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Pre-Exposure Prophylaxis: Efficacy to Implementation
Slide 1.
Pre-Exposure Prophylaxis: Efficacy to Implementation
Slide 1.
Roadmap
Slide 2.
Why do we need new HIV prevention tools?
Slide 3.
Diagnoses of HIV Infection among Men Who Have Sex with Men, by Age Group, 2007-2010--46 States and 5 U.S. Dependent Areas
Slide 4.
Diagnoses of HIV Infection among Men Who Have Sex with Men Aged 13-24 years. by Race/Ethnicity, 2007-2010--46 States and 5 U.S. Dependent Areas
Slide 5.
Number of cases diagnosed with HIV infection and HIV/AIDS prevalence, 2006-2011, San Francisco
Slide 6.
Estimated number of new HIV infections, 2006-2010, San Francisco
Slide 7.
Percent of MSM reporting unprotected anal intercourse in the last six months, the STOP AIDS Project, 2006-2011
Slide 8.
Using Antiretroviral Medications for HIV-1 Prevention
Slide 9.
Why Truvada?
Slide 10.
Phase III PrEP Studies
Slide 11.
Phase III PrEP Studies
Slide 12.
Pre-Exposure Prophylaxis Initiative (iPrEx)
Slide 13.
Efficacy (MITT) 42 % (18-60 %) Through End of Study Infection Numbers: 83 - 48 = 35 averted
Slide 14.
iPrEX: Safety and Adherence
Slide 15.
iPrEX: Adverse Events
Slide 16.
iPrEx: Nausea on History
Slide 17.
iPrEx: Numbers of Sexual Partners
Slide 18.
iPrEx: Condom Use With RAI
Slide 19.
iPrEx: Breakthrough Infections and Resistance
Slide 20.
Serodiscordant Heterosexuals: Partners PrEP
Slide 21.
Partners PrEP and TDF2: Resistance
Slide 22.
Partners PrEP and TDF2: Safety
Slide 	23.
FEM-PrEP
Slide 24.
PrEP Efficacy and Drug Detection
Slide 25.
Adherence, Drug levels and Efficacy
Slide 26.
Not all PrEP RCTs have shown a benefit
Slide 27.
Summary of the data
Slide 28.
PrEP Research Agenda
Slide 29.
Alternate Dosing - IPERGAY
Slide 30.
Recent Breakthroughs in HIV Prevention
Slide 31.
FDA Approval of TDF/FTC for PrEP July 16, 2012
Slide 32.
REMS
Slide 33.
CDC Guidance: Jan 2011 and Aug 2012
Slide 34.
Why do we need PrEP demonstration projects?
Slide 36.
The Proposed PrEP cascade
Slide 36.
Why do we need PrEP demonstration projects?
Slide 37.
Other key implementation issues
Slide 38.
PrEP Demonstration Projects in the US
Slide 39.
The Demo Project
Slide 40.
What do we want to learn?
Slide 41.
Recruitment and Eligibility
Slide 42.
Demonstration Project Timeline
Slide 43.
What does the study involve?
Slide 44.
Measuring adherence
Slide 45.
Adherence Counseling
Slide 46.
Risk Reduction Counseling
Slide 47.
Accrual
Slide 48.
Reasons for refusal
Slide 49.
How do I refer my clients?
Slide 50.
Conclusions
Slide 51.
Acknowledgements
Slide 51.
Thanks and Questions
Slide 51.