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]

So wanted to provide another update... before I start, I had this lab drawn on 03/30/2015. During that weekened, I had decided to try Dr. Oz's weekend cleanse program.

http://www.doctoroz.com/article/48-hour-weekend-cleanse

The food was delicious but it was rough and probably not the best weekend to do this right before a lab. On top of this, I had a championship ice hockey game the night before... it was one I could NOT miss.

So here are results... this was considered the "1 year mark" even though it was a month ahead of time:

HBV DNA IU/mL: < 29 IU/mL HBV DNA Detected
Total Bili: 0.6mg/dL
Dir Bili :   0.1 mg/dL  
Ind Bili : 0.5 mg/dL  ALT (SGPT) - 49 (down 5 points)
AST (SGOT) - 38 (Up 7 points, says it's 2 pts higher than normal)
ALT (SGPT) - 64 (Highest it has been for a while
Creatine - 1.16 mg/dL  
Uric Acid - 6.9 mg/dL  
Calcium - 10.2 mg/dL  
Phosphorus - 3.7 mg/dL
pH - 6.9  (up .5 and still within normal)
CK - 138 U/L  (up 4 points but still normal)
Parathyroid Hormone - 23.1 pg/mL (Might be lowest I have seen this on this particular lab. It went down a lot.)

Now for the "more numbers I don't get often" portion:

P1NP - 113.90 ng/mL (It was high)
Protein - Labeled as "Trace"
Ostase - 22.92 ug/L (Normal)
Osteocal 46.78 ng/mL (High but 8 points from normal)
HBsAg - Positive
HBe AB - Positive
HBe Ag - Negative
Fibr.Score - 0.36
Fibr.Stage - F1-F2 Moderate Fibrosis (I was F0 before treament)

All this being said, I think it's time to make some lifestyle changes very quickly! It's the only thing that could help. Feel free to comment!

[Royal36]

Thank you luckyman316.

[luckyman316]

Sounds about right, Phase III ends 2017. It the study, it mentioned that I'd be switched to open label new formula for a year so I suspect that is the last leg of it after Phase III is done. Will keep you posted on all results when I get them in  a few weeks.

[sorte]

I guess that 2018 is end time of the study and it's not equal to phase 3 close. So they continue study after phase 3 closing, which is 2017 like you mentioned.

[luckyman316]

sorte, that is what I thought too
My study completion data is actually in January of 2017. If memory serves me correct, the patent on the original drug expires then so it might be possibe they are approving it within the year and releasing it right when the patent expires.

[sorte]

Good to know that there is possibility of nuc with less side effects.
I don't understand one thing, study completion date is 2018 https://clinicaltrials.gov/ct2/show/NCT01940341?term=TAF+HBV&rank=3
and your doctor said it may be approved by FDA within one year.
I thought it may be done only after finish of the phase 3.