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Author Topic: Kidney and liver issues with Biktarvy  (Read 977 times)

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Offline venom_X

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Kidney and liver issues with Biktarvy
« on: November 07, 2019, 12:23:05 am »
I want to check with the experts here on my recent lab. Have been on Biktarvy for 4 months now.

The liver functions are busted. AST 95, ALT 45

Last check up two months ago both around 20s. Doctor wants to retest in a week to see if there’s any liver damage.

What’s more worrying is that a random urine creatinine levels dropped to 12 mg/dL. Last check up 3 months ago was 110. Lower limit should be 40 mg/dL. I searched literature only diluted urine can have a number that low.

Does this mean my kidney is not working? The blood creatinine is normal around 0.8. How to interpret this?
Infected Mid June, 2019
Acute syndrome late June, started Biktarvy
3 weeks post infection (1 week on ART): VL: 330k, CD4 400 (33%), CD8 460, CD4/CD8 ratio: 0.9
5 weeks pi: VL: 300, CD4: 500 (30%), CD8: 690, ratio: 0.7
8 weeks: VL: 30,  CD4: 590 (28%), CD8: 920, ratio: 0.6
12 weeks: VL <30, CD4: 750 (37%), CD8: 700, ratio 1.1
20 weeks: VL<30, CD4 550 (dropped from 750 from 2 months ago, 38%), CD8 450, Ratio 1.2, elevated liver enzymes

Offline ZachR

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  • Let's look at the stars again
Re: Kidney and liver issues with Biktarvy
« Reply #1 on: November 07, 2019, 06:20:56 am »
There are two, almost identical Clinical Toxicology Reports on Biktarvy. One issued by EMA, the other by FDA. The files are pdf, hence cannot upload, so google them.

It would be rather uncommon for this drug to cause liver injury at the doses used in the combination. Neither of the drugs relies heavily on hepatic processing. In the report, only bictegravir is indicated to cause hyperplasias, but at doses between 2 to 30+ times given to humans. On the other hand emtricitabine, as noted by the producer,  has been linked to mitochondrial toxicity and lactic acidosis, which raises liver enzymes, but it would raise the enzymes further and cause widespread symptoms. Emtribitabine  alone, however, hasn't been documented to cause the condition, but is linked rather because it belongs to NRTIs; it is a very weak inhibitor of m-polymerase y. TAF has been linked to a few cases of acute kidney failure, but mostly in aged people with other comorbidities and drugs.

That doesn't mean the drug is not the cause, but is rather unlikely, hence other causes should be considered too. For instance, HIV itself is a very solid risk factor for NAFLD, even when treated. For these reasons, work closely with your doctor, who will surely try to understand the cause based on tests, instead of guessing the million possibilities. Additionally, it is only a one-time shot, and might be a transient situation, for which, your doctor, rightly said, he would retest and, honestly, your enzymes are not seriously elevated. Usually, damage or failure is suspected when they raise 3+ fold the limit. Creatinine can vary dramatically based on physical activity, other conditions, food etc.
I'll add references in a few minutes.

1. https://journals.lww.com/md-journal/subjects/HIV-AIDS/Fulltext/2017/09080/Tenofovir_alafenamide_nephrotoxicity_in_an.55.aspx
2. EMA Toxicology Report on Biktarvy
3. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4150803/
4. https://www.ncbi.nlm.nih.gov/m/pubmed/30932951/
5. https://www.ncbi.nlm.nih.gov/m/pubmed/30607807/
« Last Edit: November 07, 2019, 06:53:06 am by ZachR »
25.10.19 VL 43
26.05.19  CD4+ 685 %26 VL 55
27.03.19  CD4+ 850 %31 VL 24
***Switched to Biktarvy due to side effects.
25.02.19  CD4+ 740 %30 VL 78
15.01.19  CD4+ 1600(might be wrong) %0.7 VL 54
05.11.18  CD4+ 720 VL 1,100
17.09.18  CD4+ 962 %25 VL 14,000,000 - Started first regimen on Triumeq
15.07.18 - diagnosed, CD4+ 490 %20
20.04.18 - infected

https://ibb.co/X74GV0X

Offline Jim Allen

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Re: Kidney and liver issues with Biktarvy
« Reply #2 on: November 07, 2019, 07:24:22 am »
Hiya,

Looking back clinical trials showed a high safety in this regard, some had an increased serum creatinine levels but not considered relevant & in 15% bilirubin increases noted in one study but not it was not associated with a hepatic adverse reaction.
 
