Providing PrEP – The Basics Module 2

Session Overview Who is PrEP for? Contraindications to PrEP PrEP in pregnancy Assessing risk Eligibility criteria Starting and stopping PrEP Condom use and PrEP Combination prevention

Who is PrEP intended for? PrEP should be considered for people who are HIV-negative and at significant risk of acquiring HIV infection. This includes: Key populations: most at risk of HIV - including sex workers, men who have sex with men (MSM), adolescent girls and young women (AGYW), intravenous drug users (IDUs), transgender people, prisoners Serodiscordant couples Bottom line: ANYONE who perceives themselves to be at substantial risk [Insert country specific information] Also depends on country-specific guidelines: What's approved? What's available in the private sector ? What's available in the public sector? In South Africa: phased rollout starting with sex workers, then MSM, then… There are also many demonstration/research projects looking at PrEP provision for AGYW.

Contraindications to PrEP PrEP should not be provided: HIV-1 infected or evidence of possible acute infection Suspicion of window period following potential exposure Adolescents < 35 kg or < 15 years who are not ≥ Tanner stage 3 Poor renal function (creatinine clearance <60 mL/min) Other nephrotoxic drugs (eg aminoglycosides, NSAIDs) Unwilling or unable to return for 3-monthly visits HIV-1 infected or evidence of possible acute infection suspicion that patient might be in the window period for HIV testing following potential exposure adolescents < 35 kg or < 15 years of age who are not Tanner stage 3 or greater should not be given TDF poor renal function (estimated creatinine clearance < 60 mL/min) TDF should not be co-administered with other nephrotoxic drugs, for example, aminoglycosides unwilling or unable to return for 3-monthly HIV testing, counselling and safety monitoring visits

PrEP in pregnancy Pregnancy is associated with an increased risk of HIV infection. HIV-negative women in serodiscordant relationships are at risk of acquiring HIV infection when trying to get pregnant. In serodiscordant couples, the infected partner should be initiated on ART and virologically suppressed, ideally for 6 months, before any attempts to conceive. There are limited data relating to the safety of PrEP in the foetus. Antiretroviral Pregnancy Registry shows no evidence of adverse outcomes amongst infants exposed to these medications when used as ART in utero. Country specific information about the TDF/FTC insert concerning pregnant or breastfeeding women

PrEP in pregnancy: Guidelines Vary WHO Guidance: ‘Although additional surveillance is important, at the present time, given the available safety data, there does not appear to be a safety-related rationale for discontinuing PrEP during pregnancy and breastfeeding for HIV-uninfected women receiving PrEP who become pregnant and remain at continuing risk of HIV acquisition’. South Africa NDOH Guidance: PrEP is contraindicated by the MCC, until we have further guidance from WHO and MCC we will continue to not offer PrEP to pregnant women. Southern African HIV Clinician Society Guidance: The use of TDF/FTC as PrEP in pregnant or breastfeeding women is contra-indicated. However, as the risk of seroconversion during pregnancy is high, the risks and benefits of PrEP should be discussed with potential PrEP users, allowing these women at high risk of HIV acquisition to make an informed decision regarding PrEP use. Mofenson L, et al. AIDS 2016 WHO Guidance July 2016 Bekker LG, et al. SA Journal of HIV Med. 2016

Assessing risk PrEP provides an opportunity to explore risk Important to do a risk assessment - there are no right or wrong answers, no exact measure of levels of risk, the purpose of a risk discussion is for a person to understand their own risk Explain the purpose of the risk discussion, and be sensitive to the fact that it is a personal, private and intimate discussion Need to adapt assessment according to the persons sexual activities and preferences Important not to make assumptions e.g. MSM and hetero sexual partners have anal sex PrEP is user driven, and so an understanding of their own risk and the protection PrEP offers will contribute to their decision to use PrEP, commitment to use PrEP effectively, and explore other risk reduction options

Risk assessment - Questions Risk behaviour assessment for MSM and transwomen Risk behaviour assessment for heterosexual men and women In the past 6 months: Have you had sex with men, women or both? How many men have you had sex with? How many times did you have receptive anal sex with a man who was not wearing a condom? How many of your partners were HIV-positive or of unknown HIV status? With these positive/unknown status partners, how many times did you have insertive anal sex without wearing a condom? In the past 6 months: Have you had sex with men, women or both? How many men/women have you had sex with? How many times did you have vaginal or anal sex when neither you nor your partner wore a condom? How many of your partners were HIV-positive or of unknown HIV status? With these positive/unknown status partners, how many times did you have vaginal or anal sex without wearing a condom? These are examples of questions to explore when doing a risk assessment or having a discussion about risk, but the next slide identifies the key questions.

