8/25/2016. Making Preexposure Prophylaxis Available in the Clinic: Considerations and Pathways Forward

Transcription

1 WORKSHOP SESSION: MAKING PREEXPOSURE PROPHYLAXIS AVAILABLE IN THE CLINIC: CONSIDERATIONS AND PATHWAYS FORWARD PRE-REGISTRATION IS REQUIRED PLEASE SEE THE CPT INFORMATION DESK IF THIS IS NOT YOUR SELECTED WORKSHOP Wednesday, August 24, :10 PM 4:10 PM Daily CPt evaluations will be ed to attendees to the account they used to register for the CPt. On THURSDAY, you will receive a final with the Thursday session and the overall conference evaluation, the post- CPt test questions, and a link to claiming education credit. To obtain CME, nursing, or pharmacy credits, or a Certificate of Participation for the CPt, this final evaluation must be completed by Friday, September 30, Once you complete the evaluation form you will be taken to the electronic claim form; Details are in the e-syllabus. Making Preexposure Prophylaxis Available in the Clinic: Considerations and Pathways Forward Raphael J. Landovitz, MD, MSc Associate Professor of Medicine University of California Los Angeles Center for Clinical AIDS Research and Education Los Angeles, California FORMATTED: 08/11/2016 Washington, DC: August 24,

2 Learning Objectives After attending this presentation, participants will be able to: Describe the challenges with setting up preexposure prophylaxis (PrEP) services in a clinical setting Monitor PrEP uptake in a clinical setting Describe pathways to development of successful PrEP implementation in the participant s own clinical setting Slide 5 of 39 Slide 6 of 39 Special Thank You to Sarit Golub, PhD & Demetre Daskalakis, MD MPH Clinical Trial Evidence for HIV Prevention Options (February 2016) Slide 7 of 39 Prevention of sexual transmission PROUD daily oral TDF/FTC (MSM United Kingdom) IPERGAY event-driven TDF/FTC (MSM Canada, France) Partners PrEP daily oral TDF/FTC (Serodiscordant couples Kenya, Uganda) Partners PrEP daily oral TDF (Serodiscordant couples Kenya, Uganda) TDF2 daily TDF/FTC (Heterosexual men and women Botswana) iprex daily oral TDF/FTC (MSM North and South America, South Africa, Thailand) Effect size (CI) 86% (58; 97) 86% (44; 99) 75% (55; 87) 67% (44; 81) 62% (22; 84) 44% (15; 63) CAPRISA 004 BAT-24 dosing vaginal tenofovir gel (Women South Africa) R RV 144 six injectable ALVAC/AIDSVAX (Heterosexual men and women Thailand) The Ring Study monthly vaginal ring containing dapivirine (Women South Africa, Uganda) ASPIRE monthly vaginal ring containing dapivirine (Women Malawi, South Africa, Uganda, Zimbabwe) MTN 003/VOICE daily dosing vaginal tenofovir gel R (Women South Africa, Uganda, Zimbabwe) FEM-PrEP daily oral TDF/FTC (Women Kenya, South Africa, Tanzania) FACTS 001 event-driven vaginal tenofovir gel R (Women South Africa) MTN 003/VOICE daily oral TDF/FTC (Women South Africa, Uganda, Zimbabwe) MTN 003/VOICE daily oral TDF (Women South Africa, Uganda, Zimbabwe) 39% (6; 60) 31% (1; 51) 31% (1; 51) 27% (1; 46) 15% (-21; 40) 6% (-21; 40) 0% (-40; 30) -4% (-49; 27) -49% (-129; 3) Prevention in people Bangkok Tenofovir Study daily oral TDF (PWID Thailand) who inject drugs 49% (10; 72) DELIVERY SYSTEM ACTIVE DRUG Vaccine Vaginal gel Oral pills Vaginal ring ALVAC/AIDSVAX Dapivirine Tenofovir Tenofovir disoproxil fumarate Tenofovir/ (TDF) emtricitabine (TDF/FTC) Effectiveness (%) Adapted from: Salim S. Abdool Karim, CAPRISA 2

