My Clinical Trial (TDF vs. TAF) Post Medication Resutls

[luckyman316]

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.

[luckyman316]

Sorry, the title meant to say PRE Medication results.

That being said, for numbers sake, I'm just going focus on the liver and Hep B numbers that were given to me prior to taking meds.

HBsAg - Positive
HBe Ab - Positive
HBe Ag - Negative
HBV DNA IU/mL - 22,300,000 (Increased from 18 million a month ago)
AST- 99
ALT - 219

I asked about the major increase in liver fuctions and they said that the numbers are different than the prior labs because it's a different lab

[luckyman316]

Wanted to share the last test I had, the day I started to take medication, right before I took it. Here:

FIBROTEST
Fibr. Score - 0.16
Fibr. Stage - F0, No or minimal Fibrosis
ALT - 179
AST - 82

HBV DNA IU/mL - 18,400,000
HBVLog10 - 7.26
HBe AB - Positive
HBe Ag - Negative
25- Hydroxy Vitamin D - 76.6 ng/mL

Somehow, my liver enzymes reduced as did my viral load.... without being on meds. Go figure! I'll share more after next blood test to see how much as reduced.

[luckyman316]

Sorry, my HBsAg - Positive

Is ther a way to edit these posts? I keep forgetting to add things.

[stef2011]

no need to post all tests, only hbvdna pcr and hbsag quantitative are important

[luckyman316]

Thanks, Stef.. that's what I'll focus on going forward.

[SafiSifa]

Hello Stef,

Although his HBEAG is negative, he has high level of HBV DNA. What do you think about it? Any mutant?

[stef2011]

it is not important, tdf or the new tdf formula work totally indipendently from bcp/precore, hbeag pos or neg, hbvdna and hbsag levels

another important thing is, for those planning sequential, pegintf result is indipendent from genotype, bcp/precore, hbeag.only hbsag and ip-10 levels matter for response

[SafiSifa]

what do you mean by the new tdf formula?

[luckyman316]

Not sure if you can see this, but this is the clinical trial I am on and probably what Stef means with the new formula:

TAF vs. TDF for the Treatment of HBeAg (-) CHB – U.S. and International
Evaluate the safety and efficacy of tenofovir alafenamide (TAF) compared to that of tenofovir disproxil fumarate (TDF) in treatment naïve and experienced adults with CHB as determined by the achievement of HBV DNA <29 IU/mL at Week 48.  

[luckyman316]

Wanted to share with everyone my new results after one month on clinical trial treatment. I'm only going to share the numbers that are relevant. Keep in mind, they did not do all the tests this time around (such as Fibroscan, HBsAg, Vitamin D, etc.). Those tests are done on certain schedule for the clinical trial. But here is the great news:

Total Bili: 0.2 mg/dL
Dir Bili: < 0.1 mg/dL
Ind Bili: < 0.2 mg/dL
ALT (SGPT): 88 U/L
AST (SGOT): 48 U/L
HBV DNA IU/mL - 40,200


Yes, a HUGE drop!  

Still not undetectable. I think the goal is below 48 IU/mL for the clinical trial. Hoping that happens within 6 months and my body naturally seroconverts...

[luckyman316]

Also, wanted to share my experience so far into it. At first, I thought I was getting cold spells 2 days into the medication. I was concerned with lactic acidosis so I asked my doctor and he said it never happens with Hep B patients on these meds. He said it was just a warning put on the label. Turns out, it was just the air conditioning being raised in the building I work in :)

I did have some nausea the first few days while taking these meds. At first, I was taking it with lunch and wasn't feeling right during the day. So I decided to take this before bed. Bad idea, as I had food in me but wasn't digesting right. So, I now take this at 8-9pm when I usually eat my late dinners. That made a huge difference.

I also had some diarrhea the first week on this. My stools, got a little lighter while on these meds. Nothing of concern though. I've had brief "dizzy" spells of 5 seconds or so, again nothing to be concerned with. Also, skin itching.. which I attribute to the Hep B.

Those were the worst side effects I had. Now, onto the good:

-My strength feels as if it's returning while on these meds. Not 100% but about 70% there

-My brain fog, while still there, is slowly lifting. Some days good, some days bad

-The good weight I had lost when this all started and went active, is coming back.

-Sleeping patterns are pretty good and my appetite is back to normal.

-Tinnitus (ringing) in my ears also reduces. I noticed if there was anything I did that affected my liver -- such as taking motrin or not eating the best foods, it would increase.

These are the upsides. I'm also sober -- alcohol free since I started the meds. I've had many offers for many drinks too, and I've turned them all down. No real pressure to drink from friends or other people, thank God!

[luckyman316]

Based upon my latest and prior results and after 1 month treatment on Tenofovir, what needs to change with these numbers (Obiously lower ALT and AST and Viral Load, but what else?)

Total Bili: 0.2 mg/dL
Dir Bili: < 0.1 mg/dL
Ind Bili: < 0.2 mg/dL
ALT (SGPT): 88 U/L
AST (SGOT): 48 U/L
HBV DNA IU/mL - 40,200
HBe AB - Positive
HBe Ag - Negative
25- Hydroxy Vitamin D - 76.6 ng/mL
HBsAg - Positive

FIBROTEST
Fibr. Score - 0.16
Fibr. Stage - F0, No or minimal Fibrosis

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.

