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  • 1.  Lenacapavir for PrEP leak

    Posted 20 days ago

    Good evening,

    Curious if there is any good guidance out there on counseling for leaking of LEN following injection. 
    Just had this happen in clinic today. The leak was significant enough to saturate band aid, and a couple 2x2 gauze pads. 

    In the moment, I instructed them to continue their oral PrEP, and plan to follow up with them in the next couple of days for further instructions.

    Is there any drug level lab commercially available? Anything available through the manufacturer?

    Strategies to help mitigate this?


    Thanks in advance!



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    Trevor Gabel-Baird
    Summerville SC
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  • 2.  RE: Lenacapavir for PrEP leak

    Posted 19 days ago

    We also have had this problem. The patient did not feel comfortable losing so much of the medication so we ended giving him cabotegravir (what he was on prior)  also.  We tried to get hold of medical science liaison for days and was unsuccessful.  Finally, heard back and this did not happen in the trial.   What is frustrating is that we don't get reimbursed for the cabotegravir. 



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    Tuesdae Stainbrook
    Dubois PA
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  • 3.  RE: Lenacapavir for PrEP leak

    Posted 18 days ago

    Hi Trevor,

    We have had this happen to us once in our clinic as well. Our RN estimated that half of the total volume of Yeztugo was extruded after administering the injections. After we assured the manufacturer that our nursing staff was well versed in administering LEN (we've been using Sunlenca for some time without issues) they recommended administering another half dose which they were willing to provide, but recommended continuing to use oral PrEP in the meantime. Our patient was transitioning from Apretude and we had planned approximately a week of overlap, so we felt comfortable that he was covered while we figured it out. In the end, the patient was put off enough by the experience that he decided to stick with Apretude. The MSL for ViiV said there were only 4 cases of significant leaking documented during the approval phase so they didn't have a lot of data to go on. What is significant? We would like to know this too. The bottom line is to keep the patient protected with some other form of PrEP, as you did.



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    Deb Fredell-Gonzalez
    NIDO Clinic
    Salinas, CA
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  • 4.  RE: Lenacapavir for PrEP leak

    Posted 18 days ago

    We've had 1 (maybe 2?) leaks like this during HIV treatment, so good to know it's not just us, and to know the company can help.  We just continued with that incomplete dose and pt has remained undetectable.  It's good for the company to know it happens and help us when it does, as we gain more info about it.



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    Elaine Thomas, MD
    University of Washington
    Seattle, WA
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  • 5.  RE: Lenacapavir for PrEP leak

    Posted 17 days ago

    We've had it leak out on 2 separate patients.  We ended up getting an additional box of Yeztugo from Gilead.  We submitted a Patient Safety report and also communicated with QualityComplaints@gilead.com in order to get a new box sent to us.  

    We got a new box and used one dose for the first patient.  Then when it happened a second time we used the second dose.  



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    Alexandra Danforth, PharmD, AAHIVP, BCACP
    Director, Infectious Disease and Clinical Pharmacy
    Trillium Health
    Rochester, NY
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