3 Slide 8 of 39 Sexually Transmitted Infections 30.0% Syphilis 25.0% 20.0% Rectal Chlamydia Urethral Chlamydia Pharyngeal Gonorrhea Rectal Gonorrhea 15.0% Urethral Gonorrhea 10.0% 5.0% 0.0% Baseline N = 297 Week 12 N = 272 Week 24 N = 260 Week 36 N = 247 Week 48 N = 222 Slide 9 of 39 PrEP Delivery Help us reflect on our values Empower receptive partners to take control of prevention Reduce the burden of HIV anxiety Reboot conversations about prevention Connect patients to primary care and insurance Improve our approach to sexual health Golub, SA. Developing a PrEP Program for your Practice. NYCDOMH Slide 10 of 39 Who Should be offered PrEP? CDC Guidelines Age 18 and up, HIV negative (no acute or established HIV infection) Not in a monogamous HIV-negative partnership AND ONE OF: MSM reporting ncai in past 6 months MSM with STI in past 6 months Infrequent condom use with MSM or IDU partner Ongoing sexual relationship with HIV+ partner* Potential indicators of substantial risk of acquiring HIV infection MSM HIV-positive sexual partner Recent bacterial STI High number of sex partners History of inconsistent or no condom use Commercial sex work Heterosexual Women and Men HIV-positive sexual partner Recent bacterial STI High number of sex partners History of inconsistent or no condom use Commercial sex work In high-prevalence area or network Injection Drug Users HIV-positive injecting partner Sharing injection equipment Recent drug treatment (but currently injecting) Clinically eligible Documented negative HIV test result; no signs/symptoms of acute HIV infection Creatinine clearance 60 ml/min; no contraindicated medications Documented hepatitis B virus infection and vaccination status CDC. PrEP Guidelines

4 Slide 11 of 39 That s a lot of people! Clinical Decisions Reactive vs. Proactive Formal eligibility at the clinic level? Patients for whom your clinic CANNOT provide PrEP Then what? Should all providers see PrEP consultations? Who should constitute the team? Monitoring and Evaluation Clinic capacity? Referrals Slide 12 of 39 Guidelines are for Guidance Caution with sexual history taking Slut shaming Moralizing Harm reduction Stigmatizing the concept of high risk CDC 5Ps of sexual health Partners Practices Protection Past history Pregnancy Sexual Health Assessment Slide 13 of 39 The Order Matters S. Golub found that young MSM of color better understood PrEP education AFTER being engaged in a sexual history 4

5 Slide 14 of 39 It Ain t Just a Pill New York State has developed a 9-point checklist How PrEP Works Limitations of PrEP PrEP use (dosing) Safety Baseline tests and schedule for monitoring Criteria for discontinuing PrEP Possible symptoms of seroconversion Risks and benefits during pregnancy Daskalakis et. al. Guidance for Use of PrEP to Prevent HIV Slide 15 of 39 Three Universal Truths at the Exact Same Time Verify HIV-negative status 4 th generation test or 3 rd +VL S/Sx of acute infection (VL if positive or recent exposure) What if no insurance? Creatinine screening Cr (egfr > 60 ml/min) Some advocate urinalysis for pre-existing proteinuria STI/Pregnancy Testing Get tested before starting PrEP. What do you need to feel comfortable prescribing PrEP? Slide 16 of 39 Can PrEP be prescribed same day? Prescription 1 month only (first prescription) 3 months thereafter (some prefer 2 months x 1, then Q3 months thereafter) Who needs Cr more often than every 6 months? Other services Hepatitis, HPV, meningococcal vaccination HCV screening CDC. PrEP Guidelines

