[Question #12342] Post PEP and testing

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8 months ago
Hello Drs. 
Thank you for providing this forum and lending your expertise. I'll go straight to my situation and questions.
I recently had a protected vaginal encounter with a biological female at an Asian spa in Austin, TX. Since I thought she was high risk, I took Biktarvy for two days (from a previous event). I stopped after I realized it would delay my testing window. I have since tested:
23 days PCR
34 days PCR and 4th gen
My dilemma is it has been ingrained in me and from the responses on this forum, that for conclusive results, a 4th gen is needed at 6 weeks/45 days. I have seen a recent shift in your opinion on PCR, so to my questions.
1. Could the two days of Biktarvy have resulted in a false negative with the 23 day PCR?
2. Could you explain how the combination of a PCR and 4th gen make it conclusive after 28 days? 
3. Why the shift in confidence with the PCR?
4. Do I need to take a final 4th gen at 6 weeks or 90 days?
5. What is your recommendation on post PEP testing (complete and interrupted, in my case)

Thank you for your time.



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Edward W. Hook M.D.
8 months ago
Welcome to our Forum.  I'll be glad to comment.  Before I address your specific questions, le tme say that if you had approached me for PEP, I would not have prescribed it since most CSWs do not have HIV and most (less than 1 in 2000) single exposures do not result in infection.  I would estimate your risk for HIV from the encounter you describe as being less than 1 in 100,000 and that estimate is conservative.  As for your specific questions:  

1. Could the two days of Biktarvy have resulted in a false negative with the 23 day PCR?
As you no doubt understand, there are no careful studies of this topic however I would consider your 23 day PCR results reliable.

2. Could you explain how the combination of a PCR and 4th gen make it conclusive after 28 days? 
Our confidence in PCR tests for HIV diagnosis is evolving and with that, our confidence is increasing with experience and better tests  Most experts now believe that a negative PCR test in someone not taking anti-HIV drugs provides entirely conclusive results any time more than 11 days after an exposure.  Previously, just to be sure, follow-up 4th generation testing was suggested.  I know of no instances in which someone with a negative HIV RNA PCR test after 11 days went on to become positive. 

3. Why the shift in confidence with the PCR?
See above- experience and study

4. Do I need to take a final 4th gen at 6 weeks or 90 days?
I would not

5. What is your recommendation on post PEP testing (complete and interrupted, in my case
Most people who develop HIV develop tests well before the 6 week recommendation but to be entirely conclusive, the 6 week recommendation remains the "gold standard".  Persons taking PEP who become infected (very few) typically develop positive tests while taking the meds or soon after but to be safe, most experts continue to recommend follow up testing at 4 - 6 weeks as conclusive.

I hope this information is helpful.  I am confident that you are in the clear.  EWH
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8 months ago
Thank you Dr. for your reply. I would like to utilize my follow ups and will not be argumentative in any stretch. Just want to ensure I understand crystal clear. 
1. Would my 2 doses of Biktarvy but not completing the regimen put me in the category of someone "not taking anti-HIV drugs"? I am trying to assess whether I fall into that gold standard of taking a final test at 6 weeks after PEP.
2. How does the combination of a PCR and 4th gen make it conclusive at 4 weeks? I know one tests for the virus itself and the other for Ag/Ab. Is it virtually impossible to have a negative 34 day 4th gen and PCR turn up positive after 45 days?
3. Can I resume unprotected intercourse with my regular partner at this time?
4. Would you consider it safe to give blood if I meet the blood bank's eligibility/criteria?

Thank you.
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Edward W. Hook M.D.
8 months ago
1. Would my 2 doses of Biktarvy but not completing the regimen put me in the category of someone "not taking anti-HIV drugs"? I am trying to assess whether I fall into that gold standard of taking a final test at 6 weeks after PEP.
You are somewhere in between.  So called "PEP on demand" or PrEP on Demand" involve taking the first dose of anti-HIV meds BEFORE the exposure as well as for a dose or two afterward.  You are in between but as I said, in your situation, I remain confident that you were not infected

2. How does the combination of a PCR and 4th gen make it conclusive at 4 weeks? I know one tests for the virus itself and the other for Ag/Ab. Is it virtually impossible to have a negative 34 day 4th gen and PCR turn up positive after 45 days?
At 28 days or more, over 98% of infected persons will have positive tests.  When combined with a PCR result, as described above, results are conclusive and there are no proven instances in which tests went on to become positive/

3. Can I resume unprotected intercourse with my regular partner at this time?
Yes

4. Would you consider it safe to give blood if I meet the blood bank's eligibility/criteria?
Yes

EWH
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8 months ago
Thank you Dr. This is extremely helpful. On to my last reply. And on a quick note, all of my testing after the last dose of PEP and not the event itself. 
1. To your comment- "At 28 days or more, over 98% of infected persons will have positive tests.  When combined with a PCR result, as described above, results are conclusive and there are no proven instances in which tests went on to become positive". What is it about the combination of the PCR with the 4th gen that makes it conclusive? I am not clear on this aspect. Don't antibodies have to be present to render conclusive? Is a PCR and 4th gen taken together as conclusive as a 4th gen at post 6 weeks?
2. I am not familiar with the so called "PEP on demand" or "PrEP on Demand". What is the testing protocol for those? Would it be PCR two weeks after last dose, 6 weeks w a 4th gen after last dose or a PCR and 4th at 28 days last dose? I am assuming testing would need to occur after last dosage and not after the event as I have seen some on the forum mention. 

Thank you again for your invaluable advice on this forum. Happy holidays!

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Edward W. Hook M.D.
8 months ago
Final Responses:

1. Antibodies DO NOT need to be present for a conclusive test.  My statement is based on scientific studies, reading the medical literature and attendance at scientific conferences.  As explained above  "Our confidence in PCR tests for HIV diagnosis is evolving and with that, our confidence is increasing with experience and better tests  Most experts now believe that a negative PCR test in someone not taking anti-HIV drugs provides entirely conclusive results any time more than 11 days after an exposure.  Previously, just to be sure, follow-up 4th generation testing was suggested.  I know of no instances in which someone with a negative HIV RNA PCR test after 11 days went on to become positive. " 

2.  PEP/Prep on Demand is a relatively recent development in which persons taking a dose of anti-HIV medication before and for a day following a high risk exposure.  It is primarily recommended for transsexual persons and men who have sex with other men. The data from a number of studies suggest it is as effected as PrEP for preventing HIV.  Because it is highly effective, there are few data on how to best follow-up this treatment but the follow-up regimens you list should be effective for proving that infection did not occur.

This complete this thread.  There should be no need to return on this topic.  EWH
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