[SafiSifa]

you need fibroscan and qHBSAG test regularly in order to see how the treatment goes

[luckyman316]

Hi, according to the clinical trial log I have.. Fibroscan done at every 6 month mark, qHBSAG done every 3 month. This is not something I can easily ask them to do. The trial has a "schedule" of when these tests are done.

Of course, I just want to know what needs to change here on my tests. My 2 month follow up will be in a couple weeks. I'll post more results when needed.

[stef2011]

of course you have the baselines of fibroscan and hbsag?

[luckyman316]

I just wanted to share more with 2 months on this. Of course, still not considered "undetectable". Was hoping viral load would go down more but such as is...

HBV DNA IU/mL - 7,650
HBV LOG 10 - 3.88
Total Bili -- 0.8 mg/dL
Dir Bili -- 0.2 mg/dL
ALT (SGPT) - 69
AST (SGOT) - 43

This is all I can share for this month, all other tests are irrelevant towards liver and Hep B. Next visit should show more results.

[Rome70]

you missed the most important test - hbsag quant. the other tests are irrelevant to hbsag clearance.

[Aduiski]

Luckyman, it looks to me your results are getting better, as your DNA and ALT are decreasing...so it looks to me that the therapy is working.  
You have to be satisfied, as just 2 months ago your DNA was in the millions and now only 7.5 thousands :)
Most importantly your Fibrotest showed no or minimal fibrosis...so it doesn't look to me that you will die from Hepatitis B but most likely you will just have to take medicines for the rest of your life (thats in the case they don't find better medicines down to road...but what a big deal anyway to take pills for the rest of the life).
The only thing you need to care is from now on that you don't miss your daily medications...as when missing your virus might build a resistance and make big damage to your liver.

Just find a good liver specialist (if needed get second medical opinion as well) and stick with therapy....

Wish you the best brother...

[luckyman316]

Romeo - The hbsag quant will be done during the trial (they have a schedule so I can't just ask them to do this freely at any time... I will ask my doctor though next time if he can do it outside the schedule)

[luckyman316]

Thanks, Aduiski... yes, medicine is working and believe me, I am never missing a dose, well until a "cure drug" is found. I actually found my liver specialist from the hepb.org site and could not be happier. My previous doctor, GI doctor, was helpful but wasn't aggresive enough for treament and wanted to play the waiting game. I knew I needed treatment ASAP so went for the second opinion, which got me into the clinical trial.

[Aduiski]

Well excellent...I would just add a regular 6-monthly scan with either ultrasound or even much better with MRI, to look for early HCC (which you'll have less then 1% of chance to develop as you won't be getting cirrhosis nor will you have DNA more than 2000 IU/ml.... but hey lets play the safer side for that 0.5% of risk for liver cancer during ones lifetime)...

So no much reasons to worry...you are in an excellent spot now. If you havent discovered Hep B on time you would most likely die from Hep B, so you discovered it on time, you lucky man :)

Now get back to enjoying your life bro...

[luckyman316]

I had an Ultrasound done in January.. per my request from my GI doctor. They said my liver was normal. When I started the clinical trial, they also put on the schedule an Ultrasound at the 6 month mark as well as a yearly one, so it will be about a year after my ultrasound in January.

Question though, why do you say I have less than a 1% chance to develop HCC and I won't be getting cirrhosis? Agreed, I'm in a good spot now and praying for a real cure to be out sooner rather than later.

Yes, definitely enjoying life. Just got back from a Niagara Falls vacation! :)

[Aduiski]

Becase only about 5% (on average) of Hep B peple develop HCC cancer on average...and this number is lower for people with genotype D - like yourself, probably no more than 3% (this includes both treated and untreated people)
Adding that from now on your DNA (in a month-two time) will drop bellow the critical level of 2000 and your ALT will eventually normalize as well, your chances to develop HCC during your lifetime as less then 1%, as opposed to huge number of people who don't even know about Hep B and whose are most at risk to develop HCC
Chirossis you won't develop (ok maybe again you have 0.5% to develop it but it won't happen God-willing), as even if you had mild chirosis (which you are far from having it based on your fibrotest), tenofovir would reverse it (this was shown to be the case in clinical trials), provided you keep regularly taking your meds.
So you are FREE brother...just make sure to do your regular checks and liver scans....

[luckyman316]

Thanks, Aduiski.. this actually makes me feel a little more comfortable. My Hep doctor did say my genotype was the least likely for HCC cancer. The rest of the tests being good are, well, good. I guess that's why they didn't feel a need to stick me with a needle :)

I was worried about chirossis due to the fact that I did a LOT of drinking for 3 months straight before I even knew I had Hep B (I found out about a month after a big trip that involved some major drinking, and I got weird symptoms not typical of Hep B). Now, if I could only find out what's causing my other symptoms and how to get them to go away. The meds definitely help and thankfully, clinical trial is 2 years. Hopefully, by then, something comes out for a cure drug.. I'll be first in line here in the states for it!