My Hep B Clinical Trial Log

MamaLama said...
luckyman316...great to hear from you and hope you are "feeling well" too.

crossing fingers with you for HBsAg negative as well!

Hugs,

ML

Thank you. Feeling, for me, a lot better each and every day. My mind has been the clearest it has been in a while (and even more so compared to 8 months ago) but I know it's a long journey. I feel like half of it is over but still have more to go. However, this is the best major breakthrough I have seen for myself in these labs. I go back in December and until then, I will continue to live a normal life.

ppm guy said...
hey Lucky,
congrats on your UNDETECTED. that's exciting news!!

your creatinine looks to be on the high side. Could that be a typo?

Yup, typo, it was actually 1.07... right within range.

Sorry all, been kind of quiet here but...

Since my trial continues to go (I really lucked out on the 5 year extension) then I'll share my results some more from my last visit:

HBV DNA IU/mL: No HBV DNA Detected
Total Bili: 0.6 mg/dL
Dir Bili : 0.1 mg/dL
Ind Bili : 0.5 mg/dL
AST (SGOT) - 26
ALT (SGPT) - 32
Creatinine - 1.20 mg/dL
Uric Acid - 8.2 mg/dL
Calcium - 9.7 mg/dL
Phosphorus - 3.6 mg/dL
pH - 5.5
CK - 162 U/L (Down a little but in good shape)
Parathyroid Hormone - 35.0 pg/mL
HBsAg: Positive
Fibrosis Score: 0.25
Fibrosis Stage:F0-F1, No or minimal Fibrosis

Of note, numbers on mostly everything increased slightly but not alarming and all still fall within range. I had a bad diet in November/December due to holidays so blame that for increased numbers and being a bit overweight (well more than my normal).

Additionally, my cholesterol was on the high side of the cut-off for normal and my blood pressure was VERY high, the worst it was.. I think it was 152/96 which is nowhere near normal for me. What it boils down to, is I need a good diet plan and more exercise. My exercise has been lax in the winter. I want to lose 20-30lbs by my next visit.

Lastly, I was offered the chance to participate in ANOTHER clinical trial by Janssen. My doctor said it aims at a cure within 6 months. I believe it is for:

JNJ56136379: https://clinicaltrials.gov/ct2/show/NCT02662712

It's being brought into the states and was looking for recruits. However, since it's only in Phase 2 and since I would need to go untreated for 6 months to qualify for it before I even start it, I said "No thanks... let's talk when this current trial is over in 2020 and the new one is in Phase 3. Since I don't qualify by being on this trial, and I don't want to go untreated, it could be too dangerous if the virus comes back on a viral load at an alarming rate, or I build a resistance to the meds by going off of it... and all for something that is only 6 months worth of treatment that is not a even guarantee cure yet."


Let me also add really quick.. I had to go back to get blood redrawn for the HBV DNA and Parathyroid Hormone because the labs were not able to get the results due to some tubes apparently not coming over correct to the labs (the doctor verified it was not them, it was sent properly, they think something happened in transit).

Hope everyone is well!

ppm guy said...
hey Lucky,
your numbers are still very good. You will get back on track with diet and exercise..

your trial has yielded good results, and hasn't effected your health, negatively. Having a treatment that you can take long term, maintain your health, and give you sustainable results is a blessing.

Hopefully the Janssen drug will pan out. I waited years and followed many trials waiting for the hep c cure. the trials recruit patients that are more likely to respond favorably.

Has anyone in your trial gone hbsag negative??

Thanks Barry, yeah I'm watching all these trials to see if I qualify for any and if they cure anything or when they may be available in next phases or even approved by FDA.

As far as I know, 1-2 folks have seroconverted on my trial but no official data was released on them. Just their own stories from another site I post on. Seems like it happened right after they were switched to TAF on the trial and it took about a year to do so (give or take a few months). Still praying my time is coming soon for that!

hey Lucky,
good to hear your taking care of what you can. (weight and BP). Hoprfully your gallbladder polyps remain small on your future ultrasounds. I also have a cyst on my left kidney. my cyst has been there since I started with my GI.(25 years).

Your hbv dna is below the limit of detection (>20iu/ml). that has to be a typo.

good luck with your dieting, and look forward to your progress

Hi Lucky
Good to hear from you.. good to hear your BP has normalized. Fatty liver must be under control with your normal fibrosis scan.

