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Low-level viremia?

  • 1.  Low-level viremia?

    Posted 09-24-2020 09:34
    Since BIC came to market, we've been routinely using it and at least half our patients take that medication either as new diagnoses or switch patients. Unfortunately, we've all started noticing that several of these patients have occasional or even persistent low-level viremia in the 20-200 range. Clinically, I know this doesn't matter, but it does cause anxiety in patients and it generally involves one of us asking if the patient was experiencing any illness when the lab was drawn, asking about adherence, looking at potential interactions with MVIs or other products. And we're of course concerned if the VL does go up >200. We haven't noticed this issue with other medications and have many people of DTG/F/TAF who aren't experiencing this.

    At first, I assumed some non-adherence, maybe some divalent cation interactions, poor absorption, or something related to taking the med. But many of these patients were consistently <20 on previous regimens without resistance to bic. Now that so many folks have independently noticed this and it's occurring so frequently, I'm wondering if this is a lab issue? We can only run VLs twice a week, so it's not uncommon for a patient to have his/her/their lab drawn and it need to be stored for 3-4 days prior to the test. When I asked our lab, they couldn't think of a plausible cause though.

    Has anyone, particularly those without the ability to get daily VL testing, noticed this phenomenon too?

    ------------------------------
    Katy Garrett, PharmD, BCIDP, AAHIVP
    Clinical Pharmacist
    Portland ME
    ------------------------------


  • 2.  RE: Low-level viremia?

    Posted 09-24-2020 16:43
    Katy-
    That's very interesting!  I have been dealing with a patient who did incredibly well on Atripla with a rise in CD4 from 23 to 570 in one month and 90% drop in VL.  I kept him on, even after we realized that he didn't need to be on TB treatment (!), but he developed eosinophilia and melasma.  So, I changed to BIC.  The melasma and eosinophilia are resolving, but his CD4 has sequentially dropped and I have never seen his VL under 150.  Have interrogated him about all aspects of compliance--he often takes it with grapefruit juice, so maybe that's something.  But if this is still a problem on his next lab draw, I think I'll change rx.  
    We use Quest lab, so I don't think there's a prolonged storage problem with the sample.

    ------------------------------
    Sandra Wallace
    Nicasio CA
    ------------------------------



  • 3.  RE: Low-level viremia?

    Posted 09-25-2020 00:55
    I see this over and over again on BIC and am
    worried about long term unknown effects of a constant low level of viremia and eventual resistance over years... DTG doesn't appear to cause this which is so weird given the structural similarity!

    ------------------------------
    Randy Gelow
    Phoenix AZ
    ------------------------------



  • 4.  RE: Low-level viremia?

    Posted 09-25-2020 19:58

    Has anyone raised this with BIC reps?

     






  • 5.  RE: Low-level viremia?

    Posted 09-25-2020 03:31

    I am so glad that you wrote that re: the low level viremia – I have noticed it as well – I am not sure what to make of it – but it is definitely there.  Any thoughts?  I am going to reach out to one of the drug reps to see if they have seen this in studies.

     

    Best – Sara Back

    NYC






  • 6.  RE: Low-level viremia?

    Posted 09-25-2020 15:48
    Yes, I have seen this frequently with bictegravir. I don't know if it is clinically significant but it is definitely different than with other regimens. I have talked with my medical science liaison regarding the issue and Gilead is definitely aware. 

    Timothy Price, MD
    Washington, DC 








  • 7.  RE: Low-level viremia?

    Posted 09-25-2020 21:59
    I have also noted this with many of my switch patients, mostly from Genvoya to Biktarvy, whereby there is a low level viremia that has in all patients eventually gone to VL ND.  I have talked with the local Gilead reps and the medical liaison who did not know of anyone else with this finding.  Now, all patients are ND again, so it did wither away, but still don't know the cause.  I went over supplements, foods, antacids, adherence, but nothing was remarkable.  It's interesting to hear that others have noted this as well.
    Jeff Olliffe

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  • 8.  RE: Low-level viremia?

    Posted 09-26-2020 11:07
    Hi

    I am jeetesh working in msf in Manipur .  we have started using dtg based regimens as 1sL we don't have the bic ( bictagrevir ? )

       I have three  questions 

         1. Eosinophilia is it associated with HT ? 

         2.  bic is it an injectable ?

         3.  What would you change to from bic ? 

       Regards 

       Jeet 





  • 9.  RE: Low-level viremia?

    Posted 09-26-2020 12:09
    Bic only comes in combination  as Biktarvy. It's a three drug regimen of BiC-TAF-FTC. I have changed someone to Dovato  3TC DTG once due to excessive weight gain.  The injectable PrEP Cabotegravir  which is comparable to Rilpivirine and DTG that you receive every 2 mos. will be available in about 5 mos according to ViV. Trogarzo is available intravenous. A lot of red tape to get it. Took me a month with the insurance company and manufacturer. 
    I myself have not experienced patients with eosinophilia from Biktarvy. I only had the one incident with one patient. 

    Amber

    Sent from my iPhone





  • 10.  RE: Low-level viremia?

    Posted 09-26-2020 12:57
    Thanks for anwers 

    Best

    ------------------------------
    jeetesh singh
    ------------------------------



  • 11.  RE: Low-level viremia?

    Posted 09-26-2020 00:35

    Hello,
    I have only had one patient that his happened to. It was a very interesting finding with him. First his VL went up to 74. I thought hmmm. I waited 4 weeks, remeasured him and it was up to the 200s He swore he was adherent. His CD4 count was in the 900's and >40%.  I did an archive DNA and it mimicked his previous genotype from a few years back. He was only resistant to RAL. I checked his VL again a while later and he was undetectable and has been ever since I attributed it to the magic of the archive DNA lol. 

    But in all seriousness, it was the strangest thing.

    Amber



    ------------------------------
    Amber Siegel MSN APRN AGNP-
    Midway Specialty Care Center
    Orlando, Florida
    ------------------------------



  • 12.  RE: Low-level viremia?

    Posted 09-26-2020 20:59
    I haven't really seen this, to be honest, but I will be on the lookout for it now that you all have pointed it out.

    ------------------------------
    James Adams
    Rancho Mirage CA
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  • 13.  RE: Low-level viremia?

    Posted 09-27-2020 11:07
    I have seen that in at least 10 patients. Very concerning. Most don't seem to go back to UD consistently, some I have changed to genvoya or desc/dolu and they become UD.

    ------------------------------
    Judy Davidoff
    Chase Brexton Health Services
    Baltimore MD
    ------------------------------



  • 14.  RE: Low-level viremia?

    Posted 09-27-2020 11:53
    Does the drug insert mention anything of this sort ? Just wondering if there is an explanation . 

    Jeetesh 





  • 15.  RE: Low-level viremia?

    Posted 09-29-2020 14:26
    I do not
    Recall seeing this in the drug insert.

    Sent from my iPhone