Impact of Tenofovir Chemoprophylaxis on HIV Prevention Programs

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 2

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 3

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 4

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 5

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)? 6

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? 7

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 8

Fiscal Implications ¢ Cost Effectiveness 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 9

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? 10

Policy and Ethical Considerations ¢ Legal Issues of Knowingly Engaging in High Risk Behavior (client, provider, government, law enforcement) ¢ Statutory/Regulatory ¢ Workplace Exposure Create State Registry to Track? 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? ¢ 11