Academy Exchange

 View Only
Expand all | Collapse all

New CDC PrEP Guidelines that include suggested new HIV Testing Algorithm

  • 1.  New CDC PrEP Guidelines that include suggested new HIV Testing Algorithm

    Posted 02-07-2022 12:32

    I would ask that someone address in detail the recently released new CDC Guidelines for PrEP in the next issue, if not already doing such, in the next edition of HIV Specialist and in an upcoming Academy Voice email  

     Good thing that the HIV RNA qualitative does not require refrigerated or frozen blood, unlike the HIV RNA quantitative (Viral Load).

    With the new suggested guidelines of always having a negative HIV RNA qualitative confirmatory test….it seems to me that we might also alter the PEP Guidelines and protocol. Specifically, if a 6 week post PEP initiation lab shows a negative HIV RNA, after taking PEP meds for 28 days, would that not be enough to "close the case", instead of doing a 3 month follow up?

     

    LBrian R. McMurray, MD, FACP, AAHIVS

    Music City PrEP, Medical Director 

    615 Main St. 

    Nashville, TN 37206

    cell 615-419-0428



    ------------------------------
    Brian R. McMurray, MD, FACP, AAHIVS
    Brentwood TN
    ------------------------------


  • 2.  RE: New CDC PrEP Guidelines that include suggested new HIV Testing Algorithm

    Posted 02-08-2022 02:09
    Great idea to have a feature on the new guidelines though I think many of us hold out hope that the CDC will revise these new PrEP guidelines to remove the recommendation about HIV RNA testing every 3 months.  This just does not seem cost-effective, nor evidence-based.  As to your comment about qualitative HIV RNA, the new guidelines don't specify qualitative or quantitative RNA and it seems most providers order quantitative.  Where do you see that the qualitative is preferred?  I work with jails and we regularly have issues with the refrigeration/freezing requirement--I didn't realize the quantitative does not have that requirement!  The comment about changing the PEP guidelines is intriguing, but I have seen RNA remain undetectable for weeks to months after stopping ART and I think declaring victory 2 weeks after stopping PEP would be premature.

    ------------------------------
    Hillary Liss
    University of Washington
    Seattle WA
    ------------------------------



  • 3.  RE: New CDC PrEP Guidelines that include suggested new HIV Testing Algorithm

    Posted 02-08-2022 06:17

    To clarify….the qualitative HIV RNA is less expensive than the quantitative (the Viral Load test). And importantly, the qualitative test can be performed with the sample at room temperature, whereas the quantitative (Viral Load) must be refrigerated for 24 hours before running it, or frozen if longer (per LabCorp). 

    I don't know if a seroconverted patient two weeks off PEP would still have a negative HIV RNA qualitative test result?  We are using Biktarvy for PEP at times, like for "TelePEP" where pharmacies have Biktarvy, but not Truvada and Tivicay. 



    ------------------------------
    Brian R McMurray MD FACP AAHIVS
    Music City PrEP
    Nashville TN
    ------------------------------



  • 4.  RE: New CDC PrEP Guidelines that include suggested new HIV Testing Algorithm

    Posted 03-31-2022 12:14
    Yes, please.  Is the standard to be screening with qualitative RNA for all PreP and PEP or only during therapy?  As I understand the "science" behind the recommendation,  ARV's delay the development of Antibodies thus Ab-based testing loses sensitivity.  But with the current 4th generation test, and initial screening for P24 antigen, do ARV delay the emergence of P24? 

    I currently am using a mail-order lab system for PreP and it is working great for muy very rural patients or those that can not get to a lab between 7 and 4  M-F.  I can check if they can do HIV RNA Qualitative via the blood drop on filter paper.

    I wish there was more emphasis placed on extragenital screening
    Obviously, I, al teast some training

    ------------------------------
    Christine Brennan
    LSU Health Sciences Center
    New Orleans LA
    ------------------------------



  • 5.  RE: New CDC PrEP Guidelines that include suggested new HIV Testing Algorithm

    Posted 03-31-2022 14:20
    It ends out that Dr. Susan Dale at LabCorps Burlington NC Lab which does their HIV qualitative and quantitative tests says that even the HIV RNA qualitative is to be refrigerated for 24 hours and recommends frozen. Bummer. 
    She is going to pursue if they could accept 48-72 hours at room temperature?
    Thus means that we cannot use Home Test kits for HIV RNA qualitative or quantitative testing. 


    Brian R. McMurray, MD, FACP, FACEP
    Medical Director, Music City PrEP
    9400 Coxboro Drive 
    Brentwood, TN  37027
    mobile 615-419-0428

    Sent from my iPhone with apologies for mistypes and auto correct insertions





  • 6.  RE: New CDC PrEP Guidelines that include suggested new HIV Testing Algorithm

    Posted 03-31-2022 16:22
    Has anyone prescribing oral PrEP had a breakthrough infection that was not diagnosed through 4th generation HIV antibody/Ag testing? 

