Sep 3, 2026 · 24 min · 10 segments
This week, Marianna sits down with John Faragon to talk about the recent approval of Bictegravir and Lenacapavir (or BIC/LEN) and the FDA label. Tune in to learn all about what it is and why it…
John FaragonGuestMarianna BreitmanHostAs we begin to wrap up, what are your key clinical takeaways for providers considering Biclin?
right so so this is not really part of the label just kind of my ideas you know from practical points right so i think i think so far i think everybody would agree that that's reviewed this artistry one and two they've been published and it's been out there and it's been reported at caroy and other other conferences and different cuts of the data but so far those good for switching suppressed patients who are in complex regimens these people are on you know three four or five pills on bid regimens two pills a day even And this is a small, single tablet.
The tablet, I guess, is one of the smallest or the smallest single tablet regimen.
So if you have a failure or somebody who's not suppressed, what do you do? So there's no commercial resistance assay to LEN yet.
Although resistance wasn't present in these studies, which I think is interesting, there's rare insti-resistance.
It's rare, but I think you have to be aware of those potential ones in clinic and real-life settings, and will that be different? The loading dose and the approval and the issues around the reload needed at seven days, which would be rare in studies, but in real life, we know what our patients do, right? They start in stop meds.
Recheck the serologies prior to switch to be sure they don't have active hep B and are not core antibody positive.
Make sure if they need to be revaccinated or make sure the surface antibody is where it needs to be.
And I just want to say one final thing, which I didn't really cover a lot, but there were some lipid advantages.
There was a small lipid advantage in people who were swapping off of PI-based regimens from their old regimen.
Just to be sure, if you're changing off a PI, lipid elevation reactions is obviously important, but just be aware that when you change off a PI and you remove the booster, the risk of drug interactions can be tricky.
When you stop the booster, you may potentially have drug levels of certain meds that drop.
As we begin to wrap up, what are your key clinical takeaways for providers considering Biclin?
right so so this is not really part of the label just kind of my ideas you know from practical points right so i think i think so far i think everybody would agree that that's reviewed this artistry one and two they've been published and it's been out there and it's been reported at caroy and other other conferences and different cuts of the data but so far those good for switching suppressed patients who are in complex regimens these people are on you know three four or five pills on bid regimens two pills a day even And this is a small, single tablet.
The tablet, I guess, is one of the smallest or the smallest single tablet regimen.
So if you have a failure or somebody who's not suppressed, what do you do? So there's no commercial resistance assay to LEN yet.
Although resistance wasn't present in these studies, which I think is interesting, there's rare insti-resistance.
It's rare, but I think you have to be aware of those potential ones in clinic and real-life settings, and will that be different? The loading dose and the approval and the issues around the reload needed at seven days, which would be rare in studies, but in real life, we know what our patients do, right? They start in stop meds.
Recheck the serologies prior to switch to be sure they don't have active hep B and are not core antibody positive.
Make sure if they need to be revaccinated or make sure the surface antibody is where it needs to be.
And I just want to say one final thing, which I didn't really cover a lot, but there were some lipid advantages.
There was a small lipid advantage in people who were swapping off of PI-based regimens from their old regimen.
Just to be sure, if you're changing off a PI, lipid elevation reactions is obviously important, but just be aware that when you change off a PI and you remove the booster, the risk of drug interactions can be tricky.
When you stop the booster, you may potentially have drug levels of certain meds that drop.
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