Prescribing PrEP With Your Organization: A Guide to Starting PrEP in a Clinical Setting- Part 1

1 Part I - Prescribing PrEP with your organization: A guide to starting PrEP in a clinical setting Tomasz Z. Jodlowski, PharmD, BCPS AQ-ID, AAHIVP Clinical Pharmacy Specialist, Infectious Diseases VA North Texas HCS [email protected] 1 Conflict of Interest Disclosure Statement Speaker has no financial conflicts of interest to disclose. 2 Learning Objectives Increase understanding, acceptability, and adoption of PrEP and nPEP among local clinical service providers. Increase understanding of how to incorporate screening to individuals to assess risk of acquiring HIV in their setting. Increase understanding in patient assistance programs to alleviate cost barriers for patients to get on PrEP. 3 4 5 Risk Factors for HIV Transmission Increase Risk Multiple partners (needles/sex) Sharing injection equipment HIV+ person with high viral load Condomless sex Sexually Transmitted Infections Substance abuse Decrease Risk Abstinence Reducing number of partners Less risky sexual behaviors Use of condoms PWH suppressed taking ART PrEP and nPEP Online HIV Risk Calculator: PWH= People With HIV nPEP guidelines Table 1. 6 Risk Factors for HIV Transmission: Sexual Activity Online HIV Risk Calculator: nPEP guidelines Table 1. 7 Ending the HIV Epidemic: A Plan for America Ending HIV as an Epidemic: A Plan for America 8 9 Ending the HIV Epidemic States and Jurisdictions Targets for Prevention of HIV Infection: The Basics Prior to HIV Exposure Pre-Exposure Prophylaxis (PrEP) One tablet taken daily* *Epi-PrEP and On demand/ED- PrEP- Future Direction? Time of HIV Transmission Non-occupational Post-Exposure Prophylaxis (nPEP) 3 antiretroviral medications for 28 days initiated within 72 hours of exposure After HIV Infection Treatment as Prevention (TasP) PWH with suppressed HIV viral load, cannot sexually transmit HIV to the partner U=U CDC Campaign PWH= people with HIV 10 11 CDC guidance: PrEP 101 12 Does PrEP work? Pre-exposure prophylaxis VA Clinician's Guide. PBM Academic Detailing Service Who should prescribe PrEP? Primary Care Providers Non-stigmatizing practice setting Familiar with the patient's general conditions Strong relationship with their patients Accessible HIV providers Familiar with discussing STIs Familiar with HIV risk factors and prevention Familiar with antiviral medications Answer: EVERYONE! Pre-exposure prophylaxis VA Clinician's Guide. PBM Academic Detailing Service Pre-exposure prophylaxis VA Clinician's Guide. PBM Academic Detailing Service 14 Experience at VA North Texas HCS Poster presentation. ACTHIV 2020 How do we get started? Step-wise approach for prescribing PrEP Step 1. Discussing Sexual Health & Injection Drug Use Step 2. Indications for PrEP Step 4. Check Other Baseline Labs Step 3. Assessing for Current HIV Infection Step 6. Monitoring patients on PrEP Step 5. Prescribing PrEP STEP 1. Sexual Health & IDU Assessment IDU=injection drug use 16 STEP 2. Who should be offered PrEP? 17 STEP 3. Assessment of Acute HIV Acute HIV/acute retroviral syndrome 18 STEP 3. Assessment of Acute HIV (cont) Acute HIV/acute retroviral syndrome 19 STEP 4. & 6. Recommended Clinical & Laboratory Assessment Laboratory test Baseline Every 3 months At least every 6 months Notes HIV Ab/Ag HIV symptoms HAV, HBV serology and HCV antibody Offer HAV and HBV vaccination if not immune! Consider screening HCV annually if at risk (i.e. IVDU) Serum creatinine (Scr) STI screen (syphilis, gonorrhea, chlamydia) Include urine/oral/rectal GC/CT screen if site of exposure Pregnancy test (women) Urine beta-HCG Assess side effects / Adherence Risk reduction counselling Condoms, clean needles, behavior change, SUD treatment 20 Clinic Tools Used at VA North Texas HCS 21 STEP 5. Emtricitabine 200 mg/ Tenofovir DF 300 mg (FTC/TDF) One pill once daily with or without food Starting with 30 day supply with 2 refills Then 90 day supply, no refills Side effects Nausea, headache Other: Bone health and renal function Monitoring Renal function (CrCl > 60 mL/min) Drug interactions Caution agents with renal toxic effects 22 STEP 5. Emtricitabine 200 mg/ Tenofovir AF 25 mg (FTC/TAF) FDA Approved 10/2019: FTC/TAF "not indicated in individuals at risk of HIV-1 infection from receptive vaginal sex because the effectiveness in this population has not been evaluated." One pill once a day with or without food Side effects Nausea, diarrhea Less impact on renal function or bone health Increased weight gain, lipid changes Monitoring: Renal function (CrCl >30ml/min) Drug interactions Strong p-gp inducers Summary Points Adherence is key to preventing HIV With daily use, PrEP takes several days to achieve optimal protection 7 days in rectal tissue, up to 20 days in blood or vaginal tissue PrEP does not protect against Sexually Transmitted Infections (STIs) Currently FDA approved agents also treat Hepatitis B (HBV) Screen before starting, vaccinate (if not immune) and use caution if d/c for PrEP with active HBV infection Always continue strategies for behavioral risk reduction Continuation of PrEP requires regular lab tests (Q3months) 24 Future Directions: Epi-PrEP i.e. "Vacation PrEP" Not FDA approved at this time Egan, JE et al. JAIDS 2020;84:508-513. 