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In this asynchronous online activity, we will be exploring timely clinical topics related to caring for people living with HIV.


HIV Prevention: Navigating Real World Challenges
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Ron is a 19-year-old male who visited a minute clinic three days ago with an acute onset of fever, fatigue, myalgia and headache.  His past medical history is consistent with an episode of primary syphilis and rectal gonorrhea in the past year; both were successfully treated.  He is sexually active with both male and female partners and does not consistently use barrier precautions.  He was on PrEP more than a year ago, but did not routinely follow up for his appointments and his provider stopped renewing his prescription.

His rapid HIV antibody test and influenza test were negative at the minute clinic.  He was then referred to your clinic and expresses a motivation to reinitiate PrEP?

Questions:

  1. Would you initiate PrEP for the patient at this time?  Why or why not?
  2. What other things would you do or consider at this visit?

51 thoughts on “HIV Prevention

  1. Cori Blum says:

    I’d like to know when his last possible HIV exposure was, and whether the rapid test is 3rd or 4th generation, to explore possibility of acute HIV given symptoms. Would send HIV PCR along with reflex to genotype if positive, and PrEP start labs, and if cannot rule out acute HIV would start same day with a rapid HIV treatment regimen (likely dolutegravir + Tenofovir/FTC while awaiting viral load results. If VL negative, could switch to a PrEP regimen once those results return.

    • William Short says:

      Cori are you using 4th generation rapid tests? We are not doing rapids and have everything done through ag/ab testing at our hospital with a quick turn around time (less than 24 hours).

  2. John Beltrami says:

    I would not. Given the symptoms reported, the patient may have acute HIV. I would order a rapid antigen test (e.g., Determine) to get a better indication of possible acute HIV and send off blood for an HIV viral load. I would explain to the patient why PrEP is not appropriate at this time and counsel him on acute HIV and to abstain from sex or use protection (e.g., condoms) if going to be sexually active, because if has acute HIV, then likely to have a high viral load making transmission to others more likely.

  3. John Beltrami says:

    Thanks Dr. Short. I’ve worked in non-clinical HIV/STD public health for a very long time, but just recently started seeing PrEP patients. What I’m hearing from some patients/providers is that some patients have no interest in using condoms once on PrEP and the focus of condom promotion tends to be on STI prevention. I support the concept of meeting patients where they are, but your graph is a reminder that someone on PrEP could still acquire HIV (e.g., receptive anal intercourse without condoms from someone with an extremely high VL), so it seems to me that a client not wanting to use condoms on PrEP should still be prescribed PrEP, but counseled that their chance of getting HIV is further reduced with condoms. Please let me know if you think there is a better or different approach to consider. Thank you, John

  4. William Short says:

    Great points, I usually discuss the efficacy of PReP but I remind patients that PReP does not protect against STIs. I also share some local data about the STI epidemic we are seeing in my area (Philadelphia) as well as nationally. I also discuss that there can be serious consequences of Syphilis including neurologic deficits.

    In addition, over time I add in discussion about HPV and its association with cancer, long term HSV, etc. I do not do this all at once because I do not want to make patients think I am trying to scare them into using condoms.

    • Jason Schafer says:

      I really like this approach and think that it has been an effective message for most of our PrEP patients too. The discussion of HPV and its association with cancer, in particular, is one that definitely renewed importance given the expansion of candidates for immunization. We have seen our share of PrEP patients over the age of 26, and we are now more routinely discussing the potential benefits of the HPV vaccine up to 45: https://www.cdc.gov/vaccines/acip/recs/grade/HPV-adults-etr.html.

      • William Short says:

        We are using a urine assay developed by one of our providers here to check levels and it has bene really great. I like the pharmacy calls but I have been burned because patients will tell me that they have extra meds available due to a number of reasons.

        • Jason Schafer says:

          It would be great if this urine assay became commercially available. However, I think I would still worry that it may not catch dips of adherence between visits if for example, a patient became more consistent with dosing before their visit in comparison to previous days/weeks. Have you run into this problem at all?

          • William Short says:

            I see this happening frequently in clinical practice and it is difficult. We are seeing patients being referred in who were prescribed PrEP and seroconverted and when asked they admit they were not taking it consistently. We need injectables!!

          • Eileen Donaghy says:

            We used the urine assay as part of a research project trying to determine if participants were NOT taking their meds as instructed during an Analytical Treatment Interruption phase (ATI). There seemed to be a large “grey” area. It was picking up TDF in participants who had detectable VLs and reported NOT taking their meds as instructed. The sensitivity was unclear therefore this data was not trusted.

