This document summarizes the current state of HIV prevention using pre-exposure prophylaxis (PrEP). It outlines key populations at high risk of HIV like men who have sex with men, sex workers, people who inject drugs, and provides data on HIV rates in these groups. The document reviews evidence from PrEP efficacy trials showing significant reductions in HIV risk with daily oral PrEP use. It discusses real-world implementation studies in the US and South Africa that demonstrate high adherence to PrEP resulting in no new HIV infections. Global health organizations like WHO now recommend offering PrEP to those at substantial risk of HIV as an additional prevention method.

1. Bending the Curve: PrEP for
HIV Prevention
Chris Beyrer MD, MPH
Desmond M. Tutu Professor in Public Health and Human
Rights

2. Outline
• Current Epidemiology of HIV
• Pre-Exposure Prophylaxis
(PrEP) as primary prevention
• Assessing risk in the PrEP era (once it starts)
• HIV in MSM Atlanta: A public health crisis and need for PrEP
• Tools and scale: what do we know?
• The PrEP Continuum
• PrEP Uptake
• HealthMindr: A comprehensive prevention app for MSM
• PrEP@Home

3. Where are we?
HIV has yet to be controlled
Adapted from UNAIDS Global Report 2014
39 million deaths since the pandemic began
2014: 1.5 million HIV deaths
37 million living with HIV
2.1 million new infections
< Half (37%) of people living with HIV on treatment
One country implementing PrEP

4. Key Populations for HIV (and for PrEP)
• Key populations are those individuals and communities
who have disproportionate burdens of HIV risk and disease
and lack of access to essential HIV services
• Gay, Bisexual, and other men who have sex with men
(MSM)
• Sex Workers of all genders
• People who inject drugs (PWID) of all genders
• Transgender Women who have sex with men
• Women and Girls in South, East African hyper-epidemics
• Adolescents from all of these communities
• HIV uninfected partners in discordant relationships

8. Global measures of HIV incidence among MSM

9. Global HIV
Epidemiology
among Sex
Workers
Guest Editors: C Beyrer, S Strathdee,
L-G Bekker, A-L Crago, J Butler, P Das.

10. Global HIV prevalence among adult women
sex workers, 2013.
Beyrer, et al, The Lancet, 2014.

11. Global HIV prevalence among adult women
sex workers, 2013.
Beyrer, et al, The Lancet, 2014.

12. HIV prevalence among transgender women,
2000-2011 Baral, Poteat, Beyrer LID, 2013
Pooled OR for HIV infection among TGW compared to
other reproductive people: 48.8 (95% CI 31.2-76.3)

13. PrEP Efficacy and
Effectiveness

14. PrEP Efficacy Trials, Oral and Topical

15. Bangkok Tenofovir PrEp Trial Choopanya, et al,
Lancet 2014
Efficacy: 48·9% reduction in HIV incidence (95% CI 9·6-72·2; p=0·01).

16. IPrEx Open Label Extension. RM Grant, et al. TLID, 2014.
For those on PrEP, HIV incidence was:
4·7 infections per 100 py if no drug detected
2·3 infections per 100 py with < 2 tablets/week
0·6 per 100 py with 2 to 3 tablets per week
0·0 per 100 py with 4 or more tablets per week(p<0·0001)
Reports of condomless receptive anal intercourse fell—for
both on-PrEP and off –PrEP
“Our study shows that uptake is high when barriers to PrEP
supply are eliminated.”

17. HPTN 067 / ADAPT
Daily vs. Non-daily PrEP Dosing Regimens for South
African Women
• HPTN 067/ADAPT provides information about experiences of women
receiving open-label PrEP after the HIV prevention method was
proven effective.
• Study findings support current recommendations for daily use of
oral FTC/TDF PrEP in women. The majority of women in the HPTN
067 study took oral PrEP when made available in an open-label study.
• Daily dosing resulted in better coverage of sex acts and adherence,
and higher drug levels.
HPTN 067/ADAPT Study
Results Brief on Daily vs. Non-daily PrEP Dosing Regimens for South African Women

18. Insurer Says Clients on Daily Pill
Have Stayed H.I.V.-Free
The New York times
DONALD G. McNEIL Jr. SEPT. 2, 2015

19. No New HIV Infections with Increasing Use of HIV
Preexposure Prophylaxis in a Clinical Practice Setting
Jonathan E. Volk, J Marcus, T Phengrasamy, D Blechinger, DP Nguyen, Follansbee, and C.
Hare. Clinical Infectious Diseases, Sept. 2, 2015.
Abstract
Referrals for and initiation of preexposure prophylaxis (PrEP) for HIV
infection increased dramatically in a large clinical practice setting
since 2012. Despite high rates of sexually transmitted infections
among PrEP users and reported decreases in condom use in a subset,
there were no new HIV infections in this population.
657 people, followed over 36 months, 388/person years of
observation
99% MSM

20. ATN 110:
An HIV PrEP Demonstration Project
and Safety Study for Young Men
who Have Sex with Men in the
United States
Sybil Hosek, Bret Rudy, Raphael Landovitz,
Bill Kapogiannis, George Siberry, Brandy
Rutledge, Nancy Liu, Jennifer Brothers, Jim
Rooney, and Craig M. Wilson on behalf of
the ATN 110/113 study team.