25 Future Directions: Event Driven/On Demand PrEP (2-1-1 PrEP) Not FDA approved at this time What's the 2+1+1? Event-driven oral PrEP to prevent HIV for MSM. Update to WHO's recommendation on oral PrEP. Geneva: World Health Organization. 7/2019. 26 Addressing cost barriers Ready, Set, PrEP- A national program that makes PrEP medications available at no cost to individuals (Tel: 1-855-447(HHS)-8410) State PrEP program information Uninsured: Gilead Medication Assistance Program (MAP) Commercial insurance: Copay cards available if patient has commercial insurance and has a copay. (covers up to $7,200 in co-pays per year) As you know, patients with federal/state funded benefits (i.e. Medicare, Medicaid, VA, etc.) generally cannot utilize copay cards. Both Truvada & Descovy for PrEP have copay cards available that can be used to help if a patient's commercial insurance has a copay (potentially bringing copay down to $0). These programs cover up to $7,200 in co-pays per year with no monthly limit. HCPs and/or patients can enroll, activate, re-activate, and learn more at website: I have also attached a slide (it mentions Descovy specifically, but true for Truvada as well). For uninsured patients: Website: available to help patients/providers navigate options; including but not limited to eligibility for Gilead's Prescription Assistance Program (PAP) where they may qualify for drug at no cost through Gilead, insurance enrollment options (i.e. state Medicaid eligibility, ACA marketplace insurance eligibility, etc.), etc. Additionally, Ready, Set, PrEP is a nationwide program that makes PrEP medications available at no cost to individuals who lack prescription drug coverage. This program is similar to Gilead's PAP; but is not administered by Gilead. Website: 27 PrEP & COVID-19 (CDC May 15th) Reducing number of new infection remains a public health priority and PrEP should remain available Quarterly HIV testing should continue (Lab-only visits are preferred) If lab visits are not available, consider home specimen collection kits for HIV and STI tests Self-testing via oral swab (usually not recommended for PrEP due to lower sensitivity) Use of 90-day supply of medication (plan permitting) Maintain access (tele, transfer to other active clinics, etc.) 28 Plan A? nPEP 101 Adults and adolescents: Preferred Tenofovir PLUS Emtricitabine PLUS Raltegravir OR Dolutegravir* Alternative Tenofovir PLUS Emtricitabine PLUS Darunavir WITH Ritonavir Consider source patients resistance/ARTs Baseline labs (next slide) Follow up (nPEP PrEP!) PEPLine/CDC 1-888-448-4911 Payment assistance with nPEP Common patient assistance programs form If victim of sexual assault AETC handout: Medication assistance/copays Thank you! References US Public Health Service. PreExposure Prophylaxis for the Prevention of HIV Infection in the United States-2017 Update: A Clinical Practice Guideline. USPSTF Preexposure Prophylaxis for the Prevention of HIV Infection. JAMA 2019;321(22):2203-2213. Marrazzo et al., HIV Prevention in Clinical Care Settings 2014 Recommendations of the International Antiviral SocietyUSA Panel JAMA.July 2014;312(4):390. Riddell, J et al. HIV Preexposure Prophylaxis: A Review. JAMA. 2018;319(12):1261-1268. Saag, MS et al. Anitretroviral Drugs for Treatment and Prevention of HIV Infection in Adults: 2018 Recommendations of the IAS-USA Panel. JAMA. 2018;320(4):379-396. Chen, Anders et al. Clinical Effectiveness and Cost-Effectiveness of HIV PrEP in MSM: Risk Calculators for Real-World Decision-Making. PLOS ONE. October 2014;9(10):e108742. What's the 2+1+1? Event-driven oral PrEP to prevent HIV for MSM. Update to WHO's recommendation on oral PrEP. Geneva: World Health Organization. 7/2019. Updated guidelines for ARV PEP after sexual, IDU, or other nonoccupational exposure to HIV-US, 2016. AETC NCRC nPEP Toolkit. Resources Clinical Consultation Center HIV Management Perinatal HIV HIV PrEP HIV PEP line HCV Management Substance Use Management Present case on ECHO AETC National HIV Curriculum AETC National HIV-HCV Curriculum AETC National Coordinating Resource Center Additional trainings [email protected] Additional Reference Slide (1 of 3) Additional Reference Slide (2 of 3) Additional Reference Slide (3 of 3) Uptake of Primary Care Significantly Associated with PrEP Retention in a Mid-Sized U.S. City Demographics Majority who presented were male (83.9%), MSM (75.4%) Black (18.0%), Latinx (9.8%) Filled PrEP prescription and presented to at least one appointment (85.6%) 42% left the program (median time on PrEP was 161 days) Results Retention in PrEP care was associated with being a primary care patient in clinic where PrEP was prescribed Scaling up PrEP in primary care practices should be strongly prioritized; It is associated with better retention and persistence. Proportional hazards model to determine factors associated with length of time on PrEP among patients in SUNY Upstate PrEP and HIV primary care clinics, January 1, 2015 June 30, 2019 (N=367) Co-located Prep & Primary Care vs. Separate Prep & Primary Care PrEP + primary care PrEP care only State University of New York (SUNY) Upstate HR 2.55, p<0.0001 Endreny, N, et al. AIDS 2020. PEC0603 38