  5. John Beltrami says:

    I heard that a clinic in Washington, DC checks Tenofovir drug levels, which I think is great, but wonder how costly and sustainable that model is for others to emulate. Of six PrEP clinics that I’ve actually visited (3 in Atlanta and 3 in New Jersey), all ask client about their adherence. My understanding is that data show that for the most part self report correlates with measured drug levels, particularly when a patient says that they are not adherent. I’ve read that the best focused questions are asking a patient how many pills they’ve missed in the last week and last month.

    • William Short says:

      We have had some crazy discordant results between self report and urine drug levels. I like our assay because it is urine based and not very hard to do-the problem is that it has to be sent off and picked up by Fed-EX.

  6. John Beltrami says:

    My understanding is that the # of STIs related to condomless sex is not clearly known yet. It seems some data show increases and some do not. And the reasons don’t simply relate to the idea of less condoms therefore more STIs, because with all of the extra screening, some STIs are being detected that would not have otherwise been so. And I briefly spoke with a research modeler who said that STIs should initially increase, but the fact that these STIs are treated early means that STIs should decrease over time.

  7. Eileen Donaghy says:

    This is a great conversation so far and it looks like everyone is on the same page regarding the initial question of whether or not to initiate PrEP in Ron the sexually active 19 yo.
    I definitely see, in my practice (Phila), the increase in STIs. I’m performing the “triple” screen- pharyngeal, rectal and urethral GC/CT swabs. Commonly I’m finding +CT with the rectal swab.
    It’s really important to discuss what types of sex our patients are having in order to determine their risk.
    Anyone have tips on having that “sex” talk?

    • Kandis Backus says:

      The sex talk is definitely more of an art than a science. Sex, sexual activity, and intercourse mean different things to different people. I have a patient that has been seeing me for PrEP for >1 year. He previously told me about his siblings, his grandchildren and children but, only recently disclosed that he prefers to have sex with men- declined STI testing but wanted PrEP. I also have a female PrEP patient that waited 9 months to tell me about a rash in her inner thighs. I believe cultural and comfort play a role. We like to think people will disclose their business at the first visit but it may take time.

      • Eileen Donaghy says:

        My approach is to be very open and at ease from the beginning when discussing sexual practices. Some patients require more time to open up than others but it’s our job to make them feel that they are in a safe place to discuss sex practices and ask questions as needed. No judgement. Patients have no idea that STIs can be transmitted orally and with the recent outbreak of Hep A in the Phila area, I’ve been making a point to discuss this in more detail. Getting patients to open up about what type of sex they have is sometimes a challenge- they tell us what they think is acceptable but not necessarily factual.

    • Idalina Afopa says:

      I warn my patients about using prep on demand and the risk of viral resistance that it entails. I emphasized the importance of adherence once on prep to improve the chances of HIV prevention.

      • William Short says:

        I think it is also important to note that while on-demand approach is being used and is approved in Europe, our indication is still for daily dosing (hope that will change soon). In addition, this is not an appropriate strategy for cis-gender women.

    • William Short says:

      My approach is to tell patients that it is approved for daily use and explain the on demand strategy and I explain the dosing so if they decide to do this approach-they actually use the right on-demand strategy that was studied.

    • Kandis Backus says:

      Never. I have recently read some newer published articles but, I’m still not convinced. I practice in MS- health literacy low. I worry about patients that aren’t healthcare savvy and their ability to understand PrEP on demand.

      • Jason Schafer says:

        I also worry about health literacy and/or just general confusion with the on demand dosing schedule, but would consider it an acceptable option in the right circumstances. Based upon the available data, I do believe that it is an effective method of PrEP for MSMs and at least one analysis suggests that it could reduce costs for patients: https://www.ncbi.nlm.nih.gov/pubmed/29424774. In the end however, I’m not sure that on-demand PrEP will remain in the conversation as new PrEP methods become available – LA injections, implants, longer acting tablets, etc.

      • Eileen Donaghy says:

        We definitely need to take health literacy into consideration and I’m sure my PrEP talk is different each time I engage a new patient due to the varying levels of understanding among our patients. I recently had a new couple- male/male, married for several years, monogamous, 1 partner traveled for work 2 weeks out of every month. Recent social media advertising increased their awareness and interest in using PrEP. I discussed the standard daily dosing but also the “on demand” plan seemed very appropriate in this situation. The couple was going to think about it and let me know at the next appt how they decided to proceed.

