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My Clinical Trial (TDF vs. TAF) Post Medication Resutls
Wanted to see if anyone can offer any advice. Before I started this, I did not have all these results. My viral load started a 276,000 when I first learned of Hep B, spiked up to 5 million, 12 million and now this (and last result actually was 23 million but I do not have those results in front of me).

Is this an active Chronic infection? Any chance to tell how long I've had this? Or are there any tests to determine how long I've had it?

CBC Results:
WBC - 7.0
RBC - 4,79
Hemoglobin - 14.8
Hematocrit - 45.1
MCV - 94
MCH - 30.9
MCHC - 32.8
RDW - 13.8
Platelets - 254
Neutrophils - 56
Lymphs - 32
Monoctyes - 9
Eos - 3
Basos - 0
Neutrophils (absolute) - 3.9
Lymphs (Absolute) - 2.3
Monocytes (Absolute) - 0.6
Eos (Absolute) - 0.2
Baso (Absolute) - 0.0
Immature Granulocytes - 0
Immature Grans (Abs) - 0

Comp. Metabolic Panel
Glucose - 83
BUN - 20
Creatinine, Serum - 1.16
eGFR If NonAfrican Am - 81
eGFR if African Am - 93
BUN/Creatinine Ratio - 17
Sodium, Serum - 142
Pottasium, Serum - 4.1
Chloride, Serum - 103
Carbon Dioxide, Total - 24
Calcium, Serum - 9.6
Protein, Total Serum - 6.6
Albumin, Serum - 4.3
Globulin, Total - 2.3
A/G Ratio - 1.9
Bilirubin, Total - 0.5
Alkaline Phosphatase, S - 71
AST (SGOT) - 61
ALT (SGPT) - 115

Urinanalysis Gross Exam
Specific Gravity 1.027
pH - 6.0
Urine-Color - Yellow
Appearance - Clear
WBC Esterase - Negative
Protein - Negative
Glucose - Negative
Ketones - Negative
Occult Blood - Negative
Bilirubin - Negative
Urobilinongen, Semi-Qn - 0.2
Nitrite , Urine - Negative

HBV Real-Time PCR, Quant
HBV IU/mL - 18,907,000
log10 HBV IU/mL - 7.277
HBV Copies/mL - 110,040,000
log10 HBV Copies/mL 8.042

Panel 083824
HIV 1/0/2 Abs-Index Value <1.00
HIV 1/0/2 Abs, Qual - Non Reactive

HBV Genotype/PreCore
HBV Genotype - HBV Genotype D detected
HBV PreCore Mutation - Basal Core promoter mutation at 1764 was detected. HBV PreCore Mutation 28 was detected.

Prothrombin Time (PT)
INR - 1.1

AFP, Tumor Marker (serial)
AFP, Serum, Tumor Marker - 1.7

TSH - 1.770

PTT, Activated
aPTT - 26

Hep B Surface Ab
Hep B Surface Ab, Qual - Non-Reactive

Mitochondrial (m2) Antibody - 2.8

Vitamin D, 25-Hydroxy - 59.6

HCV Ab w/Rflx to Verification
HCV Ab - 0.1

Phosphorous, Serum - 4.0

Antinuclear Antibodies Direct
ANA Direct - Negative

Ferritin, Serum - 258

HBsAg Screen - Positive Abnormal

Hep Be Ag - Negative
Hep Be Ab - Positive Abnormal
Thyroid Peroxidase (TPO) Ab - 8
Hep B Core Ab, Tot - Positive Abnormal
Hep A Ab, Total - Negative

