PrEP: Preexposure Prophylaxis to prevent HIV Lisa Pietrusza, BSN, RN FNP-DNP student, University of Pittsburgh Nov. 3, 2017 Disclosures The views expressed heroine do not necessarily reflect the official policies of the University of Pittsburgh No financial or business disclosures Acknowledgements Oliver Bacon, MD at San Francisco Dept of Public Health AIDS Free Pittsburgh Stacy Lane, DO at Central Outreach Wellness Center 1
Objectives Describe HIV prevention options Efficacy and safety of Truvada as PrEP for HIV Identify who is appropriate for PrEP How to implement PrEP Testing Counseling and Educations Prescribing and Follow-up Billing and coding for PrEP visit Why PrEP 37,600 new HIV infections in 2014, despite counseling, condoms and testing Incidence varies by population Men who have sex with men (MSM) Racial and ethnic minorities, especially young MSM of color Injection drug users PrEP is an additional layer of protection, no change in condom use during the studies New Prevention Tools are Needed 2
Prevention Methods Condoms decrease risk of HIV 70-80% if used correctly and consistently 16% of MSM use condoms every single time Efficacy drops if not used correctly and consistently PEP (post exposure prophylaxis) decreases risk of HIV 80% in occupational exposures Must be used within 72 hours of exposure PrEP decreases risk of HIV up to 96% in serodiscordant couples, similar rates in MSM and other groups Protection is controlled by the user, independent of partners viral loads and attitudes towards condoms The new blue pill for sex! What is PrEP? FDA approved in 2012 in combination with safer sex practices to reduce the risk of HIV-1 infection in adults at elevated risk Emtricitabine 200mg/tenofovir disoproxil fumarate 300mg (Truvada) Taken daily regardless of plans for sex Can be used for months-years Part of a HIV prevention plan PLUS regular monitoring for HIV, STIs, drug safety and adherence How does PrEP work? What is PrEP? https:// www.youtube.com/ watch?v=uekrjo6raye&t=214s 3
Evidence Similar risk reduction in MSM and HIV-discordant couples iprex largest, most influential PrEP study 2,451 participants, 99% risk reduction in those with blood levels equal with daily dosing PROUD Study in UK was stopped early due to unexpectedly large number of HIV infections during deferral period 544 participants, 86% relative reduction in HIV incidence Later analysis showed those that became positive during study were not taking medication as prescribed Very low NNT = 13 (90% CI 9-25) Kaiser Permanente observational study in San Francisco 657 people, 0 new HIV cases in 2.5 years PrEP Efficacy and Drug Detection Study iprex (MSM, Trans women) Partners PrEP (heterosexual) TDF-2 (heterosexual) Fem PrEP (women) Overall efficacy Overall drug detection Risk reduction w/ drug detection 44% 50% 92% 67%(single agent) 75% (combined) 82% 86%(single agent) 92% (combined) 63% 80% 78% Stopped early <40% VOICE (women) Stopped early <30% Adherence too low to assess Adherence too low to assess Bangkok IDU 49% 66% 74% Adherence and Risk Grant, R.M., et. al. (2014) Uptake of pre exposure prophylaxis, sexual practices, and HIV incidence in men and transgender women who have sex with men: a cohort study. Lancet Infect Dis., 14(9). 4
Emtricitabine/Tenofovir Has been used as combination treatment for HIV since 2004 Not HIV mono-therapy! Nucleoside/nucleotide reverse-transcriptase inhibitor Concentrates quickly and in therapeutic levels in blood and rectal tissue at 7 days Therapeutic in cervical and vaginal tissue at 20 days Safety and Side Effects 4 years of data on Truvada as PrEP Most common side effects: Headache (7%) Abdominal pain/nausea/diarrhea (4%) Weight loss (3%) Creatinine elevation in 1 in 200 people, reversible after stopping PrEP Hold for elevated creatinine and recheck at next visit then restart if normal Bone thinning or demineralization NOT associated with fractures 1% decrease after 24 months, reversible after stopping PrEP Can cause worsening of HBV if stopped in HBV positive patient What about resistance? Seroconversion is rare with adherence Non-adherent patients may acquire HIV but rarely develop drug resistance (drug levels too low) Resistance has occurred in patients with acute (seronegative) HIV at time of PrEP start 2 documented cases of HIV resistant to emtricitabine/tenofovir Out of 8,478 participants in 32 studies there were 67 HIV-1 seroconversions 5
