My Hep B Clinical Trial Log

I'm not up on my Hep B stuff...but I'm sure you are thrilled with viral load. How are you feeling?

Mike's kabs, are up and down post TP and post Hep C treatment where he remains undetected.

Been a while since I posted here, so I wanted to share:

So here is my monthly update. This lab this month did not include a lot, since the schedule did not have it. Here is what I can provide though and some comments:


HBV DNA IU/mL: < 29 IU/mL HBV DNA Detected
Total Bili: 0.3mg/dL (decrease of .3)
Dir Bili : < 0.1mg/dL
Ind Bili : < 0.3 1mg/dL
ALT (SGPT) - 54 (Stayed the same within a month, still high)
AST (SGOT) - 33 (went down 4 points. Back to Normal)
Creatine - 1.25 mg/dL (went up a, .01 above normal)
Uric Acid - 6.3 mg/dL (went down, still normal)
Calcium - 10.1 mg/dL (went up a little but within normal)
Phosphorus - 4.6 mg/dL (also went up, still within normal)
pH - 5.0
CK - 123 U/L (back to normal. last month was high)
Parathyroid Hormone - 34.1 pg/mL (went down instead of up.. has always fluctuated between down and up each month so I was expecting it to go up. Glad it did not)

I guess my concerns are as follows:

HBV DNA says < 29 HBV Detected. Does this mean that the DNA is still in my body or is the wording wrong? According to the labs, <29 was the goal as showing "undetected" so I'm thinking this just means "Less than 29". Even so, my doctor suspected a year it would take for undetected. I need to ask him next appointment

HBV LOG was not reported. It was in every lab. I'm wondering if the lab missed it or if it was not reported because it's at 0 now. I'm curious to see what happens at my 1 year mark (I'm ahead of schedule too, so 1 year is in March even though it should be in April) with the tests to check for HBSAG and such.

On a side note, my study doctor quit in December and I have a new one. I liked the old one as he knew the drugs very well because of HIV Patients. But he made a few comments towards me comparing me to HIV Patients, when I was never infected with such (Thankfully!). I reminded him this was not the case with me. Apparently he quit on the spot one day right in the new year.

Hey Vickie. The ringing in the ears is still there but very faint. I'm still not sure if this is caused by the virus or is being caused by my bite being uneven after dental work. I may be getting my bite adjusted at some point but have to see.

Joint pain is there but a lot less severe then it used to be. Exercise and rest both help.

Sorry I have not posted much. I've been pretty busy with life, but wanted to share the latest with my last appointment on March 9th as we as questions and answers I had from doctor's visit:

HBV DNA IU/mL: < 29 IU/mL HBV DNA Detected
Total Bili: 0.5mg/dL
Dir Bili : 0.1mg/dL
Ind Bili : 0.4 1mg/dL (the lab changed the way this reports now.. within normal)
ALT (SGPT) - 49 (down 5 points)
AST (SGOT) - 31 (went down 2 points. StillNormal)
Creatine - 1.15 mg/dL (went back to normal)
Uric Acid - 6.9 mg/dL (went up, still normal)
Calcium - 9.8 mg/dL (went down but within normal)
Phosphorus - 3.8 mg/dL (also went down, still within normal)
pH - 5.5 (up .5 and still within normal)
CK - 134 U/L (up 11 points but still normal)
Parathyroid Hormone - 51.3 pg/mL (Once again, went up... as I mentioned, this keeps fluctuating.)

My 2 biggest concerns:

1.) Cholesterol keeps rising... I need to exercise more, this is for sure. It wasn't listed as high just yet but it's borderline.

2.) My Protein was listed as "+1" and high. Not sure why, I had mainly fruits and veggies all week.

Now onto the important doctor's questions and answers I got:

1.) Asked why the HBV LOG 10 went up .02 from one month to another. He said it was not significant and was probably just the sensitivity of the lab at the time and I should not be concerned. He'd be more concerned if it went up a full point or more.