So yes, happy my vitamin D levels went up from 14. Still feel I could use 20 more points on there. Also need Hep A vaccine. The rest is good, except for the Hep B portion which I need to clear.
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9624973 tn?1413019730
so you only did fibromax test, which includes ( fibrotest, actitest, nash test, etc ..it may give you an idea of what's in your liver, but this is just a calculation between your blood test results.  my doctor also requested me to do fibromax (i really don't know how usefull is this ),which i did ,but i also went for fibroscan on my own ..
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thanks for the update luckyman !
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I see you had HBV DNA IU/mL: < 29 IU/mL HBV DNA Detected before too, so the sensitivity of the test is 29 IU ?
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i'm interested of your progress luckyman316. well done you!
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Hi Melcul, yes. This is what is included in the clinical trial. I'm uncertain if Fibroscan is covered by my insurance. I need to look into this. Generally, does anyone know how much one costs?
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sorte, yes it is 29iu. My doctor admitted that this was an older sensitivity from the clinical trial.
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9624973 tn?1413019730
is very cheap in european countries, in romania where i go is somewhere around 60$ ...in england although i think is a few hundred pounds
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Thanks for sharing. It's probably a few hundred US Dollars here too then.
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why they don't use some more sensitive test, I think 29 IU is not the best sensitivity ?
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Clinical trial.. you'll have to ask Gilead that question! :)
My doctor uses a better test, but they don't use that one on the clinical trial. They use what Gilead  tells them to use for Gilead's trial
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Sorry I have not been as active, updating more. They are now watching me every 2 months. I got results from my latest DXEA Scan about a month after it happened. Here it is:

Region: Spine L1, BMD: 0.889, BMC: 11.1, Area: 12.51, TScore: -2.3, ZScore: -2.3

Region: Spine L1-L2, BMD: .973, BMC: 25.5, Area: 26.23, TScore: -1.9, ZScore: -1.9

Region: Spine L1-L3, BMD: 1.021, BMC: 41.0, Area: 40.19, TScore: -1.6, ZScore: -1.6

Region: Spine L1-L4, BMD: 1.035, BMC: 57.6, Area: 55.68, TScore: -1.5, ZScore: -1.5

Region: Spine L2, BMD: 1.049, BMC: 14.4, Area: 13.72, TScore: -1.6, ZScore: -1.6

Region: Spine L2-3, BMD: 1.080, BMC: 29.9, Area: 27.68, TScore: -1.3, ZScore: -1.3

Region: Spine L2-4, BMD: 1.077, BMC: 46.5, Area: 43.17, TScore: -1.4, ZScore: -1.4

Region: Spine L3, BMD: 1.110, BMC: 15.5, Area: 13.95, TScore: -1.1, ZScore: -1.1

Region: Spine L3-L4, BMD: 1.090, BMC: 32.1, Area: 29.45, TScore: -1.3, ZScore: -1.3

Region: Spine L4, BMD: 1.071, BMC: 16.6, Area: 15.49, TScore: -1.4, ZScore: -1.4

Spine Total Adequate BMD: 1.035, BMC: 57.6, Area: 55.68, TScore: -1.5, ZScore: -1.5

Region: L.FemurNeck, BMD: 0.929, BMC: 4.7, Area: 5.02, TScore: -1.1, ZScore: -0.8

Region: L.FemurShaft, BMD: 1.145, BMC: 17.6, Area: 15.38, TScore

Region: L.FemurTotal BMD: 0.959, BMC: 31.7, Area: 33.01, TScore: -1.0, ZScore: -0.8

Region: L.FemurTotalAdequate BMD: 0.959, BMC: 31.7 Area: 33.01

Region: L.FemurTrochanter BMD: 0.744, BMC: 9.4, Area: 12.60 TScore: -1.7, ZScore: -1.6

Region: L.FemurWards BMD: 0.749, BMC: 2.1, Area: 2.80 TScore: -1.6, ZScore: -1.3

If I compare this to the other post in this thread, it's clearly obvious there is slow bone density loss going on here. This further makes me believe that I am on the old drug on this trial. Feel free to comment.
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that s a trick so in the trial you can have higher percentages of so called undetectable and put in very small writing below (hidden) und is <29, are they smart?

