HIV PrEP; a clinical perspective. A.M.J. Wensing, MD, PhD University Medical Center Utrecht

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1 HIV PrEP; a clinical perspective A.M.J. Wensing, MD, PhD University Medical Center Utrecht

2 Current oral PREP is a fixed dose once daily oral pill containing two nucleoside analogue reverse transcriptase inhibitors tenofovir- disoproxil fumarate (TDF) and emtricitabine (FTC) Most frequent user groups MSM High risk HSX Discordant couples Certain groups have shown rapid uptake, but other populations are more difficult to reach

3 Feedback on PrEP in clinical practice PrEP has added an extra level of security and brought back carefree intimacy in our relationship. I still use condoms but Iam not afraid about getting infected anymore. Only now I realise the effect of continuous fear of getting infected on my life. We have longed for a child for years. My partner has persistent low level viremia but with PrEP we feel comfortable to try natural conception I retrieved sexual pleasure but feel restricted to discuss this beneficial part of PrEP Personal communication PrEP takers - AMJ Wensing

4 Access to PrEP FDA/EMA approved Specific PrEP programmes/health Insurance in some countries Lack of access to PrEP in certain areas has resulted at internet purchase of generic versions (e.g. via websites such as There are concerns about the authenticity of medicines purchased online It is difficult for users to identify potential fake versions of drugs, contaminated drugs or drugs with low active compound as for instance is seen with online sale of Viagra.

5 PrEP supplied via internet TDM testing was offered to 249 individuals who reported purchasing PrEP on the internet (n=239) Wang et al. HIV medicine 2017

6 Informal non-presribed PrEP Informal non-medically supervised use of ARVs for HIV prevention has the potential to undermine the protective benefits of PrEP. (Buttram Seks Health 2016) Non-prescribed PrEP from internet of HIV-positive sex partners may result in inproper use of PrEP in a way that does not provide adequate protection against HIV infection Spread of resistant HIV Increase of other STI

7 Prescribed PrEP should come with Based on guidelines and regulation authority guidance prescribing PrEP should include: 1. Education of patients about proper and consistent use of PrEP 2. Provision of risk reduction counseling 3. Regular STI screening 4. Monitoring for drug toxicities 5. Baseline and follow-up monitoring for HIV infection 6. Understanding risk of resistance 7. Understanding clinical signs and laboratory results indicating acute infection

8 1. Proper use PrEP is approved by FDA/EMA as Truvada once daily The investigators in the IPERGAY trial reported 86% reduction in HIV incidence using an on-demand regimen by high risk MSM Two tablets taken 2 24 h before sex, one taken 24 h later, and one taken 48 h later. Molina et al. NEJM 2015

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10 1. Proper use Concentrations of tenofovir diphosphate are up to 100-fold higher in rectal tissue than vaginal tissue. Daily TDF/FTC-based PrEP with high adherence seems necessary for protection from vaginal exposure Louissaint et al. AIDS Res Hum Retroviruses Patterson et al. Sci Transl Med 2011; Hendrix C et al. ). AIDS Res Hum Retroviruses Cottrell et al. JID 2016

11 1. Consistent use of PrEP HIV-1 uninfected individuals should be counselled to strictly adhere to the recommended Truvada dosing schedule. The effectiveness of Truvada in reducing the risk of acquiring HIV-1 is strongly correlated with adherence as demonstrated by drug levels in plasma.

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13 2. Provision of risk reduction counseling EMA: Truvada should only be used as part of an overall HIV-1 infection prevention strategy including the use of other HIV prevention measures consistent and correct condom use FDA: Use TRUVADA for pre-exposure prophylaxis only as part of a comprehensive prevention strategy that includes other prevention measures, such as safer sex practices

14 Effect of PREP on behaviour Sex parties previously restricted to HIV-positive men only have opened up for HIV negative PREP users PrEP is regularly seen as a condom substitute Club Church Amsterdam. Hello pozzums.2017, Hughes et al. aids behav. 2017)

15 Condom use Hughes et al. AIDS behav. 2017

16 3. STI screening EMA: regular testing for other sexually transmitted infections FDA: counsel for need of STI testing CDC advises STI screening every 6 monhts

17 STI risk (meta analysis MSM) increased condomless seks increased number of sex partners Increased STI detection due to more frequent testing Kojima aids 2016

18 Jenness et al. CID 2017 STI incidence may decrease overtime A stochastic networkbased mathematical model transmission dynamics among MSM in the US Simulated PrEP uptake following the prescription indications and HIV/STI screening Over time STI will decrease mainly due to increased detection and subsequent treatment

19 STI may increase risk of HIV infection Disruptions of mucosa by various STI may facilitate transmission Asymptomatic anorectal Chlamydia trachomatis and Neisseria gonorrhoeae infections are associated with systemic CD8+ T cell activation (Vieira et al. aids 2017)

20 4. Monitoring for drug toxicity Start up a self-limited start-up syndrome of nausea, vomiting, and dizziness that usually resolved during the first month of PrEP use was observed in a minority of HSX participants. From experience with Truvada use in HIV-infected patients we know that renal toxicity and bone marrow density reductions may appear Grade 1 proteinuria occurred in 6% of subjects in the iprex trial. Grade 2-3 proteinuria and glycosuria occurred in less than 1% of subjects in the iprex trial and Partners PrEP trial. Bone marrow density reductions are recovered upon cessation of PREP in MSM in truvada iprex trial Thigpen NEJM 2012, Mugwanya JID 2016, Glidden JAIDS 2017

21 Screening for hepatitis B virus Truvada also has activity against hepatitis B virus Discontinuation of PrEP in subjects infected with HBV may be associated with severe acute exacerbations of hepatitis B virus.

