My Hep B Clinical Trial Log

October 2020 Update:

Hi All,

Just some updated numbers from the trial. FYI, I was told I may be the last person left on this trial so this time next year, it will be ended. I discussed this with my doctor and he mentioned not to worry about it too much for me, we'll do what we must to either get me on medications to continue them but it's likely a new trial will come out that I would qualify for. At the moment, I do not qualify for any trial.

With that said, in between the last tests I had and this one, I have had some major dental work done as well as a major surgery which required a one night stay in the hospital. My numbers were good before the surgery and my numbers are STILL good after the surgery. They ran additional tests as well to be sure nothing happened after surgery and so far, I am safe. So I'm having no major issues. Here is what I can share:

HBV DNA IU/mL: No HBV DNA Detected (Notice a different result this time? Hmmm)
Total Bili: 0.8 mg/dL
Dir Bili : 0.1 mg/dL
Ind Bili : 0.7 mg/dL
AST (SGOT) - 25
ALT (SGPT) - 37
Creatinine - 1.16 mg/dL
Uric Acid - 7.4 mg/dL
Calcium - 9.9 mg/dL
Phosphorus - 3.3 mg/dL
Cholesterol: 237 mg/dL (While within range, still on the high side of normal, my LDL is definitely high on here)
pH - 6.0
Fibrosis Score: 0.28 (F0-F1 -No or minimal Fibrosis)
CK - 254 U/L (This is really high again)
AFP: Not Measured This Lab
Osteocal: 22.20 1 ng/mL
Collagen T1 Crosslaps: 0.84 ng/mL (This still shows as high but better than last one)
Parathyroid Hormone - 39.5 pg/mL
HBsAgII: Positive -- (Anyone know what it is II now?)
HBe Ab: Not Measured This Lab
HBe Ag: Not Measured This Lab
HBSAG in Quantitative - Not Measured This Lab
Vitamin D, 25-Hydroxy - Not Measured This Lab

Overall, not bad for someone that just had a bunch of other medical stuff going on. I was actually expecting some stuff to be worse but seems like it's just stayed close to the same and nothing alarming. I'll definitely be asking for Vitamin D and HBSAG quantative tests next year again before I am off the trial. One day, I hope there is a cure. I'm ready for my miracle!

October 2021 Update (The Last of my clinical trial):

Here were the last and FINAL results from this Clinical Trial. The trial ended and I am now my medication through my insurance. I started this trial in 2014 and I was actually the LAST person on it, from what I was told. I consider myself lucky to be part of this and hope I have helped many with the effectiveness of this treatment of TAF. When I started, I did not know if it was TAF or TDF but since 2016 I knew 100% it was TAF when they officially extended it and put me on it.

As for my final numbers, I am not happy I was NOT cured in all this time. I strongly considered stopping treatment after 7 years when this trial ended on it but my doctor advised me against it. I still have it in my mind that I should maybe attempt to stop and see what happens. He gave me good reasons though such as some numbers and such not being where it should be for me to attempt to stop and see if I can clear it out.

I *was* however, offered to be on 2 clinical trials the past month. I have yet to decide if I want to take part in either but 1 has officially cured one of my doctor's patients. My reluctantcy is due to time constraints, me wanting to focus on other areas of my health the next 6-8 months and the fact that the trials add Interferon treatment later on in the course (something I really don't want to attempt at a younger age for myself)

Here is my final number:

HBV DNA IU/mL: <20 IU HBA DNA Detected (I hate these wordings when it does not say undetectable)
Total Bili: 0.5 mg/dL (Has stayed fairly consistent)
Dir Bili : 0.1 mg/dL
Ind Bili : 0.4 mg/dL
AST (SGOT) - 29
ALT (SGPT) - 37
Creatinine - 1.13 mg/dL
Uric Acid - 8.8 mg/dL (Considered High)
Calcium - 10.0 mg/dL
Phosphorus - 2.4 mg/dL
Cholesterol: 243 mg/dL (Down slightly but I've gained a LOT of weight in the past year and a half due to my inability to exercise right from injuries and surgeries, so I need to refocus)
pH - 6.0
Fibrosis Score: 0.26 (F0-F1 Minimal to No Fibrosis)
CK - 259 (Very high)
AFP: Not Measured This Lab
Osteocal: 28.84 ng/mL
Collagen T1 Crosslaps: 0.59 ng/mL
Parathyroid Hormone - 65.3 pg/mL
HBsAgII: Positive
HBe Ab: Not Measured This Lab
HBe Ag: Not Measured This Lab
HBSAG in Quantitative - 3599.00 IU/mL (This has gone up a lot but I was told this is ok and normal.. which I disagree with)
Vitamin D, 25-Hydroxy - Not Measured This Lab

My glucose was also high for the first time ever. I won't post the number but it has never been high in my life. I am not diabetic but if someone were to see the slight elevation they'd possibly put me there as borderline. This absolutely has everything to do with my weight gain I am sure.

Anyway, this will be my last post here on this topic. I may start another one and reference my trial posts in there, especially if I *do* opt to go on another trial, but in the meantime, thank you all for your kindness and support and advice over the many years!

I'm sure many of you have followed my journey through the clinical trial of TDF vs TAF since 2014. That journey ended at September 2021 as I was actually the very last patient to complete the trial (and one of the first few that started it).

Once that was completed, I had to go through my insurance to receive TAF - Vemlidy for 1 full year. The cost wasn't bad since insurance covered it. Unfortunately, my insurance no longer covered the medication starting July 1st, 2022. So my cost went from being $60 USD to $1683 USD a month. Needless to say, that was unacceptable and very unaffordable as well (to some, this is a monthly rent/mortgage for living in the United States).

I finally got in with my doctor and he seemed surprised when I told him this, even though I sent him an email about it over a month ago to see if he could fight my insurance. The good news, I was able to convince insurance to get me what remained for "One Last Time" before July 1st, 2022 so I was good until end of September. The bad news? I am now being forced to go back to TDF - Viread because that is covered by insurance.

My doctor doesn't know why they dropped it but only gave me the one option above. There are no more clinical trials for him to recruit me on. They tried getting me on one and did try to recruit me hard on it but I declined. They did mentioned there may be a new clinical trial in 2-3 months time that I would likely be a candidate for, and may be geared towards a cure, but didn't have any info on it at the time nor was it open yet.

Anyway, that being said, I'll be back there in September. Before I give you my numebrs, let's just say my weight puts me in an Obese stage and I am unable to lose weight on a diet alone myself but I also have two failed neck surgeries in my neck, thus making it impossible to work out to lose weight as well. My blood pressure was very high at a 150 over 105 and this was very concerning to them. It goes down when I lose weight yes, but I suspect it's higher because of the failed surgeries (my surgeons told me this could happen). On top of this, my heart rate was at a 104 and going fast, but I also walked to the facility so that could have been a contributing factor.

Anyway, here are the other results *only posting what I feel is relevant*:

Glucose - 91 mg/dL
Sodium - 140 mmol/L
Calcium - 9.8 mg/dL
Bilirubin, Total - 0.4 mg/dL
Alkaline Phosphatase - 66 IU/L
AST (SGOT) - 23 IU/L
ALT (SGPT) - 36 IU/L
pH - 7.0
HBV IU/mL - HBV DNA not detected (This means the medication is working!!!!!!)
AFP, Serum, Tumor Marker - 1.8 ng/mL
Hep B Surface Ab, Qual - Non Reactive
Hep B Surface Antigen Quant - 4168.00 IU/mL
Phosphorus- 2.9 mg/dL
HBsAg Screen - Positive

My only concerning piece is that My HBsAg Quantitative has gone UP since March 2020. They are now as follows:

In March of 2020 it was at:
1318.00 IU/mL

In September 2021 it is now at:
3599.00 IU/mL

June 2022 it is now at:
4168.00 IU/mL

I can only assume that the weigh gain and poor diet plays a big part in this because in March of 2020 I was 185lbs and June 2022 I am 255lbs. I'd be more concerned on being on a clinical trial with an increasing value like this and honestly would not want to go on it unless they can guarantee a huge knock down of value during a 1-2 year trial. Anyway, I'll share more as I get on here and will post any updates as needed if I make any crazy decisions.