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Just wanted to share latest results:

HBV DNA IU/mL: < 29 IU/mL HBV DNA Detected
Total Bili: 0.3mg/dL
Dir Bili :  < 0.1 mg/dL  
Ind Bili : <0.3 mg/dL  
AST (SGOT) - 35 (down a few points)
ALT (SGPT) - 53 (down from before, thankfully)
Creatine - 1.26 mg/dL   (.02 higher than top end)
Uric Acid - 7.5 mg/dL  
Calcium - 9.8 mg/dL  
Phosphorus - 3.3 mg/dL
pH - 5.5  
CK - 213 U/L  (this number jumped up a LOT)
Parathyroid Hormone - 60.4 pg/mL (Again, up a LOT)

I'm concerned about all these and then this comes up with urine test:


CRYSTALS: Ca OX Present
MICELLANEOUS ELEMENTS: MUCOUS

How does one even get mucous in their urine? I am not sexually active so this is a shock to me

But then I see other lab:

CS&GCtrlClr KX 34.2 which is low
Apparently lots of other required testing was "unavailable"

Then I saw this and it alarmed me that this lab could just be wrong:
CYSTATIN C - MISHANDLED BY LAB


I wonder what all happened here? Very odd!!

Anyway, I've generally been feeling pretty decent and such, and am not concerned any more at this point about overanalyzing it all. We'll see what happens in 2 months.


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dont worry about some crystals in the urine. drink more water and you should be fine.
the mucous has no significance.
the creatinine is more of a problem, you do need the cystatin c to independently test glomerular filtration capacity. Insist on it to be repeated.
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I can't "insist" on it being repeated... if I do, it's through my insurance which I will not do here. The clinical trial is on a schedule. It'll be repeated in 2 months anyway, so I will wait for then. Thank you for the advice. I agree, I have not been drinking enough water lately (and a LOT more coffee) and I need to!
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Also, question. Does these tests ever say "HBV DNA UNDETECTED" or, assuming always positive HBsAG it will always say "HBV DNA DETECTED" even if it is below 29? Like let's say the HBV DNA is actually 0, will it still say DETECTED?
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For the high pth probably some vit d receptors resistance, try to drink low calcium water less than 10mg/l  2.5liters per day....we need good kidneys unless taf will be on market very soon
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the test will say dna detected as long as there is any pos pcr signal. if there is no signal, it will say dna not detected.
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Stef, I don't know what low calcium water is. I've never heard of this.. and don't think they sell it bottle here in the states. Usually, that kind of stuff is not measured and if it is, it's probably very expensive to buy here.
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dont you have the mineral content/toxic waste reported in the states?here you can t sell water without it
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They report it, but on water bottles I don't recall seeing the content amount. Just report what is in there. So I'd never be able to tell how much
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Luckyman316 how about the alpine spring water(crystal geyser) they sell it by the walmart, Safeway or lucky? All they are 0% calcium. Thanks!
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Royal, thanks. It looks like Dasani water has no calcium in it either... at least it's not listed on there. So I went ahead with that.
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Just got my latest results back, wanted to share:

HBV DNA IU/mL: < 29 IU/mL HBV DNA Detected
HBsAg
Total Bili: 0.5mg/dL
Dir Bili :   0.1 mg/dL  
Ind Bili : 0.4 mg/dL  
AST (SGOT) - 34 (down one point)
ALT (SGPT) - 54 (up one point)
Creatine - 1.20 mg/dL   (Back to normal)
Uric Acid - 7.1 mg/dL  
Calcium - 9.3 mg/dL  
Phosphorus - 3.7 mg/dL
pH - 5.0  
CK - 274 U/L  (this number jumped up a LOT again)
Parathyroid Hormone - 67.3 pg/mL (Can't get this back down)

Anyway, they refilled stuff and sent me on my way. I suspect they are flip flopping between TAF and TDF in these bottles. Some months, that I have taken it, I develop some major "TMJ" issues and things are really messed up. Others, the issue goes away. I did a lot of reading that Tenofovir/Viread has been known to cause this issue and in some cases, patients needed surgery.

