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Tonight I officially start TAF - I'll put all my results here

For those that recall, I've been on the clinical trial for TDF vs. TAF. It's a double blinded study which means I do not which drug I was on. I tried asking my doctor today about this and he just smirked a little at me and said "we don't know" but I suspect he does know and opted not to tell me as per agreement/contract. However, this does not change the fact that going forward, I will now be treated with TAF for the remainder of the trial which last 9 months.

Anyway, I decided to mention to him that this new formula was going through FDA approval and he was well aware. I asked him how long would it take for it to be approved and he said about 9 months. He's very confident that it will go through without any hesitation.

Naturally, I asked him a series of questions, such as what happens if my insurance does not approve the new formula or if the FDA approves it before the trial ends or it does not get approved at all. Here were some of the answers I was given:

-If FDA Approves it before the trial ends, I will finish the trial as they want to collect as much data as they can.

-If FDA does no approve, the trial will be extended

-It's possible my insurance may not cover the new formula, especially if it ends up being significantly higher in price than the old formula. If that is the case, they can look at getting me onto the old formula or if it came down to it, switching me to entecavir.

-Price wise, they'd look at getting me a copay card to offset any of the pricing down the line. Asked about this and was told "could be a couple of hundred a month but we'll do our best to make it cheaper".

-I also asked about clinical trials down the line with them, which they said they don't have anything at the moment but I should look into the trials that are being aimed for the cure.

Overall, not only am I concerned about switching to TAF now (in case I have any reactions or symptoms come back) but what concerns me the most is the fact that they are even thinking about switching me from Tenofovir to entecavir. To me, this does not even make any since since Tenofovir works a LOT better.

Now, I did get a result back of my Ultrasound. Unfortunately, I have a cyst on my kidney that seems to be growing but my last blood test seems to be fine with kidney function. I also have a polyp on my gallblader which I have had for years now. More importantly, my liver: No abnormalities, perfectly normal.

On that note, I'll share my results going forward.. including the results from the blood being drawn today prior to TAF (which I should have in 2 weeks). For prior results, please see my old posts.

Please note, I am no doctor, I am a patient.... I know I get many questions via PM as if they are directed towards a doctor, but I can only answer so much based on my experience. Also, I have no way of getting TAF other than through this trial and do not know of any other way. Please feel free to ask anything you'd like. I'll answer my best and will give some feedback of the meds and how they are working for me down the line.
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Avatar universal
Just an update on my numbers here:

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!
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Avatar universal
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!
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5 Comments
Is it taf u taking same as vemlidy. And how old are you, am 32yrs and stage 2 fibrosis due to hepb positive . Doctor told me to use vemlidy. Just heard the result last saturday and have been sad and crying
Hi @Loppie888 TAF is the same as Vemlidy, that is correct. I  believe they named it such a year or two ago. Prior to that, it was only known as TAF. In my opinion, my body is tolerating TAF much better than TDF (I cannot confirm if I was ever on TDF but I suspect I was). I'm sorry you feel that way. This illness can bring on a lot of depression, as I've dealt with it from time to time. Hang in there, it does get better. I am now 42 years old. I first found out about mine when I was 36 years old and started treatment when I was 37 years old about 10 months after I found out. I think stage 2 Fibrosis was my worst too, but that was later on due to a very poor diet. I'm usually in 0-1 with minimal to no Fibrosis. Hope my answers help you!
@luckyman316 I was reading the Vemlidy or TAF an increase Cholesterol or some parameters related to that. Do you think your increase is due to the medication?
@luckyman316 what was your fibrosis score before and  now, and how was  your diet now ? what do you eat  to reverse ?
@hellolove228 my Fibrosis score was at:
Fibr. Score - 0.16
Fibr. Stage - F0, No or minimal Fibrosis

This was before I started meds back in May 2014.

My last score was from Dec 2018:
Fibrosis Score: 0.28
Fibrosis Stage: F0-F1, No or Minimal Fibrosis

So it went up slightly but not a lot, and I'll contribute that poor diet around that time frame with some extra fatty foods, but still not bad.

I don't take or eat anything in particular because there is nothing to reverse there. I just try to make sure I get a bit of everything for myself. I have cut back on fatty foods and down 15lbs since that time last year because of it. I think my Fibrosis score will be measured next visit.
Avatar universal
Good results!
Happy new year to everyone!
Helpful - 0
Avatar universal
Hey everyone, just wanted to offer up my latest test results on this as my trial continues. Looks like I'm done at end of 2020, so 2 years to pray or try and cure myself here before I make a decision whether or not I want to continue meds after 7 years or attempt for a new trial.

