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  • 1.  Fluctuating HIV-1 RNA result on Apretude

    Posted 07-29-2025 18:07

    I have a patient who has had a fluctuating HIV-1 RNA result. This is the timeline for results: 

    Met patient at an outreach event and ran a 3rd gen INSTI (HIV1/2 Ab) with negative result and ordered Apretude. Presented to clinic for first Apretude injection on 3/24 and rapid 4th gen POC test was negative and serum HIV Ag/Ab + HIV RNA qual was negative/nonreactive. He returned for 2nd Apretude injection on 4/25. His 4th gen POC test was negative, but his serum test came back HIV-1 RNA reactive. He was called into the clinic for additional labs and placed on Biktarvy by a colleague. On 5/2/25 his results were undetectable VL, Ag/AB and HIV-1 RNA all nonreactive so he discontinued Biktarvy. Patient returned for 3rd Apretude injection on 6/25 and 4th gen POC is negative, but later the serum HIV-1 RNA was reactive again. I placed the patient on Descovy to create a complete regimen. 
    He recently had the following labs done at his PCP office: HIV Ag/Ab + HIV RNA qual, HIV NAT. All results negative and his discontinued his Descovy. 
    He is scheduled for his next Apretude injection in August but plans to discontinue the medication as his relationship is now closed. Are additional labs warranted? From my understanding, Apretude can delay results for all of these HIV tests including HIV DNA. Thanks for your input! 


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    Logan Sherman
    Columbus OH
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  • 2.  RE: Fluctuating HIV-1 RNA result on Apretude

    Posted 08-04-2025 11:00

    Hi Logan, was the HIV RNA quantified?



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    Alexis Powell
    Miami Shores FL
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  • 3.  RE: Fluctuating HIV-1 RNA result on Apretude

    Posted 08-22-2025 01:49

    Was his antibody differentiation reactive? It could be delayed seroconversion since he was on PrEP (Apretude) or a biologic false positive. When you say his HIV -1 RNA was reactive, what was his viral load? Did it always show undetectable? or did he have copies/mL, logs? I can see him having a detectable viral load without a reactive antibody test in the case of an acute HIV infection while on PrEP, but he should have had a reactive antigen test since you did the p24 antigen portion as well through lab. I would recheck a 4th or 5th generation HIV Ag/Ab test, recheck VL, ensure they do a HIV 1/2 Ab Differentiation if the Ag/Ab is reactive (I know there was a shortage of reagent not too long ago), and HIV-1 DNA. If he has a detectable viral load amount, game over, he is living with HIV and I would get him back on Biktarvy. Really, the safest course of action is for this patient  to be on treatment versus prevention at this point. 



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    Martel S. Warden, MHA, MSN, APRN
    Family Nurse Practitioner
    Christian Community Health Center
    Chicago, IL 60628
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  • 4.  RE: Fluctuating HIV-1 RNA result on Apretude

    Posted 08-25-2025 15:25

    I agree with Alexis and Martel. I just wanted to add that there are high rates of false positives with Apretude which could potentially explain this situation, though I do think it's more complicated since it has happened more than just once. I would recommend getting the same labs again for his upcoming dose then an additional HIV RNA quant a few months after the last dose of Apretude is administered. My fingers are crossed hoping that all will be negative!

    "These data indicate that a single positive viral load test alone had a 9.1% positive predictive value-that is, a 9.1% chance of being true HIV acquisition rather than a false positive-in study participants whose last CAB-LA injection was within six months, and a 60% positive predictive value in participants whose last CAB-LA injection had been more than six months ago. Notably, the positive predictive value increased to 100% when study participants had a second round of confirmatory viral load testing with a new blood sample, regardless of the timing of their last CAB-LA injection."
    https://www.nih.gov/news-events/news-releases/isolated-viral-load-test-may-generate-false-positive-results-people-using-long-acting-prep 



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    Caitlin Prather, PharmD, BCACP, AAHIVP, TTS
    Clinical Pharmacist in Fairfax, VA
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