Ending HIV with PrEP: The Newest HIV Prevention Tool for Primary Care KIMBERLY BATES, GAIL BERKENBLIT, ONI BLACKSTOCK, ALIA CHISTY, E. JENNIFER EDELMAN, TIFFANY LU, RYAN NALL, VIRAJ PATEL, AND GINA SIMONCINI
Workshop Goals •To be familiar with PrEP, including safety and efficacy data •To feel comfortable applying CDC’s clinical guidelines for PrEP:
• Assessing eligibility, prescribing, and monitoring while on PrEP
•To improve general internists’ PrEP uptake
Workshop Agenda •HIV Epidemiology and Introduction to PrEP •Review of clinical evidence for PrEP •CDC PrEP clinical guidelines •Small group cases •Group discussion with panel of expert providers
HIV Epidemiology and Introduction to PrEP E. JENNIFER EDELMAN, MD, MHS
HIV Diagnoses • Overall decline by 19%: • 48,795 to 39,718 per year •
Decreasing rates among: • Heterosexuals 35% • People who inject drugs 63%
• Increasing rates among: • Men who have sex with men 6% http://www.cdc.gov/nchhstp/newsroom/2015/nhpc.html#Graphics
Lifetime Risk of HIV Diagnosis among MSM by Race/Ethnicity
**If nothing changes and current trends continue….. http://www.cdc.gov/nchhstp/newsroom/images/2016/croi_lifetime_risk_transmission_group.jpg
What is PrEP? Circumcision Antiviral Based Prevention
HIV and STI Testing HIV Prevention
Behavioral Risk Reduction
Partner Notification Addiction Treatment
What is PrEP? • Treatment as Prevention • Post-exposure prophylaxis • Pre-exposure prophylaxis
Circumcision Antiviral Based Prevention
HIV and STI Testing HIV Prevention
Behavioral Risk Reduction
Partner Notification Addiction Treatment
What is PrEP? • Treatment as Prevention • Post-exposure prophylaxis • Pre-exposure prophylaxis
Circumcision Antiviral Based Prevention
HIV and STI Testing HIV Prevention
Behavioral Risk Reduction
Partner Notification Addiction Treatment
Pre- vs Post-exposure Prophylaxis • After exposure to HIV, infection may become established • Postexposure prophylaxis (initiated soon after exposure) reduces the chance of infection
HIV infection
HIV exposure
• Pre-exposure prophylaxis begins treatment earlier (before exposure) Post-exposure prophylaxis Pre-exposure prophylaxis
0 hr
36 hrs
72 hrs
1 mos 3 mos 5 mos
Courtesy: Carlos Malvestutto, Nationwide Children’s Hospital, Ohio State University Medical Center
Estimated percentages and numbers of adults with indications for PrEP, by transmission risk group — United States, 2015 25% 20%
> 1.2 million people
15% 10% 5% 0% MSM, 18-59 y.o.
Adults who inject drugs
Heterosexually Men who have Women who active adults, sex with have sex with 18-59 yo women men
% with PrEP indications http://www.cdc.gov/mmwr/preview/mmwrhtml/mm6446a4.htm?s_cid=mm6446a4_w#Tab2
Primary Care Physician and PrEP •Primary care physicians potentially ideally suited to prescribe PrEP: • Health promotion and disease prevention • Access to individuals with substantial HIV risk • Necessary to increase healthcare capacity to deliver PrEP
Need to Improve PrEP Adoption among SGIM members • Based on a survey of 253 SGIM members conducted April & May 2015:
• 33% had previously initiated a conversation about PrEP with a patient • 35% of sample reported PrEP adoption: • 19% previously prescribed PrEP • 18% previously referred for PrEP • 5% previously prescribed and referred for PrEP
Review of Clinical Evidence for PrEP VIRAJ PATEL, MD
How does PrEP with Truvada work?
TenofovirEmtricitabine
A Novel HIV Prevention Tool: Pre-Exposure Prophylaxis for HIV (PrEP) Major Clinical Trials, published 2010-2013
2014 Full CDC Guidelines Released
iPrEX, TDF2, Partners PrEP, Bangkok Tenofovir Study
July 2012 FDA Approves Tenofovir 300mg/ Emtricitabine 200mg (Truvada®) for PrEP
2016 More effectiveness data, suboptimal implementation
How effective is PrEP?
