Aa
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.
How about taking half of the pill in that case if you say 8mg may be enough ?
Btw, does entencavir may have also similar impact on the muscles or it's rather only tdf/taf issue ? It's possible that I will start entencavir depending on my results 6 months after interferon and I'd like not to limit my gym activity which is quite high.
Btw, does entencavir may have also similar impact on the muscles or it's rather only tdf/taf issue ? It's possible that I will start entencavir depending on my results 6 months after interferon and I'd like not to limit my gym activity which is quite high.
This CK elevation is so serious that it requires an effort to clarify if the TAF is the culprit or not.
At first I would retest the CK after giving your muscles acres for a week, better two. You can retest on your own by using directlabs without a doctors orders. They also charge very low fees.
If it still is quite high, like from 400 to 800 iu, then we must suspect that TAF is too much incorporated in your muscle tissue, causing damage.
To validate this suspicion, I would then switch for one month to good old viread or entecavir, then retest. If now low and fairly normal, always considering your exercise schedule, the TAF hypothesis will substantially strengthen. Best test again after one week of rest.
Then you can restart TAF and see if the damage reappears after several weeks.
For your understanding, while TAF is very very mild on the kidneys compared with viread, it remains in the bloodstream much longer in a form in which it can penetrate the cell membrane of most tissues, increasing the final effective uptake substantially.
While the total dose of 25mg is much lower than viread s 300mg, the total uptake into muscle might still be higher due to the long availability of the drug to enter muscle tissue. Inside the muscle cells TAF will be converted to tenofovir diphosphate, just like it is with viread.
This is all of great importance and bears on the question of long term side effects with TAF. While it seems at this time that TAF is better tolerated than TDF =viread, certainly for the kidneys, the question of the collateral body burden has not really been addressed by Gilead's human trial in hbv.
The dose of 25mg was chosen high despite the fact that the phase 2 trial has clearly shown, that 8mg was equally effective in reducing the viral load.
The company likely wanted to avoid any risk that the lower dose might have lead to some patients having partial resistance problems, threatening the huge effort of the phase 3 trial to become futile.
The truth is the 25mg dose might be unnecessary high and causing avoidable side effects in other tissues, that might be hard to spot, but in a patient with intense muscle workout the problem suddenly surfaces.
The sessions re approval for TAF and the advisory Committee opinions seeing all the data from the phase 3 trial will hopefully shed some light on this.
At first I would retest the CK after giving your muscles acres for a week, better two. You can retest on your own by using directlabs without a doctors orders. They also charge very low fees.
If it still is quite high, like from 400 to 800 iu, then we must suspect that TAF is too much incorporated in your muscle tissue, causing damage.
To validate this suspicion, I would then switch for one month to good old viread or entecavir, then retest. If now low and fairly normal, always considering your exercise schedule, the TAF hypothesis will substantially strengthen. Best test again after one week of rest.
Then you can restart TAF and see if the damage reappears after several weeks.
For your understanding, while TAF is very very mild on the kidneys compared with viread, it remains in the bloodstream much longer in a form in which it can penetrate the cell membrane of most tissues, increasing the final effective uptake substantially.
While the total dose of 25mg is much lower than viread s 300mg, the total uptake into muscle might still be higher due to the long availability of the drug to enter muscle tissue. Inside the muscle cells TAF will be converted to tenofovir diphosphate, just like it is with viread.
This is all of great importance and bears on the question of long term side effects with TAF. While it seems at this time that TAF is better tolerated than TDF =viread, certainly for the kidneys, the question of the collateral body burden has not really been addressed by Gilead's human trial in hbv.
The dose of 25mg was chosen high despite the fact that the phase 2 trial has clearly shown, that 8mg was equally effective in reducing the viral load.
The company likely wanted to avoid any risk that the lower dose might have lead to some patients having partial resistance problems, threatening the huge effort of the phase 3 trial to become futile.
The truth is the 25mg dose might be unnecessary high and causing avoidable side effects in other tissues, that might be hard to spot, but in a patient with intense muscle workout the problem suddenly surfaces.
The sessions re approval for TAF and the advisory Committee opinions seeing all the data from the phase 3 trial will hopefully shed some light on this.
1 Comments
Studyforhope... Thanks for detailed explanation. The retesting of CK should not be an issue through my doctor. I'd prefer to do this since I can't pay for anything right now due to a major financial crisis I am in.
Since I am on a clinical trial, there is no "switching" to TDF unless I get off the trial and go through the doctor's office to go on the old formula permanently. Since I'm in a financial crisis at the moment (think living week after week just paying bills and getting negative balances), I don't think this is an option for me. My options are either remain on the medication via clinical trial until I clear OR get off of it completely and take nothing and hope the virus doesn't go active again and kill me,
As you can see, I'm in a VERY tough spot for myself (hence why i felt like I was blessed for an extra 5 years on the trial while I attempt to get caught up financially within that time frame).
