sc_10_15_20_1st_presenter_jodlowski_prescribing_prep_with_your_org_guide_to_starting_prep.pptx

File 1 of 2 from Prescribing PrEP With Your Organization: A Guide to Starting PrEP in a Clinical Setting- Parts I & II (webinar slides)

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

Details

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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]
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Conflict of Interest Disclosure Statement

Speaker has no financial conflicts of interest to disclose.
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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.
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https://www.cdc.gov/hiv/statistics/overview/geographicdistribution.html

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https://www.cdc.gov/hiv/statistics/overview/geographicdistribution.html

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: https://hivrisk.cdc.gov/#-sb
PWH= People With HIV
https://stacks.cdc.gov/view/cdc/38856.
nPEP guidelines Table 1.
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Risk Factors for HIV Transmission
Online HIV Risk Calculator: https://hivrisk.cdc.gov/#-sb
https://stacks.cdc.gov/view/cdc/38856.
nPEP guidelines Table 1.
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https://www.cdc.gov/endhiv/index.html
Ending the HIV Epidemic: A Plan for America
Ending HIV as an Epidemic: A Plan for America
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Ending HIV as an Epidemic: A Plan for America
https://www.cdc.gov/endhiv/index.html

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
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CDC guidance: PrEP 101
https://www.cdc.gov/hiv/clinicians/prevention/prep.html

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Does PrEP work?
https://www.cdc.gov/hiv/clinicians/prevention/prep.html
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

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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
https://www.cdc.gov/hiv/pdf/clinicians/screening/cdc-hiv-php-discussing-...
IDU=injection drug use
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STEP 2. Who should be offered PrEP?
https://www.cdc.gov/hiv/clinicians/prevention/prep.html
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STEP 3. Assessment of Acute HIV
https://stacks.cdc.gov/view/cdc/23447
https://www.cdc.gov/hiv/pdf/risk/prep/cdc-hiv-prep-guidelines-2017.pdf
https://www.cdc.gov/hiv/clinicians/prevention/prep.html

Acute HIV/acute retroviral syndrome
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STEP 3. Assessment of Acute HIV
https://stacks.cdc.gov/view/cdc/23447
https://www.cdc.gov/hiv/pdf/risk/prep/cdc-hiv-prep-guidelines-2017.pdf
https://www.cdc.gov/hiv/clinicians/prevention/prep.html

Acute HIV/acute retroviral syndrome
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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
https://www.cdc.gov/hiv/pdf/risk/prep/cdc-hiv-prep-guidelines-2017.pdf
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Clinic Tools Used at VA North Texas HCS

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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

https://aidsinfo.nih.gov/drugs/406/truvada/0/patient
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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

https://aidsinfo.nih.gov/drugs/560/descovy/0/patient

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)

https://www.cdc.gov/hiv/pdf/risk/prep/cdc-hiv-prep-guidelines-2017.pdf
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Future Directions: Epi-PrEP i.e. "Vacation PrEP"
Not FDA approved at this time

Egan, JE et al. JAIDS 2020;84:508-513.
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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.
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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)
https://www.hiv.gov/federal-response/ending-the-hiv-epidemic/prep-program

State PrEP program information
https://www.nastad.org/prepcost-resources/prep-assistance-programs

Uninsured: Gilead Medication Assistance Program (MAP)
https://www.gileadadvancingaccess.com/

Commercial insurance: Copay cards available if patient has commercial insurance and has a copay. (covers up to $7,200 in co-pays per year)
https://www.gileadadvancingaccess.com/copay-coupon-card

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:https://www.gileadadvancingaccess.com/copay-coupon-card
I have also attached a slide (it mentions Descovy specifically, but true for Truvada as well).
For uninsured patients:
Website:https://www.gileadadvancingaccess.com/is 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:https://www.hiv.gov/federal-response/ending-the-hiv-epidemic/prep-program

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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.)
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https://www.cdc.gov/nchhstp/dear_colleague/2020/dcl-051520-PrEP-during-C...
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
https://aidsetc.org/resource/non-occupational-post-exposure-prophylaxis-...
https://www.cdc.gov/hiv/risk/pep/index.html https://stacks.cdc.gov/view/cdc/38856
https://www.cdc.gov/stophivtogether/library/prescribe-hiv-prevention/bro...

https://stacks.cdc.gov/view/cdc/38856

Payment assistance with nPEP
Common patient assistance programs form
https://www.nastad.org/sites/default/files/resources/docs/cpapa_form_fil...
https://www.nastad.org/sites/default/files/PAP_form_interactive.pdf

If victim of sexual assault
https://ovc.ojp.gov/states

AETC handout: Medication assistance/copays
https://aidsetc.org/sites/default/files/CCC_PEP_patient_assist_postcard_...

Thank you!
https://www.cdc.gov/hiv/pdf/basics/prep/cdc-hiv-stsh-prep-brochure-engli...

References
https://www.cdc.gov/hiv/basics/prep.html
https://aidsvu.org/preptoolkit2018/ https://primeinc.org/hiv?s=aetc
US Public Health Service. PreExposure Prophylaxis for the Prevention of HIV Infection in the United States-2017 Update: A Clinical Practice Guideline. https://www.cdc.gov/hiv/pdf/guidelines/cdc-hiv-prep-guidelines-2017.pdf
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. https://stacks.cdc.gov/view/cdc/38856
AETC NCRC nPEP Toolkit. https://aidsetc.org/resource/non-occupational-post-exposure-prophylaxis-...

Resources
Clinical Consultation Center http://nccc.ucsf.edu/
HIV Management
Perinatal HIV
HIV PrEP
HIV PEP line
HCV Management
Substance Use Management

Present case on ECHO https://echo.unm.edu/locations-2/echo-hubs-superhubs-united-states/

AETC National HIV Curriculum https://aidsetc.org/nhc

AETC National HIV-HCV Curriculum https://aidsetc.org/hivhcv

AETC National Coordinating Resource Center https://targethiv.org/library/aetc-national-coordinating-resource-center-0

Additional trainings [email protected]

Additional Reference Slide
https://www.cdc.gov/hiv/pdf/risk/prep/cdc-hiv-prep-guidelines-2017.pdf

Additional Reference Slide
https://www.cdc.gov/hiv/pdf/risk/prep/cdc-hiv-prep-guidelines-2017.pdf

Additional Reference Slide
https://www.cdc.gov/hiv/pdf/risk/prep/cdc-hiv-prep-guidelines-2017.pdf

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
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