Efficacy Results from Clinical Trials with once daily oral PrEP Clinical trial
Participants
Number
Efficacy: % Reduction in HIV infection*
Efficacy Based on Adherence (medication detected in blood)
%
(95% CI)
%
(95% CI)
2499
42
(18-60)
92
(40-99)
(44-81)
(67-94)
(55-87)
86 90
iPrEx
MSM
Partners PrEP
HIV discordant couples
4747
TDF 2
Heterosexually active men and women
67 75
1200
62
(22-83)
84
NS
IDU
2413
49
(10-72)
74
(2-91)
1951
6
(0.59-1.52)
< 40%
-----
5029
-4
(0.97-2.3)
90%, Spec 99% • Much better than culture
FDA approved only for urogenital screening
• Some commercial labs approve processing for rectal and pharynx screening (Quest, Labcorps)
Urethral site screening
◦ Urine > urethral (better patient tolerability & test sensitivity)
Anorectal site screening
◦ Rectal swab (patient or provider collect)
Pharynx site screening
◦ Pharyngeal swab (provider collect)
Case 1 – Counseling before PrEP PrEP • Adherence is key • Not 100% • No protection against other STIs – use barriers
Circumcision Antiviral Based Prevention
HIV and STI Testing HIV Prevention
Behavioral Risk Reduction
Partner Notification
Addiction Treatment
Large Group Discussion: Questions??
What is the model for PrEP implementation in your clinic?
How did you get stakeholder buy-in? Who did you involve?
What kinds of training do residents (or PCPs) need? Trainee Education – mainly need to anticipate attitudes Teaching medical students and residents Med students hesitant to prescribe a medications for a “behavior” Residents have greater acceptance and interested in serving LGBTQ community Have to teach this is not a knowledge- based issue that pure patient education will overcome Compare to something they are familiar with like cardiovascular risk and would you start an aspirin
What kinds of tools are available for clinics? •Risk assessment- calculator that can provide patient comparisons •Protocols •Patient Info: http://www.cdc.gov/hiv/risk/prep/index.html •Patient-Provider contract
How do you do this in resident clinic when they are changing schedules all the time? •Preparing the clinic staff and environment- it takes a team •Residents- assess for risk, initiate PrEP and provide the medical care •PharmD’s- for maintenance visits( very regular appointment dates, protocol driven, can interpret labs) •Nursing, CMA, case managers and check in staff- adherence to visits, provide supportive environment
Does insurance cover PrEP? How is PrEP paid for? https://start.truvada.com/paying-for-truvada
How do you bill for PrEP?
What services do you offer in addition to PrEP? •Vaccinations? •Pap smears?
•Other?
Do you recommend alternative dosing strategies?
Ipergay – On Demand PrEP
Key Resources •Centers for Disease Control and Prevention • http://www.cdc.gov/hiv/risk/prep/ ◦ http://www.cdc.gov/hiv/pdf/prepprovidersupplement2014.pdf
•UCSF Consultation Line: • http://nccc.ucsf.edu/clinician-consultation/prep-pre-exposure-prophylaxis/
•Getting PrEP paid for: • http://fairpricingcoalition.org/medication-assistance-program-and-co-pay-programs-for-prep/
ICD-9 codes V01
Billing Codes
Description Contact with or exposure to communicable diseases
ICD-10 codes Z20 Z20.2
Contact with and (suspected) exposure to communicable diseases Contact with and (suspected) exposure to infections with a predominantly sexual mode of transmission
Z20.5
Contact with and (suspected) exposure to viral hepatitis
Z20.6
Contact with and (suspected) exposure to human immunodeficiency virus (HIV) Contact with and (suspected) exposure to other viral communicable diseases Contact with and (suspected) exposure to potentially hazardous body fluids Contact with hypodermic needle: “the appropriate 7th character is to be added to each code from category W46” A- initial encounter, D- subsequent encounter, Ssequela Contact with hypodermic needle (hypodermic needle stick NOS) Contact with contaminated hypodermic needle
V01.7
Exposure to other viral diseases
Z20.82
V15.85
Exposure to potentially hazardous body fluid Needlestick
Z77.21
E920.5
W46
W46.0 W46.1 V01.8
V07.8
Exposure to other communicable diseases
Z20.8
Other specified prophylactic measure
Z79
V07.9 042
Unspecified prophylactic measure Human immunodeficiency virus illness or disease with symptoms
V08
Human immunodeficiency virus infection , asymptomatic
Description
Z20.81
Z51.81 Z51.89 Z79.899 B20 Z21
Contact with and (suspected) exposure to other communicable diseases Contact with and (suspected) exposure to other bacterial communicable diseases Long term (current) drug therapy. Includes long term (current) drug use for prophylactic purposes Therapeutic drug level monitoring Encounter for other specified aftercare Other long term (current) drug therapy Human immunodeficiency virus (HIV) disease. Includes: AIDS; AIDS-related complex (ARC); HIV infection, symptomatic Asymptomatic human immunodeficiency virus (HIV) infection status
Extra Slides
Geographic Variation
http://mediad.publicbroadcasting.net/p/wabe/files/201405/Mera_Char_of_TVD_PrEP_HIV_in_the_Americas_2014_P28.pdf
Lifetime Risk of HIV by State
How to assess risk? •Probe history for plans on current and future: • Partner preference • Number of partners • Condomless sex • Sex partners living with HIV • Use of crystal meth/speed
Counseling •Both a biomedical and behavioral intervention • Adherence is key •No protection against other STIs • Barrier protection •Does not prevent pregnancy • Family planning