Anyway, next appt is a big one again with more numbers, more blood drawn, DEXA scan, etc. I plan to take in a better diet and do more exercise between now and then. I'm going to buy a book called "the liver healing diet" which details step by step some good recipes and such to help me along the way. Who knows, it's worth a shot! :)
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9624973 tn?1413019730
hei there luckyman, i hope you are feeling ok now, what does this mean
HBV DNA IU/mL: < 29 IU/mL HBV DNA Detected  , shouldn't come Not Detected ? or it's just a typo
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Thank you melcul. Besides some slight ringing in ear, TMJ and neck issues, I feel pretty decent. I think the sensitivity of this lab only brings it to < 29 for HBV. I don't think it will ever say undetected until I one day clear HBsAg (Which was positive in this lab)

Once I'm done the clinical trial, I will ask the doctor to do his lab which is more detailed.
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Hi luckyman i hope your doing good, just wondered if after your clinical trial  would peg interferon help you to get it undetected also now that it's 29 IU/mL HBV ?
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Fresh, I don't know. As per my doctor, he recommends I do not try it. Over the course of the past 5 years or so, he's done it on 10 patients. 3 were Genotype D, 2 were Genotype C and 5 were Genotype A. Of the 10 patients, 3 of them were cured and they were all Genotype A. He saw some of the patients report a lot of bad side effects so he would not want to see me do the same thing, especially if it's not a guaranteed cure for me.
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Over 5 years of practice he treated only 10 people with interferon ?! Is it because is states nucs are more preferred/lobbed ? What side effects he saw ?
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I don't know the exact details. That is all he told me. Sorry
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That's interesting, I just hope they make a similar drug to peg interferon with out the side effects.  
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Sharing more info from my trial results. I went back for a follow-up to my doctor today, because he was away when they drew my blood last week. To my surprise, they had the results all ready so I wanted to share it:

HBV DNA IU/mL: < 29 IU/mL HBV DNA Detected
Total Bili: 0.2mg/dL
Dir Bili :   <0.1 mg/dL  
Ind Bili : <0.2 mg/dL  
AST (SGOT) - 33 (down one point)
ALT (SGPT) - 59 (up 5 points)
Creatine - 1.21 mg/dL
Uric Acid - 7.0 mg/dL  
Calcium - 9.5 mg/dL  
Phosphorus - 3.7 mg/dL
pH - 5.5  
CK - 136 U/L  (Down a lot and normalized)
Parathyroid Hormone - 45.7 pg/mL (There's that jump back down again!)
Ostase: 18.52 ug/L
Osteocal: 39.33 ng/mL (This is for bone density and is 1 point too high. It used to be higher than this though, so clearly it's gotten better)


Overall, I'm about as happy as I can be but know I have a LONG way to go with this. I did talk to my doctor about the upcoming ARC-520 conference and he was not aware of it and thanked me for the heads up. After doing some research, they are recruiting HBeAg - Positive patients for it. So I would not qualify.

A few things.. my blood pressure was through the rough when I went to draw blood. Something like 173 over 90 which is way too high for me as it's normally a set 120/80 give or take a few points. Came back a few days later to check up just in case, it was normalized. I've been dealing with plenty of stressful situations which did not help the next day. Also, I am happy to report that my cholesterol is also NORMAL. Something you don't see in today's society often in the USA because of our bad eating habits. No complaints there!

Everything else checked out and my doctor was happy to see no toxicity with the medications or even any reported events by me as a side effect. He was also happy to see me with such a positive attitude!