However, thank you for the advice. I'll see if I can give it an extra week or two without any weight bearing exercises and discuss with the doctor about additional testing.
Since I am on a clinical trial, there is no "switching" to TDF unless I get off the trial and go through the doctor's office to go on the old formula permanently. Since I'm in a financial crisis at the moment (think living week after week just paying bills and getting negative balances), I don't think this is an option for me. My options are either remain on the medication via clinical trial until I clear OR get off of it completely and take nothing and hope the virus doesn't go active again and kill me,
As you can see, I'm in a VERY tough spot for myself (hence why i felt like I was blessed for an extra 5 years on the trial while I attempt to get caught up financially within that time frame).
However, thank you for the advice. I'll see if I can give it an extra week or two without any weight bearing exercises and discuss with the doctor about additional testing.
Your CK is indeed very high, a sure sign of leakage of enzymes from damaged muscle fibers. While this can be caused by the weight bearing exercises it is further possible that there is extra sensitivity due to a neg effect of TAF on the muscles, adding to that rise.
Your AST ist high for the same reason and at least part of your ALT elevation will come from muscle tissue not the liver. ALT is an enzyme that is present in muscle fibers as well.
it would be good to compare CK values before and after the switch to TAF.
Just to mention, in your lab results it is CREATININE not creatine and the pH value refers to the urine, not the blood.
Your AST ist high for the same reason and at least part of your ALT elevation will come from muscle tissue not the liver. ALT is an enzyme that is present in muscle fibers as well.
it would be good to compare CK values before and after the switch to TAF.
Just to mention, in your lab results it is CREATININE not creatine and the pH value refers to the urine, not the blood.
5 Comments
Weird, I thought I had responded but it's not showing up. Yes, CK is high. This happened after 6 months on TAF. The first 3 months, it was fine.
I've also noticed I've been getting stange muscle "twinges" in my thighs. It started on the left front thigh and then went away and then on the right. It was gone for a few days and now is starting on the back of the legs. Anything to do with the CK being so high? Ironically, this all started after they distributed the new bottles to me for the next 3 months, so I'm not sure if it's the medication or the after effects of working out with heavier weights now (which I've stopped to give my body a break).
You are right about the pH that is from the urine and you are right about it being CREATININE. Thanks for pointing that out.
I've also noticed I've been getting stange muscle "twinges" in my thighs. It started on the left front thigh and then went away and then on the right. It was gone for a few days and now is starting on the back of the legs. Anything to do with the CK being so high? Ironically, this all started after they distributed the new bottles to me for the next 3 months, so I'm not sure if it's the medication or the after effects of working out with heavier weights now (which I've stopped to give my body a break).
You are right about the pH that is from the urine and you are right about it being CREATININE. Thanks for pointing that out.
Also any suggestions on what to do with the CK and gettng it back to normal? It seemed to be a little higher than normal after the first 3 months but not this bad.
what about trying nad+ supplements and/or mitoq to prevent mitochondrial damage when using these nucs?not the best supplement for you luckyman316 because both suplements are quite expensive but nad+ may help, i never had sore muscles despite i restarted swimming very heavy all at once (almost 45min buttefly), it is impossible to start with butterfly after decades of no swim and have no muscles pains or cramps
Stef, I don't mind the supplements at all. I'm sitll on Vitamin D3 10,000 (sometimes 20,000 iu) daily. I actually stopped those for 2 weeks so I suspect this may have been a contributing factor on the test. Also, confused, what is nad+ ? Might be know as something different here bit if you can reccommend anything, I would be willing to try it. I'm going to also see if the black seed makes any difference for 3 months. I had to stop taking it because the taste was just so terrible even with honey, but at this point I'll suck through it and try again. I do recall I started to feel great after 2 weeks on it so why not!
vit d has an effect on CK for those on statins so i guess it can help a lot in your case too
And after i've developed hbsab, took almost a year before the the elevated alt was lowered to 30. It seems like a very slow healing process. Just need to make sure elavated alt is not caused by others like fatty liver, hcc, cirrhosis, can be verify by test like, ultrasound, liver biopsy, fibroscan. Also one should be able to notice changes physically as the immune system gets stronger in fighting the hbv.
Here is my opinion on the result, low hbv dna and elevated alt could mean your immune system is responding to the virus as well, mine took 3 to 4 years of constant elevated alt before hbsag became non-reactive
1 Comments
This is exactly what I am praying for!
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. Everyone has said this is due to weight bearing exercise. 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 TAFT a few months before losing HBsAg *which I hope is what is going on here* as the liver is now healing itself.
Hope everyone has a great day! :)
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. Everyone has said this is due to weight bearing exercise. 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 TAFT a few months before losing HBsAg *which I hope is what is going on here* as the liver is now healing itself.
Hope everyone has a great day! :)
1 Comments
Weight exercises don't make your liver enzymes jump. They make your muscles break down and rebuild in order to grow. When they do they release ALT, the same as your liver does when it's regenerating.
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