Or more simply… In the past six months: Have you had sex? Have you had unprotected (condomless) sex? Have you had sex with partners who are HIV-positive or whose HIV status you did not know? Have you had sex under the influence of alcohol and/or drugs? Key questions to explore when doing a risk assessment or having a discussion about risk.

Eligibility criteria Anyone identified as being at high risk for HIV exposure No contraindications to FTC/TDF FDC HIV-negative / not thought to be in the window period Absence of symptoms of acute HIV infection Willing and able to attend 3-monthly visits Understands that the protection provided by PrEP is not complete Recurrent use of PEP anyone identified by the provider and client as being at high risk for HIV exposure (see text box on indications for the use of PrEP) no contraindications to FTC/TDF FDC HIV-negative by routine rapid antibody test and not thought to be in the window period for HIV seroconversion absence of symptoms of acute HIV infection (recent acute viral illness) and, if symptoms reported, HIV-negative by 4th-generation HIV test or other HIV antigen test if available (this reduces, but doesn’t eliminate, the window period) willing and able to attend 3-monthly PrEP maintenance visits, inclusive of HIV counselling and testing, clinical review and safety monitoring procedures client understanding that the protection provided by PrEP is not complete, and does not prevent other STIs or unwanted pregnancies, and therefore PrEP should be used as part of a package of HIV prevention services (inclusive of condoms, lubrication, contraception, risk reduction counselling and STI management) recurrent use of PEP

Starting and stopping PrEP and effectiveness Risk via anal sex: need 7 days of daily dosing with oral PrEP to reach adequate anal/rectal tissue levels Risk via vaginal sex: need 20 days of daily dosing with oral PrEP to achieve protective vaginal tissue levels During this period, other protective precautions must be used, such as abstinence or condoms. This needs to be taken into account in users who stop and start PrEP according to their periods of risk. PrEP medications should be continued for 28 days after the last potential HIV exposure in those wanting to cycle off PrEP.

Stopping PrEP PrEP should be stopped: HIV test is positive PrEP user decides to stop Safety concerns (particularly if creatinine clearance < 60 mL/min) If the risks of PrEP outweigh the potential benefits

Stopping PrEP If a client decides to stop PrEP Explore risk and alternative prevention/risk reduction strategies with them Advise client that an HIV test will be required to reinitiate PrEP PrEP needs to be used for 28 days after last exposure to HIV Taking PrEP for 28 days after the decision to stop (and after last exposure to HIV) is based on a WHO recommendation. There is not enough evidence to know exactly how long PrEP is actually effective after stopping.

Cycling on and off PrEP PrEP is not a lifelong drug-taking intervention PrEP should be used only if there is possible exposure to HIV Risk levels expected to change People will use PrEP for variety of reasons Case example e.g. student vs. SW People can cycle off PrEP This is NOT non-adherence But, remember lead in and lead out times 7/20 days from initiation, 28 days after last exposure to HIV Taking PrEP for 28 days after the decision to stop (and after last exposure to HIV) is based on a WHO recommendation. There is not enough evidence to know exactly how long PrEP is actually effective after stopping.

Cycling on and off PrEP Duration of PrEP use may vary from person to person Start and stop PrEP depending on personal needs Perceived risk at different periods in a persons life Changes in relationships Behaviours Ability to adhere to a PrEP maintenance programme Key points to remember: It takes 7/20 days of daily TDF/FTC to reach adequate tissue levels Use other methods of protection during this time When stopping continue PrEP for 28 days after last HIV exposure

Should people use condoms when using PrEP? Your thoughts?

What about condom use when using PrEP? Remember: Do not be judgemental about a person’s personal preferences! Remind clients that: Although PrEP is highly effective, it is not 100% effective PrEP does not protect against other STIs – make a plan for STI screening; educate about signs and symptoms; check up plan PrEP does not protect against pregnancy – discuss options and provide contraception Where possible, vaccinate against all preventable STIs e.g. hepatitis A and B, HPV

PrEP should be promoted as part of combination prevention

References Mofenson L, Baggaley R, Mameletzis I. Tenofovir Disoproxil Fumarate Safety for Women and their Infants during Pregnancy and Breastfeeding: Systematic Review. AIDS. 2016 Nov 7. Bekker LG, et al. Southern African guidelines on the safe use of pre-exposure prophylaxis in persons at risk of acquiring HIV-1 infection. Southern African Journal of HIV Medicine. March 2016. World Health Organization. The consolidated guidelines on the use of antiretroviral drugs for treating and preventing HIV infection. Recommendations for a public health approach. Second edition 2016.

Acknowledgements With thanks to: The Southern African HIV Clinicians Society Wits Reproductive Health and HIV Institute The OPTIONS Programme/South Africa Anova Health Institute