End of the day though, plenty of studies or documents, however, here is the thing you seem to be presuming or questioning Biktarvy as the cause when it could be half a dozen things or nothing at all including just a lab error.  My experience is there is never any point in stressing unless there is a trend and to never jump to conclusions  ;)

The doctor has asked you to retest next week, so try to relax, retest and see what the results are. If there are elevated levels they will work with you on finding the cause.

Keep us posted.

Best, Jim

https://www.mayoclinic.org/symptoms/elevated-liver-enzymes/basics/definition/sym-20050830

https://www.ncbi.nlm.nih.gov/pubmed/28867497
https://www.ncbi.nlm.nih.gov/pubmed/28867499
https://doi.org/10.2215/CJN.02240218

« Last Edit: November 09, 2019, 02:40:59 pm by Jim Allen »
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Offline venom_X

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  • Posts: 22
Re: Kidney and liver issues with Biktarvy
« Reply #3 on: November 09, 2019, 01:42:58 pm »
Thank you Zach and Jim! I will go for another test next Monday and will provide update on how it goes. Hope it's a one time "blip" so to speak
Infected Mid June, 2019
Acute syndrome late June, started Biktarvy
3 weeks post infection (1 week on ART): VL: 330k, CD4 400 (33%), CD8 460, CD4/CD8 ratio: 0.9
5 weeks pi: VL: 300, CD4: 500 (30%), CD8: 690, ratio: 0.7
8 weeks: VL: 30,  CD4: 590 (28%), CD8: 920, ratio: 0.6
12 weeks: VL <30, CD4: 750 (37%), CD8: 700, ratio 1.1
20 weeks: VL<30, CD4 550 (dropped from 750 from 2 months ago, 38%), CD8 450, Ratio 1.2, elevated liver enzymes

Offline Jim Allen

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Re: Kidney and liver issues with Biktarvy
« Reply #4 on: November 09, 2019, 02:39:57 pm »
You're welcome. Keep us posted
HIV 101 - Everything you need to know
HIV 101
Transmission and Risks:
HIV Transmission and Risks
Read more about Testing here:
HIV Testing
Read about Treatment-as-Prevention (TasP) here:
HIV TasP
You can read about HIV prevention here:
HIV prevention
Read about PEP and PrEP here
PEP and PrEP

Offline arber_B

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  • Posts: 20
Re: Kidney and liver issues with Biktarvy
« Reply #5 on: November 27, 2019, 11:16:35 pm »
Thank you Zach and Jim! I will go for another test next Monday and will provide update on how it goes. Hope it's a one time "blip" so to speak


Hi- I have a similar situation but my ALT and AST went up higher than yours. (166 and 68) from 20 something before Biktarvy. I got the results yesterday and I am so concerned. I want to know if you did a second test? How was it? Did you change medicine?

Offline Jim Allen

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Re: Kidney and liver issues with Biktarvy
« Reply #6 on: November 27, 2019, 11:20:34 pm »
The OP updated this topic here: https://forums.poz.com/index.php?topic=72882.msg
Sooner or later everyone will have some blip in some lab result. I've had blips in charts, just retest if the doctor wants, no panic or stress needed over a single snapshot moment..
« Last Edit: November 27, 2019, 11:24:41 pm by Jim Allen »
HIV 101 - Everything you need to know
HIV 101
Transmission and Risks:
HIV Transmission and Risks
Read more about Testing here:
HIV Testing
Read about Treatment-as-Prevention (TasP) here:
HIV TasP
You can read about HIV prevention here:
HIV prevention
Read about PEP and PrEP here
PEP and PrEP

Offline venom_X

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  • Posts: 22
Re: Kidney and liver issues with Biktarvy
« Reply #7 on: December 02, 2019, 06:05:51 pm »
Thanks Jim for updating on this tread, I missed to update this one  :)

So yeah a retest 2 weeks after the elevated liver enzymes showed that both ALT and AST have now fallen back to normal (around 20) , don't know what caused the "blip" but hopefully it stays normal. 

