This document summarizes research on pre-exposure prophylaxis (PrEP) and discusses strategies for implementing PrEP. It finds that PrEP has been shown to effectively reduce HIV transmission in multiple clinical trials involving men who have sex with men, heterosexual men and women, and serodiscordant couples. However, concerns have been raised about side effects, risk compensation, and drug resistance that could present barriers to implementation. The document recommends that PrEP be implemented as part of combination prevention, with behavioral interventions to support adherence, and monitoring systems to track side effects, risk behaviors, and drug resistance. It also addresses regulatory approval, coverage under the Affordable Care Act, and targeting high-risk groups to maximize the

1. PrEP: Moving toward implementation
HealthHIV SYNChronicity Meeting
“PEP-UP & PrEPare:
Implementing New Biomedical Strategies”
Arlington, VA April 21, 2012
Sean Cahill PhD
Director, Health Policy Research
The Fenway Institute
Boston, MA

2. Outline
I. PrEP has great potential to reduce HIV infections and be
cost effective; PrEP could be most effective if combined
with TasP
II. Overcoming barriers to use
A. Patient
B. Provider
C. Payment
D. Regulation
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4. PrEP: Moving toward implementation
(February 2012, The Fenway Institute)
Summarizes PrEP and microbicides research
Looks at knowledge of, willingness to use PrEP
Addresses concerns about PrEP that could present
obstacles to implementation
Offers strategies for effective implementation
Examines policy issues related to cost and how to
make PrEP accessible to most vulnerable
Examines regulatory developments and planning
underway in U.S. and globally
Recommendations for implementation
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5. RCT evidence for preventing sexual HIV
transmission
Study Effect size (CI)
Treatment for prevention
(HPTN 052) 96% (73; 99)
PrEP for discordant couples 73% (49; 85)
(Partners PrEP with FTC/TDF)
PrEP for heterosexuals 63% (21; 48)
(Botswana TDF2 with FTC/TDF)
Medical male circumcision* 54% (38; 66)
(Orange Farm, Rakai, Kisumu)
PrEP for MSMs
(iPrEX with FTC/TDF) 44% (15; 63)
STD treatment* 42% (21; 58)
(Mwanza)
Microbicide* 39% (6; 60)
(CAPRISA 004 tenofovir gel)
HIV Vaccine 31% (1; 51)
(Thai RV144)
0% 10 20 30 40 50 60 70 80 90 100%
Abdool Karim SS & Q. Antiretroviral
prophylaxis...Lancet 2011;378:e23-5 Efficacy

6. Modeling shows PrEP and TasP could
dramatically reduce HIV infection
.
Recent modeling of PrEP implementation
coupled with scaled up treatment predicts that
PrEP could significantly reduce HIV incidence
and prevalence. Studies focused on:
MSM in San Francisco (Supervie et al., PNAS, 2010)
the general adult population in Botswana
(Supervie et al. Scientific Reports, 2011)
and serodisc heterosexual couples in S. Africa
(Hallet et al., PLoS Medicine, 2011)
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7. Key policy implication of finding that
TasP and PrEP will be most effective
Abdool Karim and Abdool Karim (The Lancet,
2011): provide PrEP and TasP “synergistically”
They are “two sides of the same coin, and
cannot be viewed in isolation from each other.”
Coordination between HRSA and CDC is key
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8. Cost effectiveness of PrEP
PrEP cost effective in U.S. models with 90%
efficacy (Paltiel et al., Clin Infect Dis, 2009)
PrEP could be cost effective in South Africa if
targeted at women at highest risk, has 70%
efficacy, and costs 50% less than current price
(Walensky et al., CROI, Boston, 2011)
PrEP and ART with serodiscordant couples in
South Africa saves $ on ART costs in general,
is cost saving overall with 80% efficacy
8 (Hallet et al., PLoS Medicine, 2011)

9. Concerns often raised about PrEP
Some have raised concerns re:
 side effects
 risk compensation (the idea that people will stop
using condoms if PrEP becomes available)
 drug resistance
However, review of five major clinical trials involving
about 6,000 participants by the Forum for
Collaborative HIV Research shows no greater risk of
side effects, no risk compensation, and no clinically
significant development of drug resistance in
participants.
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10. PrEP: Moving toward implementation
 PrEP must be accompanied by sustained care and
behavioral interventions to ensure adherence, minimize risk
compensation, and monitor side effects.
 The most effective prevention interventions will be those
that combine structural interventions with behavioral
interventions and emerging biomedical technologies.
 Because the most at-risk do not access regular clinical
care, alternative implementation arrangements will be
necessary.
 National monitoring systems are critical to preventing the
spread of drug-resistant HIV.
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11. Paying for PrEP
Cost of PrEP in the U.S. would be substantial,
perhaps $8-$9k/year.
Private insurers (Kaiser Perm., Wellpoint, Aetna)
covering, state Medicaid depts open to coverage
(FDA approval, PHS Guidance would help).
Low-cost generic medications could enable access
in low-income countries.
Prioritization of highly vulnerable populations could
increase cost-effectiveness.
Providing PrEP much less expensive than
treating someone for HIV over lifetime.
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12. Elements of ACA that could
enable access to PrEP
ACA mandates full coverage (no copays) of a
range of preventive services by private insurance
ACA mandates coverage of “essential health
benefits” by insurance offered in state health
exchanges to indivs and small groups
EHBs include prescription drugs, prevention and
wellness programs
Obama Admin. allowing states broad flexibility to
determine EHBs; advocacy needed at state level
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13. Recommendations
If FDA feels research on PrEP’s efficacy among
heterosexuals is inconclusive, it should consider
approving PrEP for MSM now.
WHO should issue guidance that takes into
account the promising results of iPrEx study,
Partners PrEP, and the Botswana CDC study.
States should provide access to PrEP as a
critical prevention service and prescription
medication under EHB provision ACA.
Global funders should fund PrEP and TasP.
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14. Recommendations
Provision of PrEP to MSM, trans should occur
in broader context of clinically competent care
CBOs, health depts should preemptively seek
to destigmatize PrEP use among target pops
Need for public education re: difference
between PEP and PrEP; PEP users should be
prioritized for PrEP
Funders should support community education
campaigns about PrEP and other biomed
interventions, enhance community
14involvement in PrEP roll-out, scale-up

15. Key messages
PrEP has shown efficacy with MSM,
heterosexual women and men, including
serodiscordant couples
Adherence is key to PrEP’s effectiveness
Regulatory approval (FDA) would give
providers the freedom to prescribe PrEP as part
of a comprehensive HIV prevention approach;
WHO approval would give countries the ability
to allow FTC-TDF to be used for PrEP
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16. Thank you
Sean Cahill PhD
Director, Health Policy Research
The Fenway Institute
Boston, MA
scahill@fenwayhealth.org
617-927-6016
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