Let us know what comes of your JNJ possibility. Happy new year Lucky

Yup, this is still going on for me and I'm happy about it! I think I have 2 more years left. My doctor has been hinting at some of the newer trials in Phase II that are targeting a cure. I may strongly consider if it goes to Phase III or right after this trial is done. Anyway, my results have gotten me down a bit. While I did lose 12lbs since my last visit due to better diet and exercise (go me), 7lbs came right back in 2 weeks. I just don't know how this keeps happening so quick. I want to keep going down, not up. Additionally, my Ultrasound Lab mentions Fatty Liver or Hepatocellur Disease and that just gets me all messed up in the head right now. Increased cyst on my kidney, increased liver size and smaller polyps on my gallbladder (which seem to actually be shrinking).

Regardless of all that, here are my lab result numbers:

HBV DNA IU/mL: HBV DNA < 20 IU/mL Detected (I'd feel comfortable if it said Not Detected again.. still does not say that)
Total Bili: 0.6 mg/dL
Dir Bili : 0.1 mg/dL
Ind Bili : 0.5 mg/dL
AST (SGOT) - 23 (up 2 pts)
ALT (SGPT) - 30 (down 1 pts)
Creatinine - 1.08 mg/dL (down .02)
Uric Acid - 7.9 mg/dL (down .5 and back within normal range)
Calcium - 10.0 mg/dL
Phosphorus - 3.3 mg/dL (up .9)
pH - 5.5 (down ..5)
CK - 157 U/L (up 30)
Parathyroid Hormone - (Not calculated this test)
HBsAg: Positive (The labs say they are supposedly measuring quantitative but I'm only getting this result)
Fibrosis Score: (Not calculated this test)
Fibrosis Stage: Not calculated this test

Some of the things that concerned me last lab, and results this lab:

Cholesterol was a little high at 233 mg/dL (down 2pts but not eno0ugh, my max should be 280)
My C&GCrtClr was 126.7 mL/min (down a few pts, still high as my max should be 125.0)
HAPTOGLOBIN (HPT) (Not Measured this lab)
Direct LDL (Not Measured this lab)

Anyway, wanted to share. I'm praying for a cure for us all sooner rather than later (either naturally or through medicine)! God Bless all!

ppm guy said...
Hi Lucky,
Wow!!! 37,000 have followed your story..
Your numbers look good
Best to you

Wow that is a lot. It is a full arena for sure. Maybe one day I'll be talking about this and how I was cured as well, in front of that many people. Hopefully that cure is very soon!

Actually aloe vera (pure) does not contain water. When you buy in a store and look the ingredients the ingredient #1 is water. That juice does not have any water.

Hey all, been a bit since I've posted an update and glad to see so many folks are following this as well. Just an update on my numbers here from my latest labs:

HBV DNA IU/mL: < 20 IU/mL HBV DNA Detected
Total Bili: 0.7 mg/dL
Dir Bili : 0.1 mg/dL
Ind Bili : 0.6 mg/dL
AST (SGOT) - 26 (up 3 pts)
ALT (SGPT) - 34 (up 4 pts)
Creatinine - 1.35 mg/dL (this went up and is too high now)
Uric Acid - 9.5 mg/dL (this went up by about 1.5 pts and is also too high now)
Calcium - 10.0 mg/dL
Phosphorus - 2.9 mg/dL (down .4)
pH - 5.5
CK - 244 U/L (up almost 100pts and now way too high)
Parathyroid Hormone - 23.9 pg/mL
HBsAg: Positive
Fibrosis Score: 0.35
Fibrosis Stage: F1-F2 Moderate Fibrosis

Everything else measured was within range. The big concern was with my Cholesterol because my LDL was way too high at 192 mg/dL and my total Cholesterol was 254 mg/dL. Defintiely glad I've gotten on some diet changes and exercises recently.

Additionally, my liver over the past year has gone from pretty much completely normal to a fatty liver to now having a mass on the right lobe of the liver. The mass was measured at 1.4 x 1.3 x 1.4cm and when discovered on the ultrasound, the doctor called me the same day and wanted me to get a MRI. It said: Hyperechoic consistent with hepatic steatosis. There is a new echogenic mass in the right lobe of the liver measuring 1.4 x 1.3 1.4cm" He comforted me a bit saying that this is fairly small and that I should not be too concerned about it, but naturally I've had some worry. I have a MRI scheduled coming up. The ultrasound also showed I had a gallstone (never had one before) and a 3rd polyp on my gallbladder now.

