My Hep B Clinical Trial Log

So here we go, got my results back pre-TAF (I officially started this so now one pill only!). Here is everything you need to know (or at least what they took):

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) - 24 (down 5 points)
ALT (SGPT) - 40 (up 2 points and still NORMAL)
Creatine - 1.14 mg/dL
Uric Acid - 6.3 mg/dL (down 1.2 pts)
Calcium - 9.8 mg/dL
Phosphorus - 4.5 mg/dL
pH - 5.5
CK - 135 U/L (back down 100pts and now normal)
Parathyroid Hormone - 36.2 pg/mL (Slight jump from last test)
HBsAg: Positive :(
Fibr. Score: 0.28
Fibr. Stage: F1, No or Minimal Fibrosis

Other things to be concerned about:

ALPHA-2-MACROGLOBULIN
296 mg/dL (range is 110.0-276.0 mg/dL so it's slightly elevated)

Apolipoprotein A1
106 mg/dL (range is 110-205 mg/dL so it's slightly low)

Osteocal - 56.61 ng/mL (range is 7.30-38.50) -- This has always been high and is associated with the bones. I'm interested to see how this one goes with TAF and if this stabilizes.

Overall, 2 weeks into TAF, I am feeling ok and no real change has occurred. The only thing I get is maybe a little more tired and I end up sleeping in during the weekend mornings, which I was not doing before. But my energy levels are pretty good at night and during the day.

DEXA scan results not in yet so I'll update when they are.

My cholesterol is all normal which is great to see and is even decreasing to the lower end of normal so my diet has been working.

This all seems excellent, though.I am not as up to speed in Hep B....more experience with the Hep.C world.

Continuing wih the study sounds like a great idea also. Mike was tested for two studies along the way.but only qualified for one. He felt like you do, that he would do anything to help.so that others did not have to go through what he has endured.

That you have more energy and focus is huge. Hoping for a bright future for you and others with Hep B.

Hugs, MamaLama

ppm guy said...
hey lucky,
good to hear your doing well. your numbers other than the CK
are consistent.

whay does your dr. say about the CK? are you on a statin?
kidneys? ca ox?

congrats on continuing with your study.

Thanks Barry.. not on any statins, kidneys are ok and they monitor the ca ox every 6 months I believe.

As for the CK, I believe the last answer I got from them was "sometimes with strenous exercise, this can go up". I am pretty active with sports so it's possible that a game I played a few days early may have affected it, or even some exercise (yoga) I did the night before. I've also seen this normalized on me tests too so it's just a matter of timing I guess.

Wanted to share some more, got results back after 6 months of TAF. Here is what I can share:

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) - 92 (up 61 points)
ALT (SGPT) - 50 (down 15 points)
Creatine - 1.20 mg/dL
Uric Acid - 8.1 mg/dL (up 1.1 pts)
Calcium - 9.6 mg/dL
Phosphorus - 3.4 mg/dL
pH - 5.5 (down 1.5)
CK - 3642 U/L (This is very high - Thought is this was related to weight bearing training)
Parathyroid Hormone - 53.1 pg/mL (Falls within normal range)
HBsAg: Positive (Was hoping this changed but I think it's getting close. No HBsAg available here in the states and while the trial is supposed to measure it, it's for internal use only and unfortunately I do not have the finances to do this test on my own).

The big concern is the ALT and CK jump. People have said this is due to weight bearing exercise, which I was doing 2 days before my tests. I find it hard to believe it would make my liver enzymes jump. Someone else mentioned this also happened to them when they went on TAF a few months before losing HBsAg *which I hope is what is going on here* as the liver is now healing itself.

Overall, I'm feeling a LOT better. Strength has returned back to me and my mind is a lot more clear, I've been having more focus as well. There's bee reports that people have cleared this virus within a year or two on TAF alone so I'm praying this is the case with me!

Hope everyone has a great day! :)

LM, thanks for the report.

I too don't like to see the AST up like that.