21. Sexual Behavior
0
1
2
3
4
5
6
Baseline WK 4 WK 8 WK 12 WK 24 WK 36 WK 48
Male partners CRAI last partner Condom broke RAI Referred for PEP

22. www.ias2015.org
Adherence:
Median TFV-DP by Race/Ethnicity
0
200
400
600
800
1000
1200
Week 4 Week 8 Week 12 Week 24 Week 36 Week 48
Overall White Latino Mixed Black/AA
4+ doses
4+ doses

23. WHO Guidance: September, 2015
GUIDELINE ON WHEN TO START ANTIRETROVIRAL THERAPY AND
ON PRE-EXPOSURE PROPHYLAXIS FOR HIV
Oral pre-exposure prophylaxis for preventing the acquisition of HIV
infection
Recommendation:
Oral PrEP containing TDF should be offered as an
additional prevention choice for people at substantial risk of
HIV infection as part of combination HIV prevention
approaches
[strong recommendation, high-quality evidence]

24. WHO: Defining Substantial Risk
Substantial risk of HIV infection is provisionally defined as HIV
incidence greater than 3 per 100 person–years in the absence of
PrEP.
HIV incidence greater than 3 per 100 person–years has been
identified among some groups of men who have sex with men,
transgender women in many settings and heterosexual men and
women who have sexual partners with undiagnosed or untreated
HIV infection.
Most of the PrEP trials reviewed for this recommendation
identified and recruited groups at substantial risk of acquiring HIV
infection… HIV incidence rate among participants in control arms
ranged between 3 to 9 per 100 person-years...

25. What people want from sex and preexposure
prophylaxis. (RM Grant, KA Koester. Current Opinion HIV/AIDS, 2015.)
• Demand for PrEP reached a tipping point in the USA in 2013,
with rapidly expanding use in 2014.
• PrEP users report fringe benefits including feeling safer
during sex, less anxiety, less HIV stigma, and stronger
relationships.
• Insights from the field of behavioral economics suggest that
PrEP’s fringe benefits are compelling because they have
salience, affect, and are experienced in the present.
• PrEP empowers users by allowing greater control over their
HIV risk, rather than relying on partners to use condoms, take
ART, or accurately disclose their status

26. Assessing Sexual Risk
in the Coming PrEP Era
• Risk assessment for gay and other MSM has
focused on the highest risk for acquisition:
unprotected receptive anal intercourse, URAI
• “Unprotected” has meant RAI without
condoms
• If PrEP is protective, what is condomless RAI +
PrEP?
• If HIV infected partners are sustainably virally
suppressed, is condomless sex protected?

27. COPE4YMSM
Combination Preventive Effectiveness for Young MSM
• NIAID R01 to develop and assess the effectiveness and
cost-effectiveness of a combination intervention with
and without daily oral Truvada (PrEP) for prevention of
HIV infection among HIV uninfected at risk young (18-
26 year old) men who have sex with men (YMSM) in
Bangkok, Thailand.
• HIV uninfected MSM with a history or current or past
(12 months) history of selling sex
• Occupational PrEP
• JHU, US CDC, Mahidol, Emory, Thai Ministry of Health
• CB, Stef Baral, Andrea Wirtz, Brian Weir
27

28. Map of Bangkok showing MSW zones
Saphankwai
Zone
Sathorn Zone
Silom Zone
Surawong Zone
Sukhumvit
Zone
Sa-nharm
Luang Zone

29. SWING Mapping: Surawong

30. Acknowledgements
Johns Hopkins
Stefan Baral, Tonia Poteat, Sheree
Schwartz, Brian Weir, Andrea Wirtz
Sex Workers and HIV
Linda-Gail Bekker, Jenny Butler, Anna-
Louise Crago, Pam Das, Leigh
Johnson, Kate Shannon, Steffanie
Strathdee, Frances Cowan, Cheryl
Overs, Donela Besada, Sharon Hillier,
Ward Cates
Meg Doherty, Bob Grant, Gottfried
Hirnshchall, Michel Kazatchkine, Ken
Mayer, Owen Ryan, Michel Sidibe
MSM Prevention: Patrick
Sullivan, Alex Carballo-Dieguez,
Thomas Coates, Steven M
Goodreau, Sybil Hosek, Ian
McGowan, Eduard J Sanders,
Adrian Smith, P. Goswami, Jorge
Sanchez
MSM Epidemiology
Frits van Griensven, Steven
Goodreau, Suwat Chariyalertsak,
Ron Brookmeyer
Supported by grants to the Center for Public Health and Human Rights at John Hopkins from
amfAR the Foundation for AIDS Research
The Bill & Melinda Gates Foundation
Project Search, USAID
The John Hopkins Center for AIDS Research (NIAID, 1P30AI094189-01A1)