Keepingitpositive, it looks like luckyman hasn't checked in since 2022. However, if you will click on his name he has his email address enabled. I suggest that you send him an email & if you decide to email him, I would put in the title you are from Healing Well.

Good luck.

I will be approaching my 10 year anniversary on TDF/TAF in 2024.

I started with a Clinical Trial in 2014 which many have seen/followed that path on here. It was a double blind study of TAF vs TDF. I believe at some point, 2016, I have officially been on TAF during the clinical trial. That ended in 2021. I was actually doing pretty good on the clinical trial, though have faced a range of health issues over time.

Since 2022, my condition for my health has only declined. While I want to blame the TAF for some of these symptoms, I also blame myself:

- I've had 2 neck surgeries since 2020

- My weight has increased a lot. In 2020 it was about 188lbs, 2021 it went up to about 220lbs, 2022 it went to 250lbs and then this year 2023 it was to 272lbs. I did find it a little odd this kept happening. I have also been less active though since 2019 when my neck issues almost left me paralyzed.

- I'm at the end of 2023 and I have seen my weight go down a bit to 258lbs, this was due to some at home exercises and a better diet.

- My diet is absolutely horrendous since 2020 to be frank. Ease and access to Door Dash deliveries has made it worse for me (I've now recognized this and started to cut back on the bad stuff).

- My Blood Pressure did go up pretty high this year (about August/September time). At one point in time, it was at 177/113. I should have been in the ER at this point but I did not. I did start Blood Pressure medication (Amlodipine at 10mg). It has helped and I'm at a better stage where I have seen as low as 136/90. I still think it can be better, though it does fluctuate. Some sort of exercise + better diet/routine will get me there I believe (It will just take time).

- I am having some weird neurological issues where, if I am outside or sometimes just sitting down, I feel very "off". I don't know how else to describe it. I'm not sure if it's coming from my neck issues or from liver or heart issues or even from the medication. I was doing good walks from 2021-2022 (usually 1-2 miles daily, even late evenings) then end of 2022 came along and I was not well. 2023 was challenging to walk because of these off feelings (clearer skies seem to trigger them more, and I've gotten feelings where I am afraid I was going to collapse/pass out while walking, I am also facing night vision issues). It got better in the spring/summer time before getting worse again in the fall/winter.. right around the time my Blood Pressure had it's huge spike.
 
- When I was on the clinical trial, I was in a good habit of at least doing my 10,000iu Vitamin D3 daily, along with MK2/MK7, Vitamin C, Magnesium, Zinc, B-12, etc. I seemed to have let that slip these past couple of years and only took it "whenever I felt like it", which often times led me to not taking it for months at a time. I am trying to get back to this routing because I believe it at least helped me to a degree.

- I've had a lot of dental problems, which I do believe the lack of Vitamin D3 is a contributing factor now. I have many teeth now that need fixing up, but money is extremely tight now so I need to take this one at a time. On top of this, my neurological issues with that "off" feeling makes it impossible for me to drive, so getting to a dentist has been extremely challenging to say the least.

- I've considered STOPPING my medication for Chronic Hepatitis B (but still unsure) since it's been so long and a lot of this is in my blood stream now. On the plus side, I just got my TAF refilled for a year so I am good until November/December 2024 (though technically I have to refill and pay the copay each month but can do so now until then). I honestly would like to reach for a cure at some point, but it's a stretch until I get health under control. I'm also not wanting to do anything crazy for the cure that would cause sides (such as getting on interferon). Plus my last hbsag reading was fairly high, it seems to have increased as my weight went up. I'd like to get this lower.

Overall, I still feel very fortunate to find this group and get and give all the advice I could give. I feel like 2024 could be "my year" after all this time... I just need to reminder myself to make the right decisions for myself.