PEPSE (Post Exposure Prophylaxis for Sexual Exposure to HIV) protocol

• Those with exposures in the recommended categories in the above table that are within 72 hours of last exposure.
• In exposures where PEP is to be considered or generally not recommended, other risks that would increase HIV transmission as detailed above should be In cases where PEP is ‘generally not recommended’, it does not need to be discussed with patient unless they have enquired about it.
• If the source patient is HIV +ve and known to have an undetectable VL, but for less than 6 months, PEP is generally not required but can be discussed with GUM senior.
• PEP is most effective if given within 24 hours of exposure; if > 72 hours PEP is not effective and should not be given.

• Patient on PrEP

PrEP is highly effective at preventing HIV and there is no indication for PEP if the exposed individual is on PrEP and taking it appropriately.

Indications for PEP in individuals on PrEP:

• Risk related to Anal sexual intercourse
  • If on daily PrEP and have taken < 4 pills in last 7 days
  • If on EBD and any missed pills
• Risk related to Vaginal/ Frontal/ Neo vaginal sexual intercourse
  • If > 48 hours since last dose or < 6 tablets in last 7 days
    
    
• Pregnant / breastfeeding
  • A pregnancy test should be undertaken in women of childbearing age but does not exclude very early pregnancy (within the preceding 3 weeks).
  • Pregnancy or breastfeeding should not alter decision to provide PEP
  • Pregnancy increases risk of transmission and primary HIV infection would increase risk of intra-uterine infection
  • Counsel that PEP is unlicensed in pregnancy
  • In women that are breastfeeding, discuss that PEP can be transferred to the baby via the breast milk
  • Use twice daily Raltegravir
    
    
• Sexual Assault
  • Possibility of higher risk of transmission given trauma (not evidence based), and if assailant from a group with higher prevalence of HIV viraemia, then PEP may be recommended more readily.
  • If assailant from low prevalence group it is likely PEP will not be indicated as sexual assault alone is not an indication for PEP.
    
    
• Chronic Hepatitis B
  • If patient is on daily TDF as Hepatitis B treatment PEP unlikely to be required but discuss with GUM senior
  • If Hepatitis B diagnosed at assessment arrange assessment with Hepatitis team; if this has not occurred when PEP course is complete continue tenofovir/emtricitabine until assessed.
    
    
• Shared use of injecting equipment (chem-sex)
  • Seroprevalence of HIV in PWID is low outside localised outbreaks (Glasgow has ongoing outbreak)
  • Consider PrEP if sexualised drug use an ongoing risk
  • PEP recommended if any contact known HIV with a detectable/unknown VL

• Baseline investigations as per table 2 – STI testing including STS, U&Es, LFTs, HIV, HepCAb, HepBsAg, HepBsAb, HepBcAb
  • If there has ever been a documented HepBsAb > 10 IU/mL , HepB testing does not need done nor HepB vaccine given
• Pregnancy test and assess need for emergency contraception
• Discuss transmission risk of individual encounter (risk tables in appendices often reassuring for patient as likely they will have overestimated risk)
• If possible, establish plasma VL if source known to be HIV positive, or HIV antibody status if this is unknown, as this will affect whether PEP should be given (but do not delay initial prescription while results awaited, if PEP is indicated).
• Discuss rationale for PEP – estimated transmission reduction of 80% but lack of conclusive evidence, most evidence from animal studies.
• Discuss safety of PEP and side effects:
  • TDF/FTC
    • very common side effects (≥1/10) include headache, dizziness, diarrhoea, nausea,
    • common side effects (≥ 1/100 to < 1/10) include insomnia and abdominal pain (122).

These side effects are usually mild, transient and rarely treatment limiting. The risk of TDF renal toxicity is usually not clinically relevant in 1 month PEP course; if creatinine clearance < 50 however,an alternative drug should be used.

• Raltegravir
  • Well tolerated
  • Common side effects – headache, diarrhoea, nausea, insomnia
  • Myopathy or rhabdomyolysis have been reported with INSTIs, therefore caution is required in individuals with a history of myopathy or who are using other medication associated with these conditions, for example statins

• Check PMH & allergies
• Check medications and OTC treatments including vitamins using HIV drug interactions website - Liverpool HIV Interactions. Raltegravir interacts with various OTC supplements and these will need usually be stopped or taken > 4 hours separate from PEP.
• Discuss importance of adherence and what to do if missed doses
• To re-attend urgently if develops seroconversion symptoms
• Need for HIV test > 45 days after PEP complete and for protected sex until then
• Discuss PrEP if likely to have ongoing risk
• Assess Hepatitis B vaccine status, if fully vaccinated and documented antibody >10 no further vaccine required. If not see appendix 3 for management.
  • If Hepatitis B vaccine required accelerated course 0,1,2,12 months can be given
• Organise any follow-up appointments

Table 2 Baseline Investigations and follow up

Non-pregnant adults:

• Emtricitabine/Tenofovir 200/245mg one tablet daily 30-day pack
• Raltegravir 1200mg once 30-day pack
  • Issue a 30-day supply along with PIL
  • Prescribe on NASH
  • If they have already received a starter pack from elsewhere this is likely to be bd raltegravir so ensure change of dosing discussed
  • If they have received a 3-day starter pack -> issue 30-day pack including 1200mg RTG
    • If they have received a 7-day starter pack they can continue on bd RTG and issue a 21-day pack of RTG 400mg bd tablets

In pregnancy raltegravir should always be 400mg bd (Can use 600mg bd if no 400mg available) If index case has known resistance discuss at MDT

Table 3 ASHH Recommendations for PEP

Missed doses

Extending PEP

If high-risk sex occurs during the last 2 days of the PEP course, extend the course:

• 48h after anal sex
• 7 days after vaginal/frontal sex

• If no concerns on blood tests can issue a HSK for STI screening 14 days after exposure
• If switching from PEP to PrEP arrange PrEP new start for <28 days later (Discuss with PrEP secretary)
  • At prep new start appointment follow up testing can be arranged and second dose Hepatitis B vaccine can be given
• If not for PrEP, arrange appointment 12 weeks post exposure for repeat HIV and syphilis testing. (The HIV test is recommended at minimum of 10.5 weeks post exposure if PEP taken, this 12 weeks is to align with syphilis testing but could be repeated earlier if significant patient anxiety). See Table 2 for required tests.