort of sound board that listens here lol Take care John