PrEP Care via Telemedicine

HIV in the Era of Covid-19: PrEP(Pre-exposure Prophylaxis)The Theory, Practice and ResultsLarry York, PharmDHIV PharmacistCesar Egurrola, BSClinical Operations/QI ManagerStephen Klotz, MDHIV Physician, ModeratorUniversity of Arizona Petersen Clinics Supported in part by the Arizona AIDS Education Training Center and UA Telemedicine 1 Disclaimer "This presentation is supported by the Health Resources and Services Administration (HRSA) of the U.S. Department of Health and Human Services (HHS) as part of an award totaling $3,278,366. The contents are those of the author(s) and do not necessarily represent the official views of, nor an endorsement, by HRSA, HHS or the U.S. Government." The views and opinions expressed in this presentation are not necessarily those of the Pacific AIDS Education and Training Centers (PAETC), the Regents of the University of California or its San Francisco campus (UCSF or collectively, University) nor of our funder the Health Resources and Services Administration (HRSA). Neither PAETC, University, HRSA nor any of their officers, board members, agents, employees, students or volunteers make any warranty, express or implied, including the warranties of merchantability and fitness for a particular purpose; nor assume any legal liability or responsibility for the accuracy, completeness or usefulness of information [,apparatus, product] or process assessed or described; nor represent that its use would not infringe privately owned rights. 2 What is PrEP? One pill once a day to reduce risk of contracting HIV > 90% protective against sexually acquiring HIV Reduces HIV acquisition risk in intravenous drug users (IVDU) Currently only two agents approved for PrEP 3 What are we trying to accomplish? A Case Study 4 Herman, a 54-year-old man (HIV-negative) comes into the hospital unable to talk normally. He is the longtime partner of Bill, a 35-year-old man who is HIV-positive, compliant with anti-retroviral therapy and whose HIV-1 RNA (viral loads) are nearly always non-detectable. Bill was hospitalized for 10 for diabetes mellitus, neuropathy and renal failure. He came to clinic weeks later; his HIV-1 viral load was >3,000 copies of RNA. Herman was hospitalized 1 month later slurring his speech and could move his tongue only to the right. The HIV-1 RNA was >1,000,000 copies and the platelets <30,000/dL. Herman was treated with plasmapheresis and ART. He is doing well and compliant with ART. 4 Another Case Study Roger is a 56-year-old man (MSM) who has "come out" two months ago. He was an insurance executive with a good income and no sexual activity with women or men for years. In the past he occasionally had HIV tests and they were all negative. (The testing was done at his place of work.) He had one male partner 3 weeks ago and was primarily the partner on the bottom. He now complains of fever, skin rash and a sore throat. On physical examination he has oral-pharyngeal thrush, tender lymphadenopathy and a macular rash on the extremities and abdomen. The HIV-1 RNA was >2,000,000 copies and the RPR was negative. He was started on ART and has done well. 5 Truvada (FTC/TDF) Single pill containing two medications Emtricitabine (FTC) 200 mg Tenofovir disoproxil (TDF) 300 mg One tablet once a day No more than 90-day prescription provided Can be taken with or without food Take missed doses as soon as remembered If close to next dose, wait until then and take 1 tablet 6 Descovy (FTC/TAF) Single pill containing two medications Emtricitabine (FTC) 200 mg Tenofovir alafenamide (TAF) 25 mg Same instructions for use as Truvada ONLY studied in MSM and transgender women Not recommended for use in cisgender women or for IVDU 7 NRTIsNucleoside/Nucleotide Reverse Transcriptase Inhibitors Indirectly inhibits enzyme required to copy viral RNA to DNA. 8 Side Effects of PrEP May experience nausea, bloating upon initiation Usually resolves within 2-3 weeks Headache Increased risk of decreased renal function Uncommon but known adverse effect from TDF Renal function usually returns to normal if PrEP stopped Increased risk of decreased bone mineral density 9 Tenofovir Disoproxil Drug Issues Primarily known for its potential renal issues Age Addition of other nephrotoxic agents Risk of renal dysfunction may be multifactorial Possibly 1-3% greater loss with TDF Calcium/vitamin D supplementation may help May also lead to decreased bone mineral density 10 Tenofovir Alafenamide Drug Issues Same concerns as TDF but appears to be lower risk Improved renal/bone adverse effect profile Not as well studied for PrEP Only recently approved Effects of missing doses less clear than with TDF regimen 11 Descovy for PrEP DISCOVER study looked at MSM and transgender women Found to be equivalent to Truvada Major concerns again relate to female use A previous PK study with TAF found poor tissue levels 11-fold lower in cervicovaginal fluid Uncertain how important adherence is for use 12 When PrEP is NOT Recommended Do not begin Truvada if CrCl < 60 mL/min If CrCl declines to < 50 mL/min, stop Truvada FTC and TDF have recommended dose adjustments Renally-adjusted doses were not studied for PrEP Descovy should be stopped if CrCl < 30 mL/min An option for PrEP in patients with mild-moderate CKD 13 PrEP (Truvada) Drug Interactions 14 PrEP (Descovy) Drug