22 5. Monitoring for HIV infection at baseline EMA: knowledge of HIV-1 status before and at least every 3 months reconfirmation of HIV negative status with antigen/antibody test during PREP use FDA: Test and reconfirm HIV-1 negative status before and subsequently test for HIV 3 monthly during PREP Partner PREP study: In over half of the cases rapid tests did not detect HIV-1 infection at what was retrospectively assessed to be the first HIV-1 infection visit Donnell AIDS 2017

23 Less frequent laboratory testing among PREP users in private settings Wu et al. CID 2017

24 Understanding the risk of resistance Inappropriate use of PrEP and lack of adequate HIVmonitoring may facilitate selection of resistance In clinical trials selection of resistance due to missed acute infections appeared mainly before initiation of PrEP Resistance selected during PrEP failure results mainly in emtricitabine resistance due to selection of M184I/V in RT, rarely 65R observed. K65R affects all NRTI except zidovudine. (Knox et al. NEJM 2017, Gatanaga et al. aids 2017), Wensing et al. Top Antiv. Med. (IAS_USA mutation figures)

25 6. Understanding the risk of resistance After cessation of PrEP mutations may rapidly become undetectable M184I by 4 weeks and M184V by weeks Risk for underestimation of resistance NGS screening may be needed to detect minority resistance variants Resistance may compromise future cart (Revewed by Parikh et al. Current opinion HIV/AIDS 2016))

26 Adapted slide from CCO

27 6. Understanding the risk of resistance Failure of PrEP due to infection with resistant HIV Most important mutations are 184I/V and 70E, 65R in RT Thymidine analogue mutations may compromise efficacy due to cross resistance to Truvada Concerns on natural polymorphism with other compounds (Knox et al. NEJM 2017, Gatanaga et al. aids 2017))

28 Detection of Acute infection: Case 50 year Male starts daily PrEP, all recommendations are followed by the prescriber 8 months after start of PrEP: weak antibody positivity in 4 th gen. HIV combotest. Ag negative. Rapid and regular HIV-RNA test: TND Nested pol PCR (DNA and RNA on PBMC and sigmoid biopsies): Negative High adherence levels: appropriate drug levels in DBS Western blot: atypical single gp160 band sexual contacts per months Chronic rectal inflammation Fever, dysuria

29 7. Recognising acute infections Partner PREP study: Time to early Fiebig stages very much influenced by the use of rapid tests PrEP delayed the time to detect seroconversion (Fiebig 5) Adjusted for Fiebig stage, viral RNA was ~2/3 log lower in those assigned to PrEP compared to placebo; ~¾ log lower in those with detectable drug levels 11% of samples in stage 2-6 had undetectable plasma viral load (subtype C) compared to 3% on placebo. Donnell AIDS 2017

30 Case: Outcome Clinical team of AmPreP programme was not fully convinced of infection but stopped PrEP out of fear of inducing drug resistance, The patient was monitored at weekly intervals. Three weeks after Ab seroconversion, HIV RNA was detected in his plasma (40,000 cp/ml) without resistance mutations using routine clinical sequencing. Combination antiretroviral therapy was started resulting in an undetectable viral load after one month. Hoornenborg CROI 2017; AmPrEP programme Amsterdam GGD

31 When to start treatment? EMA: If clinical symptoms consistent with acute viral infection are present and recent (< 1 month) exposures to HIV-1 are suspected, use of Truvada should be delayed for at least one month and HIV-1 status reconfirmed before starting Truvada for pre-exposure prophylaxis.

32 Summary PrEP is a highly successful intervention to prevent transmission of HIV Extensive counselling and monitoring is advised to accompany prescription of PrEP Recommendations for monitoring not always followed in clinical practice Fear of spread of drug resistant HIV if recommendations are not followed More insight is needed in HIV diagnosis after PrEP A.M.J. Wensing TMW 2017

33 Acknowledgement Organising Committee HIV transmission workshop Paris 2017 Jan Albert Eric Arts Charles Boucher Gina Brown Myron Cohen Walid Heneine Tom Hope Eric Hunter Phyllis Kanki Bonnie Mathieson Christiane Moog Jean Patterson Gabriella Scatlatti Ron Swanstrom Mark Wainberg Annemarie Wensing Carolyn Wiliamson

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