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HIV Earlier Treatment Workshop Biomedical Prevention: PrEP

HIV Earlier Treatment Workshop Biomedical Prevention: PrEP. Brisbane Novotel Hotel Saturday March 15 th 2014 Edwina Wright. Photo credits on final slides. http://www.aids2014.org/WebContent/File/AIDS2014_Brochure_June2013.pdf.

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HIV Earlier Treatment Workshop Biomedical Prevention: PrEP

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  1. HIV Earlier Treatment WorkshopBiomedical Prevention: PrEP Brisbane Novotel Hotel Saturday March 15th2014 Edwina Wright Photo credits on final slides

  2. http://www.aids2014.org/WebContent/File/AIDS2014_Brochure_June2013.pdfhttp://www.aids2014.org/WebContent/File/AIDS2014_Brochure_June2013.pdf

  3. Newly Diagnosed HIV Infections In Australia: Kirby Institute 2013 Annual Surveillance Report 1,253 people in 2012 http://www.australia.edu/Travel/detailed-travel-map-of-australia.html

  4. Ir Political Declaration on HIV/AIDS: Intensifying Efforts to Eliminate HIV/AIDS http://kids.britannica.com/elementary/art-89798/The-flags-of-many-countries-fly-outside-the-United-Nations United Nations, NYC June 8th, 2011

  5. Crossing the Stile

  6. Crossing the Stile • Risk factors • Demography • Host • Gender & Genetics& Health status • Behaviour • Civil Society • Prevention strategies • Condom use • HIV/STI testing • PrEP • PEP • NSPs • Circumcision • Serostatus disclosure • Treatment as Prevention • Country-level programs & wealth

  7. Strategies to reduce HIV transmission QPrEP PRELUDE

  8. Strategies to reduce HIV transmission QPrEP PRELUDE

  9. HIV Pre-Exposure Prophylaxis PrEP • Antiretroviral agents used by HIV negative people to reduce their risk of acquiring HIV infection • Sexual exposure, Injecting drug use, Conception • Antiretroviral agents • Tablets • Tenofovir • Tenofovir + emtricitabine • New agents being tested • Vaginal rings or gel • Long acting intra-muscular injections • Monthly IM GSK744 integrase inhibitor (CROI 2014 Abstract 40LB) • Periodicity • Daily, Intermittently, Peri-coitally

  10. PrEP’s efficacy in RCTs • MSM (iPrEX study) • 44% • Heterosexuals (Partners PrEP; TDF-2 study) • 62%-76% • People who inject drugs (Bangkok Tenofovir study) • 49% overall • People trying to conceive: not studied • Not ascertainable: Fem-PrEP and VOICE • Closed due to futility Grant et al, 2011; Baeten et al, 2012; Thigpen et al, 2012; Choopanya et al, 2013; Van Damme et al, 2012; Marazzo et al, 2012;

  11. iPrEX: number need to treat Glidden CROI 2014, Abstract 64

  12. PrEP Studies December 2013 N=20 underway or planned QPrEP PREPARE Freeworldmaps.net http://www.avac.org/ht/a/GetDocumentAction/i/3113 Open label extension study Demonstration study New clinical trial Studies closed- futility

  13. Why so many studies? • Why isn’t PrEP just being introduced? • It works doesn’t it? • The US alone has licensed Truvada for use as PrEP • Only 1,800 prescriptions to date

  14. PrEP’s efficacy in RCTs • MSM (iPrEX study) • 44% • Heterosexuals (Partners PreP; TDF-2 study) • 62%-76% • People who inject drugs (Bangkok Tenofovir study) • 49% overall • People trying to conceive: not studied • Not ascertainable: Fem-PrEP and VOICE • Closed due to futility All studies had monthly visits, rigorous HIV prevention & medication adherence counseling, regular STI and HIV testing etc. Why weren’t the results better? Grant et al, 2011; Baeten et al, 2012; Thigpen et al, 2012; Choopanya et al, 2013; Van Damme et al, 2012; Marazzo et al, 2012;