Interactions Descovy more likely to have interactions than Truvada TAF more susceptible to p-glycoprotein effects Efficacy may be compromised with select agents Avoid use with: Barbiturates Carbamazepine/oxcarbazepine Phenytoin Rifamycins St John's Wort 15 PrEP Activity Truvada deposits at varying rates into different tissues Estimate ~7 days for maximal rectal tissue levels Estimate ~20 days for maximal vaginal tissue/blood levels This data is not yet known for Descovy 16 On-Demand PrEP (Truvada) Recent evidence supports this potential approach 2 tablets 2-24 hours before sexual encounter 1 tablet 24 hours after sexual encounter 1 tablet 48 hours after sexual encounter Missing doses here may not be as forgiving Reliant on anticipation of a sexual encounter Not officially recommended as of yet 17 Vaginal Exposures and Adherence Far less clear how levels are affected in this tissue DOES appear to be much more susceptible to missed doses Would avoid on-demand PrEP in this group 18 Indications - MSM 19 19 Indications - Heterosexuals 20 Indications - IVDU 21 Patient Visits Typically PrEP patients are seen every 3 months Visits should be focused around: Risk reduction counseling Assessment of HIV status/signs and symptoms of acute infection STI screening as recommended or needed Medication adherence counseling 22 Virtual Visits Patients Access: Telephone needed for phone consults Smartphone or Computer with working camera needed for video consults Telemedicine Coordination: - Confirm patient's appointment type -Coordinate necessary lab work and access to virtual consults -Make sure patient has a clear understanding of follow up plan, provide in writing if possible -Make sure patient has access to all necessary testing, including STI swabs 23 Baseline Testing HIV screening test Estimated creatinine clearance Hepatitis B serologies (HBsAb, HBcAb, HBsAg) Follow up with HBV DNA if HBsAg is positive Hepatitis C screening Bacterial STI testing 24 Every 3 Month Monitoring HIV testing (preferably 4th generation) Pregnancy testing for women who may become pregnant Bacterial STI testing if signs/symptoms present Bacterial STI testing for asymptomatic MSM patients If history of STI or multiple partners 25 Every 6 Month Monitoring Monitor estimated creatinine clearance Bacterial STI testing for all sexually active patients 26 HIV 4th Generation Screening Test Preferred test, quickest identification on HIV Can detect a new infection 10-14 days after exposure May affect decision to initiate PrEP If unprotected encounter within 2-week period, may repeat test 27 Patient Snapshot by Race/Ethnicity Phase 1 01/01/2014-09/30/2016 Phase 2 10/01/2016-12/31/2018 Jai Include current data and trends from 2013-2018. Include information on reactivity rate and PrEP cascade for attrition. Demographics of PrEP patients Seroconversion prior to starting PrEP PrEP care cascade STI positivity rate (once and multiple) Extra-genital testing Rates for folks who are still engaged in care Phase 1 January 1, 2014-September 30, 2016 Phase 2 October 1, 2016-December 2018. 28 Patient Snapshot by Age Category Phase 1 01/01/2014-09/30/2016 Phase 2 10/01/2016-12/31/2018 Jai Include current data and trends from 2013-2018. Include information on reactivity rate and PrEP cascade for attrition. Demographics of PrEP patients Seroconversion prior to starting PrEP PrEP care cascade STI positivity rate (once and multiple) Extra-genital testing Rates for folks who are still engaged in care 29 Patient Snapshot by Gender Phase 1 01/01/2014-09/30/2016 Phase 2 10/01/2016-12/31/2018 Jai 30 Patient Snapshot by Sexual Orientation Phase 1 01/01/2014-09/30/2016 Phase 2 10/01/2016-12/31/2018 Jai 31 Patient Snapshot by Risk Group Phase 1 01/01/2014-09/30/2016 Phase 2 10/01/2016-12/31/2018 Jai 32 Clinical PrEP Cascade Retention Baseline 2014-2018 seroconversion prior to initiation: 5 Jai Interested Number of patients in the Database (Intakes completed) Linked Number of patients with an initial appointment Initiated Number of patients started with PrEP Retained Number of patients attending Q1 visit (of those who initiated) Adherence Number of patients attending Q4 visit (of those who initiated) Does not include all patients who have been referred for PrEP, if included we would see a greater attrition rate. 33 STI Positivity Rate HIV Positivity Rate for those maintained in care: 0% Jai Rates of testing remained the same over time for STI (urine) and RPR testing. Rates of swab testing remained the same over time ~22% of those engaged in care. 34 Increased Risk of STI Acquisition? A recent meta-analysis suggests increased STIs with PrEP Unclear association as even newer data refutes this Arguably, STI rates have increased for all MSM despite PrEP However, PrEP clearly has reduced the rate of HIV acquisition 35 U=U: Need for PrEP? Undetectable = Untransmittable Recent CDC initiative to raise awareness If HIV RNA < 200 copies/mL, do not sexually transmit HIV If patient in a monogamous, sero-discordant relationship: PrEP may not be warranted Discussion with patient regarding desire for use 36 Paying for PrEP AWP per tablet = $70.32 If high copays: Gilead offers a copay card good for several thousand dollars/year If insurance will not cover or a PA appeal is denied: Gilead may pay for medication 37 THANK YOU! 38