1. Impact of Tenofovir Chemoprophylaxis on HIV Prevention Programs Questions and Implications from Local Experience
Charles L. Henry, Director
County of Los Angeles
Department of Health Services
Office of AIDS Programs and Policy
December 9, 2004

2. Presentation Overview
Potential Beneficiaries
Program Development Considerations
Clinical Implications
Medical System Challenges
Behavioral and Health Consequences
Fiscal Implications
Policy and Ethical Considerations

3. Potential Beneficiaries
Exposure Anticipators
“I understand I’m at risk”
“My risk is frequent”
Exposure Reactors
“I didn’t care”
“I didn’t know”
Potential Target Populations
Transgenders
MSM/IDU
MSM Meth Users
Commercial Sex Workers
“I didn’t care” – knew s/he was positive and still had sex
“I didn’t know” – we had sex and then I found out s/he was positive
Discussion point: “I had a close call” – Reactors may become Anticipators

4. Program Development Considerations
Identify Qualifying Threshold Levels of Infection/Risk
Community, Group and Individual Levels
Engage Key Stakeholders in Program Assessment and Design
Develop Program Protocols, Procedures and Expectations
Conduct Resource Assessment
Provide Adequate Planning Time/Resources

5. Clinical Implications
Tracking Adverse Reactions and Long-Term Effects
Viral Resistance to Tenofovir or Other Drugs
Drug Interactions
Do We Monitor for Unrecognized Drug Interactions and Side Effects?
Tenofovir Has Anti-Hepatitis B Properties
Increased STD Morbidity
Adherence and Compliance
Discuss necessity of registry and cite limited compliance with HIV registries.
What will be the affect of this new strategy on individuals with Hepatitis B?

6. Medical System Challenges
Provider Acceptance
Will Some Providers Embrace and Others Resist?
Will Some Providers Feel That They May Be Promoting Risky Behavior?
Provider Education
How Do We Disseminate the“New” Prevention Strategy?
Who Will Establish Clinical Resources (e.g., Protocols, Hotlines, Educational Materials)?
Use example of Viagra and how it was marketed.
How do we ensure that this strategy does not set our prevention efforts back x number of years.

7. Medical System Challenges (Cont.)
Provider Readiness
How Do We Market the New Strategy?
How Do We Balance Manufacturer Marketing With Public Health Messaging?
What Are Minimal Behavioral Risk Assessment Skills and Expectations?
Who will Offer the Service?
Other example: Expert Material Review Committees

8. Behavioral and Health Consequences
Potential Increased Incidence of Gonorrhea, Chlamydia, and Syphilis
Retard Disclosure Normalization Efforts
Potential Increased Number of Sex Partners or Decreased Condom Use
Decreased Reliance on Necessary, More Intensive Interventions

9. Fiscal Implications Cost Effectiveness Complex Regimen
Does Potential Tenofovir Benefit Outweigh Underfunded Prevention and Treatment Strategies?
Hepatitis A and B Vaccines
Hepatitis C Treatment
Complex Regimen
Laboratory Testing
Counseling
Follow Up Visits and Charting
Medication Costs
STD Screening and Treatment

10. Fiscal Implications (Cont.)
Unseen Public Health Costs
Infrastructure
Monitoring (QA and CQI)
Policy Development and Dissemination
Training
Provider Support
Who will Pay for the Service?

11. Policy and Ethical Considerations
Legal
Issues of Knowingly Engaging in High Risk Behavior (client, provider, government, law enforcement)
Statutory/Regulatory
Create State Registry to Track?
Workplace Exposure
Adult Film Industry
What Are the Implications for the Use of Scarce Public Health Dollars in Populations That Already Have Significant Resources?
How Do We Limit the Abuse of Tenofovir?
Black market sales of drugs such as Viagra
One Type of Potential Abuse: Delivering Tenofovir to Sexual Partner with Unknown or HIV Negative Status
Does Tenofovir become part of Standards of Care for transgenders? Or MSM meth users?