PEP/PrEP Update (Krumland - 7/26/23)

 A recording of this presentation can be viewed HERE.

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Many thanks to Dr. Stephen Krumland of Team Vida at SRCH for an excellent update on HIV Pre-exposure Prophylaxis (PrEP) and Post-exposure Prophylaxis (PEP). This is such an important primary care topic! 

Take homes up front:

• PrEP
• All primary care providers can and should prescribe PrEP for any patient who wants it. Yes you can!
• A few specific labs should be ordered and resulted before starting PrEP (see below for details; the labs are slightly different depending on the medication being prescribed).
• PrEP is a USPSTFGrade A Recommendation, which means most health plans are required to provide it without a co-pay. 
• Yes, PHP covers PrEP and there are Patient Assistance Programs for patients who are totally uninsured.
• NCCC PrEP line (WARM): 1-855-448-7737 (M-F 9am-8pm EST)
• PEP
• The need for PEP is considered a medical emergency and requires urgent management by clinicians.
• PEP should be started within 72 hours of high risk exposure, the sooner the better.
• Clinics should have a PEP "starter pack" to ensure patients can start PEP asap after exposure (SRCH has this).
• NCCC PEP line (HOT): 1-888-448-4911 (7 days a week, 11am-8pm EST)

Pre-Exposure Prophylaxis (PrEP) is safe, effective and reliable. It is estimated that 1.8 million patients in the US are eligible for PrEP, but only 25% receive it. In a study from 2019, only 13.6% of primary care providers reported prescribing PrEP. Of note, women comprise only 8% of PrEP prescriptions even though they make up 18% of new HIV diagnoses. 

People with an increased risk for HIV via sexual exposure include: people with a known HIV-positive partner, people with one or more partners of unknown HIV status, and people who have contracted a bacterial STI (e.g. GC/CT or syphilis) in the last 6 months. People with increased risk for HIV via injection drugs include anyone who has injected drugs in the last 6 months. 

We should definitely be screening people with a good sexual and substance use history and prescribe PrEP for anyone who is at high risk, BUT also NOTE that the 2021 update from the CDC recommends we offer PrEP to anyone, even those without these risk factors, if requested!

PrEP consists of 1 of 3 possible medications (4 ways to take):

1) Truvada (F/TDF) is a DAILY single pill, ALL patients can take (including pregnant and breastfeeding). Possible side effects include AKI and worsening of CKD and decreased bone density (with continued use). Truvada is effective if taken 6 days per week for those having vaginal sex, and a minimum 4 days/week for cisgender men and transgender women having non-vaginal sex. Absolute contraindication: Do not rx for CrCl<60.

2) Descovy  (F/TAF)is also a DAILY single pill. It has not been tested or approved for use in vaginal sex. Side effects include elevated lipids and weight gain (but does NOT have renal or bone effects, so may be preferable in patients with CKD and/or osteopenia). Contraindication: Do not rx for people having vaginal sex

3) Cabotegavir (brand name Apretude) is a newer Q8 week IM injection, which takes away adherence issues of taking a daily pill. The main side effect is pain at the injection site. It has no renal effect, no bone effect. 

Alternate dosing:

There is good evidence for on demand PrEP, as an alternate to daily PrEP dosing. On Demand PrEP is not FDA approved but is recognized by the same body as an "alternate dosing" schedule. On Demand PrEP is often referred to as "event-driven PrEP", which means you take it when risky behavior is anticipated to happen. This is how you take it:

• 2 tabs, 2-24 hours prior to sexual encounter
• 1 tab,  24 hours after sexual encounter
• 1 tab, 48 hours after sexual encounter

        TOTAL 4 tabs

This is a great method for either folks who are terrible about taking a daily pill OR those who have intermittent and predictable high risk exposures. 

Okay, so which labs should I order prior to initiating PrEP?

• Check HIV status prior to starting any PrEP
• check HIV Ag/Ab for anyone who is starting for the first time or people restarting PrEP after a long stop
• check HIV Ag/Ab AND HIV RNA for anyone who is on PrEP or who has recently taken any PrEP
• Screen for other STIs prior to starting any PrEP (site-specific testing)
• gonorrhea, chlamydia and syphilis
• Check a pregnancy test (HCG) for any patient who is at risk of getting pregnant.
• Check renal function (BMP) before starting ORAL PrEP (F/TDF and F/TAF). You do not need to check renal function for Cabotegavir (Apretude)
• F/TDFis approved if CrCl>60
• F/TAF is approved if CrCl>30
• Check HBV status prior to starting ORAL PrEP (F/TDF and F/TAF) because some of these agents are used to treat HBV and can reactivate a patient's dormant HBV (do no harm).
• Check a Lipid panel for anyone starting F/TDF

What lab testing do I need to do for people on PrEP?

• Test for HIV q3 months (Ag/Ab, unless they have s/sx of acute HIV then you should add HIV RNA)
• Renal function (if ORAL PrEP) q3 months at first, then q6 months
• Routine STI screening (site specific) q3 months 

Post-Exposure Prophylaxis (PEP)

There have been no recent updates to the 2016 Guidelines. You must have had contact with a high risk body fluid -- that is blood OR something with blood in it -- to qualify for PEP. Whether it's an occupational exposure (e.g. needlestick) or a non-occupational exposure (e.g. unprotected sex), the need for PEP should be treated as a medical emergency.

PEP is 3 meds regimen (there are multiple options) x 30 days

Okay in pregnancy

Most commonly Biktarvy (coformulated BIC/FTC/TAF) or Truvada (tenofavir, emtricitabine) + Raltegravir 

Biktarvy is one pill daily x 28 days, studies show it is well-tolerated

SRCH has starter packs (5-7 days) to allow patients to start immediately while the meds are obtained for the month

Baseline PEP labs:

• HIV Ag/Ab
• Rneal, liver function
• HBV
• HCG
• STI labs

Follow-up PEP labs

Recheck HIV Ab/Ag in 4 weeks, then again in 3 months

Be sure to evaluate need for starting PrEP at the 4 week visit, again at the 3 month visit

What is DoxyPEP?

DoxyPEP is a one time doxycycline dose after high risk sexual exposure (oral, anal or vaginal). It has been shown to significantly decrease the risk of gonorrhea, chlamydia and syphilis

Doxcycline dosing: 200mg x 1 within 72 hours of high risk exposure

DoxyPEP was added in April to CDPH recommendations to anyone at high risk for STI exposure,  likely will be by the CDC soon

Note: doxycycline should NOT be given in pregnancy

If you have questions, concerns, us the PrEP warmline, the PEP hotline, and don't forget Team VIDA at SRCH!