arber_B, how do you do with your new test, did they also go back down to normal range?
Infected Mid June, 2019
Acute syndrome late June, started Biktarvy
3 weeks post infection (1 week on ART): VL: 330k, CD4 400 (33%), CD8 460, CD4/CD8 ratio: 0.9
5 weeks pi: VL: 300, CD4: 500 (30%), CD8: 690, ratio: 0.7
8 weeks: VL: 30,  CD4: 590 (28%), CD8: 920, ratio: 0.6
12 weeks: VL <30, CD4: 750 (37%), CD8: 700, ratio 1.1
20 weeks: VL<30, CD4 550 (dropped from 750 from 2 months ago, 38%), CD8 450, Ratio 1.2, elevated liver enzymes

Offline floridartist

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  • Posts: 21
  • Time stays the same, Tomorrow is already here.
    • Oil paintings of Florida
Re: Kidney and liver issues with Biktarvy
« Reply #8 on: December 03, 2019, 07:14:02 pm »
I hope your kidney and liver are ok.
Biktarvy, This morning I was prescribed this one pill a day medication in place of the three different pills a day, Novar, Discovy and Reyataz, when I got home I said to myself, Self, why did you allow yourself to do the switch ? the regimen I have been on has been tolerable for a few years, the virus load is undetectable, the t cells are high, do I really need to go for the one pill a day thing just because it is available and then face the possible side affects, the doc says there is Trivacy inside that Biktarvy. I recall I didnt tolerate Trivacy very well, excuse my spelling.
So I called a friend I met on POZ personals, seems we call each other 3 or 4 times a day, he is my friend and second opinion, we decided, hey if the three regimen pills once a night works, leave it as is, and plus I get weird over changes, so I made the calls, canceled the whole new pill treatment plan thing, you know, getting labs done again, stuff like that, so thats my Biktarvy story.
Ohh, by the way, the pharmacy says Biktarvy costs over $2000 a month, insurance covered, wow, thats like $75 or $80 a pill.  it probally costs a nickel a pill in India,     sorry if I posted in the wrong section, be well all, John
 

Offline frederick

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  • Posts: 21
Re: Kidney and liver issues with Biktarvy
« Reply #9 on: December 07, 2019, 10:41:34 am »
I hope your kidney and liver are ok.
Biktarvy, This morning I was prescribed this one pill a day medication in place of the three different pills a day, Novar, Discovy and Reyataz, when I got home I said to myself, Self, why did you allow yourself to do the switch ? the regimen I have been on has been tolerable for a few years, the virus load is undetectable, the t cells are high, do I really need to go for the one pill a day thing just because it is available and then face the possible side affects, the doc says there is Trivacy inside that Biktarvy. I recall I didnt tolerate Trivacy very well, excuse my spelling.
So I called a friend I met on POZ personals, seems we call each other 3 or 4 times a day, he is my friend and second opinion, we decided, hey if the three regimen pills once a night works, leave it as is, and plus I get weird over changes, so I made the calls, canceled the whole new pill treatment plan thing, you know, getting labs done again, stuff like that, so thats my Biktarvy story.
Ohh, by the way, the pharmacy says Biktarvy costs over $2000 a month, insurance covered, wow, thats like $75 or $80 a pill.  it probally costs a nickel a pill in India,     sorry if I posted in the wrong section, be well all, John

Hi Floridartist. You mentioned that you didn't tolerate tivicay very well. What exactly did you experience while taking tivicay (dolutegravir)?

Offline arber_B

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  • Posts: 20
Re: Kidney and liver issues with Biktarvy
« Reply #10 on: December 07, 2019, 11:59:24 am »
Thanks Jim for updating on this tread, I missed to update this one  :)

So yeah a retest 2 weeks after the elevated liver enzymes showed that both ALT and AST have now fallen back to normal (around 20) , don't know what caused the "blip" but hopefully it stays normal. 

arber_B, how do you do with your new test, did they also go back down to normal range?

I did a retest and they did not yet. ALT dropped from 166 to 91 but my AST went up from 68 to 117! My doctor wants to give it more time. She thinks that it is normal for one of those enzymes to peak and then come down while the other is lagging. She wants me to do another test later in a week or so. I am a little bit concerned.

 


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