Implementation of PrEP Who is PrEP for? HIV negative confirmed patients AND Anyone with a HIV positive partner Gay or bisexual men or MSM that have multiple partners, partners with unknown HIV status or who have had a recent STI or anal sex without a condom Injection drug users who share needles or works Any one with an increased risk for HIV AA, Transgender men and women Consider patient s lifestyle, relationship status and presence of abuse, mental illness, drug & alcohol abuse and incarceration history <18 year old on case by base basis Pregnancy Category B Prior to PrEP Start Risk Assessment Counseling Education 6
Quick, Informative Sexual History Determine risk of acquiring HIV CDC s MSM risk index Depending on setting you may be able to do detailed sexual health history including: Partners, Protection, D&A Let s talk for a minute about your sexual health If you could sum up your HIV prevention plan in 3-4 bullet points, what would they be? Counseling Condoms- every time, with lube Have free samples in clinic, offer prescription Talk with partners about their status Understanding situations that increase chances of HIV Undetectable=untransmittable Transmission risk cut by 96% if VL <200 consistently Education 1 pill, once daily, with or without food Educate about expected side effects and how to mitigate Presence of other STIs make it easier to get HIV HIV-1 may become harder to treat over time if you only take emtricitabine/tenofovir and are HIV positive PrEP does not completely eliminate risk of HIV 7
Required Testing Prior to Initiation Confirmed negative HIV-1 within 1 week of start or restart STI screen at all sites + RPR Acceptable for patient to self swab Serum Cr HBsAg HCV Ab Pregnancy if applicable History of bone disease and non-trauma related fractures Opportunity to assess Hep A & B vaccination status CDC Recommendations for HIV testing Can do rapid test at start and send for lab-based antibody confirmation (Ag/Ab or RNA) Rapid, 4th generation HIV tests, CLIA waived: Ag/Ab: Determine (HIV 1/2) Ab: Insti HIV, Uni-Gold Recombigen, HIV 1/ 2 STAT-PAK, SURE CHECK, OrqQuick, DPP If positive antibody test send for laboratory confirmatory testing, CD4 and VL Approximate Sensitivity of HIV Tests To decrease risk of resistance it is important to detect any patient with HIV prior to starting PrEP If you suspect acute HIV, delay PrEP and order RNA test Consider HIV-1 p24 antigen testing at start RNA: ~11 days post infection Lab based p24 ag/ab combo (4th gen): ~16 days post infection Lab based ab (3rd gen)/rapid ag/ab (4th gen): ~22 days post infection Rapid Ab blood test: ~28-35 days post infection 8
PrEP Prescription Emtricitabine/Tenofovir disoproxil fumarate (Truvada) 200mg/300mg, Take 1 by mouth daily, dispense 30 tablets with 2 refills NOT emtricitabine/tenofovir alafenamid (Descovy) 30 day supply, consider auto-refills May require prior authorization Do not give refills longer than HIV testing interval Financial Cost Advise patient of any office visit co-pays, lab and pharmacy costs Consider FQHC and Health Department referrals and STI testing grants All services covered under Medicaid, pharmacy costs can vary widely under private insurers Resubmit prior authorization if not approved (See p. 29 of CDC s PrEP Provider Supplement of 2014 Gilead Advancing Access co-pay coupons cover up to $3600/year in