Anyway, 2 more months and I'm back for another round!
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Good luck!
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That is so great!  Did your doctor ever say anything about the <29 iu/ml but detected?  I've only been on Viread since April but mine has been <20 iu/ml detected ever since after month one.  I test again next month (6 month mark) but don't know if I should ever get to read undetected?
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Goodluck to you man, my only concern is your fibrosis  you said you are f0 before you start treatment and now you are f2/f3 . I thought you are not suppose to progress while on treatment . Can please raise it with your doctor why the progression from f0 to f2/f3
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fibroscore is not always accurate. fibroscan and biopsy are gold standards.
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Been a while since I posted any results but here it is:

HBV DNA IU/mL: < 29 IU/mL HBV DNA Detected
Total Bili: 0.4mg/dL
Dir Bili :   0.1 mg/dL  
Ind Bili : 0.3 mg/dL  
AST (SGOT) - 33
ALT (SGPT) - 51 (down 8 points)
Creatine - 1.33 mg/dL (A little high)
Uric Acid - 6.7 mg/dL  
Calcium - 9.5 mg/dL  
Phosphorus - 3.7 mg/dL
pH - 5.5  
CK - 164 U/L
Parathyroid Hormone - 49.3 pg/mL (There's that jump back down again!)
HBsAg: Positive

Just some comments. I drank some water before the test because I had a urine sample that needed to be taken and I already went to the bathroom an hour before my tests (I had to go bad!)

My question: Why is HBV DNA not undetectable yet? I'm getting close to 2 years on this and the test does not show HBV DNA Undetectable. Will it EVER show this (even if my HBsAg is positive?)
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Im on a trial in the UK its the same testing Gilead use for me they explained <29 is the sensitivity they use.  So might even be undetectable but its hard to say.

However Im also entitled to have government testing every 6months  and that goes as low as <10 which.

ive been on the trial about 18months

Are you e antigen negative?
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Thanks, that is what was explained to me as well.. the sensitivity of the test. The place I go to also offers as low as <10 but since they do the trial with Gilead for me, we go with this. As far as I can recall:

HBsAg - Positive
HBe Ab - Positive
HBe Ag - Negative
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I had that too, even though I was only on Virwad for 6 months (but DNA was low when started which confused me).  My doctor said to see UND she has found it's taking longer with how sensitive the testing is getting.  Also, with most trials you will notice they actually consider <29 or <20 UND, .  I know it's frustrating and hopefully others will have better information.  At least you are consistant and it's not going up.  :)
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That is what I am glad about too, that the viral load is not going up. In 4 months time I'll be switched to TAF only so that will be interesting to see if anything happens.

At the moment, I've been having some flu like symptoms the past week so I suspect I'm having some sort of immune response.

I also mentioned to the doctor about my chapped/cracked lips and the salty taste coming from my gums for a month. She is sending the bottle that I suspect caused the reaction in for investigation. I thought maybe it was a magnesium deficiency of some sort but it's well within range so this as not an issue.
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With all these quant hbv pcr tests, there is a limit of the quantifiable range. Like eg less than 29 iu. But the fundamental sensitivity of the test is well below the Quant range, could be for example 10 iu. That is the qualitative limit.  Below that no signal is detected above background and it will then say dna not detected.

Different tests have different qualitative detection limits of course,  but they tend not to disclose these. All you know is that you are between the Quant and Qual limit  with your results.

if one uses an extremely sensitive test like the ngi hbv ultraqual,  the detection sensitivity is 0.3 iu. With this test  most patients und with lesser tests will still have a pos signal.
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Does 0.3iu or below offer any type of determination s seroconverstion?

Or is it only sign of further dane partical reduction?
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Even at this extreme sensitivity it only refers to Dane particles in the v peripheral blood. It is not any indication  of the likelihood of hbsag loss or seroconversion.

Also, the low dna count in the peripheral blood is somewhat misleading, since it does not accurately  reflect the virion production in the liver, since a fairly large amount of virions are trapped and extracted in the liver right after synthesis and release, since the liver has a high affinity to absorb virions. Only when this absorption  capacity gets closer to saturation, more virions escape into the general circulation.

This is different for hbsag seroconverted patients with a high antibody.  In this case the antibody blocks the virions outside from contact and absorption to hepatocytes and almost all de novo  virions enter the general circulation as immuncomplexed Dane particles. These still register in the hbv pcr test, since they contain hbv dna.
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Wow.
So in reality there is no meaningful benefit of having more sensitive testing for dna unlike hbsag quantative?  