  15. Adherence to PrEP in RCTs • Based upon plasma levels • IPrEX study (MSM): 50% • Partners-PrEP (Heterosexual partners): > 81% • TDF-2 study (Heterosexuals): 80% • Bangkok Tenofovir study (PWID): 67% • VOICE study (Mostly single women): <30% • Fem-PrEP (Mostly single women: 37% Grant et al, 2011; Baeten et al, 2012; Thigpen et al, 2012; Van Damme et al, 2012; Marazzo et al, 2012; Choopanya et al, 2013

  16. Factors that influence PrEP adherence Increased adherence • Trust and relationship support (Partners PrEP) • Older age, ≥ 40 years (Bangkok Tenofovir study) • Women (Bangkok Tenofovir study) • Polygamous marriage (Partners PrEP) Decreased adherence • Intermittent versus daily dosing (Kenyan MSM & FSW) • Post-coital dosing • Younger age (Partners PrEP) • Having less sex (Partners PrEP) • Heavy alcohol use (Partners PrEP) • PrEP use longer than 6 months (Partners PrEP) Baeten et al, 2012; Choopanya et al, 2013; Mutua et al, 2012; Kibengo et al, 2013

  17. Behavioural change in PrEP RCTs • IPrEX • Decreased risk taking; fewer partners; more partners used condoms • TDF-2 study • No decrease in condom use; decrease in sexual partners during the study • Bangkok Tenofovir study • Decreased drug use, needle sharing and sexual partners during the study • Partners PrEP • Decrease in condomless sex during study • BUT during the 12 months PartnersPrEP open-label extension study whilst there was no increase in unprotected with study partner there was a small increase in unprotected sex with outside partners, but no increase in STIs or pregnancies Grant et al, 2011; Baeten et al, 2012; Thigpen et al, 2012; 2012; Choopanya et al, 2013; Muguwanyaet al, 2013

  18. The Anthropology of PrEP In PrEP RCTs, one could have hypothesised reasonably that study participants’ PrEP adherence would be very good to justify their likely increased risk taking but this hypothesis would have been wrong • Similarly, we should test hypotheses and assumptions about how PrEP will be used in the real world, outside of clinical trials in demonstration projects and open-label extension studies • ? Who will use PrEP • ? How will people use PrEP • ? What will the adherence patterns be • ? How acceptable will PrEP be • ? For how long will people need PrEP • ? What, if any behavioural changes may occur

  19. Willingness to use HIV pre–exposure prophylaxis among Australia gay and bisexual men: findings from The PrEPARE Project 2011–2013 Martin Holt, Toby Lea, Dean Murphy, Jeanne Ellard, Marsha Rosengarten, Susan Kippax, John De Wit

  20. Who is willing to use PrEP?

  21. TAXI-KAB Study

  22. TAXI-KAB Study

  23. PrEP Demonstration Projects in Australia • New South Wales • PRELUDE study: 300 patients taking PrEP • Funded by NSW Health and Gilead sciences (drug only) • Collaboration between Kirby Institute, GP clinics • Enrolling 2014 • Victoria • VicPrEP: 200 patients: 100 taking PrEP 100 not wishing to take PrEP • Funded by Victorian Dept Health and Gilead sciences (drug only) • Collaboration between Alfred Health, CSRH, Burnet, RWH, Kirby Institute, UCSF, Univ London, Univ Colorado and Monash University, MSHC, PMC, Centre Clinic, Northside Clinic • Enrolling April-May 2014 • QPrEP • Enrolling 50 patients • Funded by Queensland Health, Gilead Sciences (study drugs) • Collaboration between Cairns Sexual Health and the HIV Foundation of Qld QPrEP PRELUDE

  24. Common themes Australian PrEP Demonstration Projects • Determine the following and associated factors • Uptake PrEP • Why PrEP not uptaken by those at risk HIV • Patterns and duration of use of PrEP • Adherence to PrEP • Acceptability of PrEP • Behavioural change with PrEP use PRELUDE QPrEP