    We are coming up on the 10th anniversary of the FDA approval of Truvada for PrEP, and the only time I have had this happen is on a first follow-up visit, when I discovered that the patient was seroconverting at the time of PrEP initiation and had a negative HIV test prior to PrEP, but then a positive Ab/Ag test 1 month later.   

    I suppose I could see the rationale for doing PCR testing prior to starting oral PrEP, but doing it every 3 months seems like a stretch, and based on zero evidence, and will likely increase the cost of care (Our lab charges us $95.10 for HIV Qualitative PCR compared to $6.75 for 4th generation Ab/Ag testing).

    --------------------------
    Marc Tribble MD
    Private Practice
    Dallas, TX

    ------------------------------
    Marc Tribble
    Uptown Physicians Group
    Dallas TX
    ------------------------------



  • 7.  RE: New CDC PrEP Guidelines that include suggested new HIV Testing Algorithm

    Posted 03-31-2022 17:30
    Marc, I have not.  The evidence doesn't seem particularly compelling for non-cab either.  That said, prior to being in systems practice my independent pharmacy was doing PrEP on CPA and we ran an RNA quarterly.  We were lucky enough to have ADAP expansion that covered medical costs of PrEP and RNA was included in the approved lab sets.  I don't have data on the volume of copays or costs billed, as that was handled by a partner agencies PrEP navigation team.

    ------------------------------
    Dan Scales PharmD, AAHIVP
    Director of Pharmacy Collaborative Care
    Vivent Health
    ------------------------------



  • 8.  RE: New CDC PrEP Guidelines that include suggested new HIV Testing Algorithm

    Posted 04-01-2022 13:05
    This message was sent securely using Zix®

    I am totally with you, Marc.  Only exception =s are if I feel there has been high risk sex AND recent seroconversion type symptoms (problematic with COVID!).
    I've seen several false positive HIV 4th generation tests, not false negatives (that I know of).
    Bigger other utility, to me, is to use the HIV RNA qualitative test to accelerate the PEP Protocol, in asserting no seroconversion, for both nPEP and occupational PEP.  Awaiting the CDC to incorporate it in that setting.

    Brian

    --
    Brian R. McMurray, MD, FACP, FACEP, AAHIVS
    Medical Director, Music City PrEP
    615 Main Street
    Nashville, TN  37206
    mobile 615-419-0428
    healthencrypt



    This message was secured by Zix®.





  • 9.  RE: New CDC PrEP Guidelines that include suggested new HIV Testing Algorithm

    Posted 03-31-2022 17:02
    I agree Brian. I was on a webinar last week with Dr. Gail Smith from CDC (and Rafi) and she was rather strongly standing by their recommendation for
    NAT testing - which is not practical or cost-effective for many clinical sites including the ones I am affiliated with. I highly doubt with 4th gen testing we
    will miss any / many infections.

    ------------------------------
    Jeffrey Kirchner
    Lancaster PA
    ------------------------------



  • 10.  RE: New CDC PrEP Guidelines that include suggested new HIV Testing Algorithm

    Posted 04-01-2022 09:15
    I thoroughly respect the science but is there not a weighting to consider.  If RNA qualitative testing results in an increase in cost and decreased access to PreP, how beneficial is the recommendation?  I understand it came from the HPTN 083, 4 cases, of HIV infection, occurred in participants that had "on-time CAB-LA injections and expected plasma CAB concentrations". the reports say CAB exposure was associated with prolonged viral suppression and delayed antibody expression.  Of course, you can say delayed antibodies ( based on when they had viral detection) but how do they know there was a prolonged viral suppression as the point in which virus entered the body could not be determined..could it? Marzinke

    ------------------------------
    Christine Brennan
    LSU Health Sciences Center
    New Orleans LA
    ------------------------------



  • 11.  RE: New CDC PrEP Guidelines that include suggested new HIV Testing Algorithm

    Posted 04-01-2022 10:35
    I am pretty firmly of the belief that cab-la needs the RNA testing.  The combination of the PK tail and the chance of delayed antibody expression creates significant concern for me.  That said, I am also of the firm belief that the best pathway to establish access in our most at risk and underserved clients is generic F/TDF, and still do not see compelling data on F/TDF that would indicate masked infection on the same timeline as CAB-LA.  As a pharmacist prescriber in CO, I am restricted by state wide protocol, which adheres to guidelines, but those with license liberty I would think expanding access would be the primary concern,

    ------------------------------
    Dan Scales PharmD, AAHIVP
    Director of Pharmacy Collaborative Care
    Vivent Health
    ------------------------------