pharmacy copays Medication Assistance Program if uninsured and <400% FPL Patient Advocate Foundation for insured individuals, <400% FPL Patient Access Network Foundation for insured individuals, <500% FPL, up to $7500/year, covers co-pays, deductibles and co-insurance costs Coding ICD-10 Z20.2 Contact with and (suspected exposure) to infection with a predominantly sexual mode of transmission Z20.6 Contact with and (suspected) exposure to HIV Z11.3 Encounter for screening for infections with a predominantly sexual mode of transmission Z70.1 Counseling related to patient's sexual behavior and orientation Z72.5 High risk sexual behavior CPT 4290F Patient screen for injection drug use (HIV) 4293F Patient screen for high-risk sexual behavior (HIV) 86701 HIV antibody test performed (HIV-1 only) 86703 HIV antibody test performed (HIV-1 and HIV-2) 87389 HIV-1 antibody test with HIV 1&2 antigens 9
Follow-up Schedule next appointment before patient leaves At every visit: HIV risk assessment and supportive counseling Assess adherence, how many missed doses in 30 days Assess side effects Screen for symptoms of acute HIV infection HIV Testing STI screening and Creatinine monitoring recommendations vary from 3-12 months Consider d/c if unable to take daily medication Immediately d/c for positive HIV test and refer to HIV provider You can prescribe! Where to get it Consider policy and procedure at your practice site Public health and STD clinics Planned Parenthood Local health departments Provider search on accesstoprep.org or glma.org Referrals for uninsured, loss of insurance related to increased risk of HIV during PrEP studies What s on the horizon Vacation PrEP studies Injectable formulation Single agent medications More research in more diverse population 10
Questions? Resourcess HIV training https://effectiveinterventions.cdc.gov/en Patient education materials www.projectinform.org Gilead patient assistance 1-855-330-5479 References Bacon, O. (2017). PrEP: You Can DO This! [powerpoint presentation] Center for Disease Control & Prevention. (2014). Laboratory Testing for the Diagnosis of HIV Infection: Update Recommendations. Retrieved from http://dx.doi.org/10.15620/cdc.23447 Center for Disease Control & Prevention. (2014). Preexposure prophylaxis for the prevention of HIV infection in the United States 2014 Clinical Providers Supplement. U.S. Public Health Dolling, D.I., Desai, M., McOwan, A., Gilson, R., Fisher, M., Schembri, G., Nardone, A. (2016). An anaylsis of baseline data from the PROUD study: an open label randomized trial of pre-exposure prophylaxis. Trials, 17(163). doe: 10.1186/s13063=016=1286-4 Gildden, D.V., Mulligran, K., McMahan, V., Anderson, P.L., Guanira, J., Chariyalertsak, S., Grant, R.M. (2017). Recovery of Bone Density Following Discontinuation of Tenofovirbased HIV pre-exposure. J Acquir Immune Defic Syndr. doi:10.1097.qai0000000000001475 11
References cont. Grant, R.M., Anderson, P.L., McMahan, V., Amico, K.R., Mehrotra, M., Hosek, S., iprex study team. Uptake of pre-exposure prophylaxis, sexual practices, and HIV incidence in men ad transgender women who have sex with men: a cohort study. Lacnet Infect Dis, 14(9). doe:10.1016/s1473-3099(14)70847-3 Liegler, T., Abdel-Mohsen, M., Bentley, L.G., Atchinson, R., Schmidt, T., Javier, J., Grant, R.M. (2014). HIV-1 Drug Resistance in the iprex Preexposure Prophylaxis Trial. JIID, 2014:210, 1217-1227. Murnane, P.M., Brown, E.B., Donnell, D.R., Coley, Y., Mugo, N., Mujugira, A., Celcum, C., & Baeten, J.M. (2015). Estimating Efficacy in a Randomized Trial with Product Nonadherence: Application of multiple methods to a trial of preexposure prophylaxis for HIV Prevention. Am J Epidemiol, 10,848-856. Tetteh, R.A., Yankey, B.A., Nartey, E.T., Lartey, M, Leufkens, H.G.M. & Dodoo, A.N.O. (2017). Pre-exposure prophylaxis for HIV prevention: Safety Concerns. Drug Saf, 40(273-283). 12