Or is there another form of testing for virion production in the liver,
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Thanks

Wow

So in reality it more sensitive testing of dna doesnt really offer anything meaningful? hbsag quantitive holds more meaningful info?

Or is there another way of measuring the activity of virions actually in the liver?

Thanks
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It is still  better to have a more sensitive dna test, the escape from liver reabsoption happens to some percentage of virions, thus lower is still better.

There is no direct test to measure in liver production of smaller  amounts of virions.

The Quant hbsag test measures the degree of surface antigen restricted gene expression and particle production. Since it can occur also from integrated non virion producing viral dna fragments, it is not as good a test for the remaining  cccDNA as we originally hoped.it looks more and more that a fairly high amount of hbsag is not produced from  cccDNA, very different from patient  to patient, likely depending on the time of virus evolution  in each case and the intensity of regeneration and consecutive integration of hbv dna fragments.
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Thanks for the detailed explination.

Its ashame re the hbsag quant ans ccdna correlation.

Didnt realise I had posted  my previous question twice sorry about that
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This format is weird. The new format, the original post shows up on the top of the page, on page 1. The old format, this post is never bumped!
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Wanted to share the latest labs with comments:

HBV DNA IU/mL: < 29 IU/mL HBV DNA Detected
Total Bili: 0.3mg/dL
Dir Bili :   < 0.1 mg/dL  
Ind Bili :<  0.3 mg/dL  
AST (SGOT) - 29 (down 4 points)
ALT (SGPT) - 13 (down 13 points and now NORMAL)
Creatine - 1.15 mg/dL
Uric Acid - 7.5 mg/dL  
Calcium - 9.8 mg/dL  
Phosphorus - 4.9 mg/dL
pH - 5.5  
CK - 247 U/L (huge jump.. wonder why?)
Parathyroid Hormone - 32 pg/mL (Back down again! 17pts less)
HBsAg: None done this lab, next lab it will be

Generally happy about the huge decrease in ALT. It's been always fluctuating at just above high cut off and now it's normal. Whatever I'm doing, seems to be working. Mainly dietary changes tbh. Concerned about CK levels but this is not first time it's high so let's see what next test reveals. They want me to go for DEXA, Ultrasound and MRI before next one. I swear, I was there less than 6 months ago. I suspect they are speeding up the trial for some reason. In February, I officially start TAF only.
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Correction on ALT, it's 38 not 13. But still a huge drop!
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Good results!

Keep my fingers crossed for you my friend.
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Thanks! I'm happy for the ALT loss. Because it was always high and nothing was every found on the physical tests, my doctor called it fatty liver. Makes sense, and looks to me it's normalizing. Now if the rest clears, I'll be happy. That is my goal.
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I forgot to mention, I also upped my Vitamin D levels to 20,000iu daily (though there is a day here and there I might skip due to the sheer fact that I forget to take it). I can assure you, doing this has made me feel a LOT better as well.
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That is awesome on your ALT!!  I was hoping I would read your DNA was not detected this time so we could see some correlation with DNA and ALT.  At least DNA is below detection.  
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I'd imagine when he switches to TAF it will go undetectable
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This is what I'm hoping for. With the ALT taking a huge drop like this (ok not HUGE but a good one), I have to wonder what else may happen. For all I know, I have HBsAG loss but still may have detectable DNA. I'll find out next month after my next test.

I can assure you, I feel a LOT better than I did even a few months ago. The only thing I've noticed is some extra tiredness, but it's not anything that puts me down and out.
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I think tiredness might be a sign your body is still fighting it.

In terms of hbsag loss.

When will they check your hbsag quantative next?
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It could be a sign of my body fighting it. Or it could be due to the fact that some nights, I go to bed at 1-2am :P In the US... no hbsag quantative (and not on this trial too). So I'm at their mercy on this one. It's something I have to do on my own when the time is right.
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Ah I see in the uk through hbv patients are entitled to it every 6months.

Yeah late nights wont help lol
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