2.) Asked him the actual meaning of my HBV DNA, whether it meant that less than 29 is detected and I could be undetected or if it meant I was still detectable but it was less than 29.

He gave me an answer pretty much identical to what I expected. He admitted that the lab the clinical trial was using was not the best and there were better labs that report as low as 10 or even 5. He said I could be any number between 1 and 29 on the lab.

I then mentioned to him that I think it's taking longer than I expected to clear and he kind of gave me a "This is where I was expecting you to be, I did say a year and it's almost a year. So as far a I'm concerned, you're on target for what we expected but all of this is just a reminder to me and you that this virus is still in you and even when undetectable, it will still live in your liver. So until that changes/you seroconvert, you need to stay on the medication or else this could come right back!"

I did say "I'm being optimistic that I'm going to clear the virus this year!" and he kind of smiled at me and told me "you could, anything is possible! the power of positivity is important!"

3.) Asked him why my AST and ALT keep fluctuating so much. He looked at me and said it's most likely from a fatty liver, as I am 30-40lbs over weight. He said that at some point, my body may have just leveled off at these numbers and so it's floating right around there. He wasn't concerned with anything serious

4.) Lastly, the new study doctor I was given, decided to take it upon herself to order me an Ultrasound. She said it should have been done every 6 months, etc. I asked about the Fibroscan and she said if it ever came down to it, she'll send me for it but right now sees no need. She did say that she had a patient who was picked up as having cirrhosis of the liver on a Fibroscan and because he displayed no symptoms of having such, they sent him for a biopsy which came back normal... odd, right?

I also had an appoint on March 30th, and had the following:

Saw the doctor today (appt window was scheduled for April but meds ran out so I had it today instead). He told me that it looks like the FDA will be approving this new formula very soon. He didn't give me a timeframe but said possibly within the year.

I had a LOT of blood drawn, since it's 1 year mark. I'll know results in a few weeks. I also had a DEXA scan done 2 weeks ago, still no results. They send to another lab for analysis. Should know within a week.

I did get results of Ultrasound back... on it, it said "unremarkable liver. No abnormalities. 13.7cm in size". That's good news indeed! They did find a cyst on each kidney and a 6mm cyst on gallbladder. I was told nothing to be concerned about, as they are fairly common, but to just watch it in a year.

After all this, I now go in every 2 months instead of every month. Clinical trial ends 2017.

Miz, I am always glad to share and willing to answer any and all questions. I love helping people as much as I can who are going through the same thing that I am going through. I have been more active on another board since it was stricly for B, so this one sort of fell through the cracks but I'll be sure to update as much as I can!

I suspect my next labs will be available to me by next week sometime. I am very happy with the ultrasound results for my liver. It actually IMPROVED from my last one in January of 2014!! I too keep praying for undetectable and even seroconversion! That would be a blessing!

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!

Hi Rachel, Sorry about the flair, but glad to see your HBV DNA dropped so dramatically! ALT back in normal range. Wonderful news. Love to hear all updates from you. Big Hugs

Thank you both of you!
Yes, I am very happy the medicine (whatever TDF or TAF) works well on me.
And the flare did help a bit in fighting the virus too.

Great to see you updating, and know your Hep B journey is helping others that follow you, luckyman. I know nothing about Hep B, but do want you to know I follow your posts. Big Hugs

Hey all, been a while since I've posted. Nothing much to report so wanted to share the latest:

Just got my latest results back:

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! :)

 hey Lucky, 

your numbers seem to be quite consistant. you have remained below the limits of quantification, but are still detected.

Hopefully your trial sponsor will continue to take care of those who committed to this trial. dont be a stranger

barry

 

Hi, just found this forum and this is my first post.

I have a question. The doctor got me started on the medicine "Viread" about 8 months ago for my chronic Hepatitis B. Is Viread the Tenofovir (or TAF) that Luckyman has been receiving?

Thanks in advance, Robert