  25. Implementation of PrEP in STD Clinics: High Uptake and Drug Detection Among MSM in the Demonstration ProjectStephanie E. Cohen, et al Abstract 954 • Results • 386 enrolled, for an overall uptake of 53% among potentially eligible clients (49% in SF vs. 64% in Miami) • Mean age of enrolled participants was 35years, 9% were African American, 35% Latino, and 46% white; 42% were uninsured and 73% had previously heard of PrEP. • In adjusted analyses more likely to enrol if • prior PrEP awareness (AOR 2.3, 95% CI 1.5-3.5) • unprotected anal sex with >5 partners (AOR 1.5, 95% CI 1.0-2.2) • >1 episode of anal sex with an HIV-infectedpartner (AOR 1.8, 95% CI 1.2-2.6) in the last 12 months • higher risk perception (AOR 1.9, 95% CI 1.2-2.8)

  26. Implementation of PrEP in STD Clinics: High Uptake and Drug Detection Among MSM in the Demonstration Project

  27. iPrEX study: doses/week and risk reduction 2 doses: 76% HIV risk reduction 4 doses: 96% HIV risk reduction 7 doses: 99% HIV risk reduction Adapted from Anderson et al, Sci Trans Med 2012

  28. Photo credits • Stile 1 http://homepage.ntlworld.com/jamiebassnett/cadairidristheminfforddpath.htm • http://www.dreamstime.com/stock-photos-stone-wall-stile-lancashire-image227729 • good condom pick with packages • http://huntandshoot.com.au/general/condoms-for-survival/ • female condom picture • http://commons.wikimedia.org/wiki/File:Female_condom_pack.jpg • STI testing kit • http://www.safesexnoregrets.nt.gov.au/freetesting.html

  29. Photo credits • alere determine combo • http://www.alere.co.uk/sexual-health/articles/alere-determinetm-hiv-combo-customer-training-239/text.htm • outline of man • http://pixabay.com/en/outline-people-man-silhouette-37469/ • woman on a laptop • http://www.clker.com/clipart-women-on-a-laptop-outline.html • HIV prevalence globally and I risk groups • http://www.unaids.org:80/en/resources/infographics/20121120resultshivprevalence/ • same sex illegal graphic • http://www.unaids.org:80/en/resources/infographics/20140108freeequal/s • woman arm injection • http://www.google.com.au/search?q=injectable+contraceptive+cost&hl=en&source=lnms&tbm=isch&sa=X&ei=DyL8UruDIMnFkQWFqIH4Cw&ved=0CAgQ_AUoAg&biw=1024&bih=576#facrc=_&imgdii=_&imgrc=k2U9B-UVVs4cuM%253A%3B7EVgpQjCgM8F7M%3Bhttp%253A%252F%252Fwww.impatientoptimists.org%252F~%252Fmedia%252FBlog%252FImages%252FBlogPosts%252FHome%252520Page%252520Features%252FF%252FFA%252520FE%252Ffc347715feaee1a447624188acb23cfec8444be8blogpostmaster_large_post_autocropped.jpg%3Bhttp%253A%252F%252Fdegrees.fhi360.org%252F2013%252F11%252Fexpanding-the-contraceptive-armamentarium%252F%3B960%3B440