I did ask the doctor about any new clinical trials that may be more towards a cure, especially since I have what is essentially 2 years left on this one at most. He mentioned 2 of them, one from Janssen (Which looks like it was Arrowhead's therapy at some point) and one from Assembly. Here are the two:

This looks like the ARO-HBV now with Janssen. He said he has heard and seen results on this and it looks very promising
http://www.natap.org/2019/HBV/090519_02.htm

He then mentioned Assembly as well, but didn't share details:
https://www.assemblybio.com/programs/hbv/

He wasn't sure if I'd qualify for either just yet but asked I keep an eye on them. Anyway, I'll leave this post at this for now. I'm doing a few things that will definitely benefit me over the course of the next year, stuff I should have focused on the past few years. Better late than never thought! I'll keep you all posted on any findings or progress as it comes along!

Adding more to this as per my results:

The liver is normal in configuration without evidence of steatosis or cirrhotic morphology. No mass is seen in the right lobe of the liver in the area of increased echogenicity seen on ultrasound. There is a minute right lobe cyst, 15:14. There is some degree of motion on in and out of phase images. I suppose an area of focal fatty change could be missed but there is no evidence of such.

Wow what a long 6 months it has been. I actually fell extremely ill from Feb-March. I was doing good trying to lose weight and at some point in January hit below the 200lb mark. Something was going on though and the weight loss was fairly rapid for me. Feb was the worse, watery diarrhea every day, tons of muscle wasting, lack of appetite and before I knew it was down another 10lbs in a month. Doctors tested me for everything (C. Diff, Lupus, all bacterial cancers, cancers, etc.) Bottom line is, nothing major was found and I was really weak then. Suddenly after that, I started to develop a heavy cough as well... right when COVID-19 hit. The doctors would not test me for COVID-19 at the time because, well, I didn't have a high fever but there was definitely something wrong and I'm still not full recovered. That being said, my body is still healing but I still had to go on the clinical trial testing. I'm feeling better day by day (short of having a tooth pulled recently and now probably needing neck surgery in the future). However, I did want to share my results here. There's improvements in most areas:

HBV DNA IU/mL: < 20 IU/mL HBV DNA Detected
Total Bili: 0.9 mg/dL
Dir Bili : 0.2 mg/dL
Ind Bili : 0.7 mg/dL
AST (SGOT) - 19 (down 7 pts)
ALT (SGPT) - 28 (down 6 pts)
Creatinine - 1.23 mg/dL (back below the upper limit and within range)
Uric Acid - 8.0 mg/dL (down 1.5pts, the same 1.5 it went up last time)
Calcium - 10.3 mg/dL
Phosphorus - 3.9 mg/dL (up 1 point)
Cholesterol: 207 mg/dL (While within range, still on the high side of normal)
pH - 5.5
CK - 84 U/L (down 160 pts and back in range)
AFP: 1.7 ng/mL
Osteocal: 29.11 ng/mL
Crosslaps: 1.26 ng/mL (This concerns me because it's telling me I have Osteoporosis? And this may explain why I'm feeling weaker lately)
Parathyroid Hormone - 23.9 pg/mL
HBsAg: Positive
HBe Ab: Positive
HBe Ag: Negative
Fibrosis Score: Not measured this lab
Fibrosis Stage: Not measured this lab

Additionally, I had the following 2 measured 2 weeks prior to these tests, something I have not measured in a while:
HBSAG in Quantitative - 1318.00 IU/mL
Vitamin D, 25-Hydroxy - 133 ng/mL

Vitamin D3 was so high that the doctors asked me to stop taking the supplements.

I do want to add my Ultrasound Findings. If you recall, 6 montths ago, theey discovered what may have been a lesion and fatty liver. The lesion was just a fatty lesion but still concerning. This Ultrasound: "No significant parenchymal abnormalities. Liver Size 13.1cm" this means everything is back to normal. Not even fatty liver!!

Unfortunately, my gallbladder still has problems: Cholelithiasis. Several small polyps measuring 3-5mm in size. Does not say how many this time.But the polyps are smaller now.

Kidney still has a stable 16 x 19 x 20 mm cyst with mid to inferior right renal cortex. This has unfortunately grown.

All things considered, especially since I was extremely ill from Feb-March, I'm doing better on my numbers here and thankfully better than I was expecting. I am happy to see the liver has shown drastic improvements overall here. Not sure what to do with gallbladder and kidney though. That is a little bit more tricky. Anyway, just wanted to share. Thanks!