Safety Issues in Pre-exposure Prophylaxis for HIV Negative Individuals, Proposals for Management of Safety Concerns, and Pending Plans for Scale-up

Forum for Collaborative HIV Research
1608 Rhode Island Avenue, NW
Washington, DC 20036

August 19, 2011

Speakers

8:30 AM

• Welcome and Introductions - Forum for Collaborative HIV Research

Veronica Miller, HIV Forum

8:35 AM

• Welcome - FDA

Debra Birnkrant, FDA

8:42 AM

• iPrEx Safety Review

Robert Grant, UCSF

8:49 AM

• USTDF-X/Botswana Safety Review

Lynn Paxton, CDC

8:56 AM

• FEM-PrEP

Lut Van Damme, FHI 360

9:03 AM

• Partners PrEP

Connie Celum, UW

Session 1: What are the safety issues of concern with pre-exposure prophylaxis?
Moderator: Roy (Trip) Gulick,  Weil Cornell Medical College

9:10 AM

Introduction of Panelists

Moderator and Panelists

9:25 AM

Panel Discussion:

• What are the medical risks of ARVs prevention and how does this compare to the risks for treatment?
•   Are there specific safety concerns with regard to prescribing ARV to HIV-uninfected individuals?
• What data are available on an increase or decrease in high risk behavior with use of PrEP?
• Is increased transmission of STDs a concern?
• What safety issues are raised by non-adherence or intermittent use?
• Are issues of resistance different in the prevention versus treatment setting? If so, how?
• Is acute infection a concern? How can acute infection be detected in real world settings?
• Is diversion a safety risk? If so, what safety issues are raised?

Panelists:
David Burns, NIH
Jared Baeten, UW
Cornelius Baker, NBGMAC, FHI 360
Homayoon Khanlou, AHF
Raphael Landovitz, UCLA
Charu Mullick, FDA

10:10 AM

Audience Participation/Written Questions for Panelists

10:25 AM

BREAK

Session 2: Remedies and their pros and cons
Moderator: Jur Strobos,  HIV Forum

10:40 AM

Introduction of Panelists

Moderator and Panelists

10:55 AM

Regulatory Perspectives

Carolyn Yancey, FDA/OSE

11:05 AM

Panel Discussion:

• Should there be a requirement for drug access for PrEP? What are the pros and cons of the following requirements for drug access:
    • Prescriber training and/or certification, including documentation of risk counseling, risk reduction plans and periodic HIV testing
    • Pharmacy certification (i.e., specialized pharmacies to dispense PrEP)
    • Documentation of HIV test during PrEP use and/or before PrEP use to detect acute infection
    • Registry for PrEP users
• Would the "cost" of the above requirements in terms of access or burdens on the healthcare system outweigh the benefits?
• How can communication plans, e.g., patient/physician education/outreach, be implemented for PrEP? What are the important elements of physician and patient education plans?
• How does one target the intended patient and physician population?
• What further studies may be needed? Who should conduct them? Design?
• How should the potential for disinhibition be handled or studied (if necessary)?
• Should there be controls for diversion? if so, what?
• What should the frequency of testing be?

Panelists:
Keith Green, AFC
Kendall Marcus, FDA
Tim Mastro, FHI 360
Conall O'Cleirigh, Mass Gen
Mike Saag, UAB
Monica Sweeney, NYC DOHMH
Carolyn Yancey, FDA/OSE

12:00 PM

Audience Participation

12:15 PM

LUNCH ON OWN

Session 3: Public Health Implications   
Moderator: Ken Mayer, Fenway Institute

1:45 PM

Introduction of Panelists

Moderator and Panelists

2:00 PM

Panel Discussion:

• What are the elements of a demonstration project to provide the most useful information about PrEP use in a “real world” setting? How will the outcomes from a demonstration project be used for PrEP management and implementation?
• What are the likely effects on resistance at a community level?
• Is resistance dependent on specific drug therapy? What is the possible relationship of resistance and adherence?
• Resource allocations: prep versus treatment?
• How do we reach the most vulnerable patients?
• What methods should be used for testing?

Panelists:
Ume Abbas, CCF
Stephanie Cohen, SF DPH
Jeanne Marrazzo, UW
Sheena McCormack, MRC
Dana VanGorder, PI
Mitchell Warren, AVAC

2:45 PM

Audience Participation

3:00 PM

BREAK

Session 4: Next Steps          
Moderator: Jur Strobos,  HIV Forum

3:15 PM

• CDC Clinical Guidance

Dawn Smith, CDC

3:25 PM

• Kaiser Permanente Plans

Michael Allerton, KP

3:35 PM

• Aetna Plans

Ed Pezalla, Aetna

3:35 PM

• Gilead Plans

Jim Rooney, Gilead

3:45 PM

Audience Participation

Session 5: Summary and Action Items         
Moderator: Jur Strobos,  HIV Forum

4:00 PM

Summary and Action Items

Lynda Dee, AAB
Dawn Fukuda, MA DOH
Linda Lewis, FDA
Jeanna Piper, NIH

4:30 PM

Adjourn

Jur Strobos