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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.
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.
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! :)
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! :)
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 :)
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 :)
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.
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.
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.
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.
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
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
Good report concerning liver but ur uric acid & calcium are at the higher side. Also ur pH (5.5) is wrongly mentioned I suppose?
Want to share more, got my results back today after a 6 month follow up and here's where I am:
Just an update as to where I am with my numbers:
HBV DNA IU/mL: No HBV DNA Detected
Total Bili: 0.3mg/dL
Dir Bili : < 0.1 mg/dL
Ind Bili :< 0.3 mg/dL
AST (SGOT) - 21
ALT (SGPT) - 30
Creatinine - 1.97 mg/dL
Uric Acid - 7.6 mg/dL
Calcium - 9.4 mg/dL
Phosphorus - 3.0 mg/dL
pH - 5.5
CK - 130 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
Everything else is in normal range, including my cholesterol which is right in the middle range. I was shocked about this because my diet was not too great two weeks prior to this test but I'll take it. One piece that I am really happy about is that is says DNA Not Detected which prior to this it said "< 29 IU/mL HBV DNA Detected" which meant I may have had a trace of DNA left in me -- or the lab wasn't as sensitive. Either way, the trial continues and I am happy about this, as I *really* need it at this point in life. I'm hoping at my next one, it says HBsAg: Negative. Fingers crossed!
Just an update as to where I am with my numbers:
HBV DNA IU/mL: No HBV DNA Detected
Total Bili: 0.3mg/dL
Dir Bili : < 0.1 mg/dL
Ind Bili :< 0.3 mg/dL
AST (SGOT) - 21
ALT (SGPT) - 30
Creatinine - 1.97 mg/dL
Uric Acid - 7.6 mg/dL
Calcium - 9.4 mg/dL
Phosphorus - 3.0 mg/dL
pH - 5.5
CK - 130 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
Everything else is in normal range, including my cholesterol which is right in the middle range. I was shocked about this because my diet was not too great two weeks prior to this test but I'll take it. One piece that I am really happy about is that is says DNA Not Detected which prior to this it said "< 29 IU/mL HBV DNA Detected" which meant I may have had a trace of DNA left in me -- or the lab wasn't as sensitive. Either way, the trial continues and I am happy about this, as I *really* need it at this point in life. I'm hoping at my next one, it says HBsAg: Negative. Fingers crossed!
5 Comments
i'm glad for this change in your results, i hope this will be followed soon by what we all expect, to be cured !
The creatinine value must be a typo.
Also, the pH refers to urine, not serum.
Also, the pH refers to urine, not serum.
creatinine was indeed a typo... it was 1.07 mg/dL
i noticed all your results was hbv dna detected but under 29 just like the rest of us, but now it says no hbv dna detected. type 0 ? or actually undetected ?
hepbcurepls that is correct... before it said under 29, and now it says undetectable. I'm not sure what to think with that. Is it the sensitivity of the test and the prior test didn't report less than 29, even undetectable? Or did I actually have a tiny bit left for the past 3 years and now after 3 years on meds, I'm finally undetectable? Quite a long time to take to go to undetectable. Not a type-o.
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!
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!
2 Comments
Yes, it is a good idea to measure your hbsag quantitative. In my view this quantity is the most indicative of how better your medication is working, as undetected hbv dna is easy to achieve.
agree, it makes sense to test it once a year and maybe consider interferon when very low
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