Pre-exposure Prophylaxis

PrEP

 Priniciples & Procedure

  • PrEP should be used in adults at high-risk of acquiring HIV infection when condoms are not used consistently.  Before PrEP is initiated, HBV serology status should be documented
    • Recommended in HIV-negative men who have sex with men (MSM) and transgender individuals when condoms are not used consistently with casual partners or with HIV-positive partners who are not on treatment. A recent STI, use of post-exposure prophylaxis or chem-sex may be markers of increased risk for HIV acquisition
    • May be considered in HIV-negative heterosexual women and men who are inconsistent in their use of condoms and have multiple sexual partners where some of whom are likely to have HIV infection and not being on treatment
  • PrEP is a medical intervention that provides a high level of protection against HIV acquisition but does not protect against other STIs and should be used in combination with other preventive interventions. PrEP should be supervised by a doctor, experienced with sexual health and use of HIV medicines, possibly as part of a shared care arrangement

Recommended Procedures

  • Documented negative fourth generation HIV test a week prior to starting PrEP. In case of suspicion of acute HIV-infection, an RNA test on plasma should also be performed.  See Primary HIV Infection (PHI). During PrEP, a fourth generation HIV test should be repeated at one month and then every 3 months. PrEP should be stopped immediately in case of early clinical signs of HIV seroconversion or a positive HIV diagnostic test and the person referred for evaluation to an HIV unit
  • Before PrEP is initiated, HBV serology status should be documented. If HBsAg positive, see Clinical Management and Treatment of HBV and HCV Co-infection in PLWH.
  • Counsel that PrEP:
    • does not prevent other types of STIs; screen for STI (syphilis, chlamydia, gonorrhoeae, HAV, HCV) when starting PrEP and regularly during use of PrEP, see Assessment of PLWH at Initial & Subsequent Visits
    • may impact renal function and bone health. Check renal function before starting PrEP and check renal function and bone mineral density during PrEP according to guidelines on TDF use. See Kidney disease.
    • like other prevention methods, only works when it is taken. Adherence counselling is recommended
    • can be prescribed long-term but that each consecutive PrEP prescription should be for a period of maximum 3 months (90 tablets) to ensure appropriate monitoring

See online video lectures PrEP-Part 1 and PrEP-Part 2 from the EACS online course Clinical Management of HIV

PrEP Regimen

  • TDF/FTC 300*/200 mg 1 tablet qd
    • In both men and women PrEP should be taken for 7 days before the first exposure and stopped 7 days after the last exposure
  • A trial with daily TAF/FTC in MSM and transgender women has shown non inferiority to daily TDF/FTC. No data are available in other high risk groups [20]
  • For MSM only, PrEP may be dosed ‘on demand’ (double dose of TDF/FTC 2-24 hours before each sexual intercourse, followed by two single doses of TDF/FTC, 24 and 48 hours after the first drug intake). There are no efficacy data with on demand PrEP with TDF/FTC in women
  • Use of generic formulations of TDF/FTC, if and where available, may help to improve the cost-effectiveness of PrEP, which is essential for its use as public health approach

* In certain countries, TDF is labelled as 245 mg rather than 300 mg to reflect the amount of the prodrug (tenofovir disoproxil) rather than the fumarate salt (tenofovir disoproxil fumarate)