6 Slide 17 of 39 Adherence Support Sigh. Need for daily adherence? Onset of maximal protection? Missed dose instructions Using refill timing and/or self-report Guidance Be clear Routinize daily dosing Discuss common AEs up-front Plan for disclosure Seasons of Risk CDC. PrEP Guidelines Slide 18 of 39 STI testing Every 3 months, even if asymptomatic S. Golub showed as many as 15% of participants will have an asymptomatic STI on PrEP at 3 months that would have gone undetected with only 6 month testing In our project, 22% of participants had an asymptomatic incident STI at 3 months CDC. PrEP Guidelines Slide 19 of 39 Purview Paradox HIV providers: Primary care providers are in the best position to prescribe PrEP Primary care providers: It would not be feasible to prescribe PrEP Krakower D et al, AIDS Behavior Arnold EA et al, PLoS One

7 Contrasting Models of PrEP Provision for HIV Specialist Slide 20 of 39 Consultation refer back to primary Service Provision Slide 21 of 39 Assignment of Important Tasks Retention/Persistence Adherence Support Interim Visits Insurance/Co-Payment Navigation Prescription (initial and refills) Medical Screening PrEP Education and Decision-making Ownership Slide 22 of 39 PrEP Payment 101 INSURED TO COVER COST FOR PrEP? YES NO Gilead Advancing Access Co-pay Card US Resident Enroll in insurance marketplace (Nov 1 Jan 31) Non-Resident/ Undocumented FQHC that serves undocumented pts Patient Advocate Foundation (PAF) Patient Access Network Foundation If > 138% FPL/yr If < 138% FPL/yr check eligibility for state Medicaid Enroll in Gilead MAP What is your income? Below $58,850 (500% FPL) Above Retail Cost of TDF/FTC 7

8 Slide 23 of 39 PrEP Payment 101 Medicaid and Private Insurance PrEP and the ACA Gilead Co-pay Assistance Card Patient Access Network (PAN) Gilead Medication Assistance Program (MAP) New York State and Washington State have PrEP assistance programs Slide 24 of 39 MediCaid and Private Insurance Medicaid Varies state-by-state In many Medicaid expansion states, PrEP visit/rx/labs covered Requirements for preauthorizations vary Private Insurance Most private insurance will cover PrEP Coverage of medications costs highly variable HIV-testing, STI-testing, lab tests may require copays Gilead co-pay card can help with medication costs but neither visit nor lab costs Slide 25 of 39 ACA Bronze Level Should expect co-pay of 50% for TDF/FTC (approx. $600 per month) Silver, Gold, or Platinum Fixed prescription co-pays $25 to $100 per month 8

9 Slide 26 of 39 Gilead Co-Pay Assistance Card Covers up to $3600 of patient s prescription copay or coinsurance per year Must be insured US or Puerto Rico resident Expires after 12 months Option for reapplications Cannot use with Medicare/Medicaid Slide 27 of 39 Patient Access Network (PAN) $4000 over one year for prescription payments Commercial insurance, Medicare, or Medicaid US or Puerto Rico residents <500% of FPL ($58,850 per individual) Gilead Medication Assistance Program (MAP) Slide 28 of 39 >12 years old Uninsured or insurance covers no prescription costs Resident of US or Puerto Rico, <500% of FPL Reapply every 6 months Independent pharmacy FedEx s TDF/FTC to patient s home 9

10 % Aware 8/25/2016 Slide 29 of 39 We can do it! Basics Education for staff at all levels Scripts/guides for clinics Training on PrEP Protocols Bullet points for phone and front desk staff Guides for nurses and counselors Awareness of PrEP by Age 7003 US MSM, Age Group Sanchez T et al, JMIR Pub Health Surveill Slide 30 of 39 We can do it! Staffing PrEP Champion PrEP Coordinator PrEP Available in Clinic PrEP Providers PrEP Counselors Slide 31 of 39 We can do it! Resources Education materials Provider checklists and/or EMR templates Tracking databases Funds to support un-/under-insured patients 10

11 We can do it! Monitoring and Evaluation Slide 32 of 39 Feedback Protocols Patient conferences Challenges Monthly Reporting Snapshot Quality Assurance Slide 33 of 39 Can we do it? Identify PrEP Champion and Coordinator Draft Policies and Procedures Identify Needed Materials Identify Staff Training Needs Mechanisms for communication Method to ensure protocols are followed 11