          • Eileen Donaghy says:

            My patient’s baseline labs were unremarkable and I called to discuss dosing. He was still unsure how he would use the Descovy (which was approved without incident) but we will discuss at his f/u appt. I’m not necessarily changing patients from Truvada to Descovy but definitely starting new patients on Descovy.
            I’ve had several established HIV+ patients question the class action lawsuit- a few requesting DEXA scans to measure bone density and others wanting to review current and past regimens for use of TDF.
            This has been a great interactive experience- thanks everyone for your interest and time.
            Eileen.donaghy2@pennmedicine.upenn.edu

  8. Idalina Afopa says:

    Due to his symptoms I too would start a HIV tx regimen and switch to prep if HIV test turns out to be neg.
    Here in the Bronx, NY we have seen an increase in STI due to prep. I have recently treated my prep pts for syphilis, GC/CT although gonorrhea seems to be more common. In our ID clinic we use a template that always include an assessment of sex practice hx, educates pt on STI prevention (prep does not prevent any other STI). Therefore we always recommend to use condoms concomitantly.
    I would say the average use of barrier is about 50%.

    • William Short says:

      That sounds very similar to Philadelphia. I am seeing a large increase in STIs in both those with HIV and those who do not have HIV. I am never judgmental in my approach but I do warn about the increase in STIs being seen and the risk associated with each of them.

      Most are unaware that syphilis can have long term consequences and it is not just s rash.

  9. William Short says:

    I just completed a monograph with an ED physician and a Nurse practitioner about PReP use in the ED. We have seen an increase in PReP use overall but not in the individuals who need it the most–what are your thoughts on using the ED to screen for PReP given they may see individuals who might not or do not have access to routine medical care.

    • Kandis Backus says:

      We have tried to use the ED to help identify those that would benefit the most from PrEP. We ran into problems post the prescription and in the ED. In our situation, most people didn’t have insurance and there wasn’t anyone dedicated to getting them Gilead access. We saw patients getting scripts they couldn’t afford. Also, the ED staff wasn’t staffed to test a large volume of patients for HIV there were other priorities. If you all get it running please share some best practices.

      • Jason Schafer says:

        We have used the ED to scale up HIV testing and, depending upon results, referral for HIV care/rapid ART, or HIV prevention services with PrEP. This approach has been relatively successful, but we have not asked the ED to engage in either PrEP or ART initiation…at least not yet. I think that our fears would be experiencing some of the problems that you are describing.

        • William Short says:

          We are working with our ED as well and they are so busy that asking to add something else to their daily regimens seems very difficult. I do believe having someone in the ED (PrEP navigator or HIV tester) that the staff could consult or ask to get involved is probably the best way to go because if left to the ED staff this will not happen and not because of lack of interest but lack of time.

          • Eileen Donaghy says:

            I agree Bill, there needs to be designated staff in the ED to ensure newly diagnosed patients are given the support and assistance needed to get into care quickly. If a serum test is done instead of a rapid test, the patient is long gone when the results return positive. That makes for a very difficult phone conversation and one that the ED medical staff have little time and training to do. The community hospitals who employ navigators have a much better chance of engaging these patients and getting them into care.

          • William Short says:

            We have a dedicated person who will follow up all HIV testing done in the ED. When the patient leaves the ED they are given his number for follow up results.

  10. Jason Schafer says:

    Have you started to use tenofovir alafenamide/emtricitabine (Descovy) as your preferred PrEP medication instead of tenofovir disoproxil fumarate/emtricitabine (Truvada)? Why or why not?

    • Eileen Donaghy says:

      In the scenario I mentioned earlier, I prescribed Descovy. The patient was well-educated about PrEP and knew of the “improved” alternative to Truvada. Are there clinical or pharmacological reasons which would lead one to prescribe Truvada instead of Descovy?

      • William Short says:

        In my practice, I have used Descovy for patients with CKD. I do not treat adolescents but that is a group I may consider.

        If I have a new start, I will prescribe F-TAF if it is covered by their insurance.

        • Jason Schafer says:

          In terms of the patients that were already on Truvada for PrEP when Descovy was approved, many of them have remained on Truvada in our practice, but we have selectively switched some that may otherwise have risk for renal dysfunction or low bone mineral density. For new starts, we are mostly using Descovy when it is covered by insurance.

          • William Short says:

            Jason, we are having to go through some prior authorizations for Descovy which I think is interesting. Once done it is always approved but it adds a layer to our work flow.

  11. William Short says:

    Has anyone had patients come in and ask questions about the commercials they are seeing for the class action law suit against TDF. This is a very common scenario I see in my practice.

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