Recommended schedule of testing and follow-up for individuals on PrEP

Once pre-exposure prophylaxis (PrEP) is initiated, patients should return for follow-up every 3 months. Clinicians may wish to see patients more frequently in the period after PrEP initiation (e.g. 1 month after initiation) to:

  • assess and re-confirm human immunodeficiency virus (HIV)-negative test status in patients with a recent pre-PrEP HIV exposure
  • assess side effects
  • monitor renal function in patients at particular renal risk
  • assess adherence
  • answer questions.

Some jurisdictions recommend a visit at month one. The Table 7.1 and Box 7.1 set out the

recommended schedule of testing and follow-up for people who are prescribed PrEP.

Table 7.1 Laboratory evaluation and clinical follow-up of individuals who are prescribed PrEP

Test

Baseline (Week 0)

About day 30 after initiating PrEP (optional)

90 days after initiating PrEP

Every subsequent 90 days on PrEP

Other frequency

HIV testing and assessment for signs or symptoms of acute infection

Y

Y

Y

Y

N

Assess side effects

N

Y

Y

Y

N

Hepatitis B serology Vaccinate if non-immune

Y

N

N

N

Y

If patient required hepatitis B vaccine at baseline, confirm immune response to vaccination 1 month after last vaccine dose

Hepatitis C serology

Y

N

N

N

12 monthly but, more frequently if ongoing risk e.g. non-sterile injection drug use and MSM with sexual practices that predispose to anal trauma

STI (i.e. syphilis, gonorrhoea, chlamydia) as per Australian STI Management Guidelines^

Y

N

Y

Y

N

eGFR at 3 months and then every 6 months

Y

N

Y

N

At least every 6 months or according to risk of CKD

Urine protein creatinine ratio (PCR) baseline

Y

N

Y

N

Every 6 months

Pregnancy test (for women of child-bearing age, not on effective contraception)

Y

Y

Y

Y

N

CKD: chronic kidney disease; eGFR: estimated glomerular. filtration rate; PrEP: pre-exposure prophylaxis; PWID: people who inject drugs STI: sexually transmissible infection

*http://www.sti.guidelines.org.au/

 

Box 7.1 PrEP follow-up procedures

At least every 3 months:

  • Repeat HIV testing and assess for signs or symptoms of acute infection to document that patients are still HIV negative. Rapid point-of-care tests (POCTs) are not recommended for monitoring patients receiving PrEP.
  • Test for sexually transmissible infections (STIs). This involves PCR tests for chlamydia (first-pass urine, pharyngeal swab and anal swab) and Neisseria gonorrhoea, (pharyngeal swab and anal swab) and a blood test for syphilis serology (1).
  • Assess side-effects, PrEP adherence and ongoing PrEP suitability.
  • Provide an authority streamlined (PBS) prescription or a private prescription of daily TD*/FTC for 90 days (see Providing PrEP for exceptions to this script duration).
  • Respond to questions and provide any new information about PrEP use.
  • Provide support for medication adherence and risk-reduction behaviours.

In addition:

  • Repeat pregnancy testing for women of childbearing age.
  • Test for hepatitis C virus (HCV) in people who inject drugs (PWID) who report continued sharing of injecting equipment and men who have sex with men (MSM) with elevated risk of HCV acquisition (e.g. sexual practices that pre-dispose to anal trauma).

At least every 6 months:

  • Monitor estimated glomerular. filtration rate (eGFR), creatinine and urine protein/creatinine ratio.
  • If the patient has risk factors for renal impairment (e.g. hypertension, diabetes), renal function may require more frequent monitoring and/or may need to include additional tests (e.g. urine protein/creatinine ratio).
  • A rise in serum creatinine is not always a reason to withhold treatment if the eGFR remains at or above 60 mL/min/1.73 m2 but an acute rise in the serum creatinine in a patient on PrEP would need full clinical evaluation and sometimes a review by a renal specialist.
  • If eGFR is declining steadily (but still at or above 60 mL/min/1.73 m2), consultation with a renal specialist or other evaluations of possible causes for declining renal function may be indicated.

At least every 12 months:

  • Test for hepatitis C.
  • Test for hepatitis B serology if the patient has not been vaccinated.

Patients who access PrEP through the Personal Importation Scheme of the Therapeutic Goods Administration (TGA) should allow a lead time of 2–6 weeks for the drug to arrive in Australia and pass customs clearance.