NEW CANADIAN. GUIDELINES: Public health and community perspectives. Camille Arkell, Moderator Dr. Darrell Tan, Gilles Charette, Dr.

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NEW CANADIAN HIV PrEP/nPEP GUIDELINES: Public health and community perspectives PRESENTED BY Camille Arkell, Moderator Dr. Darrell Tan, Gilles Charette, Dr. Joss Reimer May 16, 2018

Webinar Agenda (1 hour) Review of PrEP/nPEP guideline and key messages Dr. Darrell Tan, 20 minutes A perspective on PrEP access efforts in SE Ontario Gilles Charette, 10 minutes A public health perspective on use of the guideline in MB Dr. Joss Reimer, 10 minutes Q & A 15 minutes

Dr. Darrell Tan MD, FRCPC, PhD Scientist, Li Ka Shing Knowledge Institute Darrell is an infectious diseases physician, clinician-scientist and CIHR/OHTN New Investigator whose research focuses on clinical trials in HIV prevention and HIV/STI co-infection. He is Director of the University of Toronto Clinical Research Unit on HIV Prevention, and is leading multiple projects to optimize the implementation of HIV PrEP and PEP in Canada.

Ongoing HIV Transmission in Canada HIV new diagnoses by risk category, Canada.

Why guidelines? Overview Improve quality of care, raise awareness Reduce inappropriate variation in practice Intended audience Primarily clinicians (ED, ID, FP, RN, NP, Pharm ) Also relevant for policy-makers & community Methods 25-member panel from a range of backgrounds Supported by CIHR, CTN; no industry funding Evidence-based, rigorous methodology: GRADE

Grading of recommendations Strength of recommendations Reflects the extent to which the panel is confident that the desirable effects of an intervention outweigh undesirable effects 1 = Recommend, 2 = Consider Quality of evidence: Quality of Evidence Symbol Letter Example study designs High A Starting point for RCTs Moderate B Low C Starting point for observational Very low D

Endorsements Association of Medical Microbiology & Infectious Diseases Canada (AMMI) Canadian Association of Emergency Physicians (CAEP) Canadian Association of Nurses in AIDS Care (CANAC) Canadian HIV/AIDS Pharmacists Network (CHAP) Canadian Public Health Association (CPHA) PENDING: College of Family Physicians of Canada (CFPC)

Key Topics for Today Eligibility for PrEP ( Indications ) Recommended Regimens for PrEP Practical advice for delivering PrEP Roles for CBOs and public health

Targeting PrEP in gbmsm, British Columbia CaHR 2016: Hull, M. EPH 1.2 Lachowsky, N. EPHP 5.04 Samji, H. EPHP 2.02 Slide courtesy of Dr. M. Hull

PrEP Regimens Daily TDF/FTC (Grade 1A) gbmsm only: On-demand TDF/FTC (Grade 2A) TDF alone not recommended TAF-based regimens not recommended

Lab tests Screening Baseline 30 days Q3 mo Q 12 mo HIV Serology X X X Hepatitis A & B screen a X Hepatitis C Screen X X Gonorrhea, chlamydia & syphilis screen X X Complete Blood Count X Creatinine X X X Urinalysis X X Pregnancy screening X X Counseling Medication adherence X X X X X Risk reduction strategies X X X X X a provide vaccination if non-immune) Practical advice Routine DXA is not recommended unless otherwise indicated according to Osteoporosis Canada guidelines If PrEP prescribed in HBV co-infection, monitor as per HBV Guidelines

Regular quarterly HIV testing prior to each prescription is ESSENTIAL Dr. M.D., CCFP Firstname Lastname DOB Date Practical advice Tenofovir disoproxil fumarate/emtricitabine. 300/200 mg (Truvada) T po daily x 3 months Do NOT refill Refill times at day intervals Signature Routine STI screening at all relevant anatomic sites is part of routine PrEP care

Roles for CBOs & public health attention to syndemic conditions that may predispose people to high-risk behaviour (eg. depression, substance use) ensure the availability of other harm reduction interventions for people who inject drugs Nonprescribing health care and service providers should be encouraged to play roles in PrEP/nPEP delivery should be counselled about and considered for PrEP

Email Alex at SchnubbA@smh.ca for a unique access code

The End

Gilles Charette M4M Sexual Health Coordinator at HARS Gilles does program coordination, education, and outreach to the M4M community in SE Ontario. He has developed an online outreach program, facilitates discussion groups for MSM, delivers a counselling program and leads a monthly support group for LGBTQ+ offenders. He also works closely with health units in the region to improve access to HIV testing and treatment for the MSM community.

