1. Dawn K. Smith, MD, MS, MPH
Centers for Disease Control and Prevention
20 April 2012

4. Substantial No substantial
exposure risk exposure risk
< 72 hours since >72 hours since
exposure exposure
Source patient Source patient of nPEP not
known to be HIV+ unknown HIV status recommended
Case-by-case
nPEP recommended
determination

5.  200 MSM given 4-day starter packs (ZDV/3TC)
 Instructed when to start nPEP
Used PrEP after No PrEP after No PrEP and
high risk sex high risk sex no high risk sex
N (%) 68 (34%) 86 (43%) 46 (23%)
HIV infections 1 10 0
HIV incidence 1.5% 11.6% 0%
 Reasons for not starting nPEP
◦ Sex with a steady partner believed to be HIV-negative
◦ Did not consider the exposure high-risk
◦ Concerns about side effects
Schechter et al, JAIDS, 2004

6. Efficacy
Study mITT (CI)
Behavior Change NS
(Explore)
18% (–5, 36)
TDF/FTC oral-PrEP in MSM 44% (15, 63)
(iPrEx)
TDF/FTC oral PrEP in heterosexuals 63% (22, 83)*
(TDF2)
TDF/FTC oral PrEP in HIV-discordant couples 75% (55, 87)*
(Partners PrEP)
TDF/FTC oral PrEP in men 84% (54, 94)*
(Parters PrEP)
TDF/FTC oral PrEP in women 66% (28, 84)*
(Parters PrEP)
TDF/FTC oral PrEP in women NS 18% (-36,51)*
(FEM-PrEP)
Early ART in serodiscordant couples 96% (73, 99)
(HPTN 052)
0 10 20 30 40 50 60 70 80 90 100
% Efficacy
*Provisional

7. Recruit PrEP Flow Diagram - Provider Perspective
Self-referral
Network referral
Venue outreach
Health services
CBOs
Low
Risk
HIV Risk High Educate Lab
Test Neg Screen Yes Screen Eligible Consent? Yes
Risk Interest?
Pos Mod Not
No Eligible No
Risk
Refer for care Refer for risk-reduction services
Refill Pos Prescription
Adherence HIV Adherence Client Receives
Counseling Neg Test 3 months Counseling PrEP Services*
Risk Reduction Risk-Reduction
Counseling Counseling
Serious Toxicities * Including indicated STI diagnosis and treatment

8.  MSM
◦ NHANES (2001-2006)
 1.8 million men aged 18-59 years reported sex with a man in prior year
and self-identify as gay
 47% reported >2 male sex partners in past year
 83% HIV-uninfected
◦ National Survey of Sexual Health and Behavior
 No condom use among gay men during most recent sexual event was
39%
◦ 275,000 uninfected gay men with >2 male sex partners in
past year and no condom use at last anal sex
 Heterosexual discordant couples
◦ Estimated from multiple population-based data sources
◦ At least 140,000 discordant heterosexual couples in the U.S
◦ Approximately ½ intend future pregnancies
Sources: Xu et al. STD 2010; 37(6):399-405. Reece et al. J Sex Med 2010;7(suppl 5):266–
276:
Lampe et al. AJOG 2011: 204(6):488e.1-8

9.  Nearly all awareness and acceptability studies
in the US have been done with MSM
◦ Low awareness, substantial acceptability
 DocStyles and HealthStyles 2009
Had heard Support use or prescriptipn of PrEP Support
of PrEP public
funding of
PrEP
MSM IDU STD Discordant
clients couples
Physicians 23% 68% 67% 39% 78% 61%
and nurses
General 5% 47% 45% 48% 70% 68%
population

10. MSM HRH IDU Discordant
Couples
Clinical Services
LGBT clinics X X
STD clinics X X
Reproductive health clinics X X
Addiction treatment clinics X
Primary care clinics X X X X
HIV treatment clinics X
Supportive Services
CBOs X X X
Pharmacies X X X X
NSEPs X

11. If safe and ≥75% effective, would provide to… %
Injection drug users 69%
MSM 66%
Patients who change sex partners frequently 57%
Uninfected partner wishing to conceive with an HIV+ partner 55%
Patients with an STD 34%
2009 web survey of 2156 physicians, ½ primary care

12.  Users
◦ Unaware of level of personal risk
◦ Unaware of intervention
◦ Don’t know how or where to access the intervention
◦ Delay in seeking clinical preventive care
◦ Uninsured/unable to pay for medication
◦ Low adherence to medication
 Providers
◦ Unaware of intervention
◦ Uncertain how to deliver the intervention
◦ Wary of complexity and time involved
◦ Low index of suspicion for indications
◦ Low access to the highest risk populations
◦ Uncertain how to bill for the intervention

13. Open-label Studies Implementation Studies
(Real World Conditions)
Type-specific Acceptability (patients) Acceptability (system)
Questions Medication adherence Retention (patients)
Longer term safety Sustainability (cost)
Practice variation effects
Setting(s) Research clinics Usual clinical care sites
Population(s) Clinical trial participants (or Broad population that may
similar) benefit
Consent Research consent Clinical care consent
Incentives $ for time and effort Clinical services only
Protocol Strict research protocol Very Practice guidelines with
similar to trial protocol formal and informal variance
Care Research staff Community care providers
Provider(s)
Care Funding Research funds Insurance (public, private, or
self)

14. Open-Label Studies Implementation
Studies
MSM and iPrEx- OLE
M-F TG San Francisco, Boston, Chicago
NIAID STD Clinic
None
San Francisco, Miami
California HIV Research Program
East Bay, Los Angeles, San Diego
Heterosexual
None None
Women and
Men
Discordant None None
Couples

15.  Primary care benefits?
◦ hepatitis vaccination, reproductive health care
 Resistance?
◦ Uncommon if screening for acute infection
 Adherence?
◦ Poor in some trials, high in others
 Risk compensation?
◦ Not seen (yet), models suggest unlikely to exceed benefit
 Cost-effective?
◦ Yes, if targeted to those with high incidence

16. Factor Measures
Reach Coverage and representativeness of patients
Effectiveness Rate of new HIV infections and adverse outcomes
Adoption Availability/representativeness of settings and
clinicians who provide PrEP
Implementation Extent of delivery consistent with guidelines;
resources required and costs
Maintenance Patients: Long-term effects and attrition
Clinician/setting: sustainability of program

17. PrEP
Primarily
Treatment
Biomedical
nPEP as
Prevention
Uninfected
Person
MC Condoms
Sexual Substance
Primarily
Behavior Abuse
Behavioral
Change Change

18. Dr. Dawn K. Smith
dsmith1@cdc.gov
404.639.5166
"The findings and conclusions in this presentation have not been formally dissemination
by CDC
and should not be construed to represent any agency determination or policy."