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Avatar universal

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.
144 Responses
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Avatar universal
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.
Helpful - 1
Avatar universal
Ah I see in the uk through hbv patients are entitled to it every 6months.

Yeah late nights wont help lol
Helpful - 0
Avatar universal
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?
Helpful - 0
1 Comments
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.
Avatar universal
I'd imagine when he switches to TAF it will go undetectable
Helpful - 0
Avatar universal
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.
Helpful - 0
1 Comments
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.  
Avatar universal
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.
Helpful - 0
Avatar universal
Good results!

Keep my fingers crossed for you my friend.
Helpful - 0
Avatar universal
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.
Helpful - 0
1 Comments
Correction on ALT, it's 38 not 13. But still a huge drop!
Avatar universal
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!
Helpful - 0
Avatar universal
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.
Helpful - 0
1 Comments
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
Avatar universal
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.
Helpful - 0
2 Comments
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,
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
Avatar universal
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.
Helpful - 0
1 Comments
Does 0.3iu or below offer any type of determination s seroconverstion?

Or is it only sign of further dane partical reduction?
Avatar universal
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.  :)
Helpful - 0
1 Comments
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.
Avatar universal
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?)
Helpful - 0
2 Comments
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?
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
Avatar universal
fibroscore is not always accurate. fibroscan and biopsy are gold standards.
Helpful - 0
Avatar universal
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
Helpful - 0
Avatar universal
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?
Helpful - 0
Avatar universal
Good luck!
Helpful - 0
Avatar universal
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!
Helpful - 0
Avatar universal
That's interesting, I just hope they make a similar drug to peg interferon with out the side effects.  
Helpful - 0
Avatar universal
I don't know the exact details. That is all he told me. Sorry
Helpful - 0
Avatar universal
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 ?
Helpful - 0
Avatar universal
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.
Helpful - 0
Avatar universal
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 ?
Helpful - 0
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