  30. Photo credits • male circumcision queue • http://www.who.int/hiv/topics/malecircumcision/en/ • rectal mucosa • http://www.mtnstopshiv.org/node/2864 • two people talking • http://dickstrawser.blogspot.com.au/2010/07/lost-chord-installment-4.html • PrEP ribbon • http://www.google.com.au/search?q=PrEP&hl=en&source=lnms&tbm=isch&sa=X&ei=VqL8Up7uKM2ElQXc6ICYCg&ved=0CAcQ_AUoAQ&biw=1280&bih=541#hl=en&q=PrEP+and+HIV&tbm=isch&facrc=_&imgdii=_&imgrc=QlF-UIFhqWkVCM%253A%3BfXrvo4RsVJxDKM%3Bhttp%253A%252F%252Facelebrationofwomen.org%252Fwp-content%252Fuploads%252F2013%252F06%252Fprep1.jpg%3Bhttp%253A%252F%252Facelebrationofwomen.org%252F2013%252F06%252Fprep-can-reduce-hiv-risk-among-people-who-inject-drugs%252F%3B300%3B418 • PEPimage • http://www.google.com.au/search?q=PrEP&hl=en&source=lnms&tbm=isch&sa=X&ei=VqL8Up7uKM2ElQXc6ICYCg&ved=0CAcQ_AUoAQ&biw=1280&bih=541#hl=en&q=PEP+and+HIV&tbm=isch&facrc=_&imgdii=_&imgrc=rMnYjYHMBubybM%253A%3B8TE_cZqsZOkxBM%3Bhttp%253A%252F%252Feilemagazine.files.wordpress.com%252F2013%252F06%252Fwhat_is_pep.gif%3Bhttp%253A%252F%252Feile.ie%252F2013%252F06%252F11%252Fhiv-pep-article%252F%3B220%3B289

  31. Photo credits • End HIV • http://www.baywindows.com/FENWAY-HEALTH-COMMENDS-FDA-ON-APPROVAL-OF-FTC-TDF-AS-PRE-EXPOSURE-PROPHYLAXIS-FOR-HIV-PRE • Tasp graphic • http://www.google.com.au/search?q=PrEP&hl=en&source=lnms&tbm=isch&sa=X&ei=VqL8Up7uKM2ElQXc6ICYCg&ved=0CAcQ_AUoAQ&biw=1280&bih=541#hl=en&q=Treatment+as+prevention+and+HIV&tbm=isch&facrc=_&imgdii=_&imgrc=uq-ja0B4NyJvnM%253A%3Bm4w_Iiw6FGyd-M%3Bhttp%253A%252F%252Faids2012.msf.org%252Fwp-content%252Fuploads%252F2012%252F07%252Ftreatment-as-prevention-Graphic-e1342995129198.jpg%3Bhttp%253A%252F%252Faids2012.msf.org%252F2012%252Ftreatment-is-prevention%252F%3B500%3B500 • Pronto • http://pronto.org.au/ • microbicide • www.caprisa.org • needle exchange • http://www.canberratimes.com.au/act-news/needle-exchanges-can-curb-hep-c-20130116-2cu46.html • sex positions • http://www.betterworldbooks.com/position-sex-card-deck-id-1592333192.aspx • IVF • http://www.google.com.au/search?q=IVF&hl=en&source=lnms&tbm=isch&sa=X&ei=2UL9Urq-Hc7akgW1i4DIAw&ved=0CAcQ_AUoAQ&biw=1280&bih=541#facrc=_&imgdii=_&imgrc=Qb6leyVg8aUxAM%253A%3BurtaT4mbm8LzrM%3Bhttp%253A%252F%252Fwww.helpingnatureheal.com.au%252Fsystem%252Ffiles%252FIVF%252520egg%252520pick.jpg%3Bhttp%253A%252F%252Fwww.helpingnatureheal.com.au%252Fspecialties%252Fmature-couples-ivf%3B460%3B288 • vaccine • http://www.google.com.au/search?q=vaccines&hl=en&source=lnms&tbm=isch&sa=X&ei=a0T9UuPcMIyXiAfuj4DABg&sqi=2&ved=0CAcQ_AUoAQ&biw=1280&bih=541#facrc=_&imgdii=_&imgrc=L7w9y3Hpd2UV-M%253A%3BDhqrTQNf3Jl7kM%3Bhttp%253A%252F%252Fcsglobe.com%252Fwp-content%252Fuploads%252F2013%252F05%252Fvaccine-industry.jpg%3Bhttp%253A%252F%252Fcsglobe.com%252Fyou-have-doubts-about-the-safety-of-vaccines%252F%3B291%3B291

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