When will they repeat that part of your test..maybe primary care could just do the AST/ALT in between your full Hep B 6 month tests.

Mikes zoom up if he is ill...especially his GGTP....for essentially any little thing, post hernia surgery, pancreatitis attack, a med allergy. But it settles down when he settles down again.

Hoping you are feeling better.

This year has taught me so much about what our members experience...the fatigue, crazy nighttime insomnia, anxiety...and wishing to be well again...even though my liver is doing fine.

Hugs,

Mama Lama

ppm guy said...
hey lucky,
good to see your numbers are holding up.

about your CK, value.. when you started this thread you stated that you had significant muscle loss in your legs. since the #1 symptom of elevated CK is muscle loss, has your team ever looked into this? AST is also a possible marker for muscle loss.. but generally temporary.

Hey Barry, thanks for the response. They never really looked into the CK issue mainly because it was not an issue. It would always fluctuate. Some tests would be just in normal, some of them a little high but never that high. Ideally, we want to see what happens on the next test in November. It could also be blamed on my part of taking part of some weight training during the week since I returned to the gym after a year. I've read up a lot about some workouts can cause this to elevate if you do one right before a blood test, which was pretty much the case for me.

Responding to the other post as well, not sure still if the TAF caused it. I guess we'll see. I know it wasn't THAT high after being on it for 3 months. I've gotten some good explanations as to how the microfibers break down the muscles and such, and apparently a workout could spike up the liver enzymes and this CK level. All's I know is that I'll be taking a break for '2 weeks' prior to my next test.

Hi I am new here. I am very grateful that I found this site. I recently have a check up and my result came back was wondering am I a hep b carrier? I am very worry and is keeping me from my daily life

Market vac. Li/EA*. Acute. Past. Chronic. Hbv.
Hbsag. +. +. - +. -
Hbeag. +. +. - +/- -
Hep.b.core an igm. - +. - - -
Hep.b.core ab. - +. +. +. -
Hbeab. - - +/- +/- -
Hbsab. - - +/- - +

Wanted to share more results. For those that remember, 3 months ago, my ALT and AST took a huge spike and my CK was at an alarming rate. I decided to not work out AT ALL other than doing some yoga. Within those 3 months, I was feeling ok but was feeling some twinges in my thighs for about a month and a half, so my muscles were a concern. It eventually went away but I did mention it to the doctor. Here are my 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) - 28 (down 64 points)
ALT (SGPT) - 21 (down 29 points)
Creatinine - 1.20 mg/dL
Uric Acid - 8.3 mg/dL (up .2 pts)
Calcium - 9.2 mg/dL
Phosphorus - 4.4 mg/dL
pH - 5.5
CK - 148 U/L (Back down 3494 pts and into normal)
Parathyroid Hormone - Not measured this lab
HBsAg: Positive

Additionally, I got ultrasound results which showed my liver was completely normal. No damage to it at all. The ALT is the absolute LOWEST I have ever seen it. One thing to mention is that I've been very religious with my Vitamin D daily (10,000-20,000iu a day) as opposed to a few months ago where I'd miss doses. I was going through a small depression for a few weeks but it wasn't worth mentioning to the doctor as it suddenly changed right on November 1st and I've been happy since.

I was also hoping that HBsAg was going to be negative but I really feel it's just VERY VERY close to changing. This new formula is indeed working the way it's intended to work and I feel better (people have commented I even look better) daily on it. The new formula (TAF) was approved by the FDA last week. I am scared on what happens with the FDA approval, but being that I signed up on an agreement for 5 extra years, I should hope the drug company supplies the drug for the remainder of that time (mainly because I can't afford it monthly even with insurance, and my insurance may not approve it off the bat)... though my doctor did suggest there's a chance they may no longer supply it for free. However, 3 months ago he told me they continue to honor the agreement. Ideally, from what I read with FDA approvals and my knowledge of them from working in Pharma, they are supposed to continue on with the trials as a "Phase 4" where they honor the remainder of the trials until they are complete for research purposes while the drug hits the market. Anyway, hope my results help many and God Speed to all!

ppm guy said...
hi lucky,
Your numbers are great!!! And your ultrasound being normal, I would be quite excited.. If you get to hbsag negative, do you continue with drug, or do you just monitor hbsag? Interesting how your CK, and AST normalized.