PrEP access efforts in Southeastern Ontario G I L LES C H A R ET T E M 4 M S E X UAL H EALT H C O O R DINATO R H I V/AI DS R EGI O NAL S E RVICES ( H A RS )

Current state of PrEP locally 2 nd most common online outreach question Awareness of PrEP among health-care providers seems low Issues around coming out Full patient rosters Currently, access via referral to Infectious Disease Clinic

Strategies to address gap Local sexual health clinics (health units) Helping patients inform and advocate for themselves PrEP mailer to health care providers

PrEP info mailer to primary care Mailer to 300 primary care practitioners Package contents: Letter re: PrEP and local need with link to online module CTAC Providing HIV PrEP brochure CMAJ article: Canadian guideline on HIV pre-exposure prophylaxis and nonoccupational postexposure prophylaxis Business Card and The Sex You Want.ca postcard

Progress Inquiries from physicians Requests from MSM Meetings with Health Units/CHCs

Dr. Joss Reimer MD, MPH, FRCPC Medical Officer of Health, Winnipeg Regional Health Authority and MB Health Joss work as a Medical Officer of Health focuses on health sexuality and the prevention of drug related harms. She also maintains a clinical practice in the areas of sexual and reproductive health. Her research interests include assessing barriers to improving sexual health and reducing drug related harms for vulnerable populations both in Canada and in Colombia.

The Manitoba Experience Dr Joss Reimer MD MPH FRCPC

Key Topics for Today Epidemiology in Manitoba Situation before guidelines Provincial PEP guidelines Applying guidelines PrEP use in Manitoba

Ongoing HIV Transmission in Canada HIV new diagnoses by risk category, Canada.

Proportion of all new cases HIV Transmission in Manitoba

Current (old) Manitoba PEP Protocol

Current PEP in Manitoba

Current PEP in Manitoba

Draft New Manitoba PEP Protocol

New Risk Assessment Protocol Table 1 HIV risk assessment for PEP initiation Risk from the Likelihood that source person has transmissible HIV exposure type Substantial Low Negligible / None High / Moderate Initiate PEP Consider PEP Consider PEP / PEP not required 1 Low PEP not required PEP not required PEP not required 1 Consider PEP if occupational setting, unless source is confirmed HIV negative;(usphs) PEP not required if non-occupational setting

Exposure Risk Categories High Anal (receptive), needle sharing, percutaneous, mucous membrane, vertical Moderate Anal (insertive), vaginal (receptive, insertive), percutaneous, mucous membrane, vertical Low Oral sex (giving, receiving), oral-anal contact, sharing sex toys, blood on compromised or non-intact skin Likelihood Source has transmissible HIV Substantial HIV+ and viremic (VL >40 copies/ml) OR HIV status unknown but source from population with high HIV prevalence (e.g., MSM, PWID) Low HIV+ believed to be VL<40 with concomitant sexually transmitted infection (STI) present at the time of exposure None/Negligible Confirmed HIV negative OR HIV+ with confirmed VL<40 and no known STI present at time of exposure OR HIV status unknown, general population

New Drug Regimens Table 4 HIV PEP starter kit recommendations for adults and adolescents aged 13 years Age group Kit Drug content Dosage With normal renal function Adults and TDF/FTC 300/200 mg tablet One tablet once daily adolescents aged A RAL 400 mg tablet One tablet twice daily 13 yrs With renal dysfunction* Adults and ZDV/3TC 300/150 mg tablet One tablet twice daily adolescents aged 16 yrs B RAL 400 mg tablet One tablet twice daily *Renal dysfunction is creatinine clearance 59 ml/min. Abbreviations: 3TC = Lamivudine, FTC = Emtricitabine, RAL = Raltegravir, TDF = Tenofovir, ZDV = Zidovudine

Application

In progress npep prescribers should be readily accessible from multiple access points, including emergency rooms, HIV/STI counselling/testing centres, student health facilities, prenatal and family planning clinics and pharmacies. attention to syndemic conditions that may predispose people to high-risk behaviour (eg. depression, substance use) ensure the availability of other harm reduction interventions for people who inject drugs Nonprescribing health care and service providers should be encouraged to play roles in PrEP/nPEP delivery Screening for non-consensual sex is advised Specific interventions may include patient counselling, education, medication reminders, behavioural feedback and reinforcement, peer support, follow-up telephone calls or text messages and minimization of out-of-pocket expenses.

PrEP in Manitoba

Template in EMR PrEP in Manitoba Prompts to review eligibility & financial issues Intake, follow up, letters to primary care Requisitions Mail-out to primary care link to guidelines Referral form

FUNDING Competing priorities Treatment gaps Disadvantaged populations PrEP ongoing challenges

Questions? Please type your question or comment into the chat box.

Thank You PRESENTED BY Camille Arkell, Moderator Dr. Darrell Tan, Gilles Charette, Dr. Joss Reimer May 16, 2018