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  • 1.  Regimen simplification

    Posted 10-28-2024 17:46
    Edited by Ryan Doyle 10-29-2024 08:19

    Hello, 

    I have a patient who has been virally suppressed on Truvada (FTC/TDF), Intelence (ETR) & Isentress (RAL) and looking to simplify regimen. Patient came to me on this regimen, attempted to get records from previous provider but had difficulty getting these to determine why this is patient's regimen. Unable to get updated resistance testing due to viral suppressed status. I did receive records from prior resistance testing which does show reduced susceptibility to several NRTIs, NNRTIs and PIs, however these are from >20 years ago and no record of integrase susceptibility testing. Was looking to consider changing to single tablet regimen to minimize medications patient is taking if able. Thoughts on next steps? Looking to switch to Biktarvy for single tablet regimen with high barrier to resistance however the prior phenosense results (as referenced above) are throwing me off, just want to make sure I am not missing anything. Any advice is appreciated. 

    Thank you, 

    Ryan



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    Ryan K. Doyle, DO (he/him/his)
    rymed89@gmail.com
    Grand Rapids, MI
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  • 2.  RE: Regimen simplification

    Posted 10-29-2024 16:10

    Ryan,

    You could get a proviral DNA genotype (PhenoSense Archive). This test can be helpful when it shows mutations, though it's less helpful when it doesn't. 

    At first glance, the easiest simplification switch would be to Biktarvy + Intelence, which would reduce pill burden. However, there may be a modest reduction of bictegravir levels with this combination, which has not been studied clinically. (That same interaction applies to the combination of Isentress + Intelence, which he's on now, though there's more clinical data there.)  My guess is that it's not a clinically significant interaction in either case, but it's still not recommended.

    As for Biktarvy alone, if he has no INSTI resistance then the only relevant resistance would be NRTI resistance. There are multiple studies showing that people who are virologically suppressed do fine on Biktarvy despite NRTI resistance, as long as the bictegravir component is fully active.  However, that's an off-label use of Biktarvy, and potentially risky if there's a chance of INSTI resistance.

    Another approach would be Biktarvy + Sulenca (lenacapavir), a single-tablet regimen plus an every 6 month injection. The ARTISTRY trials are also looking at bictegravir/lenacapavir as a single-table daily oral regimen in people without INSTI resistance.  So far, the results look promising, but this isn't available yet.



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    Joel Gallant, MD, MPH
    Johns Hopkins University
    Baltimore, MD

    AXCES Research Group
    Santa Fe, NM
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  • 3.  RE: Regimen simplification

    Posted 10-29-2024 16:51

    Given that Intelence wasn't approved until 2007 and they may have had little exposure to F/TDF within the window of approval and the test result, that very old assay may no longer be relevant anyway. I would try getting an archived genotype. At the very least there should be little to no risk in simplifying to Biktarvy and Intelence while you await results. You can simplify further if you have at least 2 fully active agents in Biktarvy. If he happens to have a K65R mutation without M184V, I would simplify to Dovato, even though Biktarvy would likely offer the same protection.



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    Ben Sokoloff, DO
    Cascade AIDS Project
    Portland, OR
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  • 4.  RE: Regimen simplification

    Posted 10-29-2024 17:44

    I have had good results with putting pts on BIK who are on old regimens and a genotype is not fully available.  I would second this change.

    Good luck!



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    Sara Back
    North Central Bronx Hospital
    New York NY
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