I have had a couple of chronic issues, one being incurable(MS). I have followed many trials, for maintenance, and symptom relief for MS. Some drug companies allow their participants to stay on the drug for a given time., after the drug is approved.

My backround is with hep c. I followed Gilead trials for years. Do they have any add on drugs in the pipeline, to go go with TAF? best to you lucky

'

Thanks Barry! I'm glad it's going the right way so far. If my hbsag went negative, then I'd discuss with the doctor. Typically, what I have read, is that doctors will keep the patients on the medication for a year or two just to make sure they continue to develop stronger anti-bodies and then take them off. In some cases, the anti-bodies go strong right off the bat so they may reduce that time and then potentially give the patient a booster shot to make sure the anti-bodies stay and the viral load never comes back. I've heard that on the new formula, a few people have been cured on the drug (even though it's about 1 in every 10) so I'm hoping I become one of the lucky few.

Good to know about the trials. I suspect this is why they wanted me to sign on for 5 more years, so that they can continue on with the research with the drug as needed and they probably knew that it was going to be approved 3 months after I signed the agreement. Either that or it was just to continue to cover them in case it never did get approved but I'm guessing since they are spreading my visits out to every 6 months they will continue on since it'll cost them less now.

As for the combo therapy, nothing really in the pipepline. They will do some combo therapies like the drug + interferon (I won't even attempt though because it won't work right with my Genotype and give me many side effects) and the only other time I have heard of combo drugs is if a certain drug stops working, then they may offer something on top of the current drug to suppress the virus.

P.S.
I'm approaching 1 full year no alcohol at all.. and naturally, I'm craving a drink but I'm staying away and resisting that temptation.

Just an update as to where I am with my numbers:

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) - 21 (down 2 point)
ALT (SGPT) - 30 (up 9 points)
Creatinine - 1.16 mg/dL
Uric Acid - 6.7 mg/dL (down 1.6)
Calcium - 9.6 mg/dL
Phosphorus - 4.4 mg/dL
pH - 5.5
CK - 107 U/L (Down a little but in good shape)
Parathyroid Hormone - 45.7 pg/mL
HBsAg: Positive
Fibrosis Score: 0.24
Fibrosis Stage: F0-F1, no or minimal Fibrosis

Just a few thoughts:

-Surprised my numbers are as good as they are. I went 1+ year without drinking and had a few around New Year's but back to not drinking any more, so it helps indeed. My suggestion to anyone is just stay away, and you will slowly normalize.

-My diet for the holidays was pretty bad too. Ironically I lost a little weight and all my other numbers not related to the liver or Chronic Hep B are normal. Generally, I feel well other than some itching of the skin so I need to get back on my diet routines. Thankfully, I know what works.

-I've been fortunate enough to be told that this will continue on for the 5 extra years we agreed to prior to being approved by the FDA. Told the doctor this was something that concerned me as I was afraid it could end, and he too was concerned since they can no longer get anyone on a TAF trial but I was fortunate to get an extension and they are happy that they will be treating me for the time frame we agreed to.

-Generally, I'm feeling ok and just living a normal life but want to make the right steps into what I need to do next. I'm not looking towards any interferon treatments due to the potential sides, but maybe some additional natural ways that won't interfere with the meds. I'd also like to get my HBSAG measured in Quantitative to see where I am at with it and how close I can be to clearing. The trial does measure it, but they don't share the number as they consider it for internal. I heard they offer it in the USA now where I am, but no idea where in the USA these labs are for Quest Diagnostics. Can anyone share and guide me to the steps to get this done? Thanks!

hey lucky,
i just noticed that 13,776 people have viewed your trial thread.

Very encouraging news!! Yes prayers for a seroconvert year!!

Sandia