Speaking of new trials, I did ask my doctor about the arrowhead/Janssen(JNJ) treatment and if it was in trial. He said he knew of some that were, but was not aware about this one we are talking about on here. I'll have to send him some info since it looks so promising.

Additionally, I've kept off my 5lbs and my blood pressure was normal this time... I really do need to lose about 50lbs though. Maybe I'll work on this in 2019!

Now, the report from the labs:

HBV DNA IU/mL: HBV DNA < 20 IU/mL Detected (I'd feel comfortable if it said Not Detected again)
Total Bili: 0.5 mg/dL
Dir Bili : 0.1 mg/dL
Ind Bili : 0.4 mg/dL
AST (SGOT) - 20
ALT (SGPT) - 31
Creatinine - 1.10 mg/dL
Uric Acid - 8.4 mg/dL (This is high)
Calcium - 9.9 mg/dL
Phosphorus - 2.4 mg/dL
pH - 6.0
CK - 126 U/L (Down a lot)
Parathyroid Hormone - 40.4 pg/ML
HBsAg: Positive (The labs say they are supposedly measuring quantitative but I'm only getting this result
Fibrosis Score: 0.28
Fibrosis Stage: F1, No or Minimal Fibrosis

These are some typical results. There were some things I need to keep and eye on and I noticed they started to add Vitamin Level checks on this report, but they were all normal (Yay!). For the concerning pieces to me:

Cholesterol was a little high at 235 mg/dL (my max should be 280)
My C&GCrtClr was 129.3 mL/min (my max should be 125.0)
HAPTOGLOBIN (HPT) was 203 mg/dL (my max should be 200)
Direct LDL should be <130 mg/dL and mine was high at 182

Guess it's time to really get on a good diet/exercise plan for the new year indeed!!

Happy 2019 to all and here's to hoping for a cure! Stay positive, friends!  :)
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1 Comments
Happy New year my friend. :)
From what I understand  part of the trial forbids use of echinacea whilst on the meds  because of its immuno modulation properties..But  I'm allowed to take whatever I want because I'm not on meds. But I took echinacea because I was getting a cold/flu. I fought off the bug. BUT when I check my HBSAB it jumped up significantly it might be coincidental but thought I'd share this.

Also one of the Gastro's told me she thought the antioxidative effect of exercise might have had something to do with my results so losing some weight and getting in good shape won't do any harm buddy...

Good luck :)
Avatar universal
Been a bit since I updated, figured I'd offer some more and what has happened between my last appointment and this one:

I walked in and found out I'm about 15lbs heavier than I was from December. So I was a tad bit over 230lbs (I'm 5'10" btw)

My blood pressure went up as well, it was a 120/100... not good. I was asked to lose 5-10lbs in 2-4 weeks and monitor blood pressure.

Within 2 weeks, I lost 5lbs and my blood pressure was closer to normal.

Now, the report from the labs:

HBV DNA IU/mL: HBV DNA < 20 IU/mL Detected (Not sure how I go undetected to detected, is it the lab?)
Total Bili: 0.5 mg/dL
Dir Bili : 0.1 mg/dL
Ind Bili : 0.4 mg/dL
AST (SGOT) - 20 (down 6 pts)
ALT (SGPT) - 31 (down 1 pt)
Creatinine - 1.12 mg/dL
Uric Acid - 7.6 mg/dL
Calcium - 9.7 mg/dL
Phosphorus - 3.1 mg/dL
pH - 5.5
CK - 163 U/L (Down a little but in good shape)
Parathyroid Hormone - Not Measured This Lab
HBsAg: Positive
Fibrosis Score: Not Measured This Lab
Fibrosis Stage: Not Measured This Lab

Now for the scary part, the Ultrasound:
Impress: Fatty Liver, Gallbladder polyps, right renal cyst
To give you the basics: Gallblader is 2 polyps, 6mm each. Kidney is lower pole cyst, 13mm. Liver is 13.8cm but no focal abnormality. All of this also showed up on the last test in December.

Anyway, just wanted to share. I'll report back after my next test late this year. Trial continues (Thank goodness) but I need to focus on me and get myself in better shape to eliminate fatty liver and help out my insides.
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Avatar universal
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.
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2 Comments
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)
152/96 thats definitely high get doing some cardio buddy :)

I personally think you made a good call not doing a phase 2 trial. Phase 3 it'd be a different kettle of fish.


In terms of resistance Tenofivir has very little to nearly NO resistance. But still it wouldn't work out worth the calculated risk for a phase 2 bro
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