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

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

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

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

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?

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.

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

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

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

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?

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?