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Page 3 of 8  Guideline


              TABLE 1: Populations for pre-exposure prophylaxis consideration.
              Population     Risk group               Special considerations
              Adolescents    Any/all                  Must weigh > 35 kg. Should be allowed to consent independently but support is advisable especially to
                                                      assist with persistence.
              Women          Mostly vaginal sex but may also engage   Pre-exposure prophylaxis (PrEP) is highly efficacious when dosed daily in HIV-uninfected women. It is a
                             in oral  and anal sex    user-dependent, discreet addition to the prevention menu for women. When providing PrEP to women, it
                                 †
                                                      is important to provide it in the context of other health interventions. 27,28,29  Considerations such as pap
                                                      smears, contraception, breastfeeding and post-partum care should be covered. However, access to these is
                                                      not a prerequisite to prescribing PrEP.
              Men            Penile and oral          Pre-exposure prophylaxis works for men who are HIV-negative and at risk of HIV acquisition.
              Men who have sex   Penile, anal and oral  Tissue concentrations of TDF/FTC appear to be higher at the anal mucosa and are reached more rapidly in
              with men (MSM)                          the anal mucosa than in vaginal mucosa. It has been demonstrated in modelling studies that four doses
                                                      per week may be sufficient to safely protect MSM. Recent trials have also confirmed that on-demand PrEP
                                                      is efficacious. 28
              Pregnant and   Primarily vaginal sex but may also   Pre-exposure prophylaxis is safe in pregnancy and during lactation. There are no contraindications of
              breastfeeding women  engage in anal and oral sex  taking PrEP during pregnancy and breastfeeding. 19,25  HIV incidence is high during pregnancy and
                                                      breastfeeding, with HIV acquisition risk more than double during pregnancy and the postpartum period
                                                      compared to when women are not pregnant.  Pre-exposure prophylaxis counselling should be provided to
                                                                                30
                                                      all HIV-negative pregnant women at risk of HIV. Pre-exposure prophylaxis provision and risk reduction
                                                      counselling should be aligned with antenatal and postnatal visits. Symptoms such as nausea and
                                                      gastrointestinal symptoms are far more common and more severe than with PrEP, especially in the first
                                                      trimester, and should thus be actively managed.
                                                      There are no data yet on TAF/FTC in pregnancy.
              Serodiscordant couples   A partner has unknown or HIV-positive   Pre-exposure prophylaxis may be used as a ‘bridge’ until the partner living with HIV has an undetectable
                             status and is not virally suppressed  viral load – at that point PrEP may be discontinued depending on the preference of the couple. 31
              Safer conception  Serodiscordant couples wishing    Pre-exposure prophylaxis may be provided to the HIV-negative partner during condomless sex whilst trying
                             to conceive              to conceive, and whilst pregnant and breastfeeding. 32,33,34,35  Pre-exposure prophylaxis should be continued
                                                      until the partner living with HIV has initiated ART and achieved viral suppression (viral load
                                                      < 200 copies/mL).
              Drug using individuals   Needle sharing caries high HIV risk   Pre-exposure prophylaxis has been shown to be effective in one large RCT and some demonstration
                                                      studies of intravenous drug using populations of both sexes.
              Transgender people  Anal and oral sex   Transgender (TG) women have very high rates of HIV acquisition and PrEP is effective although specific
                                                      evidence is limited.
              MSM, men who have sex with men; PrEP, pre-exposure prophylaxis; TDF, tenofovir disoproxil fumarate; RCT, randomised controlled trial; TAF, tenofovir alafenamide; FTC, emtricitabine; ART,
              antiretroviral therapy; HIV, human immunodeficiency virus.
              †, Oral sex involves using the mouth to stimulate the penis (fellatio), vagina (cunnilingus) or anus (anilingus). The chance an HIV-negative person will get HIV from oral sex with an HIV-positive
              partner is extremely low and lower than anal or vaginal sex. The risk of HIV transmission through oral sex is even lower if the HIV-negative partner is taking PrEP.
              When should pre-exposure prophylaxis not be           •  Understanding and insight of potential PrEP user:
              offered?                                                To ensure that the PrEP user understands what PrEP is
                                                                      and the protection it provides, and has a personal plan
              •  Pre-exposure prophylaxis should not be offered to anyone
                 who is suspected or confirmed to be HIV-positive.    for its effective use
                 Providing PrEP to an individual who is HIV-positive or   •  Human immunodeficiency virus-negative status of
                 acutely  seroconverting is  sub-optimal  treatment  for   user: To ensure that the PrEP user is confirmed to be
                 HIV and could lead to antiviral drug resistance.     HIV-negative (rapid HIV testing acceptable)
              •  Individuals who refuse to HIV test should be counselled   •  Suitability and safety of PrEP for user: To assess the
                 and PrEP should not be offered.                      suitability and safety of PrEP in those with renal and/or
              •  Pre-exposure prophylaxis should be delayed in anyone   other potential contraindications.
                 with an acute viral illness that could be because of HIV
                 seroconversion. There is considerable overlap in   Step 2:  Test for human immunodeficiency virus status:
                 symptoms and signs caused by viruses; therefore, any   Human immunodeficiency virus testing is required at
                 potential PrEP client presenting with fever, myalgia,   initiation  and  at  least  3  monthly  whilst  on  pre-exposure
                 arthralgia, rash, headache, and oral or genital ulcers   prophylaxis to confirm HIV-negative status
                 might be HIV-positive but in the window period. Other   •  Follow HIV testing guidelines.
                 HIV prevention options, like condoms, should be
                 discussed, repeat testing should be arranged for 2 weeks   •  Elicit  a medical history  and conduct a  targeted
                 later, with PrEP offered then if repeat test is negative.   examination to exclude acute exposure (symptoms
              •  Tenofovir-based PrEP should not be offered to anyone with   suspicious of acute infection may be followed with repeat
                 pre-existing renal dysfunction (Estimated glomerular   testing after 2 weeks to confirm HIV-negative status).
                 filtration rate i [eGFR] < 50 mL/min). Clients can return in   •  Human immunodeficiency virus testing is advised 3–6
                 1–3 weeks to re-test eGFR to re-assess eligibility.   monthly whilst on PrEP to ensure breakthrough infection
              •  Individuals < 35 kilograms (kg) should not be given   has not occurred.
                 oral PrEP.                                         •  Human immunodeficiency virus self-testing may be used
                                                                      as an alternative whilst on PrEP.
              Simplifying pre-exposure prophylaxis to improve       •  Inconclusive HIV test results should be referred for
              access and optimise use                                 confirmatory testing.
              Pre-exposure prophylaxis is safe, well tolerated and easy   •  Pre-exposure prophylaxis should be stopped immediately
              to administer                                           in anyone with a positive or indeterminate HIV test result.
              Step 1: Check client desirability of pre-exposure prophylaxis:   •  Should an interruption in PrEP occur, then initiation
              The aims of initiation consultations for PrEP are:      testing should be performed (as above) prior to restart.


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